US20080196762A1 - Systems and methods for the accurate delivery of flow materials - Google Patents

Systems and methods for the accurate delivery of flow materials Download PDF

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Publication number
US20080196762A1
US20080196762A1 US12/108,462 US10846208A US2008196762A1 US 20080196762 A1 US20080196762 A1 US 20080196762A1 US 10846208 A US10846208 A US 10846208A US 2008196762 A1 US2008196762 A1 US 2008196762A1
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flow
pump
chamber
flow rate
chambers
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US12/108,462
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Scott Mallett
Paul Mario DiPerna
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Tandem Diabetes Care Inc
pHluid Inc
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Individual
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Assigned to TANDEM DIABETES CARE, INC reassignment TANDEM DIABETES CARE, INC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHLUID, INC.
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Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHLUID, INC.
Assigned to PHLUID, INC. reassignment PHLUID, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIPERNA, PAUL
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHLUID, INC.
Assigned to PHLUID, INC. reassignment PHLUID, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIPERNA, PAUL
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHLUID, INC.
Assigned to PHLUID, INC. reassignment PHLUID, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIPERNA, PAUL MARIO
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHLUID, INC.
Assigned to PHLUID, INC. reassignment PHLUID, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIPERNA, PAUL
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Assigned to CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P., CAPITAL ROYALTY PARTNERS II (CAYMAN) L.P., CAPITAL ROYALTY PARTNERS II L.P., PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P. reassignment CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P. SHORT-FORM PATENT SECURITY AGREEMENT Assignors: TANDEM DIABETES CARE, INC.
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Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: CAPITAL ROYALTY PARTNERS II (CAYMAN) L.P., CAPITAL ROYALTY PARTNERS II L.P., CAPITAL ROYALTY PARTNERS II L.P. - PARALLEL FUND "A" L.P., PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Abandoned legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/05—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using mechanical effects
    • G01F1/34—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using mechanical effects by measuring pressure or differential pressure
    • 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
    • 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
    • A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
    • A61M5/14593—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
    • 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
    • A61M5/16809—Flow controllers by repeated filling and emptying of an intermediate volume
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/02—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement
    • G01F11/04—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the free-piston type
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/0318—Processes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/8593—Systems
    • Y10T137/85978—With pump
    • Y10T137/85986—Pumped fluid control

