This application claims priority to EP Patent Application No. 21020053.1, filed on Feb. 4, 2021, which is incorporated herein by reference in its entirety.
Ambulatory infusion pumps are used outside and inside the hospital, for smaller volume drug delivery like 100 ml morphine to palliative care patients, or higher volume drug delivery like in case of parenteral nutrition where large volumetric pumps (LVP) are too big to carry. A big use of ambulatory infusion pumps is with chronic patients at home or with therapies that last long with the patient at home.
False alarms of infusion pumps are very problematic but frequent. It is the aim of the present invention to provide means to reduce false alarms.
Accuracy of infusion pumps is far lower than required, since mostly PVC tubes are used which show the required accuracy for 30 minutes after start of infusion but deteriorate largely after several hours or days of infusion. It is the aim of the present invention to increase and keep the required accuracy of the pump very long after start of infusion.
In order to achieve the aforementioned and further objects, according to a first aspect of the present invention, there is provided a peristaltic infusion pump tube segment having an upstream inlet and a downstream outlet and adapted to be temporally squeezed at at least one squeezed point to be generated by an engagement structure and to be moved towards said outlet for passing a medical fluid from said inlet to said outlet, characterized by a first tube portion next to said inlet and having a surrounding wall which is adapted for an upstream occlusion detection, a second tube portion downstream of said first tube portion and adapted to be temporally engaged by the engagement structure, wherein said second tube portion comprises a surrounding wall being at least partly thicker than the wall of said first tube portion, a third tube portion downstream of said second tube portion and having a surrounding wall which is adapted for an air in line detection, and a fourth tube portion next to said outlet and adapted for a downstream pressure detection.
Preferred embodiments and modifications of the first aspect of the present invention are defined in the dependent claims 2 to 11.
Preferably, the peristaltic infusion pump tube segment is, at least partly, made of silicone, in particular by a silicone molding process, preferably by a silicone injection molding process.
According to a further preferred embodiment of the first aspect, the wall of said first tube portion has a thickness which is dimensioned so as to allow a detection unit to detect even the smallest possible upstream occlusion.
According to a further preferred embodiment of the first aspect, the wall of said second tube portion is made of an elastic material which allows said second tube portion to be essentially reformed at those portions which are currently not subject to the engagement by the engagement structure.
According to a further preferred embodiment of the first aspect, the wall of said second tube portion is configured to allow a viscous fluid to be passed through by suction effect.
According to a further preferred embodiment of the first aspect, the wall of said second tube portion is essentially unpolished.
According to a further preferred embodiment of the first aspect, the wall of said third tube portion comprises at least one flat wall portion which is configured for the air in line detection in particular by means of at least one ultrasound sensor.
According to a further preferred embodiment of the first aspect, said third tube portion has a rectangular or square section at least at its external side and comprises flat wall portions configured for the air in line detection in particular by means of at least one ultrasound sensor.
According to a modification of both the aforementioned preferred embodiments, the outer surface of the at least one flat wall portion is at least partly polished.
According to a further preferred embodiment of the first aspect, said fourth tube portion comprises an essentially flat compartment configured for the downstream pressure detection.
According to a preferred modification of the above embodiment, said flat compartment comprises a long side extending in the direction of the peristaltic infusion pump tube segment.
According to a further preferred modification of the above embodiment, said flat compartment comprises a disc-like element having essentially an at least part-circle or part-elliptical shape with a diameter or width being larger than the diameter or width of said first tube portion and/or said second tube portion and/or said third tube portion.
In order to achieve the aforementioned and further objects, according to a second aspect of the present invention, there is provided an infusion pump device comprising a pump mechanism module configured as a peristaltic mechanism and including the peristaltic infusion pump tube segment according to the first aspect, wherein the upstream inlet of said peristaltic infusion pump tube segment is adapted to be fluidly connected to an outlet of a medication reservoir.
Preferred embodiments and modifications of the second aspect are defined in the dependent claims 13 to 23.
According to a preferred embodiment of the second aspect, said pump mechanism module is configured as a linear peristaltic mechanism with said peristaltic infusion pump tube segment having an essentially elongated shape.
