US20070156086A1 - Multi-stage fluid delivery device and method - Google Patents
Multi-stage fluid delivery device and method Download PDFInfo
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- US20070156086A1 US20070156086A1 US11/684,837 US68483707A US2007156086A1 US 20070156086 A1 US20070156086 A1 US 20070156086A1 US 68483707 A US68483707 A US 68483707A US 2007156086 A1 US2007156086 A1 US 2007156086A1
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- reservoir
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16804—Flow controllers
- A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M2005/14506—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons mechanically driven, e.g. spring or clockwork
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- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
A fluid delivery device for delivering a substance to a patient by way of infusion delivers the preparation at a rate of flow which varies in steps from a substantially constant higher rate, to a stepped-down substantially constant lower rate or rates. The delivery device includes one or more reservoirs, and one or more Belleville springs for applying generally constant pressures to the substance contained in the reservoirs. Each reservoir will have a different constant pressure applied in a mid-range of operation. The reservoirs can be interconnected to each other and to an infusion device in a number of arrangements, including various manifolds and flow restrictors, such that the rate of flow is controlled in steps in accordance with the pressures applied by the springs of the plurality of reservoirs.
Description
- This application is a divisional application of U.S. application Ser. No. 10/396,719, filed Mar. 26, 2003 which claims the benefit under 35 U.S.C. § 119(e) of U.S. provisional patent application Ser. No. 60/367,213, entitled “Multi-Stage Fluid Delivery Device”, filed Mar. 26, 2002, the entire contents each of which are incorporated herein by reference, in their respective entireties.
- The present invention relates to a system and method using fluid delivery devices to deliver a substance, for example, a therapeutic fluid material, to a patient by infusion, and more particularly, to a device in which the flow rate is automatically adjusted from an initial high rate to one or more stepped-down lower flow rates.
- When medicinal doses are delivered to patients by infusion, it is sometimes desirable to deliver the medicinal dose at an initially high rate and then deliver the remaining dose at one or more stepped-down lower rates. For example, it is typically desirable for an initial flow for drug infusion to be substantially higher than the desired therapeutic rate, so as to rapidly increase the blood concentration into the desired therapeutic range. This initial high rate of flow is called the “bolus rate”. Once the drug concentration has been increased into the therapeutic range, the flow rate is dropped to the rate necessary to maintain the concentration of the drug in the therapeutic range. This latter flow rate is called the “basal rate”.
- Prior to the present invention described below, to achieve a stepped adjustment of the flow rate automatically, an infusion device with an electronically-controlled pump was required. Accordingly, there is a need for a non-electronic infusion device of a simple mechanical construction which does not require a pump, and which can automatically deliver drugs to a patient by way of infusion at an initial high infusion rate, followed by one or more stepped-down lower infusion rates.
- A drug delivery apparatus, according to the present invention, comprises a non-electronic, ambulatory, disposable system that provides, during a delivery operation, at least one step decrease in flow rate of a fluid under pressure from a reservoir system. The pressure on the fluid is provided by at least one constant force spring acting on the fluid in at least one of the reservoirs. The fluid, under pressure, passes through a flow restrictor on its way to any number of suitable patient delivery devices, such as a needle device or catheter.
- Different spring forces are applied to the reservoir system. In the illustrated embodiments, at least one constant force spring is associated with each of the reservoirs, each constant force spring applying a force different from the constant force applied by one or more other constant force springs. In the illustrated embodiments, the constant force springs are Belleville springs.
- The present invention is especially useful with needles, particularly microneedles, having ports in their sides.
