JP6530947B2 - Medical device - Google Patents

Description

  The present invention provides an access means comprising a puncture needle capable of being punctured by a patient or a catheter which can be inserted into a patient's blood vessel, and a circulation through which blood of a patient can be distributed or fluid such as medicine can be injected into the patient The present invention relates to a medical device provided with a treatment apparatus having a channel and biological information measuring means capable of measuring biological information of a patient.

  Generally, in dialysis treatment, introduction or discharge of dialysate between a blood circuit for circulating the patient's blood extracorporeally, a dialyzer connected in the middle of the blood circuit, an ironing type blood pump, and the dialyzer A dialysis treatment apparatus having a dialysis apparatus main body capable of removing water while performing hemodialysis treatment is used. Since the dialysis treatment performed by such a dialysis treatment device is usually performed for about 4 hours every other day, the hemodynamics of the patient being treated will change significantly, and in particular, excess water removal (water removal) It is an important issue to effectively and reliably prevent the reduction of blood pressure by the

  Furthermore, patients who need dialysis treatment often have cardiovascular complications such as arrhythmias, so it is necessary to monitor hemodynamic abnormalities and their causes by monitoring heartbeats and pulses. is there. An electrocardiograph capable of measuring an electrocardiogram is widely used as a means for monitoring such information on the heartbeat and pulse of the patient, and, for example, at least a pair of electrodes (measuring means for electrocardiograms) are provided to the patient during blood purification treatment. Closely attached, and the patient's electrocardiogram is measured from the potentials of the electrodes.

  On the other hand, in blood purification treatment, the patient punctures the artery-side puncture needle and the vein-side puncture needle, and the patient's blood is collected from the artery-side puncture needle and blood purification treatment is performed while circulating in the blood circuit extracorporeally. The blood needs to be returned to the patient from the venous puncture needle. However, in the process of circulating blood extracorporeally, the puncture needle is unintentionally pulled out of the patient's puncturing part due to, for example, body movement or the like, and there is a risk that the blood may leak to the outside particularly in the vein side 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 leak sensor or the like (see, for example, Patent Document 1).

Japanese Patent Application Publication No. 2013-530753

  However, in the above-mentioned 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. Therefore, the cost is increased, and it is necessary to attach the plurality of electrodes and sensors before the treatment, which causes a problem that the workability before the treatment is deteriorated. In addition, at the time of treatment, in order to detect a leak, blood leaked from the puncture needle needs to touch the leak sensor, but it does not necessarily leak to a place where the leak sensor exists, and leak is always accurate Difficult to detect. The above problem is not limited to blood purification treatment, but the same applies to, for example, infusion treatment in which a catheter is inserted into a patient's blood vessel and a drug or the like is administered into the patient's body. It takes place in

  The present invention has been made in view of such circumstances, and can measure the biological information and detect the withdrawal of the access means from the patient accurately by the biological information measurement means, and also before treatment and treatment An object of the present invention is to provide a medical device capable of improving the operability of time (including blood return in blood purification treatment).

The invention according to claim 1 is an access means comprising a puncture needle which can be pierced by the patient or a catheter which can be inserted into the blood vessel of the patient, and the blood of the patient or the fluid such as medicines through the access means. In a medical device provided with a therapeutic device having a flow passage which can be injected and 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 patient side wiring is extended to the fixing portion, the device side wiring is extended to the flow passage, and the patient side wiring and the device side wiring are connected in a state where the fixing portion and the flow passage are connected Are configured to be electrically connected, and both the detachment of the access means from the patient and the withdrawal of the flow passage from the access means are made based on the measurement values obtained by the biological information measurement means. Detectable And characterized in that it is.

  The invention according to claim 2 is the medical device according to claim 1, wherein one or more of the biological information measurement means are formed on the fixed portion, and each of the biological information measurement means is obtained by the one or more biological information measurement means. It is characterized in that the withdrawal of the access means from the patient can be detected based on the measurement value.

  The invention according to claim 3 is the medical device according to claim 1 or 2, wherein the fixing portion on which the biological information measuring means is formed is laterally protruded to fix the access means to the patient. It is characterized in that it comprises a fixed wing portion.

