Device to dispense fluids

• US 10,232,131 B2
• Filed: 10/01/2015
• Issued: 03/19/2019
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Gray, Larry B., Beavis, Russell H., Kerwin, John M., Kane, Derek G.
• Primary Examiner(s): Stimpert, Philip
• Application Number:
  US14/872,761
• Publication Number:
  US 20160022903A1
• Time in Patent Office: 1,265 Days
• Field of Search: 7386118, 7386127, 7386128
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 : with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 : mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1581 : Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 : Needle extractors
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 2005/1586 : Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/16863 : Occlusion detection
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/0294 : Piezoelectric materials
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 : Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3341 : stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3389 : Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/3546 : Range
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2206/22 : eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2207/00 : Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 : for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/141 : with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1413 : Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14216 : Reciprocating piston type
• CPC Class Codes: A61M 5/14224 : Diaphragm type
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 : pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/148 : flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/152 : pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/168 : 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 flow control in general G05D7/00
• CPC Class Codes: A61M 5/16804 : Flow controllers
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 : by controlling the degree of opening of the flow line
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/16886 : for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: B23P 15/00 : Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/09 : Pumps having electric drive
• CPC Class Codes: F04B 43/1253 : by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 7/00 : Piston machines or pumps characterised by having positively-driven valving
• CPC Class Codes: F04C 2230/60 : Assembly methods
• CPC Class Codes: G01F 22/00 : Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
• CPC Class Codes: G05B 23/02 : Electric testing or monitoring
• CPC Class Codes: G05D 7/0647 : the plurality of throttling means being arranged in series
• CPC Class Codes: G05D 7/0676 : by action on flow sources G05D7/0688, G05D7/0694 take precedence
• CPC Class Codes: G08C 17/02 : using a radio link
• CPC Class Codes: H04B 7/2609 : Arrangements for range control, e.g. by using remote antennas
• CPC Class Codes: Y10T 29/49236 : Fluid pump or compressor making
• CPC Class Codes: Y10T 29/494 : Fluidic or fluid actuated device making
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/49828 : Progressively advancing of work assembly station or assembled portion of work

Abstract

An apparatus to dispense fluids may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. The apparatus includes an acoustic volume sensor that acoustically excites a fixed-volume chamber and a measurement chamber with a loudspeaker and measures the acoustic response with microphones acoustically coupled to the fixed volume chamber 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

1. An apparatus to dispense fluid comprising:

a first portion containing a substrate having flexible membrane material thereon and incorporating therein;

a fluid path from a reservoir port to a cannula;

at least one valve covered by a valve portion of the flexible membrane material;

at least one pump covered by a pump portion of the flexible membrane material; and

a dispensing chamber, the dispensing chamber containing a variable fluid volume and covered by a dispensing chamber portion of the flexible membrane material, wherein the dispensing chamber portion of the flexible membrane is a different material from one of the valve portion and the pump portion of the flexible membrane material;

a second portion comprising;

a mechanical assembly that interacts mechanically with the pump portion and valve portion of the flexible membrane material in such a manner as to achieve pumping of fluid along the fluid path; and

an acoustic volume sensor assembly to measure the change in fluid volume of the dispensing chamber, the acoustic volume sensor assembly comprising;

a structure containing a fixed-volume chamber, a first port, a measurement chamber, and a second port, the structure is located within the apparatus so that the dispensing chamber and measurement chamber share a boundary defined by the dispensing chamber portion of the flexible membrane material, the first port acoustically couples the fixed-volume chamber to the measurement chamber;

a printed circuit board disposed within the structure, the printed circuit board including;

a loudspeaker, the loudspeaker generating pressure waves in the fixed-volume chamber;

a reference microphone, the reference microphone producing a reference signal;

a sensing microphone acoustically coupled to the measurement chamber via a second port, the sensing microphone producing a sensing signal in response to the pressure waves that travel through the first port, the measuring chamber and the second port before reaching the sensing microphone; and

a processor configured to calculate a change in volume of the measurement chamber wherein the processor determines the volume of fluid displaced from the dispensing chamber.

2. The apparatus to dispense fluid according to claim 1 wherein the sensing microphone and loudspeaker are located to prevent the loudspeaker pressure waves from impacting the sensing microphone without passing through the measurement chamber.

3. The apparatus to dispense fluid according to claim 1 further comprising a flared aperture on at least one of the first and second ports, wherein the flared aperture is proximal to the measurement chamber.

4. The apparatus to dispense fluid according to claim 1 further comprising a dispensing spring, wherein the dispensing spring provides additional resilience to the a dispensing chamber portion of the flexible membrane material.

