US20130138075A1 - Variable flow control device, system and method - Google Patents

Abstract

A device, system and method are provided for controlling the rate of infusion of fluids during infusion therapy using non-electric infusion devices. Rotation of a flow regulator dial causes an orifice connected to the inlet to modify its position relative to a particular one or more orifices or groove portions, the characteristics of which provide a certain flow rate characteristic. The regulator allows for the infusion pump to infuse at a rate that may be varied during use by the user.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims priority from co-pending Provisional Patent Application No. 61/565,120, filed on Nov. 30, 2011 and entitled “INFUSION SYSTEM WITH VARIABLE FLOW RATE ADJUSTMENT”, the foregoing application being incorporated herein, by reference, in its entirety.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to a device, system and method useful in infusion therapy, and more particularly, useful for varying the flow rate during infusion therapy.
• 2. Description of the Related Art
• Infusion therapy requires the use of an infusion device (a source of positive pressure). There are several types of infusion devices which include: mechanical pumps, elastomeric pumps, gravity flow, electric/electronic pumps among others. Non-electric pumps and gravity infusions have a general disadvantage in that they often do not provide a sufficiently stable flow rate.
• Flow rate control in mechanical, elastomeric and other non-electrical pumps is generally accomplished with the use of certain small diameter tubing (rate set) that regulates the flow. This presents the following limitations:
• • The flow cannot be adjusted during the infusion. Instead a new infusion set has to be used when a different rate is required. This adds cost and it may it may increase the risk of contamination.
  • In order to change the flow rate, the tubing diameter has to change and thus multiple rate sets have to be made available and changed during infusion. This may or may not be possible during certain therapies.
  • The nominal flow rate of these sets does not correspond to the flow rate during use due to the viscosity of the fluid often leading to patient and clinician confusion and errors.
• Flow rate control in gravity infusions is generally accomplished with roller clamps or flow regulators that allow clinicians to determine a certain position to obtain a desired flow rate. Roller clamps are imprecise and they have generally no flow rate markings. Flow regulators in the prior art offer limited accuracy, versatility and pressure rating performance.
• A clinician using flow regulators is generally unaware of the various factors that affect the performance of flow regulators including, the imprecise position of the flow regulator, relative temperature, relative humidity, patient backpressure factors, and the variability of pressure from the source of the medication. These factors can result in significant variances in flow rates and could adversely affect patients to a significant extent.
• Flow rate controllers are generally labeled in ml/hour without taking into account the specific effect of the viscosity of the fluid which has a significant effect on the flow rate thus invalidating the significance of the markings of the device and confusing the clinician.
• Safety concerns regarding infusions have been escalating in hospitals and in regulatory circles. The FDA has started presenting new guidance documents that regulate infusion system submissions to increase the threshold of requirements for such infusion systems.
• Additional design requirements are becoming more apparent in Europe, Canada, Japan, the US and many other countries relative to improved control of flow rates and specific material biocompatibility regulations for fluid delivery devices.
• Non-electric infusions systems are generally controlled by certain small diameter tubing (rate set) that regulates the flow. This method presents limitations including inability to change flow rate without changing the rate set, incorrect flow rate labeling due to the varying viscosities of fluids administered, and undesired flow rates due to device design limitations, patient and environmental factors. U.S. Pat. No. 4,904,239 (“the '239 patent”) to Winchell et al., discloses an infusor having a distal flow regulator for dispensing a liquid under pressure at a predetermined flow rate. The '239 patent discloses the use of a non-adjustable, preselected flow regulator including a capillary bore. Col. 5 of the '239 patent, lines 9-14, disclose that a seal design permits the use of dramatically different length regulators for different desired flow rates, while still using the same size housing and connecting means, i.e, the preselected flow rate of the infusor can be changed simply by changing the length of the flow regulator. Thus, a particular flow regulator of the '239 patent has limited flow control characteristics.
• U.S. Pat. No. 5,009,251 (“the '251 patent”) to Pike et al., discloses a variable fluid flow controller for regulating the rate of flow from a source of fluid under pressure, including a plurality of unique flow restriction passageways, a valve associated with each passageway and a rotatable cam for selectively opening any one of the valves while maintaining the remaining valves closed. The flow restriction passageway of the '251 patent preferably comprises a channel etched on the surface of a first silicon wafer and enclosed by a second wafer to form a fluid flow passageway, one of the first or second wafers having a plurality of apertures therethrough for intersecting the passageway at various distances along its length.
• U.S. Pat. No. 5,234,413 (“the '413 patent”) to Wonder et al., discloses an infusion rate regulating device for varying the rate of flow of fluids for infusion to a patient at extremely low, but constant, flow rates. The regulator of the '413 patent is interposed at a point on a supply tube between a fluid reservoir and a patient. An input port directs fluid to a fluid metering groove of variable cross-sectional area on a metering plate which is formed as a part of the output port. The metering plate is rotated axially, relative of the input port, allowing fluid to enter the fluid metering groove at any point and flow toward the output port through a fluid metering groove which increases in depth or cross-sectional area at an essentially constant rate. Depending on the point at which the fluid enters the fluid metering groove flow path of the device in the '413 patent, the flow rate selected can be any rate from full off to full flow.
• What is needed is a flow control device for a gravity flow or mechanical infusion system that provides clinicians with precision in controlling the flow rate through the device.
SUMMARY OF THE INVENTION
