Device for automatic inflation of vascular balloon catheter and system for performing angioplasty

Abstract

The invention relates to a device (4) for the automatic inflation of a vascular balloon catheter (6) by means of a fluid, comprising a fluid delivery device (12), a pressure sensor device (16) and a control device (18), a catheter interface (8) being designed to be detachably connected to the balloon catheter (6), in particular without tools, the invention relates to a balloon catheter (6) comprising a device (4) having a catheter interface (8), a fluid delivery means (12) configured to be able to discharge fluid from the device (4) at the catheter interface (8) by means of a motor (32), and a pressure sensor means (16) configured to be able to measure the pressure of the fluid discharged by the device (4), such that the fluid can flow from the device (4) into the balloon catheter (6) via the catheter interface (8), the fluid delivery means (12) being configured to discharge the fluid from the device (4) at the catheter interface (8), and the pressure sensor means (16) being configured to measure the pressure of the fluid discharged by the device (4). The control means (18) are designed to control the amount of fluid discharged from the device (4) by means of the fluid conveying means (12), depending on the pressure measured by the pressure sensor means (16), by actuating a motor (32) of the fluid conveying means (12).

Description

Technical Field

[0001] The present disclosure relates to a device for automatically expanding a vascular balloon catheter, in particular angioplasty catheter or percutaneous transluminal angioplasty catheter (for PTA: percutaneous transluminal angioplasty or PTCA: percutaneous transluminal coronary angioplasty) by means of a fluid. The device comprises a catheter interface, a fluid delivery device, a pressure sensor device and a control device. The catheter interface is configured to be detachably connected to the balloon catheter, in particular without tools, so that fluid can flow from the device into the balloon catheter via the catheter interface. The fluid delivery device is configured to be able to discharge the fluid from the device at the catheter interface by means of a motor. The pressure sensor device is configured to be able to measure the pressure of the fluid discharged by the device. The control device is configured to be able to control the amount of fluid discharged from the device by means of the fluid delivery device by manipulating the motor of the fluid delivery device according to the pressure measured by the pressure sensor device. The present disclosure also relates to a system for perforation angioplasty, comprising a device according to the present disclosure and a balloon catheter. Background Art

[0002] For example, a device of this type is disclosed in EP 0 490 979 B1. Conventional devices have a catheter interface, a fluid delivery device, a pressure sensor device, and a control device. The fluid delivery device is configured to deliver fluid to the balloon catheter via the catheter interface. In order to control the expansion of the balloon catheter or the balloon of the balloon catheter, the pressure in the balloon catheter or the balloon can be measured by means of the pressure sensor device. The control device is configured to control the fluid delivery device based on the pressure measured by the pressure sensor device. In order to deliver the fluid from the balloon catheter, conventional devices have a piston syringe that can only be manually operated.

[0003] During angioplasty, the inflation of the balloon of a balloon catheter causes an interruption of the blood supply. A problem with conventional devices is that the interruption of the blood supply can be excessively long, and if overpressure occurs in the balloon catheter, the excess fluid causing the overpressure can only be removed from the balloon catheter with a certain delay.

[0004] CN 108096676 A discloses a tracheal tube, ie a tube for the trachea. The balloon operates at an overpressure of approximately 25 to 30 mbar.

[0005] DE 10 2005 060 197 A1 discloses a completely implantable device. This device therefore does not allow for the emptying of a balloon catheter, as the evacuated gas would be pumped back into the balloon during inflation. Furthermore, it is a floating catheter with a latex balloon that operates only at a minimal overpressure of a few millibars.

[0006] DE 10 2014 003 306 A1 discloses a balloon catheter for anal irrigation. Even such a balloon catheter is not emptied.

[0007] US2007 0 197 963A1 discloses a device for applying an already emptied balloon catheter. This device is not intended for or capable of emptying a balloon catheter, as it primarily uses a peristaltic pump. However, such a pump cannot generate a vacuum, as the peristaltic hose does not "regenerate itself" when a negative pressure is generated in it. However, if the hose were locked to achieve this characteristic, the hose would no longer be compressed and, therefore, no longer be pumpable. A peristaltic pump can only generate minimal negative pressure. According to US2007 0 197 963A1, only the balloon of the balloon catheter is emptied, not the catheter of the balloon catheter. Summary of the Invention

[0008] It is therefore an object of the present invention to provide a device for automatic inflation of a balloon catheter which is capable of minimizing the duration of interruption of the blood supply and / or reducing the amount of fluid in the balloon catheter in a timely manner.

[0009] This object is achieved by a device having the features of claim 1 and by a system having the features of claim 14. Advantageous developments are the subject matter of the dependent claims.

