AU619754B2 - Flow control device for administration of intravenous fluids - Google Patents

Description

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WORLD INTELLECTUAL PROPERTY ORGANIZATION SInternational Bureau INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (51) International Patent Classification 4 (1 International Publication Number: WO 88/ 09893 F16K 5/10, 35/00, 37/00 Al (3)InteratiQ Pu a ti at1 ecember 1988 (15.12.88) (21) International Application Number: PCT/US88/01903 (81) Designated States: AT (European patent), AU, BE (European patent), CH (European patent), DE (Euro- (22) International Filing Date: 1 June 1988 (01.06.88) pean patent), DK, FI, FR (European patent), GB (European patent), IT (European patent), JP, KR, LU (European patent), NL (European patent), NO, SE,.

(31) Priority Application Numbers: 056,129 SE (European patent).

118,438 (32) Priority Dates: 1 June 1987 (01.06.87) Published 9 November 1987 (09.11.87) With international search report.

Before the expiration of the time limit for amending the (33) Priority Country: US claims and to be republished in the event of the receipt of amendments.

(71) Applicant: MASTER MEDICAL CORPARATION [US/US]; 4247 East Hazelwood, Phoenix, AZ 85018 Aus (72) Inventor: ASLANIAN, Jerry, L. 4247 Eaat Hazel- 4 wood, Phoenix, AZ 85018 A 9 (74) Agent: NELSON, Gregory, Nelson Roediger, rATENT OpCe I 2623 North Seventh Street, Phoenix, AZ 85006 C' AO. J.P. 9 MAR 1989 (54) Title: FLOW CONTROL DEVICE FOR ADMINISTRATION OF INTRAVENOUS FLUIDS (57) Abstract An apparatus and system for controlling and metering the administration of IV fluids. A rotatable valve body (502) is positioned within the valve chamber (505) and a valve passageway (509) of variable cross-sectional area is provided either in the chamber or on the valve member. The effective area and length of the flow passageway interposed between the inlet (506) and outlet (508) to the valve is adjustable to regulate flow by moving the valve body relative to the valve member. Various accessories can be selectively attached to the valve body including a backplate (510) which facilitates singlehanded operation and an optional cover plate (550) which may be secured to the backplate to provide security from patient tampering. In the preferred embodiment the valve housing and internal valve members are fabricated from dissimilar plastic materials of different hardness to improve the sealing therebetween. In another embodiment, the flow passage has two circumferential portions (850,860) interconnected by a bridge (855) to provide flow regulation over substantially 3600 range of rotation.

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r 46 -iiir-i: ii~~ i i i f v SWO 88/09893 PCT/US88/01903 FLOW CONTROL DEVICE FOR ADMINISTRATION OF I INTRAVENOUS FLUIDS The present invention relates to a device for regulating and controlling the flow of intravenous (IV) and parenteral fluids. More particularly, the present invention relates to a flow metering device for precisely establishing and maintaining a preselected flow rate during the administration of IV liquids to the patient.

The gravity administration of fluids by IV infusion is a common medical procedure. Representative intravenous fluids include blood, plasma, dextrose and isotonic saline solutions. IV infusions are generally carried out with the container of IV fluid suspended above the patient. Customarily such containers have a seal which is broken by the insertion of a spike and the fluid is delivered to the patient at an administration needle through a drip chamber and flexible tubing connected to the spike.

The purpose of the drip chamber is to facilitate the determination of the flow or drip rate through the tubing.

The infusion rate is generally regulated by use of an external pinch valve or roller clamp associated with the tubing for the more common gravity type infusions.

Initially when infusions are carried out, the tubing and needle are purged of air by initiating a flow of fluid through the tubing. The needle is then inserted into a venapuncture site at a suitable location such as in the forearm or wrist of the patient and infusion of fluid is initiated. Preferably when the venapuncture site occurs in the lower arm of the patient, the arm should be properly stabilized on a contoured IV arm support. Medical personnel administering the IV will adjust the pinch valve or roller to restrict the IV tubing and the number of drops passing through the drip chamber are counted.

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pCT/US88/01903? WO 88/09893 2 The appropriate flow rate is established by trial and error, by progressively restricting or opening the tubing at the pinch valve.

The administration procedure described above requires the attention of medical personnel for a substantial time in the initial establishment of the proper flow rate and in continual monitoring. It is the general practice of medical personnel to periodically check the flow rate by counting the drops of fluid that pass through the drip chamber. Conventional procedures as described not only require substantial time but are often inaccurate.

Temperature changes cause expansion and contraction of the IV tubing allowing the flow rate to vary. The tubing may loose "memory" and collapse under continuous squeezing necessitating constant readjustment of the setting.

Roller clamps or pinch valves of the general type described have a tendLncy to slip off the tubing which can pose a threat to the patient.

Independent tests have indicated that conventional pinch valves and roller clamps maintain flow only within about 25% accuracy thereby requiring constant readjustment. Accordingly, it will be appreciated that control of infusion rates with an acceptable degree of accuracy using conventional pinch valves and roller clamps is extremely difficult even with constant attention on the part of attending medical personnel.

Various expedients have been resorted to in an effort to correct the problem set forth above. Flow regulating devices of various types have been developed and can be found in the prior art. U. S. Patent No. 3,785,378 to Stewart shows a valve for the administration of intravenous fluids which has an annular member forming a central passage through which fluid is flowable to an end face having multiple grooves. The °inner ends of the multiple grooves communicate with the passage and a flow lil:~ ii i j

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SWO 88/09893 PCT/US88/01903 control member is rotatable to place the flow port successively and selectively in communication with the grooves to vary the flow rate.

Another approach to the problem is found in U.

S. Patent No. 3,877,428 to Seagle et al which patent shows an infusion control device for selectively controlling the rate of administration of fluids to a patient. The control device is attachable along the IV tubing and includes a rotatable metering member defining a capillary flow path between the input and output of the control device. A metering plate is axially rotatable with respect to the input and output ports to vary the effective length of the flow path so as to regulate flow between full flow and zero flow conditions.

A somewhat similar approach is shown in U. S.

Patent No. 3,880,401 whch discloses a flow metering valve having'inner and outer component parts which are movable relative one to another at screw threads to effect relative axial movement of a metering valve plug with respect to a metering bore for regulating and terminating flow through the valve flow passage.

Prior U. S. Patent Nos. 4,294,246 and 4,361,147, commonly assigned with the present application, disclose devices which represent substantial improvements over the prior art. A flow passage is provided within a nousing and is connectable to a source of IV fluid and to a delivery tube terminating at an administration needle. In the metering apparatus, a metering pin is axially movable within the flow passage relative to a valve seat and defining a flow'passageway and a variable area flow notch which are positionable relative to the valve seat to regulate flow from a full flow purge position to a flow blocking position. In the preferred embodiment, the position- ing of the metering pin is accomplished by a cam engaging a portion of the metering pin which forms a cam follower.

The cam is manually adjustable by a dial on the device to accomplish accurate, repeatable and continuous flow ad- 1 1 1 1 1 l 1 y 1 3 1 1 1 1 1 i i y i i i l v l i

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a C r m m mem me m justment over a full range. The system incorporates the metering apparatus, source of IV fluid, drip chamber and administration means. This apparatus and isystem works particularly well providing a high degree of accuracy and is competitive even with electronic flow controllers.

The foregoing devices, particularly those described immediately above, provide substantial improvements over conventional pinch valve and roller clamps, nevertheless, are not economically justifiable in some applications or for some medical facilities. Accordingly, there exists a need for a reliable, accurate and repeatable IV flow control device which is simple, effective, accurate and which can be provided to the medical care industry at low cost.

