VALVE FOR ADMINISTRATION OF MULTIPLE DRUG FLUIDS
20170246443 · 2017-08-31
Inventors
Cpc classification
A61M39/225
HUMAN NECESSITIES
F16K11/083
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F16K11/085
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
International classification
Abstract
A drug administration valve (100) comprises a valve housing (200) having a plurality of drug inlets (D1 to D4) for receiving drug fluids, such as cytostatic, one flushing inlet (F) for receiving a flushing fluid, and an outlet (O). A valve member (300) rotationally arranged in the housing has a passageway (320; 321) presenting a single inlet (322) and a single outlet (324).The valve member (300) presents a plurality of drug positions for guiding an associated drug fluid to the outlet (O), and one or more flushing positions for guiding a flushing fluid through the same passageway (320; 321) as the drug fluids in order to flush said passageway (320; 321) from any drug residuals. The valve member (300) is prevented from rotating from one drug position to another drug position without passing one of said flushing positions
Claims
1. A valve for administration of two or more drug fluids, comprising: a valve housing having: an inner circumferential surface, a plurality of drug inlets for receiving said drug fluids and fluidly connected to associated drug outlets arranged at the inner circumferential surface of the housing, and one flushing inlet for receiving a flushing fluid, and fluidly connected to one or more flushing outlets arranged at the inner circumferential surface of the housing; and a valve member having a rotational axis and provided with a passageway presenting a single inlet arranged at an outer circumferential surface of the valve member and a single outlet arranged coaxially with said rotational axis; wherein the valve is arranged such that the valve member can be rotated into: a plurality of drug positions in each of which the single passageway inlet is fluidly connected to a respective one of said drug outlets for guiding an associated drug fluid via a flow path defined by said passageway to said passageway outlet, and one or more flushing positions in which the single passageway inlet is fluidly connected to a respective one of said one or more flushing outlets for guiding said flushing fluid through the same flow path defined by said passageway in order to flush said passageway from any drug residuals, and wherein the valve member is prevented from rotating from one drug position to another drug position without passing one of said flushing positions.
2. The valve according to claim 1, wherein said plurality of drug outlets and said one or more flushing outlets all are arranged at the inner circumferential surface of the housing on a common axial level with respect to said rotational axis.
3. The valve according to claim 1, wherein said one or more flushing outlets comprises a plurality of flushing outlets defining the same plurality of flushing positions, and wherein said one flushing inlet is fluidly connected to each one of said plurality of flushing outlets.
4. The valve according to claim 1, wherein said drug inlets and said flushing inlet are arranged on a common axial level with respect to said rotational axis.
5. The valve according to claim 1, wherein said drug inlets and said flushing inlet are arranged on different axial levels with respect to said rotational axis.
6. The valve according to claim 1, wherein the outer circumferential surface of the valve member is sealingly engaged with the inner circumferential surface of the housing.
7. The valve according to claim 1, wherein the passageway of the valve member comprises, in the flow direction, a first part extending from the inlet of the passageway towards the rotational axis, and a second part extending coaxially with the rotational axis from an radially inner end of the first part towards the channel outlet opening.
8. The valve according to claim 1, wherein the valve member is prevented from rotating from one drug position to another drug position without passing a flushing position by the provision of rotational stop means limiting the rotational movement of the valve member.
9. The valve according to claim 1, wherein the valve member is prevented from rotating from one drug position to another drug position without passing a flushing position by the provision the same number of flushing positions as the number of drug positions, said flushing positions being interlaced with the drug positions.
10. The valve according to claim 1, wherein valve member is prevented from rotating from one drug position to another drug position without passing a flushing position by the provision of a higher number of flushing positions than the number of drug positions, said flushing positions being interlaced with the drug positions and at both ends of the administration sequence.
11. The valve according to claim 1, wherein said circumferential inner surface of the housing and said circumferential outer surface of the valve member are cylindrical.
12. The valve according to claim 1, wherein said circumferential inner surface of the housing and said circumferential outer surface of the valve member are frusto-conical.
13. The valve according to claim 3, wherein the flushing inlet is fluidly connected to said plurality of flushing outlets via an annular flushing fluid distribution channel.
