JP6516514B2 - Medical device - Google Patents

Description

  The present invention relates to a medical device capable of causing a predetermined operation of a therapeutic means to be performed by an operator operating a confirmation key.

  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. Such dialysis treatment apparatus usually comprises display means capable of displaying information on the treatment of the patient.

  As such display means, those consisting of a touch panel or the like that can be operated by touching the predetermined range on the screen by the operator are widely used, and in addition to information related to the treatment of the patient, the operator such as a blood pump It is possible to operate the treatment means for performing the treatment. Also, conventionally, a confirmation display for causing the operator to confirm a predetermined operation for treatment and a confirmation key (confirm key) for the operator to operate when the user agrees with the content of the confirmation display are configured It has been proposed that a predetermined operation for treatment is performed by the operator operating the confirmation key. Since such prior art does not relate to a document known invention, there is no prior art document information to be described.

  However, in the above-mentioned prior art, by making the operator visually confirm the confirmation display, it is possible to confirm whether the predetermined operation on the treatment means of the operator is appropriate or not, and the safety can be ensured. There is a possibility that the confirmation key may be operated without visually confirming the confirmation display due to the operator's familiarity of the operation or the operation requiring an emergency, and further securing of safety is required.

  The present invention has been made in view of such circumstances, and an object thereof is to provide a medical device capable of assuring safety of predetermined operation of a treatment means more reliably.

The invention according to claim 1 has a blood circuit for circulating the patient's blood extracorporeally, and can display a treatment means for treating the patient and information on the treatment of the patient, as well as performing a predetermined operation of the treatment means. A confirmation display for causing the operator to confirm and a display means capable of displaying a confirmation key for the operator to operate when agreeing to the content of the confirmation display, the operator operating the confirmation key wherein the medical device the can to perform a predetermined operation of the treatment means, on condition that the confirmation key predetermined time has elapsed from the display of the confirmation display is operated, as to perform the predetermined operation of the treatment means by And the predetermined operation is an operation that may damage the patient if the blood circuit is connected to the patient, and the confirmation display indicates that the blood circuit is in contact with the patient. Characterized in that it is a display to the effect that to make sure that they have not been.

  The medical device according to a second aspect of the present invention is the medical device according to the first aspect, further comprising: determination means for determining whether or not a predetermined time has elapsed from the display of the confirmation display until the confirmation key is operated. And performing the predetermined operation of the treatment means on condition that it is determined that the predetermined time has elapsed.

  The invention according to claim 3 is that, in the medical device according to claim 1 or 2, when the predetermined time does not elapse until the confirmation key is operated from the display of the confirmation display, the operation with respect to the confirmation key is not accepted. It is characterized by

  The invention according to claim 4 is the medical device according to claim 3, wherein, when a predetermined time does not elapse from the display of the confirmation display until the confirmation key is operated, notification that the operation for the confirmation key is not received is notified. It is characterized by

  The invention according to claim 5 is characterized in that in the medical device according to any one of claims 1 to 4, the therapeutic means comprises a blood purification device for purifying the blood of a patient.

  According to the invention of claim 1, the predetermined action of the treatment means is performed on condition that the confirmation key is operated after the predetermined time has elapsed from the display of the confirmation display, so the operator visually recognizes the confirmation display. The predetermined operation of the treatment means can be performed only when the confirmation key is operated after passing the predetermined time, and the safety at the time of the predetermined operation can be ensured more reliably.

  According to the second aspect of the present invention, the apparatus further comprises determination means for determining whether or not a predetermined time has elapsed from the display of the confirmation display until the confirmation key is operated, and the determination means determines that the predetermined time has elapsed. Since the predetermined operation of the treatment means is performed under the condition, it is possible to perform the predetermined operation of the treatment means more reliably only when the predetermined time has elapsed.

  According to the invention of claim 3, when the predetermined time does not elapse from the display of the confirmation display until the confirmation key is operated, the operation with respect to the confirmation key is not received, so compared with the one that receives and controls the operation with the confirmation key, Control can be simplified.

  According to the invention of claim 4, when a predetermined time does not elapse from the display of the confirmation display to the operation of the confirmation key, a notification that the operation on the confirmation key is not received is notified, so the operation of the confirmation key is not accepted. An operator can be made to grasp a state.

  According to the invention of claim 5, since the therapeutic means comprises a blood purification apparatus for purifying the blood of the patient, it is possible to more reliably ensure the safety at the predetermined operation for the treatment by the blood purification apparatus. it can.

