Medical infusion system

Abstract

The present invention relates to a medical infusion system, in particular an infusion system with a flexible catheter having a distal region for connection to an infusion container and a proximal region with a patient connection port. According to the invention, the patient connection port has a closure device, which is gas-permeable and liquid-tight. The invention also relates to application in intravenous administration in the medical field.

Description

[0001] This application is a divisional application of the Chinese patent application entitled “Medical Infusion System” and application number 201980070180.1, filed on April 23, 2021. Technical Field

[0002] The invention relates to a medical infusion system with a flexible tube having a distal region for connection to an infusion container and a proximal region having a patient connection port. Background Art

[0003] US5,954,485A discloses a free flow protection device for an infusion pump of a medical infusion system, wherein the free flow protection device prevents the infusion liquid from flowing freely to the patient connection port. The device is part of a medical infusion system, wherein the infusion liquid from the infusion container flows to the patient connection port through a hose. During the operation of the infusion system, the patient connection port is connected to the catheter on the patient side. During the operation of the infusion system, if the infusion container is suspended above the patient connection port and the patient connection port is connected to the patient's catheter, then without additional measures, the infusion liquid flows freely into the patient's vein until the patient's blood pressure and the hydrostatic pressure of the infusion system balance each other. This free flow may be disadvantageous because it may lead to over-medication of the patient. Moreover, bubbles in the hose entering the patient's blood flow may have undesirable consequences. US5,954,485 discloses a device for preventing this free flow of infusion liquid. The device includes a clamping area that closes or releases the hose according to the position of a lever. The device is assigned to an infusion pump that controls the flow of the infusion liquid through the hose. Summary of the invention

[0004] It is an object of the present invention to provide a medical infusion system which is of the type mentioned at the outset and which allows a first filling of the infusion system to be carried out in a safe and contamination-free manner.

[0005] For a medical infusion system, this object is achieved by the fact that the patient connection port is provided with a closure device, which has a gas-permeable and liquid-tight design. The solution according to the invention allows the first filling of the hose and the connection of the patient connection port to the patient access portion (particularly the catheter on the patient side) without any possibility of contamination by the user or the patient in the area of ​​the patient connection port. The gas permeability of the closure device ensures that bubbles generated in the hose during the first filling can escape in the area of ​​the patient connection port. At the same time, the liquid-tight design ensures that no infusion liquid can escape in the area of ​​the patient connection port during the first filling. Preferably, the closure device is designed so that it is only effective when the infusion system is attached to be ready for operation on the patient side, so as not to hinder the infusion of the infusion liquid to the patient access portion (patient access), which is desired to be carried out after the "ready to operate" attachment, in particular via the catheter into the patient's vein. The terms "distal region" and "proximal region" are relative to the patient, that is, the patient connection port of the infusion system is close to the patient, i.e. proximal, while the end region for connecting to the infusion container is far from the patient and is therefore distal relative to the hose.

[0006] In one embodiment of the invention, the closure device has a closure cap which is held on the patient connection port in a pressure-tight manner. This ensures that the closure cap will not accidentally detach from the patient connection port due to the delivery pressure generated by the infusion pump.

[0007] In another embodiment of the invention, the patient connection port or the closure cap has a closure membrane which closes the patient connection port such that the patient connection port is permeable to air and repels infusion solutions. Preferably, the closure cap with the closure membrane remains on the patient connection port during connection of the patient connection port to the patient access portion. Alternatively, the closure membrane is connected to the patient connection port such that the closure membrane remains in the region of the corresponding through-opening of the patient connection port even after removal of the closure cap. Advantageously, the closure membrane is automatically pierced once the patient connection port is connected to the patient access portion.

[0008] In another embodiment of the invention, the distal region has a drip chamber with a piercing mandrel. The piercing mandrel is configured to connect the drip chamber to a closure stopper of an infusion container.

[0009] In another embodiment of the invention, the hose is provided with a flow control device, in particular in the form of a roller clamp. The hose, the drip chamber, the roller clamp and the patient connection port form a transfer system for a medical infusion system in order to transfer the infusion liquid from the infusion container to the patient access portion.