Definitions

  • This disclosure relates to an apparatus and associated methods for dispensing flow materials, such as fluids or gasses at known, measurable, and adjustable rates. Additionally, the present disclosure relates to flow regulators, flow restrictors having reshapable lumina which reshape as a function of pressure, which results in an increase in the flow rate by about a fourth order of magnitude, as well as clamps that are adjustable based on the observed flow rate.
  • Pumps and flow regulators provide relatively constant and known flow volume over time while maintaining isolation of the flow material.
  • the pumps of the present disclosure provide real time monitoring of the volume of flow material delivered over time, and provides for adjustment of the pump or flow regulators to modulate the flow rate.
  • flow may be substantially modeled to a desired flow profile with real time adjustments of the flow rates.
  • FIG. 1 is a block diagram of an embodiment of a sequence of the devices of the present disclosure in the direction of the flow of a flow material;
  • FIG. 2 is a block diagram of an embodiment of the interrelationship of the devices of the present disclosure
  • FIG. 3 is a perspective view of an embodiment of a pump of the present disclosure having three chambers;
  • FIG. 4 is a perspective view of an embodiment of a pump of the present disclosure having two chambers
  • FIG. 5 is a perspective view of an embodiment of a pump of the present disclosure having two chambers
  • FIG. 6 is a perspective view of an embodiment of a pump of the present disclosure having two chambers
  • FIGS. 7A to 7C are graphs of an embodiment illustrating the relationship of volume of the chambers of a three chamber pump as flow material flows by action of the pump;
  • FIGS. 8A and 8B are perspective views of an embodiment of a flow regulator
  • FIG. 9 is a side view of an embodiment of a flow regulator.
  • FIG. 10 is a graph illustrating the combined flow potential of the combination of the flow regulators and pump of the present disclosure that provide for relatively accurate flow over time of a flow material based on the flow rate feedback provided from the pump.
  • real time shall be understood to mean the instantaneous moment of an event/condition or the instantaneous moment of an event/condition plus short period of elapsed time used to make relevant measurements, optional computations, and communicate the measurement or computation, wherein the state of an event/condition being measured is substantially the same as that of the instantaneous moment irrespective of the elapsed time interval. Used in this context “substantially the same” shall be understood to mean that the data for the event/condition remains useful for the purpose for which it is being gathered after the elapsed time period.
  • Incorporated by reference are pumps, including infusion pumps, that measure flow rate in real time or about real time.
  • Incorporated by reference are flow regulators, including flow restrictors and clamps that are useful for modulating flow rate.
  • the present disclosure is directed to systems and methods for the substantially accurate delivery of flow material over time. For example, insulin dosages must be accurately delivered to patients over time.
  • the present disclosure provides devices and methods that allow for accurate delivery of flow materials at relatively constant, yet adjustable, flow rates.
  • the inventors of the present disclosure have discovered novel systems and methods for the delivery of flow materials controllably and predictably. Specifically, the systems and methods of the present disclosure accomplish the substantially accurate delivery of flow materials while isolating the flow material.
  • the lack of contact (isolation) between control and measurement devices and the flow material is useful in many applications, including the delivery of sterile flow materials or flow materials that cannot be contacted for safety reasons.
  • FIG. 1 there is shown a system for dispensing a flow material.
  • the system comprises pump 100 , flow regulator 200 , and delivery device 300 .
  • pump 100 comprises an infusion pump that (1) provides feedback as to the flow rate in about real time, and (2) maintains isolation of the flow material from the devices for effecting delivery and measuring flow rate.
  • Flow regulator 200 comprises one or more devices disposed downstream from pump 100 designed to regulate flow rate and provide relatively constant flow, including adjustably constant flow (substantially constant flow rate that may be adjusted as needed in real time).
