MINIATURE IV INFUSION LINE AIR ELIMINATOR

Abstract

Described is an infusion fluid air eliminating device comprising a body having a fluid passage region with a fluid inlet and a fluid outlet so as to define a fluid path from the fluid inlet to the fluid outlet, and a hydrophobic membrane, wherein the hydrophobic membrane covers the fluid passage region along a portion between the fluid inlet and the fluid outlet in a substantially sealed arrangement relative to the environment wherein there is provided a cavity on the side of the membrane facing the fluid passage region, and a pressurization unit is provided to pressurize the membrane against the fluid passage region such that the membrane essentially closes the cavity between the fluid inlet and the fluid outlet at one location when the pressure in the fluid is below a predetermined threshold value, and opens when the pressure in the fluid is not below the threshold value.

Claims

1. An infusion fluid air eliminating device comprising a body having a fluid passage region with a fluid inlet and a fluid outlet so as to define a fluid path from the fluid inlet to the fluid outlet, and a hydrophobic membrane, characterized in that: the hydrophobic membrane covers the fluid passage region at least along a portion between the fluid inlet and the fluid outlet in a substantially sealed arrangement relative to the environment wherein there is provided a cavity on the side of the membrane facing the fluid passage region through which cavity fluid can pass from the fluid inlet under pressure to the fluid outlet, and a pressurization unit is provided to pressurize the membrane against the fluid passage region such that the membrane essentially closes the cavity between the fluid inlet and the fluid outlet at at least one location when the pressure in the fluid is below a predetermined threshold value, and opens when the pressure in the fluid is not below the threshold value, whereby air bubbles which may be contained in the fluid can escape from the cavity through the membrane, wherein the predetermined threshold value corresponds to or is greater than the pressure to break the surface tension of the fluid.

2. The device according to claim 1, wherein the pressurization unit is adapted to pressurize against the fluid passage region the membrane on its side facing away from the fluid passage region.

3. The device according to claim 1, wherein the pressurization unit comprises at least one spring element.

4. The device according to claim 3, wherein the spring element extends substantially over the entire width of the fluid passage region transversely or angularly to the direction of flow of the fluid from the fluid inlet to the fluid outlet, and further wherein the spring element has an elongated shape.

5. The device according to claim 3, wherein the at least one spring element is a plurality of spring elements and the plurality of spring elements are spaced from each other in the flow direction of the fluid from the fluid inlet to the fluid outlet.

6. The device according to claim 5, wherein sealing of the membrane is done on and after the last downstream spring element to assure an antisiphon action.

7. The device according to claim 3, wherein the spring element comprises a tube made of elastic material.

8. The device according to claim 3, wherein the spring element comprises a sponge-like material.

9. The device according to claim 3, wherein the spring element comprises a bent flat part.

10. The device according to claim 3, wherein the spring element is arranged in the area of the fluid outlet.

11. The device according to claim 10, wherein the spring element comprises a layer of elastic material and the elastic material is stretched so as to pressurize the membrane against the fluid outlet.

12. The device according to claim 3, further comprising a cover arranged on the body so as to cover the side of the membrane facing away from the fluid passage region.

13. The device according to claim 12, wherein the cover includes at least one air outlet opening.

14. The device according to claim 12, wherein the spring element is arranged at least partly under pretension between the cover and the membrane.

15. The device according to claim 14, characterized in that the pressurization unit is supported at least partly on the side of the cover facing the membrane.

16. The device according to claim 1, wherein the fluid passage region comprises a protrusion at at least one point between the fluid inlet and the fluid outlet, against which protrusion the membrane rests with its side facing the fluid passage region.

17. The device according to claim 16, wherein the protrusion extends substantially over the entire width of the fluid passage region transversely or angularly to the direction of flow of the fluid from the fluid inlet to the fluid outlet.

18. The device according to claim 16, wherein the protrusion is arranged in the area of the fluid outlet or surrounds the fluid outlet.

19. The device according to claim 16, further comprising at least three protrusions, wherein the at least three protrusions are spaced apart from each other in the direction of flow of the fluid from the fluid inlet to the fluid outlet, thereby dividing the cavity into at least two cavity sections.

