JP2016193119A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of causing biological information measurement means to accurately measure biological information and detect separation of access means from a patient, and improving workability before treatment.SOLUTION: In a medical device including a vein side puncture needle b that can puncture a patient, a blood purification device 1 capable of circulating blood of the patient through the vein side puncture needle b, and electrocardiogram measurement means 2, 3 capable of measuring electrocardiogram information on the patient, the electrocardiogram measurement means 2 is formed in a stationary portion M integrated with the vein side puncture needle b, and based on the measurement value acquired by the electrocardiogram measurement means 2, can detect separation of the vein side puncture needle b from the patient.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an access means comprising a puncture needle that can be punctured by a patient or a catheter that can be inserted into a blood vessel of a patient, and the circulation through which the patient's blood can be circulated or a liquid such as a drug can be injected into the patient via the access means. The present invention relates to a medical device including a treatment apparatus having a path and biological information measuring means capable of measuring biological information of a patient.

  In general, in dialysis treatment, a blood circuit for circulating a patient's blood extracorporeally, a dialyzer connected in the middle of the blood circuit, an iron-type blood pump, and a dialyzer are introduced or led out. A dialysis treatment apparatus having a dialysis apparatus main body that can be dehydrated while performing hemodialysis treatment is used. Since the dialysis treatment performed by such a dialysis treatment apparatus is usually performed for about 4 hours every other day, the hemodynamics of the patient being treated changes greatly. In particular, the removal of excess water (water removal) It is an important issue to effectively and reliably prevent the decrease in blood pressure due to.

  In addition, patients who need dialysis treatment often have cardiovascular complications such as arrhythmia, so it is necessary to understand the circulatory abnormalities and their causes by monitoring heart rate and pulse rate. is there. An electrocardiograph capable of measuring an electrocardiogram is generally used as a means for monitoring information related to the heart rate and pulse of the patient. For example, during blood purification treatment, at least a pair of electrodes (electrocardiogram measuring means) ) Are closely attached, and the electrocardiogram of the patient is measured from the potential of these electrodes.

  On the other hand, in the blood purification treatment, the patient is punctured with an arterial puncture needle and a vein puncture needle, the patient's blood is collected from the arterial puncture needle and subjected to extracorporeal circulation in the blood circuit, followed by blood purification treatment. It is necessary to return the blood to the patient from the venous puncture needle. However, in the process of circulating blood extracorporeally, the puncture needle may be unintentionally removed from the puncture portion of the patient due to body movement, for example, and the blood may leak to the outside, particularly in the case of the venous puncture needle. is there. In order to detect such detachment of the puncture needle, conventionally, blood leaking from the puncture needle has been detected by a blood leakage sensor or the like (see, for example, Patent Document 1).

Special table 2013-530753 gazette

  However, in the above prior art, a sensor for measuring biological information such as an electrocardiogram and a sensor for detecting blood leakage are required, and a plurality of sensors are required for each object to be measured and detected. For this reason, there is a problem that the cost is increased, and it is necessary to attach the plurality of electrodes and sensors before the treatment, and the workability before the treatment is deteriorated. In order to detect blood leakage during treatment, blood leaked from the puncture needle needs to touch the blood leakage sensor, but it does not necessarily leak to the place where the blood leakage sensor is located. It is difficult to detect. The above-mentioned problem is not limited to blood purification treatment, but is also the same in, for example, infusion treatment in which a catheter is inserted into a patient's blood vessel to administer a drug or the like into the patient's body (however, in this case, the infusion fluid leaks) Will occur.

  The present invention has been made in view of such circumstances, and allows the biological information measuring means to accurately measure the biological information and detect the access means to be detached from the patient, and can also perform pre-treatment and treatment. An object of the present invention is to provide a medical device capable of improving workability at the time (including blood return in blood purification treatment).

  According to the first aspect of the present invention, there is provided an access means comprising a puncture needle that can be punctured by a patient or a catheter that can be inserted into a blood vessel of the patient, and the patient's blood is circulated through the access means or a liquid such as a medicine is given to the patient. In a medical device comprising a treatment device having a flow path that can be injected and a biological information measuring means capable of measuring biological information of a patient, the biological information measuring means is a fixed part integrated with the access means The access means can be detected to be detached from the patient based on the measurement value obtained by the biological information measurement means.