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FIG. 1 schematically illustrates a multi-stage fluid delivery device for delivering fluids to a patient by infusion in accordance with an embodiment of the present invention; -
FIG. 2 shows a graph of the flow rate versus time provided by the system shown inFIG. 1 ; -
FIG. 3 illustrates the delivery flow rate from a reservoir of the type employed in an embodiment of the present invention plotted against the displacement of the constant force spring; -
FIG. 4 is perspective view of an apparatus in accordance with an embodiment of the present invention in an unactuated state; -
FIG. 5 illustrates a perspective view of the apparatus ofFIG. 4 in an actuated state; -
FIG. 6 is a bottom plan of the upper portion of the housing of the apparatus shown inFIGS. 4 and 5 ; -
FIG. 7 is a perspective view of the bottom portion of the housing of the apparatus shown inFIGS. 4 and 5 ; -
FIG. 8 is a top plan view of the bottom portion of the housing shown inFIG. 7 ; -
FIG. 9 is a top plan view of a shelf used to support a reservoir in the apparatus shown inFIGS. 4 and 5 ; -
FIG. 10 is a sectional view of the apparatus shown inFIGS. 4 and 5 in the process of being actuated; -
FIG. 11 schematically illustrates an alternative embodiment of a fluid infusion device in accordance with the present invention employing only one reservoir in an unactuated state; -
FIG. 12 schematically illustrates the embodiment ofFIG. 11 in an actuated state; -
FIG. 13 illustrates another alternative embodiment of a fluid infusion apparatus in accordance with the present invention; -
FIG. 14 illustrates the flow rate versus time provided by the embodiment ofFIG. 13 ; -
FIG. 15 illustrates yet another alternative embodiment of a fluid infusion device in accordance with the present invention for mixing two different therapeutic preparations during infusion while providing an automatic step-down in the flow rate; and -
FIG. 16 is a schematic exploded sectional view of yet another embodiment of a fluid infusion device in accordance with the present invention. - The embodiments of the present invention described below include an infusion device of a simple mechanical construction which does not require a pump, and which can automatically deliver drugs to a patient by way of infusion at an initial high infusion rate, followed by one or more stepped-down lower infusion rates. While the primary application of the invention will be to provide only two rates of flow, there are many applications in which several different flow rates may be desirable such as, for example, when the desired or target therapeutic rate decreases with time. In order to facilitate control of the rate of flow as well as the amount of drug delivered at the various rates, both the initial high rate of drug flow, as well as the one or more stepped-down rates of flow, are substantially constant.
- In the fluid delivery device shown in
FIG. 1 , a plurality of reservoirs “A” through “N” are provided. Each reservoir includes at least one spring for applying pressure to the fluid contained in the reservoir. In the preferred embodiment, the reservoir “A” will include a spring to apply the greatest constant pressure to the contained fluid, and each of the remaining reservoirs “B” through “N” will apply progressively lower constant pressures to the fluids contained therein. As shown inFIG. 1 , the outlets from the reservoirs “A” through “N” are connected with each other through a common fluid connection or manifold comprisingflow line 10, and are connected through acommon flow restrictor 11 to aninfusion device 13, which may be a needle or an array of needles. - In the preferred embodiment, each of the reservoirs “A” through “N” is provided with at least one spring, which when actuated, will apply a force to the reservoir and pressurize the fluid contained therein. As shown in
FIG. 3 , the springs of each reservoir are designed to apply a substantially constant pressure to the fluid within the reservoir over a mid-range of operation as the fluid flows out of the reservoir.FIG. 3 illustrates the rate of flow from a reservoir plotted against the displacement of the spring pressurizing the reservoir. - In
