Micro-fluidic chambers for use in liquid medicament delivery systems
10556057 · 2020-02-11
Assignee
Inventors
Cpc classification
Y10T137/0318
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M2205/0244
HUMAN NECESSITIES
Y10T137/8326
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M5/16877
HUMAN NECESSITIES
G01R33/302
PHYSICS
A61M5/36
HUMAN NECESSITIES
International classification
A61M5/14
HUMAN NECESSITIES
A61M5/36
HUMAN NECESSITIES
Abstract
Micro-fluidic chambers for use in a liquid medicament delivery system, include a bottom substrate and a top cover, the top cover being spaced from the bottom substrate so as to define a height of the chamber, wherein, one or more walls or fillings are positioned in the chamber, the walls or fillings defining a fluid channel there between such that the fluid channel extends from an inlet conduit to an inlet of the chamber to an outlet conduit connected to an outlet of the chamber, wherein, each of the walls or fillings has a height less than the height of the chamber so as to define a fluid gap between a top surface of each wall or filling and the top cover; and wherein, the dimensions of the walls or fillings and the chamber are such that the fluid gap will be filled with liquid by capillary forces via the fluid channel when liquid is introduced into the fluid chamber.
Claims
1. A micro-fluidic chamber for use in a liquid medicament delivery system, the micro-fluidic chamber comprising: a bottom substrate and a top cover, the top cover being spaced from the bottom substrate so as to define a height of the micro-fluidic chamber; wherein, two or more walls or fillings are positioned in the micro-fluidic chamber, the walls or fillings forming a fluid channel between the walls or fillings, the fluid channel extending uninterrupted from an inlet conduit connected to an inlet of the micro-fluidic chamber to an outlet conduit connected to an outlet of the micro-fluidic chamber; wherein, each of the walls or fillings has a height less than the height of the micro-fluidic chamber so as to define a fluid gap between a top surface of each wall or filling and the top cover; and wherein, the dimensions of the walls or fillings and the micro-fluidic chamber are such that the fluid gap will be filled with liquid by capillary forces via the fluid channel when liquid is introduced into the micro-fluidic chamber; wherein, the top cover comprises a flexible membrane; and wherein, the fluid channel comprises a meander-like shape.
2. The micro-fluidic chamber of claim 1, wherein a height of the fluid gap is from 0.02 to 0.2 mm.
3. The micro-fluidic chamber of claim 2, wherein a height of the fluid gap is from 0.05 and 0.15 mm.
4. The micro-fluidic chamber of claim 1, wherein the flexible membrane comprises a gas-permeable membrane.
5. The micro-fluidic chamber of claim 1, wherein at least one of a part of the surface of the bottom structure, the walls, and the top cover facing toward an inner volume of the micro-fluidic chamber is hydrophilic.
6. A pressure sensor for use in a liquid medicament delivery system, the pressure sensor comprising: a rigid bottom structure and a top cover, the top cover comprising a flexible, resilient membrane being spaced from the rigid bottom structure so as to define a height of a chamber; wherein, two or more walls or fillings are positioned in the chamber, the walls or fillings forming a fluid channel between the walls or fillings, the fluid channel extending uninterrupted from an inlet conduit connected to an inlet of the chamber to an outlet conduit connected to an outlet of the chamber; wherein, each of the walls or fillings has a height less than the height of the chamber so as to define a fluid gap between a top surface of each wall or filling and the top cover; wherein, the dimensions of the walls or fillings and the chamber are such that the fluid gap will be filled with liquid by capillary forces via the fluid channel when liquid is introduced into the chamber; wherein, the fluid channel comprises a meander-like shape; and wherein, when there is no pressure difference between an external pressure of the chamber and an internal pressure of the chamber, the top cover remains flat and when the external pressure of the chamber is less than the internal pressure, the top cover bulges outwards.
7. The pressure sensor of claim 6 wherein, wherein a height of the fluid gap is from 0.02 to 0.2 mm.
8. The pressure sensor of claim 7 wherein, wherein a height of the fluid gap is from 0.05 and 0.15 mm.
9. The pressure sensor of claim 6, wherein the flexible resilient membrane comprises a gas-permeable membrane.
10. The pressure sensor of claim 6 wherein, a detection system is arranged to measure a deformation of the top cover of the chamber.
11. The pressure sensor of claim 6 wherein, wherein at least one of a part of the surface of the rigid bottom structure, the walls, and the top cover facing toward an inner volume of the chamber is hydrophilic.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(19) Referring to
(20) The height H2 of the walls 13 may be less than the overall height H1 of the chamber 1. As a result, there may be a fluid gap 3 between the top cover 12 and the upper surface 131 of the walls 13, with a height H3=H1H2. The dimensions of the chamber and the walls, particularly the heights H1, H2, H3 may be chosen such that there are non-negligible capillary forces acting on a fluid 4 present in the micro-fluidic chamber 1. Fluid 4 in the fluid channel 2 may be dragged by said capillary forces into the fluid gap 3.