14. The valve according to claim 13, further comprising a plurality of flushing grooves formed in the inner circumferential surface of the valve housing, said flushing grooves extending at least partly in the direction of the rotational axis and being fluidly connected to a respective one of said plurality of flushing outlets and to said annular flushing fluid distribution channel.
15. The valve according to claim 14, wherein said circumferential inner surface of the housing and said circumferential outer surface of the valve member are cylindrical.
16. The valve according to claim 1, further comprising means for providing a tactile response to a user at each of said drug and flushing positions.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The inventive concept, some non-limiting embodiments and further advantages of the inventive concept will now be further described with reference to the drawings.
[0040] Each embodiment is illustrated with a number of figures marked with letters (e.g.
[0041]
[0042]
[0043]
[0044]
[0045] The present inventive concept relates to disposable valves for administration of drug fluids. For example, the drug fluids may include various types of cytostatics which are to be infused into the vascular system of a patient intravenously in order to treat her/him from cancer. Other fluids which may be administered by the present inventive valve include volume expanders, blood-based products, blood substitutes, medications, nutritional solutions, etc.
[0046] In one example, a drip chamber may be provided before the valve. Preferably, one drip chamber is provided in connection to each bag storing the fluids. In another example, a drip chamber may be provided downstream the valve. The advantage of using a drip chamber downstream the valve is that only one drip chamber is necessary.
[0047] In addition, a booster pump may be utilized to pre-set a flow rate by a predetermined pressure in the tube. In one example, the booster pump is provided before the valve. In another example, the booster pump is provided after the valve.
[0048] Some embodiments may be used together with and/or have integrated backflow valves. Backflow valves may be used (i) to prevent backflow (reflux) in the tubing which is presently used for administration, and (ii) to prevent backflow in other tubings fluidly connected by the valve.
[0049] In one example, the flushing tubing may have a backflow valve. In another example, a backflow valve may be arranged on each drug tubing. In another configuration, backflow valves may be integrated in the valve inlets. Yet in another example, a backflow valve may be integrated in the fluid passageway of the valve member. In still another example, a backflow valve may be integrated in the valve outlet or arranged on an outlet tubing.
[0050] It may also be an advantage to use backflow valves with an elastomeric connector element allowing the valve to be a closed system before connection and/or after disconnection of inlets.
[0051] However, such need for separate backflow valves may be avoided if the inventive valve is configured such that circumferentially adjacent flushing and drug positions are sufficiently spaced in the rotational direction.
First Embodiment of a 4-Drug Valve (FIG. 1)
[0052] Reference is now made to
[0053] The valve 100 comprises a cylindrical housing 200 (
[0054] In the assembled valve 100 (
[0055] Alternatively, other ways of engaging sealingly is conceivable. In one example, a sealing element (not shown) may be arranged in between the outer cylindrical valve member surface 302 and the inner cylindrical housing surface 204. For example, the sealing element may be made of a thin, flexible material which may be fitted snugly between the valve member and the housing. For example, the sealing member may be an O-ring.
[0056] Reference numeral 207 indicates an inwardly directed flange or rim on the inner surface of the housing. Reference numeral 307 indicates a corresponding annular recess in the valve body 301 which receives the flange 207 in the assembled state in order to maintain the valve member 300 in the housing 200.
[0057] The housing 200 and the valve member 300 may be fabricated in any material which does not react chemically to any considerably extent with the intended drug fluids to be used, and which thereby and also in other aspects is suitable for medical applications. Moreover, the material must be suitable for sterile environments. Examples of materials include plastic materials. The plastic material may be transparent or opaque depending on the medical application.
[0058] The housing 200 may be fabricated in the same material as the valve member 300. Alternatively, the housing 200 may be fabricated in a material which is different from that of the valve member 300. In particular, the material of the housing 200 and the valve member may have different hardness. Different hardness may be used for providing the tactile feedback means.
[0059] Different hardness and different material may also be used for providing improved sealing engagement.
[0060] The housing 200 illustrated in
[0061] A valve according to the inventive concept generally comprises a plurality of drug inlets D1, D2, etc and a single flushing inlet F, all arranged at the outer housing surface 206. In this embodiment there are four drug inlets D1 to D4 arranged at a first level L1 with respect to the rotational axis and a single flushing inlet F arranged at a second level L2 axially above the drug inlet level L1 (
[0062] The four drug inlets D1 to D4 are fluidly connected to the inner housing cavity 205 at separate outlets 208 and may be integrally formed with the cylindrical housing wall 202 and shaped as pipes or studs. In this embodiment, the four drug outlets 208 located at level L1 are angularly spaced at 90 degrees about the rotational axis.