  The invention according to claim 4 relates to the medical device according to any one of claims 1 to 3, wherein the biological information measuring means is closely attached to the skin of a patient and measures the patient's electrocardiogram. It is characterized by getting.

The invention according to claim 5 is the medical device according to claim 4, further comprising an electrocardiogram acquisition means for acquiring an electrocardiogram based on the measurement signal from the biological information measurement means, and electrocardiogram information obtained by the electrocardiogram acquisition means. On the basis of which it is possible to detect the withdrawal of the access means from the patient.
The invention according to a sixth aspect is characterized in that, in the medical device according to the fifth aspect, when an abnormality is recognized in the electrocardiogram acquired by the electrocardiogram acquisition means, a predetermined notification is performed.
The invention according to claim 7 is that in the medical device according to any one of claims 1 to 6, detection of detachment of the access means from the patient or detachment of the flow passage from the access means is detected. It is characterized by having provided the alerting | reporting means which performs predetermined | prescribed alerting | reporting as conditions.
The invention according to claim 8 is the medical device according to any one of claims 1 to 7, wherein a state in the process of withdrawal of the access means from the patient or a state completely detached from the patient is detected. It is characterized by being made possible.

  According to the invention of claim 1, the living body information measurement means is formed in the fixed part integrated with the access means, and from the patient of the access means based on the measurement value obtained by the living body information measurement means. Since it is possible to detect the withdrawal of the patient's body, it is possible to accurately perform the measurement of the biological information and the detection of the withdrawal of the access means from the patient by the biological information measurement means, and also before and during the treatment (in blood purification treatment Can improve the workability of blood return).

  According to the invention of claim 2, one or more living body information measuring means are formed on the fixed part, and based on the respective measured values obtained by the one or more living body information measuring means, from the patient of the access means It is possible to detect the state of the access means in more detail, such as the state in the process of leaving the patient from the access means or the state of complete withdrawal.

  According to the invention of claim 3, since the fixing portion on which the biological information measuring means is formed is formed by projecting laterally to fix the access means to the patient, the biological information measuring means The fixing portion can be formed firmly and surely.

  According to the invention of claim 4, the biological information measuring means is closely attached to the skin of the patient and can measure the patient's electrocardiogram, so access is made while measuring the patient's electrocardiogram as the biological information more accurately Withdrawal of the means from the patient can be detected more reliably.

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

Overall schematic view showing a medical device according to an embodiment of the present invention The perspective view which shows the treatment apparatus in the same medical device The front view and side view which show the puncture needle and fixing | fixed part attached to the front-end | tip of the blood circuit in the same medical device IV-IV sectional view in FIG. 3 The perspective view which shows the same 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 same medical device VII-VII sectional view in FIG. 6 The perspective view which shows the connection part with the puncture needle in the front-end | tip part of the same blood circuit Front and side views showing a state in which a puncture needle is connected to the tip of a blood circuit in the same medical device XX sectional view in FIG. 9 The perspective view which shows the state which connected the puncture needle to the front-end | tip part of the same blood circuit The front view and side view which show the flexible tube by which the wiring was formed in the same in the medical device Three views showing the clamping means in the same medical device The perspective view which shows the holding means Front view and side view showing a state in which the blood circuit is held by the holding means XVI-XVI sectional view in FIG. 15 The perspective view which shows the state which clamped the blood circuit by the same clamping means Graph showing an electrocardiogram (normal time) measured by the electrocardiogram measurement means in the same medical device Graph showing the electrocardiogram (at the time of withdrawal) measured by the measuring means for electrocardiogram in the same medical device Graph showing electrocardiogram (when baseline changes due to sweating) measured by electrocardiogram measurement means in the same medical device Graph for explaining the waveform of the electrocardiogram measured by the measuring means for electrocardiogram in the same medical device The front view and side view which show the puncture needle and fixing | fixed part attached to the front-end | tip of the blood circuit in the same medical device The XXIII-XXIII line sectional view in FIG. The perspective view which shows the same 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 apparatus 1, electrocardiogram measurement means 2 and 3 (biological information measurement means), and wires (patient side wire 4a and device side wire 4b). , The electrocardiogram acquiring means 12, the clamping means 13, and the external information processing apparatus 14, and the blood purification apparatus 1 and the external information processing apparatus 14, and the external information processing apparatus 14 and the electrocardiogram acquiring means 12 are electrically Signal transmission and reception is enabled. The blood purification apparatus 1 includes a blood circuit (6a, 6b), a dialyzer 7, a puncture needle (artery-side puncture needle a, a vein-side puncture needle b) as an access unit, a clamping unit 13 and the like. ing. Further, the blood purification apparatus 1 and the external information processing apparatus 14 constitute the "therapeutic device" 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 blood of a patient extracorporeally, and as shown in FIGS. Connected to the blood circuit (6a, 6b), the dialyzer 7 as a blood purifier connected to the blood circuit (6a, 6b) for performing hemodialysis treatment, and connected to the dialyzer 7 to supply dialysate And a dialysate discharge line L2 connected to the dialyzer 7 for discharging drainage.

