Device for Administration of Fluid Medicaments
20180036480 ยท 2018-02-08
Inventors
- Brechtje Riphagen (Utrecht, NL)
- Lucas Alphonsus Maria Evers (Zeist, NL)
- Jan Willem Marinus Mijers (Haarlem, NL)
- Lex Alexander Franciscus Van Rossum (Raalte, NL)
Cpc classification
A61M5/165
HUMAN NECESSITIES
A61M2005/1652
HUMAN NECESSITIES
A61L31/048
HUMAN NECESSITIES
A61L31/14
HUMAN NECESSITIES
A61M2205/0216
HUMAN NECESSITIES
A61M5/16827
HUMAN NECESSITIES
International classification
A61M5/165
HUMAN NECESSITIES
A61M5/14
HUMAN NECESSITIES
A61M5/168
HUMAN NECESSITIES
A61L31/14
HUMAN NECESSITIES
Abstract
A device 2 for the administration of fluids to a human or animal body comprising a housing 3 with a first inlet 28, at least one second inlet 29, 30, one outlet 31 and a collecting point, wherein the first inlet 28 communicates with the collecting point through a first channel and the outlet 31 communicates with the collecting point. The second inlet 29, 30 communicates with the collecting point or an indicator chamber 24, 25 through a second channel 21, 22 in which a valve 26, 27 is arranged, the valve 26, 27 being adjustable between a first position and a second position, wherein, in the first position of the valve 26, 27, the second channel 26, 27 communicates with the indicator chamber 24, 25 and, in the second position of the valve 26, 27, the second channel 21, 22 communicates with the collecting point.
Claims
1. Device (2) for the administration of fluids to a human or animal body, comprising a housing (3) with a first inlet (28), at least one second inlet (29, 30), one outlet (31) and a collecting point, wherein the first inlet (28) communicates with the collecting point through a first channel and the outlet (31) communicates with the collecting point, characterized in that the second inlet (29, 30) communicates with the collecting point or an indicator chamber (24, 25) through a second channel (21, 22) in which a valve (26, 27) is arranged, the valve (26, 27) being adjustable between a first position and a second position, wherein, in the first position of the valve (26, 27), the second channel (21, 22) communicates with the indicator chamber (24, 25), and, in the second position of the valve (26, 27), the second channel (21, 22) communicates with the collecting point.
2. Device (2) according to claim 1, characterized in that the indicator chamber (26, 27) and/or the housing (3) is at least in part transparent or translucent for visible electromagnetic radiation.
3. Device (2) according to claim 1, characterized in that the indicator chamber (24, 25) comprises a hydrophobic filter element and/or an indicator element (60, 61) which changes its color in case of fluid contact.
4. Device (2) according to claim 3, characterized in that the indicator element (60, 61) is made of a sintered plastic material.
5. Device (2) according to claim 4, characterized in that the plastic material comprises at least one additive which changes its color in case of fluid contact.
6. Device (2) according to claim 4, characterized in that the plastic material is polyethylene.
7. Device (2) according to claim 3, characterized in that the hydrophobic filter element or the indicator element (60, 61) abuts on a wall of the indicator chamber (24, 25) with at least one opening (58, 59) communicating with the ambience air of the device (2).
8. Device (2) according to claim 1, characterized in that an inlet opening (50, 51) of the indicator chamber (24, 25) is covered by an elastic sealing element (52, 53) acting as a check valve which is closed in a pressure-less state.
9. Device (2) according to claim 3, characterized in that the indicator chamber (24, 25) comprises at least one insertion element (54, 55) which holds the sealing element (52, 53) in its position by contacting the sealing element (52, 53) and/or which receives the hydrophobic filter element and/or the indicator element (60, 61).
10. Device (2) according to claim 7, characterized in that the wall of the indicator chamber (24, 25) with at least one opening (58, 59) is embodied as a wall element (56, 57), which is fixed on the insertion element (54, 55).
11. Device (2) according to claim 1, characterized in that an indicator mechanism is arranged within the indicator chamber, comprising at least one movable part which moves with respect to the indicator chamber when the indicator chamber is filled with a fluid.