• A device, system and method are provided for controlling the rate of infusion of fluids during infusion therapy using non-electric infusion devices. The flow control device of the present invention improves flow control, as well as safety resulting from such improved flow rate control, when compared to the performance of flow regulator devices in the prior art. The flow control device of the present invention has a design and method of construction that optimizes flow rate and functionality, safety and ergonomics in applications such as those that can be used with non-electric pumps including, but not limited to: mechanical pumps, gravity flow, elastomeric pumps, and other similar devices or applications.
• In one particular embodiment of the invention, a variable flow control device is provide in which the rotation of a flow regulator dial causes an orifice connected to the inlet to modify its relative position with respect to a groove or open-topped channel connected to the fluid outlet, via an orifice at one end of the groove, thus defining the fluid path. In this embodiment, one or more characteristics (diameter, width, depth, etc.) of the groove may be varied along the length of the groove, as desired.
• In another particular embodiment of the invention, rotation of the a regulator dial causes an orifice connected to the inlet to align with one of a plurality of orifices connected to the outlet. The diameter of each orifice of the plurality may be graduated such that the different orifices represent a percentage of flow from 1% to 100% in specific increments. In one particular embodiment, ten orifices are provided each orifice providing a 10% greater flow rate of the total possible flow rate than its immediately prior neighbor, starting from the smallest orifice to the largest, with the first orifice providing 10% of the total possible flow rate and the tenth orifice providing 100% of the total possible flow rate.
• In a further particular embodiment of the invention, rotation of a flow regulator dial causes an orifice connected to the inlet to align with one of various combinations of orifices connected to the outlet that represent the permutation of orifices as a digital counter (BINARY).
• Additionally, in a further particular embodiment of the invention, improved flow regulation or control is achieved by providing combining two or more adjustable dial layers, each having a variable flow control mechanism in accordance with the present invention. In one particular embodiment, one or more additional variable flow control layers are added after the first or main variable flow control layer to provide a combination of coarse and fine control levels, thus greatly enhancing the actual flow rate controllability through the device.
• The present invention solves important limitations inherent to non-electric infusion systems. Other features which are considered as characteristic for the invention are set forth in the drawings and the appended claim.
• Although the invention is illustrated and described herein as embodied in a variable flow control device, system and method, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
• The construction of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of the specific embodiment when read in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings in which like reference numerals refer to like elements and in which:
• FIG. 1 is an exploded, perspective view of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 2 is an exploded view, taken from the side, of the flow control device ofFIG. 1;
• FIG. 3 is a top plan view of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 3A is a cut-away view of the flow control device ofFIG. 3, taken along the section lines A-A;
• FIG. 4A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 4B is a top plan view of the portion of the flow control device ofFIG. 4A;
• FIG. 5A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 5B is a top plan view of the portion of the flow control device ofFIG. 5A;
• FIG. 6A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 6B is a top plan view of the portion of the flow control device ofFIG. 6A;
• FIG. 7 is an exploded, perspective view of a flow control device in accordance with another particular embodiment of the invention;
• FIG. 8 is an exploded view, taken from the side, of the flow control device ofFIG. 7;
• FIG. 9 is a top plan view of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 9A is a cut-away view of the flow control device ofFIG. 9, taken along the section lines A′-A′;
• FIG. 10A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 10B is a top plan view of the portion of the flow control device ofFIG. 10A;
• FIG. 11A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 11B is a top plan view of the portion of the flow control device ofFIG. 11A;
• FIG. 12A is a side plan view of a portion of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 12B is a top plan view of the portion of the flow control device ofFIG. 12A;
• FIG. 13 is an exploded, perspective view of a flow control device in accordance with a further particular embodiment of the invention;
• FIG. 14 is an exploded view, taken from the side, of the flow control device ofFIG. 13;
• FIG. 15 is an exploded, perspective view of a flow control device in accordance with still another particular embodiment of the invention;
• FIG. 16 is an exploded view, taken from the side, of the flow control device ofFIG. 15;
• FIG. 17 is a top plan view of a flow control device in accordance with one particular embodiment of the invention;
• FIG. 17A is a cut-away view of the flow control device ofFIG. 17, taken along the section lines A″-A″;
• FIG. 18 is a top plan view of the portion of the flow control device in accordance with one particular embodiment of the invention;
• FIG. 19 is a perspective view of an infusion system with a pump, a syringe and a flow regulator in accordance with one particular embodiment of the present invention;
• FIG. 20 is a perspective view of a flow regulator according to the invention and its connectors to the remainder of the infusion system;
• FIG. 21 is a perspective view of a flow control device in accordance with still another particular embodiment of the present invention;
• FIG. 22 is a perspective view of an infusion pump that can be used in an infusion system in accordance with one particular embodiment of the invention; and
• FIG. 23 is a perspective view of an exemplary luer lock for use in one particular embodiment of an infusion system in accordance with the present invention.
• FIG. 24 is an exploded, perspective view of a flow control device in accordance with still another particular embodiment of the invention;
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT:
• Referring now toFIGS. 1-6B, there is shown a variableflow control device100 in accordance with one particular embodiment of the present invention. Theflow control device100 optimizes the delivery of fluids in conjunction with non-electric infusion pumps and gravity flow, so as to control the infusion of fluids for infusion therapy administration without the use of electronic infusion devices. Theflow control device100 is a variable flow regulator that can be provided as part of a complete infusion system or set. One example of one such complete infusion system or set is illustrated inFIG. 19.