[0010] In another embodiment of the invention, the hose is assigned a non-return valve having an opening pressure greater than the hydrostatic pressure of the infusion system, which non-return valve is located in the proximal region of the hose in the assembled operating state. The hydrostatic pressure of the infusion system results from the fact that the infusion container filled with infusion liquid is located at a height above the patient access, preferably about 1 m above the patient access. The non-return valve serves as a free flow protection, since it keeps the hose closed as long as only the hydrostatic pressure of the infusion system is effective in the hose. If the infusion container is located about 1 m above the patient access, the hydrostatic pressure in the hose is about 100 mbar. The opening pressure of the non-return valve is therefore advantageously about 150 mbar.

[0011] In another embodiment of the invention, the hose is assigned an infusion pump which, during operation, applies a pressure to the infusion liquid to be delivered which is greater than the opening pressure of the non-return valve. Preferably, during operation, the infusion pump applies a delivery pressure of 200 mbar to the infusion liquid to be delivered, so that operation of the infusion pump opens the non-return valve and allows the infusion liquid to flow through the hose. The non-return valve is advantageously assigned to the hose in the region between the infusion pump and the patient connection port.

[0012] In another embodiment of the invention, the closure membrane opens at a water breakthrough pressure that is greater than the delivery pressure of the infusion pump. This ensures that during the first filling of the hose, the patient connection port remains closed even when the infusion pump has already started its operation. This allows the first filling of the hose to be completed in a bubble-free manner so that when the patient connection port is connected to the patient access portion, the infusion liquid can be supplied to the patient's vein without contaminating the patient connection port or the patient access portion. At a delivery pressure of the infusion pump of about 200 mbar, the water breakthrough pressure of the closure membrane is at least 250 mbar.

[0013] In another embodiment of the invention, a pressure sensor is assigned to the hose on the output side of the infusion pump, which detects a pressure rise above the delivery pressure of the infusion pump. When the first filling of the hose is completed and the infusion pump continues to deliver infusion liquid in the direction of the patient connection port, a pressure rise above the delivery pressure occurs, which is detected by the pressure sensor.

[0014] In another embodiment of the invention, the pressure sensor is attached to a signaling device, so that once a pressure rise exceeding the delivery pressure is detected, the signaling device emits a signal. The signaling device preferably emits a light signal and / or an acoustic signal. The signal is used to inform the user that the first filling process is over and the drive of the infusion pump can be switched off.

[0015] In another embodiment of the invention, the pressure sensor is attached to the control device of the infusion pump so that when a pressure increase exceeding the delivery pressure is detected, the drive of the infusion pump is switched off and / or the signaling device is actuated to generate an optical signal and / or an acoustic signal. In this way, the infusion pump is switched off in an automatic manner once the first filling process is over. Alternatively or additionally, when a pressure of 200 mbar is detected, the pressure sensor emits a corresponding signal, which is processed by the control device and / or is optically and / or acoustically discernible to the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Further advantages and features of the present invention will become apparent from the claims and from the following description of a preferred exemplary embodiment of the invention, which is shown in the drawings.

[0017] The single FIGURE is a schematic representation of an embodiment of a medical infusion system according to the invention. DETAILED DESCRIPTION

[0018] The infusion system 1 has a transfer system between an infusion container 2 and a patient access (not shown). The medical infusion system 1 is used to transfer an infusion liquid from the infusion container 2 to the patient access in order to administer a drug or a nutrient solution to a patient. The provided patient access is in particular an intravenous patient access to which the infusion system 1 can be connected.

[0019] The medical infusion system 1 has a flexible hose 6, which is advantageously transparent. The hose 6 is firmly connected in the distal region to a drip chamber 5, which is provided with a puncture mandrel 4 at the distal side. When the infusion system 1 is in an assembled state ready for operation, the puncture mandrel 4 has been inserted into the elastic closure plug 3 in the region of the lower side of the infusion container 2 by a press-fit engagement. The puncture mandrel 4 has at least one channel, which extends into the interior of the infusion container 2 and through which the infusion liquid from the infusion container 2 is transferred into the drip chamber 5 and from there into the hose 6. In the assembled state ready for operation, the infusion container 2 is suspended in a fixed position, in particular on a stand. The stand is advantageously provided with rollers so that the infusion container 2, including the infusion system 1, can be moved on a floor surface.