According to a further preferred embodiment of the second aspect, said peristaltic infusion pump tube segment is replaceable and/or disposable.
According to a further preferred embodiment of the second aspect, the infusion pump device comprises an upstream pressure sensor provided at said first tube portion.
According to a further preferred embodiment of the second aspect, said pump mechanism module comprises an engagement structure adapted to generate at least one squeezed point in said second tube portion and to move it in the direction towards said outlet of said peristaltic infusion pump tube segment.
According to a further preferred embodiment of the second aspect, said engagement structure comprises a plurality of engagement units arranged side by side along the length of said second tube portion of said peristaltic infusion pump tube segment, wherein each engagement unit comprises a follower head which is movable at an angle, in particular a right angle, relative to said second tube portion and adapted to be brought into engagement with said second tube portion in order to squeeze it, wherein said engagement structure is further configured so that the follower heads are temporally brought into engagement with said second tube portion one after another.
According to a modification of the above embodiment, at least one engagement unit comprises a support, a follower body moveably mounted at said support and provided with the follower head, a ball bearing rotatably mounted at said follower body, a cam rotatably mounted at said support and in sliding engagement with said ball bearing, and a spring biasing said moveable follower body with said follower head away from said second tube portion of said peristaltic infusion pump tube segment.
According to a further modification of the above embodiment, said engagement structure comprises a drive unit, wherein the cam of each equipment unit is fixedly mounted to a common rotary shaft which is rotated by said drive unit, and wherein the rotational angle offset of the cam relative to said rotary shaft increases from engagement unit to engagement unit so that the follower heads are temporally brought into engagement with said second tube portion of said peristaltic infusion pump tube segment from engagement unit to engagement unit.
According to a still further modification of the above embodiment, the follower head is mounted upon a stem fixed to the follower body and the engagement unit further comprises a sealing membrane with an opening through which said stem extends in an at least essentially sealing manner.
According to a further preferred embodiment of the second aspect, the infusion pump device comprises a first air in line sensor, in particular an air in line ultrasound sensor, provided at said third tube portion.
According to a further preferred embodiment of the second aspect, the infusion pump device comprises a downstream pressure sensor provided at said fourth tube portion.
According to a further preferred embodiment of the second aspect, the infusion pump device comprises an air eliminating filter which is in fluid communication with the outlet of said peristaltic infusion pump tube segment and a second air in line sensor adapted to detect air in a fluid path downstream of said air eliminating filter.
According to a third aspect of the present invention, there is provided a medication reservoir for the infusion pump device of the second aspect, made of a single or multiple layered barrier polypropylene foil and sterile-packaged in a nitrogen filled aluminium bag.
So, according to a preferred embodiment of the present invention, the pump uses a linear peristaltic structure reducing friction with a ball bearing at each follower. The total construction of the infusion mechanism results in a small size weight and friction while reducing noise to minimum. The followers preferably comprise spring-loaded side walls, so that there is no kink at the sides during infusion, and are also subject to a removing action without friction by use of the same ball bearing resulting in squeezing the infusion tube through the same follower, wherein each follower comprises a runner at each side so as to slip without friction with side followers. In particular, the whole mechanism and motor assembly is included in one independent part comprising only one rod for assembly and a screw on the other side to adjust the distance from a pressure plate so as to operate with nominal pressure. In particular, the screw is adapted to adjust a squeezing gap in the infusion pump tube segment resulting in an adjustment of the maximum downstream occlusion pressure the infusion pump tube segment can withstand before leaking backwards, at nominal value. So, any contact points with the pump body are minimal, and also the motor and mechanism noise is not transmitted thought the body to the air, a very important feature for infusion pumps. According to a preferred embodiment, the mechanism has a silicone liquid ingress sealing membrane provided not over the followers as in prior art but at an intermediate point below their edge.
According to a preferred embodiment, the infusion segment is made by a relatively new silicon injection molding so that the accuracy tolerance is below 3% and is kept during all infusion time since silicone does not essentially change its form or shape after being squeezed by the followers. Injection molded silicon tubes have also a better accuracy than standard extruded silicon tubes showing large dimensional variations during extrusion.
