DEVICE AND METHOD FOR AUTOMATICALLY VENTING AND FILLING A CATHETER

Abstract

The invention relates to an apparatus and a method for the automatic deaerating and filling of a catheter connected to a blood vessel of a patient with blood, in particular in preparation for hemodialysis, and in particularly by means of a cannulation robot. The invention implements this in particular by the deaerating and filling of a fluid channel fluidly connected to the catheter by means of a deaeration device, by the detecting of the deaerating and/or filling of the fluid channel by a sensor device which generates a measurement signal containing information on the deaerating and/or filling of the fluid channel, and by the controlling of the deaeration device as a function of the measure-ment signal by means of a control device with electrical circuitry so as to achieve the automated deaerating and/or filling of the fluid channel and the catheter.

Claims

1. An apparatus for the automatic deaerating and filling of a catheter connected to a blood vessel of a patient with blood comprising a fluid channel section for guiding fluid flows, a deaeration device for deaerating the catheter, wherein the fluid channel section comprises: at least one fluid channel through which fluids can flow, a blood inflow channel configured for catheter attachment and for a fluid connection to the fluid channel, an air outflow channel configured for a fluid connection to the fluid channel and the deaeration device such that air can be conveyed out of the fluid channel and out of the catheter connected to the blood inflow channel through the air outflow channel by means of the deaeration device, whereby the catheter connected to the blood vessel and the fluid channel can be filled with blood, wherein the apparatus comprises a sensor device designed to measure the deaerating and/or filling of the fluid channel and to generate a measurement signal containing information on the deaerating and/or filling of the fluid channel, and wherein the apparatus comprises a control device having electrical circuitry which is configured to automatically control the deaeration device for deaerating and/or filling the fluid channel as a function of the measurement signal.

2. The apparatus according to claim 1 comprising a blood outflow channel designed to deliver the blood from the fluid channel to an extracorporeal blood guidance system.

3. The apparatus according to claim 1, wherein the fluid channel section comprises a sensor section S designed to detect the entry of blood into the fluid channel by means of the sensor device.

4. The apparatus according to claim 1, wherein the sensor device and/or the deaeration device is/are a part of the fluid channel section.

5. The apparatus according to claim 1, wherein the fluid channel section comprises a rinsing inflow channel designed for the supplying and the flowing of a physiological rinsing fluid through said fluid channel.

6. The apparatus according to claim 5, wherein the fluid channel section comprises a first valve, by means of which the air flow through the fluid channel can be varied, and a second valve, by means of which the rinsing fluid flow through the fluid channel can be varied.

7. The apparatus according to claim 5, wherein the fluid channel section comprises a blood outflow channel (9 in fluid connection with the fluid channel for delivering the blood from the fluid channel to an extracorporeal blood guidance system, and a third valve, by means of which the fluid flow in the blood outflow channel can be varied.

8. The apparatus according to claims 5, wherein the fluid channel section comprises: a second fluid channel and a second blood inflow channel for connecting a second catheter to the second fluid channel to form a fluid connection between the second catheter and the second fluid channel.

9. The apparatus according to claim 8, comprising a second sensor section S designed to detect the entry of blood into the second fluid channel by means of a second sensor device.

10. The apparatus according to claim 8, comprising a second sensor device designed to measure the deaerating and/or filling of the second fluid channel, utilizing the second sensor section, and to produce a second measurement signal containing information on the deaerating and/or filling of the second fluid channel, wherein the control device is designed to automatically control the deaeration device for deaerating and/or filling the second fluid channel as a function of the second measurement signal.

11. The apparatus according to claim 5, wherein the air outflow channel is fluidly connected to the second fluid channel for the deaeration of same such that air can be conveyed out of the second fluid channel and out of the second catheter connected to the blood inflow channel through the air outflow channel by means of the deaeration device, whereby the second catheter connected to the blood vessel and the fluid channel can be filled with blood, wherein the fluid channel section exhibits a fourth valve, by means of which the air flow through the second fluid channel can be varied, wherein the second fluid channel is fluidly connected to the rinsing inflow channel such that the physiological rinsing fluid can be supplied to and flow through the second fluid channel, wherein the fluid channel section exhibits a fifth valve, by means of which the rinsing fluid flow through the second fluid channel can be varied.