(21) In one embodiment, the specific dimensions may depend on the liquid used. In another embodiment, the specific dimensions may additionally or alternatively depend on the properties of the surfaces of the top cover 12 and the top 131 of the walls 13. Such factors may eventually define the interface tensions between the liquid, surfaces, and the gas/air in the chamber, which then may define the effective capillary forces for a certain geometric setting of a micro-fluidic chamber. In one exemplary embodiments, where liquid medicaments are aqueous solutions, at least some surfaces, such as the surface of the top surface 131 of the wall 13 and the surface of the top cover 12 facing toward surface 131, may be hydrophilic, with a contact angle <90. Such an embodiment may thereby increase the overall capillary effect. In another exemplary embodiment, where the liquid medicaments are aqueous solutions, the height H3 of the gap 3 may comprise between 20 and 200 m. In another embodiment, the height H3 of the gap 3 may comprise between 50 and 150 m.
(22) In one embodiment, a diameter of a micro-fluidic chamber 1 may, for example, comprise between about 2 to 10 mm. In another embodiment, the fluid channels may comprise a width of, for example, 0.1 to 1 mm, while the height H2 of the walls 13 comprise between 0.25 to 5 mm, or alternatively, 0.5 and 1 mm. In yet another embodiment, the aspect ratio between the width of the fluid channel 2 and the height H2 can lie between 0.25 and 5, or alternatively, comprise about 1.
(23) When a micro-fluidic chamber 1 according is filled through inlet 21 with a liquid 4, the liquid may flow essentially along the fluid channel 2. The capillary forces may then drag liquid 4 in the fluid channel 2 into the adjacent sections of the gap 3, thereby effectively supplanting air present in the gap. As it may be energetically more favorable for air to form spherical bubbles with minimum surface toward the hydrophilic surroundings, no or minimal air bubbles may remain in the gap 3.
(24) Referring now to
(25) Air bubbles in the gap may be energetically less preferable than air bubbles in the fluid channel 2. As a consequence, air bubbles may not form in the gap 3 at a later stage, and if they do, they will migrate into the fluid channel 2. Air bubbles in the fluid channel 2, on the other hand, may not enter the gap 3 for energy reasons, but may be transported away by the liquid stream.
(26) The shown capabilities of a micro-fluidic chamber 1 may be independent from its orientation in space. Since the capillary forces and interface tensions responsible for the smooth filling of the gap can be stronger than the gravitational force acting on the liquid, as well as the buoyancy force acting on the air bubbles in the liquid, the micro-fluidic chamber may be completely filled with liquid 4 independent on its orientation. Thus, the filling behavior of such a micro-fluidic chamber may become more predictable and reproducible.
(27) Since the operational internal volume of a micro-fluidic chamber may be smaller than that of a hollow micro-fluidic chamber with similar dimensions, the dead volumethe portion of the fluid volume in a fluid system that can never be drained and eventually will be lostmay be considerably reduced.
(28) Furthermore, the air bubbles that do enter the chamber through the inlet may be guided through the fluid channel to the outlet. Since the effective cross-sectional area of the fluid channel may be essentially constant over its length, the liquid flow may also be constant over its length, and does not drop at certain positions. Thus, bubbles may not be caught in the fluid chamber.
(29) Still referring to
(30) Alternatively, instead of having a single fluid channel 2, the walls 13 of a micro-fluidic chamber may define two or more fluid channels within the chamber, extending from a common inlet to a common outlet. For example, such an embodiment of an exemplary micro-fluidic chamber 1 is illustrated in
(31) A curved or meandering design of the fluid channel may be utilized in fluid chambers with larger base areas, since the longest possible distance between the fluid channel and an outer edge of the gap is relatively short. In addition, the meandering fluid channel can be used to limit the maximum flow through a fluidic system.
(32) In yet another embodiment, a straight fluid channel may be utilized in micro-fluidic chambers. For example, such an embodiment of a micro-fluidic chamber 1 comprising a straight fluid channel is illustrated in
(33) Referring now to
(34) Referring now to
(35) In one embodiment, the walls 13 may be realized as an integral part of the bottom substrate 11. In such an embodiment, the fluid channel 2, and even the inlet and outlet conduits can, as an example, be produced by embossing the necessary void structures into a flat bottom structure 11. To obtain the necessary gap 3, one may arrange a thin spacer layer with height H3 between the bottom layer structure and the top layer 12 around the chamber, or may produce the gap together with the fluid channel and the walls in the embossing step. In an alternative embodiment, the micro-fluidic chambers may be manufactured via injection molding.
(36) In one particular embodiment, the walls 13 may comprise separate filling structures, mounted onto a flat bottom layer 11. In such an embodiment, a filling body may be attached to a bottom layer, and then may be arranged between said bottom layer and a adjacent top layer in a sandwich-like manner.