According to a preferred embodiment, since an injection silicon is used that is formed by a mold, the infusion pump tube segment is provided with several tube portions which are better adapted to each function as follows:
Preferably, the wall of said first tube portion can have a thickness of about 0.5 mm, whereas the wall of said second tube portion can have a thickness of about 1.0 mm.
According to a further preferred embodiment, said first tube portion has an inner diameter of about 2.5 mm and an outer diameter of about 4 mm, said second tube portion has an inner diameter of about 2 mm and an outer diameter of about 4 mm and said third portion has an inner diameter of about 2 mm and an outer width of about 4 mm.
Preferably, the infusion pump tube segment comprises at least partly a shore hardness of about 50.
The pump preferably comprises means to reduce false alarms for air in line which are very often in hospital and home settings and are very annoying. A further preferred embodiment of the present invention uses a first air in line sensor downstream the pumping mechanism on the infusion pump tube segment so to sense the absence of liquid which leads to a bag empty alarm and a second air in line sensor downstream of an air eliminating filter put inside the drug compartment, so to eliminate the alarm generated by the first air in line sensor if no air is detected downstream and only bubbles but not full air is present at the first air in line detector. Also, preferably, it is detected if a filter is defective, and alarms for the defective filter are generated, if bubbles are detected by the second detector.
The pump 1 according to a preferred embodiment as shown in the
As to be seen from
The pump 1 additionally includes a smaller safety rechargeable battery (not shown), so that the pump 1 can even run during a battery change and alarm when the main battery has been depleted. This secondary battery is recharged by the main battery or an external power pack cable which is to be connected to the pump 1 and also charges the battery pack, while an external charger for replacement battery packs also exists.
The pump 1 includes a dual microcontroller electronic control for redundancy safety (not shown), and, as schematically depicted in
As also shown in
According to the preferred embodiment shown in
In order to help verify infusion and alarm conditions, the pump 1 includes an upstream pressure sensor 20 and a downstream pressure sensor 22, as to be seen from
As further shown in
The pump 1 comprises means to reduce false alarms for air in line; these are very often in hospitals and home settings and are very annoying. In the embodiment shown in
The infusion pump tube segment 30, which is individually shown in
Since in particular the injection silicon formed by a mold is used, the infusion pump tube segment 30 comprises several portions 34 to 37 that are adapted to a certain function as follows:
An infusion pump infusion set anti-kicking tubing is connected through barb connectors (not shown) to the infusion pump tube segment 30 at each side, i.e. at its inlet 32 and at its outlet 33. Furthermore, said compartment 37a includes a small seed (not shown) inserted inside its cavity to reduce high pressure variations and oscillations and to increase accuracy wherein that part has a hard cover on the top for better pressure reading but also to secure a barb connector aside it.
In the shown embodiment, the pump mechanism module 40, which is individually shown in
The total design of the pump mechanism module 40 is for small size weight and friction while reducing noise to minimum. The follower bodies 42 comprise spring loading side walls so that they do not kick at the sides during infusion (noise reduction) and perform a removing follower action without friction using the same ball bearing 44 that causes the squeezing of the infusion tube segment 30 through the same follower head 42a. Each follower body 42 is provided with a runner 49 at each side where it slips without friction with the neighboring follower body 42 as to be seen from
In case a follower body 42 is blocked, the cam 43 at the removing follower cycle (after having squeezed the infusion pump tube segment 30) will do it but with friction, as there is no ball bearing at the back side. This is why a spring force which is subject to the infusion pump tube segment 30 causes a removement of a follower body 42 without friction for small blocks, whereas the use of the cam 43 is the last means to force the infusion pump tube segment 30 to open but at a friction price to pay.
The pump mechanism module 40 as shown in
The mechanism has a silicone liquid ingress sealing membrane 45 provided (not over the follower heads 42a as in prior art but) at an intermediate point 51 below the edge of the follower heads 42a, as to be seen from the
Number | Date | Country | Kind |
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21020053.1 | Feb 2021 | EP | regional |