  According to a second aspect of the present invention, in the medical device according to the first aspect, at least one of the biological information measuring means is formed on the fixing portion, and each of the biological information measuring means obtained by the one or more biological information measuring means is provided. The access means can be detected to be detached from the patient based on the measured value.

  According to a third aspect of the present invention, in the medical device according to the first or second aspect, the fixing portion on which the biological information measuring means is formed protrudes laterally to fix the access means to the patient. It is characterized by comprising a fixed wing portion.

  According to a fourth aspect of the present invention, in the medical device according to any one of the first to third aspects, the biological information measuring means is attached in close contact with the patient's skin and measures the electrocardiogram of the patient. It is characterized by obtaining.

  The invention according to claim 5 is the medical device according to claim 4, further comprising electrocardiogram acquisition means for obtaining an electrocardiogram based on a measurement signal from the electrocardiogram measurement means, and electrocardiogram information obtained by the electrocardiogram acquisition means Based on the above, it is possible to detect the detachment of the access means from the patient.

  According to the first aspect of the present invention, the biological information measuring means is formed in the fixed portion integrated with the access means, and based on the measured value obtained by the biological information measuring means, the patient of the access means Since it is possible to detect the detachment of the living body, it is possible to accurately measure the biological information and to detect the detachment of the access means from the patient by the biological information measuring means, and before and during treatment (in blood purification treatment) (Including blood return) can be improved.

  According to the invention of claim 2, at least one biological information measuring means is formed in the fixed portion, and based on the respective measured values obtained by the one or more biological information measuring means, the access means receives from the patient. Therefore, it is possible to detect the state of the access means in more detail, such as a state in the process of leaving the access means from the patient or a state in which the access means is completely removed.

  According to the third aspect of the present invention, the biological information measuring means is formed of a fixed wing portion that protrudes laterally and fixes the access means to the patient. It is possible to form the fixed portion firmly and securely.

  According to the invention of claim 4, since the biological information measuring means is attached in close contact with the patient's skin and can measure the patient's electrocardiogram, it is accessed while measuring the patient's electrocardiogram as biological information more accurately. The removal of the means from the patient can be detected more reliably.

  According to the invention of claim 5, the electrocardiogram acquisition means for obtaining the electrocardiogram based on the measurement signal from the electrocardiogram measurement means is provided, and the access means from the patient based on the electrocardiogram information obtained by the electrocardiogram acquisition means. Since the detachment can be detected, the detachment of the access means from the patient can be detected easily and accurately based on the electrocardiogram information obtained by the electrocardiogram acquisition means.

1 is an overall schematic diagram showing a medical device according to an embodiment of the present invention. The perspective view which shows the treatment apparatus in the medical device Front view and side view showing puncture needle and fixing part attached to tip of blood circuit in same medical device IV-IV line sectional view in FIG. The perspective view which shows the puncture needle and fixing | fixed part The front view and side view which show the connection part with the puncture needle in the front-end | tip part of the blood circuit in the medical device VII-VII line sectional view in FIG. The perspective view which shows the connection part with the puncture needle in the front-end | tip part of the blood circuit Front view and side view showing a state where a puncture needle is connected to the distal end of the blood circuit in the medical device XX sectional view in FIG. The perspective view which shows the state which connected the puncture needle to the front-end | tip part of the blood circuit Front view and side view showing flexible tube having wiring formed therein in the medical device Three views showing the clamping means in the medical device A perspective view showing the clamping means Front view and side view showing a state in which the blood circuit is clamped by the clamping means XVI-XVI line sectional view in FIG. The perspective view which shows the state which clamped the blood circuit in the clamping means The graph which shows the electrocardiogram (normal time) measured by the electrocardiogram measuring means in the medical device The graph which shows the electrocardiogram (at the time of detachment) measured by the electrocardiogram measuring means in the medical device The graph which shows the electrocardiogram (at the time of the fluctuation | variation of the base line by perspiration) measured by the electrocardiogram measuring means in the medical device Graph for explaining waveform of electrocardiogram measured by electrocardiogram measuring means in the medical device Front view and side view showing puncture needle and fixing part attached to tip of blood circuit in same medical device XXIII-XXIII sectional view taken on the line in FIG. The perspective view which shows the puncture needle and fixing | fixed part

