WO2017109522A1

WO2017109522A1 - Pre-filled pressure infusion set

Info

Publication number: WO2017109522A1
Application number: PCT/HU2016/000034
Authority: WO
Inventors: Ричард ПУШКАШ
Original assignee: Ричард ПУШКАШ
Priority date: 2015-12-21
Filing date: 2016-05-26
Publication date: 2017-06-29
Also published as: HU4926U

Abstract

A pre-filled pressure infusion set which can be used for delivering emergency medical aid or under military combat conditions, consisting of an infusion bag, a tube, a fluid supply regulator, at least one drug metering port, a check valve, possibly a plunger for gauging pressure, and a turbine-like fluid supply indicator, which rotates inside an at least partially transparent housing. The tube has a spiral or serpentine portion. The infusion bag is disposed in a pressurized pocket that encloses the infusion bag on at least four sides. Inside the pocket or between the pocket and the infusion bag there is a pneumatic cuff, to which a switching valve and a pump are connected by an air tube. Inside the pocket there is a layer of memory foam having a self-adhesive layer disposed thereon with a removable protective film. The tube is pre-filled with an infusion solution and is connected to the infusion bag by a socket with a stopper or by a fixed coupling. The pocket and the pneumatic cuff are made partially or completely of a transparent material, and the pocket can be made of a mesh material. A cap, which can be opened as necessary, is preferably attached to the check valve. Also claimed is a variant of the set in which certain components are made of a fluorescent material or are covered with a fluorescent layer.

Description

Pre-filled Infusion Set under Pressure

The object of the utility model is a pre-filled infusion set, which consists of an infusion bag (an infusion device under the influence of excessive pressure) and also a pre-filled infusion system. The device can be perfectly used for emergency ambulance in the military and others

extreme conditions.

During infusion therapy, fluids, electrolytes, drugs, and parenteral nutrients are injected directly into the vascular bed. At the moment, this usually happens with the following actions:

1. preparation of devices, (infusion bag, infusion system, intravenous or intraosseous needle, disinfection solution, adhesive tape for fixing the needle, tourniquet, infusion stand; various devices in

in most cases they are delivered separately packed, from various manufacturers)

2. removing the infusion bag,

3. extraction of the infusion system,

4. the connection of the infusion system and the infusion bag,

5. hanging the bag in an elevated place or in the hands of another person providing assistance at a height of at least 0, 75-1 meters

6. ridding the infusion system of air (filling with an infusion solution),

7. puncture of a vein,

8. connection of infusion and the beginning of dosing,

9. fixing the needle and the system with adhesive tape,

10. a constant dosage of infusion from a height of 1 meter, with which the person providing assistance monitors the process in order to avoid bleeding, air embolism, as well as blood coagulation in an automatically non-closing cannula.

11. Replacing an empty infusion bag with a new one is possible only if the drip capacity of the system remains full,

12. In the event of an empty drip container, the entire infusion system must be removed, re-free from air and reconnected.

Replacing an empty infusion bag with a new one is possible only if the drip capacity of the system remains full. And in the case of an empty drip tank, you should remove the entire infusion system, re-release it from the air and reconnect. When providing medical care at night, the usual infusion system is difficult to notice, even with a night vision device, therefore, in case of poor lighting, an additional light source should be used, which can be dangerous in a military environment.

In order to accelerate medical care, as well as enhance safety, proposals were made to improve the procedure and

equipment. An example of this is the description of US patent US 2004078024 (A1) entitled "Formed, filled, sealed solution container, port and method forestablishing flow between the container and an administration set", in which it is recommended to insert a connecting element between the infusion bag and the system that can operate with one hand, and which makes an audible sound when connected, and is also protected from accidental disconnection.

This device speeds up the procedure, but does not eliminate the stage of clearing the system of air, and also does not differ further from the generally accepted method. Also known devices with a built-in motor for moving the infusion bag, so that there is no need for constant monitoring. An example of this is the device described in patent number P9800827 called "Infusion pump with a tubular needle holder" (Infuzios szivattyii csoszerii tutartoval). There are also more simple, mechanical devices that usually create infusion pressure by compressing rigid plates between which an infusion bag is placed. An example is U.S. Patent No.