Briefly, the present invention achieves the above objects and advantages and provides a unique IV control device which can be adjusted to maintain various settings from zero to full flow with accuracy and repeatability.

According to the present invention there is provided an IV metering valve, for use in an IV system having a source of fluid connectable to an administration needle via a flexible tubing line, comprising: a plastics housing defining a generally cylindrical valve chamber which chamber is closed at one end thereof, 25 said housing having an inlet and outlet connectable in said tubing and communicating with said valve chamber at axially spaced apart locations; a plastics valving member rotatable within said valve chamber; said valving member having a generally cylindrical surface defining a flow path having a first portion, a second portion spaced axially from the first portion and a bridging portion providing communication between said frst and second portions; each of the first and second portions of the flow path extending 35 substantially around said cylindrical surface such that, throughout its length, said first portion -is axially aligned with said inlet and said second portion is axially aligned with said outlet whereby said flow path provides Scommunication between said inlet and outlet throughout a I I:

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Si Si substantially complete revolution of the valving member within said valve chamber; said first portion having opposed ends and said second portion having opposed ends, with the opposed ends of each of said first and second portion being mutually spaced by a land portion defined by said cylindrical surface, said bridging portion providing said communication between one of said ends of the first portion and one of said ends of the second portion such that in all conditions of flow from the inlet to the outlet, other than in a fast flow purge position for the valving member, flow in the first portion and the second portion is in opposite respective directions circumferentially of the valving member; said first portion of the flow path being of varying cross-sectional area throughout at least part of its length whereby said inlet is able to be selectively registered with a location along said first portion and said outlet selectively registered with a corresponding position along the second portion to regulate flow along the flow path from said inlet to said outlet; said valving member being rotatable to said fast flow purge position in which the inlet communicates substantially directly with said bridging portion and said outlet communicates with said second portion.

In accordance with the preferred embodiment, the flow control device of the present invention comprises a housing of a first plastic material which has an inlet and outlet port. A flow metering member having a variable area flow passage is rotatable within the housing by means of a manually adjustable dial. The flow metering member selectively places the inlet and outlet port in communication via the flow passageway to regulate the flow from a purge position through a flow adjusting range and to a stop flow position. The housing inlet and outlet are connectable in the IV tubing line which attaches the source of IV fluid to the administration needle. The metering member is fabricated of a second plastic material which is selected to effect sealing and minimize heat shrinkage. In other aspects or, the present invention, a -4ci i: ::i if i '-FS ;-a iiB1 ~I j I it r Wi r ia i: SWO 88/09893 PCT/US88/01903 kI 1 11 housing or backplate member may be selectively attachable to the valving member to provide additional gripping surface for the medical attendant. A security cover may also

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WO 88/098913 WO 8809893PCTAII;S88/O 1903 -2, WO 88/09893 PC !US8/ S903 be associated with the valving member to secure the valving member from tampering or inadvertant adjustment by unauthorized persons.

The above and other objects and advantages of the present invention will become more readily apparent from the following description, claims and drawings in j which: Figure 1 is a perspective view of the metering device of the present invention; Figure 2 is an exploded view of the metering device shown in Figure 1; Figure 3 is a sectional view taken along lines 3-3 of Figure 1; Figure 4 is a plan view of the metering face of the rotary metering member; Figure 5 is a sectional view taken along lines of Figure 4 showing the metering groove in a linear display; Figure 6 is a partial detail view showing the relationship of the metering member and the inlet and outlet; Figures 7A to 7C are plan views of the metering member illustrating various positions thereof; Figure 8 is an exploded view of an alternate embodiment of the present invention; Figure 9 is a sectional view taken along lines 9-9 of Figure 8; i Figures 10, 11 and 12 are partial sectional l views as indicated in Figure 9; Figure 13 is an exploded view of another embodiment of the present invention;.

Figure 14 is a sectional view taken along lines 14-14 of Figure .13; Figure 15 is a rear perspective view of the embodiment of the invention sown in Figures 13; I F igure 16 is a perspective view of a detacha'ble backplate; lI l 1J l i S WO 88/0983 PCT/US88/0190 6 Figure 17 is an exploded perspective view of i another embodiment of the present invention; Figure 18 is a sectional view taken along lines 18-18 of Figure 17; Figure 18A is a view similar to Figure 18 showing the valve of this embodiment in a purge position; Figure 19 is an exploded perspective view of still another embodiment of the flow control device of the i present invention; Figures 20 and 20A are sectional views taken along lines 20-20 of Figure 19 showing the flow control valve in two different positions; Figure 21 is a perspective view of a valve assembly including an optional backplate and cover; Figure 22 is an exploded perspective view of the assembly shown in Figure 21; Figure 23 is a perspective view similar to Figure 21 with the cover plate removed; Figure 24 is a sectional view; Figure 25 is a rear exploded view of the flow control valve and connecting tubing; Figure 26 is a perspective view similar to Figure 21 with the cover in an open position; ;t Figure 27 is an exploded view of another embodiment of the metering valve; SFigure 28 is a sectional view of the valve of Figure 27; Figures 29 and 30 are exploded views showing another embodiment of the present invention; Figure 31 is an enlarged perspective view of the valve metering drum; Figure 32 is a sectional view taken along lines 32-32 in Figure 31; Figure 33 is an enlarged cross-sectional view of a portion of the metering drum shown in Figure 31; Figures 34 and 35 are exploded views of still another embodiment of the valve of the present invention; WO 88/0989 PCT/US88/01903 i| l l Sw 88/09893 PCT/US88/01903 Figure 36 is an enlarged perspective view of the 1 modified form of the metering drum seen in Figures 34 and Figures 37 and 38 are cross-sectional views taken along lines 37-37 and 38-38 of Figure 36; Figures 39 and 40 are cross-sectional views showing different operational conditions of the valve; Figure 41 is an exploded view of still another embodiment; Figure 42 is an enlarged perspective view of the rotatable metering drum or member shown in Figure 41; Figure 43 is a partial transverse sectional view through the inlet fitting showing the valve in an assembled position prior to heating; Figure 44 is a view similar to Figure 43 after the assembly has been heated; Figure 45 is a view similar to Figure 44 with the valving member rotated slightly counterclockwise to achieve ultra-low flow rates; Figure 46 is a sectional view along lines 46-46 of Figure 45; and j i Figure 47 is a longitudinal cross-sectional view of a completed valve in an "off" position.

Turning now to the drawings, Figures 1 and 2 generally show an embodiment of the flow control device of the present invention which is designated by the numeral Valve 10 includes a generally planar rear wall 12 to which is secured an annular body member 14 which define a P cylindrical valving chamber 16. Wall 12 may be configured i in any desired shape for convenience but preferably ex-i tends laterally and longitally and longitudinally beyond the annular i housing member 14 to provide a surface which can be easily 1 accomodated and gripped by the user when adjusting the valve. In the simplest form, the marginal portion of the rear wall 12 extending beyond the annular housing 14 could be eliminated so the external valve body would be cylindrical.

'i I :i PCT/US88/01903 WO 88/09893 Inlet fitting 20 and outlet fitting 22 extend from the rear of backplate 12 and are adapted to b,e connected to conventional IV tubing which, respectively, connect to a container of an appropriate IV solution and to the administration needle, not shown. Inlet fitting 20 communicates with metering chamber 16 through port 24.