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
As shown in FIG. 1, the medical device according to the present embodiment includes a blood purification device 1, electrocardiogram measuring means 2, 3 (biological information measuring means), and wiring (patient-side wiring 4a and device-side wiring 4b). And an electrocardiogram acquisition means 12, a clamping means 13, and an external information processing device 14. The blood purification device 1 and the external information processing device 14, and the external information processing device 14 and the electrocardiogram acquisition means 12 are electrically connected to each other. It is possible to send and receive signals by connecting to. The blood purification apparatus 1 includes a blood circuit (6a, 6b), a dialyzer 7, a puncture needle (arterial side puncture needle a, vein side puncture needle b) as access means, a clamping means 13, and the like. ing. Moreover, the blood purification apparatus 1 and the external information processing apparatus 14 constitute the “treatment apparatus” of the present invention.

  The blood purification apparatus 1 according to this embodiment includes a hemodialysis apparatus for performing hemodialysis treatment and water removal while circulating the patient's blood extracorporeally. As shown in FIGS. A blood circuit (6a, 6b) for connecting the blood circuit (6a, 6b) and a dialyzer 7 as a blood purifier for performing hemodialysis, and a dialysate 7 connected to supply dialysate And a dialysate discharge line L2 that is connected to the dialyzer 7 and discharges the drainage liquid.

  The blood circuit constitutes a “flow passage” according to the present invention, is composed of a flexible tube through which a liquid such as blood can flow, and has an arterial blood circuit 6a and a venous blood circuit 6b. ing. An arterial puncture needle a (see FIGS. 1 and 3) can be connected to the tip of the arterial blood circuit 6a, and an iron blood pump 8 and an air trap chamber 9a for defoaming are provided in the middle. Arranged. On the other hand, a venous puncture needle b (see FIGS. 1 and 3) is connected to the distal end of the venous blood circuit 6b, and an air trap chamber 9b for removing bubbles is connected midway.

  The arterial puncture needle a and the venous puncture needle b according to the present embodiment constitute an “access means” (puncture needle that can be punctured by a patient) of the present invention, and as shown in FIGS. It consists of a cannula (intravascular placement) attached to a fixed part M made of resin or the like. The fixing portion M is integrated with a vein-side puncture needle b (same as an arterial-side puncture needle a) as an access means, and is configured by coupling a joint f, a forceps flexible tube g, and a joint c. Has been. Further, the joint f in the fixing portion M is integrally formed with a fixing wing portion R that protrudes laterally and fixes the vein side puncture needle b (or the arterial side puncture needle a) to the patient. .

  On the other hand, as shown in FIGS. 6 to 8, a luer connector having a joint d made of a hard resin or the like and a lock ring L at the distal end of the arterial blood circuit 6 a and the distal end of the venous blood circuit 6 b, and A support portion j that rotatably supports the lock ring L is formed. As shown in FIGS. 9 to 11, the lock ring L is fitted with the joint c on the puncture needle side fitted to the joint d. The fitting state can be locked by screwing a convex portion h (see FIG. 3) formed on the joint c at L. By holding the forceps flexible tube g with forceps, the flow path between the artery side puncture needle a or the vein side puncture needle b and the artery side blood circuit 6a or the vein side blood circuit 6b is blocked. To get.

  Then, when the blood pump 8 is driven with the patient punctured with the arterial puncture needle a and the venous puncture needle b, the blood of the patient collected from the arterial puncture needle a passes through the arterial blood circuit 6a. Then, after the blood purification is performed by the dialyzer 7, the air is removed in the air trap chamber 9b, passes through the venous blood circuit 6b, and returns to the patient's body through the venous puncture needle b. Thereby, the blood of the patient can be purified by the dialyzer 7 while circulating outside the body with the blood circuit (6a, 6b).

  The dialyzer 7 is formed with a blood introduction port 7a, a blood outlet port 7b, a dialysate inlet port 7c, and a dialysate outlet port 7d in the casing, and among these, the blood inlet port 7a has an arterial blood circuit 6a. The base end of the venous blood circuit 6b is connected to the blood outlet port 7b. The dialysate introduction port 7c and the dialysate lead-out port 7d are connected to a dialysate introduction line L1 and a dialysate discharge line L2 extending from the blood purification apparatus 1, respectively.

