EP4133502A1 - Ensemble médical pour canulation - Google Patents

Ensemble médical pour canulation

Info

Publication number
EP4133502A1
EP4133502A1 EP21717084.4A EP21717084A EP4133502A1 EP 4133502 A1 EP4133502 A1 EP 4133502A1 EP 21717084 A EP21717084 A EP 21717084A EP 4133502 A1 EP4133502 A1 EP 4133502A1
Authority
EP
European Patent Office
Prior art keywords
time
patient
blood treatment
point
programmed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21717084.4A
Other languages
German (de)
English (en)
Inventor
Stefan Wegner
Reiner Spickermann
Klaus Balschat
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP4133502A1 publication Critical patent/EP4133502A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6072—Bar codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/609—Biometric patient identification means

Definitions

  • the present invention relates to a medical set according to claim 1 and a method according to claim 18, furthermore a digital storage medium according to claim 19, a computer program product according to claim 20 and a computer program according to claim 21 or according to each of the preambles or generic terms of these claims.
  • Extracorporeal blood treatment is known from practice.
  • blood is taken from the patient, which is transported extracorporeally along a blood circuit and z. B. is passed through a blood filter.
  • the patient's vessel usually a fistula or a shunt, is punctured ("cannulated") using cannula (s) and connected to line sections, which in turn are connected to the extracorporeal blood circuit at the beginning of the blood treatment session using suitable connectors can.
  • the patient's vessel is usually punctured in a preparation room, that is to say spatially separated from the blood treatment device by means of which the planned blood treatment is carried out later.
  • An object of the present invention can be seen in proposing a medical set and a method for determining a point in time of the puncture.
  • a digital storage medium, a computer program product and a computer program are to be specified.
  • the object according to the invention is achieved by a medical set with the features of claim 1 and a method with the features of claim 18.
  • a digital storage medium with the features of claim 19 a computer program product with the features of claim 20 and by a computer program with the features of claim 21.
  • the present invention relates to a medical set (hereinafter also for short: set), which a
  • User information device or can be separate therefrom.
  • the user information device of the set for its part has a determination device and an evaluation device, which can be two separate devices or a common device.
  • the determination device is programmed to determine a point in time which is related to the process of puncturing a blood vessel of a patient for whom a blood treatment by means of a blood treatment device is pending or planned in the near future.
  • the determination device is further programmed, this point in time to the evaluation device of the
  • the evaluation device is programmed to optionally send the determined point in time and / or the information related to the determined point in time to the transmission device of the to submit medical kits. As an alternative or in addition, it is programmed to determine a period of time based on the determined point in time and to transmit information relating to this certain period of time to the transmission device.
  • the transmitting device of the medical set according to the invention is programmed to receive this information. It is also programmed to send a signal relating to a point in time or period of time mentioned herein to at least one receiving device, which can be part of the set or independent of it.
  • the method according to the invention for determining a point in time or a period of time with reference to the puncture of a vessel (or the moment of puncturing) of a patient for the purpose of an upcoming or planned blood treatment by means of the blood treatment device comprises the step of providing a medical set according to the invention.
  • the method according to the invention further comprises at least one of the following steps: a. Inputting of the point in time of a puncture of a vessel of the patient that has taken place by the user; and / or b. Authenticating the user and / or the patient at or by means of the user information device; and / or c. Entering and / or specifying the point in time by means of the user information device at which the blood treatment device is (again) ready to start a or the next blood treatment, the Time entered by the user or determined by means of the control or regulating device of the blood treatment device.
  • Entered or transmitted information calculate all further times and / or periods of time mentioned herein and then transmit them to a device provided for this purpose for output and / or for further processing.
  • the present invention also comprises a corresponding programming or configuration of a suitable device or a section thereof, in particular for carrying out the method step in question.
  • the digital, in particular non-volatile, storage medium according to the invention in particular in the form of a machine-readable carrier, in particular in the form of a diskette, memory card, CD, DVD, EPROM, FRAM (Ferroelectric RAM) or SSD (Solid State Drive), in particular with electronic or optically readable control signals, can interact in such a way with a programmable hand-held and / or mobile receiver / transmitter of the user or patient, or for the user or patient, in particular their programmable computer system, that they are programmed or reprogrammed in a user information device of a medical set according to the invention will.
  • the computer program product according to the invention has a volatile, volatile program code or a signal wave stored on a machine-readable carrier to initiate the programming or reprogramming of a programmable hand-held and / or mobile receiver / transmitter of the user or the patient (or in each case for this), the z .
  • a smartphone, tablet, laptop or the like can be in a
  • a computer program product can be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. electronic device with a computer program), a network of computer-implemented computer programs (e.g. client / server system, cloud computing system, etc.) or a computer on which a computer program is loaded, runs, is stored, executed or developed.
  • a computer program stored on a carrier
  • an embedded system as a comprehensive system with a computer program
  • a network of computer-implemented computer programs e.g. client / server system, cloud computing system, etc.
  • a computer on which a computer program is loaded, runs, is stored, executed or developed.
  • machine-readable carrier denotes a carrier that contains data or information that can be interpreted by software and / or hardware.
  • the carrier can be a data carrier, such as a floppy disk, CD, DVD , a USB stick, a flash card, an SD card and the like, as well as any other storage device mentioned herein or any other storage medium mentioned herein.
