System and Method for Automated Cannulation

Abstract

The invention relates to a system (100) for data-dependent automated cannulation of patient blood vessels, in particular for hemodialysis, comprising: at least one cannulation robot (1) configured for automated cannulating of patient blood vessels, a control system (50, 51) comprising at least one data processing device and which is configured to implement a control procedure which controls the at least one cannulation robot subject to program parameters, at least one user interface device (80), enabling user input by means of which a patient is registered in the control system (50, 51), whereby in consequence of this control system registration procedure, an individually assigned patient identifier, which is referred to as the registered patient identifier, is used for the registered patient, and wherein the control system is configured to define the program parameters as a function of the registered patient identifier and control the at least one cannulation robot (1) as a function of the registered patient identifier. The invention furthermore relates to a corresponding method.

Claims

1. A system for data-dependent automated cannulation of patient blood vessels, in particular for hemodialysis, comprising: at least one cannulation robot configured for automated cannulating of patient blood vessels, a control system comprising at least one data processing device and which is configured to implement a control procedure which controls the at least one cannulation robot subject to program parameters, at least one user interface device enabling user input by means of which a patient is registered in the control system, whereby in consequence of this control system registration procedure, an individually assigned patient identifier, which is referred to as the registered patient identifier, is used for the registered patient, and wherein the control system is configured to define the program parameters as a function of the registered patient identifier and control the at least one cannulation robot as a function of the registered patient identifier.

2. The system according to claim 1, which comprises a patient database and a data storage apparatus, in which the patient database is stored, which contains the patient data sets of a plurality of patients, in each case comprising at least one patient identifier.

3. The system according to claim 1, wherein the at least one cannulation robot is configured to automatically perform a first venipuncture for insertion of a first cannula into a blood vessel for automatic withdrawing and routing of the blood to a blood guiding system.

4. The system according to claim 3, wherein the at least one cannulation robot is configured to automatically perform a second venipuncture for insertion of a second cannula into a blood vessel for automatically returning the blood from the blood guiding system for performing hemodialysis.

5. The system according to claim 1, wherein the control system is configured to implement a selection process for selecting the program parameters to be used for the automated cannulation as a function of the registered patient identifier.

6. The system according to claim 1, wherein the selection process is configured to access a data matrix in which the necessary program parameters are linked based on treatment data and thereby determinable, wherein the system comprises a data storage apparatus in which the data matrix is stored.

7. The system according to claim 1, wherein the control system is configured to implement at least one preparatory procedural step after the recording of the registered patient identifier and prior to the start of the automated cannulation as a function of the registered patient identifier which prepares the automatic withdrawal of the blood sample from the patient's blood vessel by means of the cannulation.

8. The system according to claim 1, wherein the control system is configured to implement at least one accompanying procedural step during the withdrawing of the blood sample obtained by the automated cannulation as a function of the registered patient identifier which is performed at least in part or entirely parallel to the cannulation.

9. The system according to claim 1, wherein the control system is configured to implement at least one secondary procedural step after the start of the automated cannulation and/or after the completion of the cannulation of the at least one blood vessel and/or after withdrawal of the blood sample obtained by means of the automated cannulation as a function of the registered patient identifier.

10. The system according to claim 1, wherein the system comprises an identification system which detects the position and/or dimensions and/or condition of the body part to be venipunctured positioned in the treatment chamber, continuously and/or in real time, by means of a sensor system based on measuring radiation and/or light and/or ultrasound, and stores it in the form of identifying data.

11. The system according to claim 1, wherein the system comprises an identification device for detecting identifying data providing information on the position, dimensions and/or condition of the body part to be cannulated and/or the blood vessel of the patient and a data storage apparatus for storing the identifying data as a function of the registered patient identifier, wherein the system is configured to prepare a further automated treatment by applying historical data containing the stored identifying data as a function of said registered patient identifier.

12. The system according to claim 1, wherein the at least one user interface device is positioned or positionable at a different geographic location than the at least one cannulation robot.