  • flow regulator 200 may be omitted from the devices of the present disclosure, according to various embodiments.
  • Flow regulators include, among other devices, flow restrictors, clamps, etc., disclosed in the incorporated references, as well as those well known and understood by artisans.
  • Delivery device 300 comprises those devices and implements that facilitate delivery from the pump to a specific target.
  • delivery device 300 includes tubing, needles, luer connectors, etc., which are readily identifiable by artisans on a case-by-case basis.
  • pumps 100 and flow regulators 200 may by regulated via a microprocessor to provide control or adjustability to flow rate, as illustrated by an embodiment of the interrelationship in FIG. 2 .
  • microprocessor 500 monitors the state of the devices of the present disclosure at time intervals. Accordingly, flow rate from pump 100 is determined using pressure sensor(s) 504 and temperature sensor(s) 506 .
  • Clock 502 provides a time interval measurement device, whereby flow rate data 508 from pump 100 may be determined in about real time.
  • adjustments may be made to the devices disclosed herein to adjust flow rate 510 .
  • adjustments to flow rate are effected by modulating pump 100 to increase or decrease flow rate, as disclosed in the incorporated applications.
  • flow regulators 200 may be adjusted 512 to provide relatively constant flow rate.
  • Flow regulators 200 may either be passive or self adjustable, that is they are adjusted based on the inherent flow characteristics of the flow materials (e.g., the pressure of flow material, the volume of flow material, etc.) or are controlled actively by microprocessor 500 .
  • microprocessor 500 controls output devices 514 responsible for adjustments to pump 100 or flow regulator 200 .
  • FIG. 3 illustrates an embodiment of pump 100 that may be used in accordance with the present disclosure.
  • pump 100 comprises first chamber 110 , second chamber 120 , and third chamber 125 .
  • First chamber 110 and second chamber 120 hold gas 112 .
  • the gas is pressurized in first chamber 110 and released into second chamber 120 to drive the device separating second chamber 120 from third chamber 130 .
  • flow material 113 in third chamber 125 is isolated from gas 112 and the devices to measure flow rate or flow volume, namely pressure sensors 115 , 117 .
  • temperature sensors may also be disposed within first and second chamber to improve the accuracy to the flow volume measurements.
  • FIG. 4 illustrates embodiments of pump 100 that may be used in accordance with the present disclosure.
  • Pump 100 comprises first chamber 110 and second chamber 120 , together with pressure sensor 115 .
  • a temperature sensor may be optionally installed to improve accuracy for flow rate or flow volume determination.
  • flow material contained in second chamber 120 is isolated from the gas and the devices to measure flow rate or flow volume. Flow material travels through flow conduit 130 , and may flow through flow regulator 200 , according to embodiments.
  • the embodiment illustrated in FIG. 4 provides fill conduit 150 for refilling second chamber with flow material.
  • an initial calibration is performed and after first chamber 110 , is pressurized whereby the volume in second chamber 120 may be determined at any point during flow of the flow material.
  • FIG. 5 illustrates embodiments of a variation of FIG. 4 , where first chamber 110 comprises a collapsible or flexible container.
  • first chamber 110 is a container that is hangable from intravenous hanging devices standard in most hospitals.
  • FIG. 6 illustrates embodiments of a variation of FIGS. 4 and 5 , where first chamber 110 and second chamber 120 are separated by a movable barrier 122 .
  • FIG. 7A-7C illustrates the volume characteristics of each chamber of pump 100 , illustrated by a pump has three chambers (for example, the embodiment illustrated in FIG. 3 ) by the solid lines and a pump that has 2 chambers for the dashed line. Accordingly, the volume of first chamber 110 remains constant throughout operation. Because the pressure of first chamber 110 is much greater than the pressure of second chamber 120 , according to embodiments, first chamber 110 maintains sufficient pressure to deliver flow material from third chamber 125 .
  • the volume in second chamber 120 increases thereby decreasing the pressure in second chamber 120 .
  • the change in volume slows until it reaches equilibrium with the pressure (plus other physical factors that impede flow of the flow material) in third chamber 125 .