  A plurality of hollow fibers are accommodated in the casing portion of the dialyzer 7, and the inside of the hollow fibers is used as a blood flow path, and the space between the outer peripheral surface of the hollow fibers and the inner peripheral surface of the casing portion is dialyzed. It is a liquid flow path. A hollow fiber membrane is formed in the hollow fiber by forming a large number of minute holes (pores) penetrating the outer circumferential surface and the inner circumferential surface, and impurities in the blood are passed through the membrane in the dialysate. It is comprised so that it can permeate | transmit.

  As shown in FIG. 1, the blood purification apparatus 1 includes a dual pump 10 formed across the dialysate introduction line L1 and the dialysate discharge line L2, and a bypass line that bypasses the dual pump 10 in the dialysate discharge line L2. It has the water removal pump 11 connected. One end of the dialysate introduction line L1 is connected to the dialyzer 7 (dialyte introduction port 7c), and the other end is connected to a dialysate supply device (not shown) for preparing a dialysate having a predetermined concentration. In addition, one end of the dialysate discharge line L2 is connected to the dialyzer 7 (dialysate outlet port 7d), and the other end is connected to a drainage means (not shown) and supplied from the dialysate supply device. After the dialysate reaches the dialyzer 7 through the dialysate introduction line L1, the dialysate is sent to the drainage means through the dialysate discharge line L2.

  The dewatering pump 11 is for removing water from the blood of the patient flowing through the dialyzer 7. That is, when the dewatering pump 11 is driven, the volume of the liquid discharged from the dialysate discharge line L2 becomes larger than the amount of dialysate introduced from the dialysate introduction line L1, and moisture from the blood is increased by the larger volume. Is removed. In addition, you may make it remove a water | moisture content from a patient's blood by means (for example, what uses what is called a balancing chamber etc.) other than the compound pump 10 and the water removal pump 11. FIG.

  The blood purification apparatus 1 according to the present embodiment includes an input unit 20, a control unit 21, a display unit 22, and a notification unit 24. For example, the display unit 22 provides information related to blood purification treatment in real time. Can be displayed. As shown in FIG. 2, the display unit 22 can display various information on, for example, a touch panel type liquid crystal screen, and is configured such that display contents are controlled by the control unit 21. The control means 21 is electrically connected to an actuator such as the blood pump 8 in addition to controlling the display contents of the display means 22, and can control these actuators.

  The input unit 20 is connected to the control unit 21 and is electrically connected to the output unit 17 in the external information processing apparatus 14 so that information (data) output from the output unit 17 can be input. Yes. Thus, the information input by the input means 20 is transmitted to the control means 21 and can be displayed as a graph or numerical value on the display means 22. In the present embodiment, the display content of the external information processing apparatus 14 can be viewed on the display means 22 by the browser 23. Note that the input unit 20 and the output unit 17 of the external information processing apparatus 14 may be connected not only by wiring but also wirelessly.

  The notification unit 24 is electrically connected to the control unit 21. When an abnormality is detected in the patient or device in the course of blood purification treatment, the notification unit 24 outputs a predetermined notification (for example, output of voice or sound effect, lighting of a warning lamp) Or blinking, etc.) to allow the surrounding medical staff to grasp the abnormality. Further, the notification unit 24 according to the present embodiment is configured so that the abnormality is recognized in the electrocardiogram acquired by the electrocardiogram acquisition unit 12, and the access unit (the arterial puncture needle a or the venous side puncture needle b) is detached from the patient. Is detected, a predetermined notification can be made.

  The electrocardiogram measuring means 2 and 3 are attached to the patient's skin in close contact with each other and constitute biometric information measuring means capable of measuring the patient's electrocardiogram (biological information). And is electrically connected to the electrocardiogram acquisition means 12. The electrocardiogram acquisition means 12 is configured to obtain, in real time, an electrocardiogram as shown in FIG. 18, for example, based on the measurement signals from the electrocardiogram measurement means 2 and 3 (in the figure, a normal electrocardiogram is shown). ing. The waveform of the electrocardiogram is usually shaped as shown in FIG. 21, and a baseline β serving as a reference for obtaining the measured waveform heights (P wave, R wave, T wave, and U wave heights). In a normal electrocardiogram, the base line β is constant and stable as shown in FIG.