  The blood circuit, which constitutes the "flow passage" according to the present invention, is composed of a flexible tube through which a fluid such as blood can flow, and has an arterial blood circuit 6a and a venous blood circuit 6b. ing. An artery-side puncture needle a (see FIGS. 1 and 3) can be connected to the tip of the artery-side blood circuit 6a, and an iron-type blood pump 8 and an air trap chamber 9a for defoaming are provided along the way. It is arranged. On the other hand, a vein-side puncture needle b (see FIGS. 1 and 3) is connected to the tip of the vein-side blood circuit 6b, and an air trap chamber 9b for degassing is connected in the middle.

  The artery-side puncture needle a and the vein-side puncture needle b according to the present embodiment constitute the “access means” (puncture needle capable of puncturing the patient) of the present invention, and as shown in FIGS. It consists of a cannula (intravascular placement) attached to fixed part M which consists of resin etc. The fixing portion M is integrated with a vein-side puncture needle b (also the artery-side puncture needle a) as an access means, and the joint f, the forceps flexible tube g, and the joint c are connected. It is done. In addition, at the joint f in the fixing portion M, a fixed wing R is integrally formed so as to protrude laterally and fix the vein side puncture needle b (or the artery side puncture needle a) to the patient. .

  On the other hand, as shown in FIGS. 6-8, a luer connector having a joint d made of a hard resin or the like and a lock ring L at the tip of the arterial blood circuit 6a and the tip of the venous blood circuit 6b, The lock ring L is supported by a support portion j which supports the lock ring L in a rotatable manner, and as shown in FIGS. 9 to 11, the lock ring L is engaged with the joint c on the puncture needle side. The engagement state can be locked by screwing a convex portion h (see FIG. 3) formed on the joint c with L. In addition, by clamping the flexible tube g for forceps with a 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. It is supposed to get.

  Then, when the blood pump 8 is driven while the patient punctures the artery-side puncture needle a and the vein-side puncture needle b, the patient's blood collected from the artery-side puncture needle a passes through the artery-side blood circuit 6a. After the blood purification is performed by the dialyzer 7, the air trap chamber 9b performs degassing, passes through the vein side blood circuit 6b, and returns to the patient's body through the vein side puncture needle b. As a result, the patient's blood can be purified by the dialyzer 7 while circulating in the blood circuit (6a, 6b) extracorporeally.

  A blood inlet port 7a, a blood outlet port 7b, a dialysate inlet port 7c and a dialysate outlet port 7d are formed in the housing of the dialyzer 7. Among these, an arterial blood circuit 6a is formed in the blood inlet port 7a. The proximal end of the blood supply port 7b is connected to the proximal end of the venous blood circuit 6b. The dialysate inlet port 7 c and the dialysate outlet port 7 d are respectively connected to the dialysate inlet line L 1 and the dialysate outlet line L 2 extended from the blood purification apparatus 1.