FIG. 3 , in region “L” at low levels of spring displacement, the flow rate increases and decreases as the displacement of the spring against the reservoir increases and decreases. In region “H” at high levels of spring displacement, the flow rate increases and decreases as the displacement of the spring increases and decreases. Between the two regions “L” and “H” is the mid-range “M” of operation of the reservoir and the flow rate is maintained substantially constant as the displacement of the reservoir changes. The pressure within the reservoir is directly proportional to the flow rate. Accordingly, the curve shown inFIG. 3 also corresponds to the pressure within the reservoir plotted against the displacement of the spring, and shows that the pressure on the fluid remains substantially constant through the mid-range “M” of operation. The amount of fluid in a reservoir corresponds to the spring displacement for that reservoir. Thus when a reservoir is operating in a mid-range “M” as shown inFIG. 3 and fluid flows out of the reservoir, the spring displacement will decrease while applying a substantially constant pressure to the contained fluid, causing the fluid to flow out of the reservoir at a substantially constant rate until the spring displacement moves into the region “L”. - In the preferred embodiment, one of the reservoirs, for example reservoir “A”, in the system of
FIG. 1 , has a spring which applies the greatest spring pressure to the contained fluid in the mid-range “M” of reservoir operation and this reservoir initially will be filled with fluid to be in this mid-range. Each of the remaining reservoirs “B” through “N” will apply progressively lower pressures to the contained fluids in their mid-ranges M. - Returning to
FIG. 1 , when the reservoirs “A” through “N” are initially actuated to apply pressure to their contained fluids, the pressure in reservoir “A” will be transmitted to the reservoirs “B” through “N” through thefluid connection 10. As a result, the reservoirs “B” through “N” will be hyper-inflated to region “H” as shown inFIG. 3 . With this arrangement, the therapeutic preparation flows first out of the reservoir “A” through the flow restrictor and out through theinfusion device 13 to the patient. The high back pressure provided by the reservoir “A” to the reservoirs “B” through “N” will initially prevent any substantial flow from occurring from the reservoirs “B” through “N” to the infusion device. As a result, the flow rate through the infusion device will be controlled to be at a high constant rate in accordance with the spring pressure provided by the spring of the reservoir “A”. - As the reservoir “A” empties, the spring of the reservoir “A” will eventually contract into the non-constant flow rate region “L”, as shown in
FIG. 3 . At this point of the operation, most of the fluid will have been dispensed from the reservoir “A”. The drop in pressure in the reservoir “A” transmitted to the reservoir “B” will cause the reservoir “B” to transition from the region “H” shown inFIG. 3 into the constant flow rate region “M”, whereupon the flow from the second reservoir “B” to the infusion device will be at a substantially constant rate as the spring of the reservoir “B” contracts. During this period, with the flow from the reservoir “B” substantially constant, there will be still some flow from the reservoir “A”, but the flow from reservoir “A” will be less than 1% of the total volume of flow of the system and most of the flow will be at the substantially constant rate determined by the spring pressure applied to the contained fluid of reservoir “B”. In this manner, a constant stepped-down level of flow is achieved. The pressure in the reservoir “B” in the mid-range “M” will be transmitted to the remaining reservoirs of the system to maintain the remaining reservoirs hyper-inflated and prevent any substantial flow from the remaining hyper-inflated reservoirs. The transition of an outflow coming from reservoir “B” to an outflow coming from the remaining reservoirs will occur in the same manner as described above in connection with the transition from reservoir “A” to reservoir “B”, and as a result the system achieves a stepped flow rate with time as shown inFIG. 2 . - As described above, the system of the invention may comprise more than two reservoirs, but in the most useful application of the invention, only two flow rates are needed, in which case, the system of
FIG. 1 would be implemented with only two reservoirs, “A” and “B”. However, any number of reservoirs, and reservoir configurations can be included to create a desired stepped delivery profile. - In accordance with the preferred embodiment of the invention, the reservoirs are contained in a housing as shown in