• In the present preferred embodiment, theflow control device100 of the present invention is constructed with biocompatible materials. Preferably,flow control device100 is designed with a geometry that is conducive to hand manipulation with sufficient gripping areas to avoid slippage and to facilitate rotation as a way to select a specific flow rate. Theflow control device100 is made with materials that allow for the infusion apparatus to be operated under gravity, as well as, pressurized at higher pressure ranges, such as from 5 PSI-40 PSI, as required by elastomeric devices and mechanical infusion devices. The main flow rate variation is accomplished by adjusting the fluid path dimensions. Rotation of one half of the flow regulator component in one direction moves the fluid path exit point along the channel and effectively changes total fluid path length and diameter such that fluid flow decreases or stops depending on the degree to which it is rotated. Rotation in the opposite direction moves the fluid path exit point towards the upstream fluid path entry point, changing effective internal fluid path length and diameter such that flow is increased.
• Theflow control device100 includes three primary elements: aninlet handle110; anoutlet handle130; and aseal120, enclosed (i.e., “sandwiched” or sealingly engaged) between theinlet handle110 and theoutlet handle130. The outer surface of the inlet handle110 includes a circumferential face orviewing portion112 upon which ascale114 showing selectable flow rates is imprinted. In the present embodiment, theinlet handle110 andscale114 provide a flow regulator dial that is rotatable relative to the outlet handle130 to control the fluid flow through thedevice100.
• The inlet handle110 includes aport116 which serves as the fluid inlet to thedevice100. Theport116 includes adistal orifice116athat allows fluid input to theport116 to flow to the rest of thedevice100. The inlet handle110 additionally includes ashaft118 that includes acollar portion118athat engages a snap fitting138 of the outlet handle130 to form a rotatable snap-fit coupling which holds theseal120 in place between theinlet handle110 and theoutlet handle130. More particularly, theshaft118 passes through acentral hole122 in theseal120 and is entrapped in the snap fitting138 of the outlet handle130, by itscollar118a.
• The outlet handle130 includes an internal groove or “channel”132 open at the top and of varying diameter, through which fluid passes to anorifice132aat one end of thegroove132 connected to anoutlet port134. The relative positions (i.e., overlap) of theinlet handle orifice116aand theoutlet handle groove132 determines the flow rate. Theoutlet port134 of the outlet handle130 permits fluid to flow from thedevice100 to tubing connected to a connector, preferably some form of universal connector, to allow connection to a patient.
• During assembly, theseal120 is seated into an area of similar geometry to theseal120 in the order to maintain the hole ororifice124 through theseal120 in alignment with theinlet handle orifice116a.For example, as can be seen more particularly fromFIGS. 5B and 6B, the lower portion of the inlet handle110 includes a chamber orcavity117, sized and shaped to receive theseal120 without permitting slippage. For example, theprojections126 on theseal120 fit intomating recesses117ain thecavity117 to prevent theseal120 from moving in thecavity117, and thus maintaining theorifice116ain direct alignment with theorifice124, as shown more particularly inFIG. 3A. This alignment permits fluid from the inlet handle110 to flow through theseal120 and into thegroove132 of the outlet handle. Theseal orifice124 is aligned with theorifice116aandgroove132, both during assembly and during flow. Theseal120 ensures that fluid is contained within thegroove132, and that fluid input to thedevice100 via theport116 can only flow in a path defined by the orifices in each of theinlet handle110 and seal120 and groove132 of the outlet handle130, to exit thedevice100 through theport134 of theoutlet handle130.
• The inlet handle110 and outlet handle130 are preferably made of a material sufficiently robust to withstand the pressures of the intended use. In one particular embodiment of the invention, it is intended that thedevice100 be used in a pressurized infusion system. Consequently, the material selected forinlet handle110 and outlet handle130 is preferably selected to operate under a wide range of pressures from 5-40 PSI (i.e., the device being operable for the entire range), making thedevice100 compatible with pressurized devices. In one particular preferred embodiment, the material for the inlet and outlet handles110,130 are selected to be polycarbonate or other materials of similar hardness coefficient. For example, the inlet and outlet handles can be made of a hard plastic to ensure precise sealing. Theseal120 is made of a soft plastic to provide a cushioned seal when placed between the inlet and outlet handles110,130 and seals the device to prevent fluid leakage. The tolerance of the molds to produce the inlet and outlet handles should take into account that the inlet and outlet handles should be of sufficient tightness to avoid fluid leakage.
• Fluid viscosity, relative position of device, atmospheric pressure, ambient temperature and other factors affect actual flow rates. Calibration of flow rates and enhanced controllability are important clinical features. The flow control device of the present invention may be calibrated and delivered to the user with charts that correlate fluid viscosity with flow rate for various fluids under various conditions as part of the operating manual. The charts provided may include adjustment factors to account for and compensate for, among other factors that affect actual flow rates, fluid viscosity, relative position of device, atmospheric pressure, and/or ambient temperature and other factors.
• Conventional flow regulators are rated in ml/hr (milliliters per hour) and based on gravity flow for a low viscosity “Saline solution”. This way of labeling flow regulators is misleading and cannot be correlated to parametric variations. Instead, thedevice100 has a numbering system that replaces the otherwise imprecise ml/hr indicators with numbers either from 1-6, 1-10 or 1-100% thus avoiding empirical discrepancies when different fluids are utilized. For example, in the present particular embodiment shown inFIGS. 1 and 2, thescale114 on thedevice100 is labeled 1-6, which in the present example are not a numerical value in ml/hr. Each number on thescale124 is aligned with a hash mark124a,and thescale124 additionally includes intervening hash marks124adisposed halfway between the numbers, which hash marks are alignable with an indicator orarrow136 on the outlet handle130, for easy and understandable selection of the flow. More particularly, theinlet handle110 and gasket orseal120, with the aligned orifices,116a,124, rotate relative to thegroove132 of the outlet handle130, to align theorifices116a,124 with different portions of thegroove132, thus controlling the flow between theinlet port116 and theoutlet port134.
