# US 10,369,299 B2 · Device to determine volume of fluid dispensed

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- Number: US 10,369,299 B2
- Document ID: US10369299B2
- Status: Granted
- Kind: B2
- Application number: 14/872,676
- Filed: 2015-10-01
- Published: 2016-01-28
- Granted: 2019-08-06
- Earliest claimed: 2006-02-09
- Assignees: New Power Concepts LLC
- Applicants: DEKA Products Limited Partnership
- Inventors: Dean Kamen; Larry B. Gray; Russell H. Beavis; John M. Kerwin; Derek G. Kane
- Web page: https://patentgrep.com/patent/US10369299B2

## CPC

- A61M 5/14248: {of the skin patch type}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150175: {Adjustment of penetration depth}
- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap}
- A61B 5/15186: {Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/14212: {Pumping with an aspiration and an expulsion action}
- A61M 5/14232: {Roller pumps}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/14586: {pressurised by means of a flexible diaphragm}
- A61M 5/148: flexible (A61M5/155 takes precedence)
- A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
- A61M 5/16804: {Active flow controllers}
- A61M 5/16809: {by repeated filling and emptying of an intermediate volume}
- A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)}
- A61M 5/3287: {Accessories for bringing the needle into the body; Automatic needle insertion (A61M5/20, A61M5/31525 take precedence)}
- B23P 15/00: Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
- F04B 7/00: Piston machines or pumps characterised by having positively-driven valving
- F04B 43/02: having plate-like flexible members, e.g. diaphragms (F04B43/14 takes precedence)
- F04B 43/09: Pumps having electric drive
- G01F 22/00: Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
- G05D 7/0676: {by action on flow sources (G05D7/0688, G05D7/0694 take precedence)}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/1427: {Multiple blood sampling, e.g. at periodic or pre-established intervals}
- A61B 5/15107: {Piercing being assisted by a triggering mechanism}
- A61B 5/15119: {comprising shape memory alloys}
- A61B 5/15121: {comprising piezos}
- A61B 5/15123: {comprising magnets or solenoids}
- A61B 5/15125: {comprising a vacuum or compressed fluids}
- A61B 5/6833: {Adhesive patches}
- A61B 2560/0412: Low-profile patch shaped housings
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61M 5/141: {with capillaries for restricting fluid flow}
- A61M 5/14216: {Reciprocating piston type}
- A61M 5/14224: {Diaphragm type}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/152: pressurised by contraction of elastic reservoirs
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 5/16813: {by controlling the degree of opening of the flow line}
- A61M 5/16863: {Occlusion detection}
- A61M 5/16886: {for measuring fluid flow rate, i.e. flowmeters}
- A61M 5/172: electrical or electronic
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/365: {Air detectors (A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626)}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 2005/1402: {Priming}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2005/14506: {mechanically driven, e.g. spring or clockwork}
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1583: {Needle extractors}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/0266: Shape memory materials
- A61M 2205/0294: Piezoelectric materials
- A61M 2205/04: implanted
- A61M 2205/16: with back-up system in case of failure
- A61M 2205/18: with alarm
- A61M 2205/3303: Using a biosensor
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3341: stabilising pressure or flow to avoid excessive variation
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3389: Continuous level detection (A61M2205/3393 takes precedence)
- A61M 2205/3523: using telemetric means
- A61M 2205/3546: Range
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/8206: battery-operated
- A61M 2205/8237: Charging means
- A61M 2206/22: eliminating pulsatile flows, e.g. by the provision of a dampening chamber
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2209/045: for filling, e.g. for filling reservoirs
- A61M 2230/201: Glucose concentration
- F04B 43/1253: {by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing}
- F04C 2230/60: Assembly methods
- G05B 23/02: Electric testing or monitoring
- G05D 7/0647: {the plurality of throttling means being arranged in series}
- G08C 17/02: using a radio link
- H04B 7/2609: {Arrangements for range control, e.g. by using remote antennas}
- Y10T 29/49236: Fluid pump or compressor making
- Y10T 29/494: Fluidic or fluid actuated device making
- Y10T 29/49412: with assembly, disassembly or composite article making
- Y10T 29/49826: Assembling or joining
- Y10T 29/49828: Progressively advancing of work assembly station or assembled portion of work
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B23P: METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS (arrangements for copying or controlling B23Q)
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- G05D: SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G08C: TRANSMISSION SYSTEMS FOR MEASURED VALUES, CONTROL OR SIMILAR SIGNALS (fluid pressure transmitting systems F15B; mechanical means for transferring the output of a sensing member into a different variable G01D5/00; mechanical control systems G05G)
- H04B: TRANSMISSION
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