  • a computer program according to the invention comprises a program code by means of which a programmable hand-held and / or mobile receiver / transmitter of the user or the patient (or each for them) is programmed or reprogrammed in a user information device of a medical set according to the invention when the computer program runs on a computer.
  • Embodiments according to the invention can have some, some or all of the following features in any combination, unless this is technically impossible for a person skilled in the art to recognize.
  • Advantageous further developments of the present invention are each also the subject matter of the subclaims.
  • the medical set has a blood treatment device with a control or regulating device, by means of which a blood treatment of the patient can be controlled or regulated using the blood treatment device.
  • the receiving device is a portable device, for example a hand-held and / or mobile receiver / transmitter, which is used herein e.g. B can be a smartphone.
  • the receiving device can be accessed by the patient or accessed by a user who, for example, belongs to the nursing staff or the medical profession.
  • both the patient and the user have access to one receiving device each.
  • the receiving device can optionally be a monitor, a display, a tablet or another hand-held device, for example a personal digital assistant (PDA), a beeper, a smartphone or the like.
  • PDA personal digital assistant
  • beeper a smartphone or the like.
  • the receiving device can serve to provide information, e.g. B. for their knowledge by the User or the patient, for example in the form of an input / output device or a display of the user information device.
  • control or regulating device of the blood treatment device can be, include, or map or assume its function.
  • the determined point in time indicates a point in time at which the (blood) vessel, e.g. B. the shunt that the patient was punctured.
  • the evaluation device is programmed to determine a period of time that has elapsed since the patient was punctured.
  • the evaluation device is programmed to determine the point in time, which corresponds to the end of a period of time defined as maximum permissible, after which it is not possible to connect the patient to the blood treatment device or to start the blood treatment session without further measures with regard to the punctured vessel and / or is not recommended without endangering the patient's welfare.
  • the period of time specified as the maximum permissible can be regarded as a period in which blood clotting in the cannulas and line sections, with which the patient is connected by means of puncture in advance of an upcoming blood treatment session, can be excluded according to predetermined criteria.
  • the determined point in time is a point in time in the future at which the blood treatment device is likely to be ready or ready again, according to predetermined criteria or according to the experience of the user, a new one
  • Begin blood treatment session the preparation of a blood treatment session takes some time, the so-called preparation or set-up time (removing or inserting disposables, disinfecting, rinsing, priming, reading in patient data and the like).
  • preparation or set-up time removing or inserting disposables, disinfecting, rinsing, priming, reading in patient data and the like.
  • the determined point in time of these embodiments if communicated early, can help to puncture the patient not too early, but also not too late.
  • the determined point in time is a point in time in the future at which the patient can be connected to the blood treatment device for the purpose of blood treatment as early as possible or may be connected as late as possible.
  • a suitable point in time or time period for the puncture of the patient can then be determined. This point in time / period is preferably determined according to certain criteria.
  • a point in time can be determined which corresponds to the beginning of the period defined as maximum permissible.
  • the beginning of the maximum permissible period defines the earliest possible point in time for a puncture of the patient.
  • the period specified as the maximum permissible can be in the future and through its beginning and / or its end can be determined or defined by these points. It can be understood here as a period of time within which the patient should be punctured in order to ensure that blood, which flows through the puncture into the cannulas connected to his vascular system and from these continuing line sections, then there until they are connected Line sections with the blood tubing set or the blood treatment device stands (i.e. no longer flows), will not clot and therefore the patient can be connected to the extracorporeal blood circuit of the blood treatment device at a later point in time by means of the connector of the line sections without the risk of blood clots.
  • the beginning of the blood treatment corresponds to the connection of the patient's vascular system to the extracorporeal blood circuit of the blood treatment device, for example by means of connectors provided for this purpose.
  • the predetermined criteria include or take into account the history of the specific patient.
  • the history includes, for example, the average time between cannulation and the start of treatment. B. was recorded and averaged over several treatment sessions. From this, among other things, typical behavioral patterns of the patient can be recorded (speed of movement, orientation, going to the toilet, etc.). Conversely, the average time can provide a clue as to when the patient who has just been cannulated in the preparation room is likely to be - or based on those who are identical or comparable to the specific patient Experiences made under the circumstances - e.g. B. will reach the treatment room.
  • a suitable point in time or period of time for the puncture of the patient can be determined, which also takes into account the history of the patient.
  • the history of the patient can consequently preferably also be taken into account when defining the specific criteria.
  • the user information device of the medical set in particular its input / output device, can be programmed in such a way that the determined point in time can be entered manually into it.
  • the manual input is preferably done by a user.
  • the point in time referred to herein as the determined point in time is determined by the medical set, in particular by means of the determination device of the user information device.
  • the medical set or its user information device is or comprises a hand-held and / or mobile receiver / transmitter.
  • the mobile receiver / transmitter can be assigned to the user and / or the patient, i. H. the user and / or the patient can each carry it with them or with them.
  • the receiver / transmitter is configured to only receive signals, in other embodiments it is configured to only transmit signals. In some embodiments, the receiver / transmitter is configured to send and receive signals. In some embodiments, the determination device of the set is configured and / or programmed to automatically determine the point in time at which the patient's vessel was punctured.
  • sensor assemblies such. B. optical sensors, cameras or the like, and one or more these associated time recording device (s), for example in the form of a clock, can be provided.
  • the medical kit includes an identification device.
  • the identification device can be programmed or configured to link information on the determined point in time and / or on the specific period of time with information on the identity of the punctured patient, e.g. B. in a data record.