  A plurality of hollow fibers are accommodated in the housing of the dialyzer 7, and the inside of the hollow fibers serves as a blood flow path, and dialysis is performed between the outer peripheral surface of the hollow fiber and the inner peripheral surface of the housing. It is supposed to be the flow path of the liquid. In the hollow fiber, a large number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface are formed to form a hollow fiber membrane, and impurities and the like in blood are contained in the dialysate through the membrane. It is configured to be transparent to

  The blood purification apparatus 1 is, as shown in FIG. 1, a duplex pump 10 formed across the dialysate inlet line L1 and the dialysate outlet line L2, and a bypass line bypassing the duplex pump 10 in the dialysate outlet line L2. It comprises with the water removal pump 11 connected. Then, one end of the dialysate introduction line L1 is connected to the dialyzer 7 (dialysate introduction port 7c), and the other end is connected to a dialysate supply device (not shown) for preparing a dialysate having a predetermined concentration. Further, 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 the drainage means (not shown), and supplied from the dialysate supply device. After the dialysate passes through the dialysate introduction line L1 and reaches the dialyzer 7, it is sent to the drainage means through the dialysate discharge line L2.

  The water removal pump 11 is for removing water from the patient's blood 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 the dialysate introduced from the dialysate introduction line L1, and Is removed. The water may be removed from the patient's blood by means other than the dual pump 10 and the water removal pump 11 (for example, using a so-called balancing chamber or the like).

  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 performs real time information related to blood purification treatment. Can be displayed on the As shown in FIG. 2, the display means 22 can display various information on, for example, a touch panel liquid crystal screen, and the display contents are controlled by the control means 21. The control means 21 is electrically connected to an actuator such as the blood pump 8 in addition to the control of the display contents of the display means 22 so that these actuators can be controlled.

  The input unit 20 is connected to the control unit 21 and is electrically connected to the output unit 17 of the external information processing apparatus 14, and can input information (data) output from the output unit 17. There is. Thus, the information input by the input unit 20 is transmitted to the control unit 21 and can be displayed on the display unit 22 as a graph, a numerical value or the like. Further, in the present embodiment, the display contents of the external information processing apparatus 14 can be browsed by the display means 22 by the browser 23. The input unit 20 and the output unit 17 of the external information processing apparatus 14 may be connected by wireless or the like in addition to the one connected by the wiring.

  The notification unit 24 is electrically connected to the control unit 21. When an abnormality is detected in the patient or the device in the blood purification treatment process, predetermined notification (for example, output of sound or sound, lighting of a warning light) is performed. Or, it is for making a surrounding medical worker grasp the said abnormality by performing blinking etc.). Furthermore, the notification means 24 according to the present embodiment removes the access means (the arterial side puncture needle a or the vein side puncture needle b) from the patient when an abnormality is recognized in the electrocardiogram acquired by the electrocardiogram acquisition means 12 When is detected, predetermined notification can be performed.

  The electrocardiogram measurement means 2 and 3 are attached closely to the skin of the patient and constitute biological information measurement means capable of measuring the patient's electrocardiogram (biological information) The electrocardiogram acquisition means 12 is electrically connected to the electrocardiogram acquisition means 12 as well as a pair of electrodes attached. The electrocardiogram acquisition means 12 is configured to obtain, for example, an electrocardiogram as shown in FIG. 18 (in the figure, a normal electrocardiogram is shown) in real time based on measurement signals from the electrocardiogram measurement means 2 and 3 ing. The waveform of the electrocardiogram is usually shaped as shown in FIG. 21 and is used as a reference for determining the height of the measured waveform (P wave, R wave, T wave and U wave height). In the normal electrocardiogram, as shown in FIG. 18, the baseline β is constant and stable.

  Here, the electrocardiogram measurement means 2 (biometric information measurement means) according to the medical device of the present embodiment is, as shown in FIGS. 3 to 5, an access means (in the present embodiment, a vein side puncture needle b) and One or more (two in the present embodiment) are formed in the integrated fixed portion M (in the present embodiment, the fixed wing portion R integrally formed with the joint f constituting the fixed portion M) Wirings (patient side wiring 4 a and device side wiring 4 b) are extended from the respective electrocardiogram measurement means 2. Although the electrocardiogram measurement means 2 according to the present embodiment is formed on the fixed wing R integrally formed with the joint f, other parts (the fixed part M integrated with the puncture needle) For example, it may be formed in another part in the joint f, the flexible tube for forceps g or the joint c, etc.).