US3734351 (A) under the name PRESS FOR A DEFORMABLE BAG, in which one plate rotates around an axis compared to another, the compression force is provided by a screw and a coil spring. There are also infusion devices that work under pressure according to the pneumatic principle due to a container with air placed between flexible or rigid elements, which, in devices with a fairly simple construction, operate using a manual spherical pump, or due to the energy of a gas cylinder under high by distance. It is such an apparatus that is described in U.S. Pat. No. 4,407,716 (A) under the name Apparatus for the induced infusion of a liquid from a flexible liquid bag.

The device described in patent N ° W09320772 (A1) under the name FLUID CONTAINER ANDCONNECTION COMPONENT undergoes similar physical processes: there is also a pre-filled container and infusion system, between which there is a sterile connecting element, which is also suitable for ridding the system of air. Here the system is already pre-connected, thus reducing the number of assembly and installation steps, as well as the possibility of contamination, but the system still needs to be cleaned of air. To control the flow of fluid into the infusion system, a drip chamber is built in, which indicates the flow rate and, accordingly, the fact of flow

liquids. The disadvantage of the drip chamber is that it can only be used if the system is in an upright position. Under normal medical conditions, this is not difficult - the infusion bag is hung on the infusion stand, or it is held by the carer, so the drip chamber is in

necessary position. In military conditions, or in the case of moving a patient on a stretcher, such a system is not very convenient and appropriate. Even the fixation of the system and the preservation of its position can be difficult in a military environment, hanging tubes and wires can catch, break.

Our goal is to create a greatly simplified use infusion set that can be easily connected even in night light.

Our solution is partly based on the observation that when using pneumatic pressure instead of gravitational, there is no need

using a stand or assistant to hold the bag. Also, we noticed that to monitor the flow of fluid, you can use the turbine wheel, rotating in a transparent case, so we get rid of the need to keep the system in an upright position. Thus, the infusion bag can be fixed to the patient’s body, or in any other way. Further observations showed that if the system is pre-connected and filled with an infusion solution, you can skip

purification from air, as well as a significant part of other preparatory actions. The presence of hanging tubes can also be avoided by replacing a portion of the tube with a spiral hose. Also an important observation is that, details that are important in terms of the medical procedure

(couplings, valves, flow regulator, turbine, etc.) should be fluorescently labeled for more convenient use at night.

Thus, the proposed utility model is a pre-filled infusion set consisting of an infusion bag, a wire, a flow regulator, at least one drug dispenser, a check valve, and there is also a flow indicator on the wire. The feed indicator has an inlet and outlet connector, a turbine housing, a turbine, and a cover. The turbine axis is freely mounted and secured with the help of the bearing holes of the turbine housing and the cover, the turbine axis is located near the supply line, which connects the input and output connectors.

The turbine housing and / or cover are at least partially made of transparent material. A wire (tube) has at least one

wavy or spiral segment. The infusion bag is located in the pocket under pressure, which surrounds the bag on four sides. In the pocket or between the pocket and the infusion bag

pneumatic cuff to which with an air tube

a switching valve and a pump are connected. In the pocket there is a layer of foam with memory, on which is placed a self-adhesive layer with a shipboard protective film. The tube is pre-filled with infusion solution, and connected to the infusion bag with a plug or

fixed connection. The pocket and the pneumatic cuff are partially or completely made of transparent material; the pocket can be made of mesh material. We recommend attaching a cap to the check valve, which can be opened if necessary.

A pocket variant with a reinforcing sheet is also possible; a memory foam is placed on this element.

A kit option is also possible in which a fluid supply regulator, a medicine dispenser, a check valve, a turbine, a changeover valve, and at least a portion of the tube are made of or coated with a fluorescent material.

Another kit option is equipped with a safety valve in the air tube, the safety valve can also be equipped with an integrated piston pressure sensor.