• Referring now toFIGS. 7-12B, there is shown a variableflow control device200 in accordance with another particular embodiment of the present invention. Theflow control device200 is similar in many respects to that ofFIGS. 1-6B. More particularly, theflow control device200 includes aninlet handle210 including aninlet port216,orifice216a,scale214, chamber orcavity217 andshaft218, all of which operate similarly to the correspondingly named parts described in connection withFIGS. 1-6B. Theflow control device200 additionally includes aseal220 and anoutlet handle230. However, instead of a single orifice, theseal210 includes a plurality oforifices222 alignable between theorifice216aof theinlet handle210 and achannel236 containing anoutlet orifice232 connected to theoutlet port234 of theoutlet handle230.
• However, the scale on the outlet handle210 is mounted, in the present embodiment, on adial214 that can be rotated relative to the body of theinlet handle210. Thechamber217 containing theseal220 forms the base of thedial214, so that, when received in thechamber217, theseal220 is rotated when thedial214 is rotated. Rotation of thedial214 to a discretely marked position will align one of the orifices222 (or no orifice, in the case of the “OFF” setting) with theinlet orifice216aand with thechannel236 of theoutlet handle230. Thechannel236 is sized to receive fluid from any of theholes222 and channel it to theoutlet orifice232 at the base of thechannel236.
• In one particular embodiment of the invention, the scale on thedial214 is operable between Off and 10 and theseal220 includes 10orifices222. Rotation of thedial214 relative to the arrow orindicator236 on the outlet handle230 places adifferent orifice222 between theinlet orifice216aand thechannel236 containing theoutlet orifice232. Each of thedifferent orifices222 are differently sized from one another to provide a correspondingly different flow through theseal220, and thus out theoutlet port234. In the present example eachorifice222 is sized to provide a percentage of flow through theseal220. In the example shown, each of the 10 markings on the scale of thedial214 represents 10% of the flow, such that aligning thenumber 1 on thedial214 with thearrow236 aligns anorifice222 that permits fluid to flow at a flow rate of 10% of the total possible flow rate, between theinlet orifice216aand theoutlet orifice232. Similarly, selecting the hash mark next to thenumber 2 represents 20% of the total possible flow rate, while selecting the hash mark next to thenumber 10 represents 100% of the total possible flow rate. Although the present example uses 10discrete orifices222 to provide flow rates changeable at 10% increments, this is not meant to be limiting, as more orfewer orifices222 can be used. For example, if desired, 100orifices222 can be provided to permit the selection of a flow rate between 0 and 100% in 1% increments. Other numbers oforifices222 can be used without deviating from the spirit of the invention.
• Additionally, theflow control device200 is preferably made of the same materials, and for operation in the same pressure range, as thedevice100, described above. Additionally, thedevice200 is assembled using a snap-fit coupling between ashaft218, having acollar218a,and a snap fitting238 on the outlet handle230, with theseal220 disposed there between.
• Alternately, if desired, instead of a plurality oforifices222 being provided on theseal220, the plurality of orifices can be provided on a face of the outlet handle, as shown more particularly in the embodiment ofFIGS. 13 and 14. Referring more particularly toFIGS. 13 and 14, the seal can be theseal120, as described in connection with the embodiment ofFIG. 1. Similarly, the inlet handle can be the outlet handle110 described in connection with the embodiment ofFIG. 1. Thus, the combination of outlet handle110 and seal120 would operate as described in connection withFIG. 1 (i.e., with the single orifice of theseal120 fixedly aligned with theorifice116aof the inlet handle). However, instead of the outlet handle130, thedevice300 includes the outlet handle330, the face of which includes a plurality oforifices332, each of a different size, as described in connection with theorifices222 ofFIG. 7. The outlet handle330 contains various internal “channels” connecting theorifices332 to theoutlet port334, through which the fluid travels. Rotation of the inlet handle110 relative to the outlet handle330 provides fluid from theinlet port116, via theorifices116a(see, for example,FIG. 3A) and 124, to an aligned one of theorifices332. The diameter of the aligned one of theorifices332 and/or the channel connecting it to theport334, define the rate of flow.
• As with the other embodiments, the numbers on thescale114 can be aligned with the arrow or indicator336 to align theorifices116a,124 with a particular desiredorifice332 and provide the fluid to theoutlet port334 at the rate defined by the particularrespective orifice332.
• Referring now toFIGS. 15-18, there is shown aflow control device400 in accordance with a further embodiment of the present invention. Thedevice400 includes anoutlet handle410 having arotating dial414, anoutlet handle430 and aseal420 including specialized groupings oforifices422 defined for each possible discrete setting for thedial414. Theflow control device400, i.e., theelements410,420 and430, is preferably made of the same materials, and for operation in the same pressure range, as the corresponding elements of thedevice100, described above. Additionally, thedevice400 is assembled using a snap-fit coupling between a shaft and snap fitting, with theseal420 disposed therebetween, as was described in connection with the previous embodiments.
• Additionally, in the present embodiment, the rotation of the flow regulator dial414 causes the flow from theinlet orifice416 to be connected to the outlet handle430, via a particular group oforifices422 in theseal420. More particularly, theseal420 includes fifteen discrete positions, each of which has a unique group orcombination422 of orifices representing a specific binary number. In the present example, theorifice416amay be a single orifice, as shown, which is large enough to feed fluid to all of the orifices422ain aparticular group422. Alternately, if desired, theinlet416 can be configured to have fourorifices416a,one for alignment with each of the four possible orifice locations in agroup422 on theseal420. Additionally, if desired, theorifice416acan be in the form of a slot or groove (such as thegroove436 on the outlet handle), to ensure that fluid from theinlet port216 will be provided to any open orifice in a group oforifices422. The number of orifices open between theinlet orifice416a,and theoutlet slot436 andorifice432, as well as their sizes, define the flow rate for each particular position or setting of thedial414. As can be seen, with the use of four possible orifices422apergroup422, there are fifteen possible flow rate settings available to theflow rate device400, as shown in Table 1, here below.

