Infusion pressure measuring device for medical devices, infusion system

Abstract

The present disclosure provides a perfusion pressure measuring device of a medical instrument, a perfusion system, comprising: a perfusion liquid inlet; a first perfusion liquid outlet in communication with the perfusion liquid inlet; a perfusion liquid storage cavity, one end of the perfusion liquid storage cavity being in communication with the first perfusion liquid outlet; the other end being provided with a piston part; the piston part slides along the inner wall of the shell of the perfusion liquid storage cavity to indicate the pressure of the perfusion liquid following the pressure fluctuation of the perfusion liquid storage cavity; the perfusion liquid pressure measuring device of the present disclosure is simple in structure, low in cost, convenient to measure, and can realize high-precision pressure measurement by accurately calibrating the corresponding relationship between the position of the piston part and the pressure.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, specifically to a perfusion pressure measuring device for a medical device and a perfusion system for a ventricular assist device. Background Technology

[0002] Existing liquid contact measuring devices in injection pipelines suffer from high costs, while non-contact measuring devices lack sufficient accuracy. Furthermore, the silicone balloon pressure storage devices used to reduce pressure fluctuations in the injection system have several drawbacks, including small pressure vessels, easy silicone failure, and difficulties in air venting during initial use. Particularly problematic is that operators cannot monitor the real-time pressure within the pressure vessel using such devices, making it impossible to determine if the filter in the injection pipeline is clogged or when to replace it. Moreover, when using such devices and needing filter replacement, additional hydraulic lines are required to maintain normal operation of the injection pipeline; however, this increases the operator's workload and introduces numerous uncontrollable factors, increasing operational risks. Therefore, there is an urgent need for a pressure measuring device and injection system that can address at least one of the aforementioned problems. Utility Model Content

[0003] To overcome at least one of the many problems in the related art, a first aspect of this disclosure provides a perfusion pressure measuring device for a medical device, comprising: Infusion fluid inlet; The first infusion fluid outlet is connected to the infusion fluid inlet; The perfusion fluid storage chamber has one end connected to the first perfusion fluid outlet and the other end provided with a piston. The piston slides along the inner wall of the injection fluid storage chamber in response to pressure fluctuations, thereby indicating the pressure of the injection fluid.

[0004] In some optional embodiments, a first pressure measuring unit and a second pressure measuring unit are included; The first pressure measuring unit is located in the piston section; The second pressure measuring unit is located outside the housing of the filling fluid storage cavity and is used to receive the measurement signal from the first pressure measuring unit.

[0005] In some optional embodiments, a second perfusion fluid outlet and a pressure regulating section are included; The second infusion fluid outlet is connected to both the infusion fluid inlet and the first infusion fluid outlet; The pressure regulating part is located between the inner wall of the housing of the injection fluid storage chamber and the piston part, and adjusts the output pressure of the second injection fluid outlet according to the pressure fluctuation of the injection fluid.

[0006] In some optional embodiments, a handle portion is included, which is disposed outside the housing of the infusion fluid storage chamber and connected to the piston portion.

[0007] In some optional embodiments, the outer wall of the housing of the perfusion fluid storage chamber is provided with a mark indicating at least one of the upper limit or lower limit of the perfusion pressure.

[0008] A second aspect of this disclosure provides a perfusion system for a ventricular assist device, including a perfusion pressure measuring device for any of the medical devices described in the first aspect. It also includes: a filtration unit and a pumping device; The filter section is located upstream of the inlet of the injection fluid; The pumping device is located downstream of the second injection fluid outlet; At least a portion of the injection fluid can flow sequentially through the filter section and the pumping device.

[0009] In some optional embodiments, a one-way valve is also included, which is located on the communication path between the filter section and the filling fluid inlet.

[0010] In some optional embodiments, the perfusion fluid pressure measuring device further includes a replacement marker; When the pressure measured by the filling pressure measuring device is less than or equal to the pressure indicated by the replacement mark, it prompts that the filter section should be replaced.

[0011] In some optional embodiments, a pressure measuring unit is also included, which is located upstream of the filter unit.

[0012] The technical solution disclosed herein has the following advantages or beneficial effects: One end of the injection fluid storage chamber of this disclosure is connected to the first injection fluid outlet; the other end is provided with a piston part; the piston part slides along the inner wall of the injection fluid storage chamber shell to indicate the pressure of the injection fluid, following the pressure fluctuation of the injection fluid storage chamber; the purpose of measuring fluid pressure is achieved in a simple structural manner, and the device of this disclosure is low in cost, convenient for measurement, and high-precision pressure measurement can be achieved by accurately calibrating the correspondence between the position of the piston part and the pressure.