Near the pump, a gas pressure cartridge can be connected to the diverter valve.

The plug-in connector is a tubular element with a screw or bayonet connector. To one end of the plug connector tube

the tube is connected, at the other end there is a screw or bayonet connector, to which the connector of the infusion bag or the corresponding element of the bayonet connector is connected. In the connector with a plug is the bottom perforation, which closes the passage between the tube and connector, at least part of this perforation in the connected state is parallel to the bottom of the connector and placed opposite it. The wall connecting the lower perforation to the internal shield of the connector with a plug is flexible, preferably in the form of an accordion. On the side of the lower perforation, right next to the tube, a vertical pin with a hole is attached to the wall of the connector with a plug. The stud axis is parallel to the axis of the screw or bayonet connector.

To further describe the utility model, we will use the following illustrations:

Fig. 1: view of the infusion set in space,

Fig. 2: view of the fluid flow indicator in space,

Fig. 3: view of the components of the fluid flow indicator in space, Fig. 4: front view of the pocket, without pneumatic cuff,

Fig. 5: side view, sectional view of a pocket and related parts in an inflated state,

Fig. 6: view of the bayonet connector with a plug in space,

Fig. 7: side view of the bayonet connector with a plug, in partial section. In fig. 1 shows a version of the infusion set in which the tube 2 is connected inseparably with the connector 25 of the infusion bag 1. The kit consists of an infusion bag 1, as well as a system in which the infusion bag 1 is connected to the pocket 18, namely, the pneumatic cuff 3 located therein. The pneumatic cuff 3 is connected via an air tube 7 to the switching valve 6 and pump 5. The pump 5 is a closed vessel with flexible walls, preferably the size of a palm, which can be squeezed by hand, as is the case with a device for measuring blood pressure. The switching valve 6 has at least three positions:

pressure increase, pressure support, as well as pressure reduction. A safety valve or piston for measuring pressure (opening at a pressure of 300-325 Hgmm) combined with a safety valve should be integrated into the switching valve 6 or as a separate element in the air tube 7. Such pistons are commercially available, for example W

from Mason Tayler Medical Products Co. Next to the pump 5, in order to quickly create pressure, a high pressure gas cartridge can be connected to the switching valve 6. Tube 2 should preferably contain a fluid supply sensor 8, a fluid supply regulator 4, a drug dispenser port 23, and a check valve 10, which also provides the standard ability to connect a cannula 22 and is one of the devices for separating the solution contained in the system. In fig. 1, the cannula is already shown in connected form, but one of the steps for preparing the system is to connect the cannula 22 to the check valve 10. In the transport position, the check valve 10 has a removable cap. This cap is threaded and protects against

contamination and fluid leakage from the system before using it, since the check valve 10 in case of excessive pressure in the system

may open if fluid regulator 4 is in the open position. If the cap 10 is not suitable for preserving pressure, a closing valve with two possible positions can be integrated in the tube 2.

The system shown in fig. 1 is designed for use under normal conditions, but if necessary, on the tube 2, you can use several additional elements from the above. Part of the tube 2 is a spiral 17, due to which a rather large length of the tube 2 can be placed in a relatively small size and with great flexibility. Thanks to the spiral 17, the hanging elements can be kept to a minimum, which is extremely important during transportation.

Instead of spiral 17, a corrugated tube can also be used.

The fluid supply regulator 4 in this case is an inclined sliding type regulator, but it can also be replaced by another type of regulator.

In fig. 2 shows an increase in the fragment of Fig. 1, in which the indicated indicator of the flow (fluid supply) recommended by us is shown in more detail 8.

The stream indicator 8 in a simplified form inherits the structure of flow meters with a rotary blade. The liquid enters from the input connector 11 and leaves through the original connector 12, between which flows, affecting the turbine housing 13, thereby rotating the turbine 24 located in the housing 13, thanks

loose connection of the bearing holes located in the cover 14 and the axis 15. The turbine 24 consists of at least two blades mounted on the axis 15 and the axis 15 itself.