Similarly, fitting 22 communicates with the metering chamber 16 through outlet port 26. Ports 24 and 26 are shown as being diametrically opposed in the valve chamber 16. A small projection 30 is provided at the intersection of the backplate in the interior of housing member 14 to serve as a stop. The rear wall, inlet and outlet connections and housing are formed as an integral member preferably by injection molding and are preferably selected from a plastic material which is moldable, rigid, hard, heat resistant, medically acceptable, chemically inert, sterilizable and which will hold tolerance even under high temperatures. Typical of these classes of plastics are ABS, XT Polymer as manufactured by Cyro Industries and polycarbonate. A particular critical requirement is that the material must not flow or deform under hoop stress. Other similar materials exhibiting these characteristics are known to those in the plastic arts.

Circular gasket 32 having a diameter adapted to be received within the rear of chamber 16 which is provided and occupies a position immediately adjacent the rear wall 12. The gasket has a notch 34 which cooperates with projection 30 to keep the gasket in position and to prevent it from rotating within the chamber 16. Circular port 35 aligns with port 24 in the backplate and port 36 aligns with port 26 in the backplate to allow flow of fluid across the gasket. Preferably the gasket is of a plastic material which is softer than that of the housing.

Preferably the housing and gasket should have a Shore hardness differential. Typically one component would be on the Shore A scale and the other on the Shore D scale.

In addition, the gasket must not appreciably shrink when 1 1 iii 1 1 1 1 'i j 1 1 1 1 i"A r i

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Typically, gasket 32 would be formed from a material such as silicone, silicone rubber, Neoprene, C-flex, Krayton manufactured by Shell Chemical, Gaflex, LDP or plasticized

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Rotary flow control member 40 is provided with a generally cylindrical hub 42 having a valving face 44. The hub is receivable within valving chamber 16. In the assembled position, the valving face 44 engages the outer face of gasket 32. A central axle 48 is received within opening 50 axially positioned within the metering hub 16 and aligned with hole 52 in gasket 32 to facilitate rotation of member 40. A dial 54 is secured to the outer surface of the rotary member 40 and is preferably providad with projections 56 to accomodate firm gripping by the user. The user can conveniently rotate the valving member relative to the valve body. The dial 56 extends beyond the edge of the housing 14 to facilitate rotation of the rotary flow control member.

The valving function is accomplished at valving face 44. Valving face 44 is provided with an arcuate groove 60 which extends for approximately 3300 to 350°0. A land area 62 is provided intermediate the opposite ends 64 and 65 of the groove and when the land 62 aligns with the inlet port 34 in gasket 32, the metering valve is in the off position as flow is blocked, as seen in Figure 7A.

Metering groove 60 is constructed having an area of approximately 1800 in regime A of substantially uniform depth. Regime B which extends the remainder of the length of the groove is of varying cross-section diminishing in area as land 62 is approached toward end 65. Regime B may be of various cross-sectional configurations diminishing i'ar i; i: i- I ii:zi n i-i;i ~lg 43 :;s ~-9

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,i i i d i s WO 88/09893 PCT/US88/01903 in cross-sectional area as the land is approached to provide a decreasing flow path and providing increasing resistance to flow as the area decreases.

Valving member 40 may be rotated by means of dial 54 to place inlet port 24 and outlet port 26 in communication via regime A of the metering groove. In this position, the valve is in the full flow or purge position.

As seen in Figure 7C, flow through the device is directed through the flow passage in Regime A which is of substantially uniform cross-section and provides a full flow or purging condition which is generally used to void the system of air.

The metering portion of Regime B of the metering groove may be of various cross-sectional configurations and is shown as being of generally uniform width but having decreasing depth. The metering portion of Regime B may also be of uniform depth and having a decreasing width or in some cases may decrease in both width and depth. It is also possible to reverse the orientation of the flow passage and the metering notch, as illustrated in Figure 7B. With the flow directed from inlet port 24 through part of Regime B to the outlet port 26, metering is achieved and as the metering member is rotated counterclockwise as seen in Figure 1, flow is decreased continually and with precise regulation throughout the flow range.

The advantages of the metering valve of the type described above is that it is accurate, repeatable and is simple to operate. The use of selected plastic materials of different groups, one for the moveable member and the other for the housing or sealing member, achieves economy and also increases the reliability of the valve as the materials serve to seal the va2§Vo so that the requirement for additional O-rings or other sealing devices between the relatively moving parts isminimized. Leakage is a problem in such valves and is of two, types. External leakage in which fluid escapes from the unit and internal a i :i:

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iat ri i i i 'i rii i ~d ir f: ,9 ii i- ;i i 1 i~ ::i a -ia 1 ii PCT/US88/01903 WO 88/09893 rn-Ir SWO 88/09893 PCT/US88/01903 11 leakage which is contained but which may adversely effect the accuracy of the unit. A silicon fluid may be added to reduce frictional resistance to movement.

Figures 8 through 13 illustrate another embodiment of the present invention having a housing member 60 fabricated from a suitable rigid, hard plastic material as described above. The housing 60 includes a generally planar rear wall 62 with a generally cylindrical nub 64 thereon which defines a cylindrical valving chamber 65. An inlet fitting 68 and an outlet fitting 70 are positioned to communicate with the chamber 65 at diametrically opposed inlet and outlet ports 72 and 74.

Rotative metering member 80 includes a generally cylindrical hub 82 which is rotatably received within chamber 65 about axle 98 which is received in a recess at the rear of the chamber 65 in a tight fit. Preferably the rotative member is molded of a suitable relatively soft plastic material such as described above dissimilar from that of the housing 60 so that a suitable fluid-tight seal is formed between the relatively hard and soft plastic materials of the two components. The relative characteristics of the preferred materials of the housing and rotative member have been discussed above with regards to Figures 1 to 7 and a differential Shore hardness is requisite. The hub 80 is provided with a generally circular dial 84 which is serrated or provided with raised portions 86 for improved gripping characteristics.

Metering of flow between the inlet port 72 and outlet port 74 is accomplished via flow passage 90 which is formed in the surface of the cylindrical barrel or hub 82. As best seen in Figure 9, the metering passage is formed having a regime or Section A which is of substantially uniform corss-sectional area and which extends approximately 1800 or more around the outer cylindrical surface of the hub. The portion of the flow passage in regime B decreases in cross-sectional area having a maximum area at the intersection with regime A and diminishing ili: j i' 1 i It; 1 1 "i 141 WO 88/09893 P-T/US88/0199 12 to the point of termination 94. A land area 95 is provided intermediate the opposite ends of the flow passageway 90. As selen in Figures 10, 11 and 12, the flow passageway has the greatest cross-sectional area in the regime A and decreasing in cross-sectional area in regime B. Again, by rotating the dial member 80, the flow can be entirely blocked at inlet port 72 by registering lands with port 72 and flow can be varied from full flow or purge to a reduced rate continuously over the flow range of the valve. The use of plastic materials having dissimilar hardness and other characteristics for the housing and rotative valving member provides better sealing against fluid leakage out of the metering flow passageway and maintains exact, non-bypassing and constant fluid volumes to be contained totally within the passageway with no false fluid delivery via bypassed seepage.

In Figures 13 through 16, another embodiment of the present invention is shown which is generally desig- nated by the numeral 100 and again includes a valve body member 102 having an inlet 104 and outlet 106 communicat- ing with a flow chamber 108 defined by generally cylindrical body member 110. Again, the body member is fabri- i cated preferably by injection molding from a selected plastic that is relatively hard as has been described above. A generally annular, elastomeric sealing member 112 is positioned within hub 110. Member 112 is formed of a softer plastic material than is rotatable metering member 125. For example, sealing member 112 typically would be selected from the group of softer material described above whereas members 100 and 125 would be fabricated from the rigid, hard materials as described. Member 112 has oppositely disposed ports 114 and 116 which register with the inlet 104 and outlet 106 respectively. Projection 118 on the interior of huosing 110 cooperates with a notch 120 1 1 1 1 1 1 1 1 l 1 1 1 1 5 f 1 WO 88/09893 PCT/US88/01903 13 ii in the elastomeric member to prevent it from turning and twisting and to insure proper registry within the valve housing.

