Infusion tube assembly, infusion device, and infusion method

An infusion device includes an infusion pump and an infusion tube assembly. The infusion tube assembly includes a first tube body connected to the infusion pump, a tube joint structure having first, second and third tube joints, a second tube body, and a clamping device on the second tube body. The clamping device is to clamp the second tube body. An infusion method includes instructing the infusion pump to perform an infusion operation. When bubbles are detected in a liquid in the infusion tube assembly, the infusion pump is instructed to stop the infusion operation and a bubble alarm is generated. After the infusion pump stops the infusion operation, it is determined whether a pressure of the liquid first drops to a first pressure value and then rises to a second pressure value. If yes, a rinsing operation is performed.

BACKGROUND

Technical Field

The present disclosure relates to an infusion tube assembly, an infusion device, and an infusion method, and more particularly to the infusion tube assembly, the infusion device, and the infusion method which may perform removal of bubbles.

Description of Related Art

In a medical treatment, when infusion is required for a patient, an infusion device including an infusion pump and an infusion tube is used to deliver liquid medicine to the patient's vein. However, during the delivery of the liquid medicine, bubbles may enter the infusion tube, and thus the bubbles need to be removed, so as to prevent the bubbles from entering the patient's body with the liquid medicine.

The clinical practice for removing the bubbles generally has to remove the infusion tube from the infusion pump and discharge some of the liquid medicine so as to remove the bubbles together with the medicine liquid. However, this method may not only cause inconvenience to nursing staffs but also waste liquid medicine during the removal of the bubbles. Therefore, how to improve the removal of the bubbles in the infusion tube is an important issue currently.

SUMMARY

According to one embodiment of the present disclosure, an infusion assembly is applied to an infusion pump. The infusion tube assembly includes a first tube body, a tube joint structure, a second tube body, and a clamping device. The first tube body is configured to be connected to the infusion pump. The tube joint structure has a first tube joint, a second tube joint, and a third tube joint. The first tube joint is connected to one end of the first tube body. One end of the second tube body is connected to the second tube joint. The clamping device is disposed on the second tube body and is configured to clamp the second tube body.

According to some embodiments of the present disclosure, the infusion tube assembly further includes a liquid container engaged to the third tube joint.

According to another embodiment of the present disclosure, an infusion device includes an infusion pump, a first tube body, a tube joint structure, a second tube body, and a clamping device. The first tube body is configured to be connected to the infusion pump. The tube joint structure has a first tube joint, a second tube joint, and a third tube joint. The first tube joint is connected to one end of the first tube body. One end of the second tube body is connected to the second tube joint. The clamping device is disposed on the second tube body and is configured to clamp the second tube body.

According to some embodiments of the present disclosure, the infusion device further includes a liquid container engaged to the third tube joint.

According to some embodiments of the present disclosure, the tube joint structure is Y-shaped.

According to some embodiments of the present disclosure, an angle between the first tube joint and the third tube joint is an acute angle.

According to some embodiments of the present disclosure, an angle between the first tube joint and the second tube joint is an obtuse angle.

According to another embodiment of the present disclosure, an infusion method is applied to an infusion pump connected to an infusion tube assembly, in which the infusion tube assembly includes a first tube body, a tube joint structure connected to the first tube body, and a second tube body connected to the tube joint structure. The infusion method includes the following steps. The infusion pump is instructed to perform an infusion operation. When bubbles are detected in a liquid delivered in the infusion tube assembly, the infusion pump is instructed to stop the infusion operation and a bubble alarm is generated. After the infusion pump stops the infusion operation, the method determines whether a pressure of the liquid drops to a first pressure value. If the pressure of the liquid drops to the first pressure value, the method further determines whether the pressure of the liquid rises to a second pressure value. If the pressure of the liquid rises to the second pressure value, a rinsing operation is performed.

According to some embodiments of the present disclosure, the method further includes before determining whether the pressure of the liquid drops to the first pressure value, generating a prompt signal for clamping the second tube body.

According to some embodiments of the present disclosure, the method further includes before determining whether the pressure of the liquid rises to the second pressure value, generating a first prompt signal for installing a liquid container at the tube joint structure.