An apparatus for determining the volume of fluid dispensed. The apparatus has an acoustic volume sensor that acoustically excites a reference volume and a measurement chamber with a loudspeaker and measures the acoustic response with microphones acoustically coupled to the reference and the measurement chamber. The loudspeaker and sensing microphones are connected to the measurement chamber by separate ports. A detachable dispensing chamber is coupled to the acoustic volume sensor. The volume of the fluid dispensed is determined by a processor based on the acoustic response of the microphones to acoustic excitement by the loudspeaker.

## Claims

### Claim 1

An apparatus for determining a volume of fluid dispensed comprising:
an acoustic volume sensor comprising:
a structure containing a fixed-volume chamber, a first port, and a measurement chamber, wherein the first port comprises a first tube portion and acoustically couples the fixed-volume chamber to the measurement chamber to form an acoustically contiguous region, the measurement chamber having a gas-filled measurement region;
a printed circuit board disposed within the structure, the printed circuit board defining the fixed-volume chamber within the structure and the printed circuit board including:
a loudspeaker acoustically coupled to the fixed-volume chamber, wherein the loudspeaker excites the acoustically contiguous region;
a reference microphone acoustically coupled to the fixed-volume chamber, the reference microphone producing a first pressure signal based on the response of the fixed-volume chamber to excitement by the loudspeaker; and
a sensing microphone acoustically coupled to the measurement chamber via a second port comprising a second tube portion, the sensing microphone producing a second pressure signal based on the response of the measurement chamber to excitement by the loudspeaker;
a dispensing chamber, containing a variable fluid volume, an exit channel and a resilient membrane, wherein the dispensing chamber is attached to the structure and the resilient membrane defines a boundary of the gas-filled measurement region; and
a processor in communication with the loudspeaker, the reference microphone and the sensing microphone, the processor comprising:
receiving the first pressure signal and the second pressure signal at a first instance;
receiving the first and second pressure signals at a second instance;
determining a change in volume of the gas-filled measurement region associated with the first and second pressure signals at the first instance and the first and second pressure signals at the second instance; and
determining the volume of fluid dispensed from the dispensing chamber to the exit channel associated with the change in the volume of the measurement region.

### Claim 2 (depends on 1)

The apparatus for determining the volume of fluid dispensed according to claim 1 wherein the sensing microphone and loudspeaker are located to prevent loudspeaker pressure waves from impacting the sensing microphone without passing through the measurement chamber.

### Claim 3 (depends on 1)

The apparatus for determining the volume of fluid dispensed according to claim 1 further comprising a flared aperture attached to at least one of the first and second ports, wherein the flared aperture is further attached to the measurement chamber.

### Claim 4 (depends on 1)

The apparatus for determining the volume of fluid dispensed according to claim 1 further comprising a dispensing spring, wherein the dispensing spring provides additional resilience to the resilient membrane.

### Claim 5 (depends on 4)

The apparatus for determining the volume of fluid dispensed according to claim 4 wherein the dispensing spring is part of the acoustic volume sensor.

### Claim 6 (depends on 1)

The apparatus for determining the volume of fluid dispensed according to claim 1 further comprising a reservoir, valve, and a fluid line wherein the fluid line fluidically connects the reservoir to the valve and fluidically connects the valve to the dispensing chamber.