  • the identification device can be part of the user information device or independently thereof.
  • Identification device programmed or configured for detecting a QR code (Quick Response) or the like.
  • the identification device can be programmed to record biometric data, i. H. it is provided, for example, for reading in a fingerprint, for performing an iris scan, for face recognition or the like.
  • the identification device is programmed or configured to assign information on the identity in an anonymized manner to the determined point in time or to the specific period of time. This can be done, for example, by the patient wearing a bracelet with a QR code that has only been assigned once. The user can scan this code, e.g. B. after the puncture, whereby, for example, the time of the puncture would be linked to the QR code, but not necessarily to the real name of the patient.
  • Blood treatment device this patient can then be identified again by scanning the QR code again.
  • the determined point in time can thus be assigned to the specific patient without errors.
  • a radio frequency identification tag (RFID tag) can also be provided for identification in certain embodiments together with a sensor arrangement suitable for this purpose.
  • the user information device, its identification device and / or the identification device are programmed or configured to allow data entry or manipulation, i. H. to allow a change or deletion of the corresponding values, in particular the information relating to the determined point in time, the determined period, the maximum permissible period and / or the like, only after successful authentication of the user and / or the patient.
  • the user information device is part of the blood treatment device.
  • the control or regulating device of the blood treatment device is programmed or configured to at least temporarily block the execution of at least one function of the blood treatment device on the basis of the reception of the signal from the transmission device. In this case, blocking takes place in particular when the duration of the specific period between the determined point in time and the current time exceeds the duration of the period defined as maximum permissible, which can be represented by the signal.
  • the blood treatment device and / or the receiver / transmitter of the user or of the patient are programmed to display a recommendation for or against a blood treatment based on the reception of the signal from the transmitter device. This can be done on a visual indicator, e.g. B. a display, but also as a pure color signal, z. B. by means of LEDs that switch, for example, from green to red, the signal from the transmitting device should show that the period of time specified as the maximum permissible has been exceeded.
  • a visual indicator e.g. B. a display, but also as a pure color signal, z. B. by means of LEDs that switch, for example, from green to red, the signal from the transmitting device should show that the period of time specified as the maximum permissible has been exceeded.
  • these devices can be programmed to indicate any measures to be taken, for example rinsing or re-cannulation, or to prompt them to do so.
  • the medical kit is or includes a portable device.
  • the medical set or a part thereof for example the user information device, has a data connection to a central or distributed computing unit, for example via WLAN, WiFi, Bluetooth, Near Field Communication (NFC), cellular radio, etc.
  • a central or distributed computing unit for example via WLAN, WiFi, Bluetooth, Near Field Communication (NFC), cellular radio, etc.
  • the medical set is a personal smartphone of the patient or comprises one which is programmed for the above-mentioned tasks.
  • a corresponding software application can use the means provided by this device for authentication (unlocking the screen with fingerprint sensor, camera, PIN code, password, entering a pattern and the like) to both the patient and, optionally, the user , i.e. the supervising medical professional, to clearly identify or to check their authorization.
  • the respective functionalities of the application can be accessed or activated, for example the possibility of manually entering the puncture time as the determined time.
  • the control device of the blood treatment device is programmed to upgrade the blood treatment device prior to a blood treatment and the blood treatment or steps thereof to initiate or trigger (e.g. by notifying the user), to control, to control or to regulate. Since the blood treatment device is thus aware of the remaining time z. Until the end of the current blood treatment session, until the completion of its upgrade for the next treatment session, until a possible start of the next patient's blood treatment session, etc., it may e.g. B. by means of suitable, above-mentioned programming, a corresponding indication (or signal) at the appropriate time when it is ready for the subsequent treatment session, or when the vessel of the next patient should optimally be punctured.
  • the patient's whereabouts within the treatment rooms can be tracked and his identity can be verified, for example using a Real Time Location System (RTLS) that is programmed to determine the patient's proximity to certain devices , in particular to sensor arrangements provided for this purpose and / or to the blood treatment device.
  • RTLS Real Time Location System
  • This continuous monitoring can be used to determine the patient-related points in time, for example to determine the point in time of the puncturing and the point in time of its appearance on the blood treatment device assigned to it for the blood treatment.
  • the data of the clinic's treatment plan for the corresponding day e.g. B. by means of the network or IT system of the clinic, used for processing, which advantageously leads to an optimized sequence of successive or parallel blood treatment sessions.
  • it is provided to adapt or optimize existing treatment schedules on the basis of the patient-related points in time that have been determined. If, for example, it is foreseeable that a specifically observed patient will come to a blood treatment device later than noted for him in the treatment schedule, in view of the point in time of his cannulation, an ongoing treatment, i.e.
  • a treatment currently carried out using this treatment device and still ongoing may be in favor of the currently treated one Patients last longer than originally set in the treatment schedule (for example, due to changed settings on the blood treatment device, which can affect the currently ongoing treatment session). For the patient currently being treated, this can mean a more effective and / or gentler treatment session. Conversely, if the patient under consideration is cannulated prematurely, an ongoing treatment session of the currently treated patient - if this is suitable - can be shortened or brought to an early end (for example by increasing the blood and / or dialysate flow or increasing the ultrafiltration rate).
  • the premature patient can be treated without a long waiting time and thus without the risk of a mandatory re-puncture.