20. The device according to claim 19, wherein the cover includes at least two air discharge openings, a first air discharge opening being in communication with a first cavity section and a second air discharge opening being in communication with a second cavity section.

21. The device according to claim 16, wherein at least one spring element is arranged over a protrusion so that it pressurizes the membrane against the protrusion.

22. The device according to claim 16, wherein the fluid passage region comprises a recess having an outwardly open side covered by the membrane, whereby the recess forms the cavity.

23. The device according to claim 22, wherein the body has a substantially planar surface into which the recess is incorporated and to which the membrane is attached in a substantially sealed arrangement relative to the environment.

24. The device according to claim 22, wherein the recess comprises a bottom on which the protrusion is arranged.

25. The device according to claim 23, wherein the protrusion terminates in the plane spanned by the surface.

26. The device according to claim 22, wherein the recess is bounded by two spaced side walls extending in the direction of flow of the fluid from the fluid inlet to the fluid outlet, and the protrusion is adjacent to at least any one of the two side walls.

27. The device according to claim 22, wherein the protrusion arranged in the area of the fluid outlet and/or surrounding the fluid outlet is adjacent to the downstream end of the recess with respect to the direction of flow of the fluid from the fluid inlet to the fluid outlet or is arranged outside and downstream of the recess.

28. An infusion pump mechanism cartridge comprising an infusion fluid air eliminating device, the device comprising a body having a fluid passage region with a fluid inlet and a fluid outlet so as to define a fluid path from the fluid inlet to the fluid outlet, and a hydrophobic membrane, the hydrophobic membrane covers the fluid passage region at least along a portion between the fluid inlet and the fluid outlet in a substantially sealed arrangement relative to the environment wherein there is provided a cavity on the side of the membrane facing the fluid passage region through which cavity fluid can pass from the fluid inlet under pressure to the fluid outlet, and a pressurization unit is provided to pressurize the membrane against the fluid passage region such that the membrane essentially closes the cavity between the fluid inlet and the fluid outlet at at least one location when the pressure in the fluid is below a predetermined threshold value, and opens when the pressure in the fluid is not below the threshold value, whereby air bubbles which may be contained in the fluid can escape from the cavity through the membrane, wherein the predetermined threshold value corresponds to or is greater than the pressure to break the surface tension of the fluid.

29. The infusion pump mechanism cartridge according to claim 28, further comprising a first air sensor provided upstream of the fluid inlet and a second air sensor provided downstream of the fluid outlet.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] FIG. 1 shows an infusion fluid air eliminating device according to a preferred first embodiment in an exploded view.

[0045] FIG. 2 shows a perspective view of the body of the device of FIG. 1 from above.

[0046] FIG. 3 shows a perspective view of the body of FIG. 2 along with a portion of a fluid inlet tube and a portion of a fluid outlet tube as well as a membrane arranged on the body.

[0047] FIG. 4 shows the same arrangement as FIG. 3, but with additionally elastomeric tubes as spring elements arranged upon the exterior of the membrane.

[0048] FIG. 5 shows a perspective view of the arrangement of FIG. 4 upon which a cover is additionally arranged, and hence the whole assembly of the infusion fluid air eliminating device according to the preferred first embodiment.

[0049] FIG. 6 shows a perspective view of the device of FIG. 5 from below.

[0050] FIG. 7 shows a longitudinal section through the device of FIG. 5 from the fluid inlet to the fluid outlet.

[0051] FIG. 8 shows, similar to FIG. 4, an arrangement of the body, the membrane and the pressurizing unit of an infusion fluid air eliminating device according to a preferred second embodiment.

[0052] FIG. 9 shows, similar to FIG. 5, the whole assembly of the device according the preferred second embodiment.

[0053] FIG. 10. shows a longitudinal section through the device of FIG. 9.

[0054] FIG. 11 shows a longitudinal section through an infusion fluid air eliminating device according to a preferred third embodiment.

[0055] FIG. 12 shows the interior of an infusion pump mechanism cartridge according to a preferred embodiment including the infusion fluid air eliminating device.

DESCRIPTION OF A PREFERRED EMBODIMENT

[0056] FIGS. 1 to 7 show an infusion fluid air eliminating device 2 according to a preferred first embodiment comprising a body 10 which is rectangular- or cube-shaped and, hence, has a planar surface 10a. The body 10 is provided at its one narrow end portion with a fluid inlet 12 and at its opposite other narrow end portion with a fluid outlet 14. In the embodiment shown, both the fluid inlet 12 and fluid outlet 14 are embodied as through holes.