  Here, the electrocardiogram measuring means 2 (biological information measuring means) according to the medical device of the present embodiment includes an access means (in this embodiment, the venous puncture needle b) as shown in FIGS. One or more (in this embodiment, two in this embodiment) are formed in the integrated fixing portion M (in this embodiment, the fixed wing portion R formed integrally with the joint f constituting the fixing portion M). Wiring (patient-side wiring 4a and apparatus-side wiring 4b) is extended from each of the electrocardiogram measuring means 2. The electrocardiogram measuring means 2 according to the present embodiment is formed on the fixed wing R integrally formed with the joint f. However, as long as the fixed portion M is integrated with the puncture needle, other parts ( For example, it may be formed in another part of the joint f, the forceps flexible tube g or the joint c).

  As shown in FIG. 4, the patient-side wiring 4a is composed of a lead wire having one end 4aa connected to the electrocardiogram measuring means 2 and the other end 4ab positioned at the proximal end of the joint c. The measured value (voltage) obtained by the measuring means 2 can be transmitted to the device side wiring 4b as a signal (electric signal). In addition, as shown in FIG. 7, the device-side wiring 4b has one end 4ba positioned at a support portion j formed at the distal end of the venous blood circuit 6b, and the other end 4bb as a clamped portion. 5, and is electrically connected to the patient side wiring 4 a, the signal (electrical signal) transmitted through the patient side wiring 4 a is transmitted to the electrocardiogram acquisition means 12 and the external information processing apparatus 14. It is possible to transmit to the blood purification apparatus 1 via this.

  That is, when fitting the joint d on the puncture needle side to the joint d and locking it to connect the venous side puncture needle b side and the tip of the venous blood circuit 6b, as shown in FIG. 10, the patient side wiring 4a The other end 4ab of the device and one end 4ba of the device-side wire 4b are in contact with each other and are electrically connected, so that the electrocardiogram measuring means is connected via these wires (patient-side wire 4a and device-side wire 4b). 2 detection signals (electrical signals) can be transmitted to the blood purification apparatus 1 side.

  Further, as shown in FIG. 12, the device-side wiring 4b is formed inside the distal end portion of the venous blood circuit 6b (flow passage), and in this embodiment, the flow path of the venous blood circuit 6b is formed. It is integrally formed in the thick part which comprises. As a result, the detection signal (electrical signal) can be satisfactorily transmitted by the apparatus-side wiring 4b without obstructing the flow of a liquid such as blood in the vein-side blood circuit 6b. The patient-side wiring 4a according to the present embodiment is formed inside the forceps flexible tube g (flow passage) (in the thick portion constituting the flow path, etc.), like the device-side wiring 4b.

  Furthermore, as shown in FIGS. 1, 13, and 14, the blood purification apparatus 1 according to the present embodiment includes clamping means 13 that can clamp the flow passage (in this embodiment, the distal end portion of the venous blood circuit 6b). In addition, the clamping means 13 is connected to the tip 4bb of the wiring (device-side wiring 4b) in a state where the flow passage (tip of the venous blood circuit 6b) is clamped, and the electrocardiogram measuring means 2 (biological information measuring means) ) Detection signal can be transmitted to the blood purification apparatus 1.

  More specifically, as shown in FIGS. 6 to 8 and 9 to 11, a sandwiched portion 5 is formed at the distal end portion of the venous blood circuit 6 b, and the sandwiched portion 5 includes A pair of projecting portions 5a projecting in the direction is formed, and a base end 4bb of the device side wiring 4b is formed in the projecting portion 5a. However, the holding means 13 is configured to be fixed to the blood purification apparatus 1 and to hold the held portion 5 formed at the distal end portion of the venous blood circuit 6b, as shown in FIGS. Furthermore, it has an arcuate groove 13a that follows the outer peripheral surface of the distal end portion of the venous blood circuit 6b, and a fitting portion 13b that can fit the protruding portion 5a.

  15 to 17, the venous blood circuit 6b is clamped by the clamping means 13 by fitting the protruding portion 5a to the fitting portion 13b while attaching the venous blood circuit 6b along the groove 13a. Then, the other end 4bb of the device side wiring 4b and the conductor 13c formed in the clamping means 13 are electrically connected, and the measurement value (voltage) obtained by the electrocardiogram measurement means 2 is used as a signal (electric signal) as an electrocardiogram. It can be transmitted to the blood purification apparatus 1 via the acquisition means 12 and the external information processing apparatus 14.