• 	TABLE 1
  	ORIFICE

  POSITION No.	ONE	TWO	THREE	FOUR

  1	1	0	0	0
  2	0	1	0	0
  3	1	1	0	0
  4	0	0	1	0
  5	1	0	1	0
  6	0	1	1	0
  7	1	1	1	0
  8	0	0	0	1
  9	1	0	0	1
  10	0	1	0	1
  11	1	1	0	1
  12	0	0	1	1
  13	1	0	1	1
  14	0	1	1	1
  15	1	1	1	1

• As shown more particularly inFIG. 18, the size of each orifice422ain agroup422 is, preferably, different from the size of every other orifice422ain thegroup422, which provides the high resolution of fifteen unique possible dial positions. Additionally, the size of the holes should gradually increase. For example, in order to effectuate the fifteen unique settings of Table 1, in the present illustrative example, theorifice2 must be larger than (i.e., have a greater flow through) theorifice1. Similarly,orifice3 must be larger thanorifices1 and2, combined, andorifice4 must be larger thanorifices1,2 and3 combined. In one particular embodiment of the invention, the second orifice is double the flow rate of the first orifice, the third orifice is double the flow rate of the second orifice and the fourth orifice is double the flow rate of the third orifice, and so on for the total number of orifices used. Note that that use of four orifices per group is not meant to be limiting, as more or fewer orifices422apergroup422 may be used without departing from the scope of the invention. For example, in another particular embodiment of the invention (not shown), each group of orifices could have between 1 and 3 orifices, thus defining 8 unique flow rate settings, as defined by Table 2, herebelow.