[0063] The flushing inlet F at level L2 is arranged between the two drug inlets D4 and D1 and is fluidly connected to the inner housing cavity 205 at a separate flushing outlet 210. As for the drug inlets, the flushing inlet F may be integrally formed with the cylindrical housing wall 202 and shaped as a pipe or stud.
[0064] An axially oriented flushing groove 212a is formed in the inner housing surface 204 or the housing wall 202 and extends axially from level L2 down to the flushing outlet at level L1. As shown in
[0065] It will be noted that the above described fluid passageways formed in the housing are so arranged that the drug fluids and the flushing fluid are kept separate from each other when flowing towards the inner housing cavity 205 and the valve member 300.
[0066] In operation, the drug positions and the flushing positions of the valve 100 are defined by the angular positions of the drug outlets 208 and the angular positions of the flushing grooves 212a to 212d, respectively.
[0067] With reference to
[0068] As shown in
[0069] In use, a neutral fluid, such as a saline solution, or equivalently a saline fluid, may be is led into the flushing inlet F by means of a tube. This neutral fluid, termed “flushing fluid” may comprise a sterile solution of sodium chloride (NaCl). The flushing inlet F may be provided with a connection device for connecting said tube or may be glued to the tube. In a non-limiting example, connection devices comprise male and female Luer connectors. It is clear, however, that any type of connection devices may be used.
[0070] The valve member 300 will now be described more in detail with reference Figs le to li. A handle 304 integrally formed with the cylindrical valve member body 301 allows the valve member 300 to be rotated by the user into the eight different valve positions. The radial direction of the handle 304 will in known manner allow the user to identify the present valve position and it will be noted that
[0071] The cylindrical valve member body 301 (
[0072] In the embodiment in
[0073] A feature of the valve 100 is that the single flushing inlet F is in permanent fluid connection with each one of the flushing grooves 212a to 212d in order to distribute the flushing fluid to these grooves in the flushing positions of the valve. In the embodiment in
[0074] In the assembled state of the valve 100, the single inlet 322 of the valve member 300 is located at the same level L1 as the bottom part of the flushing grooves 212a to 212d receiving the flushing fluid. The bottom part of the flushing grooves 212a to 212d may be considered to constitute flushing fluid outlets 210 of the housing. Thus, by rotation of the handle 304, the single inlet 322 of the valve member 300 may be brought into alignment with the fluid outlets 210 at the flushing grooves 212a to 212d for receiving the flushing fluid via the flushing inlet F.
[0075] In the assembled valve 100, the single inlet 322 of the valve member 300 is located at the same level L1 as the drug outlets 208 in the housing 200, as shown in
[0076] The actual geometrical design of the channel 320 inside the valve member 300 may not be critical and may differ from the 90 degree bend configuration shown. The positions of the single inlet 322 and the single outlet 324 of the passageway 320 are more important.
[0077] In the assembled valve, the resilient lip 224 at the housing bottom is operatively engaged with a contoured circumferential surface 310 of a bottom groove 312 of the valve member 300 (
[0078] In some embodiments, the contoured circumferential surface 310 and the resilient lip 224 may be formed as a protrusions, notches, grooves or recesses with smooth or sharp edges to create a forced clockwise rotation, or a forced clockwise rotation with a possibility to turn one position back from a flushing position to a previous drug position.
[0079] The operation of the valve in
[0080]
[0081] Thus, if no drug yet has been administered through the valve, this position may also be considered as a priming position. However, the term flushing position will be used also for positions where priming is intended. Priming is normally performed at an initial stage in order to remove air from the valve, and from the tubings downstream the valve.
[0082] The initial flushing also serves to prepare the veins for the infusion to verify that the infusion is working properly.