13. The system according to claim 1 comprising a data storage apparatus which is positioned at a different geographic location than the at least one cannulation robot and the at least one user interface device.

14. The system according to claim 1, wherein the control system is designed to register the registering patient as a function of successful system authentication, ascertain a patient identifier and/or recognize patients as registered patients by identifying the registered patient identifier.

15. A method for data-dependent automated cannulation of patient blood vessels comprising the following steps: Recording a registered patient identifier upon a patient registering at a user interface device which is data-linked to a data processing control system; Determining program parameters as a function of the registered patient identifier by the control system; and Controlling a cannulation robot set up for the automated cannulation of patient blood vessels and which is data-linked to the control system as a function of the program parameters for the automated cannulation of a patient's blood vessel based on the patient's registered patient identifier.

Description

[0139] Further preferential configurations of the system according to the invention and the method according to the invention are yielded by the following description of example embodiments in conjunction with the figures and their description. Unless expressly specified or contextually indicated otherwise, the same reference numerals are substantially used to identify equivalent components in the example embodiments. Shown are:

[0140] FIG. 1 a schematic representation of an example embodiment of the system according to the invention.

[0141] FIG. 2 a schematic representation of an example embodiment of the cannulation robot applicable to the inventive system.

[0142] FIG. 3 a schematic representation of an example embodiment of the inventive method or the operative control procedure in the inventive system respectively.

[0143] FIGS. 4 to 11 show example embodiments of the substeps of the FIG. 3 method.

[0144] FIG. 12 shows an example embodiment of the inventive method or the operative control procedure in the inventive system respectively.

[0145] FIG. 1 shows a clinical system 100 for data-dependent automated cannulation of patient blood vessels in preparation for hemodialysis as an example embodiment of the inventive system. The system 100 comprises two cannulation robots 1, each configured for the automated cannulation of patient blood vessels. A control system 50, 51 of the system 100 is designed to implement a control procedure able to control each of the two cannulation robots as a function of program parameters. The control system 50, 51 comprises a central control apparatus 50. Control devices 51 in each case control a cannulation robot 1 and are regarded as component parts of the control system 50, 51, its task in the clinical system 100 comprising the implementing of the at least one automatic cannulation of a patient's body part 30 as a function of the patient's patient identifier. The control apparatus 50 and the control device 51 each have a data processing device with a data processor and a data storage as well as a communication device for establishing a data link to another communication device of the system. The data links of the apparatus 1, 80, 90 to the control device 50 create a networking of the system components into a data exchange network. In the present case, the network comprises the control apparatus 50 as the central computer.

[0146] The system 100 comprises two user interface devices 80, implemented in the example as authentication devices 80 based on a fingerprint scanner, by means of which patients previously registered in the system are authenticated. The registration of a patient comprises collecting data relevant to the clinical admission, in particular storing an image of his fingerprint in a patient database for comparison and assigning an intrasystem patient identifier to the patient data of the patient, referred to here as the patient identifier. After the registered patient has registered, the control system recognizes the patient as the registered patient, his patient identifier is referred to as the registered patient identifier subsequent registration.

[0147] The system 100 comprises a data storage apparatus 90, which can be a hard disk server, in which at least one database is stored. In particular, the patient database which the system accesses on the basis of the registered patient identifier in order to read the necessary patient data of the registered patient for the automated cannulation is stored in the data storage apparatus 90. The patient data can be regularly supplemented by data collected by the system, e.g. identifying data of an identification device, as well as by optional observation data on the course of a completed cannulation or hemodialysis respectively as well as data on the treatment performed. A patient data set thus results, its accuracy enabling subsequent treatments of the patient in the clinical system to be continuously improved. In this example embodiment, the patient data in particular comprises data on the hemodialysis to be performed on the patient. This patient data in particular comprises vascular structure data, which will be described below.

[0148] The control apparatus 50 implements the control procedure of the system, this being in the form of program code executable by the data processors. The control procedure controls the at least one cannulation robot as a function of program parameters, and selects to that end appropriate, patient-dependent program parameters; i.e. subject to the registered patient identifier, subsequent patient registration and prior to the start of the cannulation. The control procedure performs to that end a selection process which is stored in the system.