  As shown in FIG. 4, the patient side wire 4a is composed of a lead wire having one end 4aa connected to the electrocardiogram measurement means 2 and the other end 4ab located at the base end of the joint c. The measured value (voltage) obtained by the measuring means 2 can be transmitted as a signal (electric signal) to the device side wiring 4b. Further, as shown in FIG. 7, the device-side wire 4b is located at the support portion j formed at one end of the vein-side blood circuit 6b at one end 4ba, and the other end 4bb is a pinched portion The electrocardiogram acquisition means 12 and the external information processing apparatus 14 are made of a signal (electrical signal) transmitted by the patient side wiring 4a by being electrically connected to the patient side wiring 4a. It is possible to transmit to the blood purification apparatus 1 via

  That is, when the joint c on the puncture needle side is fitted into the joint d and locked to connect the vein side puncture needle b side and the tip of the vein side blood circuit 6b, as shown in FIG. 10, the patient side wiring 4a And the other end 4ab of the device-side wiring 4b is in contact with each other and electrically connected to each other. Therefore, the measuring means for electrocardiogram via these wires (the patient-side wiring 4a and the device-side wiring 4b) The second detection signal (electrical signal) can be transmitted to the blood purification apparatus 1 side.

  Further, as shown in FIG. 12, the device-side wire 4b is formed inside the tip of the vein-side blood circuit 6b (flow passage), and in the present embodiment, the flow path of the vein-side blood circuit 6b is It is integrally formed in the thick part which comprises. As a result, the detection signal (electrical signal) can be favorably transmitted by the device-side wiring 4b without impeding the flow of liquid such as blood in the vein-side blood circuit 6b. In addition, the patient side wiring 4a which concerns on this embodiment is formed in the inside (in the thick part etc. which comprise a flow path) of the flexible tube g (flow passage) for forceps similarly to the apparatus side wiring 4b.

  Furthermore, as shown in FIGS. 1, 13 and 14, the blood purification apparatus 1 according to the present embodiment can hold the holding means 13 capable of holding the flow passage (in the present embodiment, the tip of the vein-side blood circuit 6b). In addition to being provided, the holding means 13 is connected to the tip 4bb of the wiring (device side wiring 4b) in a state where the holding means 13 holds the flow path (the tip of the vein side blood circuit 6b), and the electrocardiogram measuring means 2 (biological information measuring means Can be transmitted to the blood purification apparatus 1).

  More specifically, as shown in FIGS. 6-8 and 9-11, a pinched portion 5 is formed at the tip of the vein-side blood circuit 6b. A pair of projecting portions 5a protruding in the direction is formed, and a base end 4bb of the device-side wiring 4b is formed on the projecting portion 5a. However, the clamping means 13 is fixed to the blood purification apparatus 1 and is configured to be able to clamp the pinched portion 5 formed at the tip of the vein side blood circuit 6b, as shown in FIGS. Further, it has an arc-shaped groove 13a following the outer peripheral surface of the tip of the vein-side blood circuit 6b, and a fitting 13b capable of fitting the protrusion 5a.

  Then, as shown in FIGS. 15-17, the vein side blood circuit 6b is held by the holding means 13 by fitting the projecting portion 5a to the fitting portion 13b while attaching the vein side 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 holding means 13 are conducted, and the measured value (voltage) obtained by the measuring means 2 for electrocardiogram is used as a signal (electric signal). It can be transmitted to the blood purification apparatus 1 through 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 electrocardiogram of the patient obtained in real time by the electrocardiogram measurement means 2 and 3 is inputted by the input means 15. It is made possible. The external information processing apparatus 14 can input and monitor the electrocardiogram acquired by the electrocardiogram acquisition unit 12 in real time, and 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 means 16 is electrically connected to the input means 15, and can determine whether the electrocardiogram inputted in real time by the input means 16 satisfies a predetermined condition or not, and in the present embodiment, the input in real time It is configured to be able to determine whether the electrocardiogram is abnormal (for example, arrhythmia etc. based on the waveform of the electrocardiogram). Furthermore, the determination means 16 according to the present embodiment can detect detachment of the vein side puncture needle b from the patient based on the electrocardiogram input in real time.