• 	TABLE 2
  	ORIFICE

  	POSITION No.	ONE	TWO	THREE
  	1	1	0	0
  	2	0	1	0
  	3	1	1	0
  	4	0	0	1
  	5	1	0	1
  	6	0	1	1
  	7	0	1	1
  	8	1	1	1

• Additionally, if desired, in addition to, or instead of, the seal having groups of orifices, as described, the outlet handle, itself, may include a sequence of orifices, defined by Table 1, that permit fluid to flow through from seal into one such group of orifices. The relative position of the inlet handle and seal orifices with a particular group of orifices in the outlet handle determines the flow rate. One particular example of aflow rate device500, wherein theorifice groups532 are on the outlet handle, instead of on the seal, is shown inFIG. 24. More particularly, the inlet handle orifice is aligned with a slot522 on theseal520, which can be aligned with each linear orifice group of532 on the outlet handle530 by rotating the inlet handle510 relative to the outlet handle to align with a setting marked on thedial514. This changes the position of the slot522 (and inlet orifice) relative to the surface of the outlet handle530, and aligns the slot522 with one of the particular orifice groups532. Channels in the outlet handle530 direct the fluid from eachorifice532aof agroup532 to the outlet port534 of thedevice500.
• Referring now toFIGS. 19-20, there is shown apump1 and asyringe2 inserted in thepump1. Aflow regulator3 according to the invention is connected to thesyringe2. Theflow control device3 can be any of thedevices100,200,300,400 discussed hereinabove. Thepump1 is designed with a pressure rating that is higher than elastomeric devices. Thesyringe2 is a conventional, commercially available syringe. The flow regulator is provided with the necessary tubing and with commercially available universal female and male luer lock connectors. Thefemale luer lock4 is connected to the source of infusion and the male luer lock8 is connected to the patient via a catheter or an additional extension infusion set.
• FIG. 22 shows theinfusion pump1 ofFIG. 19 on a larger scale. The illustratedinfusion pump1 is the preferred embodiment in the context, but it will be understood that theflow regulator3 according to the invention may also be used with other infusion pumps. The novel pump haslabel surface10 for branding and the like. A rotatingknob11 or handle11 may be used to initialize the pump. Aviewing window12 is provided for ascertaining that the syringe is properly inserted in thepump1.
• The following sequence may be performed by the user/patient in order to initialize the system and start the delivery of the infusion medicament:
• • First, theregulator3 must be set to zero in order to block any flow there through. Then the luer lock connector is attached to the filledsyringe2.
  • Next, the needle set is connected to the luer lock on theregulator3.
  • Then the pump drive is opened by rotating thehandle11 counterclockwise until it stops.
  • Then thesyringe2 is loaded and locked into thepump2 by inserting the syringe plunger into thepump1 and rotating the syringe 90° until it “clicks” in place.
  • Next, the user can verify that the syringe flange shows in theviewing window12, so as to confirm that the syringe is properly loaded.
  • Now, the pump is ready for activation. It is activated by rotating thehandle11 clockwise.
  • The system is primed by turning the regulator dial toposition5, for instance, and, when the first drop of fluid comes out of the needle set, turning it back to the zero position.
  • Now the infusion can be started as prescribed by the health provider. The user should thereby refer to the flow control guide.
  • The delivery may be stopped by turning the regulator dial to the zero or off position.
  • The syringe may be removed after the regulator has been set to zero and thehandle11 is rotated counterclockwise until the stop is reached.
• FIG. 23 is an enlarged view of aluer lock4 for use in the novel infusion system. The luer lock is particularly easy to handle due to its ergonomic geometry.
• The entireflow control device3 and connection system is illustrated inFIG. 19. Thefemale luer lock4 is provided for conventional connection to the delivery end of thesyringe2. A removable cap7 is provided so as to protect theluer lock4 during shipping and storage. A tubing section6 leads from theluer lock4 to the inlet side of theflow regulator3. The outlet side of theflow regulator3 is connected via tubing7 to a further connector8 (here, a male luer lock), which is connected into the delivery IV tubing system9.
• The flow control device or regulator of the present invention is different from all other flow regulators in the market, in part, because all others are unable to withstand the considerable pressures supplied by thepump1, or other pumps with similar pressure ratings. Additionally, the flow control device of the present invention provides greater resolution for more accurately controlling the rate of fluid flow.
• As can be seen from the foregoing,flow control device3 allows for the infusion pump to infuse a rate that is controllable by the user. Additional flow regulation control can be accomplished by incorporating one or more supplemental adjustable dial layers. For example, referring now toFIG. 21, there is shown another embodiment of a flowrate control device20, wherein two22,24 are used to improve precision in controlling flow rate. The first layer (22,30) provides a coarse control with methods described in connection with the foregoing embodiments discussed above. The second layer (24,32) provides a fine control, again with methods described in the foregoing embodiments discussed above. This is not meant to be limiting, as additional layers may be provided without departing from the scope of the invention.
• More particularly, as shown inFIG. 21, the two layers are designed to provide a combination of coarse and fine control levels, thus greatly enhancing the actual flow rate controllability based on the selections/adjustments made on thefirst dial22 andsecond dial24. Each of thedials22,24 may work in accordance with the principles described herein. Thesecond dial24 may provide fine flow control, further refining the output controlled by thefirst dial22, which provides coarse flow control. In one particular embodiment, the second dial has a base diameter ranging between 0-10% of the first dial, which has a diameter ranging between 0-100% (coarse flow control). The combination of the first and the second dials22,24 yields significantly enhanced control. Additional layers having a compounding effect on enhanced resolution, controllability and accuracy of thedevice20 may be provided. Each layer may use the same or a different flow control mechanism as any other layer, as desired. For example, the coarse layer, including thedial22 andoutlet handle portion30, can make use of a variable diameter groove for controlling flow, such as described in connection with thedevice100FIG. 1, while the second layer, including thedial24 and theoutlet handle portion32 may make use of one of the other flow control mechanisms described in connection with thedevices200,300,400,500. This is not meant to be limiting, as any combination of layers and any number of layers utilizing the variable flow control mechanisms described in connection with thedevices100,200,300,400,500 may be used in any of the layers without departing from the spirit of the present invention.
• As can be seen from the foregoing, the present invention implements features that improve flow control as well as safety resulting from such improved flow rate control when compared to the performance of devices in the prior art. The invention solves important limitations inherent to non-electric infusion systems. Non electric infusions systems are generally controlled by certain small diameter tubing (rate set) that regulates the flow. This method presents limitations including inability to change flow rate without changing the rate set, incorrect flow rate labeling due to the varying viscosities of fluids administered, and undesired flow rates due to device design limitations, patient conditions and environmental factors.
• The flow rate control devices described hereinabove can be used in connection with gravity infusion devices and/or pressurized infusion devices, including constant or semi-constant force infusion devices. Additionally, if desired, a pressure sensor may be provided the output of which can be used to by self-adjusting mechanism or circuit to automatically adjust the flow rate of the flow rate device to reduce flow changes relative to pressure variations, patient conditions and other therapy factors.
• The present disclosure is provided to allow practice of the invention, after the expiration of any patent granted hereon, by those skilled in the art without undue experimentation, and includes the best mode presently contemplated and the presently preferred embodiment. Nothing in this disclosure is to be taken to limit the scope of the invention, which is susceptible to numerous alterations, equivalents and substitutions without departing from the scope and spirit of the invention.