  • the patient who is being treated "accelerated” can either be discharged if medically justifiable with a treatment goal (kT / V or ultrafiltration volume) that has not been achieved, which is compensated for by a subsequent blood treatment session, or he can be replaced by changed therapy parameters (see above) achieve the treatment goal faster.
  • a treatment goal kT / V or ultrafiltration volume
  • the determined point in time can thus influence the treatment session of at least one patient.
  • the medical set can be provided or programmed accordingly for this purpose.
  • the invention or kit does not include a device programmed to recognize a needle and / or does not include its use.
  • the invention or the set does not include a motion detection device and / or does not use the same.
  • the invention or kit does not include a device programmed to puncture a vessel, e.g. B. no cannulation robot or automat, and / or not their use.
  • Such events can include, for example, delays in a patient treated immediately beforehand on the same blood treatment device, delays in performing hygienic measures, delays by the patient himself, for example because of restricted mobility, because of going to the toilet or because of personal discomfort.
  • the lack of staff is also a common reason for such delays.
  • the duration of this period between the puncturing and the start of treatment is a coagulation of the Blood in the cannula (s) or in the line sections connected to them possible, which makes further measures necessary before the pending blood treatment of the patient can actually be started.
  • Blood treatment device may be connected. This question can advantageously be answered by means of the present invention.
  • the present invention can e.g. B. by recording the period of time that has passed since the patient's vessel was punctured, and due to the fact that this period of time is known to the user at the blood treatment device, ensure that at the time of starting the blood treatment by means of the blood treatment device based on empirical values In all likelihood, blood clotting has not yet taken place in the cannulas and the connected pipe sections. Otherwise, optionally prompted by a note of the medical set, the cannulas are replaced and / or rinsed before the blood treatment session, which would have to be interrupted or interrupted again in the event of a late detection of coagulation.
  • the invention not only can patient safety be increased, but the time required for the upcoming blood treatment session can also be made predictable.
  • patient-related histories can be created using the determined data, for example with regard to the blood clotting time and thus indirectly for the period defined as maximum permissible, and / or statistical evaluations, for example with regard to the reasons for delays that have occurred.
  • FIG. 1 shows a simplified representation of a blood treatment device as an optional component of a first embodiment of a medical set according to the invention
  • FIG. 2 shows, in a simplified representation, a medical set according to the invention in a second embodiment
  • FIG. 3 shows, in a greatly simplified representation, the time sequence of the method according to the invention in a first embodiment
  • FIG. 4 shows, in a simplified representation, a medical set according to the invention in a third embodiment
  • FIG. 5 shows, in a greatly simplified representation, the time sequence of the method according to the invention in a second embodiment.
  • Fig. 1 shows a simplified representation
  • Blood treatment device as an optional part of a first embodiment of a medical set according to the invention.
  • Blood treatment device 100 optionally connected to an extracorporeal blood circuit 300 and a
  • Drain hose system to an optional effluent bag 400.
  • the extracorporeal blood circuit 300 has a first line 301, here in the form of an arterial line section.
  • the first line 301 is in fluid connection with a blood treatment device, here by way of example a blood filter or dialyzer 303.
  • the blood filter 303 has a dialysis fluid chamber 303a, through which dialysis fluid is passed in use, and a blood chamber 303b, through which blood is passed in use.
  • the dialysis chamber 303a and the blood chamber 303b are mostly separated from one another by means of a semi-permeable membrane 303c. Blood and dialysis fluid are mostly passed through the blood filter 303 using the countercurrent principle.
  • the blood is purified in the blood filter 303.
  • the extracorporeal blood circuit 300 also has at least one second line 305, here in the form of a venous line section.
  • Both the first line 301 and the second line 305 serve to connect them to the vascular system of the patient P (on the left in FIG. 1).
  • a connector 308 is provided on the second line 305.
  • corresponding connectors 307 ′ and 308 ′ are provided for connecting the patient P or his vascular system to the extracorporeal blood circuit 300.
  • the first line 301 is optionally connected to a (first) hose clamp 302 for blocking or closing the line 301.
  • the second line 305 is optionally connected to a (second) hose clamp 306 for blocking or closing the line 305.
  • the blood treatment device 100 which is represented schematically only by some of its devices and in FIG. 1, has a blood pump 101.
  • the blood pump 101 conveys blood through sections of the extracorporeal blood circuit 300 and in the direction of the blood filter or dialyzer 303, as indicated by the small arrowheads which generally indicate the direction of flow in each of the figures.
  • a pump for dialysis fluid 121 which can be designed as a roller pump or as another occluding pump, fresh dialysis fluid is drawn from a source 200 along the
  • Dialysis fluid supply line 104 is pumped into the dialysis fluid chamber 303a. The dialysis fluid leaves the
  • Dialysis fluid chamber 303a as dialysate, possibly enriched by filtrate, in the direction of the effluent bag 400.
  • the filtrate can comprise water that was withdrawn from the blood in the blood filter.
  • Dialysate and filtrate are referred to individually or collectively as effluent.
  • the effluent is immediately discarded by means of a dialysate drain line 102 or, especially in the case of acute treatment, is supplied to the effluent bag 400 and initially stored therein.
  • the effluent is removed from the effluent bag 400 by means of a pouring line 403, e.g. B. discarded in a sink or a differently designed sink 600.
  • the source 200 can be, for example, a bag or a container.
  • the source 200 may also be a fluid line from which on-line and / or continuously generated or mixed liquid is provided, e.g. B. a hydraulic outlet or connection of the blood treatment device 100.