  On the other hand, the electrocardiogram acquisition means 12 is electrically connected to the input means 15 of the external information processing apparatus 14, and the patient's electrocardiogram obtained in real time by the electrocardiogram measurement means 2 and 3 is input by the input means 15. It is possible. The external information processing device 14 can input and monitor the electrocardiogram acquired by the electrocardiogram acquisition unit 12 in real time. As shown in FIG. 1, in addition to the input unit 15, the determination unit 16 and the output unit 17 And storage means 18 and display means 19.

  The determination unit 16 is electrically connected to the input unit 15 and can determine whether or not an electrocardiogram input in real time by the input unit 16 satisfies a predetermined condition. In the present embodiment, the determination unit 16 inputs in real time. It is configured to be able to determine whether or not the electrocardiogram is abnormal (for example, arrhythmia based on the waveform of the electrocardiogram). Further, the determination means 16 according to the present embodiment can detect the detachment of the venous puncture needle b from the patient based on the electrocardiogram input in real time.

  That is, when the venous puncture needle b is detached from the patient, the measured impedance changes, and as shown by α in FIG. 19, a steep change occurs in the baseline of the electrocardiogram input in real time. By detecting such a steep baseline change, it can be determined that the venous puncture needle b has been detached (withdrawn) from the patient. When the baseline fluctuates due to patient sweating, as shown in FIG. 20, the baseline fluctuates gently. Therefore, when a gradual change in the baseline is detected, the venous puncture needle b is not detached from the patient. It is determined that this is due to sweating.

  Further, when the venous puncture needle b and the fixing portion M are detached from the distal end portion of the venous blood circuit 6b, the patient side wiring 4a and the device side wiring 4b are electrically disconnected (the other end of the patient side wiring 4a). 4ab and one end portion 4ba of the device side wiring 4b are physically separated from each other. Accordingly, if the distal end portion of the venous blood circuit 6b is detached while the puncture state of the venous puncture needle b is maintained, an electrocardiogram cannot be obtained by the electrocardiogram acquisition means 12, so that the determination means 16 causes the venous side of the venous puncture needle b to Detachment from the tip of blood circuit 6b can be detected. That is, detection of detachment of the access means (vein side puncture needle b) from the flow path (the distal end portion of the venous side blood circuit 6b) is detected based on the presence or absence of signal transmission by the electrocardiogram measurement means 3 or the electrocardiogram acquisition means 12. Can do it.

  In this way, based on the measurement values obtained by the electrocardiogram measurement means 2 and 3 (biological information measurement means) or the electrocardiogram information obtained by the electrocardiogram acquisition means 12, the access means (venous puncture needle b) It is possible to detect detachment from the patient, and the access means (venous puncture) is configured by electrically connecting the patient side wire 4a on the puncture needle side and the device side wire 4b on the treatment device side. The needle b) is also configured to be able to detect separation from the flow path (the distal end portion of the venous blood circuit 6b).

  The output unit 17 is electrically connected to the determination unit 16 and determines that a predetermined condition is satisfied by the determination unit 16 (in this embodiment, the electrocardiogram input in real time is abnormal or the venous puncture needle b is The determination result can be output to the blood purification apparatus 1. The storage means 18 is electrically connected to the input means 15, and an electrocardiogram and other information inputted in real time by the input means 15 (for example, waveform data and numerical values from the start of blood purification treatment, recording of occurrence of abnormality) , Past treatment data, etc.) can be stored and saved, and is constituted by a memory mounted on the external information processing apparatus 14, a portable recording medium, or the like.

  The display unit 19 is electrically connected to the input unit 15 and the storage unit 18 and can display an electrocardiogram input in real time by the input unit 15 or various information stored in the storage unit 18. For example, it is composed of a liquid crystal screen or the like. In addition, as described above, the blood purification apparatus 1 according to the present embodiment requests the display content by the display means 19 (for example, transmits a request signal) and sends the display content to the display means 22 in response to the request. A browser 23 that can be displayed is provided.

  The input means 20 of the blood purification apparatus 1 according to the present embodiment is connected to the output means 17 of the external information processing apparatus 14, and based on the electrocardiogram information obtained by the electrocardiogram acquisition means 12 via the output means 17, the veins The detachment of the side puncture needle b (access means) from the patient can be detected, and the detachment of the vein puncture needle b (access means) from the distal end portion of the venous blood circuit 6b can be detected. . In addition, on the condition that the detachment of the venous puncture needle b (access means) from the patient or the distal end of the venous blood circuit 6b is detected in this way, a predetermined notification is made by the notification means 24. .