[0057] The body comprises a fluid passage region 16 which defines a fluid path from the fluid inlet 12 to fluid outlet 14 and includes a recess 18 having an outwardly open side which faces the viewer of the FIGS. 1 and 2. The recess 18 has a rectangular shape, comprises a bottom 18a and is bounded by four sidewalls including two spaced short sidewalls extending transversely to the longitudinal extension of the body 10 and two spaced long sidewalls 18b extending in the direction of the longitudinal extension of the body 10 and, hence of the flow path from the fluid inlet 12 to fluid outlet 14, wherein one of both the long sidewalls 18b is visible in FIG. 2. In the embodiment shown, the bottom 18a of the recess 18 is arranged in parallel to the plane spanned by the planar surface 10a of the body 10 so that the sidewalls of the recess 18 have the same height and, hence, the depth of the recess 18 is at each point the same. As described above and to be shown from the FIGS. 1, 2 and 7, the recess 18 forms a cavity.

[0058] As further shown in FIGS. 1, 2 and 7, the body 10 comprises four protrusions 20a, 20b, 20c and 20d which are spaced apart from each other in the direction of the longitudinal extension of the body 10 and, hence, in the direction of flow of the fluid from fluid inlet 12 to fluid outlet 14, thereby dividing the recess 18 into four cavity sections. The protrusions 20a, 20b and 20c each have an elongated shape extending transversely to the longitudinal extension of the body 10. The protrusions 20a, 20b and 20c are arranged on the bottom 18a of the recess 18 and terminates in the plane spend by the planar surface 10a of the body 10. Moreover, as shown in FIGS. 1 and 2, the elongated protrusions 20a, 20b and 20c each extend over the whole width of the recess 18 so as to join at their ends both the long sidewalls 18b. In the embodiment shown, the most downstream fourth protrusion 20d is defined by a portion of the downstream portion of the planar surface 10a of the body 10 which portion includes the fluid outlet 14 so that the fourth protrusion 20d surrounds the fluid outlet 14 as shown in the FIGS. 1, 2 and 7. At the same time, the fourth protrusion 20d defines the downstream border of the recess 18 by forming the downstream short sidewall so that the fourth protrusion 20d is adjacent to the downstream end of the recess 18 with respect to the longitudinal extension of the body 10 and, hence, of the flow of the fluid from fluid inlet 12 to fluid outlet 14.

[0059] As shown in the FIGS. 1 and 3 to 7, a fluid inlet tube 22 is to be coupled to the fluid inlet 12 and a fluid outlet tube 24 is to be coupled to the fluid outlet 14 wherein in the given figures only portions of the tubes 22 and 24 are depicted. As further shown in these figures, the tubes 22 and 24 are arranged at the backside of the body 10 opposite to its planar surface 10a.

[0060] As shown in the FIGS. 1, 3, 4 and 7, the planar surface 10a of the body 10 is covered by a membrane 26 which is a hydrophobic membrane and, hence, is able to let air pass through, but to hold fluid back. In the embodiment shown, the membrane 26 has essentially the same shape as the planar surface 10a of the body and is only fixed with his surrounding edge portion 26a to the corresponding surrounding edge portion of the planar surface 10a in a sealed arrangement relative to the environment, in particular by welding. Thus, the membrane 26 loosely lies upon all the protrusions 20a to 20d, so that by lifting the membrane 26 a small gap appears between the top of the protrusions 20a to 20d and the inner side of the membrane facing the recess 18 so as to allow the fluid to flow from the fluid inlet 12 over the protrusions 20a to 20d to the fluid outlet 14, wherein in particular along the top of the fourth protrusion 20d a fluid path occurs from the recess 18 to the fluid outlet 14.