  • a further source 201 with a substituate can optionally be provided. It can correspond to the source 200 or be a separate source.
  • each optional pumps namely the pump 111 for substituate, the pump 121 for dialysis fluid and the pump 131 for the effluent.
  • the optional pump 111 is provided to draw substituate out of the optional source 201, for example a bag and to supply the second line 305 with a heating bag via an optionally available bag heater HI.
  • the pump 121 is provided in order to supply dialysis fluid from a source 200, for example a bag, and via an optionally available bag heater H2 with a heating bag to the blood filter 303 by means of the dialysis fluid supply line 104.
  • the dialysis fluid supplied in this way emerges again from the blood filter 303 via the dialysate drain line 102, supported by the optional pump 131, and can be discarded.
  • An optional arterial sensor PSI is provided upstream of the blood pump 101. During treatment of the patient, it measures the pressure in the arterial line.
  • a further, optional pressure sensor PS2 is provided downstream of the blood pump 101, but upstream of the blood filter 303 and, if provided, upstream of an addition point 25 for heparin. It measures the pressure upstream of the blood filter 303 (“pre-hemofilter”).
  • Yet another pressure sensor can be provided as PS4 downstream of the blood filter 303, but preferably upstream of the pump 131, in the dialysate drain line 102 for measuring the filtrate pressure of the blood filter 303.
  • Blood leaving the blood filter 303 flows through an optional venous blood chamber 29, which has a venting device 31 and / or another May have pressure sensor PS3. The blood is then returned to the patient (reinfused).
  • a control or regulating device 150 which is only indicated, can be configured to regulate or control the blood treatment device 100 for the purpose of a blood treatment session. In this example it is part of the
  • Blood treatment device 100 In some embodiments, the control or regulating device 150 can also be present separately from the blood treatment device 100.
  • the control or regulating device 150 can be in wired or wireless signal connection with any of the components of the medical set mentioned herein.
  • Fig. 1 also shows two users U1 and U2. They can be part of the medical nursing staff or a doctor.
  • the user U1 is involved in the preparation of the blood treatment, for example by having the vessel of the patient P punctured in preparation for the blood treatment, for example in a preparation room, that is to say e.g. B. a room separated from the treatment room (indicated on the right in FIG. 1) in which the treatment will take place (indicated on the left in FIG. 1).
  • FIG. 2 shows a simplified illustration of a medical set according to the invention in a first embodiment.
  • the blood treatment device 100 optionally included in the set is only indicated schematically here, unlike in FIG. 1.
  • a user information device 500 of the set which by way of example can be or include the smartphone of the patient P, comprises in the embodiment of FIG. 2, optionally in each case, an identification device 507, a determination device 501, an evaluation device 509, an input / output device 503 for input and / or output of information, a time recording device 505 and / or a transmission device 160.
  • the determination device 501 is used
  • User information device 500 for determining the point in time tp at which the patient P's vessel was punctured also: cannulated.
  • a large number of configurations and possible uses of the determination device 501 are contemplated according to the invention. Some of these embodiments are described below with reference to FIG. 2.
  • the determination device 501 can be configured to detect the puncture of the vessel of the patient P, preferably automatically, and thus to determine and / or to determine the point in time tp (see FIG. 3) at which the puncture took place, preferably also automatically deposit.
  • the detection can take place, for example, by means of sensors of the user information device 500 or by means of other devices of the medical set. They can be provided, for example, in or on the puncture bed or the chair or for their monitoring, on which / on which the patient P usually sits down for the puncture of his vessel. Suitable sensors can respond to pressure or changes in pressure (e.g. due to changes in Weight on the patient bed or the chair by the patient P who has sat on it), react to heat radiation from the patient P in the immediate vicinity of the patient bed or the chair, etc. Suitable sensors can be optical sensors, such as cameras, which detect the presence of the patient P, e.g. B. on the puncture table or chair can determine.
  • the point in time tp can be determined as a first, but sufficient approximation, for example, as the point in time at which the patient P z. B. lies down on the puncture table or sits on the chair or leaves it again.
  • An optional sensor 551 which is present at a fistula or puncture site 250 of the patient P, can also be detected automatically.
  • the sensor 551 can be an optical sensor which checks whether blood is present in the line sections 301 ', 305'. However, it can also be another sensor that can detect a puncture that has taken place, for example a pressure sensor.
  • the sensor 551 is present here by way of example in a likewise optional puncture transmission device 550, which can send the message about a successful puncture to the user information device 500 or its determination device 501.
  • the corresponding transmission can take place wirelessly, for example via NFC, RFID or Bluetooth, or other wireless or wired methods.
  • the aforementioned sensor 551 can be part of a cannulation robot for the automatic and / or mechanical puncture of a vessel of the patient P.
  • a robot is optionally part of the medical set. He can be configured as disclosed in DE 102017 201 434 A1, US 2019/0374700 A1, EP 0654 244 B1, US 2015/0065916 A1 or WO 2015/052719 A1, the disclosures of which are fully part of the present disclosure by reference.
  • Determination device 501 as described above, this can be in signal connection with the optional time recording device 505.
  • the time recording device 505 can be or have a clock and / or it can be provided to be in signal connection with an external clock (not shown in FIG. 2), for example a network clock, a station clock or an atomic clock.