  According to the present embodiment, the electrocardiogram measuring means 2 (biological information measuring means) is formed in the fixing portion M integrated with the venous puncture needle b (access means), and the electrocardiogram measuring means 2 Based on the obtained measurement value, it is made possible to detect the detachment of the venous puncture needle b from the patient, and therefore the electrocardiogram is used to measure the electrocardiogram information (biological information) and detect the detachment of the venous puncture needle b from the patient. The measuring means 2 can be accurately performed, and the workability before and during treatment (including blood return in blood purification treatment as in this embodiment) can be improved.

  In addition, one or more electrocardiogram measuring means 2 according to the present embodiment is formed in the fixing portion M, and based on the respective measured values obtained by the one or more electrocardiogram measuring means 2, the venous puncture needle b Since the detachment from the patient can be detected, the state of the venous puncture needle b can be detected in more detail, such as a state in which the venous puncture needle b is in the process of detachment from the patient or a state in which the venous puncture needle b is completely detached. Can do. A single electrocardiogram measuring means 2 may be formed in the fixed part M.

  Further, since the fixing part M on which the electrocardiogram measuring means 2 (biological information measuring means) is formed is formed of a fixed wing part R that protrudes laterally and fixes the venous puncture needle b to the patient. The measuring unit 2 (biological information measuring unit) can be more firmly and reliably formed on the fixed portion M. Furthermore, in the present embodiment, the biological information measuring means is attached in close contact with the patient's skin and can measure the patient's electrocardiogram, so that the vein side can be measured while measuring the patient's electrocardiogram as biological information more accurately. The detachment of the puncture needle b from the patient can be detected more reliably.

  Further, the apparatus includes an electrocardiogram acquisition unit 12 that obtains an electrocardiogram based on measurement signals from the electrocardiogram measurement units 2 and 3, and based on the electrocardiogram information obtained by the electrocardiogram acquisition unit 12, from the patient of the venous puncture needle b Therefore, the detachment of the venous puncture needle b from the patient can be detected easily and accurately based on the electrocardiogram information obtained by the electrocardiogram acquisition means 12.

  In addition, according to the present embodiment, the electrocardiogram measuring means 3 as the biological information measuring means is formed in the fixing part M integrated with the venous puncture needle b (access means), and the fixing part M The signal from the electrocardiogram measuring means 3 is treated in a state where a wire is extended from the terminal to the distal end (flow passage) of the venous blood circuit 6b and the venous puncture needle b is connected to the distal end of the venous blood circuit 6b. It is possible to transmit to the devices (blood purification device 1 and external information processing device 14), and it is possible to detect detachment from the distal end portion (flow channel) of the venous puncture needle b based on the presence or absence of signal transmission. Therefore, in accordance with the signal from the electrocardiogram measurement means 3, the detection of the detachment of the venous puncture needle b from the patient and the detection of the detachment of the venous puncture needle b from the distal end portion of the venous puncture needle b are accurately performed. Before and during treatment (this embodiment In blood purification therapy as it is possible to improve the workability including) blood return.

  Moreover, since the wiring (patient-side wiring 4a and device-side wiring 4b) according to the present embodiment is formed inside the venous blood circuit 6b and the flexible tube g (flow channel) for forceps, an operator or the like It is possible to prevent the signal from being interfered with by mistakenly interfering with the wiring, and to detect the detachment of the vein side puncture needle b from the distal end portion of the vein side blood circuit 6b with higher accuracy. . Furthermore, the treatment apparatus according to the present embodiment includes the holding means 13 that can hold the venous blood circuit 6b (flow passage), and the holding means 13 holds the distal end portion of the venous blood circuit 6b. Since the signal of the electrocardiogram measuring means 2 can be transmitted to the treatment apparatus by being connected to the distal end portion (the other end portion 4bb) of the wiring (device side wiring 4b), the venous blood circuit 6b is sandwiched between the sandwiching means 13 By doing so, signal transmission can be performed satisfactorily and reliably.