12. The apparatus according to claim 1, wherein the fluid channel section, and/or at least one catheter connected to the fluid channel section, are designed as disposable items.

13. The apparatus according to claim 1, wherein the deaeration device comprises a pump or a displacement device wherein the displacement device comprises a displacing plunger arranged in a hollow cylinder which draws the fluid into the fluid chamber of the hollow cylinder or drives it out of same through an opening in the hollow cylinder.

14. The apparatus according to claim 1, wherein the apparatus comprises a reservoir containing the physiological rinsing fluid for filling the catheter and which comprises a connection channel by means of which the reservoir is fluidly connected to the air outflow channel of the fluid channel section, wherein the control device and the deaeration device are thereto designed to a) convey the air through the connection channel into the physiological rinsing fluid contained in the reservoir by means of the deaeration device to deaerate the catheter where it evacuates the connection channel by buoyancy and rises to the surface of the physiological rinsing fluid, b) optionally convey the blood through the catheter and the fluid channel into the reservoir where it mixes with the physiological rinsing fluid contained in the reservoir, c) and after the physiological rinsing fluid is deaerated, convey it out of the reservoir through the connection channel and through the fluid channel section into the catheter.

15. The apparatus according to claim 14, wherein the deaeration device is formed by a displacement device which comprises a displacing plunger arranged in a hollow cylinder which draws the fluid into the fluid chamber of the hollow cylinder through an opening in the hollow cylinder or drives it out of same through the opening, and wherein the reservoir is formed by the fluid chamber of a displacement device.

16. A cannulation robot for automatically cannulating the blood vessel of the patient with a cannula which comprises an apparatus according to claim 1, designed to automatically deaerate and fill a catheter connected to the cannula with blood after the automatic cannulation of the blood vessel by means of the apparatus, in particular in preparation for hemodialysis.

17. A system comprising an extracorporeal system of channels and an apparatus according to claim 1, wherein the control device is designed to automatically perform the deaerating and/or filling of the catheter and at least one fluid channel with blood and automatically guide the blood after it enters into the fluid channel section into the extracorporeal channel system via the blood outflow channel.

18. A method for the automatic deaerating and filling of a catheter connected to a blood vessel of a patient with blood in preparation for hemodialysis, comprising the steps: Deaerating and filling of a fluid channel fluidly connected to the catheter by means of a deaeration device; Detecting the deaerating and/or filling of the fluid channel by means of a sensor device which produces a measurement signal containing information on said deaerating and/or filling of the fluid channel; Controlling the deaeration device as a function of the measurement signal by means of a control device with electrical circuitry so as to achieve the automated deaerating and/or filling of the fluid channel and the catheter.

Description

[0108] Further advantages, features and possible applications of the present invention are yielded by the following detailed description of at least one example embodiment and/or by the figures. Unless otherwise described or contextually indicated otherwise, the same reference numerals are substantially used to identify equivalent components in the embodiments. The figures show the following example embodiments of the invention:

[0109] FIG. 1 shows a schematic view of an inventive apparatus according to a first example embodiment.

[0110] FIG. 2a shows a schematic view of an inventive apparatus according to a second example embodiment.

[0111] FIG. 2b shows a schematic view of an overfill protection for use with the apparatus of FIG. 2a.

[0112] FIG. 2c shows a schematic view of a check valve for use with the apparatus of FIG. 2a.

[0113] FIG. 3 shows a schematic view of an inventive apparatus according to a third example embodiment.

[0114] FIG. 4 shows a schematic view of a combined deaeration and flushing system for use with the apparatus of FIG. 1, 2a or 3, in four different phases.

[0115] FIG. 5 shows a schematic view of the example embodiment of a cannulation robot comprising an apparatus according to the invention.

[0116] FIG. 6 shows a schematic view of the example embodiment of an inventive method for the automatic deaerating and filling of a catheter connected to a blood vessel of a patient.