  • the determination device 501 can be informed by manual input by the user U1 on the input / output device 503 that the Patient P was punctured at time t p. It can thus be provided that the user U1 actively enters the point in time t p into the input / output device 503 configured as a touchscreen, keyboard input or the like, which z. B. the touch screen or the display of a smartphone of the patient P can be.
  • Determination device 501 can be programmed to read in or take over time t p thus entered.
  • the time tp is transmitted from the determination device 501 to the evaluation device 509.
  • the evaluation device 509 is used
  • User information device 500 to forward the point in time tp and / or further information based on the point in time tp to the sending device 160 so that it can be sent by the latter to one or more receiving devices as described below.
  • the information based on the point in time tp can include the end point in time t2 of a period T max defined by the set or user Ul as a maximum permissible, or further information on points in time which the set or the user Ul based on such a period T max were determined.
  • the time period referred to herein as T max is determined by the time period between two points in time t1 or t2 (see also FIG. 3), with point in time t1 being the point in time from which the patient's blood first enters the cannulas or the line sections 301 'or 305 'is present, while the point in time t2 is the point in time from which the occurrence of blood coagulation in the line sections 301' or 305 'is to be expected.
  • the length of the time period T max can be known from empirical values, look-up table (s), etc., which can preferably be shortened by a safety time buffer.
  • the end of the time period T max thus advantageously indicates the point in time up to which no blood coagulation is to be expected in the cannulas or the line sections 301 'or 305'.
  • t p tl
  • the information generated by the evaluation device 509 can consist, for example, of the end of the period T max , i.e. the point in time t2, or comprise this, since this corresponds to the point in time after which a blood treatment can no longer be started without further ado, possibly without the benefit of the Endangering the patient.
  • the information can relate to a period T which lies between the point in time tp of the puncture and a current time, and the information as to whether the duration of the period T is less than the duration of the period T max , i.e. T ⁇ T max applies, that is, whether a blood treatment could be started at the current time without any concerns about blood clotting.
  • the information generated by the evaluation device 509 can optionally include information on the identity of the patient P and / or on his authentication. As an alternative or in addition, information on the authentication of the user U1 or U2 can optionally be included according to the invention.
  • the identity of the patient P can be determined by means of the identification device 507.
  • Information relating to the identity can be linked to information on the determined point in time tp or to information that was determined or calculated on the basis of this. It can thus be ensured that a point in time tp is not inadvertently assigned to a patient P other than the patient P who was actually punctured or still to be punctured at the point in time t p.
  • a comparatively simple type of identification is, for example, the unlocking of the patient P's smartphone when the smartphone is used as a
  • User information device 500 or as part thereof is used, because it can be assumed that such unlocking cannot be effected by any other patient in the clinic than patient P.
  • Information about the identity can be anonymized, for example by assigning a QR code, a fingerprint or the like.
  • the information generated by the evaluation device 509 is transmitted to the transmission device 160.
  • the sending device 160 is configured to send the information it has received from the evaluation device 509 to a receiving device, for example the input / output device 503, for example a display of the user information device 500, and / or to at least one receiver / transmitter 170 of the user U1 or U2, for example its smartphone, beeper or tablet, to be sent or passed on for information by this and / or to the control or regulating device 150 or another device of the blood treatment device 100.
  • a receiving device for example the input / output device 503, for example a display of the user information device 500, and / or to at least one receiver / transmitter 170 of the user U1 or U2, for example its smartphone, beeper or tablet, to be sent or passed on for information by this and / or to the control or regulating device 150 or another device of the blood treatment device 100.
  • the control or regulating device 150 or the other device of the blood treatment device 100 can be configured to receive the aforementioned information from the transmitting device 160, in particular the time tp of the puncture of the patient P, preferably additional information on the identity of the patient P.
  • the control or regulating device 150 can also be programmed to recognize that the patient P is to be connected to the blood treatment device 100 for the purpose of blood treatment, B. on the basis of the information transmitted to it on identity may be possible.
  • the point in time at which its treatment session is to begin is referred to herein as point in time t ⁇ .
  • the blood treatment device 100 or its control or regulating device 150 can be programmed in various ways to recognize that the patient P is now waiting for blood treatment by means of the blood treatment device 100.
  • One simple way is for the user U2 to enter personal data of the patient P such as his name, insurance data, previous treatment settings, etc. on the blood treatment device 100 or to have it entered by the latter, for example from a patient card.
  • the blood treatment device 100 or its control or regulating device 150 is programmed to recognize the proximity of the punctured patient P and to determine or determine the point in time of the recognition as point in time t ß at which the start of the blood treatment session is imminent. to be determined and transmitted to the evaluation device 509.
  • the detection takes place, for example, by means of sensors, e.g. B. motion sensors and / or camera.
  • the evaluation device 509 By transmitting the time t ß , the evaluation device 509 is made possible to relate the times tp and t ß of the specific patient P and evaluate whether the time t ß is still within the time period T max , that is, whether tl dt ß ⁇ t2 applies.
  • the evaluation device 509 can determine the period T that has passed between the point in time tp of the puncture and the point in time t ß (as the current time) and whether the duration of the period T is still less than the duration of the period T defined as the maximum permissible max is (T ⁇ T max ).
  • the evaluation device 509 is programmed to transmit the result of its evaluation to the transmission device 160, which in turn sends this evaluation and / or the consequence of this evaluation to at least one receiver / transmitter 170 of the user (U1, U2) and / or of the patient P and / or to the control or regulating device 150 of
  • Blood treatment device 100 transmitted.
