U.S. patent application number 13/690702 was filed with the patent office on 2013-05-30 for variable flow control device, system and method.
This patent application is currently assigned to EMED TECHNOLOGIES CORP. (NV). The applicant listed for this patent is EMED TECHNOLOGIES CORP. (NV). Invention is credited to PAUL LAMBERT.
Application Number | 20130138075 13/690702 |
Document ID | / |
Family ID | 49841801 |
Filed Date | 2013-05-30 |
United States Patent
Application |
20130138075 |
Kind Code |
A1 |
LAMBERT; PAUL |
May 30, 2013 |
VARIABLE FLOW CONTROL DEVICE, SYSTEM AND METHOD
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.
Inventors: |
LAMBERT; PAUL; (EL DORADO
HILLS, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EMED TECHNOLOGIES CORP. (NV); |
El Dorado Hills |
CA |
US |
|
|
Assignee: |
EMED TECHNOLOGIES CORP.
(NV)
EL DORADO HILLS
CA
|
Family ID: |
49841801 |
Appl. No.: |
13/690702 |
Filed: |
November 30, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61565120 |
Nov 30, 2011 |
|
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|
Current U.S.
Class: |
604/500 ;
604/248 |
Current CPC
Class: |
A61M 39/10 20130101;
A61M 5/142 20130101; A61M 5/16813 20130101; A61M 5/16881
20130101 |
Class at
Publication: |
604/500 ;
604/248 |
International
Class: |
A61M 5/168 20060101
A61M005/168 |
Claims
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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 1, further including a
second flow rate control mechanism disposed between said inlet port
and said outlet port;
7. The flow rate control device of claim 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 of claim 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 of claim 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 to
claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 to
claim 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 of claim 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 of claim 19, wherein the
characteristic varied is the diameter of the channel.
21. The flow rate control device of claim 19, wherein said inlet
handle includes a scale marked in simple numerical units.
22. The flow rate control device of claim 19, further including a
second flow rate control mechanism disposed between said inlet port
and said outlet port;
23. The flow rate control device of claim 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 of claim 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 of claim 19 in fluid communication
with said infusion device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] 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
[0002] 1. Field of the Invention
[0003] 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.
[0004] 2. Description of the Related Art
[0005] 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.
[0006] 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: [0007] 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. [0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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).
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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
[0027] 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:
[0028] FIG. 1 is an exploded, perspective view of a flow control
device in accordance with one particular embodiment of the
invention;
[0029] FIG. 2 is an exploded view, taken from the side, of the flow
control device of FIG. 1;
[0030] FIG. 3 is a top plan view of a flow control device in
accordance with one particular embodiment of the invention;
[0031] FIG. 3A is a cut-away view of the flow control device of
FIG. 3, taken along the section lines A-A;
[0032] FIG. 4A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0033] FIG. 4B is a top plan view of the portion of the flow
control device of FIG. 4A;
[0034] FIG. 5A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0035] FIG. 5B is a top plan view of the portion of the flow
control device of FIG. 5A;
[0036] FIG. 6A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0037] FIG. 6B is a top plan view of the portion of the flow
control device of FIG. 6A;
[0038] FIG. 7 is an exploded, perspective view of a flow control
device in accordance with another particular embodiment of the
invention;
[0039] FIG. 8 is an exploded view, taken from the side, of the flow
control device of FIG. 7;
[0040] FIG. 9 is a top plan view of a flow control device in
accordance with one particular embodiment of the invention;
[0041] FIG. 9A is a cut-away view of the flow control device of
FIG. 9, taken along the section lines A'-A';
[0042] FIG. 10A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0043] FIG. 10B is a top plan view of the portion of the flow
control device of FIG. 10A;
[0044] FIG. 11A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0045] FIG. 11B is a top plan view of the portion of the flow
control device of FIG. 11A;
[0046] FIG. 12A is a side plan view of a portion of a flow control
device in accordance with one particular embodiment of the
invention;
[0047] FIG. 12B is a top plan view of the portion of the flow
control device of FIG. 12A;
[0048] FIG. 13 is an exploded, perspective view of a flow control
device in accordance with a further particular embodiment of the
invention;
[0049] FIG. 14 is an exploded view, taken from the side, of the
flow control device of FIG. 13;
[0050] FIG. 15 is an exploded, perspective view of a flow control
device in accordance with still another particular embodiment of
the invention;
[0051] FIG. 16 is an exploded view, taken from the side, of the
flow control device of FIG. 15;
[0052] FIG. 17 is a top plan view of a flow control device in
accordance with one particular embodiment of the invention;
[0053] FIG. 17A is a cut-away view of the flow control device of
FIG. 17, taken along the section lines A''-A'';
[0054] FIG. 18 is a top plan view of the portion of the flow
control device in accordance with one particular embodiment of the
invention;
[0055] 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;
[0056] FIG. 20 is a perspective view of a flow regulator according
to the invention and its connectors to the remainder of the
infusion system;
[0057] FIG. 21 is a perspective view of a flow control device in
accordance with still another particular embodiment of the present
invention;
[0058] 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
[0059] 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.