[0020] In the flow direction of the infusion system 1, the drip chamber 5 is followed by a roller clamp 7, which is arranged to manually control the flow of the infusion liquid through the hose 6. The infusion system 1 is also assigned a non-return valve 9 (described in more detail below) and a patient connection port 10 at the proximal end region of the hose 6. The patient connection port 10 is closed by a closure cap 11.

[0021] In the assembled state ready for operation, the hose 6 is attached to an infusion pump 8 which is provided with a drive (not shown in detail) in order to mechanically act on the jacket of the hose 6 and thereby transport the infusion liquid through the hose 6. For this purpose, the hose 6 is placed in a manner known per se into a corresponding receiving area of ​​the infusion pump 8 and fixed therein.

[0022] Finally, on the output side of the infusion pump 8, the hose 6 is assigned a pressure sensor 12, which is attached to a control device S (described in more detail below).

[0023] In a manner not shown in detail, the patient connection port 10 is provided with a closure film, which closes the patient connection port so that the latter is permeable to air and repels infusion solution, that is to say, liquid-tight. The closure film is directly assigned to the through opening of the patient connection port 10 or is assigned to the closure cap 11. In both cases, the closure film is used to close the proximal end of the infusion system 1 in a liquid-tight manner but at the same time allowing air to pass, and thus close the hose 6. If the closure film is assigned to the closure cap 11, when the patient connection port 10 is connected to the patient access portion, the closure cap is preferably kept on the patient connection port 10, so as to automatically achieve the separation of the closure film when connected, and the escape of the infusion liquid will not occur at the connection portion between the patient connection port 10 and the patient access portion. The patient connection port 10 and the patient access portion are preferably provided with complementary Luer lock connectors. If the closure film is directly assigned to the patient connection port 10, the closure cap 11 can be removed from the patient connection port 10, and the infusion liquid cannot escape from the patient connection port 10. This is because the closure membrane continues to close the patient connection port 10 until the patient connection port 10 is securely connected to the patient access portion by means of a corresponding Luer lock connection. During the connection, the closure membrane is advantageously pierced or cut in some other way, as a result of which the infusion liquid can flow. The air permeability of the closure membrane ensures that when the infusion system 1 is filled for the first time, air bubbles can reach the patient connection port 10 through the hose 6 and can escape at the patient connection port 10, so that the first filling with infusion liquid is allowed in a bubble-free manner.

[0024] To set the infusion system 1 to the operating state, the puncture mandrel 4 is introduced into the closure stopper 3 of the infusion container 2. The infusion container 2 is already suspended in a fixed position at a height H, which is preferably about 1 m above the patient access. The puncture mandrel 4 is pressed from below into the closure stopper 3 until the infusion liquid can flow through the channel of the puncture mandrel 4 into the drip chamber 5. The roller clamp 7 is opened. The hose 6 is installed in the area of ​​the infusion pump 8 provided with an electric drive.

[0025] The check valve 9 has an opening pressure greater than the hydrostatic pressure caused by the height difference between the suspended infusion container 2 and the patient access portion (i.e., the patient connection port 10). Therefore, as long as the infusion pump 8 is not started, the check valve 9 closes the hose 6 in the area between the infusion pump 8 and the patient connection port 10. The check valve 9 defines a free flow protection device. However, once the infusion pump 8 is started, the opening pressure of the check valve 9 is lower than the delivery pressure of the infusion pump 8. Therefore, after starting the infusion pump 8, since the delivery pressure of the infusion liquid increases in the hose 6, the check valve 9 opens, so that the infusion liquid is delivered until the patient connection port 10. The patient connection port 10 is closed by the closed membrane. Any bubbles are also transmitted in the direction of the patient connection port 10 together with the infusion liquid. Due to the air permeability of the closed membrane, the corresponding air can escape to the environment in the area of ​​the patient connection port 10. At the same time, the closed membrane is designed to repel the infusion solution so that the infusion solution accumulates in the area of ​​the closed membrane of the patient connection port 10. When the infusion liquid is further delivered by the operation of the infusion pump 8, the pressure in the hose 6 must therefore rise. The corresponding increase in pressure is monitored by a pressure sensor 12 arranged on the output side of the infusion pump 8. As soon as the pressure in the hose rises above the normal delivery pressure of the infusion pump 8, the pressure sensor 12 sends a signal to the control device S, which then actuates an acoustic signal and / or optical signal generator (not shown) and / or switches off the driver of the infusion pump 8. If only the acoustic signal and / or optical signal generator is actuated, the user (in particular hospital personnel) must switch off the driver of the infusion pump 8 based on the detection of the corresponding signal. If the control device S directly actuates the driver of the infusion pump 8, the driver of the infusion pump 8 can be automatically switched off when a corresponding pressure increase is detected.