  • the change in volume in third chamber 125 mirrors that of second chamber 120 , whereby the volume of second chamber 120 and third chamber 125 together is constant.
  • FIGS. 4-6 there would be no parabolic, stepwise appearance. Rather the entire line for both chambers would represent a parabolic change in volume profile shown by the dashed lines for FIGS. 7A and 7B . Where flow regulators are disposed downstream, these lines maybe modified to be substantially linear.
  • the dispensed volume of flow material 113 from pump 100 may be determined. Because the time interval is also known, flow rate may also be calculated, according to embodiments. Thus, according to embodiments, knowledge of flow volume or flow rate allows the parameters driving pump 100 to be adjusted to dispense flow material in a known, substantially controlled manner. For example, according to embodiment illustrated in FIG. 3 , if the flow rate is determined to be too rapid, microprocessor 500 may delay effecting the delivery of the next aliquot of pressurized gas from first chamber 110 to second chamber 120 for a prescribed time period.
  • Flow regulators 200 may also be used to provide adjustments to achieve substantially constant flow rate.
  • control of flow rate may be effected through the use of flow regulators 200 .
  • flow regulator 200 comprises a flow restrictor as illustrated in FIGS. 8A and 8B .
  • flow regulator 200 comprises a predictably flexible member having lumen 222 .
  • Increased pressure of flow material causes the aperture of lumen 222 to increase in a predictable fashion as described in greater detail in incorporated by reference U.S. Utility application Ser. Nos. 11/462,962 (filed Aug. 7, 2006) and 11/694,841 (filed Mar. 30, 2007).
  • these flow regulators are controlled indirectly by pump 100 , because either the pressure of flow material or volume of flow material is outcome determinative of the flow rate.
  • flow regulator 200 may also comprise pump 214 and expandable member 210 system as shown in an embodiment illustrated in FIG. 9 .
  • Expandable member 210 expands and contracts within lumen 222 of vessel for transporting flow material 220 .
  • the pressure within expandable member 210 is increased by pump 214 to cause expandable member 210 to occupy additional cross sectional area of lumen 222 , as described in greater detail in incorporated by reference U.S. Utility application Ser. No. 12/039,693 (filed Feb. 28, 2008).
  • Such flow regulators 200 may be coupled to microprocessor 500 to effect a known, substantially controlled flow rate or delivered flow volume.
  • microprocessor 500 controls flow regulator 200 , according to embodiments, the flow rate or delivered flow volume over time is adjustable in real time.
  • the combination of at least pump 100 or pump 100 and at least one flow regulator 200 provide a predicable flow rate profile that may be adjusted to some predetermined flow profile, while preserving isolation of the flow material.
  • a predetermined flow profile is illustrated by the line representing “Desired Flow Rate.” Because of the many variables at play in pumping a flow material, however, the “Actual Flow Rate” does not exactly model the desired flow rate. However, using microprocessor to modulate flow rate based on real time flow rate feedback from pump 100 , pump 100 or flow regulator 200 may be adjusted (illustrated by the solid line in FIG. 10 ) as disclosed herein and in the incorporated by reference patent applications to substantially model the predetermined flow profile.
  • predetermined flow profile is both linear and constant in FIG. 10 ; according to embodiments, however, the predetermined flow profile need be neither linear nor constant.
  • the real time feedback provided by pump 100 will allow nearly any conceivable predetermined flow profile, provided the line representing the course is continuous.
  • the pump will both dispense flow material and measure flow rate.
  • One or more flow regulators will be disposed downstream of the pump, according to embodiments. Other embodiments will omit the flow regulator.
  • Microprocessor will obtain readings from the sensors and clock and calculate volume dispense or flow rate, which data will them be used by microprocessor to output adjustments to at least one of the pump or flow regulator (s) to substantially effect a desired flow profile by modulating the flow rate using the devices and methods disclosed herein and within the incorporated by reference applications.