12. Device (2) according to claim 11, characterized in that the movable part has a color mark.
13. Device (2) according to claim 1, characterized in that the second channel (21, 22) and/or the first channel (20) comprises a filter chamber (36, 37) in which a hydrophilic filter member (70, 100) and/or a hydrophobic filter member (71, 101) is arranged, wherein the hydrophilic filter member (70, 100) separates the filter chamber (36, 37) into to sub-chambers and wherein the hydrophobic filter member (71, 101) covers an opening (72) of the filter chamber (36, 37) which is in communication with the ambience air of the device.
14. Device (2) according to claim 13, characterized in that the hydrophilic filter member (70, 100) is supported by protrusions (80) extending from at least one wall of the filter chamber (36, 37).
15. Device (2) according to claim 1, characterized in that a check valve (33, 34, 35) is arranged within the first channel (20) and/or within the second channel (21, 22).
16. Device (2) according to claim 1, characterized in that the collecting point is embodied as a collecting chamber (23).
17. Device (2) according to claim 16, characterized in that the collecting chamber (23) is ring-shaped.
18. Device (2) according to claim 1, characterized in that at least one section (73) of the valve (26, 27) has a cylindrical shape, the radial surface of which comprises a recess (43, 44) extending over the circumference of the radial surface, wherein the recess (43, 44) provides a communication between the second channel (21, 22) and the indicator chamber (24, 25) in the first position of the valve (26, 27), and between the second channel (21, 22) and the collecting point in the second position of the valve (26, 27).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] A particular preferred embodiment of the device according to the invention is described hereinafter with reference to figures, whereat
[0032]
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[0034]
[0035]
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[0039]
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[0044]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0045]
[0046]
[0047] The first channel 20 extends through the housing starting from the first inlet 28 and ending at the collecting chamber 23. Within the first channel 28 check valve 33 is arranged in the vicinity of the collecting chamber 23, preventing back flow from the collecting chamber 23 into the first channel 20.
[0048] The collecting chamber 23 is essentially ring-shaped. There is a protrusion 38 formed on the inner wall of the ring-shaped collecting chamber 23, which protrusion 38 extends marginally into the first channel 20. The protrusion 38 results in the fluid fed to the first channel 20 being separated into two half streams, flowing through the collecting chamber 23 in different directions, i.e. clockwise and counterclockwise, when it enters the collecting chamber 23. The end of outlet channel 32 and protrusion 38 have an angle difference of 180. The collecting chamber 23 is realized by providing a clearance in the housing 3, into which a cylindrical-shaped insertion member 64 with a recess 65 formed on its radial surface is inserted. The collecting chamber 23 is formed by the recess of insertion member 64 and the circumferential surface of the clearance.
[0049] The second channels 21, 22 extend through the housing 3, starting from the second inlets 29, 30 and ending at the indicator chambers 24, 25, or at the collecting chamber 23. The second channels 21, 22 each have a branched structure, wherein one of the valves 26, 27 is arranged at the branching point such that an adjustable fluid connection between the second channels 21, 22 and the indicator chambers 24, 25 or between the second channels 21, 22 and the collecting chamber 23 can be provided there. In each second channel, one of the check valves 34, 35 is arranged preventing backflow from the collecting chamber 23 or the indicator chambers 24, 25 towards the second inlets 29, 30. In order to minimize the dead volume of the device 2 the branches 39, 40, 41, 42 of the second channels 21, 22 are designed to be very short and extend merely through the walls separating the valves 26, 27 from the indicator chambers 24, 25 and the walls separating the valves 26, 27 from the collecting chamber 23. The minimal thickness of these walls depend on the desired mechanical stability of the device 2. The second channels 21, 22 further comprise filter chambers 36, 37, in which a hydrophilic filter member (not shown) or, in the present embodiment, a respective hydrophobic filter member (not shown) are arranged. In the sectional view of
[0050] Each of the valves 26, 27 comprise a cylindrical section. On the radial surface of the cylindrical sections a corresponding recess 43, 44 is formed. The recesses 43, 44 extend over the radial surface of the cylindrical sections of the valves 26, 27 in order to provide an adjustable fluid connection between the second channels 21, 22 and the indicator chambers 24, 25 (first position of the valves 26, 27) or the collecting chamber 23 (second position of the valves 26, 27), whereat the adjustment is carried out by turning the cylindrical sections about their axial directions, moving the recesses 43, 44 at the same time. The grip portions 13, 14 shown in
[0051] Indicator chambers 24, 25 communicate with the second channels 21, 22 in the first position of the valves 26, 27, which is the starting adjustment during employment of the device 2. The indicator chambers 24, 25 comprise each an inlet opening 50, 51, a sealing element 52, 53, an insertion element 54, 55, a wall element 56, 57 with an opening 58, 59 and an indicator element 60, 61. The inlet openings 50, 51 have a protruded edge against which the sealing elements 52, 53 rest. Sealing elements 52, 53 are supported by protrusions 62, 63 formed on the insertions elements 54, 55. Protrusions 62, 63 exert an initial tension on sealing elements 52, 53 such that they seal inlet openings 50, 51 in a pressure-less state. The sealing elements 52, 53 can be fixed on the protrusions 62, 63, by welding, gluing or the like, in order to simplify the assembly of the device 2 during manufacturing. The sealing elements 52, 53 act as check valves, as their outer edges can only be raised in the inflow direction.