[0026] If the height difference H is 1 m, the static pressure of the liquid in the infusion system 1 is 100 mbar. The non-return valve 9 has an opening pressure of about 150 mbar. The delivery pressure generated by the activation of the infusion pump 8 is preferably greater than 150 mbar and is advantageously a maximum of 200 mbar. The pressure sensor 12 is advantageously designed so that at a pressure greater than 200 mbar, it sends a corresponding signal to the control device S. At the values ​​stated above, the water breakthrough pressure of the closing membrane is advantageously at least 250 mbar.

[0027] It is thus ensured that the first filling of the infusion system 1 takes place safely and in a bubble-free manner.Now, the patient connection port 10 can be connected to the patient access, as a result of which the closure membrane opens and enables the infusion liquid to flow to the patient access.

Claims

1. A medical infusion system (1) having a hose (6), the hose (6) having a distal region and a proximal region, the distal region being used for connection to an infusion container (2), the proximal region having a patient connection port (10), characterized in that: The patient connection port (10) is provided with a closure device having a gas-permeable and liquid-tight design, wherein the hose (6) is assigned a non-return valve (9), the non-return valve (9) having an opening pressure greater than the hydrostatic pressure of the infusion system (1), the hydrostatic pressure being caused by the height difference between the suspended infusion container (2) and the patient connection port (10) in the assembled operating state of the infusion system (1), wherein the non-return valve (9) is in the position of In the proximal region of the hose (6), wherein the hose (6) is attached to an infusion pump (8), the infusion pump (8) being provided with a drive so as to mechanically act on the sheath of the hose (6) and thereby transmit the infusion liquid through the hose (6), the hose (6) being placed in a receiving region of the infusion pump (8) and fixed in the receiving region, and the check valve (9) being located in the hose (6) in the region between the infusion pump (8) and the patient connection port (10).

2. The medical infusion system according to claim 1, characterized in that: The closure device has a closure cap (11) which is held on the patient connection port (10) in a pressure-tight manner.

3. The medical infusion system according to claim 1 or 2, characterized in that: The patient connection port (10) or the closure cap (11) has a closure membrane which closes the patient connection port (10) so that the patient connection port (10) is permeable to air and repels infusion solutions.

4. The medical infusion system according to any one of the preceding claims, characterized in that The distal region has a drip chamber (5), and the drip chamber (5) has a puncture core shaft (4).

5. The medical infusion system according to any one of the preceding claims, characterized in that The hose (6) is assigned a flow control device, in particular in the form of a roller clamp (7).

6. A medical infusion system according to any one of the preceding claims, characterized in that During operation, the infusion pump (8) applies a pressure greater than the opening pressure of the check valve (9) to the infusion liquid to be delivered.

7. A medical infusion system according to any one of the preceding claims, characterized in that The sealing membrane opens under water breakthrough pressure, and the water breakthrough pressure is greater than the delivery pressure of the infusion pump (8).

8. The medical infusion system according to any one of claims 6 and 7, characterized in that: At the output side of the infusion pump (8), the hose (6) is assigned a pressure sensor (12), which detects a pressure increase above the delivery pressure of the infusion pump (8).

9. The medical infusion system according to claim 8, characterized in that: The pressure sensor (12) is attached to a signaling device such that the signaling device emits a signal upon detecting a pressure rise above the delivery pressure.

10. The medical infusion system according to claim 9, characterized in that: The signaling device is configured to emit a light signal and / or an acoustic signal.

11. The medical infusion system according to any one of claims 8 to 10, characterized in that: The pressure sensor (12) is attached to the control device (S) of the infusion pump (8) so that when a pressure increase exceeding the delivery pressure is detected, the driver of the infusion pump (8) is switched off and / or the signaling device is actuated to generate a light signal and / or an acoustic signal.

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