[0149] The selection process is designed to access a data matrix which is stored in the data storage apparatus 90 and in which the necessary program parameters are linked based on patient data and treatment data and thereby determinable. Upon the registration of the patient, the system can realize that only one hemodialysis procedure is to be performed on said patient based on its own stored schedule or based on user input during registration. This information can be known as treatment data. Depending on this treatment data, the system can determine which patient-specific conditions and data in the patient data set are to be observed during hemodialysis.

[0150] Patient-specific conditions and data for hemodialysis can include vascular structure data, the patient-specific required type and size of fixation tape and swabbing material or disinfectant, data on the type of cannula to be used in the cannulation, etc. The data matrix can additionally contain information on the vascular structure data, type and size of fixation tape and swabbing material or disinfectant and type of cannula to be used in the cannulation program parameters needing to be observed for the hemodialysis treatment. The system then automatically prepares the automated cannulation as a function of these patient-specific parameters by relaying the type and size of fixation tape and swabbing material or disinfectant and type of cannula to be used in the cannulation program parameters to a pick-and-place system for medical equipment so that the pick-and-place system 70 of the system can furnish the required equipment in a standardized equipment box and by relaying the vascular structure data from the patient data set corresponding to the vascular structure data program parameter to the cannulation robot selected by the system for cannulation or instructing the cannulation robot to access said vascular structure data.

[0151] Apart from hemodialysis-specific information, the patient data set can also contain information required for other treatments and which is likewise patient-specific, e.g. information on patient medication to be periodically dispensed by the system.

[0152] In the example embodiment of the clinical system, the apparatus 1, 50, 80, 90 are in part arranged at different geographical locations. A first group of system apparatus can be disposed within the same building complex of the clinic. This includes the apparatus 1 and 80 connected to the control apparatus 50 in FIG. 1 by the continuous lines. The data storage apparatus 90 preferably allocated to the inventive system can be arranged at a clearly separate geographic location from these system apparatus, e.g. in another building. The data storage apparatus 90 can, however, also be used by other clinical systems. As suggested as a connection by the dotted line, a further user interface device 80 and a cannulation robot 1 can be disposed at a further geographically different location, e.g. in an ambulatory hemodialysis treatment station which, for example, can be based at the residence of a dialysis patient. This further user interface device 80 and cannulation robot 1 can likewise be mobile, e.g. in an ambulance, train or ship, provided a data link to the system is maintained.

[0153] FIG. 2 shows an example embodiment of a cannulation robot 1 used by the system 100 according to the invention.

[0154] The cannulation robot 1 comprises a robot-controlled tool arm device 2 which has a jointed tool arm 2a connected at one end to the cannulation robot 1 and supporting a tool head 2b on the other end. The tool head is realized in the present case as an exchangeable function-specific module subject to the type of treatment, e.g. cannulation, applying fixation tape or swabbing. In the figure, the tool head is configured for venipuncture, or cannulation respectively, and holds a cannula 3 to be inserted into the blood vessel in the arm 30 of the patient. A further tool head (not shown) holds the disinfecting device for the program-controlled application of disinfectant at the site of the patient's skin to be cannulated.

[0155] The cannulation robot 1 comprises an observation device 5 which in the present case has a camera, by means of which the automated cannulation procedure can be observed in real time by an observer at a remote location. The video data from the cannulation is additionally or alternatively stored in the patient data storage.

[0156] The cannulation robot 1 comprises an identification device 6, with which the position and dimensions of the patient's arm 30 and the position and structure of the patient's subcutaneous blood vessels as well as the morphology of the skin and the blood vessels can be detected. To this end, the identification device 6 comprises a vascular structure measuring device (not specifically shown) which is configured to produce at least one image of the blood vessels by means of ultrasound. These measurements can in particular occur prior to the cannulation and/or during and/or after the cannu-lation. The vascular structure data produced by the vascular structure measuring device can be stored as patient data and furnished in subsequent treatments as historical data, which can improve the cannulation in patient-specific manner.