[0010] The device disclosed herein is suitable for automatically inflating a balloon catheter using a fluid. The fluid can be a liquid, in particular a saline solution and / or a contrast agent. For example, iopromide, iodixanol, ioxanol, iohexol, iopamidol, iomeprol, diamylen, gadodiamide, or gadolinium can be used as a contrast agent. For dilution, the contrast agent is preferably diluted with a saline solution, such as 0.9% NaCl. Gadodiamide or gadolinium can also be used undiluted. A suitable mixing ratio of contrast agent to diluent is a ratio of 1:1 to 1:3, preferably approximately 1:2.

[0011] The device has a catheter interface, a fluid delivery device, a pressure sensor device and a control device.

[0012] The catheter hub is designed to be detachably connectable to the balloon catheter, in particular without tools, so that fluid can flow from the device via the catheter hub into the balloon catheter. The catheter hub can be designed in particular as a Luer connection.

[0013] The fluid delivery device is configured to expel the fluid from the apparatus at the catheter interface by means of a motor.

[0014] The fluid delivery device can be configured in particular as a piston syringe, and the piston of the piston syringe can be connected to a motor in such a way that the piston can be moved by means of the motor. The motor can be configured as a linear motor that directly transmits linear motion to the piston. Alternatively, the motor can also be configured as a rotary motor. In this case, a transmission mechanism can be provided by means of which the rotary motion of the motor can be converted into a linear motion, which causes the piston to move.

[0015] Alternatively, other forms of transmission for the linear motion of the piston may be used, such as a toggle lever, a scissor joint or a rod structure for converting the rotary motion of the motor into the linear motion of the piston.

[0016] The motor can in particular be an electric, electromechanical, pneumatic or hydraulic motor.

[0017] The pressure sensor device is configured to measure the pressure of the fluid discharged by the device. In particular, the pressure sensor device can be configured to measure the pressure of the fluid discharged by the device at the catheter interface and / or the piston of a piston-type syringe and / or other suitable positions. Preferably, a pressure sensor (as a part of a pressure sensor device) can be arranged at the catheter interface, especially at the outside of the device, and in the state in which the catheter interface of a balloon catheter is connected to the device or the device, the pressure sensor and the balloon of the balloon catheter or the balloon catheter are in fluid communication. The pressure sensor device or pressure sensor can be connected to the control device wired or wirelessly.

[0018] The control device is configured to control the amount of fluid discharged from the device via the fluid transport device by actuating a motor of the fluid transport device based on the pressure measured by the pressure sensor device, either directly (by monitoring the amount of fluid transported by the fluid transport device) or indirectly (by monitoring the delivery rate of the fluid transported by the fluid transport device). In particular, the control device can be configured to achieve a predetermined setpoint pressure in the balloon catheter or a balloon of the balloon catheter by delivering a corresponding amount of fluid from the device into the balloon catheter.

[0019] According to the present disclosure, the fluid delivery device is configured to be able to draw the fluid into the apparatus at the catheter interface by means of the motor.

[0020] In other words, the fluid delivery device is configured to selectively deliver fluid from the device to 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 to the device when the balloon catheter is connected to the device or the catheter interface of the device.

[0021] The device can be configured to form a closed system with the balloon catheter when connected to the balloon catheter, i.e., fluid only moves 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.

[0022] Because the device according to the present disclosure is configured to selectively expel or aspirate fluid via a delivery device, it is advantageous to rapidly change the volume of a balloon of a balloon catheter during angioplasty.

[0023] The device disclosed herein enables initial evacuation of a balloon catheter, that is, applying a strong, low pressure to the balloon catheter to remove any remaining air remaining after flushing the balloon catheter and, in particular, to prevent it from being reintroduced into the catheter. Air interferes with inflation and is particularly dangerous if the balloon catheter ruptures. This is because, unlike inflation fluid, residual air in a balloon catheter will expand explosively at pressures of 10 bar or more and, in the worst case, damage the vessel or even cause it to explode. Furthermore, air trapped in the vessel can lead to thrombosis.

[0024] The delivery device may be configured to expel fluid at a rate of 0.33 ml / s or greater (1 ml / s) and to aspirate fluid at a rate of 10 to 15 ml / s.

[0025] According to one aspect of the present disclosure, the control device can be configured to cause fluid to be drawn in via the fluid delivery device when the pressure measured by the pressure sensor device exceeds a predetermined threshold. The predetermined threshold can correspond to a nominal pressure that would normally be present during angioplasty. Alternatively, the predetermined threshold can be greater than the nominal pressure, thereby defining an allowable pressure range or nominal pressure range for performing angioplasty at the nominal pressure and the predetermined threshold.