  • the consequence of the evaluation is a go or stop signal for the user (U1, U2) to take note of or in the direction of the control or regulating device 150.
  • the patient P can, without concern about blood clotting in the line sections 301 ', 305 'can be connected to the lines 301, 305 of the extracorporeal blood circuit 300 for the purpose of blood treatment by means of the corresponding connectors 307', 308 ', and the control or regulating device 150 can initiate the blood treatment.
  • the time t ß lies after the time t2, ie after the end of the maximum permissible period T max ( ie t ß > t2) or the duration of the period T is greater than the duration of the period T max ( ie
  • T> T max it can be determined that a blood treatment by means of the blood treatment device 100 may not take place, since blood clotting in the cannulas or the line sections 301 ', 305' of the patient P cannot be ruled out.
  • Control device 150 can block the blood treatment of patient P in this case.
  • control or regulating device 150 can provide an indication of what action is to be taken before the start of the planned
  • Blood treatment session is to be carried out, for example, whether the patient P is to be re-punctured, whether the cannula (s) and the line sections 301 ', 305' are to be rinsed, or the like.
  • the evaluation device 509 is connected downstream of the determination device 501 and can determine and / or add further information to the information transmitted to it by the determination device 501. In some embodiments, however, the latter is not the case, rather the function of the evaluation device 509 is limited to merely forwarding results to the determination device 501. In such cases in particular, evaluation device 509 and determination device 501 can be designed by a common device. In other embodiments, evaluation device 509 and determination device 501 are devices configured separately from one another.
  • Fig. 3 shows, in a greatly simplified representation, the time sequence of the method according to the invention in a first embodiment.
  • the vessel or vessels of the patient P are punctured, and the point in time tp at which this occurs or is considered to have occurred is determined by the
  • Determination device 501 (see FIG. 2) determined. This can be done automatically, for example by means of optical sensors or cameras, or by the user U1 manually entering the corresponding point in time tp of the puncture, for example via the input / output device 503 of FIG.
  • User information device 500 or the like.
  • Line sections 301 ', 305' should no blood coagulation have occurred. Since this can no longer be guaranteed after the end of this, that is to say after time t2, a blood treatment should no longer be started for the patient P in question after time t2 for reasons of patient safety.
  • the point in time t ⁇ is recorded, analogously to the manner described in connection with FIG. 2, at which the patient P is in the vicinity of the Blood treatment device 100, the patient is to be connected to the blood treatment device 100 or the treatment is to begin.
  • This point in time is designated in FIG. 3 by t ß for a first case and by t ß 'for a second case.
  • time t ß this is still within the time period T max previously defined as maximum permissible (see FIG. 3 above), that is to say before its end t2. Accordingly, the control or regulating device 150 can cause the blood treatment device 100 to start the blood treatment for the patient P for the reasons mentioned above.
  • T max previously defined as maximum permissible
  • Control device 150 was determined outside the time period T max previously defined as maximum permissible (see FIG. 3 below), that is to say after its end t2. Accordingly, the control or regulating device 150 in this embodiment will block the blood treatment device 100, e.g. B. in such a way that no blood treatment can be started, or the user U2 refrains from connecting the patient to the blood treatment device 100 without further measures. In this case, the patient P z. B. first punctured again or the line sections 301 ', 305' are flushed in order to avoid complications during the blood treatment.
  • FIG. 4 shows a simplified illustration of a medical set according to the invention in a second embodiment. As in FIG. 2, the blood treatment device 100 optionally included in the set is only indicated schematically in FIG. 4.
  • User information device 500 and its devices can also be used without restriction in the
  • User information device 500 of FIG. 4 can be implemented.
  • the user information device 500 of the set comprises, optionally, a determination device 501, an evaluation device 509, an input / output device 503, a time recording device 505 and / or a transmission device 160.
  • the determination device 501 is used
  • User information device 500 for determining a suitable point in time tp or time period T max for puncturing the patient P's vessel.
  • T max time period for puncturing the patient P's vessel.
  • the determination device 501 can be configured to determine, at an upstream point in time t0, a point in time U B in the future at which the
  • Blood treatment device 100 is expected to be ready for the start of the blood treatment session planned for patient P.
  • the point in time t ⁇ may have been transmitted to the determination device 501 (directly or indirectly), preferably automatically, by the control or regulating device 150 of the blood treatment device 100. So z. B. with the beginning of the blood return towards the end of the treatment session of the previous patient P, at the beginning of the priming of the blood tubing set intended for the treatment session of the patient P, etc., a message is sent to the determination device 501 as to when the blood treatment device 100 is to start the blood treatment of the patient P will be available.
  • the detection of the time t ß at which the blood treatment device 100 will be available for the start of the planned blood treatment of the patient P also through active manual input at the time t0, for example by the user U2 a receiver / transmitter 170 (not shown in FIG. 4).
  • the determination device 501 can be programmed to read in or take over the time t ß transmitted or entered in this way and to transmit it to the evaluation device 509.
  • the evaluation device 509 is used
  • User information device 500 for this purpose, based on the time t ß determined as above and the maximum permissible time period T max to information generate, which relate to a suitable point in time tl, at or from which it makes sense to puncture the patient P with a view to avoiding blood clotting for the upcoming blood treatment.
  • the point in time t1 can subsequently be transmitted to the transmission device 160.
  • the point in time of the puncture tp is advantageously in the period of time T max , that is to say between the points in time t1 and t2 with a period of time T as the interval from the point in time t ß , where T ⁇ T max .