FIGS. 4 through 10 . The apparatus has a stable unactuated state as shown inFIG. 4 and an actuated state shown inFIG. 5 . The apparatus comprises anupper housing portion 15 and alower housing portion 17. To actuate the apparatus from the unactuated state shown inFIG. 4 to the actuated state shown inFIG. 5 , the upper andlower housing portions FIG. 5 . Theupper housing portion 15, as shown inFIG. 6 , is provided withtabs 19 which extend radially inward from the bottom edge of theupper housing portion 15. In the assembled device, thetabs 19 fit inslots 21 defined in the cylindrical side wall of thelower housing portion 17. Between theslots 21,ledges 23 extend radially inward from the inner wall of thelower housing portion 17 as shown inFIG. 8 .Ledges 23 support ashelf 25 which is shown inFIG. 9 . Theshelf 25 is provided withslots 27 extending radially inward and the shelf is positioned in thelower housing portion 17 with theslots 27 aligned with theslots 21 in the wall of thelower housing portion 17. - The sectional view of the apparatus shown in
FIG. 10 is taken along different vertical planes extending from the vertical axis of the housing through the sidewalls of the housing as indicated in a view line shown inFIG. 8 .FIG. 10 is a sectional side view of an assembled embodiment of the present invention, where the right side of the sectional view ofFIG. 10 extends through one of theslots 21, and the left side of the sectional view ofFIG. 10 extends through one of theledges 23. As shown inFIG. 10 , areservoir 29 is supported on theshelf 25 and areservoir 31 is supported on abottom wall 33 of thelower housing portion 17. - A first spring, such as a
Belleville spring 35, is provided in the housing in the space between thereservoir 29 and theupper housing portion 15 and is adapted to engage thereservoir 29 when the apparatus is actuated. Asecond Belleville spring 37 is provided in the housing between thereservoir 31 and theshelf 25, and is adapted to engage thereservoir 31 when the apparatus is actuated. - Wedge shaped
bosses 39 are provided on the underside of the top wall of theupper housing portion 15 positioned to engage the radially outer section of the top surface of thespring 35 when the apparatus is actuated and to force thespring 35 into engagement with thereservoir 29. There are four of thebosses 39, which are positioned at 90° intervals around thespring 35. Thetabs 19 engage the radially outer section of the top surface of thespring 37 when the apparatus is being actuated to force thespring 37 in engagement with thereservoir 31. - Wedge shaped
detents 41 extend radially inward from the bottom edge of the inner surface of the sidewalls of the housingupper portion 15 and are lodged in complementary shapedrecesses 43 in the outer surface of the sidewall of the housinglower portion 33 when the apparatus is unactuated, and hold the apparatus stably in the unactuated state. Thedetents 41 slope inwardly from the bottom edge so that they easily slide out of therecesses 43 when the upper andlower housing portions - A second set of
detents 45 are provided on the inner sidewall of theupper housing portion 15 above and vertically aligned with thedetents 41 and are adapted to lodge in therecesses 43 when the apparatus is compressed fully to the actuated state. Thedetents 45 upon lodging in therecesses 43 will hold the apparatus in the actuated state so as to prevent the apparatus from popping back to the unactuated state and prevent reuse of the apparatus. - When the device is actuated both of the
springs spring 35, will be displaced into its operating region “M” and apply a constant force to the fluid in thereservoir 29. The pressure in thereservoir 29 will be transmitted to the fluid in thereservoir 31 by the fluid connection between the reservoirs and cause thespring 37 to be displaced into its operating region “H”. Each reservoir shown generally at 29 and 31, includes at least one fluid connection that connects the reservoirs to a manifold which connects to an infusion device. In the embodiment shown, the manifold can contain a flow restrictor located between the manifold and the infusion device. The infusion device could be a needle which is hidden when the apparatus is unactuated and which is driven into the skin of the patient when the apparatus is actuated. - The resulting apparatus will produce a stepped rate of flow from a high rate to a low rate in the manner described above in connection with
FIG. 1 . The apparatus shown inFIGS. 4 through 10 can be extended to include any number of reservoirs and springs in the stack of reservoirs. In the preferred embodiment all the springs in the apparatus are compressed at once when the apparatus is actuated. However, in another embodiment of the present invention, it is possible to have additional sets of tabs so arranged to actuate the springs in stages with successive detents provided, and with the apparatus actuated successively between stages by increased pressure applied to compress the housing. In such arrangements multiple drug infusion and/or multiple delivery rates could be carried out. - In the above described systems, the reservoirs are connected to a common output connection or manifold as shown in