  That is, when the vein-side puncture needle b separates from the patient, the impedance to be measured changes, so that a steep change occurs in the baseline of the electrocardiogram input in real time, as indicated by α in FIG. By detecting such a steep baseline change, it can be determined that the vein-side puncture needle b has been detached (extracted) from the patient. If the baseline fluctuates due to the patient's sweating, the baseline gently shakes as shown in FIG. 20. Therefore, when such a gradual change in the baseline is detected, the vein puncture needle b is not detached from the patient. , Is determined to be due to sweating.

  Furthermore, when the vein-side puncture needle b and the fixing portion M separate from the tip of the vein-side blood circuit 6b, the patient-side wire 4a and the device-side wire 4b are electrically disconnected (the other end of the patient-side wire 4a 4 ab physically separates from one end 4 ba of the device-side wiring 4 b. Therefore, if the tip of the vein-side blood circuit 6b is detached while maintaining the puncturing state of the vein-side puncture needle b, an electrocardiogram can not be obtained by the electrocardiogram acquisition means 12; Detachment from the tip of the blood circuit 6b can be detected. That is, based on the presence or absence of transmission of a signal by the electrocardiogram measurement means 3 or the electrocardiogram acquisition means 12, the detachment of the access means (vein-side puncture needle b) from the flow passage (tip of vein-side blood circuit 6b) is detected. It is possible to

  Thus, based on the measurement values obtained by the electrocardiogram measurement means 2 and 3 (biological information measurement means) or the electrocardiogram information acquired by the electrocardiogram acquisition means 12, the access means (vein-side puncture needle b) The access means (vein-side puncture) is configured by allowing detection of detachment from the patient and electrically connecting the patient-side wire 4a on the puncture needle side and the device-side wire 4b on the treatment device side. The detachment of the needle b) from the flow passage (the tip of the venous blood circuit 6b) can also be detected.

  The output unit 17 is electrically connected to the determination unit 16, and it is determined that the predetermined condition is satisfied by the determination unit 16 (in the present embodiment, the electrocardiogram input in real time is abnormal, or the vein side puncture needle b is a patient When it is determined that the user has left the device, the determination result can be output to the blood purification apparatus 1. The storage unit 18 is electrically connected to the input unit 15, and the electrocardiogram or other information input in real time by the input unit 15 (eg, waveform data and numerical values from the start of blood purification treatment, recording of occurrence of abnormality) Can store and store past treatment data etc., and is configured of 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 the electrocardiogram input in real time by the input unit 15 or various information stored by the storage unit 18. For example, it comprises a liquid crystal screen or the like. Further, as described above, the blood purification apparatus 1 according to the present embodiment requests the display content by the display unit 19 (for example, transmits a request signal), and the display content is displayed on the display unit 22 according to the request. It has the browser 23 which can be displayed.

  The input unit 20 of the blood purification apparatus 1 according to the present embodiment is connected to the output unit 17 of the external information processing apparatus 14, and based on the electrocardiogram information obtained by the electrocardiogram acquisition unit 12 via the output unit 17, The detachment of the side puncture needle b (access means) from the patient can be detected, and the detachment of the vein side puncture needle b (access means) from the tip of the vein side blood circuit 6b can be detected. . Further, on the condition that the detachment of the vein-side puncture needle b (access means) from the tip of the patient or the vein-side blood circuit 6b is detected as described above, predetermined notification is performed by the notification means 24. .

  According to the present embodiment, the electrocardiogram measurement means 2 (biological information measurement means) is formed in the fixed portion M integrated with the vein-side puncture needle b (access means), and the electrocardiogram measurement means 2 Since detachment of the vein puncture needle b from the patient can be detected based on the obtained measurement value, it is possible to measure the electrocardiogram information (biometric information) and detect the detachment of the vein puncture needle b from the patient. While being able to be correctly performed by the measurement means 2 for operation, the workability of before and at the time of treatment (including blood return in blood purification treatment as in this embodiment) can be improved.