A schematic view showing a medical device according to an embodiment of the present invention The perspective view which shows the external appearance of the main part in the medical device Flow chart showing control contents in the same medical device A schematic view showing the display contents by the display means of the medical device A schematic view showing the display contents by the display means of the medical device (the state in which the confirmation display and the confirmation key at the time of predetermined operation are displayed) A schematic view showing the display contents by the display means of the medical device (in a state where the notification that the operation is not accepted is displayed) A schematic view showing the display contents by the display means of the medical device (the state in which the confirmation display and confirmation key at the time of other predetermined operation are displayed) A schematic view showing the display contents by the display means of the medical device (the state in which the confirmation display and the confirmation key at the time of another predetermined operation are displayed)

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The medical device according to the present embodiment comprises a blood purification device for purifying the patient's blood while circulating the blood extracorporeally, and as shown in FIG. 1, the blood circuit 1, the blood pump 2, and the dialyzer 3 (blood purification means ), The vein-side air trap chamber 4, the duplex pump 5, the water removal pump 6, the display means 7, the control means 8, and the determination means 9. The duplex pump 5 and the water removal pump 6 and the like are disposed in the apparatus main body H (see FIG. 2).

  The blood circuit 1 is composed of a flexible tube through which a fluid such as blood can flow, and is configured to include an arterial blood circuit 1a and a venous blood circuit 1b. In the artery-side blood circuit 1a, an artery-side puncture needle a can be connected to the tip thereof, and an ironing type blood pump 2 is disposed in the middle. On the other hand, a vein-side puncture needle b can be connected to the tip of the vein-side blood circuit 1b, and a vein-side air trap chamber 4 for degassing is connected in the middle.

  Then, when the blood pump 2 is driven in a state where the artery-side puncture needle a and the vein-side puncture needle b puncture the patient, the patient's blood is collected from the artery-side puncture needle a and passes through the artery-side blood circuit 1a. After the blood purification is performed by the dialyzer 3, the deaeration is performed in the vein side air trap chamber 4 and the vein side puncture needle b returns to the patient's body through the vein side blood circuit 1b. As a result, the patient's blood can be purified by the dialyzer 3 while being circulated extracorporeally in the blood circuit 1.

  A blood inlet port 3a, a blood outlet port 3b, a dialysate inlet port 3c, and a dialysate outlet port 3d are formed in the housing of the dialyzer 3. Among these, an arterial blood circuit 1a is formed in the blood inlet port 3a. The proximal end of the blood supply port 3b is connected to the proximal end of the venous blood circuit 1b. The dialysate inlet port 3c and the dialysate outlet port 3d are respectively connected to the dialysate inlet line L1 and the dialysate outlet line L2 extended from the apparatus main body H.

  Further, a plurality of hollow fibers are accommodated in the housing portion of the dialyzer 3, and the inside of the hollow fibers serves as a blood flow path, and the outer peripheral surface of the hollow fibers and the inner peripheral surface of the housing portion The space between them is the dialysate flow path. 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 apparatus main body H includes a double pump 5 formed across the dialysate introduction line L1 and the dialysate discharge line L2, a bypass line L3 connected by bypassing the double pump 5 in the dialysate discharge line L2, and the bypass It comprises with the water removal pump 6 connected to the line L3. Then, one end of the dialysate introduction line L1 is connected to the dialyzer 3 (dialysate introduction port 3c), 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 3 (dialysate outlet port 3d), and the other end is connected to the drainage means (not shown), and supplied from the dialysate supply device. The dialysate passes through the dialysate introduction line L1 to reach the dialyzer 3, flows through the dialysate flow path, and then is sent to the drainage means through the dialysate discharge line L2 and the bypass line L3.

  The water removal pump 6 is for removing water from the patient's blood flowing through the blood flow path in the dialyzer 3. That is, when the dewatering pump 6 is driven, the volume of the liquid discharged from the dialysate discharge line L2 is 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 water removal pump 6 (for example, one using a so-called balancing chamber or the like).

  The apparatus body H of the blood purification apparatus is provided with a display means 7 as shown in FIG. The display means 7 has a touch-panel-type liquid crystal screen 7a that allows an input operation when the operator touches it with a finger or the like. For example, as shown in FIG. In addition to being able to display venous pressure, blood pressure, pulse and the like), the operator is supposed to be able to perform a predetermined operation on the blood purification apparatus (therapeutic means).