Claims (25)

I claim:

1. A flow rate control device, comprising:

an inlet handle including an inlet port;

an outlet handle including an outlet port;

a seal sealingly engaged between said inlet handle and said outlet handle;

at least one of said inlet handle, outlet handle or seal including a plurality of differently sized orifices; and

at least a portion of said inlet handle being rotatable relative to said outlet handle to a selectively align one or more of said plurality of differently sized orifices between said inlet port and said outlet port.

2. The flow rate control device ofclaim 1, wherein said seal includes said plurality of differently sized orifices and rotation of a dial on the inlet handle rotates the seal to change the alignment of said plurality of differently sized orifices relative to the inlet port and outlet port;

3. The flow rate control device ofclaim 1, wherein said outlet handle includes said plurality of differently sized orifices in fluid communication with said outlet port, and rotation of said inlet handle changes the alignment of said inlet port and an orifice through the seal with said plurality of differently sized orifices.

4. The flow rate control device ofclaim 1, wherein each one of said plurality of differently sized orifices is differently sized from every other one of said plurality of differently sized orifices.

5. The flow rate control device ofclaim 1, wherein said plurality of differently sized orifices are arranged in groups representing different specific binary numbers and rotation of said portion of said inlet handle relative to said outlet handle selectively aligns a group of said plurality of differently sized orifices between said inlet port and said outlet port.

6. The flow rate control device ofclaim 1, further including a second flow rate control mechanism disposed between said inlet port and said outlet port;

7. The flow rate control device ofclaim 6, wherein the outlet handle includes a first outlet handle portion including said channel and a second outlet handle portion rotatable relative to said first outlet handle portion disposed between said outlet orifice and said outlet port.