FIG. 1 . The pressure applied to each of the reservoirs is immediately transmitted to the other reservoirs and as a result, the pressure in all of the reservoirs will be equalized. Thus, the plurality of reservoirs may be considered a reservoir system which applies the same pressure to the fluid contained by the reservoir system. In another embodiment of the present invention, each reservoir, or subgroup of reservoirs, can be separately connected via a separate flow restrictor to an infusion device as shown inFIG. 13 . Reservoirs, or subgroups of reservoirs can also be connected in series as shown inFIG. 15 . In still another embodiment of the present invention, the reservoir system, instead of being a plurality of reservoirs, could be a single reservoir with a plurality of springs having different mid-ranges of operation where the springs apply different constant pressures to the fluid contained in the reservoir system as shown inFIGS. 11 and 12 . - The embodiment of the invention illustrated in
FIGS. 11 and 12 comprises such a system, in which a single reservoir is designed to deliver a therapeutic fluid to an infusion device at an initially high constant rate, which then steps down to a lower constant rate.FIGS. 11 and 12 illustrate the reservoir and spring configuration of the embodiment, wherein the housing is substantially as described above. As shown inFIG. 11 , the system comprises asingle reservoir 51 which is acted upon by Belleville springs 53 and 55 applying pressure to thereservoir 51 from opposite sides.FIG. 11 shows the system in an unactuated state. - When the system is actuated, the
springs spring 53 is compressed into a mid-range “M”, andspring 55, having a different response characteristic, is forced into a high range “H” of operation. In this mid-range, thespring 53 is designed to apply greater force to the reservoir than thespring 55. As a result, the fluid within thereservoir 51 will be pressurized in accordance with the force applied to the reservoir by thespring 53, and thespring 55 will be displaced to its non-constant force region “H”. - When the device is actuated as shown in
FIG. 12 , the fluid will flow out of thereservoir 51 at a constant rate determined by thespring 53, whereupon thespring 53 will pass from the region “M” into the region “L” ofFIG. 3 , and thespring 55 will pass from the region “H” into the region “M”. The rate flow from thereservoir 51 will then be controlled to be at a lower constant rate determined by thespring 55, whereupon thespring 55 will pass from the region “M” into the region “L” ofFIG. 3 , and flow will substantially cease. Thus, in this manner, the system provides a stepped rate of flow starting with an initial high constant rate, and then stepping down to a lower constant rate until complete. - In yet another embodiment of the present invention, instead of connecting the reservoirs through a common flow restrictor, each reservoir could be connected to the infusion device through separate flow restrictors. Some of the reservoirs may be arranged to connect to the infusion device through a common flow restrictor, while other reservoirs are connected to the infusion device through separate flow restrictors as shown in
FIG. 13 . The degree of flow restriction provided by the flow restrictors and the stiffness of each individual spring may be varied to tune the system to achieve the desired variation in flow rate with time.FIG. 14 shows a flow rate variation provided by the system ofFIG. 13 . -
FIG. 15 shows still another embodiment of the present invention and an arrangement of the reservoirs and their interconnection with the infusion device. As shown inFIG. 15 , the outlet of areservoir 67 is connected to aninlet 68 of areservoir 69, which is provided with anoutlet 71 on the opposite side of thereservoir 69 from theinlet 68. Theoutlet 71 is connected through aflow restrictor 73 to aninfusion device 75. In the arrangement ofFIG. 15 , thereservoir 67 is provided with the stronger spring to exert the greatest constant pressure on the contained fluid, whereby thereservoir 69 will be hyper-inflated. With this arrangement, the therapeutic preparation within thereservoir 67 will flow into thereservoir 69 and mix with the therapeutic preparation in thereservoir 69 and the mixed therapeutic preparations will flow from thereservoir 69 through theflow restrictor 73 and theinfusion device 75 to the patient at a constant flow rate determined by the spring of thereservoir 67. - When the