Abstract

Pumps and flow regulators provide relatively constant and known flow volume over time while maintaining isolation of the flow material. The pumps of the present disclosure provide real time monitoring of the volume of flow material delivered over time, and provides for adjustment of the pump or flow regulators to modulate the flow rate. Thus, flow may be substantially modeled to a desired flow profile with real time adjustments of the flow rates.

Description

    RELATED APPLICATION
  • This application is a continuation of and claims the benefit of and Paris Convention priority of U.S. Utility application Ser. Nos. 11/343,817, filed 31 Jan. 2006; 11/462,962, filed 7 Aug. 2006; 11/694,841, filed 30 Mar. 2007; 11/744,819, filed 4 May 2007; 12/020,498, filed 25 Jan. 2008; and 12/039,693, filed 28 Feb. 2008, the contents of which are each incorporated by reference herein in its entirety.
    • BACKGROUND
  • This disclosure relates to an apparatus and associated methods for dispensing flow materials, such as fluids or gasses at known, measurable, and adjustable rates. Additionally, the present disclosure relates to flow regulators, flow restrictors having reshapable lumina which reshape as a function of pressure, which results in an increase in the flow rate by about a fourth order of magnitude, as well as clamps that are adjustable based on the observed flow rate.
    • SUMMARY
  • Pumps and flow regulators provide relatively constant and known flow volume over time while maintaining isolation of the flow material. The pumps of the present disclosure provide real time monitoring of the volume of flow material delivered over time, and provides for adjustment of the pump or flow regulators to modulate the flow rate. Thus, flow may be substantially modeled to a desired flow profile with real time adjustments of the flow rates.
    • DRAWINGS
  • The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which:
  • FIG. 1 is a block diagram of an embodiment of a sequence of the devices of the present disclosure in the direction of the flow of a flow material;
  • FIG. 2 is a block diagram of an embodiment of the interrelationship of the devices of the present disclosure;
  • FIG. 3 is a perspective view of an embodiment of a pump of the present disclosure having three chambers;
  • FIG. 4 is a perspective view of an embodiment of a pump of the present disclosure having two chambers;
  • FIG. 5 is a perspective view of an embodiment of a pump of the present disclosure having two chambers;
  • FIG. 6 is a perspective view of an embodiment of a pump of the present disclosure having two chambers;
  • FIGS. 7A to 7C are graphs of an embodiment illustrating the relationship of volume of the chambers of a three chamber pump as flow material flows by action of the pump;
  • FIGS. 8A and 8B are perspective views of an embodiment of a flow regulator;
  • FIG. 9 is a side view of an embodiment of a flow regulator; and
  • FIG. 10 is a graph illustrating the combined flow potential of the combination of the flow regulators and pump of the present disclosure that provide for relatively accurate flow over time of a flow material based on the flow rate feedback provided from the pump.
    •  DETAILED DESCRIPTION
  • Specific reference is made to the patent applications incorporated by reference herein, including U.S. Utility application Ser. Nos. 11/343,817, filed 31 Jan. 2006; 11/462,962, filed 7 Aug. 2006; 11/694,841, filed 30 Mar. 2007; 11/744,819, filed 4 May 2007; 12/020,498, filed 25 Jan. 2008; and 12/039,693, filed 28 Feb. 2008.
  • In the following detailed description of embodiments of the invention, reference is made to the accompanying drawings in which like references indicate similar elements, and in which is shown by way of illustration specific embodiments in which the present disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present disclosure, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical, functional, and other changes may be made without departing from the scope of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims. As used in the present disclosure, the term “or” shall be understood to be defined as a logical disjunction and shall not indicate an exclusive disjunction unless expressly indicated as such or notated as “xor.”
  • As used herein, the term “real time” shall be understood to mean the instantaneous moment of an event/condition or the instantaneous moment of an event/condition plus short period of elapsed time used to make relevant measurements, optional computations, and communicate the measurement or computation, wherein the state of an event/condition being measured is substantially the same as that of the instantaneous moment irrespective of the elapsed time interval. Used in this context “substantially the same” shall be understood to mean that the data for the event/condition remains useful for the purpose for which it is being gathered after the elapsed time period.
  • Incorporated by reference are pumps, including infusion pumps, that measure flow rate in real time or about real time. Incorporated by reference are flow regulators, including flow restrictors and clamps that are useful for modulating flow rate. The present disclosure is directed to systems and methods for the substantially accurate delivery of flow material over time. For example, insulin dosages must be accurately delivered to patients over time. The present disclosure provides devices and methods that allow for accurate delivery of flow materials at relatively constant, yet adjustable, flow rates.
  • The inventors of the present disclosure have discovered novel systems and methods for the delivery of flow materials controllably and predictably. Specifically, the systems and methods of the present disclosure accomplish the substantially accurate delivery of flow materials while isolating the flow material. The lack of contact (isolation) between control and measurement devices and the flow material is useful in many applications, including the delivery of sterile flow materials or flow materials that cannot be contacted for safety reasons.