[0117] FIG. 1 shows an apparatus 1 for the automatic deaerating and filling of a catheter 25 and a cannula 26 connected to a blood vessel of a patient with blood. The apparatus is used in preparation for hemodialysis. The apparatus comprises: a fluid channel section 2 for guiding fluid flows, a deaeration device 3 for deaerating the catheter, wherein the fluid channel section comprises: a fluid channel 4 through which fluids can flow, a blood inflow channel 5 configured for the catheter attachment and for a fluid connection to the fluid channel, an air outflow channel 6 configured for a fluid connection to the fluid channel and the deaeration device such that air can be conveyed out of the fluid channel and out of the catheter connected to the blood inflow channel through the air outflow channel by means of the deaeration device, whereby the catheter connected to the blood vessel and the fluid channel can be filled with blood. The apparatus thereby comprises a sensor device 7 designed to measure the filling of the fluid channel and to generate a measurement signal containing information on the filling of the fluid channel. The apparatus 1 further comprises a control device 8 with electrical circuitry which is configured to automatically control the deaeration device 3 for deaerating and/or filling the fluid channel as a function of the measurement signal.

[0118] A sensor device 7 is arranged at sensor section S of fluid channel section 2. The control device 8 is connected to the sensor device 5 in order to receive the measurement signal. The control device 8 is also connected to the deaeration device 3, here a peristaltic pump, in order to induce by means of its control the conveyance of the air out of the air outflow channel 6 via the channel connector 6a and via the air duct 15 to the deaeration device.

[0119] The fluid channel section 2 here additionally comprises an air outflow channel 6 with a channel connector 6a. The valve 11 is a check valve designed to block or open the fluid channel 4 so as to enable, prevent or respectively regulateas controlled by the control device 8the passage of air through the fluid channel 4 toward the deaeration device 3. The valve 11 serves as a first valve by means of which the air flow through the fluid channel can be varied.

[0120] The fluid channel section 2 here additionally comprises a blood outflow channel 9 with a channel connector 9a. The valve 12 is a check valve designed to block or open the blood outflow channel 9 so as to enable, prevent or respectively regulateas controlled by the control device 8the passage of blood in the direction of the channel connector 9a. The valve 12 serves as a third valve by means of which the air flow through the fluid channel can be varied.

[0121] The channel connectors 5a, 6a and 9a are in particular luer lock connections.

[0122] FIG. 2a shows an apparatus 1 for the automatic deaerating and filling of a catheter 25 and a cannula 26 connected to a blood vessel of a patient with blood, wherein the apparatus is used in preparation for hemodialysis. The apparatus comprises: a fluid channel section 2 for guiding fluid flows, a deaeration device 3 (see FIG. 1 or 2b) for deaerating the catheter, wherein the fluid channel section comprises: a fluid channel 4 through which fluids can flow, a blood inflow channel 5 configured for catheter attachment and for a fluid connection to the fluid channel 4, an air outflow channel 6 configured for a fluid connection to the fluid channel and the deaeration device such that air can be conveyed out of the fluid channel 4 and out of the catheter 25 connected to the blood inflow channel through the air outflow channel 6 by means of the deaeration device 3, whereby the catheter connected to the blood vessel and the fluid channel can be filled with blood. The apparatus thereby comprises a sensor device 7, in particular an optical measuring device, designed to measure the filling of the fluid channel and to generate a measurement signal containing information on the filling of the fluid channel. The apparatus 1 further comprises a control device 8 (not shown) with electrical circuitry which is configured to automatically control the deaeration device 3 for deaerating and/or filling the fluid channel as a function of the measurement signal. The control by means of the control device 8 preferably ensues such that the entry of the blood into the measuring zone of sensor 7 is detected during the deaeration by the deaeration device 3 and the deaeration device 3 is immediately stopped upon such entry being detected so that no further air is conveyed and the control device 8 closes check valve 11. In this state, physiological rinsing fluid stored in reservoir 21c can be introduced into the fluid channel 4 via the channel intersecting point 9 where the rinsing fluid mixes with the blood drawn into the fluid channel 4. In particular, a conveyor device, in particular a pump, e.g. a peristaltic pump, can be provided in the channel intersecting point 9 or in another channel 17 or in a reservoir 21a, 21b, 21c with which the fluid can be pumped from reservoir 21a, 21b, 21c on the condition that the channel 17 blockable there by means of the non-return valve 13 and check valve 12 is respectively open. Preferably the control device is hereby designed to open the check valve 12 as needed in order to simultaneously or during the same period feed the rinsing fluid, a first drug solutione.g. heparinand a second drug solutione.g. a beta blockeras needed into the fluid channel 4 where the respective fluids mix with the blood contained in the fluid channel 4.