[0026] Safety during the angioplasty procedure can be increased if a predetermined threshold value is provided, above which aspiration of fluid is automatically initiated.

[0027] According to one aspect of the disclosure, the control device can be configured to inhibit the intake of fluid by means of the fluid conveying device after exceeding the predetermined threshold value and after a subsequent pressure drop of the pressure measured by the pressure sensor device when the predetermined threshold value is reached again.

[0028] If the device is configured to cause aspiration of fluid only when a predetermined threshold is exceeded, excessive loading of the body tissue of the body cavity during movement of a balloon catheter connected to the device can be advantageously reduced or completely eliminated without excessively reducing the force required to expand the body cavity.

[0029] According to one aspect of the present disclosure, the fluid can be a liquid and the device can have a venting device, by which the gas mixed with the liquid can be discharged from the device. The venting device can especially be arranged at the catheter interface. Alternatively, the venting device can also be constructed on the fluid transport device.

[0030] If a fluid is used to inflate the balloon catheter, the force transmission from the motor to the tissue to be expanded can be improved by the fluid. If a ventilator is provided, this improved force transmission can be ensured in an advantageous manner.

[0031] According to one aspect of the present disclosure, the control unit can be configured to control or otherwise control the fluid delivery device so that the fluid is delivered at different predetermined delivery rates. In particular, different setpoint curves for the delivery rate can be stored in the control device. Preferably, the delivery rate during fluid aspiration is greater than the delivery rate during fluid discharge.

[0032] If different predetermined delivery rates are set, the reaction time of the device can be adapted to different requirements during angioplasty.

[0033] According to one aspect of the present disclosure, a control unit can be configured to adjust the fluid delivery device based 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. Preferably, the different pressure levels and / or a sequence of predetermined pressure levels can be stored in the control device.

[0034] 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 the overpressure can be reduced but also the vacuum can be re-applied so that in this case the balloon catheter can also be expanded and / or removed.

[0035] According to one aspect of the present disclosure, the motor of the fluid delivery device can have a tensioning mechanism that is configured to tension when discharging fluid and to relax when drawing fluid in. The tensioning mechanism can in particular be a spring, preferably a pressure spring. In particular, the fluid delivery device can be configured as a piston syringe and the pressure spring can be arranged or mounted on the piston of the piston syringe, so that the pressure spring is tensioned (by the motor) when the piston moves to discharge fluid from the piston syringe and is relaxed when the piston moves to draw fluid into the piston syringe.

[0036] The operational safety of the device can be improved if a tensioning mechanism is provided in the motor. The tensioning mechanism is capable of causing fluid to be sucked into the device when the energy supply to the motor is interrupted.

[0037] According to one aspect of the present disclosure, the control device may include a data interface configured to transmit data to and / or from a smartphone, tablet computer, or another device, in particular a medical device. In particular, the data interface may be configured to enable a wired or wireless connection to the smartphone, tablet computer, or another medical device. Preferably, the data interface may be configured to enable connection via a transmission standard such as USB, Wi-Fi, NFC, Bluetooth (BT), or Bluetooth Low Energy (BLE).

[0038] Alternatively, the data interface can be designed as a pressure interface and the control device can be designed to control the fluid conveying device as a function of the pressure measured at the pressure interface.

[0039] If a data interface is provided, the device according to the present disclosure can be operated and / or monitored cost-effectively.

[0040] According to one aspect of the present disclosure, the device may have an operating unit connected to a control device or a data interface, and the operating unit is configured to receive control instructions from a person and transmit them to the control device. The operating unit may be connected to the control device or the data interface by wire or wirelessly.

[0041] If the device is equipped with an operating unit, the operability of the device can advantageously be ensured independently of peripheral devices.

[0042] According to one aspect of the present disclosure, the operating unit can be configured in the form of a manual inflation syringe. The operating unit can, in particular, have a pistol grip or a toggle grip. Preferably, the operating unit can have a slide switch or a toggle switch, by means of which a predetermined threshold value for the pressure of the discharged fluid and / or a target pressure can be preset.

[0043] If the operating unit is designed in the form of a manual inflation syringe, it can be easily adapted to the device according to the disclosure.

[0044] According to one aspect of the present disclosure, the operating unit may be an inflation syringe or a piston syringe, by means of which a control fluid can be conveyed to a control fluid port of the inflation syringe or piston syringe by movement of a piston, the device may have a pressure port configured to be connectable to the control fluid port of the inflation syringe or piston syringe, the pressure sensor device may be configured to measure the pressure of the control fluid, in particular at the pressure port, and the control device may be configured to control the fluid conveying device based on the pressure of the control fluid, in particular measured at the pressure port. The control fluid port may be configured, in particular, as a Luer connection.