[0061] As further to been seen from the FIGS. 1, 4 and 7, there is provided a pressurization unit 30. The function of this unit 30 is to pressurize and, hence, to bias the membrane 26 against the fluid passage region 16 and its recess 18 so that the membrane 26 comes in contact with the top of the protrusions 20a to 20d with the result that the flow path between the fluid inlet 12 and the fluid outlet 14 can be blocked. However, this is only the case when the pressure in the fluid is below a predetermined threshold value which corresponds or is greater than the pressure to break the surface tension of the fluid. However, the pressurization unit 30 is adapted to generate a pressure having a value which is below said predetermined threshold so that the membrane 26 is lifted by the pressure in the fluid in case the pressure in the fluid is above said predetermined threshold value. In the embodiment shown, the pressurization unit 30 is arranged at the side of the membrane 26 facing away from the recess 18 and, hence, at the exterior of the membrane 26.

[0062] Preferably, the pressurization unit 30 comprises at least one spring element 32a, 32b which extends substantially over the entire width of the fluid passage region 16 or the recess 18 or the membrane 26 transversely or angularly to the longitudinal extension of the body 10 and, hence, to the direction of flow of the fluid from the fluid inlet 12 to the fluid outlet 14. Although preferably, a plurality of such spring elements 32a, 32b are provided spaced from each other in the longitudinal extension of the body 10 and, hence, in the flow direction of the fluid from the fluid inlet 12 to fluid outlet 14. It is further preferred that a spring element is arranged over a protrusion (e.g. 20b, 20d) so that it pressurizes the membrane 26 against such protrusion.

[0063] According to the first preferred embodiment of the device 2, there are two spaced spring elements 32a, 32b which each have an elongated shape and are provided as a tube made of elastic material, preferably an elastomer tube.

[0064] As further shown in the FIGS. 1, 5 and 7, a cover 34 is provided which is arranged on the body 10 so as to cover the side of the membrane 26 facing away from the fluid passage region 16 and the recess 18 and, hence, the exterior of the membrane 26 and also to cover the pressurization unit 30. The cover 34 is formed such that at its inner side facing the membrane 26 there is provided a space which accommodates the spring elements 32a, 32b of the pressurization unit 30, as to be seen from FIG. 7. The depth of such space is dimensioned such that the spring element 32a, 32b of the pressurization unit 30 are supported on the inner side of the cover 34 and further arranged under pretention between the cover 34 and the membrane 26.

[0065] In the embodiment shown, the cover 34 includes two air discharge openings 26a, 26b, wherein the air discharge opening 26a is in communication with the one cavity section being the second cavity section in the order of cavity sections from the fluid inlet 12 to fluid outlet 14 and with the other air discharge opening 26b being in communication with the most downstream fourth cavity section, as in particular it becomes clear from FIG. 7.

[0066] In FIGS. 8 to 10 it is shown an infusion fluid air eliminating device 2′ according to a preferred second embodiment which differs from the above described preferred first embodiment in that the pressurization unit 30 comprises in addition to the tube-formed spring elements 32a, 32b a bent flat part 38 as a further spring element which is arranged upon the membrane 26 in the area of the fluid outlet 14 so that in that area the membrane 26 is sandwiched between the bent flat part 38 and the fourth protrusion 20d. The bent flat part 38 is preferably made of rubber-like material. As further shown in the FIGS. 8 to 10, the bent flat part is curved above and comprises a free end 38a facing upwards through a slit-shaped opening 36c which is additionally included in the cover 34.

[0067] Moreover, FIG. 11 shows a longitudinal section through a device 2″ according to a preferred third embodiment which differs from the second embodiment of the FIGS. 8 to 10 that instead of the spring elements 32a, 32b a flat sponge 40 is provided so that the pressurization unit 30 of the preferred third embodiment comprises the bent flat part 38 and the sponge 40.

[0068] With respect thereto, it should be added that in alternative embodiments not shown here the pressurization unit 30 can comprise only the bent flat part 38 or the sponge 40.

[0069] The infusion fluid air eliminating device 2 as described above can be easily integrated into an infusion pump mechanisms cartridge 50 including a pump mechanism 52 as exemplarily shown in FIG. 12 (which also applies to the device 2′ or 2″ according to the second and third embodiments as described above). For a convenient false alarm avoidance, the infusion pump mechanisms cartridge 50 further includes two air-in-line detectors 56, 58, which both are preferably ultrasonic sensors, wherein a first sensor 56 is provided upstream of the fluid inlet 12 of the device 2 so as to detect air bubbles in the fluid inlet tube 22, and a second sensor 58 is provided downstream of the fluid outlet 14 of the device 2 so as to detect possible air bubbles in the fluid outlet tube 24.