[0052] The insertion elements 54, 55 are of cylindrical shape. They are each inserted into a corresponding clearance provided on the housing 3 and fixed on the circumferential surfaces of the clearance by, for instance, a frictional connection, tongue and groove connection, welding or gluing. The wall elements 56, 57 are adapted to the cross sectional shape of the insertion elements 54, 55 and are fixed on the wall elements 56, 57. They, furthermore, are transparent or translucent for visible light. The insertion elements 54, 55 receive indicator elements 60, 61 which consist in the present embodiment of sintered polyethylene (PEL). Indicator elements 60, 61 abut on the wall elements 56, 57 and cover the openings 58, 59. As mentioned hereinbefore, sintered polyethylene is a porous plastic material such that air can pass through it. However, if the material is in contact with a fluid, it gets densified to an impervious state. Therefore, the openings 58, 59 are sealed by indicator element 60, 61, if a fluid enters the indicator chambers 24, 25 and gets in contact with indicator elements 60, 61. So, the air located within the second channels 21, 22 before employment of the device 2 is driven to indicator chambers 24, 25 by the fluids entering the second inlets 29, 30 and escapes via the openings 58, 59, provided that the valves 26, 27 are in their first positions. When the fluids reach the indicator elements 60, 61, the latter are densified and seal openings 58, 59.
[0053] Indicator elements 60, 61 furthermore feature the property of a change in colour in case of fluid contact, which property can be achieved by additives. This allows for an easy observation whether a fluid has reached not only the respective indicator chamber 24, 25, but the indicator element 60, 61 as well, i.e. that the air contained in the second channel 21, 22 upstream the indicator element 60, 61 was removed, and that the second channel 21, 22 and the recess 43, 44 of the valve 26, 27 are filled with the fluid fed to the respective second inlet 29, 30. If administration of the fluid fed to one of the second inlets 29, 30 is to be started, the respective valve 26, 27 is switched from its first position to its second position, in which the respective second channel 21, 22 communicates with the collecting chamber 23. Switching of both valves 26, 27 can occur at the same time or at different points in time, depending on the administration schedule set for a patient. Due to the fact, that the respective second channel 21, 22 and the respective recess 43, 44 are already filled with fluid, the delay between switching of the valve 26, 27 and administration of the fluid to a patient is shortened, which allows for a more precise dosage. In the second positions of the valves 26, 27, the fluids fed to the second inlets 29, 30 flow to the collecting chamber 23 via recesses 43, 44 and enter the collecting chamber 23 at locations with an angle difference with respect the protrusion 38 and thus, with respect to the end portion of the first channel 20, of 90. The fluids fed to the second inlet 29, 30 converge with the fluid fed to the first inlet 28 at these locations. The mixture of said fluids flows from there to the outlet channel 32 and to the outlet 31 of the device 2.
[0054] The check valves 33, 34, 35 comprise each a cylindrical body with a protruding edge on one side and an elastic cover being fixed on the other side and having a slit formed therein. The elastic cover is formed such that it is openable by a fluid flowing in the inflow direction and closable by fluid flowing in the outflow direction. The protruding edge rests against a corresponding contact surface of the housing 3 to which the protruding edge can be fixed, e.g., by means of welding or gluing.