[0157] The vascular structure measuring device can be further configured to detect prior puncture sites on the skin and/or blood vessel. The control procedure can use this information particularly with dialysis patients in order to implement and/or proceed with the cannulation pursuant to the rope ladder technique or buttonhole technique. Buttonhole technique information for the cannulation robot comes from the patient data. In the buttonhole technique, the cannulation robot always inserts the cannula at the same angle relative to the blood vessel, or arteriovenous fistula respectively, at the same position and through the buttonhole channel. A robot is destined to provide consistent quality in executing this buttonhole technique, which is crucial to the success of the technique. The buttonhole technique is therefore a particularly preferential type of procedure for performing the cannulation employing a cannulation robot or, respectively a control procedure. The robot also offers advantages in the case of the rope ladder technique compared to manual cannulation sirice, on the one hand, the blood vessel morphology in the vascular structure can be determined and known, whereby the control procedure can select an optimal next site at a distance from the previous puncture and, on the other hand, cannulation can ensue without any vibration at maximum precision.

[0158] Possible procedural steps of the cannulation robot, in particular cannulation robot 1, and steps of the control procedure or the inventive method respectively can be deduced from the previously described process steps Px, in particular P1 to P8, and process steps Sx, in particular S1 to S11.

[0159] FIG. 12 shows a first general example embodiment of the inventive method 200 used in the previously described system 100. The inventive method in principle preferably provides for the implementation of the process steps also applied in the system with the control procedure. The process steps comprise Step 201:Recording a registered patient identifier by a patient registering at a user interface device which is data-linked to a data processing control system; Step 202:Determining program parameters as a function of the registered patient identifier by the control system; and Step 203:Controlling a cannulation robot set up for the automated cannulation of patient blood vessels and which is data-linked to the control system as a function of the program parameters for automated cannulation of a patient's blood vessel based on the patient's registered patient identifier.

[0160] FIG. 3 shows an overview of a further example embodiment of the inventive method 300, here for performing dual cannulation of an arteriovenous fistula for a hemodialysis, in particular employing an example embodiment of the inventive system, e.g. system 100. The method 300 provides for the following sequence of steps in this order: [0161] Step 310: Preparing the automated cannulation [0162] Step 320: Registration with patient identification, preparation [0163] Step 330: Analyzing historical vascular structure data and/or detecting current vascular structure data of the arm 30 inserted into the treatment chamber 8, for planning the cannulation [0164] Step 340: Automatically disinfecting the skin area to be punctured [0165] Step 350: Automatically performing the first venipuncture and cannulation [0166] Step 360: Automatically performing the second venipuncture and cannulation [0167] Step 370: Performing the hemodialysis [0168] Step 380: Automatic post-treatment of punctured site by pressure, swab, gauze

[0169] Step 320 ensues alternatively and preferably before step 310.

[0170] FIG. 4 shows an example embodiment of preparatory step 310 (preparation):

[0171] The system and/or the control procedure begins with the analysis of the task (310a), which yields for example from the patient data of the registered patient in combination with a treatment plan stored in the system. Alternatively, the system is provided the information on the plan, in particular as treatment data on a planned hemodialysis at a specific time, during/prior to/or subsequent patient registration.

[0172] The system checks whether database entries already exist with respect to the planned hemodialysis and compares them to the treatment plan (310b). The system determines the vascular structure data from the patient database on the (registered) patient and calculates the possible venipuncture sites using an applicable algorithm (310c). All the data is analyzed and measures derived therefrom, in particular whether a physician needs to be consulted or whether automated cannulation with subsequent hemodialysis is authorized (310d).

[0173] The system decides the exact sequence of the process steps for the automated cannulation with ensuing hemodialysis (310e). The system transmits data on needed equipment to the pick-and-place system (310f). The system checks whether the availability of the requested equipment, in particular also the availability of the desired cannulation robot, is automatically confirmed (310g). The system in particular selects a suitable fixation tape for the later fixation of cannulas on the arm (310h). The fixation tape is in particular portioned and sized by the pick-and-place system into patient-dependent and treatment-dependent sections and transferred into a standardized equipment box automatically operated by the cannulation robot (310i). Appropriate catheters and/or cannulas are selected (310j) in patient-dependent and treatment-dependent manner and provided in the equipment box (310k). The equipment box is automatically transported to the cannulation robot (310l). The system sends a status update to the cannulation robot (310m).