  • the sending device 160 is configured to send the information about the point in time t1, which it received from the evaluation device 509, to devices provided for this purpose, which are provided to output this. These devices can, for example, the input / output device 503 of FIG.
  • User information device 500 for example a display, and / or the receiver / transmitter 170 of the user Ul or U2, for example its beeper, smartphone or tablet.
  • a device can be accessed by the patient P, for example as his smartphone.
  • Fig. 5 shows, in a greatly simplified representation, the time sequence of the method according to the invention in a second embodiment.
  • the control or regulating device 150 of the blood treatment device 100 transmits information about the status of the blood treatment device 100 to the determination device 501, in particular information about the future time t ß at which the blood treatment device 100 is used for the blood treatment of the patient P. can be started (see Fig. 4).
  • a point in time t1 can be determined by means of the evaluation device based on the point in time t ⁇ , which in this embodiment is set equal to the end t2 of a suitable time period T.
  • the point in time t1 and each subsequent point in time within the maximum permissible period T max is suitable for puncturing the vessels of the patient P. Puncturing after the determined point in time t1 or within the determined time period T max can ensure that the patient P's blood does not coagulate in the cannulas and the line sections 301 ', 305' while the patient P is waiting for the start of the blood treatment.
  • first line (arterial line section)
  • PSI PSI, PS2 arterial pressure sensor (optional)
  • Tmax defined as the maximum permissible period

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Abstract

La présente invention concerne un ensemble médical comprenant un dispositif émetteur (160) et un dispositif d'informations utilisateur (500). Le dispositif d'information d'utilisateur (150) comporte à son tour un dispositif de détermination (501) et un dispositif d'évaluation (509). Le dispositif de détermination (501) est programmé pour déterminer un point temporel se rapportant au processus de perforation d'un vaisseau d'un patient (P) au point temporel (tP, tB) dans le but d'un traitement du sang imminent ou planifié au moyen du dispositif de traitement du sang (100) et pour transmettre le point temporel (tP, tB) au dispositif d'évaluation (509). Le dispositif d'évaluation (509) est programmé pour transmettre des informations concernant le point temporel déterminé (tP, tB) au dispositif émetteur (160) et/ou programmé pour déterminer une période de temps (T, Tmax) sur la base du point temporel déterminé (tP, tB) et pour transmettre les informations concernant la période de temps déterminée (T, Tmax) au dispositif émetteur (160). Le dispositif émetteur (160) est programmé pour recevoir les informations et pour transmettre un signal concernant le point temporel ou la période de temps (T, Tmax) à un dispositif récepteur.
EP21717084.4A 2020-04-10 2021-04-08 Ensemble médical pour canulation Pending EP4133502A1 (fr)

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DE102020110112.0A DE102020110112A1 (de) 2020-04-10 2020-04-10 Medizinisches Set für Kanülierung
US17/173,011 US11925742B2 (en) 2020-04-10 2021-02-10 Cannulation time tracking
PCT/EP2021/059160 WO2021204937A1 (fr) 2020-04-10 2021-04-08 Ensemble médical pour canulation

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IL107523A (en) 1993-11-07 2000-01-31 Ultraguide Ltd Articulated needle guide for ultrasound imaging and method of using same
DE102010008479A1 (de) 2010-02-18 2011-08-18 Fresenius Medical Care Deutschland GmbH, 61352 Verfahren zum Handhaben von Daten eines Patienten, medizinische Behandlungsvorrichtung und computerlesbares Speichermedium
MX344664B (es) * 2011-05-24 2017-01-04 Deka Products Lp Sistemas y metodos de tratamiento de la sangre.
DE102013002231A1 (de) 2013-02-11 2014-08-14 Fresenius Medical Care Deutschland Gmbh Vorrichtung und Verfahren zur Erzeugung und Anzeige von für medizinische Geräte und medizinische Behandlungen spezifischen Grafikkodierungen
US20150065916A1 (en) 2013-08-29 2015-03-05 Vasculogic, Llc Fully automated vascular imaging and access system
DE102013111084A1 (de) 2013-10-07 2015-04-09 B. Braun Avitum Ag Dialysevorrichtung mit Bewegungserfassungseinrichtung und Gestensteuerung
CN105813585B (zh) 2013-10-07 2020-01-10 泰克尼恩研究和发展基金有限公司 通过杆操纵实现的针转向
KR20230037063A (ko) * 2014-06-03 2023-03-15 암겐 인코포레이티드 제어 가능한 약물 전달 시스템 및 사용 방법
DE102017201440B3 (de) 2017-01-30 2018-05-30 Fresenius Medical Care Deutschland Gmbh Kanülierautomat zur Erkennung und Manipulation eines Blutgefäßes, sowie entsprechendes Verfahren
DE102017201434A1 (de) 2017-01-30 2018-08-02 Fresenius Medical Care Deutschland Gmbh Kanülierautomat
DE102017201437A1 (de) 2017-01-30 2018-08-02 Fresenius Medical Care Deutschland Gmbh System und Verfahren zur automatisierten Kanülierung
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US10603479B2 (en) * 2018-08-28 2020-03-31 Access For Life Inc. Vascular access device and method

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US20210316059A1 (en) 2021-10-14
US11925742B2 (en) 2024-03-12
WO2021204937A1 (fr) 2021-10-14
DE102020110112A1 (de) 2021-10-14

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