Rotatable valving member 125 includes a hub 128 which is rotatably received within elastomeric sealing i member 112. Member 125 is secured in place at bore 129 in the rear of the valving member by axle 130 which has a tapered head 131 which compresses to allow it to be inserted through hole 129 and thereafter expands to secure member 125 in place. A circular dial 132 is positioned at the face of the unit and provides a surface for gripping by the user for manipulation and attendant adjustment of the flow rate.

As seen in Figure 14, a valving passageway 140 is provided in the annular surface of the hub having a land area 128 intermediate the opposite ends of the passageway. The passageway is generally configured as has been described with reference to Figures 8 through 12 having a purge and flow metering region so additional detailed description is not deemed necessary. It will be apparent that as the hub 125 is rotated by means of dial 132 relative to the inlet 104 and outlet 106, valving will be accomplished from a stop position through full flow and metering.

As seen in Figure 15, the rear surface 142 of valve body 102 is provided with a pair of diametrically opposited lugs 145 which extend outward from surface 142.

i Each of the lugs 145 has a radially extendig wiwing or projection 147. Lugs 145 are integrally formed with the valve housing.

In the event the user requires additional gripping surface for holding the valve body when making adjustments to the flow rate, the optional backplate 150 as shown in Figure 16 may be attached to the rear of the valve body. The backplate 150 consists of an elongate panel 152 having a width generally. corresponding to the width of the body of valve 102 and having sufficient WO 88/09893 PCT/US88/01903 14 length to extend at least to or beyond the termination ofI the inlet and outlet ports 104 and 106. The opposite sides of body 150 are provided with forwardly extending flanges 156 and 158 which provide a further gripping surface to facilitate manipulation of the valve. A pair of bayonnet slots 160 and 162 are defined in the opposite sides of the valve body adapted to receive lugs 145. To secure the backplate 150, lugs 145 are inserted in the wide portion of the bayonnet slots and the valve body is then rotated, locking the valve body to the valve plate.

Apertures 168 and 169 may be provided at opposite ends of the backplate so the backplate and the valve can be secured to appropriate locations such as an IV stand.

Another embodiment of the IV valve of the present invention is shown in Figures 17, 18 and 18A and is generally designated by the numeral 200. In this embodiment, the valve includes a body member 202 which is generally cylindrical defining a valving chamber 204 which is i stepped having a shoulder 205 forming a smaller diameter section 206 at the rear of the chamber and a larger section 208 at the open end of the chamber. Fitting 210 defines an inlet port 212 which communicates at the rear of the valve chamber with the smaller diameter section 206. Fitting 216 defines a port 218 which communicates with the larger diameter section 208 of the chamber in the area adjacent shoulder 202. As best seen in Figure 17, i the inlet and outlet are positioned approximately 1800 apart diametrically opposed on the housing.

The rotary valve member 220 has a body which has a larger diameter inner cylindrical section 222 and a smaller diameter cylindrical section 224 which form an K interference fit within the valve chamber 204 but permits rotation of the valve member. A dial surface 225 is pro- ;1 I vided on the outer face of valve body having an annular flanged skirt 226 with an inwardly turned lip 227 which engages a peripheral flange 228 on the valve body 202. As.

best seen in Figures 18 and 18A, lip 227 serves to secure a portion ot the metering pin which forms a cam follower.

The cam is manually adjustable by a dial on the device to accomplish accurate, repeatable and continuous flow ad- WO 88/09893 PCT/US88/01903 the valve body in position to prevent separation of the assembled valve. The flange may also cooperate with a projection on the valve body to serve as a stop or limit as to rotation in either direction.

S- Preferably the valve body is a rigid, hard plastic material such as ABS, XT or the like which has the i characteristics of being able to be bonded by solvents.

The valve body member 220 preferably is a semi-rigid material such as PVC, LDP, C-Flex or other similar materials known to those of the art which accomodate tolerance variations and will maintain the proper seal with the rigid material of the body. The characteristics of the preferred materials has been set forth.

The valving function is accomodated by means of a helical ramp 240 formed in the outer surface of thei rotary valve member 220. An axially extending groove 242 $i Sis provided in the outer surface of the valve body member, ii The keyway-like groove 242 is molded into the valve body and extends axially past ramp 240 intersecting the larger diameter portion 244 of the rotary valve member. A smallI section of helical ramp 240 forms a land 245 immediately adjacent the groove 244 which remains in contact with shoulder 202 of the valve body. The remainder of the ramp portion is in the form of a helix which is ramped towards the open end of the rotary valve member and intersects the groove 242 at the other end, as best seen in Figure 17. i.

Tihk e In operation, the valve 200 i iin the full open or purge position as seen in Figure 18A when the groove 242 is aligned with the lower port 218. In this position, t| fluid will flow through the inlet port 212 and down along the chamber in space 250 at the rear of the valve and through groove 242 to outlet 218. When the rotary valve Y*.

1 member is rotated to a flow metering position, IV fliud I i' will flow from the inlet through the passageway defined by i shoulder 202 and helical ramp 220 to the outlet port 218. l J As the valve body member is further rotated, the reduced size of the flow passageway and increased flow passage *w -the wjeM~l poA w0-o 88/09893 PCT/US88/01903 16 11 length will effect flow metering. When groove 242 is positioned at about four o'clock, the land 245 will block the channel creating a full off position.

The advantages of embodiment 200 are that the construction is simple and may be manufactured by plastic molding techniques. The construction utilizing a rigid, hard plastic housing and a softer material for the rotary I valve member eliminates the need for expensive and complex seal arrangement between the body parts. The valve provides a full range of flow regulation throughout the rotation of the valving member.

Still another embodiment of the present invention is shown in Figures 19 and 20 and is generally designated by the numeral 300. In embodiment 300 a valve body 302 is provided having a generally frustroconical valve chamber 304. A peripheral flange 306 is provided at the openitig to valve chamber 304 which cooperates -in locking fashion with flange 340 and projection 342 on the j^ valve body. Inlet fitting 308 defines an inlet port 310 which communicates with the valve chamber 304 at the rear of the valve. An outlet fitting 312 defines outlet port j 314 which communicates with the valve chamber 304 at an intermediate position.

Valving is accomplished through rotation of valving member 322 which is provided with internal body member 325 which is generally frustroconical and tightly engages the valve chamber 304. Valve body 325, terminates I at a location spaced from the rear wall of chamber 304 so a passageway 328 is provided at the rear of the valve chamber. *1 A valving passageway 330 is provided on the interior surface of the valve body 302. Passageway 330 starts approximately at the intersection of the outlet port 314 with chamber 304 and proceeds in helical fashion j around the interior of the chamber 304 for approximately 300 The passageway 330 has its maximum cross'-sectional area at its intersection with the outlet port and diminwhich is selected to effect sealing and minimize heat shrinkage. In other aspects o the present invention, a -4 a- SWO 88/09893 PCT/US88/01903 17 ishes in cross-sectional area to its termination point 309. The passageway may be provided a taper at one or both side walls or the bottom wall of the groove may decrease in depth proceeding along the groove. An axial slot 335 is provided in the outer surface of the frustroconical rotary valve body to establish a full-flow or purge position.

The full open or purge position is provided when the groove 335 is in the six o'clock position communicating with outlet port 314, as seen in Figure 20A. It will be apparent from Figure 20A that fluid will flow through the inlet port 310, along passageway 328 and through groove 335 to outlet port 314. Rotating the valve member 322 in a clockwise position causes the groove 335 to communicate with the more shallow portion of the helical passageway 330 to regulate flow. The portion 333 of frustroconical chamber 304 devoid of-the passageway 330 provides a full off position when in registry with the outlet port 314, as shown in Figure 20.