reservoir 67 empties sufficiently to pass into the region “L” as shown inFIG. 3 , the flow rate will drop to that controlled by the spring ofreservoir 69, and the mixture of the two therapeutic preparations will continue to flow from thereservoir 69 through theinfusion device 75 to the patient. The continued flow at the lower constant rate will be a mixture of the two therapeutic preparations because the therapeutic preparation in thereservoir 67 will mix with the therapeutic preparation in thereservoir 69 as it flows into thereservoir 69, and the preparations will remain mixed in thereservoir 69 when the flow from thereservoir 67 drops off, as it passes into the region “L”. Through judicious choice of springs, variations in therapeutic mixture composition can be achieved and delivered. - The arrangement of
FIG. 15 is used to inject a mixture of therapeutic preparations which are not compatible with one another, preventing their being stored in a mixed state. If the delivery time is sufficiently short relative to the pharmacokinetic clearance time, the limited mixing of the pharmaceutical preparations during delivery will not affect either of the pharmaceutical preparations. - In still another embodiment of the present invention shown in
FIG. 16 , amain body 81 hasrecesses recesses body 81. Anupper film 87 closes theupper recess 83 and a lower film 89 closes thelower recess 85 to define upper and lower reservoirs. Thefilms 87 and 89 are bonded to the upper and lower planar surfaces of themain body 81 around the edges of therecesses films 87 and 89 are preferably mechanically held in position on the upper and lower surfaces of themain body 81 by means of retainingrings 90 and 91, respectively. Belleville springs 92 and 93 are arranged to engage and apply spring forces to thefilms 87 and 89, and to the upper and lower reservoirs enclosed in therecesses films 87 and 89. - As shown in
FIG. 16 , themain body 81 further defines a fill-port 95 in the sidewall thereof. The fill-port 95 is connected by afluid connection 97 to the upper and lower reservoirs, that is, the reservoirs created by thefilms 87 and 89 coveringrecesses septum 99. - In addition, the upper reservoir is connected by a
fluid connection 101 to anoutlet port 103, which is closed byseptum 105. Thefluid connection 101 defined in thebody 81 can be made small enough to serve as a flow restrictor for fluid being dispensed from the reservoir. Theseptums - In operation the reservoirs of the device are filled through the fill-port 95 causing the
film members 87 and 89 to inflate and engage thesprings spring 93 may be the stronger spring, such that whenspring 93 is displaced to its mid-range of operation, thespring 92 is displaced to the region “H”. As a result, fluid will be dispensed through theoutlet fluid connection 101 to an infusion device at a high constant initial rate controlled by thespring 93 and thereafter at a stepped down lower rate controlled by thespring 92. - The apparatus of
FIG. 16 is advantageous over prior art designs because it provides a way of doubling the drug capacity of the device without resorting to the use of larger springs. In addition, the device is in the form of a sealed, conveniently modular, drug-filled disk. Moreover, it provides a convenient and compact way for a flow restrictor to be implemented in the fluid pathway from the reservoirs to the infusion device. By employing themain body 81 between the springs of the device, a full range of motion of both springs can be utilized, effectively doubling the delivery capacity of the device without substantially increasing its size. - In still another embodiment, if separate fill ports are provided for each of the reservoirs and a separate fluid connection is provided between the two reservoirs, the upper and lower reservoir may be filled with different therapeutic preparations to be mixed upon infusion. The therapeutic preparation in the lower reservoir with the stronger spring will flow into and mix with the therapeutic preparation in the upper reservoir and the mixed therapeutic preparations will flow through the infusion device to the patient as described in connection with the embodiment of
FIG. 15 . The apparatus ofFIG. 16 thus provides a convenient efficient apparatus for carrying out the concept of the invention illustrated inFIG. 15 . - As described above the springs in the embodiment of
FIG. 16 are put under stress by filling the reservoirs causing thefilms 87 and 89 to expand to engage and displace thesprings springs FIGS. 4 through 10 . - As described above, the system of the present invention provides a delivery system for delivering a therapeutic preparation to a patient by way of infusion, wherein the rate of flow of the therapeutic preparation to the patient is carried at an initially high, generally constant rate, and then is stepped down to one or more lower rates. The device achieves this flow rate control with a simple mechanical construction without the need of pumps or electronics.
- Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims.