[0123] FIG. 2b shows a connection possibility between the deaeration device 3 and the channel connector 6a of the fluid channel section. A channel connector 41a, which can in particular be connected to channel connector 6a via a luer lock connection, is thereby connected to the deaeration device by a channel, whereby a bypass channel with overfill protection reservoir 41b is provided in which any liquid possibly infiltrating through the connector 41a is collected. This thereby protects the deaeration device, which can comprise a vacuum pump, from entry of liquid.

[0124] FIG. 2c shows an example embodiment of a check valve which can be used in the apparatus according to the invention. The check valve comprises a pin 19, by means of which an elastically deformable tube channel 17 can be compressed and thereby closed. In the image on the left, the pin is not deflected, in the image on the right, it is deflected in order to block the channel.

[0125] Alternatively, the fluid channel section 2 in FIG. 2c can comprise an upper plate section 16 with an opening for the pin and a lower plate section 18 defining a depression covered by an elastically deformable membrane arranged between the upper and lower plate section. The pin presses the membrane downward in a closure portion of the channel to block the channel formed by the depression and the membrane. The pin can be deflected by means of an electrically driven actuator device controlled by the control device.

[0126] FIG. 3 shows an apparatus 100 for the automatic deaerating, filling and flushing of a first catheter 25 and cannula 26 connected to a blood vessel of a patient as well as for the automatic deaerating, filling and flushing of a second catheter 25 and cannula 26 connected to another blood vessel of a patient with blood. After the deaerating, filling and flushing of the first and second catheteralso called priming the catheterthe blood is cleansed by an extracorporeal dialysis device (not shown). The apparatus 100 comprises: a fluid channel section 102 for guiding fluid flows, a deaeration device 3 (see FIG. 1 or 2b) for connecting to the channel connector 106a of the air outflow channel 106, a rinsing inflow channel 108 through which fluid with rinsing fluid which can be conveyed by a conveying device, in particular a pump (not shown), can flow from a reservoir filled with rinsing fluid via the channel connector 108a. The entry of blood into the measuring zone S of the fluid channel section is in each case detected by means of the sensor devices 107, 107 which can comprise optical sensors.

[0127] The rinsing fluid can be conveyed into the first fluid channel 104 and the second fluid channel 104 simultaneously or at staggered intervals. The fluid flow of the air between the first fluid channel 104 and the air outflow channel 106 can be controlled by valve 111 arranged at the first fluid channel 104, and the fluid flow of the rinsing fluid between the rinsing inflow channel 108 and the first fluid channel 104 can additionally be controlled by means of the control device. The fluid flow of the air between the first fluid channel 104 and the air outflow channel 106 can additionally be controlled by valve 111 arranged at the second fluid channel 104 and the control device can additionally control the fluid flow of the rinsing fluid between the rinsing inflow channel 108 and the second fluid channel 104. A check valve 113 serves in closing the air outflow channel 106, controlled by the control device. Valve 114 closes off the blood outflow channel running from the first fluid channel 104 and opening into the channel connector 112, valve 114 closes off the blood outflow channel running from the second fluid channel 104 and opening into the channel connector 112. The rinsing inflow channel and air outflow channel 115, 115 provided for the deaerating of each catheter are identical here in that a channel 115, 115 through which matter can flow in both directions is used for the flowing of the air and for the flowing of the rinsing fluid toward the catheter. The fluid channel section exhibits a channel intersecting point 109, on one side of which opens the first 115 and the second 115 fluid channelsthrough which fluid can flow in both directionsand on the other side of which opens the one (and only) rinsing inflow channel 108 leading away from the one (and only) air outflow channel 106. This thereby enables efficiently producing the fluid channel section 102 and enables the apparatus 100 to operate it efficiently.