According to some embodiments of the present disclosure, the method further includes after no bubbles are detected during the rinsing operation, generating a second prompt signal for removing the liquid container and opening the second tube body.

According to some embodiments of the present disclosure, the method further includes determining whether the bubbles are detected while the rinsing operation is performed. If no bubbles are detected during the rinsing operation, the infusion pump is instructed to continuously perform the infusion operation for a predetermined period of time and then stop the infusion.

In summary, the disclosure provides the infusion tube assembly, the infusion device, and the infusion method. By using the infusion structure and the infusion method, the bubbles in the infusion tube can be effectively removed with a simple. The removal of the bubbles may be performed without taking out the infusion tube. Furthermore, since the liquid container is connected to the tube joint structure, the loss of the liquid medicine can be reduced during the removal of the bubbles. In addition to reducing the loss of the liquid medicine, the liquid medicine flowing into the liquid container may be recycled and reused.

DETAILED DESCRIPTION

FIG.1toFIG.3are schematic views showing an infusion tube assembly and an infusion device10in different operation states in accordance with one embodiment of the present disclosure. Referring toFIG.1, in the present embodiment, the infusion device10includes an infusion pump100and the infusion tube assembly applied to the infusion pump100. The infusion pump100is configured to deliver liquid medicine to a patient's body by using the infusion tube assembly in a controlling manner. The infusion pump100has a display screen110, a controller120, a pressure sensor130, a bubble sensor140, and an alarm150. The display screen110is used to display different operating states and prompt signals of the infusion pump100. The controller120is electrically connected to the display screen110, the pressure sensor130, the bubble sensor140and the alarm150, so as to control the operation of the infusion pump100, and display the operation state and the prompt signal on the display screen110. The pressure sensor130is used to measure a pressure of a liquid in the infusion tube200. The bubble sensor140is used to detect whether the liquid in the infusion tube200contains bubbles. When the bubbles are detected, a bubble alarm is issued through the alarm150. In some embodiments, the infusion pump100is a push pump, a cylindrical pump, or a digital peristaltic pump, and has two types of power including kinetic power and mechanical power.

As shown inFIG.1, the infusion tube assembly includes the infusion tube200and a tube joint structure300. The infusion tube200includes a first tube body210and a second tube body220. The first tube body210is partially disposed in and connected to the infusion pump100. One end of the first tube body210is connected to a vial (not shown), and the other end of the first tube body210is connected to the tube joint structure300. In the present embodiment, the tube joint structure300has a first tube joint310, a second tube joint320and a third tube joint330. The first tube joint310is connected to the first tube body210relative to one end of the infusion pump100. One end of the second tube body220is connected to the second tube joint320. In other words, the liquid in the first tube body210is pushed by the infusion pump100to flow through the first tube joint310, the second tube joint320, and the second tube body220, and then flows into the body of the patient.

The tube joint structure300is disposed at a position which is a distance D1away from the end of the infusion pump100. For example, one side of the infusion tube200with the liquid flowing to the infusion pump100may be defined as an upstream, while the other side of the infusion tube200with the liquid leaving the infusion pump100may be defined as a downstream. The tube joint structure300is disposed at the downstream of the infusion pump100which is the distance D1away from the end of the infusion pump100. In some embodiments, the distance D1is in a range from about 5 cm to about 15 cm. When the distance D1is greater than 15 cm, it takes more time to remove the bubbles, which is not beneficial for the infusion operation to be performed. When the distance D1is less than 5 cm, the installation of a liquid container (the liquid container500will be discussed below) at the tube joint structure300may likely to interfere with the infusion pump100, resulting in operational inconvenience. The tube joint structure300has a stopping element332which is disposed on the third tube joint330of the tube joint structure300. When the liquid flows from the first tube body210into the second tube body220, the stopping element332is used to ensure that the liquid does not flow out of the third tube joint330. In some embodiments, the tube joint structure300is Y-shaped. In some embodiments, an angle a is formed between the first tube joint310and the third tube joint330, while an angle b is formed between the first tube joint310and the second tube joint320, and the angle a is smaller than the angle b. For example, the angle a between the first tube joint310and the third tube joint330is an acute angle less than 90 degrees, while the angle b between the first tube joint310and the second tube joint320is an obtuse angle greater than 90 degrees. Since the angle b between the first tube joint310and the second tube joint320has the aforementioned relationship, it is beneficial for the liquid to smoothly flow from the first tube body210into the second tube body220.