[0013] The pressure regulating unit of this disclosure adjusts the output pressure of the second injection fluid outlet according to the pressure fluctuations of the injection fluid in the injection fluid storage chamber, thereby maintaining pressure stability in the injection pipeline. That is, the pressure measuring device of this disclosure can not only be used to measure pressure, but also to regulate the pressure in the injection pipeline.

[0014] This invention allows the piston to be moved by pulling the handle to fill the injection fluid storage chamber, and then the pressure measuring device is connected to the injection pipeline. This achieves a simple and efficient way to discharge the gas in the pressure measuring device, avoiding its impact on the injection operation and greatly improving the efficiency of the user.

[0015] The perfusion fluid pressure measuring device disclosed herein also includes a replacement mark; when the pressure measurement value of the perfusion pressure measuring device is less than or equal to the pressure indicated by the replacement mark, the filter section is replaced; this greatly improves the safety of the perfusion system of the ventricular assist device. Attached Figure Description

[0016] The accompanying drawings are provided to better understand this disclosure and do not constitute an undue limitation thereof. Wherein: Figure 1 This is a cross-sectional schematic diagram of an infusion pressure measuring device for a medical device according to an embodiment of the present disclosure; Figure 2 This is a front view schematic diagram of an infusion pressure measuring device for a medical device according to an embodiment of the present disclosure; Figure 3 This is a top view schematic diagram of an infusion pressure measuring device for a medical device according to an embodiment of the present disclosure; Figure 4 This is a schematic diagram of the perfusion system of a ventricular assist device according to an embodiment of the present disclosure; Figure 5 This is a schematic diagram of the maintenance principle of the perfusion system of the ventricular assist device according to an embodiment of the present disclosure. Detailed Implementation

[0017] The exemplary embodiments of this disclosure are described below with reference to the accompanying drawings, including various details of the embodiments to aid understanding, and should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Similarly, for clarity and brevity, descriptions of well-known functions and structures are omitted in the following description.

[0018] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0019] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0020] To overcome at least one of the many problems in the related art, the first aspect of this disclosure provides an infusion pressure measuring device for a medical device, comprising: an infusion fluid inlet; a first infusion fluid outlet, the first infusion fluid outlet being connected to the infusion fluid inlet; an infusion fluid storage chamber, one end of the infusion fluid storage chamber being connected to the first infusion fluid outlet; and a piston portion provided at the other end; the piston portion sliding along the inner wall of the housing of the infusion fluid storage chamber in response to pressure fluctuations in the infusion fluid storage chamber to indicate the pressure of the infusion fluid.

[0021] like Figures 1 to 3 The perfusion pressure measuring device of the medical device shown, wherein Figure 2 and 3 The front view and top view of the perfusion pressure measuring device of the aforementioned medical device are shown respectively. Figure 3 By cutting at position AA in the top view shown, we can obtain... Figure 1 A cross-sectional view of the infusion pressure measuring device of the medical device shown.

[0022] exist Figure 3 The sectional view shown illustrates the main structure of the perfusion pressure measuring device of the medical device of this disclosure. It includes a tubing connector 106, which is a tee structure and includes an inlet (hereinafter referred to as perfusion fluid inlet 206, see [link]). Figure 4 It has two outlets (hereinafter referred to as the first perfusion fluid outlet and the second perfusion fluid outlet, respectively). The first perfusion fluid outlet is connected to the perfusion fluid storage chamber; the perfusion fluid inlet is connected to both the first perfusion fluid outlet and the second perfusion fluid outlet (see...). Figure 4The port connected to pipeline 207 is connected. In operation, after the injection fluid enters through the injection fluid inlet, a portion of the injection fluid enters the injection fluid storage chamber through the first injection fluid outlet, and the other portion flows out through the second injection fluid outlet. In actual use, the second injection fluid outlet of the pressure measuring device is connected to the target device (such as to an internal pumping device), and / or the injection fluid inlet is connected to a pressure source. The environmental back pressure introduced by the second injection fluid outlet and / or the injection fluid inlet acts on the injection fluid storage chamber, ultimately making the pressure formed by the liquid flowing into the injection fluid storage chamber equal to the environmental back pressure, thereby maintaining a certain liquid level in the injection fluid storage chamber. In practice, to maintain an appropriate volume in the injection fluid storage chamber and avoid the problem of excessive volume, a piston part 108 is provided at the end of the injection fluid storage chamber away from the first injection fluid outlet. The piston part squeezes the injection fluid in the injection fluid storage chamber to balance the environmental back pressure. It is understandable that when the ambient back pressure changes, the pressure inside the filling fluid storage chamber will change accordingly, thereby causing a change in the position of the piston. Whether it's pressure fluctuations at the filling fluid inlet or the second filling fluid outlet, they will ultimately cause pressure fluctuations in the first filling fluid outlet, which is directly connected to the filling fluid storage chamber. This, in turn, affects the pressure fluctuations and liquid level changes within the filling fluid storage chamber, ultimately leading to a change in the piston position. That is, the piston slides along the inner wall of the filling fluid storage chamber's housing, following the pressure fluctuations, to indicate the filling fluid pressure. Therefore, by calibrating the relationship between the piston position and the ambient back pressure, the ambient back pressure or the pressure of the measured filling path can be understood in real time by monitoring the piston position. In some embodiments, the calibration results can be marked on the outer wall of the filling fluid storage chamber's housing for easy visual observation of the piston position to obtain the pressure measurement value. After completing the pressure calibration, the pipe connector 106 of the filling pressure measuring device disclosed herein is connected to the pipeline at the point to be measured, and the pressure at the pipeline to be measured can be obtained in real time by monitoring the piston position. As described above, the perfusion fluid pressure measuring device of this disclosure has a simple structure, low cost, and convenient measurement. Furthermore, high-precision pressure measurement can be achieved by accurately calibrating the correspondence between the piston position and pressure. In some embodiments, a sealing device 105 is provided between the piston and the inner wall of the perfusion fluid storage chamber to prevent leakage of perfusion fluid through the gap between them.