[0060] 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:
[0061] Referring now to FIGS. 1-6B, there is shown a variable flow
control device 100 in accordance with one particular embodiment of
the present invention. The flow control device 100 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. The flow control device 100 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 in FIG. 19.
[0062] In the present preferred embodiment, the flow control device
100 of the present invention is constructed with biocompatible
materials. Preferably, flow control device 100 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. The flow control device 100 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.
[0063] The flow control device 100 includes three primary elements:
an inlet handle 110; an outlet handle 130; and a seal 120, enclosed
(i.e., "sandwiched" or sealingly engaged) between the inlet handle
110 and the outlet handle 130. The outer surface of the inlet
handle 110 includes a circumferential face or viewing portion 112
upon which a scale 114 showing selectable flow rates is imprinted.
In the present embodiment, the inlet handle 110 and scale 114
provide a flow regulator dial that is rotatable relative to the
outlet handle 130 to control the fluid flow through the device
100.
[0064] The inlet handle 110 includes a port 116 which serves as the
fluid inlet to the device 100. The port 116 includes a distal
orifice 116a that allows fluid input to the port 116 to flow to the
rest of the device 100. The inlet handle 110 additionally includes
a shaft 118 that includes a collar portion 118a that engages a snap
fitting 138 of the outlet handle 130 to form a rotatable snap-fit
coupling which holds the seal 120 in place between the inlet handle
110 and the outlet handle 130. More particularly, the shaft 118
passes through a central hole 122 in the seal 120 and is entrapped
in the snap fitting 138 of the outlet handle 130, by its collar
118a.
[0065] The outlet handle 130 includes an internal groove or
"channel" 132 open at the top and of varying diameter, through
which fluid passes to an orifice 132a at one end of the groove 132
connected to an outlet port 134. The relative positions (i.e.,
overlap) of the inlet handle orifice 116a and the outlet handle
groove 132 determines the flow rate. The outlet port 134 of the
outlet handle 130 permits fluid to flow from the device 100 to
tubing connected to a connector, preferably some form of universal
connector, to allow connection to a patient.
[0066] During assembly, the seal 120 is seated into an area of
similar geometry to the seal 120 in the order to maintain the hole
or orifice 124 through the seal 120 in alignment with the inlet
handle orifice 116a. For example, as can be seen more particularly
from FIGS. 5B and 6B, the lower portion of the inlet handle 110
includes a chamber or cavity 117, sized and shaped to receive the
seal 120 without permitting slippage. For example, the projections
126 on the seal 120 fit into mating recesses 117a in the cavity 117
to prevent the seal 120 from moving in the cavity 117, and thus
maintaining the orifice 116a in direct alignment with the orifice
124, as shown more particularly in FIG. 3A. This alignment permits
fluid from the inlet handle 110 to flow through the seal 120 and
into the groove 132 of the outlet handle. The seal orifice 124 is
aligned with the orifice 116a and groove 132, both during assembly
and during flow. The seal 120 ensures that fluid is contained
within the groove 132, and that fluid input to the device 100 via
the port 116 can only flow in a path defined by the orifices in
each of the inlet handle 110 and seal 120 and groove 132 of the
outlet handle 130, to exit the device 100 through the port 134 of
the outlet handle 130.