[0070] Intravenous fluid from an infusion pump enters the cavity formed by the recess 18 at its upstream end through the fluid inlet 12, and the fluid free from air leaves the fluid path fluid at its downstream end through the fluid outlet 14 so as to enter the fluid outlet line 24.

[0071] The depth of said cavity is preferably narrow in full or in parts like the spring elements 32a, 32b, comparable to smallest air bubbles.

[0072] There are means having an intrinsic antisiphon function like the spring elements 32a, 32b creating a pressure slightly higher than atmospheric pressure on the fluid to let it pass through the cavity to the downstream fluid outlet 14.

[0073] The recess 18 has one side covered by a sealed hydrophobic membrane 26 along all four recess borders so that for fluids it defines a closed cavity, but for air an open one, and an internal pressure higher than atmospheric pressure expels air bubbles out. Accordingly, after the fluid with air bubbles has entered the recess 18, an antisiphon action increases the pressure in the fluid by means of infusion pump action, and the pressurized air bubbles come into contact with the hydrophobic membrane 26 through which they are expelled out to the air wherein this phenomenon can be achieved in a particularly effective manner by having the depth of the cavity 26 smaller than the diameter of the bubbles. The recess 18 acts also as a collider of small air bubbles to bigger ones, until they become big enough to explode on the membrane 26.

[0074] There may be several smaller or zero depth protrusions 20a to 20d in the flow path, forcing the fluid to lift the membrane 26 and, hence, to push it higher to have space to pass through, and so forcing air bubbles out. After passing over the plurality of protrusions 20a to 20d, the fluid is free from air bubbles to exit into the fluid outlet 14.

[0075] An antisiphon action may be additionally enforced by the provision of an external antisiphon unit (not shown) in the infusion line increasing working pressure in the fluid.

[0076] An important component for contributing the antisiphon effect is the pressurization unit 30 which pressurizes the membrane 26 against the fluid passage region 16 such that the membrane 26 substantially closes the cavity forming recess 18 between the fluid inlet 12 and the fluid outlet 14 when the pressure in the fluid is below a predetermined threshold value corresponding to or being greater than the pressure to break the surface tension of the fluid, and opens when the pressure in the fluid is above the threshold value, whereby air bubbles which may be contained in the fluid can escape from the cavity 18 through the membrane 26.

[0077] Preferably, the pressurization unit 30 comprises at least one spring element. According to a modification, the spring element comprises a flow restrictor, like an elastomeric tube 32a, 32b, to be biased from above upon the membrane 26 over a protrusion 20b, 20d and preferably extends along the protrusion 20b, 20d transverse to the flow, wherein the most downstream protrusion 20d is provided in the area of the fluid outlet 14. At the protrusions 20b, 20d, fluid and air bubbles will have to pass between the membrane 26 and the protrusions 20b, 20d whereby the membrane 26 elevates slightly to generate a gap, which preferably is smaller than any air bubble, in a way that all air bubbles come in contact with the membrane 26 and are eliminated.

[0078] According to a further embodiment of FIG. 11, the spring element may comprise a sponge 40 which is arranged above the membrane 26 and presses it in contact with the protrusions 20b, 20c so as to increase the pressure in the fluid while air passes through the sponge easily. According to a further modification as shown in the FIGS. 8 to 11, the spring element may comprise a rubber sheet plate 38 which compresses the membrane 26 over a downstream portion of the fluid passage region having a surface which is elevated towards the membrane 26 so that the fluid cannot pass through if the pressure in the fluid is below the antisiphon pressure (free flow avoidance) but also air cannot come through and fill the fluid path in case of an open infusion line end or a low line pressure (normal antisiphon action), since the rubber sheet plate 38 covers all those parts. So, the rubber sheet plate 38 causes an antisiphon effect. In addition, that part of the membrane 26 under the rubber sheet plate 38 can be paint with a sealing air sealant. The sponge 40 and/or the rubber sheet plate 38 can be compressed to a nominal antisiphon pressure by the cover 34. After all, the pressure exercised on the membrane 26 results in an antisiphon valve effect.