[0023] In some optional embodiments, the infusion pressure measuring device includes a first pressure measuring unit and a second pressure measuring unit; the first pressure measuring unit is located on the piston part; the second pressure measuring unit is located outside the housing of the infusion fluid storage cavity and is used to receive the measurement signal from the first pressure measuring unit. As described above, marking the correspondence between the calibrated piston part position and pressure on the outer wall of the infusion fluid storage cavity housing allows for real-time observation of the infusion fluid pressure. However, in practice, many inconveniences still exist, such as the difficulty in electronically recording pressure changes in real time; or the slow speed and large error of visual observation and reading the scale; or the piston part being located inside the infusion fluid storage cavity, making it inconvenient to observe its position. Therefore, in some embodiments, a first pressure measuring unit 104 and a second pressure measuring unit 109 are further provided in the infusion fluid pressure measuring device to solve this problem. For example... Figure 1 As shown, the first pressure measuring unit is located on the piston part, and thus can move with the movement of the piston part; the second pressure measuring unit is located outside the housing of the filling fluid storage cavity and is used to receive the measurement signal from the first pressure measuring unit. Preferably, the first pressure measuring unit can be a magnetic element, and the second pressure measuring unit installed outside the housing can obtain the position of the piston part by sensing the magnetic field signal of the magnetic element, thereby avoiding the problem that the piston part is placed inside the filling fluid storage cavity and it is inconvenient to observe its position. Preferably, the second pressure measuring unit can convert the magnetic field signal into an electrical signal, which is convenient for electronic recording of real-time pressure changes. In practice, the second pressure measuring unit 109 is a reusable part. In order to reduce the consumption of parts and save on usage costs, the second pressure measuring unit 109 can be set in the annular receiving space formed by the inner housing 111 and the outer housing 110. The pressure measuring device is set in the inner cavity formed by the inner housing 111. When the pressure measuring device is damaged, only the pressure measuring device needs to be replaced, while the second pressure measuring unit can continue to be used. Or, when the second pressure measuring unit needs to be replaced, the pressure measuring device can continue to be used.

[0024] In some optional embodiments, the infusion pressure measuring device includes a second infusion fluid outlet (see...). Figure 4 The pipe fitting 106 shown is connected to the outlet of pipe 207, and a pressure regulating part 107. In some examples, the pressure regulating part is an elastic element, such as a spring. The elastic element is sleeved on the piston rod of the piston part. Figure 1As shown, the housing of the filling fluid storage chamber of the filling fluid pressure measuring device further includes an end cap 103. The end cap is used to close the filling fluid storage chamber to form a closed filling fluid storage chamber. One end of the piston rod 102 is connected to the piston body of the piston part, and the other end extends out of the end cap. The elastic element is disposed between the end cap and the piston part, and is connected to both the end cap and the piston part respectively. When the piston part moves away from the pipeline joint 106 under the action of the filling fluid pressure, the pressure regulating part is in a compressed state and stores energy; when the filling pressure decreases, the pressure regulating part relaxes and releases energy to push the piston part to move in the opposite direction to compensate for the pressure. Since the second filling fluid outlet is connected to the filling fluid inlet and the first filling fluid outlet respectively, the pressure regulating part adjusts the output pressure of the second filling fluid outlet according to the pressure fluctuation of the filling fluid in the filling fluid storage chamber to maintain the pressure stability in the filling pipeline. It can be seen that the pressure measuring device disclosed herein can not only be used to measure pressure, but also to regulate the pressure of the filling pipeline.