In some embodiments, the clamping device400is disposed on the second tube body220and is configured to clamp the second tube body220. In the present embodiment, the clamping device400may be a slide clamp, but the invention is not limited thereto. In other embodiments, the clamping device400may be a roller clamp or another suitable device. A user may open the clamping device400to allow the liquid in the second tube body220to flow into the patient's body. As shown inFIG.1, when the clamping device400is in an open state, the liquid in the second tube body220may flow through the clamping device400, thereby allowing the liquid to be delivered to the patient. In contrast, if the clamping device400is in a closed state, the liquid in the second tube body220cannot flow through the clamping device400, that is, the liquid cannot be continuously delivered to the patient.

Referring toFIG.2,FIG.2is a schematic view showing the infusion tube assembly and the infusion device10in another operation status in accordance with one embodiment of the present disclosure. As shown inFIG.2, the clamping device400is in a closed state, such that liquid in the second tube body220cannot flow through the clamping device400. Thereafter, the infusion device10may further include a liquid container500configured to accommodate the liquid flowing out of the third tube joint330. The liquid container500is detachably connected to the third tube joint330of the tube joint structure300and has a variable volume510, but the invention is not limited thereto. For example, the liquid container500may be a container having an opening, and the opening is closed with a waterproof ventilation membrane and the opening may allow the liquid to flow out of the third tube joint330. The liquid container500may also be an empty syringe having a variable volume510to accommodate the liquid flowing out of the third tube joint330. In some embodiments, the volume of the liquid container500is selected to be related to the distance D1. For example, when the distance D1is 5 cm, the discharged bubble-containing volume is about 1.807 mL, and thus the volume of the liquid container500needs to be greater than 1.807 mL. When the distance D1is 10 cm, the discharged bubble-containing volume is about 2.16 mL, and thus the volume of the liquid container500needs to be greater than 2.16 mL. When the distance D1is 15 cm, the discharged bubble-containing volume is about 2.513 mL, and thus the volume of the liquid container500needs to be greater than 2.513 mL.

Referring toFIG.3,FIG.3is a schematic view showing the infusion tube assembly and the infusion device10in another operation status in accordance with one embodiment of the present disclosure. As shown inFIG.3, when the clamping device400is in the closed state, the liquid in the second tube body220cannot continue to pass through the clamping device400and flows to the third tube joint330instead. At this time, the liquid flowing out of the third tube joint330passes through the stopping element332on the third tube joint330and then flows into the liquid container500. In the present embodiment, the liquid container500has a variable volume510which may collect the liquid flowing out through the third tube joint330, and the liquid may be recycled and reused without wasting the liquid medicine.

Referring toFIGS.4and5,FIG.4is a flow chart showing an infusion method40in accordance with one embodiment of the present disclosure, andFIG.5is a chart showing pressure variation of the liquid in the infusion tube when the infusion method40ofFIG.4is performed. The infusion method40is described below in conjunction with the infusion device10shown inFIG.1toFIG.3. The infusion method40includes operations S400to S490. In other words, the infusion method40may be applied to an infusion pump100which is connected to an infusion tube assembly, in which the infusion tube assembly includes a first tube body210, a tube joint structure300connected to the first tube body210, and a second tube body220connected to the tube joint structure300. In addition to operations S400to S490shown inFIG.4, additional operations can be provided before, during, and after the infusion method40, and some operations described herein can be replaced, eliminated, or moved around to achieve additional embodiments without departing from the scope of the present disclosure.