Figure 3 also shows a flow indicator 8, this time in section.

The cover 14 (if it is not made by 3D printing technology) is installed separately, in the corresponding socket on the turbine housing 13. To monitor the flow of fluid, the cover 14 must be at least partially transparent, the turbine housing 13 itself can also be completely transparent, and in the case of a variant for night use, the turbine 24 is fluorescent, or there are fluorescent designations on it. A minimum clearance should be left between the side of the turbine 24 and the cover 14, so that in the case of an opaque liquid it is also possible to observe the flow. In the case of the option for night use, especially important details (switching valve 6, fluid supply regulator 4, drug dispenser 23, cannula 22,

check valve 10) should be highlighted with fluorescent designations. Such a designation can also be placed on the tube 2, for example, a strip along the tube.

In fig. 4 shows the design of pocket 18, this time without

pneumatic cuff. Pocket 18 surrounds the infusion bag 1 on at least four sides. In the case of the set option shown in the figure, one of the sides of the pocket 18 is reinforced with a fixing sheet 9. The fixing sheet 9, firstly, helps to avoid wrinkling of the infusion bag 1 when the fluid is supplied, thereby supplying without residues and, secondly, due to its less embossed the surface and the foam layer with a memory 19 of a thickness of 7-10 mm., as well as a self-adhesive layer 20, covered with a protective film 21, can be easily glued to uneven surfaces on the patient's body. Pocket 18 is recommended to be made of transparent or mesh material. Not the pneumatic cuff 3 shown in this figure fills

the space between pocket 18 and the infusion bag 1, the figure shows that this means an environment of more than 180 degrees. A larger airspace minimizes changes in the volume of the pneumatic cuff 3 when fluid is supplied from the infusion bag 1, thereby reducing the need for additional pumping. So, in the case of increasing the size of the pocket 18 by increasing the mass, cost and cost of the material, the possibility of less careful monitoring of pressure is provided, or completely eliminates the need for observation.

In fig. 5, a sectional view shows a pneumatic cuff 3 located between the pocket 18 and the infusion bag 1. In the manufacturing embodiment shown in the figure, free parts are only at the ends

pneumatic cuff 3, which partially protrude from under the pocket 18. The pneumatic cuff 3 is preferably made of rubber or other flexible material, but like pocket 18, part or all of the cuff can be transparent, for convenient monitoring of the condition of the infusion bag 1.

In fig. Figures 6 and 7 show a variant with a bayonet lock of the connector with a plug 26 between the connector 25 of the infusion bag 1 and the tube 2. The connector with the plug 26 is a tubular element with a tube 2 connected to one end and a lead thread (4 pcs.)

bayonet connector on the shield 33, to which the protrusions 27 of the connector 25 are connected. The bayonet connector has two possible positions. The first position is shown in fig. 6 transport position, when the connector with the plug 26 is located at a distance from the connector 25 and there is no fluid supply between the tube 2 and the infusion bag 1. It is desirable that this position was fixed by the first branch of the lead thread 28 near the edge. When connecting, the connector with plug 26 should be rotated counterclockwise, as a result of which the axis movement becomes free, and then at the end of the process

connections, turning clockwise the protrusions 27 are rotated into the internal branch of the lead thread 28, thereby stabilizing connection. With a threaded connection, a similar process occurs, but only with a circular motion, in which the thread on the connectors 26 and 25 together creates a fluid flow. In the transport position, the thread of these two elements also contacts, but at a greater distance. In the case of a threaded version of the kit, the thread is on the connector 25 and the shield 33.

Using the option described here with the connector with plug 26 makes it possible to use the system of the first infusion set with

the next infusion bag without getting rid of the system from the air. There is no need to clean the system from air, because the infusion bags 1 in the set in the transport position are completely filled and, thanks to the closed system, if the infusion bag 1 is empty (according to our observations, about 20 mm3 remains in it), the tube 2 stops along its entire length, liquid remains in it, due to a small vacuum, an air bubble cannot form in the tube 2, and the check valve 10 prevents the return flow of blood or air. In case of non-separable connection of the infusion bag 1 and tube 2, it is also possible to connect a new, pre-filled infusion set. In this case, it is necessary to separate the cannula 22 from the check valve 10, and in its place connect a new infusion set through the check valve 10.