[0045] The operating unit can be realized cost-effectively if the data interface is designed as a pressure interface that is compatible with the control fluid interface of an inflation syringe or a piston syringe.

[0046] According to one aspect of the present disclosure, the operating unit may have a display portion configured to display status data of the device. In particular, the operating unit may be configured as a touch-sensitive screen.

[0047] The present disclosure further relates to a system for performing angioplasty, in particular percutaneous transluminal angioplasty (PTA) or percutaneous transluminal coronary angioplasty (PTCA), having a balloon catheter and a device according to the present disclosure.

[0048] According to one aspect of the present disclosure, the device can be configured to generate low pressure or vacuum in the balloon catheter (that is, in the balloon and / or in the catheter of the balloon catheter) to expel gas present in the catheter or empty liquid present in the catheter from the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The invention is described in more detail below with reference to preferred exemplary embodiments and with reference to the accompanying drawings.

[0050] Figure 1 A schematic diagram showing a system according to the present disclosure according to a first embodiment is shown.

[0051] Figure 2 Shown is a schematic view of a fluid delivery device according to the present disclosure.

[0052] Figure 3 A schematic diagram showing a system according to the present disclosure according to a second embodiment is shown.

[0053] Figure 4 A schematic diagram showing a system according to the present disclosure according to a third embodiment is shown.

[0054] Figure 5 A schematic diagram showing an electrically operated unit according to the present disclosure according to a first embodiment is shown.

[0055] Figure 6 A schematic diagram showing an electrically operated unit according to the present disclosure according to a second embodiment is shown.

[0056] Figure 7 A schematic diagram showing an electrically operated unit according to the present disclosure according to a third embodiment is shown.

[0057] Figure 8 A schematic diagram showing a system according to the present disclosure according to a fourth embodiment is shown.

[0058] Figure 9 A schematic diagram shows a fluid mechanically operated unit according to the present disclosure with a quick release in a deactivated position according to a first embodiment.

[0059] Figure 10 A schematic diagram showing a fluid mechanically operated unit according to the present disclosure with a quick release in an activated position according to a first embodiment is shown.

[0060] Figure 11 A schematic diagram showing a fluid mechanical operating unit according to the present disclosure according to a second embodiment is shown.

[0061] Figure 12 A schematic diagram shows a fluid mechanically operated unit according to the present disclosure according to a third embodiment with a quick release in a deactivated position.

[0062] Figure 13 A schematic diagram showing a fluid mechanically operated unit according to the present disclosure with a quick release in an activated position according to a third embodiment is shown. DETAILED DESCRIPTION

[0063] Figure 1 A schematic diagram of a system 2 according to the present disclosure with a device 4 and a balloon catheter 6 according to a first embodiment is shown.

[0064] The device 4 comprises a catheter connection 8 in the form of a three-way valve 10, a fluid conveying 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 connection 8 does not necessarily have to be designed in the form of a three-way valve 10, but can also be formed by a simple valve, for example.

[0065] The catheter interface 8 or the three-way valve 10 is designed so that the balloon catheter 6 can be connected to the catheter interface 8 or the three-way valve 10 without tools and can be disconnected 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 in particular designed as a Luer connection point, which is compatible with the Luer connection point on the balloon catheter 6.

[0066] The connection point 26 is fluidically connected to the piston syringe 14 of the fluid conveying device 12 .

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

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

[0069] Operating units 20 and 22 are designed so that a person operating control device 18 can issue control commands or presettings and obtain status information about device 4. For this purpose, operating unit 20 is connected to control device 18 via a cable, at least for signaling purposes. Operating unit 20 can also be connected to control device 18 so that it is supplied or can be supplied with electrical power via control device 18. Operating unit 22 is connected or can be connected to control device 18 via radio.

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

[0071] The pressure prevailing in balloon 30 can be determined using pressure sensor device 16, which is in fluid communication with balloon 30 via connection points 24 and 28 of catheter port 8 or three-way valve 10. In the system according to the first embodiment, pressure sensor device 16 is designed as a single pressure sensor.

[0072] The pressure ascertained by means of pressure sensor means 16 can be output by means of control means 18 or operating units 20 and / or 22 or corresponding output means, for example in the form of a display.

[0073] By means of operating unit 20 or 22 , a threshold value and / or a setpoint value for the pressure ascertained by means of pressure sensor unit 16 can be predefined for control unit 18 .

[0074] The control device 18 is designed to actuate the conveying device 12 as a function of predefined threshold values ​​and / or setpoint values.