The construction of this embodiment provides a simple and effective valving member providing a purge position, full off and infinite adjustability throughout the metering range. The construction of the valve allows the valve components to be molded of plastic preferably with the valve body of a softer semi-rigid material and the other component being made of a rigid material to achieve sealing. As mentioned above, the rigid material may be ABS or XT or the like with the other component made from LDP, PVC or similar materials well-known to those in the plastic molding arts.

Figures 21 through 26 show still another embodiment of the present invention which is generally designated by the numeral 500. In tnis embodiment, the basic flow control device is provided with several accessories which may be included at the option of the user. The embodiment of these figures includes the basic metering valve designated by the number 502 which may be in the i i d ia k :ii -r r! i 1 1.

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3 r i i i i- ~:f f r isi~;$ I ~B -:t i a f ggwiie i~ It n ;i WO 88/09893 PCT/US88/01903 18 form of any of the valves heretofore described having a rotary dial member 504 for adjusting flow through the valve housing 505 and having inlet and outlet fittings 506 and 508 respectively. The basic valve 502 is an in-line valve adapted to regulate IV fluid flow from full flow to i an off position with infinite variation between these positions by selective positioning of the variable area flow passageway 509.

The valve -502 is compact and is designed to be manually operated and in some applications its size and weight are an advantage as for example in an extension IV set where the light weight would exert little pull on the needle at the venapuncture site. However, in some other instances, it is desirable that the valve lend itself to one-hand operation. This allows the medical attendant to adjust the valve with one hand while performing other operations with the other hand. To this end, an optional backplate providing additional area for the user to grasp may be provided. The backplate of this embodiment is generally designated by the numeral 510 and can be molded as a one-piece unit from a suitable plastic material. The backplate includes a generally planar rear surface 512 and opposite forwardly extending side edges 514 and 516. The ide edges are generally parallel and are spaced apart a distance less than the diameter of the body of valve 502.

The'side edges 514 and 516 both diverge outwardly at an intermediate location having a curvature generally corresponding to the curvature of the circular housing of the valve member 502 to form a receptacle 515 for housing 505 of the metering valve. In this way, valve 502 can be positioned in the backplate 510 and secured by an interference-fit witt the valve body. Projections 525 extend in the receptacle 515 to engage the body 505 of the valve when inserted into the backplate. 'Note that in the assembled position, the diameter of the dial 504 exceeds the width of the backplate so that the operator can confirl K: WO 88/09893 PCT/US88/01903 19 veniently grasp the unit with the backplate resting in the palm of the hand and use the thumb and forefinger to grasp the dial from the rear to make the necessary adjustment.

The opposite ends of the backplate are recessed at 520 and 522 to accomodate the incoming and outgoing IV fluid lines 521 and 523. An upwardly extending projection 530 is provided at the upper left hand edge of the backplate as viewed in Figures 21 and 22. Projection 530 serves as part of a release mechanism when the valve i7 used with a cover as explained below. The lower opposite sides 514 and 516 are provided with apertures 532 and 534 to accomodate a cover if desired.

The cover which may be optionally attached to the backplate is generally designated by the numeral 550.

The cover may be oppositely attached when it is desired to provide additional security to prevent either intentional or inadvertent adjustment of the setting of the valve as, for example, in the case of juvenile patients. The cover 550 includes a generally flat cover plate 552 having opposite depending sides 554 and 556. A portion of the cover is configured as a generally cylindrical receptacle 560 adapted to receive the dial portion 504 of contained valve 502. The lower end of opposite sides 554 and 556 depend below the cover plate 552 and are provided with inwardly extending pins or axles 562 which are receivable within holes 532 and 534 at the opposite sides of the backplate.

Since the device is preferably made of a suitable flexibleplastic, sides 554 and 556 can be deflected outwardly a sufficient distance to engage the cooperating holes 532 and 534. Thus, when assembled, the cover is pivotally attached to the backplate and may be positioned in an open position as shown in Figure 26 or pivoted upwardly to a closed position as shown in Figure 21. Latch members 558 at the interior of the sides 554 a 55556, engage the edge of the back cover to secure the cover in a closed position. Projection 575 extends upwardly from the upper, right hand edge of the front cover as seen in Figure 26.

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another embodiment of the valve of the present invention; :7:1 WO 88/1 *09893 PCT/US88/0190 3 i 7 Thusi, to open the cover, projection 530 on the backplate 4 and projection 575 on the cover plate may be easily forced N t in opposite directions to unlock the cover. A cut-out 580 is provided in the face of the cover so that the attendant i can. visually determine the setting of the valve. Alter- i natively, the backplate and cover may be molded as one piece and incorporate a connecting "live" hinge of a thin plastic membrane that allows opening and closing of the security cover.

In Figures 27 and 28, an alternate configuration for the valve generally designated by the numeral 600 is illustrated. Here the valve body 602 is generally cylindrical defining a valving chamber 604 having an inlet and an outlet 606 and 608, respectively. Annular flange 610 extends about valve body to receive rotary valve member 1 615. The rotary valve member includes a barrel 618 having a variable area metering slot 620 formed in the wall which is rotatable to regulate flow. The barrel 618 is preferably of a softer plastic material than housing body 602 for h better sealing and is further selected to resist shrinkage. Barrel or body 618 has a concentric bore 626 with keyway 628 to receive axle 630 of the separate dial assembly 632. The dial 632 is of a more rigid plastic material and is locked in the barrel against rotation by axial key 635 which is received in keyway 628. Annular locking 1 member 640 with flanged section 642 engages flange 610 toi secure the assembly. The circular dial portion may have a I beveled and serrated edge for better manual control. i Flange 610 has a vertically extending stop por- tion 650 which terminates at pointer. 655. The rotation of the dial and associated barrel is limited as flange 642 i will engage the stop 650. Thus, bi-directional operation 1 is achieved with flow increasing in one direction of operation and decreasing in the other. Appropriate i indicia may be placed on the face of dial 632 which is cooperable with pointer 655 to provide an indication of:, flow setting.

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SWO 88/09893 PCT/US88/01903 21 Figures 29 through 33 illustrate another embodiment of the present invention which is generally designated by the numeral 700. In this embodiment, the valve includes a generally cylindrical housing 702 which defines a valve chamber 704 which is closed at end 705. Fitting 710 defines an inlet port 712 which communicates with valve chamber 704. Fitting 711 is oppositely disposed from fitting 710 and defines an outlet port 718.

A rotary valve member 720 ts a knob 724 with a circular outer rim 725 which is knurled to facilitate manual rotation of the unit by the user. A cylindrical projection 726 extends axially from the knob having a generally Y-shaped projection 729 at its outer end which facilitates proper alignment of the axle assembly with cylindrical metering drum 730.

The metering drum 730 has a generally cylindrical body 732 having an open upper end 734 and a closed bottom end 736. As best seen in Figure 32, the closed end 736 is configured having a recess 738 therein conforming to the general Y-configuration of the projection 729 on the end of the axle. Thus, when drum 730 is placed over axle 726 and the components are forced together, projection 729 will seat in recess 738 to insure proper alignment of the two components and to prevent relative rotation between these members.

The inner cylindrical wall 740 of the drum may be axially grooved at 742 and a cooperative rib 741 may be provided on the outer cylindrical surface of the axle to further accomodate alignment of the parts and resist relative rotation between the components.