  Furthermore, as shown in FIG. 5, the display means 7 according to the present embodiment indicates that the operator agrees with the confirmation display A for making the operator confirm the predetermined operation of the blood purification apparatus and the contents of the confirmation display A. Is supposed to be able to display the confirmation key B for operating. At a position adjacent to the confirmation key B, a cancel key C for canceling a predetermined operation when the content of the confirmation display A is not agreed is displayed. Then, the operator can perform the predetermined operation of the blood purification apparatus by touching and operating the confirmation key B and cancel the predetermined operation by touching and operating the cancel key C by the operator. it can.

  The control means 8 can control the display contents of the display means 7 and perform predetermined operations (for example, drive control of actuators such as the blood pump 2, the dual pump 5 or the water removal pump 6) in the blood purification apparatus (therapeutic means) It is possible to perform opening / closing control of clamping means such as a valve. The control means 8 according to the present embodiment causes the display means 7 to display a treatment related treatment, and when the blood purification apparatus performs a predetermined operation, the confirmation display A, the confirmation key B and the cancel key C are displayed at predetermined positions on the screen 7a. When the confirmation key B is touched and operated, the predetermined operation of the blood purification apparatus can be performed according to the determination result of the determination means 9.

  The predetermined operation of the blood purification apparatus is, for example, an operation where safety can not be confirmed by various sensors included in the blood purification apparatus, or an operation other than blood purification treatment, and if the patient is connected to the blood circuit 1, harm may occur. Turn off the monitoring of various devices in the blood purification device (at the time of parameter setting not recommended), or the operation performed by the parameter that the maker of the blood purification device does not recommend In addition to the one that shuts off the supply and does not perform monitoring itself, the operation that performs monitoring but includes not ignoring the alarm operation is also included. That is, if it operates automatically without asking the operator for confirmation, it means an operation that is undesirable for safety, and the confirmation display A is displayed to cause the operator to perform the operation confirmation, and the confirmation key is only accepted if it is agreed It is set to operate B.

  The display contents by the confirmation display A are different according to the predetermined operation of the blood purification apparatus, for example, in the case where the drainage process for collecting the drainage in the blood circuit 1 is performed after the blood purification treatment is completed, FIG. As shown, confirmation display A, confirmation key B and cancellation key C are displayed, "Please confirm that the arterial and venous side blood is not connected to the patient. After checking, please press the confirmation key." Ru. In addition, when the solution replacement step of filling the dialysate with the dialysate introduction line L1 and the dialysate discharge line L2 is completed, as shown in FIG. After confirming that there is no chemical solution remaining and that the composition is as prescribed, proceed to the next step. "Confirmation display A, confirmation key B and cancel key C are displayed. Furthermore, when changing the dialysate flow rate to a value other than the recommended value (for example, 100 mL / min), as shown in FIG. 8, a confirmation of "Change the dialysate flow rate to 100 mL / min. Are you sure?" Display A, confirmation key B and cancel key C are displayed.

  The determination means 9 is electrically connected to the control means 8 and determines whether or not a predetermined time (for example, about one second) has elapsed from the display of the confirmation display A until the confirmation key B is operated. 8 is configured to cause the blood purification apparatus to perform a predetermined operation on condition that the determination means 9 determines that the predetermined time has elapsed. That is, on the condition that the confirmation key B is operated after a predetermined time has elapsed since the display of the confirmation display A, the predetermined operation of the blood purification apparatus is performed.

  Further, in the present embodiment, when the predetermined time does not elapse from the display of the confirmation display A until the confirmation key B is operated, the operation for the confirmation key B is not received, and a message indicating that the operation is not received is displayed on the screen 7a. It is comprised so that it can alert | report by. For example, when the confirmation key B is operated before a predetermined time elapses from the display time point of the confirmation display A, it is determined that the confirmation display A is not viewed or not sufficiently observed, and the operation is not received As shown in FIG. 6, by displaying the notification display D, control is performed to notify that the operation is not accepted. The notification that the operation is not accepted is not limited to the display by the display unit 7, and may be, for example, lighting or blinking of a warning light, output of sound or sound from a speaker, or the like.

Next, the control contents by the control means according to the present embodiment will be described based on the flowchart of FIG.
First, the confirmation key A is displayed on the screen 7a of the display means 7 together with the confirmation display A in S1 (see FIG. 5), and the elapsed time from the display of the confirmation key B is measured in S2. Then, the presence or absence of the operation on the confirmation key B is determined in S3, and if there is the operation, the process proceeds to S4, and the determination means 9 determines whether a predetermined time has elapsed since the display of the confirmation display A. If it is determined in S4 that the predetermined time has elapsed, the operation for the confirmation key B is accepted (S5), and the predetermined operation is performed (S6), and it is determined that the predetermined time has not elapsed in S4 For example, as shown in FIG. 6, a notification that the operation is not accepted is performed (S8).