  Further, one or more of the electrocardiogram measurement means 2 according to the present embodiment are formed on the fixed portion M, and the vein side puncture needle b is formed based on the respective measurement values obtained by the one or more electrocardiogram measurement means 2 Detection of the patient's withdrawal from the patient, so that the condition of the vein puncture needle b can be detected in more detail, such as the condition in the process of withdrawal of the vein puncture needle b from the patient or the condition of complete withdrawal. Can. Alternatively, the single electrocardiogram measurement means 2 may be formed on the fixed portion M.

  Further, the fixed part M on which the electrocardiogram measurement means 2 (biological information measurement means) is formed is formed of a fixed wing R which is formed to project laterally and fixes the vein side puncture needle b to the patient. The second measuring means 2 (ecological information measuring means) can be formed on the fixed portion M more firmly and reliably. Still further, in the present embodiment, the biological information measurement means is closely attached to the skin of the patient and can measure the patient's electrocardiogram, so the patient's electrocardiogram as the biological information can be measured more accurately while the vein side Withdrawal of the puncture needle b from the patient can be detected more reliably.

  In addition, an electrocardiogram acquisition means 12 for obtaining an electrocardiogram based on measurement signals from the electrocardiogram measurement means 2 and 3 is provided, and based on electrocardiogram information obtained by the electrocardiogram acquisition means 12 The withdrawal of the vein-side puncture needle b can be easily and accurately detected from the patient by the electrocardiogram information obtained by the electrocardiogram acquisition means 12.

  In addition, according to the present embodiment, the electrocardiogram measurement means 3 as the biological information measurement means is formed in the fixing portion M integrated with the vein-side puncture needle b (access means), and the fixing portion M The wiring is extended from the end to the tip (flow passage) of the vein side blood circuit 6b, and the signal of the measuring means 3 for electrocardiogram is treated in a state where the vein side puncture needle b and the tip of the vein side blood circuit 6b are connected. The apparatus (the blood purification apparatus 1 and the external information processing apparatus 14) can be transmitted, and the detachment of the vein side puncture needle b from the tip (flow passage) can be detected based on the presence or absence of transmission of a signal. Therefore, according to the signal from the measurement means 3 for electrocardiogram, detection of withdrawal of the vein side puncture needle b from the patient and detection of detachment of the vein side puncture needle b from the tip of the vein side 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.

  Further, since the wires (the patient side wire 4a and the device side wire 4b) according to the present embodiment are formed inside the vein side blood circuit 6b and the flexible tube g (flow passage) for forceps, the worker etc. It is possible to prevent the interference with the wiring and interfering with the transmission of the signal by mistake, and it is possible to more accurately detect the detachment of the vein side puncture needle b from the tip of the vein side blood circuit 6b. . Furthermore, the treatment apparatus according to the present embodiment includes the pinching means 13 capable of pinching the venous blood circuit 6b (flow passage), and the pinching means 13 pinches the tip of the venous blood circuit 6b. It is connected to the tip (the other end 4bb) of the wiring (the device side wiring 4b) and can transmit the signal of the measuring means 2 for electrocardiogram to the treatment apparatus, so the vein side blood circuit 6b is held by the holding means 13 By doing this, signal transmission can be performed well 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, detection of the detachment of the vein puncture needle b from the patient and the tip of the vein blood circuit 6b is biological information It can be accurately performed by the signal by the measuring means. In addition, the biological information measuring means is closely attached to the skin of the patient and can measure the patient's electrocardiogram, so the patient of the vein side puncture needle b and the patient's electrocardiogram as the biological information can be measured more accurately Withdrawal from the tip of the venous blood circuit 6b can be detected more reliably.

  As mentioned above, although this embodiment was described, the present invention is not limited to this, for example, the therapeutic device applied has access means which consists of a catheter which can be penetrated in a patient's blood vessel besides blood purification device 1 It may be an infusion device. In this case, the flow passage is connected to the access means so that a liquid such as a drug can be infused into the patient via the access means. The biological information measurement means is not limited to the electrocardiogram measurement means using electrodes as in the present embodiment, and for example, a thermocouple, a temperature sensor using infrared rays, a pulse wave sensor using light, ultrasonic waves, etc. A blood flow sensor using light or the like may be used. In addition, as shown in FIGS. 22-24, one end 4aa of the patient side wiring 4a may be formed along the fixed wing R, and in this case, the other end 4aa may be another member. It can prevent that a worker's finger etc. interfere.