  Furthermore, since it comprises biological information measuring means capable of measuring the biological information of the patient, in addition to the measurement of the biological information, the detection of the detachment of the venous puncture needle b from the patient and the distal end portion of the venous blood circuit 6b is detected. This can be accurately performed by a signal from the measuring means. In addition, since the biological information measuring means is attached in close contact with the patient's skin and can measure the electrocardiogram of the patient, while measuring the patient's electrocardiogram as the biological information more accurately, The detachment from the distal end portion of the venous blood circuit 6b can be detected more reliably.

  As mentioned above, although this embodiment was described, this invention is not limited to this, For example, the treatment apparatus applied had the access means which consists of a catheter which can be penetrated in the blood vessel of a patient other than the blood purification apparatus 1. An infusion device may be used. In this case, the flow passage is connected to the access means, and a liquid such as a medicine can be injected into the patient via the access means. Further, the biological information measuring means is not limited to the electrocardiogram measuring means using electrodes as in the present embodiment. For example, a temperature sensor using a thermocouple or infrared light, a pulse wave sensor using light, ultrasonic waves, A blood flow sensor using light or the like may be used. 22 to 24, one end 4aa of the patient-side wiring 4a may be formed along the fixed wing portion R. In this case, another member is attached to the one end 4aa. And the operator's fingers can be prevented from interfering with each other.

  Furthermore, the electrocardiogram measuring means 2 (biological information measuring means) according to this embodiment is attached to the fixing part M of the venous puncture needle b, but may be attached to the fixing part of the arterial puncture needle a. Alternatively, it may be attached to both the fixed portions of both the artery side puncture needle a and the vein side puncture needle b. Furthermore, in the present embodiment, the detection of detachment of the venous puncture needle b (access means) from the patient and the vein of the venous puncture needle b according to the signal from the biological information measurement means (electrocardiogram measurement means 2). Both the detection of the detachment from the distal end portion of the side blood circuit 6b can be detected, but only the detection of the detachment of the vein side puncture needle b (access means) from the patient may be possible. The blood purification apparatus 1 may have the function of the external information processing apparatus 14, and an abnormal signal generated in the external information processing apparatus 14 is finally input to the blood purification apparatus 1 via the central monitoring apparatus. You may make it do.

  The biological information measuring means is formed in a fixed part integrated with the access means, and based on the measurement value obtained by the biological information measuring means, the medical means capable of detecting the removal of the access means from the patient As long as it is a device for use, it can be applied to a device having a different external shape or a device to which other functions are added.

DESCRIPTION OF SYMBOLS 1 Blood purification apparatus 2, 3 ECG acquisition measuring means (biological information measuring means)
4a Patient side wiring 4b Device side wiring 5 Clamped part 6a Arterial side blood circuit 6b Vein side blood circuit 7 Dialyzer (blood purifier)
DESCRIPTION OF SYMBOLS 8 Blood pump 9a Arterial side air trap chamber 9b Vein side air trap chamber 10 Duplex pump 11 Dewatering pump 12 Electrocardiogram acquisition means 13 Holding means 14 External information processing apparatus 15 Input means 16 Determination means 17 Output means 18 Storage means 19 Display means 20 Input means 21 Control means 22 Display means 23 Browser 24 Notification means

Claims (5)

The access means comprises a puncture needle that can be punctured by a patient or a catheter that can be inserted into a blood vessel of the patient, and a flow passage through which the patient's blood can be circulated or a liquid such as a drug can be injected into the patient. A treatment device;
A biological information measuring means capable of measuring the biological information of the patient;
In a medical device comprising:
The biological information measuring means is formed in a fixed portion integrated with the access means, and can detect the detachment of the access means from the patient based on the measurement value obtained by the biological information measuring means. Medical device characterized by being made.   One or more of the biological information measuring means is formed on the fixed part, and based on the respective measured values obtained by the one or more biological information measuring means, it is possible to detect the detachment of the access means from the patient. The medical device according to claim 1, wherein   3. The medical device according to claim 1, wherein the fixing portion on which the biological information measuring means is formed is formed of a fixed wing portion that is formed so as to protrude laterally and fixes the access means to a patient. Equipment.   The medical device according to any one of claims 1 to 3, wherein the biological information measuring means is attached in close contact with a patient's skin and can measure an electrocardiogram of the patient.   It comprises an electrocardiogram acquisition means for obtaining an electrocardiogram based on a measurement signal from the electrocardiogram measurement means, and based on the electrocardiogram information obtained by the electrocardiogram acquisition means, the access means can be detected from the patient. The medical device according to claim 4.

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