Preferably, the valve housing 702 is a rigid, hard plastic material such as ABS, XT or the like, which has the characteristics of being able to be bonded by solvents and which will resist deformation and deflection.

One particularly suitable material is a type of ABS sold under the trade name Kadon. Similarly, the rotative valve assemb:ly consisting of the axle 726 and integral manual o C

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i;: I L; SWO 8809893 PCT/US88/01903 dial 724 is similarly fabricated from rigid hard plastic material. Drum 730 is preferably a semi-rigid material such as PVC, LDP, C-Flex or other similar materials known to those in the art which accomodate tolerance variations and ,will maintain the proper seal with the rigid material of the body. The valving function is accomodated by means of a flow channel 744 and a metering groove 745 formed in the outer surface of the drum 730 and shown in exagerated form in Fig. 31. The flow channel 744 is generally U-shaped or V-shaped in cross-section and communicates at one end with a metering groove 745 which extends part-way around the drum leaving a land area 746 as seen in Fig. 32. The metering groove is of varying cross-sectional area decreasing from a maximum at the point of intersection with the flow channel 744.

In operation, the valve is in the full open or purge position when a portion of flow channel 744 is aligned with the inlet port 712 and the opposite end of the channel is aligned with the outlet port 718. In this position, fluid will flow through the inlet port and along I the channel 744 to the outlet port to provide a full flow and flow purging condition. i When the rotary valve member 720 is rotated to a flow metering position, IV fluid will flow from the inlet through a passageway defined by a portion of the channel 744 and a portion of the metering groove 745 to the outlet |718. As the valve body is further rotated, a longer circumferential portion of the metering passageway 745 is placed in the flow path and the interposition of greater 1 length of the metering groove in the flow path will effect K metering of flow. When the drum is rotated to a position in which land 746 is in registry with the inlet port 712, the valve is in a flow-blocking or "off" position.: The unit includes an 0-ring 750 about the inner end of the drum which is received in an annular seat 751 in the valve body. The components including the valve -1 1 1 1 1 1 1 1 1 i 1 i i 1 1 1 i* i t 1 1 CIL-'= I j-anLU U4, -LO aejJLn 1:uc t-_wcnU diU VJ Dl o U lCty be of various cross-sectional configuratins diminishing 4 i: rrl; I i; WO 88/09893 PCT/US88/01903 body, dial assembly with the drum, may be snapped together with flanges 751 on the underside of the dial engaging the external lip 732 about the opening in the valve body. The outer surface of the dial is provided with appropriate indicia 760 for indicating the flow position of the valve.

The indicia cooperate with a reference marker 762 formed as an integral part of the valve body.

One particular problem that exists in the use of a drum of softer material having sealing characteristics, is that in order to maintain sealing an interference fit must exist between the drum and the inner surface of the valving chamber. Often an interference fit imposes a tactile resistance to rotation and interferes with the smooth operation of the valve. Further, because of the close tolerances that must be maintained in parts of this type, any irregularity in the molding process such as non-concentricity of either the housing or the drum may cause inaccuracy.

To avoid such problems, the drum 730 of the valve of this embodiment is configured having a sealing band as best shown in Figure 33 which is an enlarged and slightly exagerated cross-sectional view of a portion of the drum. The drum as shown has an end wall 736 and cylindrical side wall 732 of generally uniform thickness.

However, a circumferential band 760 extends axially in either direction from the metering and flow passageways 744, 745. The band typically extends approximately onethird of the overall axial length of the drum. 0The band projects radially inward at 765 and may also extend radially outward at 766. The outer surface of the band defines an upwardly extending ramp portion 767 terminating at lip 768 which lip defines the opposite axial dimensions of the purge and metering grooves.

Accordingly, the bank 760 of increased radial thickness in the area of the flow and metering grooves provides increased sealing to prevent leakage from the groove. However, because the band does not extend axially r

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WO 88/09893 PCT/US88/01903 24 the entire length of the drum, proper tactile resistance K and smoothne S of operation is assured. Further, the sealing band w.l accomodate shrinkage of the part and accomodate any non-concentricity that may occur in the i molding process.

Still another embodiment of the present inven tion is illustrated in Figs. 34 40 generally indicated by the numeral 800. In this embodiment, the drum and flow passageways formed in the drum are arranged so that the drum regulates flow over substantially a 3600 range of rotation. With the valves described with reference to prior drawing figures, flow regulation occurs only over approximately 1800 of the drum. With the present embodiment, substantially the entire 3600 surface of the dru;m is used as a fiow path. This permits flow ranges to be spread over a greater circumferential length making the operation of the unit easier and more precise since a small movement will not have as great an effect on the flow rate. Also, because the flow regulation is extended over a full 3600, the appropriate indicia carried on the dial may be made larger, making them easier to read and providing a greater number of graduations indicating various flow positions.

Referring to Figs. 34 to 40, the valve of the present embodiment is generally constructed as has been i described with reference to Figs. 29 to 33 having a generally cylindrical valve body 802 defining a valve chamber |804 which is closed at one end by wall 805 and open at the other end.. The inlet 812 and outlet 814 communicate with the valve chamber and are oositioned approximately 180 0 apart with the outlet being axially offset from the inlet. iK A rotary valve member 810 has a stem or axle 812 and an integrally formed dial member 814 which is prefera- S bly knurled about its outer periphery to facilitate manual I irotation by the user. Cylindrical drum 820 rotates with axle 812 and snugly engaged in the valve chamber. As has been pointed out above, the valve body is preferably a WO 8809893 PCT/US88/0 l WO 88/09893 PCT/US88/01903. rigid, nard plastic material such as ABS, XT or the like as is the dial member and integral axle. The drum is preferably a semi-rigid plastic material such as PVC, LDP, i C-flex or other similar material. The drum may be suitably grooved at 815 and the axle provided with cooperating splines or projections 816 to be received in the grooves for properly aligning these components when they are assembled and to prevent relative rotation. The dial assembly may include an annular flanged skirt 821 with an inwardly turned lip engageable with a peripheral flange 822 on the valve body to secure the valve body in position and prevent separation of the assembled components while permitting rotation of the dial and drum members relative to the valve body.

The configuration of the drum 820 permits the drum to turn substantially 3600 to increase accuracy and to facilitate ease of adjustment although the ports themselves are spaced only 180° apart. To this end, the outer Li surface of the drum is provided with a first circumferential metering groove 850 which begins adjacent land area 854. Metering groove 850 extends circumferentially about the drum 820 and progressively increases in cross-sectional area from the distal end 852 to area 853 of the groove where the metering groove intersects axial bridge section 855. Groove 850 may be of various cross-sectional shapes as for example V-shaped, U-shaped or the like and is of varying cross section decreasing progressively from section 853 to section 852. The metering groove 850 comnmunicates axially with flow channel 860 across bridge section 855. Channel 860 extends circumferentially from V bridge section 855 along outer surface of the drum generally parallel to the metering groove and terminates at i end wall 862 adjacent land area 854. It will be seen that the inlet port 812 is axially ally aligned with the metering groove 850 and the outlet port 814 is axially displaced I from the inlet port to align with the flow channel 860. WO 88/09893 PCT/US88/0190: 26 Thus, with the drum 820 in a position with the inlet port 812 directly aligned with land area 854, flow through the valve is blccked. As the drum is rotated a short distance in the direction of the arrow as seen in Figure 36, the inlet port 812 is moved into registry with metering groove 850, to the position in Figure 39.

Accordingly, fluid flows along the metering groove 850 across bridge 855 into the channel 860 which is in regis- try with outlet 814. As the valve is rotated in a clockwise position, the point of registry of inlet and the metering groove is at a location of increasing depth along the metering groove thus permitting an increased flow rate through the metering groove, across bridge 855, to channel 860 to the outlet.