  According to the above embodiment, the operator performs the confirmation display because the predetermined operation of the blood purification apparatus (treatment means) is performed on condition that the confirmation key B is operated after a predetermined time has elapsed since the display of the confirmation display A. The predetermined operation of the blood purification apparatus can be performed only when the confirmation key B is operated after the predetermined time when A may be visually recognized, and the safety at the time of the predetermined operation can be ensured more reliably. In particular, in the present embodiment, the determination means 9 is provided to determine whether or not a predetermined time has elapsed from the display of the confirmation display A until the confirmation key B is operated, and the predetermined time has elapsed in the determination means 9 Since the predetermined operation of the blood purification apparatus is performed on the condition that the determination is made, the predetermined operation of the treatment means can be performed only when the predetermined time has elapsed more reliably.

  In addition, when a predetermined time does not elapse from the display of the confirmation display A until the confirmation key B is operated, the operation with respect to the confirmation key B is not received, so the control is simplified compared with the one that receives and controls the operation with the confirmation key B. Can be Furthermore, when a predetermined time does not elapse from the display of the confirmation display A to the operation of the confirmation key B, a notification that the operation on the confirmation key B is not received is notified, so that the operation of the confirmation key B is not received Can make people understand. In particular, since the treatment means according to the present embodiment comprises the blood purification apparatus for purifying the blood of the patient, the safety at the time of the predetermined operation for the treatment by the blood purification apparatus can be ensured more reliably.

  The present embodiment has been described above, but the present invention is not limited thereto. For example, when the confirmation key B is operated at a time when a predetermined time has not elapsed since the display of the confirmation display A, the same screen is displayed again Alternatively, different screens may be displayed. In addition, when a predetermined time does not elapse from the display of the confirmation display A until the confirmation key B is operated, notification that the operation for the confirmation key B is not received may not be performed. Furthermore, depending on the medical institution in which the present treatment apparatus is installed, the determination by the determination means 9 may be optionally performed (that is, mode setting as a safe mode can be made possible). In addition, although the medical device which concerns on this embodiment is applied to the hemodialysis apparatus for performing hemodialysis treatment, it may be an apparatus for performing another therapy.

Under the condition that the confirmation key is operated after the predetermined time has elapsed from the display of the confirmation display, the predetermined action of the treatment means is to be performed , and the predetermined action is that the blood circuit is connected to the patient In the case of a medical device that is an operation that may cause harm to the patient and the confirmation display is a display for confirming that the blood circuit is not connected to the patient , the appearance shape is different or other functions It can apply also to the thing etc. which were added.

1 blood circuit 2 blood pump 3 dialyzer (blood purification means)
4 Venous side air trap chamber 5 Duplex pump 6 Water removal pump 7 Display means 8 Control means 9 Judgment means A Confirmation display B Confirmation key C Cancel key

Claims (5)

A treatment means for treating the patient , having a blood circuit for circulating the patient's blood outside the body ;
Information on the treatment of the patient can be displayed, and a confirmation display for causing the operator to confirm the predetermined operation of the treatment means and a confirmation key for the operator to operate when the contents of the confirmation display are agreed Obtaining display means,
A medical device, comprising: an operator operating the confirmation key to perform the predetermined operation of the treatment means.
A predetermined operation of the treatment means is performed on condition that the confirmation key is operated after a predetermined time has elapsed since the display of the confirmation display , and in the predetermined operation, the blood circuit is connected to the patient A medical device characterized in that it is an operation that may harm the patient if it is done, and the confirmation display is a display for confirming that the blood circuit is not connected to the patient .   A determination means is provided to determine whether or not a predetermined time has elapsed from the display of the confirmation display until the confirmation key is operated, and the treatment means is determined on the condition that the predetermined time has elapsed by the determination means. The medical device according to claim 1, wherein the predetermined operation is performed.   The medical device according to claim 1 or 2, wherein the operation on the confirmation key is not accepted when a predetermined time does not elapse from the display of the confirmation display until the confirmation key is operated.   The medical device according to claim 3, wherein, when a predetermined time does not elapse from the display of the confirmation display until the confirmation key is operated, a notification that the operation on the confirmation key is not received is notified.   The medical device according to any one of claims 1 to 4, wherein the therapeutic means comprises a blood purification device for purifying the blood of a patient.

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