Claims (17)
1. A fluid delivery device to deliver a substance to a patient at a stepped decreasing delivery rate comprising:
a reservoir system having at least first and second reservoirs, adapted to apply at least one substantially constant first pressure to a fluid contained in said reservoir system throughout at least one first mid-range of operation to provide a fluid flow;
said reservoir system further adapted to apply at least one substantially constant second pressure to a fluid contained in said reservoir system throughout at least one second mid-range of operation to provide a fluid flow, wherein said second pressure is less than or equal to said first pressure wherein at least a first spring positioned adjacent to said first reservoir to apply pressure to said first reservoir and in response, said first reservoir applying said first pressure to said fluid;
at least a second spring positioned adjacent to said second reservoir to apply pressure to said second reservoir and in response, said second reservoir applying said second pressure to said fluid;
said reservoir system further adapted to apply said first pressure and thereafter said second pressure as fluid flows from said reservoir system, said second pressure applied as a stepped decrease in applied pressure from said first pressure;
an infusion device; and
a fluid connection for communicating said fluid flow from said reservoir system to said infusion device.
2. A fluid delivery device as recited in claim 1 wherein:
said first spring applies a decreasing pressure as said first spring contracts below said first mid-range of operation; and
said second spring applies a decreasing pressure as said second spring contracts below said second mid-range of operation.
3. A fluid delivery device as recited in claim 1 wherein:
said first spring provides said first mid-range of operation while maintaining said first substantially constant pressure on said first reservoir, and provides said fluid flow from said reservoir system at said first substantially constant rate; and
said first substantially constant pressure prevents said second spring from contracting into said second mid-range of operation.
4. A fluid delivery device as recited in claim 1 wherein:
said first spring applies said decreasing pressure as said first spring contracts below said first mid-range of operation and allows said second spring to contract into said second mid-range of operation; and
said second spring provides said second mid-range of operation while maintaining said second substantially constant pressure on said second reservoir, and provides said fluid flow from said reservoir system at said second substantially constant rate, wherein said second substantially constant rate is lower than or equal to said first substantially constant rate.
5. A fluid delivery device as recited in claim 1 wherein:
said fluid connection comprises at least one series connection between an outlet of said first reservoir and an inlet of said second reservoir; and
said fluid connection further comprises a series connection between an outlet of said second reservoir and said infusion device, said outlet of said second reservoir being separate from said inlet of said second reservoir.
6. A fluid delivery device to deliver a substance to a patient at a stepped decreasing delivery rate comprising:
at least first and second reservoirs;
at least first and second springs having at least a mid-range of operation and being positioned adjacent to said first and second reservoirs respectively;
at least one infusion device;
a fluid communication path including said first and second reservoirs, and said at least one infusion device; and
at least one flow restrictor in said fluid communication path.
7. A fluid delivery device as claimed in claim 6 wherein said first and second reservoirs are in parallel in said fluid communication path.
8. A fluid delivery device as claimed in claim 6 wherein said first and second reservoirs are in series in said fluid communication path.
9. A fluid delivery device as claimed in claim 6 wherein at least one reservoir and at least one flow restrictor are in series in said fluid communication path, and at least two reservoirs are in parallel in said fluid communication path.
10. A fluid delivery device as claimed in claim 6 wherein:
a fluid flow is provided by said first and second reservoirs at a first substantially constant flow rate when said first spring is in said first mid-range of operation; and
a fluid flow is provided by said first and second reservoirs at a second substantially constant flow rate when said second spring is in said second mid-range of operation, wherein said second flow rate is less than or equal to said first flow rate.
11. A fluid delivery device to deliver a substance to a patient at a stepped decreasing delivery rate comprising:
first and second reservoirs having at least one common reservoir wall, wherein said first reservoir is disposed on a first surface of said common reservoir wall and said second reservoir disposed on a second surface of said common reservoir wall;
at least first and second springs having at least a mid-range of operation and being positioned adjacent to said first and second reservoirs respectively;
a fluid communication path including said reservoirs and at least one infusion device; and
a flow restrictor in said fluid communication path.
12. A fluid delivery device as claimed in claim 11 further comprising a fill port within said common reservoir wall and accessing said first and second reservoirs.