At the point the inlet port 812 is in communication with the terminal end of the metering groove, the valve is in the full flow position or purge position as seen in Figure 40. A direct flow path from inlet to outlet is established via channel 860. In this position, the system may be purged of air prior to IV administration or a rapid infusion may be administered through the system.

The exterior of the dial surface may be provided K with appropriate indicia indicating various increments of flow rate from closed position to full flow and purge.

Since the metering occurs over a full 360° of the dial surface, more precise setting of the valve is permitted. Further, additional graduations may be provided on the dial surface for the convenience of the user. The flow channel serves as a fluid passage and all flow positions of the valve from initiation of metering through the full range of metering to purge. As is the case with prior embodiments, the valve provides accuracy, repeatability with minimum of moving parts. The components may be con- veniently fabricated by plastic molding techniques and the use of plastic materials of dissimila?: hardness provides a sealing at the inner face of the drum and valve chamber.

Ii::i r: F; Ii L vaive DoCy. rne Dacrpiate iLvU consistLS rE an etongart-e panel 152 having a width generally corresponding to the width of the body of valve 102 and having sufficient I WO 88/09893 PCT/US88/01903 27 r Tlii bi:3i i-"l r i =SE=i Another embodiment L i is illustrated in Figures 41 through 47 and is generally designated by the numeral 900. -In this embodiment, the valve member and flow passageways are configured as described with reference to Figures 34 to 40 so that the drum regulates flow over substantially a 3600 range -of rotation. The primarary advantage of the embodiment shown in Figures 41 to 47 is the achievement of a precise, ultra low infusion rate that is highly desirable in intravenous therapy. In the administration of IV fluids, a low flow rate is often necessary, particularly to maintain a KVO (keep vein open) setting. It is not uncommon for patients with long hospitalization periods or other certain physical conditions to develop veins which are collapsed or atrophied. Therefore, medical practice is to maintain the patient connected to an ultra low -rate intravenous feeding. The intravenous feeding maintains the patient's vein in an open condition and provides medical personnel a pathway for quick access for administration of medications or drugs. KVO settings are typically in the range of cc. per hour. Such low infusion rates have not been possible with low-cost gravity devices as found in the prior art. Until now, these precise ultra-low rates were only possible with any degree of reliability with computerized volumetric pumps which are expensive and are not available at all medical facilities. Conventional devices such as roller clamps and prior infusion control devices are not capable of achieving with accuracy and repeatability low rates in the range of 5 cc. per hour.

Referring to Figures 41 to 47, the valve i:-.iO is generally constructed as has been described with reference to Figures 34 to 40 having a generally cylindrical valve body 902 defining valve chamber 904 which is closed at the lower end by wall 905 and open at ,the opposite end. Inlet :fitting 912 and outlet fitting 914 communicate with valve chamber 904 at RA1\ ports 916 and 918, respectively. The inlet fitting 912 ii 1.

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and outlet fitting 914 are positioned approximately 180° apart with the outlet fitting 914 being axially offset from the inlet as best shown in Figure 47.

Dial member 910 has a stem or axle 911 and an integrally formed dial member 918 which is preferably knurled about its outer periphery to better facilitate manual rotation by the user. Valve member or drum 920 rotates as'a unit with axle 911 and is snugly engaged in the valve chamber with valve body 902. The method of fitting the rotary valve member 920 precisely to the internal geometry'and physical characteristics of the housing will be described hereafter.

Valve body 902 is preferably formed from a suitable rigid, hard plastic material. Various thermosetting and thermoplastic materials are known to those in thf-- art and are selected for their rigidity and ability to maintain a precise molded shape such as ABS, XT or the like.

The valving member 920 is selected from the class of materials known as elastomeric thermoplastic materials which exhibit some cold flow characteristics. Materials in this class include polyethylene, PVC and LDP and plastics such as those sold under the trademarks C-Flex and Santoprene are representative of these materials.

The valve member 920 may be longitudinally grooved and axle 911 is provided with cooperating splines 916 to be received within the valving member 920 to properly align these components at assembly. Dial member 910 includes an annular flange 921 with an inwardly turned lip engageable with a peripheral flange 922 on the valve body to prevent separation of the assembled components while at the same time permitting rotation of dial 910 and valve member 920 relative to the valve body.

The outer surface of the member 920 is provided with grooving which selectively communicates the valve inlet and outlet to achieve flow regulation. Preferably, the member 920 is configured to permit substantiall-y 3600 of rotation. To this end, as best seen in Figure 42, the

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ii ill:i ~1Se WO 88/09893 PCT/US88/01903 29 outer surface of the valving member 920 is provided with a first circumferential metering groove 950 which begins i adjacent land area 954. Metering groove 950 extends circumferenti.ally about member 920 and progressively increases in cross-sectional area from area 952 to the intersection with axial bridge section 955. Groove 950 may be of various cross-sectional shapes, as for example V-shape, U-shape or the like. Metering groove 950 communicates axially with flow channel 960 across bridge section 955. Flow channel 960 extends circumferentially from bridge section 955 along the outer surface of the member generally parallel to the metering groove and terminates at end wall 962 adjacent land area 954. It will be seen that inlet port 916 is axially aligned with metering groove 950 and the outlet port 918 is axially dis- 1j placed from the inlet port to align with flow channel 960.

As has been explained with reference to Figures 34 to metering or flow control is provided through substantially a 3600 range.

S With the valving member 920 in the position shown in Fig. 47. inlet port 916 is directly aligned with land area 954 and flow through the valve is blocked. As dial 910 is rotated a short distance in the direction of the arrow as shown in Fig. 42, inlet port 916 is moved out of registry with-node 970. Node 970 is located on land area 954 and is thermo-formed and has a shape precisely conforming to the cross-sectional geometry of port 916. A similar node 972 exists at the opposte side of the drum and precisely conforms to outlet port 918.

In the "off" position, node 970 is in exact registry with inlet port 916 and similarly node 972 is in direct registry with outlet port 914. Slight rotation of the dial will move node 970 to the position shown in Figures 45 and 46 which allows a minute volume of fluid to flow- from the inlet port and into the clearance area into 1 I I WO 88/09893 PCT/US88/01903, All channel 950. As rotation of the valve continues, nodes j 970 and 972 move further out of registry with their i associated ports.

As best seen in Figures 42 and 47, the nodes 970 and 972 are in the form of small generally convex protru- sions on the surface of the valving member 920. The pro- trusions, as will be explained hereafter, are formed in situ in a remolding process in the land area of the valving member. The nodes have a peripheral imprint exactly conforming to and, in fact, determined by the precise outlines of the inlet and the outlet ports 916 and 918. In the "off" position, as seen in Fig. 44, the nodes and ports are in registry providing a tight fluid seal.

When the nodes are moved slightly out of registry with the associated port, as seen in Figs. 45 and 46, limited flow i is permitted maintaining an ultra-low KVA rate. Further rotation of the valve will result in the inlet port being i aligned with the metering groove 950 or bridge 955 and purge and normal flow regulation as described with reference to Figs. 34 to 40 are achieved.