[0067] The inlet handle 110 and outlet handle 130 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 the device 100 be used in a pressurized
infusion system. Consequently, the material selected for inlet
handle 110 and outlet handle 130 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 the device 100
compatible with pressurized devices. In one particular preferred
embodiment, the material for the inlet and outlet handles 110, 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. The seal 120
is made of a soft plastic to provide a cushioned seal when placed
between the inlet and outlet handles 110, 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.
[0068] 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.
[0069] 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, the device
100 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
in FIGS. 1 and 2, the scale 114 on the device 100 is labeled 1-6,
which in the present example are not a numerical value in ml/hr.
Each number on the scale 124 is aligned with a hash mark 124a, and
the scale 124 additionally includes intervening hash marks 124a
disposed halfway between the numbers, which hash marks are
alignable with an indicator or arrow 136 on the outlet handle 130,
for easy and understandable selection of the flow. More
particularly, the inlet handle 110 and gasket or seal 120, with the
aligned orifices, 116a, 124, rotate relative to the groove 132 of
the outlet handle 130, to align the orifices 116a, 124 with
different portions of the groove 132, thus controlling the flow
between the inlet port 116 and the outlet port 134.
[0070] Referring now to FIGS. 7-12B, there is shown a variable flow
control device 200 in accordance with another particular embodiment
of the present invention. The flow control device 200 is similar in
many respects to that of FIGS. 1-6B. More particularly, the flow
control device 200 includes an inlet handle 210 including an inlet
port 216, orifice 216a, scale 214, chamber or cavity 217 and shaft
218, all of which operate similarly to the correspondingly named
parts described in connection with FIGS. 1-6B. The flow control
device 200 additionally includes a seal 220 and an outlet handle
230. However, instead of a single orifice, the seal 210 includes a
plurality of orifices 222 alignable between the orifice 216a of the
inlet handle 210 and a channel 236 containing an outlet orifice 232
connected to the outlet port 234 of the outlet handle 230.
[0071] However, the scale on the outlet handle 210 is mounted, in
the present embodiment, on a dial 214 that can be rotated relative
to the body of the inlet handle 210. The chamber 217 containing the
seal 220 forms the base of the dial 214, so that, when received in
the chamber 217, the seal 220 is rotated when the dial 214 is
rotated. Rotation of the dial 214 to a discretely marked position
will align one of the orifices 222 (or no orifice, in the case of
the "OFF" setting) with the inlet orifice 216a and with the channel
236 of the outlet handle 230. The channel 236 is sized to receive
fluid from any of the holes 222 and channel it to the outlet
orifice 232 at the base of the channel 236.
[0072] In one particular embodiment of the invention, the scale on
the dial 214 is operable between Off and 10 and the seal 220
includes 10 orifices 222. Rotation of the dial 214 relative to the
arrow or indicator 236 on the outlet handle 230 places a different
orifice 222 between the inlet orifice 216a and the channel 236
containing the outlet orifice 232. Each of the different orifices
222 are differently sized from one another to provide a
correspondingly different flow through the seal 220, and thus out
the outlet port 234. In the present example each orifice 222 is
sized to provide a percentage of flow through the seal 220. In the
example shown, each of the 10 markings on the scale of the dial 214
represents 10% of the flow, such that aligning the number 1 on the
dial 214 with the arrow 236 aligns an orifice 222 that permits
fluid to flow at a flow rate of 10% of the total possible flow
rate, between the inlet orifice 216a and the outlet orifice 232.
Similarly, selecting the hash mark next to the number 2 represents
20% of the total possible flow rate, while selecting the hash mark
next to the number 10 represents 100% of the total possible flow
rate. Although the present example uses 10 discrete orifices 222 to
provide flow rates changeable at 10% increments, this is not meant
to be limiting, as more or fewer orifices 222 can be used. For
example, if desired, 100 orifices 222 can be provided to permit the
selection of a flow rate between 0 and 100% in 1% increments. Other
numbers of orifices 222 can be used without deviating from the
spirit of the invention.
[0073] Additionally, the flow control device 200 is preferably made
of the same materials, and for operation in the same pressure
range, as the device 100, described above. Additionally, the device
200 is assembled using a snap-fit coupling between a shaft 218,
having a collar 218a, and a snap fitting 238 on the outlet handle
230, with the seal 220 disposed there between.