[0128] FIG. 4 shows a schematic view of a combined deaeration and flushing device 50 for use with the apparatus in FIG. 1, 2a or 3 in four different phases which are respectively controlled by the control device controlling the deflection of the plunger 51. The deaeration and flushing device 50 is a displacement device 50, in particular a syringe 50, having a displacing plunger 51 which is movable inside a hollow cylinder 52 and arranged so as to be able to be driven by an actuator device (not shown) of the apparatus. The syringe 50 is a reservoir filled under sterile conditions which is automatically loaded by the apparatus or manually loaded into the connecting position in which the opening port 53 is connected to the channel connector 6a or 6a for the syringe disposed with a sterile physiological rinsing fluid. In the second phase, to deaerate the fluid channel and the catheter, the plunger 51 is deflected in order to enlarge the fluid chamber 54. The air 61 thereby passes through the opening port 53 of the syringe into the fluid chamber in Phase II and pushes upward through the rinsing fluid 60 due to the density differences between the air and the rinsing fluid, the air thereby separated from the opening port 53. Deaeration here does not yet stop at that moment of the blood reaching the measuring zone S of the sensor device but rather a further predetermined volume of the blood is further conveyed in Phase III such that a specific volume of blood 63 reaches the rinsing fluid in the fluid chamber of the syringe 54. In Phase IV, the mixture of rinsing fluid and blood is returned to the fluid channel and the catheter in order to flush them. The movement of the plunger and thus the flushing process can be repeated as needed.

[0129] FIG. 5 shows a schematic view of the example embodiment of a cannulation robot 300 comprising an apparatus 1, 1, 100 according to the invention. The arm of a patient is positioned in the treatment chamber 308 and immobilized there by means of the fixation straps 311, 312. The components of the apparatus are supported by a base 307 which in particular comprises a supporting frame 306.

[0130] The cannulation robot 300 serves in the automatic cannulation of the patient's blood vessel with a cannula and comprises an apparatus 1, 1 or 100. The cannulation robot is thereby configured to perform the automatic deaerating and filling of a catheter connected to the cannula with blood, in particular in preparation for hemodialysis, after the automatic cannulation of the blood vessel by means of said apparatus 1, 1, 100. The cannulation robot 300 comprises a control and drive device 315a, by means of which a movable robotic arm 315 of the cannulation robot can be driven and controlled. The control device 2 of the cannulation robot here comprises the control device of the inventive apparatus and is electrically connected to the deaeration device (not visible) integrated here into the fluid channel section, the sensor device (not visible) arranged at the fluid channel section and the check valves (not visible) integrated into the fluid channel section, in particular in order to receive the measurement signal from the sensor device. The fluid channel section 320 of the inventive apparatus is connected here to the tool head whichcontrolled by the robotic arm 315positions the cannula 26 connected to the catheter 25 for the automated cannulating of the blood vessel. Rinsing fluid is conveyed from the storage reservoir 318 of the cannulation robot through flushing tube 321 via the channel connector 322 of fluid channel section 320 for flushing into the fluid channel (not visible) of fluid channel section 320, the blood is further conveyed through the blood tube 323 to an extracorporeal dialysis system via channel connector 324 of the fluid channel section 320. The dialysis system comprises an extracorporeal channel system and an inventive cannulation robot 300, wherein the control device 2 is thereby designed to automatically perform the deaeration and/or filling of the catheter and at least one fluid channel with blood and to automatically guide the blood into the extracorporeal channel system via the blood outflow channel after it enters into the fluid channel section.

[0131] FIG. 6 shows a schematic view of the example embodiment of an inventive method 200 for the automatic deaerating and filling of a catheter connected to a blood vessel of a patient, comprising the steps:

[0132] Deaerating and filling a fluid channel fluidly connected to the catheter by means of a deaeration device; (201)

[0133] Detecting the deaerating and/or filling of the fluid channel by means of a sensor device which produces a measurement signal containing information on said deaerating and/or filling of the fluid channel; (202)

[0134] Controlling the deaeration device as a function of the measurement signal by means of a control device having electrical circuitry in order to achieve the automated deaerating and/or filling of the fluid channel and the catheter. (203)