The formation of the nodes in situ is accomplished by applying heat to the assembled vlve. When the i valve components as shown in Fig. 41 are assembled, the vlving member 920 and housing 902 are engaged in an interference fit in the range of .001" to .002". The assembled condition prior to heating is shown in Fig. 43 in which the valving member 920 is tightly positioned in chamber i 904 due to the interference fit. After assembly, the valve is subjected to a heating process, typically in the range of 140 0 F to 180 0 F for a period of 1/2 to 2 hours. As has been described above, the body 902 of the valve is formed of a relatively rigid plastic material and the i valving member 920 is formed from a softer material of the i class of materials known as thermoplastic elastomers. The 1 prolonged heating of the assembled valve causes the materials, particularly the elastomeric material of the valving member, to dimensionally stabilize and, in doing 1 1 .I -i .y -l ii 'i y e .K 'B 'i embodiment of these figures includes the basic metering valve designated by the number 502 wnich may be in the SWO 88/09893 PCT/US88/01903 31 so, exhibit some slight creep or flow. This causes the ^T valving member and housing to closely mate or conform to i one another adjusting any small configurational differ- i ences that may exist due to dimensional differences that may occur in the fabrication and assembly process. Since i the material of the valving member will creep or flow j slightly, the plastic material in the area of the ports will flow slightly, the plastic material in the area of the ports will flow into the ports forming the nodes 970 and 972, as seen in Fig. 44. The peripheral image of each port is transferred to the adjacent surface of the valving member and a slight convexity extends from the periphery.

Thus, in the heating process, each valving member becomes perfectly fit or seated within the valve chamber and each drum is provided with a pair of opposed nodes at the inlet and outlet port which nodes have a molded image conforming to the exact contours and irregularities of its associated port. This imprint becomes a personal, prominent and individual characteristic of the particular assembly componentry.

Once the heating process is completed, the resulting valve has an individualized sealing or closing barrier to prevent flow of incoming fluid when the valve i .i is in the closed position with the nodes in registry with their associated port. When the nodes are moved to a position of partial registry, as seen in Figs. 45 and 46 through slight rotation of the drum, fluid is allowed to pass to the metering port in a precise and predictable J flow rate. The in situ formation of the nodes and the remolding of the valving member under heat and pressure I i provides a highly accurate valve with positive seating. i The nodes formed in this manner allow the valve to achieve i the ultra low KVA flow settings. It is possible to utilize the unique fabrication process with other arrangements such as an arrangement in whieI" the drum is relatively rigid and the surrounding housing portion ifjp!'a'P. A H" the width of the backplate so that the operator can con- PCT/US88/01903 WO 88/09893 softer, elasftomeric material with the flow passageway provided in the surface of the housing. In other words, any assembly in which precision fit of the plastic components is required, could utilize the assembly process described above.

Thus, it will be seen from the foregoing that the basic valve as described herein can be economically manufactured and provide the accuracy and repeatability necessary. In addition, the valve can further be provided with a backplate as an accessory to enhance the operation of the device and to make it compatible with one-hand operation. If security is desired, the optional cover plate can be attched to the backplate. In its simplest and most economical form, the valve alone can be used in IV administration. For other applications, the medical attendant can add either the backplate or the backplate and the cover plate as required and dictated by the particular application and procedure.

The unique design and construction of the valving components avoids complex sealing arrangement and are economical to fabricate so the unit canbe provided to health care facilities as an inexpensive, disposable item which achieves a repeatable range of flow from KVA to purge. This unit resists tampering and is accurate and simple for the medical, attendants to operate giving accurate, repeatable results.

It will be obvious to those skilled in the art to make various changes, alterations and modifications to the invention described herein. To the extent those changes, alterations and modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. i w Ir i:j~i i i i; II: i t ii i i: i i i:-ai I :I 1~ I 1.

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Claims (13)

1. An IV metering valve, for use in an IV system having a source of fluid connectable to an administration needle via a flexible tubing line, comprising: a plastics housing defining a generally cylindrical valve chamber which chamber is closed at one end thereof, said housing having an inlet and outlet connectable in said tubing and communicating with said valve chamber at axially spaced apart locations; a plastics valving member rotatable within said valve chamber; said valving member having a generally cylindrical surface defining a flow path having a first portion, a second portion spaced axially from the first portion and a bridging portion providing communication between said first and second portions; each of the first and second portions of the flow path extending substantially around said cylindrical surface such that, throughout its length, said first portion is axially aligned with said inlet and said second portion is axially aligned with said outlet whereby said flow path provides communication between said inlet and outlet throughout a substantially complete revolution of the valving member within said valve chamber; said first portion having opposed ends and said second portion having opposed ends, with the opposed ends of each of said first and second portion being mutually spaced by a land portion defined by said cylindrical surface, said bridging portion providing said communication between one of said ends of the first portion and one of said ends of the second portion such that in all conditions of flow from the inlet to the outlet, other than in a fast flow purge position for the valving member, flow in the first portion and the second portion is in opposite respective directions circumfnerentially of the valving member; said first portion of the flow path being of varying cross-sectional area throughout at least part of its length whereby said inlet is able to be selectively registered with a location along said first portion and said outlet selectively registered with a corresponding position along the second' 4 -33- a 'rll'i i' t- i :1r i: i 1 i!: 1 It i;ia r i i i i i: i i i:: I I'i c ii iitF ja '9 1 S i i j j j '"I ;t I I 4 portion to regulate f low along the f low path f rom said inlet to said outlet; said valving member being rotatable to said fast flow purge position in which the inlet communicates substantially directly with said bridging portion and said outlet communicates with said second portion.

2. The valve of claim 1, wherein said housing is a first plastic material and said valving member is of a second relatively softer plastic material.

3. The valve of claim 2, wherein said valving member has a node on said cylindrical surface, which node oem *conforms to the configuration of the inlet and is in :0 **registry with the inlet in an off-position for the valve, *0whereby predetermined rotation of the valving member displaces the node from registry with the inlet to establish an ultra-low flow condition for the valve.

The valve of claim 3, wherein said land area is registrable with the inlet in said off-position and wherein said node is positioned in said land area.

5. The valve of claim 3 or claim 4, wherein said valving member has a further node on said cylindrical surface, said further node conforming to the configuration @0 5 of said outlet and being in registry with the outlet in said off-position.

6. The valve of any one of claims 1 to 5, wherein said 0 bridging portion has a cross-sectional area larger than ease athe cross-sectional area of either said first or second flow path portions.

The valve of any one of claims 1 to 6, wherein said first and second portions of said flow path are substantially coextensive around said cylindrical surface and said second flow path portion is of substantially uniform cross-sectional area.

8. The valve of any one of claims 1 to 7, wherein said valving member defines an axially extending recess receiving a projection therein and being interiorly supported by said projection and further including dial means associated with said projection.

9. The valve of claim 8, further including a valve AV -34- S- .1. end of the drum which is received in an annular seat 751 in the valve body.

The ,components including the valve said valve in a position with the dial means accessible, plate detachably securable to said backplate at pivotal means whereby the cover plate is positionable in an open position exposin a sii ith the dial means to permit adjustment of 1 said valve and havitending longitudi position covering said recess providing a gripping surface to allow the valve to i valve to prevent inadvertent adjustment of the dial means.

11. The valve of claim 10, fuwherein said cover plate is plate detachably securable to said backplate at pivotal means whereby the cover plate is positionable in an open position exposing said dial means to permit adjustment of said valve and having a closed position covering said valve to prevent inadvertent adjustment of the dial means. 11. The valve of claim 10, wherein said cover plate is provided with a window therein exposing at least a part of S"the dial of said valve in said closed position. 15

12. The valve of any one of claims 9 to 11, further including cooperable locking members on said cover plate and said backplate for securing said backplate and cover plate in said closed position.

13. The valve of claim 1, substantially as herein described with reference to Figures 34 and 35, Figures 36 to 38, Figures 39 and 40, or Figures 41 to 47, of the accompanying drawings. SDATED: 20 November 1991 PHILLIPS ORMONDE FITZPATRICK Attorneys For: MASTER MEDICAL CORPORATION F 4 S 4 -35. i 1 I 1 C 1 'sV i 1