[0075] If the pressure in the balloon 30 determined by means of the pressure sensor device 16 is less than the set value, the control device 18 activates the fluid delivery device 12 in such a way that the fluid flows from or by the fluid delivery device 12 via the connection positions 26 and 24 of the catheter interface 8 to or into the balloon catheter 6 or the balloon 30 .

[0076] If the pressure in balloon 30 determined by means of pressure sensor device 16 is greater than or equal to a setpoint value and less than or equal to a threshold value, control device 18 controls fluid conveying device 12 so that no fluid flows from or into balloon catheter 6 or balloon 30 .

[0077] If the pressure in the balloon 30 determined by means of the pressure sensor device 12 is greater than a threshold value, the control device 18 controls the fluid delivery device 12 so that the fluid flows from or by the balloon 30 or the balloon catheter 6 via the connection positions 24 and 26 of the catheter interface 8 to or to the fluid delivery device 12.

[0078] Figure 2 A schematic diagram of a fluid delivery device 12 is shown. The fluid delivery device 12 has a piston syringe 14 and a motor unit or motor 32.

[0079] The piston-type syringe 14 includes a hollow barrel 34 having a surrounding wall 36. The hollow barrel 34 is open on one side and has an end wall 38 on the side opposite the open side. A piston 40 is inserted into the hollow barrel 34 on the open side of the hollow barrel 34. The piston 40 is movable in the hollow barrel 34 and, together with the surrounding wall 36 and the end wall 38, defines a fluid chamber 42. The size of the fluid chamber 42 can be varied by the movability of the piston 40 relative to the hollow barrel 34.

[0080] The fluid outlet 44 is formed on the end wall 38. The fluid outlet 44 is fluidically connected to the line connection 8 or the connection point 26 of the three-way valve 10.

[0081] If piston 40 moves toward end wall 38, the fluid in fluid chamber 42 is conveyed out from fluid outlet 44 and conveyed to connection position 26 or conduit interface. Therefore, the movement of piston 40 toward end wall 38 causes the discharge of fluid on conduit interface 8 or its connection position 24.

[0082] As the piston 40 moves away from the end wall 38, a depression is created at the fluid outlet 44, which causes fluid to be drawn from the connection location 26 or the catheter hub 8 and thus to the catheter hub 8 or its connection location 24. When the balloon catheter 6 is connected to the catheter hub, the movement of the piston from the end wall causes fluid to be drawn from the balloon catheter 6 or the balloon 30 to the connection location 24.

[0083] A seal 52 is arranged on the circumferential surface of the piston 40 between the piston 40 and the surrounding wall 36 of the hollow cylinder 34 , which seal seals the fluid chamber 42 .

[0084] A piston rod 54 connected to the piston 40 is provided on the side of the piston 40 facing away from the end wall 38. An external thread 56 is formed on the piston rod 54 at the end section of the circumference of the piston rod 54 facing away from the piston 40. Two gears 58 and 60 belonging to the motor 32 are arranged on both sides of the external thread 56 and mesh with the external thread 56.

[0085] Gears 58 and 60 are designed or coordinated with external thread 56 such that counter-rotation of gears 58 and 60 results in a translation of piston rod 54 or piston 40. Rotation axes 62 and 64 extend perpendicularly to the axial direction or longitudinal axis of piston rod 54. The rotation of gears 58 and 60 is caused by activation of motor 32.

[0086] A coupling 66 is provided on the end face of the piston rod 54 facing away from the piston 40, by means of which the piston rod 54 can be moved relative to the hollow cylinder 4. If the coupling 66 is rotated motor-driven (in particular, by means of a motor 32 connected to the coupling 66) when the gears 58 and 60 are stationary, the meshing of the gears 58 and 60 in the external thread 56 causes the piston rod 54 to move relative to the rotation axes 62 and 64 of the gears 58 and 60. The gears 58 and 60 and the coupling 66 are all driven by the motor 32. Alternatively, it is also possible that the device 12 can also be configured so that the gears 58, 60, and / or the coupling 66 are driven by separate motors.

[0087] In order to be able to determine the 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 in a signal-related manner (see Figure 1 ). Depending on the change in position of the piston 40 , the amount of fluid discharged or drawn in can be determined by means of the control device 18 .

[0088] Figure 3 A schematic diagram of a system 102 according to the present disclosure according to a second embodiment is shown. 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 radio-connected operating unit 22.

[0089] Figure 4A schematic diagram of a system 202 according to the present disclosure according to a third embodiment is shown. 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 radio-connected operating unit 22 instead of a wired-connected operating unit 20.