[0025] In some optional embodiments, the infusion pressure measuring device includes a handle portion, which is disposed outside the housing of the infusion fluid storage chamber and connected to the piston portion. For example... Figure 1 As shown, the handle 101 is connected to the end of the piston rod located outside the end cap. The handle controls the movement of the piston within the perfusion fluid storage chamber to adjust the volume of the perfusion fluid in the storage chamber. In the prior art, balloon pressure storage devices are commonly used. When this device is connected to the perfusion pipeline, it is difficult to expel the gas inside the device. However, when using the pressure measuring device of this disclosure to adjust the pressure of the perfusion pipeline, before connection, the piston can be moved by pulling the handle to fill the perfusion fluid storage chamber, and then it can be connected to the perfusion pipeline. This allows for simple and efficient expulsion of gas from the pressure measuring device, preventing it from affecting the perfusion operation and greatly improving the efficiency of the user.

[0026] In some optional embodiments, the outer wall of the perfusion fluid storage chamber is marked, the marking indicating at least one of the upper or lower limit of the perfusion pressure. For example... Figure 4 In the illustrated embodiment, the housing of the perfusion fluid storage chamber is provided with multiple pressure markers. For example, these include an upper pressure limit marker 201 to indicate that the pressure inside the perfusion fluid storage chamber has reached its upper limit, and a lower pressure limit marker 203 to indicate that the pressure inside the perfusion fluid storage chamber has reached its lower limit. In practice, other markers can be set as needed to prompt the user.

[0027] A second aspect of this disclosure provides a perfusion system for a ventricular assist device, including a perfusion pressure measuring device of any of the medical devices described in the first aspect. The system further includes a filter and a pumping device; the filter is located upstream of the perfusion fluid inlet; the pumping device is located downstream of the second perfusion fluid outlet; the pumping device is, for example, a blood pumping conduit for pumping blood. At least a portion of the perfusion fluid can flow sequentially through the filter and the pumping device. Figure 4 The diagram illustrates a perfusion system connected to a ventricular assist device (VAD) as described above. The perfusion system includes a filter 209 upstream of the perfusion pressure measurement device and a pumping device downstream of the perfusion pressure measurement device. A pressure source 208 is connected upstream of the filter, providing pressure to the perfusion fluid supplied by the upstream pipeline 205 and pumping it downstream. The inlet of the pumping device 212 is connected to the second perfusion fluid outlet. For safety purposes, the filter filters the perfusion fluid flowing through it to prevent impurities from entering the body. It is understood that as perfusion time progresses, the accumulated impurities in the filter gradually increase, leading to increased fluid resistance and consequently a decrease in pressure at the perfusion fluid inlet of the pressure measurement device, affecting the downstream perfusion pressure. In severe cases, when the perfusion pressure drops below the ambient pressure, the pumping device may malfunction. To avoid this problem, the pressure measurement device of this disclosure has the function of regulating pressure loss in the perfusion pipeline. For example, when a pressure drop occurs due to a clogged filter, the piston of the pressure measuring device moves towards the pipe joint to compensate for the pressure loss, thereby maintaining the normal injection pressure of the injection system. Conversely, when the pressure source is too high, the liquid pressure in the injection fluid storage chamber increases, pushing the piston away from the pipe joint to store excess injection fluid, thus maintaining stable flow and pressure in the injection pipeline.

[0028] In some optional embodiments, the infusion system further includes a one-way valve 211, which is located on the communication path between the filter section and the infusion fluid inlet. In practice, the pressure measured by the pressure measuring device can be monitored to reflect the clogging status of the filter. When clogging occurs and affects normal infusion, the pipeline between the filter section and the one-way valve can be disconnected and the filter section replaced. Due to the presence of the one-way valve, backflow of liquid in the infusion pipeline is effectively prevented, ensuring that the infusion fluid replenished by the pressure measuring device flows towards the pumping device. In some preferred embodiments, a pressure measuring sensor 210 can also be installed downstream of the filter section. This pressure measuring sensor is closer to the filter section and can more accurately measure the pressure change at the outlet of the filter section, so as to replace the filter section in a timely manner.