In fig. 7, the section shows the recommended design of the bayonet connector with a plug 26. The plug with a plug 26 has a perforated bottom 32 that blocks the passage between the tube 2 and connector 25, at least part of this bottom in the connected state is parallel and placed opposite the bottom of the connector 29. Perforated wall the bottom connecting with the internal shield of the connector with a plug in the best case should be made in the form of an accordion 31, since this form is able to withstand significantly movement along the axis, while creating a minimum of voltage. An alternative to this may be a larger diameter membrane, placed radially, but due to this, the size of the connector with a plug 26 will increase too. On the side of the perforated bottom 32 on the side of the tube 2 on the perforated bottom there is a vertical spike 30, attached to the wall of the connector with a plug 26. Stud hole 30

opens into space from the side of the tube 2.

In fig. 7, the plug connector is shown in the transport position. When the connectors with the plug 26 are connected on the axis of the holes 28, the spikes 27 change their position, as well as the connector 25 and the bottom of the connector 29. When the bottom of the connector 29 lies on the perforated bottom 32, it begins to put pressure on the accordion 31, which subsequently contracts. In this case, the spike 30 first reaches the perforated bottom 32, and then to the bottom of the connector 29, and punctures them.

The displacement (the length of the axial part of the slots 28) should be such that the hole on the end or side of the stud 30 fully fits into the space of the connector 29. When connected, liquid may be released between the connectors 29 and 32, thereby preventing air from entering the tube 2. Such a connection at the same time provides protection for the connected surfaces (especially the bottom of the connector 29 and the perforated bottom 32), as well as the rapid replacement of the infusion bag 1, without the need to get rid of air.

When using the version we offer,

filled infusion set under pressure, the time of medical care is significantly reduced compared to

conventional infusion set and consists of the following steps:

- preparation of devices (there is also less work, as the number of devices has decreased),

- extracting the infusion set from the package,

- removing the protective film from the adhesive layer on the pocket, sticking the pocket on any surface,

- inflation of a pneumatic cuff

- if the kit is equipped with a connector with a plug, then - connection in one motion,

- puncture of a vein, - removing the protective cap of the infusion system and connecting the check valve.

- The next infusion bag can be connected instead of an empty bag, there is no need to rid the system of air. Thanks

The design of the check valve and the kit does not need to be rid of air even with a completely empty bag, so replacement is quick enough. Thanks to the check valve there is a possibility

simultaneously provide medical care to several patients, since there is no need to monitor the flow of fluid from the infusion bags, which can remain connected, even when empty. The check valve allows the flow of fluid exclusively into the veins of the patient, but not in the opposite direction, therefore, if the fluid runs out in the infusion bag or the flow is interrupted, blood cannot flow into

in the opposite direction, that is, to the infusion system. There is therefore no danger of losing blood or clotting in the cannula or system. If the proportions of the volume of the pneumatic cuff are appropriate, the infusion solution can be injected into the patient’s body without observation and at a faster rate than in the case of gravity infusion. Another advantage is that this infusion system does not have a drip chamber, which, with excessive pressure, could cause an air embolism.

Due to the fact that when using this system is not used

gravitational pressure, there is no need to use racks and keep the bag at a height (assistant work is not necessary). The full procedure for connecting the infusion can be carried out lying on the ground, neither the patient nor the person

providing assistance should not get up, so the connection can be made even in the dugout. The glued pocket and spiral tube do not hang down, therefore, if necessary, the patient can be transported without holding the infusion system and without interrupting the flow of fluid.

The device recommended by us is suitable for achieving our goals, as the technology becomes much simpler and faster, and it decreases the need for observation, and the device itself can be used in night and military conditions.