8. The flow rate control device ofclaim 7, wherein said second flow rate control mechanism includes a channel having at least one characteristic that is varied along the length of the channel with an outlet orifice at one end of said channel.

9. A variable flow rate infusion system, comprising:

an infusion device that dispenses fluid pressurized to between 5 PSI and 40 PSI; and

the flow control device ofclaim 1 in fluid communication with said infusion device.

10. A method of adjusting an infusion rate to a patient, comprising the steps of:

connecting a flow rate control device according toclaim 1 to a patient;

initiating the flow of fluid to the patient; and

rotating at least a portion of the inlet handle relative to the outlet handle to select a rate of fluid flow.

11. A flow rate control device, comprising:

an inlet handle including an inlet port;

an outlet handle including an outlet port

a seal including at least one seal orifice sealingly engaged between said inlet handle and said outlet handle;

a first flow rate control mechanism selected from the group consisting of:

a plurality of differently sized orifices alignable between said inlet port and a

first flow rate control mechanism outlet port; and

a channel having at least one characteristic that is varied along the length of the channel selectively alignable between said inlet port and said first flow rate control mechanism outlet port; and

at least a second flow rate control mechanism disposed in line with said first flow rate control mechanism, said second flow rate control mechanism selected from the group consisting of:

a plurality of differently sized orifices alignable between said first flow rate control mechanism outlet port and said outlet port; and

a channel having at least one characteristic that is varied along the length of the channel selectively alignable between said first flow rate control mechanism outlet port and said outlet port.

12. The flow rate control device ofclaim 11, wherein at least one of said first flow rate control mechanism or said second flow rate control mechanism is a plurality of differently sized orifices, with said plurality of differently sized orifices being arranged in groups representing different specific binary numbers and rotation of said portion of said inlet handle relative to said outlet handle selectively aligns a group of said plurality of differently sized orifices between said inlet port and said outlet port.

13. The flow rate control device ofclaim 11, wherein one of said first flow rate control mechanism or said second flow rate control mechanism is a plurality of differently sized orifices and the other one of said first flow rate control mechanism or said second flow rate control mechanism is a channel having at least one characteristic that is varied along the length of the channel.

14. The flow rate control device ofclaim 11, wherein each of said first flow rate control mechanism and said second flow rate control mechanism are a plurality of differently sized orifices.

15. The flow rate control device ofclaim 11, wherein each of said first flow rate control mechanism and said second flow rate control mechanism are a channel having at least one characteristic that is varied along the length of the channel.

16. A variable flow rate infusion system, comprising:

an infusion device that dispenses fluid pressurized to between 5 PSI and 40 PSI; and

the flow control device ofclaim 11 in fluid communication with said infusion device.

17. A method of adjusting an infusion rate to a patient, comprising the steps of:

connecting a flow rate control device according toclaim 11 to a patient;

initiating the flow of fluid to the patient; and

adjusting the alignment of at least one of said first flow rate control mechanism or said second flow rate control mechanism to select a rate of fluid flow.

18. The method ofclaim 17, wherein adjusting the alignment of the first flow rate control mechanism provides coarse flow rate control and adjusting the alignment of the second flow rate control mechanism provides fine flow rate control.

19. A flow rate control device, comprising:

an inlet handle including an inlet port and an inlet orifice;

an outlet handle including an outlet port and a channel having at least one characteristic that is varied along the length of the channel, said channel including an outlet orifice at one end of said channel, said outlet orifice connected to said outlet port;

a seal including a seal orifice sealingly engaged between said inlet handle and said outlet handle with said seal orifice aligned between said inlet orifice and said channel;

the flow rate control device configured such that rotation of said inlet handle and seal relative to said outlet handle changes the position of the seal orifice relative to said channel, thus changing the flow rate; and

said inlet handle, outlet handle and seal composed of materials, the combination of which withstands pressure up to 40 PSI.

20. The flow rate control device ofclaim 19, wherein the characteristic varied is the diameter of the channel.

21. The flow rate control device ofclaim 19, wherein said inlet handle includes a scale marked in simple numerical units.

22. The flow rate control device ofclaim 19, further including a second flow rate control mechanism disposed between said inlet port and said outlet port;

23. The flow rate control device ofclaim 22, wherein the outlet handle includes a first outlet handle portion including said channel and a second outlet handle portion rotatable relative to said first outlet handle portion disposed between said outlet orifice and said outlet port.

24. The flow rate control device ofclaim 23, wherein said second flow rate control mechanism includes a second channel having at least one characteristic that is varied along the length of the second channel and a second outlet orifice at one end of said second channel.

25. A variable flow rate infusion system, comprising:

an infusion device that dispenses fluid pressurized to between 5 PSI and 40 PSI; and

the flow control device ofclaim 19 in fluid communication with said infusion device.

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