  • According to embodiments illustrated by FIG. 1, there is shown a system for dispensing a flow material. The system comprises pump 100, flow regulator 200, and delivery device 300. According to embodiments, pump 100 comprises an infusion pump that (1) provides feedback as to the flow rate in about real time, and (2) maintains isolation of the flow material from the devices for effecting delivery and measuring flow rate.
  • Flow regulator 200 comprises one or more devices disposed downstream from pump 100 designed to regulate flow rate and provide relatively constant flow, including adjustably constant flow (substantially constant flow rate that may be adjusted as needed in real time).
  • According to the embodiments, flow regulator 200 may be omitted from the devices of the present disclosure, according to various embodiments. Flow regulators include, among other devices, flow restrictors, clamps, etc., disclosed in the incorporated references, as well as those well known and understood by artisans.
  • Delivery device 300 comprises those devices and implements that facilitate delivery from the pump to a specific target. In medical applications, for example, delivery device 300 includes tubing, needles, luer connectors, etc., which are readily identifiable by artisans on a case-by-case basis.
  • According to embodiments, and as disclosed herein and in the incorporated references, pumps 100 and flow regulators 200 may by regulated via a microprocessor to provide control or adjustability to flow rate, as illustrated by an embodiment of the interrelationship in FIG. 2. As illustrated in FIG. 2 and disclosed more fully in the incorporated applications, microprocessor 500 monitors the state of the devices of the present disclosure at time intervals. Accordingly, flow rate from pump 100 is determined using pressure sensor(s) 504 and temperature sensor(s) 506. Clock 502 provides a time interval measurement device, whereby flow rate data 508 from pump 100 may be determined in about real time.
  • Using flow rate data 508, adjustments may be made to the devices disclosed herein to adjust flow rate 510. According to embodiments, adjustments to flow rate are effected by modulating pump 100 to increase or decrease flow rate, as disclosed in the incorporated applications. Similarly, flow regulators 200 may be adjusted 512 to provide relatively constant flow rate. Flow regulators 200 may either be passive or self adjustable, that is they are adjusted based on the inherent flow characteristics of the flow materials (e.g., the pressure of flow material, the volume of flow material, etc.) or are controlled actively by microprocessor 500. According to embodiments, microprocessor 500 controls output devices 514 responsible for adjustments to pump 100 or flow regulator 200.
  • FIG. 3 illustrates an embodiment of pump 100 that may be used in accordance with the present disclosure. Incorporated by reference U.S. Utility patent application Ser. Nos. 11/343,817 (filed Jan. 31, 2006), 11/744,819 (filed May 4, 2007), and 12/020,498 (filed Jan. 25, 2008) disclose pumps 100 suitable for use in the present disclosure, for example. As shown in the embodiment in FIG. 3, pump 100 comprises first chamber 110, second chamber 120, and third chamber 125. First chamber 110 and second chamber 120 hold gas 112. The gas is pressurized in first chamber 110 and released into second chamber 120 to drive the device separating second chamber 120 from third chamber 130. Artisans will recognize that flow material 113 in third chamber 125 is isolated from gas 112 and the devices to measure flow rate or flow volume, namely pressure sensors 115, 117. Optionally, temperature sensors may also be disposed within first and second chamber to improve the accuracy to the flow volume measurements.
  • FIG. 4 illustrates embodiments of pump 100 that may be used in accordance with the present disclosure. Pump 100 comprises first chamber 110 and second chamber 120, together with pressure sensor 115. A temperature sensor may be optionally installed to improve accuracy for flow rate or flow volume determination. As with the previous embodiments, flow material contained in second chamber 120 is isolated from the gas and the devices to measure flow rate or flow volume. Flow material travels through flow conduit 130, and may flow through flow regulator 200, according to embodiments. The embodiment illustrated in FIG. 4 provides fill conduit 150 for refilling second chamber with flow material.
  • In two chamber versions of pump 100, an initial calibration is performed and after first chamber 110, is pressurized whereby the volume in second chamber 120 may be determined at any point during flow of the flow material.
  • FIG. 5 illustrates embodiments of a variation of FIG. 4, where first chamber 110 comprises a collapsible or flexible container. For example, first chamber 110 is a container that is hangable from intravenous hanging devices standard in most hospitals.
  • Likewise, FIG. 6 illustrates embodiments of a variation of FIGS. 4 and 5, where first chamber 110 and second chamber 120 are separated by a movable barrier 122.
  • According to embodiments, FIG. 7A-7C illustrates the volume characteristics of each chamber of pump 100, illustrated by a pump has three chambers (for example, the embodiment illustrated in FIG. 3) by the solid lines and a pump that has 2 chambers for the dashed line. Accordingly, the volume of first chamber 110 remains constant throughout operation. Because the pressure of first chamber 110 is much greater than the pressure of second chamber 120, according to embodiments, first chamber 110 maintains sufficient pressure to deliver flow material from third chamber 125.
  • Because a movable barrier is disposed between second chamber 120 and third chamber 125 in the exemplary example of FIG. 3 (or due to the movable or collapsible nature of the second chamber 120 in FIGS. 4-6), these volumes of each of second chamber 120 and third chamber 125 are variable. As observed in FIG. 7B, over the time interval from time (t) zero to time 11, the volume of second chamber 120 rises as flow material is dispensed from pump 100 due to operation of the movable barrier and pressure that is transferred from first chamber 110 to second chamber 120, wherein the pressure in second chamber 120 exceeds the pressure in third chamber 125, thereby advancing movable barrier in the direction of third chamber 125. Because discrete aliquots of pressure are delivered from first chamber 110 to second chamber 120 at various time intervals, the change in volume is greatest when the pressure differential between second chamber 120 and third chamber 125 is greatest.