[0090] Figure 5 A schematic diagram of an operating unit 22 according to the present disclosure according to a first embodiment is shown. The operating unit 22 is constructed in the form of a tablet with a touch-sensitive screen 70. The operating unit 22 is configured to display an area 72 indicating a pressure value, an area 74 indicating a diameter value of the balloon catheter 6, and an area 76 indicating a slide switch on the touch-sensitive screen 70. The operating unit 22 is configured so that the value in one of the areas 72 or 74 can be changed by first activating one of the areas 72 or 74 by tapping (see FIG. 1 ). Figure 5 72 in the image) and then changing the value of the activated area by a scraping motion along the area 76.

[0091] Figure 6 A schematic diagram of an operating unit 1022 according to the present disclosure according to a second embodiment is shown. The operating unit 1022 is configured in the form of a slide switch and has a slider 1078 that is movable along a linear guide 1080. The operating unit 1022 is configured to preset a threshold value or a nominal value for the pressure measured by the pressure sensor device 16 by moving the slider 1078 along the linear guide 1080 of the control device 18.

[0092] Figure 7 A schematic diagram of an operating unit 2022 according to the present disclosure according to a third embodiment is shown. The operating unit 2022 is designed in the form of a compressible ball. The operating unit 2022 is configured to preset a threshold value or a setpoint value for the pressure measured by the pressure sensor device 16 depending on the degree of compression of the control device 18.

[0093] exist Figure 5 、 Figure 6 and Figure 7 The operating units 22, 1022 and 2022 shown in FIG are configured as cordless operating units. Alternatively or additionally, it is also possible that the operating units 22, 1022 and 2022 are configured to be connectable to the control device 18 by means of a cable.

[0094] Figure 8A schematic diagram of a system 302 according to the present disclosure is shown according to a fourth embodiment. System 302 according to the third embodiment differs from systems 2, 102, and 202 according to the first three embodiments only in that system 302 according to the fourth embodiment has a fluid-mechanical (i.e., hydraulic or pneumatic) operating unit 3022 instead of an electrical or electronic operating unit 20, 22, 1022, or 2022, and is equipped with a pressure port 378 and a pressure sensor 380, which is fluidically connected to pressure port 378 and connected to control device 18 in terms of signaling. Preferably, pressure sensor 380 is designed as part of pressure sensor unit 316 according to the present disclosure.

[0095] The pressure port 378 is designed to be connectable to the operating unit 3022 .

[0096] Figure 9 A schematic diagram of a fluid mechanics operating unit 3022 according to a first embodiment is shown.

[0097] The operating unit 3022 is configured in the form of a manual inflation syringe 3024 .

[0098] Inflation syringe 3024 includes a hollow cylinder 3026 having a surrounding wall 3028. Hollow cylinder 3026 is open on one side and has an end wall 3030 on the side opposite the open side. A piston 3032 is inserted into hollow cylinder 3026 on the open side of hollow cylinder 3026. Piston 3032 is movable within hollow cylinder 3026 and, together with surrounding wall 3028 and end wall 3030, defines a fluid chamber 3034. The size of fluid chamber 3034 can be changed by the movability of piston 3032 relative to hollow cylinder 3026.

[0099] A fluid outlet 3036 is formed on the end wall 3030 , which fluid outlet forms a control fluid connection according to the present disclosure. The fluid outlet 3036 is fluidically connected or connectable to the pressure connection 378 .

[0100] When the piston 3032 moves toward the end wall 3030, the fluid in the fluid chamber 3034 (i.e., the control fluid according to the present disclosure) is delivered from the fluid outlet 3036 to the pressure port 378. Therefore, the movement of the piston 40 toward the end wall 38 increases the pressure on the pressure port 378.

[0101] When the piston 3032 moves away from the end wall 3030 , a depression is created at the fluid outlet 3036 , which causes fluid to be drawn in from the pressure port 378 and thereby reduces the pressure on the pressure port 378 .

[0102] A seal 3038 is provided on the circumference of the piston 3032 , between the piston 3032 and the surrounding wall 3028 of the hollow cylinder 3026 , and the seal seals the fluid chamber 3034 .

[0103] A piston rod 3040 connected to the piston 3032 is provided on the side of the piston 3032 facing away from the end wall 3030. An external thread 3042 is formed on the piston rod 3040 at the end section of the circumference 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 3046. The threaded block 3044 is connected to the rocker 3046 in an articulated or pivotal manner, and the rocker 3046 is connected to the hollow cylinder 3026 in an articulated or pivotal manner. The threaded block 3044 has a threaded section 3048 on the side facing the external thread 3042 of the piston rod (see FIG. 3048 ). Figure 10 ), the threaded section is configured to be able to engage with the external thread 3042. The threaded block 3044 and the rocker 3046 together form a quick release device, which is configured to be able to be moved to a deactivated position by means of the rocker 3046, in which the threaded block 3044 or its threaded section 3048 is engaged with the external thread 3042 (see Figure 9 ) and can be moved by means of the rocker 3046 into an activated position in which the threaded block 3044 or its threaded section 3048 does not engage with the external thread 3042 (see Figure 10 ). Preferably, the quick release or its rocker 3046 is preloaded by means of a spring (not shown) such that the quick release is preloaded into its deactivated position and can only be adjusted into its activated position by overcoming the preload.