[0174] FIG. 5 shows an example embodiment of preparation step 320 (registration, authentication, with subsequent preparation of the clinical treatment):

[0175] The system authenticates the patient (320a). this can ensue by means of password, pin or pattern, chip card, FRID chip, SIM card with mTan procedure, imprinted digital certificate or 2D code, TAN/iTAN, preferably using biometrics. If the authentication failswhich can occur if the patient is not yet registeredthe system acknowledges with an error message; registration was previously described above and is its own procedure. Upon registration, the system learns of the pending treatmentin this case, a hemodialysis. Directly after registration, the system preferably immediately begins automatically preparing for the hemodialysis, whereby no time is lost, which can be critical in an emergency. In particular, the pick-and-place system for medical equipment is activated (320d).

[0176] The automatically equipped patient-dependent equipment box is transported from the pick-and-place system to the cannulation robot (320e). The pick-and-place system transmit a status report (320f). The equipment box is positioned in the cannulation robot (320g). The equipment box, in particular its seal, is automatically checked for soundness in order to guarantee the sterility of the contents (320h). The cannulation robot registers the completeness and sterility of the equipment, it is now ready for cannulationthis information is shown in a user display of the cannulation robot (320i). As a safety step, it is provided for a healthcare professional assisting the patient to be authenticated in order to brief the patient and authorize the cannulation robot for the patient (320j). Steps 320k to 320m are performed parallel to steps 320e to 320j. The system transmits patient data, particularly vascular structure data and planned venipuncture sites, in particular from the patient database, to the data processing device of the cannulation robot (320k), the consistency of the transmitted data is checked (320l), and the transmission either repeated until consistent or confirmed if transmitted accurately (320m).

[0177] The system checks the preparation status (320n) and informs personnel in the event of problems (320p), or (320o) decides to continue the treatment (320q).

[0178] FIG. 6 shows an example embodiment of vascular identification step 330 (fistula identification):

[0179] The patient positions his arm in the treatment chamber of the cannulation robot (330a). The fixation device positions the fixing elements (330b) and checks the arm fixation (330c). If the event of insufficient fixation, a readjustment is made (330d). Identification of the fistula commences (330e). The vascular structure measuring device detects at least one image of the vascular structure containing the fistula, this being known on the basis of the patient data, and automatically checks the image for abnormalities, e.g. stenosis, hematoma, infections or pronounced fistula changes (330f). The identifying data is compared to historical identifying data from the patient data set (330g). Upon discrepancies, the automatic vascular identification is repeated and if again unsuccessful or abnormal (330i), a physician called in (330j). When the fistula is identified as per the historical data without abnormalities, the fistula and cannulation technique is confirmed (330k). The proper venipuncture site is then determined on the basis of the preceding preparatory analysis and/or by comparing the current vascular structure data to historical data (330l). The identified venipuncture site is shown on a display of the cannulation robot in relation to an image of the armin particular for confirmation by personnel for safety reasons (330m). The readiness of the automatic cannulation is displayed (330n) and, parallel thereto, the readiness to transmit patient data to the database. A physician or authenticated healthcare professional is prompted to confirm (330p).

[0180] FIG. 7 shows an example embodiment of step 340 for the automatic disinfecting of the skin of the arm to be cannulated:

[0181] Automatic disinfection by the disinfecting device of the cannulation robot is started (340a). The appropriate disinfection technique is selected in patient and/or treatment-dependent manner (spraying or wiping with a swab; 340b). The disinfection tool head is activated or grasped by the tool arm (340c), the disinfection process begins (340d). The quality of the disinfection is checked by a testing device for disinfection control, an optional component of the cannulation robot and/or the disinfecting device (340d). If the check is positive, disinfection is terminated, otherwise the disinfection and test process is repeated (340f).