Operations S400to S490are described below. At operation S400, an infusion pump100is instructed to perform an infusion operation. For example, the controller120of the infusion pump100may control the infusion pump100to perform the infusion operation. The first tube body210is partially disposed in and connected to the infusion pump100. One end of the first tube body210is connected to the vial (not shown), and the other end is connected to the tube joint structure300. The liquid flows from the first tube body210to the tube joint structure300and is delivered to the patient's body through the second tube body220.

Operation S410is performed to detect whether there are bubbles in the liquid delivered in the infusion tube200of the infusion tube assembly. For example, the bubble sensor140of the infusion pump100may detect whether there are bubbles in the liquid. If there are no bubbles in the liquid, the infusion pump100continuously performs the infusion operation. If there are bubbles in the liquid, operation S420is performed.

At operation S420, the infusion pump100is instructed to stop the infusion operation and a bubble alarm is generated. For example, the aforementioned controller120may generate the bubble alarm at this time. Furthermore, the controller120may display the bubble alarm on the display screen110, or may further send out an alarm sound through the alarm150to clearly remind the user that bubbles appear in the liquid. Referring toFIG.5, in a period from the infusion pump100performing the infusion operation through the bubble sensor140in the infusion pump100detecting the bubbles, to the infusion pump100stopping the infusion operation and generating the bubble alarm, the pressure of the liquid is maintained at a position A and has no significant changes. In the present embodiment, the pressure of the liquid is converted by an analog-to-digital converter (ADC). Because different converters have different initial values with the pressure sensor130, subsequent measured ADC values fall within a range of values. For example, as shown inFIG.5, the ADC value of the pressure of the liquid is about 1220 during the period from the start of the infusion operation to about 85 seconds at which the infusion operation is stopped and the bubble alarm is generated. In some embodiments, the ADC value changes are the pressure differences of the pressure sensor130, and the voltage values output by the pressure sensor130is at a millivolt (mV) level. As a result, the voltage value needs to be amplified by an amplifier, so as to convert the analog voltage signal to a software-determinable digital ADC value. For example, in the present embodiment, the calculation of the ADC value is obtained by the following equation (1), in which the voltage V in the equation (1) is the voltage output through the amplifier.

At operation S430, a prompt signal is generated for clamping the second tube body220. For example, the controller120may generate the prompt signal at this time and display the prompt signal on the display screen110. As shown inFIG.2, after the prompt signal is generated, the effect of clamping the second tube body220may be achieved by the user's manual operation or automatically closing the clamping device400by machine, but the disclosure is not limited thereto. The effect of clamping the second tube body220may be achieved by other suitable methods. As a result, the liquid will stop flowing in the second tube body220without flowing into the patient's body.

Operation S440is performed to determine whether the pressure of the liquid drops to a first pressure value. As shown by point B ofFIG.5, when the second tube body220is clamped, the pressure of the liquid drops to the first pressure value. For example, the ADC value of the pressure of the liquid drops from the initial pressure of the liquid, e.g., about 1220, to the first pressure value, e.g., about 870, and the initial pressure of the liquid drops about 350 to the first pressure value. In some embodiments, the reference value of the first pressure value may be different due to a different infusion pump100selected by the user. In general, the ADC value between the initial pressure of the liquid and the first pressure value may differ in a range between about 250 and about 450. Referring back to operation S440, after the prompt signal for clamping the second tube body220is generated, the controller120may detect whether the pressure of the liquid drops to the first pressure value, thereby determining whether the second tube body220is already clamped to prevent the liquid from flowing into the patient's body with bubbles in subsequent operations of removing bubbles. If the pressure of the liquid drops to the first pressure value, the controller120determines that the second tube body220is already clamped, and proceeds to operation S450. If the pressure of the liquid does not drop to the first pressure value, the controller120determines that the second tube body220is not clamped, and returns to operation S430to generate and display the prompt signal for clamping the second tube body220on the display screen110to remind the user to clamp the second tube body220.