[0104] A rotary knob 3050 is provided on the end side of the piston rod 3040 facing away from the piston 3032, by means of which the piston rod 3040 can be moved manually relative to the hollow cylinder 3026. If the rotary knob 3050 is manually rotated in the deactivated position of the quick release device (see Figure 9 ), the engagement of the threaded section 3048 in the external thread 3042 causes a movement of the piston rod 3040 relative to the threaded block 3044 and thus relative 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 can be moved axially and the piston 3032 can be moved particularly quickly in the axial direction of the piston 3032 by means of the movement of the rotary handle 3050 (see FIG. Figure 10 (double arrow in the middle).

[0105] In order to operate the device 4 in the system 302 by means of the operating unit 3022, the size of the fluid chamber 3034 is changed by changing the axial position of the piston 3032 relative to the hollow cylinder 3026 by rotating the handle 3050 (with a quick release device that can be activated or deactivated), thereby changing the pressure of the fluid at the fluid outlet 3036 and thus changing the pressure of the fluid at the pressure port 378. This pressure change is measured by the pressure sensor 380. The control device 18 of the device 4 of the system 302 is configured to convert the pressure measured at the pressure port 378 or the pressure change 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 change is generated in the balloon catheter 6. "Conversion" means, in particular, that the pressure generated by the fluid delivery device 12 is higher than the pressure generated manually by the operating unit 3022 and / or that the pressure change curve generated by the fluid delivery device 12 is smoothed relative to the pressure change curve generated manually by the operating unit 3022.

[0106] Figure 11 A schematic diagram of a fluid mechanical operating unit 4022 according to the present disclosure according to a second embodiment is shown. 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 4046 of the fluid mechanical operating unit 4022 according to the second embodiment is hingedly or pivotally connected to a trigger 4052. The provision of the trigger 4052 enables a pistol grip (not shown) to be provided on the inflation syringe 4024 of the operating unit 4022, thereby 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.

[0107] Figure 12 A schematic diagram of a fluid mechanically operated unit 5022 according to the present disclosure is shown according to a third embodiment with a quick release in a deactivated position. Figure 13 A schematic diagram of a fluid mechanically operated unit 5022 according to the present disclosure is shown with a quick release in an activated position according to a third embodiment.

[0108] 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 the threaded block 5044 is configured as an eccentric member, which is rotatably mounted on the hollow cylinder 5026 so that the rotation axis of the threaded block 5044 is parallel to the longitudinal axis of the piston rod 5040. The threaded block 5044 has a recess 5054 through which the piston rod 5040 extends.

[0109] The recess 5054 is constructed eccentrically so that the inner surface of the threaded section 5048 of the recess 5054 engages with the outer thread 5042 of the piston rod 5040 in the first position of the threaded block 5044 relative to the hollow cylinder 5024 (see Figure 12 ), and in a second position in which the threaded block 5044 is twisted relative to the hollow cylinder 5024 compared to the first position, the threaded block 5044 does not engage with the external thread 5042 of the piston rod 5040 (see Figure 13 ).

[0110] In the fluid-mechanically operated unit 5022 according to the third embodiment, the quick-release device is therefore formed solely by the threaded block 5044. A rocker as in the fluid-mechanically operated units 3022 and 402 according to the first two embodiments is not required.

[0111] 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.

[0112] Reference Signs List

[0113] 2 System According to the First Embodiment

[0114] 4 Devices

[0115] 6 Balloon Catheter

[0116] 8 Catheter interface

[0117] 10 Three-way valve

[0118] 12 Fluid transport devices

[0119] 14 piston syringe

[0120] 16 Pressure sensor devices

[0121] 18 Control devices

[0122] 20 Wired operating unit

[0123] 22 Operating units via radio connection

[0124] 24 Connection position of the conduit side of the three-way valve

[0125] 26 Connection position of the fluid delivery device side of the three-way valve

[0126] 28 Connection location of the pressure sensor device side of the three-way valve