  • As the movable barrier advances, the volume in second chamber 120 increases thereby decreasing the pressure in second chamber 120. Thus, with less pressure exerted on the movable barrier, the change in volume slows until it reaches equilibrium with the pressure (plus other physical factors that impede flow of the flow material) in third chamber 125. The change in volume in third chamber 125 mirrors that of second chamber 120, whereby the volume of second chamber 120 and third chamber 125 together is constant.
  • According to the embodiments in FIGS. 4-6, there would be no parabolic, stepwise appearance. Rather the entire line for both chambers would represent a parabolic change in volume profile shown by the dashed lines for FIGS. 7A and 7B. Where flow regulators are disposed downstream, these lines maybe modified to be substantially linear.
  • Based on the measurements of the temperature sensor(s) 115, 117, the dispensed volume of flow material 113 from pump 100 may be determined. Because the time interval is also known, flow rate may also be calculated, according to embodiments. Thus, according to embodiments, knowledge of flow volume or flow rate allows the parameters driving pump 100 to be adjusted to dispense flow material in a known, substantially controlled manner. For example, according to embodiment illustrated in FIG. 3, if the flow rate is determined to be too rapid, microprocessor 500 may delay effecting the delivery of the next aliquot of pressurized gas from first chamber 110 to second chamber 120 for a prescribed time period. If the flow rate is determined to be too slow, more rapid delivery of aliquots of pressurized gas from first chamber 100 to second chamber 120 may be effected, thereby causing the flow rate to be more rapid for a longer period of time (see FIG. 7B and FIG. 7C). Flow regulators 200 may also be used to provide adjustments to achieve substantially constant flow rate.
  • According to embodiments, such as those illustrated in FIGS. 4-6, control of flow rate may be effected through the use of flow regulators 200. For example and according to embodiments, flow regulator 200 comprises a flow restrictor as illustrated in FIGS. 8A and 8B. Accordingly, flow regulator 200 comprises a predictably flexible member having lumen 222. Increased pressure of flow material causes the aperture of lumen 222 to increase in a predictable fashion as described in greater detail in incorporated by reference U.S. Utility application Ser. Nos. 11/462,962 (filed Aug. 7, 2006) and 11/694,841 (filed Mar. 30, 2007). According to embodiments, these flow regulators are controlled indirectly by pump 100, because either the pressure of flow material or volume of flow material is outcome determinative of the flow rate.
  • According to embodiments, flow regulator 200 may also comprise pump 214 and expandable member 210 system as shown in an embodiment illustrated in FIG. 9. Expandable member 210 expands and contracts within lumen 222 of vessel for transporting flow material 220. Thus, when a slow flow rate is needed, the pressure within expandable member 210 is increased by pump 214 to cause expandable member 210 to occupy additional cross sectional area of lumen 222, as described in greater detail in incorporated by reference U.S. Utility application Ser. No. 12/039,693 (filed Feb. 28, 2008). Such flow regulators 200 may be coupled to microprocessor 500 to effect a known, substantially controlled flow rate or delivered flow volume. Moreover, because microprocessor 500 controls flow regulator 200, according to embodiments, the flow rate or delivered flow volume over time is adjustable in real time.
  • Artisans will recognize that other flow regulators that have the characteristics of providing a predictable flow rate either via a feedback mechanism or by the pump are expressly and inherently contemplated as being within the range of equivalents of the flow regulators applicable to the present disclosure.
  • The combination of at least pump 100 or pump 100 and at least one flow regulator 200 provide a predicable flow rate profile that may be adjusted to some predetermined flow profile, while preserving isolation of the flow material. For example, as illustrated in FIG. 10, a predetermined flow profile is illustrated by the line representing “Desired Flow Rate.” Because of the many variables at play in pumping a flow material, however, the “Actual Flow Rate” does not exactly model the desired flow rate. However, using microprocessor to modulate flow rate based on real time flow rate feedback from pump 100, pump 100 or flow regulator 200 may be adjusted (illustrated by the solid line in FIG. 10) as disclosed herein and in the incorporated by reference patent applications to substantially model the predetermined flow profile. Artisans will readily observe that the predetermined flow profile is both linear and constant in FIG. 10; according to embodiments, however, the predetermined flow profile need be neither linear nor constant. The real time feedback provided by pump 100 will allow nearly any conceivable predetermined flow profile, provided the line representing the course is continuous.
  • Also disclosed herein are methods for accomplishing the same as disclosed in detail in the incorporated by reference patent applications. Generally, the pump will both dispense flow material and measure flow rate. One or more flow regulators will be disposed downstream of the pump, according to embodiments. Other embodiments will omit the flow regulator. Microprocessor will obtain readings from the sensors and clock and calculate volume dispense or flow rate, which data will them be used by microprocessor to output adjustments to at least one of the pump or flow regulator (s) to substantially effect a desired flow profile by modulating the flow rate using the devices and methods disclosed herein and within the incorporated by reference applications.
  • While the apparatus and method have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not to be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.