At operation S450, after the pressure of the liquid drops to the first pressure value, a prompt signal for installing the liquid container500at the tube joint structure300is generated. For example, the controller120may generate the prompt signal at this time and display the prompt signal on the display screen110. As shown inFIG.2, after the prompt signal is generated, the effect of installing the liquid container500at the tube joint structure300may be achieved by the user's manual operation or by machine automatically. In the greater detail, the tube joint structure300may include a first tube joint310connected to the first tube body210, a second tube joint320connected to the second tube body220, and a third tube joint330. The liquid container500is configured to be installed at the third tube joint330. In some embodiments, when the liquid container500is installed at the third tube joint330, the liquid may pass through the stopping element332on the third tube joint330and flow into the liquid container500.

Operation S460is performed to determine whether the pressure of the liquid rises to a second pressure value is performed. As shown by point C inFIG.5, when the liquid container500is installed at the tube joint structure300, the pressure of the liquid rises to the second pressure value. In other words, the second pressure value is greater than the first pressure value. For example, the pressure of the liquid may rise from the first pressure value, e.g., about 870, to the second pressure value, e.g., about 1200, with a difference between the first pressure value and the second pressure value, e.g., about 330. In some embodiments, the reference values of the first pressure value and the second pressure value may be different due to the different infusion pumps100selected by the user. In general, the ADC value between the first pressure value and the second pressure value may differ in a range between about 250 and about 450. Referring back to operation S460, after the prompt signal for installing the liquid container500at the tube joint structure300is generated, the controller120may detect whether the pressure of the liquid rises to the second pressure value, thereby determining whether the liquid container500is already installed at the tube joint structure300. If the pressure of the liquid rises to the second pressure value, the controller120determines that the liquid container500is already installed at the tube joint structure300, and proceeds to operation S470. If the pressure of the liquid does not rise to the second pressure value, the controller120determines that the liquid container500is not installed at the tube joint structure300, and returns to operation S450to generate and display the prompt signal for installing the liquid container500at the tube joint structure300on the display screen110to remind the user to install the liquid container500at the tube joint structure300.

At operation S470, a rinsing operation is performed. In other words, the infusion pump100rapidly compresses the infusion tube to achieve the effect of rapid infusion. As shown inFIG.3, when the rinsing operation is performed, the controller120may control the infusion pump100to perform the infusion operation. As a result, the liquid flows into the liquid container500through the third tube joint330of the tube joint structure300. The liquid in the liquid container500may be recycled and reused without wasting the liquid medicine. Referring toFIG.5, when the rinsing operation is performed, the pressure value first rises from the second pressure value and gradually stabilizes during the rinsing operation. For example, the pressure value may be about 1200, which is slightly lower than the pressure of the liquid when the infusion operation is started at operation S400.

Operation S480is performed to detect whether there are bubbles in the liquid. For example, the controller120may utilize the bubble sensor140of the infusion pump100to detect whether there are bubbles in the liquid. If there are no bubbles in the liquid, operation S490is performed. If there are bubbles in the liquid, operation S470is returned to perform a rinsing operation.

Operation S490is performed to generate a prompt signal for removing the liquid container500and opening the second tube body220. For example, the controller120may generate the prompt signal at this time and display the prompt signal on the display screen110. After the prompt signal is generated, the effect of removing the liquid container500and opening the second tube body220may be achieved by the user's manual operation or by machine automatically, but the present disclosure is not limited thereto. For example, as shown inFIG.1, opening the second tube body220may be achieved by releasing the clamping device400to allow the liquid to flow through the first tube body210and the second tube body220, thereby delivering the liquid to the patient's body.

After operation S490, the infusion pump100may continuously infuse the liquid for a period of time and then the infusion operation is stopped, in which the length of time may be decided by the user, e.g., a doctor or a nursing staff, to determine the amount of liquid medicine needed by the patient.

In summary, the disclosure provides the infusion tube assembly, the infusion device, and the infusion method. By using the infusion structure and method, the bubbles in the infusion tube may be effectively removed with a simple. The removal of the bubbles may be performed without taking out the infusion tube. Furthermore, since the liquid container is connected to the tube joint structure, the loss of the liquid medicine can be reduced during the removal of the bubbles. In addition to reducing the loss of the liquid medicine, the liquid medicine flowing into the liquid container may be recycled and reused.