13. A fluid delivery device as claimed in claim 11 further comprising an outlet port within said common reservoir wall and accessing at least one of said first and second reservoirs.
14. A fluid delivery device as claimed in claim 11 wherein:
a fluid flow is provided by said first and second reservoirs at a first substantially constant flow rate when said first spring is in said first mid-range of operation; and
a fluid flow is provided by said first and second reservoirs at a second substantially constant flow rate when said second spring is in said second mid-range of operation, wherein said second flow rate is less than or equal to said first flow rate.
15. A method for infusing a fluid at a stepped decreasing delivery rate comprising:
applying at least one substantially constant first pressure to a fluid contained in a reservoir system having first and second reservoirs to provide a fluid flow;
applying at least one substantially constant second pressure to a fluid contained in said reservoir system to continue said fluid flow at a reduced rate, wherein said second pressure is less than or equal to said first pressure and is applied as a stepped decrease in applied pressure from said first pressure; and
directing said fluid flow to an infusion device.
16. A method for infusing a fluid as claimed in claim 32 wherein said first and second reservoirs are connected in parallel.
17. A method for infusing a fluid as claimed in claim 32 wherein said first and second reservoirs are connected in series.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/684,837 US20070156086A1 (en) | 2002-03-26 | 2007-03-12 | Multi-stage fluid delivery device and method |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US36721302P | 2002-03-26 | 2002-03-26 | |
US10/396,719 US7214221B2 (en) | 2002-03-26 | 2003-03-26 | Multi-stage fluid delivery device and method |
US11/684,837 US20070156086A1 (en) | 2002-03-26 | 2007-03-12 | Multi-stage fluid delivery device and method |
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US10/396,719 Division US7214221B2 (en) | 2002-03-26 | 2003-03-26 | Multi-stage fluid delivery device and method |
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US20070156086A1 true US20070156086A1 (en) | 2007-07-05 |
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US11/684,837 Abandoned US20070156086A1 (en) | 2002-03-26 | 2007-03-12 | Multi-stage fluid delivery device and method |
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US10/396,719 Active 2024-07-23 US7214221B2 (en) | 2002-03-26 | 2003-03-26 | Multi-stage fluid delivery device and method |
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US (2) | US7214221B2 (en) |
EP (3) | EP3351277A1 (en) |
JP (1) | JP4603266B2 (en) |
CN (1) | CN1784247B (en) |
AU (1) | AU2003218371B2 (en) |
BR (1) | BR0308694A (en) |
CA (1) | CA2480072A1 (en) |
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ES (2) | ES2406711T3 (en) |
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WO2022108901A1 (en) * | 2020-11-17 | 2022-05-27 | Becton, Dickinson And Company | Pressure management method for a drug delivery device |
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ZA200407530B (en) | 2006-06-28 |
US20030216684A1 (en) | 2003-11-20 |
US7214221B2 (en) | 2007-05-08 |
AU2003218371B2 (en) | 2008-06-12 |
DK1594559T3 (en) | 2013-05-27 |
EP1594559A4 (en) | 2008-08-13 |
CA2480072A1 (en) | 2003-10-09 |
WO2003082371A2 (en) | 2003-10-09 |
EP2578253A3 (en) | 2013-11-27 |
EP1594559A2 (en) | 2005-11-16 |
EP2578253A2 (en) | 2013-04-10 |
EP1594559B1 (en) | 2013-02-13 |
WO2003082371A3 (en) | 2006-02-02 |
EP3351277A1 (en) | 2018-07-25 |
CN1784247B (en) | 2010-05-26 |
JP2006507022A (en) | 2006-03-02 |
CN1784247A (en) | 2006-06-07 |
BR0308694A (en) | 2007-01-09 |
ES2673480T3 (en) | 2018-06-22 |
JP4603266B2 (en) | 2010-12-22 |
AU2003218371A1 (en) | 2003-10-13 |
EP2578253B1 (en) | 2018-03-14 |
ES2406711T3 (en) | 2013-06-07 |
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