[0029] In some optional embodiments, the infusion fluid pressure measuring device further includes a replacement mark; when the pressure measured by the infusion pressure measuring device is less than or equal to the pressure indicated by the replacement mark, the filter section is replaced. Figure 4 As shown, the replacement mark 202 is positioned between the upper pressure limit mark 201 and the lower pressure limit mark 203. It should be noted that, for safety reasons, the lower pressure limit is not located at the lowest point 204 of the filling fluid storage chamber, but rather at a distance from the lowest point, to ensure that the pressure measuring device can always provide pressure replenishment to the filling pipeline. Preferably, the liquid between the lower pressure limit mark and the replacement mark needs to have sufficient volume to ensure that the filling fluid storage chamber has enough liquid to replenish the filling pipeline during filter replacement. This portion of liquid is called warning liquid 301. When replacing the filter, the operator can observe the distance between the piston and the lower pressure limit mark to adjust the replacement speed.

[0030] In some optional embodiments, see Figure 5 The perfusion system further includes a pressure measuring unit located upstream of the filter unit to monitor the pressure pumped by the pressure source, so as to ensure that the perfusion system of the ventricular assist device operates at a normal pressure value or pressure range.

[0031] This disclosure provides a maintenance method for the perfusion system of any of the ventricular assist devices described in the second aspect. The method includes the following steps: (1) During the operation of the perfusion system of the ventricular assist device, the pressure measurement value of the perfusion pressure measuring device is monitored in real time. In practice, this can be done by observing the position of the piston of the pressure measuring device or by monitoring the pressure measurement value of the second measuring unit 109. (2) When the pressure measurement value is lower than the pressure indicated by the replacement mark, the filter needs to be replaced. The operator can manually disconnect the upstream and downstream pipelines of the filter and replace it with a new filter. During the replacement process, the operator needs to pay close attention to the position of the piston to prevent it from moving beyond the lower pressure limit mark in the direction of the pipeline joint. Preferably, the second pressure measuring unit 109 can emit sound, light, or other signals when the pressure reaches the replacement mark to prompt the operator that the filter needs to be replaced.

[0032] The specific embodiments described above do not constitute a limitation on the scope of protection of this disclosure. Those skilled in the art, after considering the specification and practicing the technical solutions disclosed in this application, will readily conceive of other embodiments of this disclosure. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary technical means in the art not disclosed in this disclosure. The specification and embodiments are considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0033] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A perfusion pressure measuring device for a medical device, characterized in that: include: Infusion fluid inlet; The first infusion fluid outlet is connected to the infusion fluid inlet; The perfusion fluid storage chamber has one end connected to the first perfusion fluid outlet and the other end provided with a piston. The piston slides along the inner wall of the injection fluid storage chamber in response to pressure fluctuations, thereby indicating the pressure of the injection fluid.

2. The injection pressure measuring device according to claim 1, characterized in that, It includes a first pressure measuring unit and a second pressure measuring unit; The first pressure measuring unit is located in the piston section; The second pressure measuring unit is located outside the housing of the filling fluid storage cavity and is used to receive the measurement signal from the first pressure measuring unit.

3. The injection pressure measuring device according to claim 1, characterized in that, Includes a second injection fluid outlet and a pressure regulating section; The second infusion fluid outlet is connected to both the infusion fluid inlet and the first infusion fluid outlet; The pressure regulating part is located between the inner wall of the housing of the injection fluid storage chamber and the piston part, and adjusts the output pressure of the second injection fluid outlet according to the pressure fluctuation of the injection fluid.

4. The injection pressure measuring device according to claim 1, characterized in that, It includes a handle portion, which is located outside the housing of the infusion fluid storage chamber and is connected to the piston portion.

5. The injection pressure measuring device according to claim 1, characterized in that, The outer wall of the infusion fluid storage chamber is marked with a mark indicating at least one of the upper limit or lower limit of the infusion pressure.

6. An infusion system for a medical device, comprising the infusion pressure measuring device according to any one of claims 1-5, characterized in that, It also includes: a filtration unit and a pumping device; The filter section is located upstream of the inlet of the injection fluid; The pumping device is located downstream of the second injection fluid outlet; At least a portion of the injection fluid can flow sequentially through the filter section and the pumping device.

7. The infusion system according to claim 6, characterized in that, It also includes a one-way valve, which is located on the communication path between the filter section and the filling fluid inlet.

8. The infusion system according to any one of claims 6 or 7, characterized in that, The injection fluid pressure measuring device also includes a replacement marker; When the pressure measured by the filling pressure measuring device is less than or equal to the pressure indicated by the replacement mark, it prompts that the filter section should be replaced.

9. The infusion system according to any one of claims 6 or 7, characterized in that, It also includes a pressure measuring unit, which is located upstream of the filter unit.

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