[0127] 30 Balloon

[0128] 32 Motors for fluid transport devices

[0129] 34 Hollow barrel of piston syringe

[0130] 36 Piston syringe wall

[0131] 38 End wall of piston syringe

[0132] 40 piston syringe piston

[0133] 42 Fluid chamber of piston syringe

[0134] 44 Fluid outlet of piston syringe

[0135] 52 Seal between piston and surrounding wall

[0136] 54 piston rod

[0137] 56 External thread of piston rod

[0138] 58, 60 motor gears

[0139] 62, 64 rotation axis

[0140] 66 Coupling part on piston rod

[0141] 68 Position measuring device

[0142] 70 touch-sensitive screen

[0143] 72 to 76 areas on the touch-sensitive screen

[0144] 102 System according to the second embodiment

[0145] 202 System according to the third embodiment

[0146] 302 System according to the fourth embodiment

[0147] 378 pressure port

[0148] 380 Pressure Sensor

[0149] 1022 Operation unit according to the second embodiment

[0150] 1078 Slide

[0151] 1080 Linear Guide

[0152] 2022 Electric operation unit according to the third embodiment

[0153] 3022 Fluid mechanics operating unit according to the first embodiment

[0154] 3024 Expansion Syringe

[0155] 3026 Hollow barrel for expansion syringe

[0156] 3028 Expansion Syringe Wall

[0157] 3030 Expansion syringe end wall

[0158] 3032 Expansion Syringe Piston

[0159] 3034 Fluid Chamber of the Inflation Syringe

[0160] 3036 Fluid outlet for inflation syringe

[0161] 3038 Seal between piston and surrounding wall

[0162] 3040 piston rod

[0163] 3042 piston rod external thread

[0164] 3044 threaded block

[0165] 3046 Joystick

[0166] 3048 threaded section

[0167] 3050 Rotating handle on piston rod

[0168] 4022 Fluid mechanics operating unit according to the second embodiment

[0169] 4024 Expansion Syringe

[0170] 4032 Expansion Syringe Piston

[0171] 4046 Joystick

[0172] 4052 Trigger

[0173] 5022 Fluid mechanics operating unit according to the third embodiment

[0174] 5026 Hollow barrel for expansion syringe

[0175] 5032 Expansion Syringe Piston

[0176] 5040 piston rod

[0177] 5042 external thread

[0178] 5044 threaded block

[0179] 5048 threaded section

[0180] 5054 blank space

Claims

1. A device (4) for automatically expanding a vascular balloon catheter (6), in particular an 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 detachably connectable to the balloon catheter (6), in particular without tools, so that 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 discharge 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 the pressure of the fluid discharged by the device (4), and The control device (18) is configured to control the amount of fluid discharged from the apparatus (4) by means of the fluid conveying device (12) by operating the motor (32) of the fluid conveying device (12) according to the pressure measured by the pressure sensor device (16), It is characterized by: The fluid delivery device (12) is configured to be able to draw the fluid into the apparatus (4) at the catheter interface (8) by means of the motor (32).

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

3. The device (4) according to claim 2, characterized in that The control device (18) is designed to inhibit the intake of fluid by means of the fluid conveying device (12) after exceeding the predetermined threshold value and after a subsequent pressure drop of the pressure measured by the pressure sensor device (18) when the predetermined threshold value is reached again.

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

5. The device (4) according to any one of claims 1 to 4, characterized in that The control unit (18) is configured to control the fluid delivery device (12) so that the fluid is delivered at different predetermined delivery rates.

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

7. The device (4) according to any one of claims 1 to 6, characterized in that Energy storage device for storing electrical energy, allowing overpressure reduction and evacuation in the event of a power outage.

8. The device (4) according to any one of claims 1 to 6, characterized in that The motor (32) of the fluid conveying device has a tensioning mechanism which is designed to be tensioned when discharging fluid and to be relaxed for aspirating fluid.

9. The device (4) according to any one of claims 1 to 8, characterized in that The control device (18) has a data interface which is designed to enable data transmission to and / or from a smartphone, a tablet computer or another device.

10. The 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, and the operating unit is configured to receive control instructions from a person and transmit them to the control device (18).

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

12. The device (4) according to claim 11, characterized in that The operating unit (3022; 4022; 5022) is an inflation syringe (3024; 4024; 5024), by means of which a control fluid can be delivered by moving a piston (3032; 4032; 5032) to a control fluid interface of the inflation syringe (3024; 4024; 5024), The data interface is configured as a pressure interface (378) which can be connected to a control fluid interface of the inflation syringe (3024; 4024; 5024). The pressure sensor device (316) is configured to measure the pressure of the control fluid at the pressure interface (378), and The control device (18) is configured to control the fluid delivery device (12) based on the pressure of the control fluid measured at the pressure interface (378).

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

14. A system (2; 102; 202; 302) for performing an angioplasty procedure, comprising a balloon catheter (6) and a device (4) according to any one of claims 1 to 13.

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

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