[0074] Alternately, if desired, instead of a plurality of orifices
222 being provided on the seal 220, the plurality of orifices can
be provided on a face of the outlet handle, as shown more
particularly in the embodiment of FIGS. 13 and 14. Referring more
particularly to FIGS. 13 and 14, the seal can be the seal 120, as
described in connection with the embodiment of FIG. 1. Similarly,
the inlet handle can be the outlet handle 110 described in
connection with the embodiment of FIG. 1. Thus, the combination of
outlet handle 110 and seal 120 would operate as described in
connection with FIG. 1 (i.e., with the single orifice of the seal
120 fixedly aligned with the orifice 116a of the inlet handle).
However, instead of the outlet handle 130, the device 300 includes
the outlet handle 330, the face of which includes a plurality of
orifices 332, each of a different size, as described in connection
with the orifices 222 of FIG. 7. The outlet handle 330 contains
various internal "channels" connecting the orifices 332 to the
outlet port 334, through which the fluid travels. Rotation of the
inlet handle 110 relative to the outlet handle 330 provides fluid
from the inlet port 116, via the orifices 116a (see, for example,
FIG. 3A) and 124, to an aligned one of the orifices 332. The
diameter of the aligned one of the orifices 332 and/or the channel
connecting it to the port 334, define the rate of flow.
[0075] As with the other embodiments, the numbers on the scale 114
can be aligned with the arrow or indicator 336 to align the
orifices 116a, 124 with a particular desired orifice 332 and
provide the fluid to the outlet port 334 at the rate defined by the
particular respective orifice 332.
[0076] Referring now to FIGS. 15-18, there is shown a flow control
device 400 in accordance with a further embodiment of the present
invention. The device 400 includes an outlet handle 410 having a
rotating dial 414, an outlet handle 430 and a seal 420 including
specialized groupings of orifices 422 defined for each possible
discrete setting for the dial 414. The flow control device 400,
i.e., the elements 410, 420 and 430, is preferably made of the same
materials, and for operation in the same pressure range, as the
corresponding elements of the device 100, described above.
Additionally, the device 400 is assembled using a snap-fit coupling
between a shaft and snap fitting, with the seal 420 disposed
therebetween, as was described in connection with the previous
embodiments.
[0077] Additionally, in the present embodiment, the rotation of the
flow regulator dial 414 causes the flow from the inlet orifice 416
to be connected to the outlet handle 430, via a particular group of
orifices 422 in the seal 420. More particularly, the seal 420
includes fifteen discrete positions, each of which has a unique
group or combination 422 of orifices representing a specific binary
number. In the present example, the orifice 416a may be a single
orifice, as shown, which is large enough to feed fluid to all of
the orifices 422a in a particular group 422. Alternately, if
desired, the inlet 416 can be configured to have four orifices
416a, one for alignment with each of the four possible orifice
locations in a group 422 on the seal 420. Additionally, if desired,
the orifice 416a can be in the form of a slot or groove (such as
the groove 436 on the outlet handle), to ensure that fluid from the
inlet port 216 will be provided to any open orifice in a group of
orifices 422. The number of orifices open between the inlet orifice
416a, and the outlet slot 436 and orifice 432, as well as their
sizes, define the flow rate for each particular position or setting
of the dial 414. As can be seen, with the use of four possible
orifices 422a per group 422, there are fifteen possible flow rate
settings available to the flow rate device 400, as shown in Table
1, here below.
TABLE-US-00001 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
[0078] As shown more particularly in FIG. 18, the size of each
orifice 422a in a group 422 is, preferably, different from the size
of every other orifice 422a in the group 422, 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, the orifice 2 must be
larger than (i.e., have a greater flow through) the orifice 1.
Similarly, orifice 3 must be larger than orifices 1 and 2,
combined, and orifice 4 must be larger than orifices 1, 2 and 3
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 orifices 422a per group 422 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-US-00002 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
[0079] 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 a flow rate
device 500, wherein the orifice groups 532 are on the outlet
handle, instead of on the seal, is shown in FIG. 24. More
particularly, the inlet handle orifice is aligned with a slot 522
on the seal 520, which can be aligned with each linear orifice
group of 532 on the outlet handle 530 by rotating the inlet handle
510 relative to the outlet handle to align with a setting marked on
the dial 514. This changes the position of the slot 522 (and inlet
orifice) relative to the surface of the outlet handle 530, and
aligns the slot 522 with one of the particular orifice groups 532.