(37) Such micro-fluidic chambers may thereby be manufactured in large numbers and on continuous production lines which may, for example, reduce the effective costs per piece and increase their viable use as with for disposable products, such as for parts of an infusion pump device that are disposed after use for hygienic reasons.
(38) In one embodiment, the micro-fluidic chamber may be used with pressure sensors for fluidic systems, such as, for example, for pressure sensors for miniaturized pump systems such as infusion pump devices for liquid medicaments. For example, a pressure sensor with a micro-fluidic chamber may comprise a rigid bottom structure 11 and a flexible, resilient membrane 120 as the top layer 12. When there is no pressure difference between the external pressure and the internal pressure of the fluidic system, the top layer membrane 120 may remain flat. In the case of a positive pressure difference, the membrane 120 may bulge outwards. The resulting displacement of the outer surface of the flexible membrane 120 then may be used to determine the current pressure difference. In the case of a negative pressure difference, where the flexible membrane 120 may be displaced inwards toward the chamber 1, the walls 13 may support the membrane 120, thereby avoiding an occlusion of the micro-fluidic chamber 1, or even damage of the membrane 120. In such embodiments, the pressure sensor with a micro-fluidic chamber may comprise reduced dead volume.
(39) In an alternative embodiment of a micro-fluidic chamber for use in a pressure sensor, the roles of the bottom substrate and the top layer may be reversed. In such a variant, the top layer may comprise a rigid structure, while the bottom substrate may comprise a flexible, resilient membrane. Thus, the walls or fillings may protrude from the flexible membrane. To measure the pressure in the fluid system, the deformation of the flexible bottom structure may be measured.
(40) In such embodiments, various systems may be utilized to measure the displacement of the flexible membrane 120. For example, referring to
(41) Referring now to
(42) Referring now to
(43) Still referring to
(44) As the internal pressure increases, the first capacitor electrode 61 may eventually touch the second capacitor electrode 61, and the ohmic resistance R between the two layers drops to zero. This event may also be detected by suitable electronic means, and can be usedin addition or as an alternative to the capacitanceas an input for a control system of an infusion pump device.
(45) Referring now to
(46) In yet another embodiment, the second capacitor electrode 62 may be located on the opposite side of the chamber 1, below the bottom structure, or integrated into the bottom structure.
(47) In another embodiment, micro-fluidic chambers may be utilized in degassing devices for fluidic systems, such as in infusion pump devices for liquid medicaments. For example, referring to
(48) As discussed above, prior to the first use, the degassing device with a micro-fluidic chamber can be filled without air bubbles, independent on the orientation of the device in space, due to the characteristics of the micro-fluidic chamber 1. Then, during the operational use of the fluidic system, an air bubble 71 may be flushed into the degassing device, along with the stream of liquid 4, and it can move along the meandering fluid channel 2. The interface tensions may inhibit the entrance of even of small air bubbles into the gap 3. However, the air 7 in the air bubble 71 may nonetheless be able to pass the gas-permeable membrane 121, provided that there is a sufficiently high difference of the partial pressure of the gas between the fluidic system and the other side of the gas permeable membrane. For an air bubble in the fluidic system the partial gas pressure may be substantially similar to the liquid pressure.
(49) When the surface characteristics of the walls 13, the bottom structure 11, and the gas permeable membrane 121 are selected, it may become energetically preferable for an air bubble 71 to be in contact with the gas permeable membrane 121. However, in another embodiment, it is also possible that an air bubble may be drained through the gas permeable membrane indirectly, via the liquid, since the gas can be solved in the liquid. This effect may assist in the removal of small air bubbles with a large surface compared to their volume. Although the air bubbles 71 may not enter the gap 3, gas 7 solved in the liquid may migrate into the gap 3, and permeate through the membrane 121. Thus a degassing device with a micro-fluidic chamber 1 may have a larger effective membrane surface compared to the operational internal volume, which may correlate to a faster dissolution of air bubbles and reduced dead volume.
(50) In one embodiment, to provide the air bubbles more time to drain through the gas-permeable membrane, while at the same time maintaining a sufficiently high through-put of liquid, a degassing device may be combined with a bubble trap.
(51) Referring now to
(52) Referring now to
(53) In one exemplary embodiment, the additional outlets 231 in
(54) It should now be appreciated that micro-fluidic chambers as disclosed herein may provide a smaller dead volume that may be fillable without air remaining in the chamber. Such micro-fluidic chambers may be filled essentially independent on its orientation in space such that it may be provided as a pressure sensor for use in a fluidic system, particularly in an infusion pump device for liquid medicaments. Degassing devices may also be provided comprising the micro-fluidic chambers for use in a fluidic system, and particularly, in an infusion pump device for liquid medicaments. Furthermore, infusion pump devices or parts of an infusion pump device, and liquid medicament delivery systems can comprise such micro-fluidic chambers, such as pressure sensor and/or a degassing device.
(55) It is noted that the terms substantially and about may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
(56) While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.