[0182] FIG. 8 shows an example embodiment of step 350 for the first venipuncture and cannulation of the skin of the arm to be cannulated:

[0183] The first automated cannulation begins (350a). The tool arm grabs the first cannula tool head equipped with the preselected patient and/or treatment-dependent cannula (350b). The cannula head is positioned relative to the arm 30 and to the predetermined puncture site, in particular the angle of the cannula is thereby aligned relative to the skin surface at the puncture site in a predetermined manner (350c). The cannula is inserted into the skin and the fistula (cannulation; 350d). A priming step is automatically performed to test the fluid connection between the cannula and the fistula by means of an aspiration test (350e). The pressure in the cannula is checked by means of a pressure measuring device of the cannulation robot (3500. A fixation tape is provisionally positioned by means of a fixation tape device in order to pro-visionally immobilize the cannula and/or catheter (350g). The cannula head releases the cannula (350h), the fixing of the cannula is subsequently reinforced by the fixation tape device (350i). Medication is planned subject to the authorization of authorized personnel (350j) and then automatically administered to the patient by a medicating device of the cannulation robot (350k). The end of the catheter is positioned in a seating in preparation of connecting to the hemodialysis machine (350l).

[0184] FIG. 9 shows an example embodiment of step 360 for the second venipuncture and cannulation of the skin of the arm to be cannulated:

[0185] The tool arm grabs the second cannula tool head equipped with the second preselected patient and/or treatment-dependent cannula (360a). The cannula head is positioned relative to the arm 30 and to the predetermined puncture site, in particular the angle of the cannula is thereby aligned relative to the skin surface at the puncture site in a predetermined manner (360b). The cannula is inserted into the skin and the fistula (cannulation; 360c). A priming step is automatically performed to test the fluid connection between the cannula and the fistula by means of an aspiration test (360d). The pressure in the cannula is checked by means of a pressure measuring device of the cannulation robot (360e). A fixation tape is provisionally positioned by means of a fixation tape device in order to provisionally immobilize the cannula and/or catheter (350f). The cannula head releases the cannula (360g), the fixing of the cannula is subsequently reinforced by the fixation tape device (360h). The end of the second catheter is positioned in another seating in preparation of connecting to the hemodialysis machine (360i).

[0186] FIG. 10 shows an example embodiment of hemodialysis step 370, with substeps carried out by means of appropriately designed optional system apparatus:

[0187] The arm is released from the fixation of the cannulation robot (330a). Additional equipment is connected, e.g. Fresenius VenAcc (330b). The readiness of the patient to be connected to the hemodialysis machine is indicated in the display (330c). The readiness of the medical personnel is awaited (330d). If their readiness is not registered (330e), steps 330c and 330d are repeated. After registering the readiness of the medical personnel, the connection to the hemodialysis machine is made (330f), hemodialysis started (330g) and performed (330h). At the end of the hemodialysis, its completion is displayed (330i); medical personnel are awaited (330j). If their readiness is not registered (330k), steps 330i and 330j are repeated. After registering the readiness of the medical personnel, data on the hemodialysis is displayed (330m), which the personnel can supplement if needed (330n) and redisplay. The data is ultimately added to the patient data and stored in the database 330o).

[0188] FIG. 11 shows an example embodiment of post-treatment step 380, with substeps carried out by means of appropriately designed optional system apparatus:

[0189] The arm of the patient is fixated (380a), the access tubes of the blood guiding system are closed in controlled manner under aseptic conditions (380b). The tubing set is removed (380c), the fixation tape is removed (380d), the cannulas are withdrawn and removed in controlled manner under aseptic conditions (380e). A swab is grasped (380f) and a gentle pressure applied to the puncture site with the swab (380g). The arm fixation is released (380h), a finish signal is displayed for the patient (380i). A cleaning and disinfection process is prompted to clean and disinfect the cannulation robot (380j). The cannulation robot is reset into a standby mode and its readiness for the next cannulation registered in the system and/or displayed (380k).