  Furthermore, although the electrocardiogram measurement means 2 (biological information measurement means) according to the present embodiment is attached to the fixed portion M of the vein side puncture needle b, it is also possible to attach it to the fixation portion of the artery side puncture needle a It is good also as what is attached to the fixed part of both the artery side puncture needle a and the vein side puncture needle b, respectively. Furthermore, in the present embodiment, detection of withdrawal from the patient of the vein side puncture needle b (access means) and detection of the vein of the vein side puncture needle b according to the signal from the biological information measurement means (electrocardiogram measurement means 2) Although both detection of detachment from the tip of the side blood circuit 6b is possible, it may be possible to only detect detachment of the vein puncture needle b (access means) from the patient. The function of the external information processing apparatus 14 may be provided to the blood purification apparatus 1, and an abnormality signal generated by the external information processing apparatus 14 is finally input to the blood purification apparatus 1 via the central monitoring apparatus. You may do it.

The biological information measuring means is formed on the fixed part integrated with the access means , the patient side wiring is extended to the fixed part, the device side wiring is extended to the flow passage, and the fixed portion and the flow passage are The patient side wiring and the device side wiring are electrically connected in the connected state, and based on the measurement value obtained by the biological information measuring means, the access means is separated from the patient, and from the access means. The present invention can be applied to a medical device which can detect both of the flow passage and the like, which has a different external shape or to which another function is added.

1 Blood purification device 2, 3 Measurement means for electrocardiogram (biological information measurement means)
4a Patient side wire 4b Device side wire 5 Clamped portion 6a Arterial side blood circuit 6b Vein side blood circuit 7 Dialyzer (blood purifier)
8 blood pump 9a artery side air trap chamber 9b vein side air trap chamber 10 duplex pump 11 water removal pump 12 electrocardiogram acquisition means 13 pinching means 14 external information processing device 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 Informing means

Claims (8)

An access means comprising a puncture needle or a catheter which can be inserted into a patient's blood vessel, and a flow passage through which blood of the patient can be circulated or liquid such as medicine can be injected into the patient through the access means. A treatment device,
Biological information measuring means capable of measuring biological information of a patient;
In the medical device provided with
The living body information measurement means is formed in a fixed part integrated with the access means, and patient side wiring is extended in the fixed part, device side wiring is extended in the flow path, and the fixation is performed The patient side wiring and the device side wiring are electrically connected in a state where the unit and the flow path are connected, and based on the measurement value obtained by the biological information measuring unit, the access unit from the patient A medical device characterized in that it is possible to detect both detachment and detachment of the flow passage from the access means .   The one or more living body information measurement means are formed in the fixed portion, and detection of the access means from the patient can be detected based on respective measurement values obtained by the one or more living body information measurement means. The medical device according to claim 1, characterized in that it is   The medical device according to claim 1 or 2, wherein the fixing part on which the biological information measuring means is formed is formed by projecting laterally to fix 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 closely attached to the skin of a patient and can measure an electrocardiogram of the patient. An electrocardiogram acquiring means for acquiring an electrocardiogram based on the measurement signal from the biological information measuring means is provided, and the detachment of the access means from the patient can be detected based on the electrocardiogram information obtained by the electrocardiogram acquiring means. The medical device according to claim 4, characterized in that: The medical device according to claim 5, wherein when an abnormality is recognized in the electrocardiogram acquired by the electrocardiogram acquisition means, a predetermined notification is performed. 7. The information processing apparatus according to any one of claims 1 to 6, further comprising notification means for performing a predetermined notification on condition that detachment of the access means from the patient or disconnection of the flow path from the access means is detected. Medical device according to the above. The medical device according to any one of claims 1 to 7, wherein it is possible to detect a state in the process of withdrawal from the patient of the access means or a state in which the access means is completely withdrawn from the patient.

Images