[0083] In the illustrated 1.sup.st flushing position, the handle 304 is aligned with the flushing inlet F and flushing groove 212a (
Flushing inlet F.fwdarw.Down along flushing groove 212a to level L1.fwdarw.Flushing outlet 210.fwdarw.Inlet opening 322.fwdarw.Fluid passageway 320.fwdarw.Outlet opening 324.fwdarw.Bottom opening 222.fwdarw.Bottom channel 220.fwdarw.Outlet O
[0084]
Drug inlet D1.fwdarw.Drug outlet 208 at level L1.fwdarw.Inlet opening 322.fwdarw.Fluid passageway 320.fwdarw.Outlet opening 324.fwdarw.Inlet opening 222.fwdarw.Bottom channel 220.fwdarw.Outlet O
[0085] When the administration of the first drug fluid at drug inlet D1 has been terminated, and a subsequent drug fluid (at drug inlet D2) in the sequence should be administered to the patient, the handle 304 is rotated clockwise as indicated by arrows 404 and 406.
[0086] The valve member 300 will now first reach the subsequent second flushing position as indicated by arrow 404 and illustrated in
[0087] In this subsequent second flushing position, the single channel inlet 322 of the valve member 300 is aligned with the next flushing groove 212b and the flow path of the flushing fluid will be as follows:
Flushing inlet F.fwdarw.Circular distribution channel 213 at level L2.fwdarw.Down along flushing groove 212b to level L1.fwdarw.Flushing outlet 210.fwdarw.Inlet opening 322.fwdarw.Fluid passageway 320.fwdarw.Outlet opening 324.fwdarw.Bottom opening 222.fwdarw.Bottom channel 220.fwdarw.Outlet O
[0088] It will especially be noted that the flushing fluid and the drug fluid will follow the same flow path in passageway 320 through the valve member 300. Thus, the flushing fluid will now efficiently remove any residuals of the first drug fluid from the channel passageway 320 before the next drug in the sequence is administered via drug inlet D2.
[0089] With reference to the indicated flowpath FP in
[0090] When the flushing has been terminated in the second flushing position in
[0091] Having the drug inlets D1 to D4 distributed over 360 degrees may provide the following advantages: [0092] The inlets are distributed with maximum angular space to improve the sealing capability by using as much sealingly area as possible. [0093] The inlets are distributed with maximum angular space to improve space for the operators' finger and thumb. [0094] Fully closed valve positions may be arranged between the flushing positions and the drug positions.
[0095] In the following, a number of alternative embodiments will be described with reference to
Second Embodiment of a 4-Drug Valve (FIG. 2)
[0096] The embodiment of the valve 300 in
[0097] The main difference compared to
[0098] Another difference in relation to the embodiment in
[0099] As mentioned in connection with the previous embodiment in
[0100] From a manufacturing point of view, a cylindrical housing may be designed with an open bottom or a closed bottom. An open bottom makes it possible to make a feathered feature as a tactile response, with a mould tool from below. An open bottom also makes it possible to create a larger flange or a rim in the tooling split line, because of a mould tool from below. More complex design may be achieved with an open bottom. A closed bottom on the other hand may result in a simpler valve member, where valve member and its passageway is created with two moulds only.
Third Embodiment of a 4-Drug Valve (FIG. 3)
[0101] The embodiment of the valve 300 in
[0102] The main differences compared to the embodiment in
[0107]
Flushing inlet F.fwdarw.Up along inclined flushing groove 212c to level L1.fwdarw.Flushing outlet 210.fwdarw.Inlet opening 322.fwdarw.Down through passageway channel 320.fwdarw.Outlet opening 324.fwdarw.Bottom channel 220.fwdarw.Outlet O
[0108]
[0109] In this position, the distribution channel 213 is now “active” (
Flushing inlet F.fwdarw.Into flushing channel 213 at level L2.fwdarw.Along circular flushing channel 213 at level L2 to the bottom of flushing groove 212d.fwdarw.Up along inclined flushing groove 212d to level L1.fwdarw.Flushing outlet 210 at level L1.fwdarw.Inlet opening 322.fwdarw.Down through passageway channel 320.fwdarw.Outlet opening 324.fwdarw.Bottom channel 220.fwdarw.Outlet O
[0110] A conical embodiment according to
[0115] The embodiment in
First Embodiment of a 2-Drug Valve (FIG. 4)
[0120] The embodiment of the valve 300 in
[0128] In use of a valve according to