Channels in the outlet handle 530 direct the fluid from each
orifice 532a of a group 532 to the outlet port 534 of the device
500.
[0080] Referring now to FIGS. 19-20, there is shown a pump 1 and a
syringe 2 inserted in the pump 1. A flow regulator 3 according to
the invention is connected to the syringe 2. The flow control
device 3 can be any of the devices 100, 200, 300, 400 discussed
hereinabove. The pump 1 is designed with a pressure rating that is
higher than elastomeric devices. The syringe 2 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. The female luer lock 4 is
connected to the source of infusion and the male luer lock 8 is
connected to the patient via a catheter or an additional extension
infusion set.
[0081] FIG. 22 shows the infusion pump 1 of FIG. 19 on a larger
scale. The illustrated infusion pump 1 is the preferred embodiment
in the context, but it will be understood that the flow regulator 3
according to the invention may also be used with other infusion
pumps. The novel pump has label surface 10 for branding and the
like. A rotating knob 11 or handle 11 may be used to initialize the
pump. A viewing window 12 is provided for ascertaining that the
syringe is properly inserted in the pump 1.
[0082] The following sequence may be performed by the user/patient
in order to initialize the system and start the delivery of the
infusion medicament: [0083] First, the regulator 3 must be set to
zero in order to block any flow there through. Then the luer lock
connector is attached to the filled syringe 2. [0084] Next, the
needle set is connected to the luer lock on the regulator 3. [0085]
Then the pump drive is opened by rotating the handle 11
counterclockwise until it stops. [0086] Then the syringe 2 is
loaded and locked into the pump 2 by inserting the syringe plunger
into the pump 1 and rotating the syringe 90.degree. until it
"clicks" in place. [0087] Next, the user can verify that the
syringe flange shows in the viewing window 12, so as to confirm
that the syringe is properly loaded. [0088] Now, the pump is ready
for activation. It is activated by rotating the handle 11
clockwise. [0089] The system is primed by turning the regulator
dial to position 5, for instance, and, when the first drop of fluid
comes out of the needle set, turning it back to the zero position.
[0090] Now the infusion can be started as prescribed by the health
provider. The user should thereby refer to the flow control guide.
[0091] The delivery may be stopped by turning the regulator dial to
the zero or off position. [0092] The syringe may be removed after
the regulator has been set to zero and the handle 11 is rotated
counterclockwise until the stop is reached.
[0093] FIG. 23 is an enlarged view of a luer lock 4 for use in the
novel infusion system. The luer lock is particularly easy to handle
due to its ergonomic geometry.
[0094] The entire flow control device 3 and connection system is
illustrated in FIG. 19. The female luer lock 4 is provided for
conventional connection to the delivery end of the syringe 2. A
removable cap 7 is provided so as to protect the luer lock 4 during
shipping and storage. A tubing section 6 leads from the luer lock 4
to the inlet side of the flow regulator 3. The outlet side of the
flow regulator 3 is connected via tubing 7 to a further connector 8
(here, a male luer lock), which is connected into the delivery IV
tubing system 9.
[0095] 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 the pump 1, 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.
[0096] As can be seen from the foregoing, flow control device 3
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 to FIG. 21, there is shown another
embodiment of a flow rate control device 20, wherein two 22, 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.
[0097] More particularly, as shown in FIG. 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 the first dial 22 and
second dial 24. Each of the dials 22, 24 may work in accordance
with the principles described herein. The second dial 24 may
provide fine flow control, further refining the output controlled
by the first dial 22, 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 dials 22, 24 yields significantly enhanced control.
Additional layers having a compounding effect on enhanced
resolution, controllability and accuracy of the device 20 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 the dial 22 and outlet handle portion 30, can make
use of a variable diameter groove for controlling flow, such as
described in connection with the device 100 FIG. 1, while the
second layer, including the dial 24 and the outlet handle portion
32 may make use of one of the other flow control mechanisms
described in connection with the devices 200, 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 the devices 100, 200, 300, 400, 500
may be used in any of the layers without departing from the spirit
of the present invention.
[0098] 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.
[0099] 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.
[0100] 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.
* * * * *