[0055]
[0056]
[0057] The upper sub-chamber of the filter chamber 37 communicates with the downstream portion of the second channel 22 via an outlet 46, which is formed on the insertion member 76. Within the downstream portion of the second channel 22, a check valve 35 is arranged. Downstream the check valve 35, the second channel 22 leads to a recess 44 located on the radial surface of the cylindrical section 73 of the valve 27. The valve 27 is fixed on the housing by means of a tongue 74 and groove 75 connection, whereat the groove 75 is formed on the radial surface of the cylindrical section 73. By means of the grip portion 14, the valve 27 is manually turnable in an easy manner. The lower sub-chamber of the filter chamber 37 communicates with the second inlet 30.
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[0067] Referring to
[0068] A second effect observable with prior art infusion systems is the so-called over shoot occurring with the flow rate 112 between 0.5 h and 1 h and between 3.25 h and 3.5 h. This problem is remedied with the device 2, as can be seen on the course of flow rate 110.
[0069] A third effect observable with prior art infusion systems are flow rate fluctuations occurring if one of two or more flow rates is set to another value by means of a pump. Such fluctuations occur with the flow rate 112 between 5.0 h and 5.25 h, where the pump setting is set from 0.5 ml/h to 1.0 ml/h, and between 6.0 h and 6.25 h, where the pump setting 115 is set from 1.0 ml/h to 0.5 ml/h. With the flow rate 113 such fluctuations occur between 3.0 h and 3.25 h, where the pump setting 114 is set from 6.0 ml/h to 10 ml/h, and between 4.0 and 4.25 h, where the pump setting 114 is set from 10 ml/h to 6 ml/h. These fluctuations are remarkably minimized with the device 2, as can be seen on the course of flow rates 110, 111.
[0070] The courses of flow rates 110, 111 are in general remarkably closer to the courses of the respective pump settings 114, 115, i.e. a more precise dosage is achieved.
[0071] While the invention has been described with reference to a specific embodiment, the description is merely explanatory and is not to be construed as limiting the scope of the invention. Various modifications may be conceived by those skilled in the art without departing from the scope of the invention as defined by the claims.
LIST OF REFERENCE NUMERALS
[0072] 1 infusion system [0073] 2 device [0074] 3 housing [0075] 4 tube [0076] 5 tube [0077] 6 tube [0078] 7 tube [0079] 8 external filter chamber [0080] 9 opening [0081] 10 tube [0082] 11 male connector [0083] 12 female connector [0084] 13 grip portion [0085] 14 grip portion [0086] 20 first channel [0087] 21 second channel [0088] 22 second channel [0089] 23 collecting chamber [0090] 24 indicator chamber [0091] 25 indicator chamber [0092] 26 valve [0093] 27 valve [0094] 28 first inlet [0095] 29 second inlet [0096] 30 second inlet [0097] 31 outlet [0098] 32 outlet channel [0099] 33 check valve [0100] 34 check valve [0101] 35 check valve [0102] 36 filter chamber [0103] 37 filter chamber [0104] 38 protrusion [0105] 39 branch [0106] 40 branch [0107] 41 branch [0108] 42 branch [0109] 43 recess [0110] 44 recess [0111] 45 outlet [0112] 46 outlet [0113] 50 inlet opening [0114] 51 inlet opening [0115] 52 sealing element [0116] 53 sealing element [0117] 54 insertion element [0118] 55 insertion element [0119] 56 wall element [0120] 57 wall element [0121] 58 opening [0122] 59 opening [0123] 60 indicator element [0124] 61 indicator element [0125] 62 protrusion [0126] 63 protrusion [0127] 64 insertion member [0128] 65 recess [0129] 70 hydrophilic filter member [0130] 71 hydrophobic filter member [0131] 72 opening [0132] 73 cylindrical section [0133] 74 tongue [0134] 75 groove [0135] 76 insertion member [0136] 77 protruding edge [0137] 80 protrusions [0138] 90 openings [0139] 91 inner space [0140] 100 hydrophilic filter member [0141] 101 hydrophobic filter member [0142] 102 insertion member [0143] 103 housing element [0144] 104 housing element [0145] 105 housing element [0146] 106 housing element [0147] 110 flow rate over time [0148] 111 flow rate over time [0149] 112 flow rate over time [0150] 113 flow rate over time [0151] 114 pump setting over time [0152] 115 pump setting over time