List of designations:

I - infusion bag

- a tube

- pneumatic cuff

- fluid flow regulator

5- pump

6- switching valve

7- air tube

8- fluid supply sensor

9- fixing sheet

10-way valve

I I - input connector

12- source connector

13- turbine housing

14- cover

15 axis

17- spiral tube

18- pocket

19- memory foam

20 - self-adhesive layer

21- protective film

22- cannula

23- port drug dispenser

24- turbine

25-way

26-way plug

27th ledge

28- lead thread

29- bottom of the connector

30 thorn - accordion

- perforated bottom board

Claims

Requirements

1. A pre-filled infusion set under pressure, which consists of an infusion bag (1), a tube (2), a fluid supply regulator (4), at least one drug dispensing port (23), a check valve (10), on the tube (2 ) there is a fluid supply sensor (8), which has an input connector (11) and an initial connector (12), a turbine housing (13), a turbine (24) and a cover (14), an axis (15) of the turbine (24) holds holes

the bearing of the turbine housing (13) and the cover (14) with a movable connection, the axis (15) is located near the supply line that connects the input connector (11) and the original connector (12), the turbine housing (13) and / or the cover (14) although partially made of transparent material, there is at least one spiral or wavy section on the tube (2), the infusion bag (1) is in the pocket under pressure (18), which surrounds the infusion bag (1) on at least four sides, in the pocket (18), or between the pocket (18) and

the infusion bag (1) is the pneumatic cuff (3), to

an air tube (7) is connected to the pneumatic cuff (3), which connects it to the switching valve (6) and the pump (5), in the pocket (18) there is a layer of foam with memory (19), on a layer of foam with memory (19)

there is a self-adhesive layer (20) with a removable protective film (21), the pocket (18) is at least partially made of a transparent or mesh material, the pneumatic cuff (3) is at least partially transparent, the tube (2)

pre-filled with infusion solution, the tube (2) is attached to the infusion bag (1) with a plug with a plug (26), or fixed, and a removable protective cap is attached to the check valve (10).

2. A pre-filled infusion set under pressure, described in paragraph 1 of the requirements with the following characteristics: pocket (18) has a part with a fixing sheet (9), a layer of memory foam (19) is attached to this part.

3. A pre-filled infusion set under pressure, described in paragraph 1 or 2, with the following characteristics: flow regulator liquids (4), drug dispensing port (23), check valve (10), turbine (24), switching valve (6) are at least partially made of

fluorescent material or coated with a fluorescent layer.

4. A pre-filled infusion set under pressure, described in paragraph 1, 2 or 3, with the following characteristics: there is a safety valve in the air tube (7).

5. The pre-filled infusion set under pressure, described in paragraph 4, with the following characteristics: the safety valve is made with an integrated piston for measuring pressure.

6. A pre-filled infusion set under pressure, described in paragraphs 1, 2, 3, 4 or 5, with the following characteristics: near the pump (5), a high-pressure gas cartridge is connected to the switching valve.

7. A pre-filled infusion set under pressure, described in paragraphs 1, 2, 3, 4, 5, or 6, with the following characteristics: a connector with a plug (26) is a tubular element with a thread or

by a bayonet connector, a tube (2) is attached to one end of the connector tube with a plug (26), a thread is located on the other end of the shield (33), or a tab of the bayonet connector (27), or a lead thread (28), is a connector with a plug (26) ) is connected using the thread of the connector (25) of the infusion bag (1) or the corresponding bayonet element located on the connector (25), in the connector with a plug (26) there is a perforated bottom (32) that overlaps the line connecting the tube (2) and connector (25), at least part of this bottom in the connected state is parallel and meschena opposite the bottom connector (29), a wall, connecting the perforated bottom (32) with

an internal shield of the connector with a plug (26), flexible, preferably in the form of an accordion (31), on the side of the perforated bottom (32) directly near the tube (2), a vertical spike (30) with a hole is attached to the wall of the connector with a plug (26), axis stud (30) parallel to the axis of the threaded or bayonet connector