Claims (20)

1. A system comprising:
an pump that is configured to measure flow rate of a flow material in about real time; and
at least one flow regulator for providing substantially constant flow rate;
wherein at least one operating parameter of the pump is adjustable to change the flow rate in about real time.
2. The system of claim 1, wherein the at least one flow regulator comprises a variable flow reshapable flow restrictor.
3. The system of claim 1, wherein the at least one flow regulator comprises an adjustable clamp system.
4. The system of claim 1, wherein the at least one flow regulator comprises a variable flow reshapable flow restrictor and an adjustable clamp system.
5. The system of claim 1, wherein the flow material is isolated from the devices of the pump for pumping the flow material and measuring the flow material.
6. The system of claim 1, wherein the flow material is contained in a sterile chamber and the pump preserves the sterility of the flow material.
7. The system of claim 1, wherein the pump comprises at least two chambers.
8. The system of claim 7, wherein the pump comprises at least three chambers.
9. The system of claim 7, wherein the pump comprises at least three chambers.
10. The system of claim 1, further comprising a microprocessing unit that is configured to accept and substantially execute a flow profile.
11. A method comprising providing:
a pump capable of measuring flow rate of a flow material in about real time;
a microprocessor for determining a flow volume over an elapsed time period; and
a flow regulator for modulating a flow rate within a specified range of flow rates;
wherein the flow material is isolated from the devices used to measure flow rate.
12. The method of claim 11, wherein the at least one flow regulator comprises a variable flow reshapable flow restrictor.
13. The method of claim 11, wherein the at least one flow regulator comprises an adjustable clamp system.
14. The method of claim 11, wherein the at least one flow regulator comprises a variable flow reshapable flow restrictor and an adjustable clamp system.
15. The method of claim 11, wherein the flow material is isolated from the devices of the pump for pumping the flow material and measuring the flow material.
16. The method of claim 11, wherein the flow material is contained in a sterile chamber and the pump preserves the sterility of the flow material.
17. The method of claim 11, wherein the pump comprises at least two chambers.
18. The method of claim 17, wherein the pump comprises at least three chambers.
19. The method of claim 17, wherein the pump comprises at least three chambers.
20. The method of claim 11, further comprising a microprocessing unit that is configured to accept and substantially execute a flow profile.
US12/108,462 2002-07-19 2008-04-23 Systems and methods for the accurate delivery of flow materials Abandoned US20080196762A1 (en)

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US10/200,109 US7008403B1 (en) 2002-07-19 2002-07-19 Infusion pump and method for use
US11/343,817 US7374556B2 (en) 2002-07-19 2006-01-31 Infusion pump and method for use
US12/108,462 US20080196762A1 (en) 2002-07-19 2008-04-23 Systems and methods for the accurate delivery of flow materials

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US11/343,817 Expired - Fee Related US7374556B2 (en) 2002-07-19 2006-01-31 Infusion pump and method for use
US12/108,462 Abandoned US20080196762A1 (en) 2002-07-19 2008-04-23 Systems and methods for the accurate delivery of flow materials

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US11/343,817 Expired - Fee Related US7374556B2 (en) 2002-07-19 2006-01-31 Infusion pump and method for use

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JP2005533559A (en) 2005-11-10

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