5. The apparatus to dispense fluid according to claim 4 wherein the dispensing spring is part of the acoustic volume sensor.

6. An apparatus to dispense fluid comprising:

a first portion containing a substrate having flexible membrane material thereon and incorporating a fluid path that fluidically connects;

a reservoir;

at least one valve covered by a valve portion of the flexible membrane material;

at least one pump covered by a pump portion of the flexible membrane material;

and

a dispensing chamber, the dispensing chamber containing a variable fluid volume and covered by a dispensing chamber portion of the flexible membrane material;

a second portion comprising;

a mechanical assembly that interacts mechanically with the pump portion and valve portion of the flexible membrane material in such a manner as to achieve pumping of fluid along the fluid path; and

an acoustic volume sensor to measure the change in fluid volume of the dispensing chamber, the acoustic volume sensor comprising;

a structure containing a fixed-volume chamber, a first port, a measurement chamber and a second port, wherein the structure is located within the apparatus so that the dispensing chamber and measurement chamber share a boundary defined by the dispensing chamber portion of the flexible membrane material, wherein the first port acoustically couples the fixed volume chamber to the measurement chamber to form an acoustically contiguous region;

a printed circuit board disposed within the structure, the printed circuit board including a loudspeaker and a sensing microphone, wherein the loudspeaker and sensing microphone are acoustically coupled to the measurement chamber via the first port and the second port respectively, wherein the pressure waves generated by the loudspeaker in fixed-volume chamber subsequently pass through the first port, the measuring chamber and then the second port before reaching the sensing microphone, the sensing microphone produces a first signal based on the response of the measurement chamber to excitement by the loudspeaker; and

a processor in communication with the loudspeaker and the sensing microphone, the processor receiving a first signal at a first instance, the processor receiving the first signal at a second instance, and the processor determining a change in an acoustic characteristic of the measurement chamber associated with the first signal at the first instance and the first signal at the second instance, the processor is configured to calculate a change in volume of the measurement chamber associated with a change in an acoustic characteristic of the measurement chamber, wherein the processor determines a volume of fluid displaced from the dispensing chamber associated with the change in the volume of the measurement chamber.

7. The apparatus to dispense fluid according to claim 6 further comprising a flared aperture on at least one of the first and second ports, wherein the flared aperture is proximal to the measurement chamber.

8. The apparatus to dispense fluid according to claim 6 further comprising a dispensing spring, wherein the dispensing spring provides additional resilience to the a dispensing chamber portion of the flexible membrane material.

9. The apparatus to dispense fluid according to claim 8 wherein the dispensing spring is part of the acoustic volume sensor.

15. The apparatus to dispense fluid according to claim 6, wherein the dispensing chamber portion of the flexible membrane material is a different material from one of the valve portion and the pump portion of the flexible membrane material.

10. An apparatus to dispense fluid comprising:

a first portion containing a substrate having flexible membrane material thereon and incorporating therein;

a fluid path from a reservoir port to a cannula

at least one valve covered by a valve portion of the flexible membrane material;

at least one pump covered by a pump portion of the flexible membrane material;

and

a dispensing chamber, the dispensing chamber containing a variable fluid volume and covered by a dispensing chamber portion of the flexible membrane material, wherein the dispensing chamber portion of the flexible membrane material is a different material from one of the valve portion and the pump portion of the flexible membrane material;

a second portion comprising;

a mechanical assembly that interacts mechanically with the pump portion and valve portion of the flexible membrane material in such a manner as to achieve pumping of fluid along the fluid path; and

an acoustic volume sensor to measure the change in fluid volume of the dispensing chamber, the acoustic volume sensor comprising;

a structure containing a fixed-volume chamber, a first port, a measurement chamber, and the second port, wherein the structure is located within the apparatus so that the dispensing chamber and measurement chamber share a boundary defined by the a dispensing chamber portion of the flexible membrane material and the first port acoustically couples the fixed-volume chamber to the measurement chamber;

a printed circuit board disposed within the structure, the printed circuit board including;

a loudspeaker generating pressure waves in the fixed-volume chamber;

a sensing microphone acoustically coupled to the measurement chamber via a second port, the sensing microphone producing a first signal based on the response of the measurement chamber to excitement by the loudspeaker, wherein the loudspeaker soundwaves pass through the first port, the measuring chamber and the second port before reaching the sensing microphone; and

a reference microphone producing a second signal; and

a processor configured to calculate a change in volume of the measurement region associated with a change in an acoustic characteristic of the measurement chamber, the processor determines a volume of fluid displaced from the dispensing chamber associated with the change in the volume of the measurement region.

11. The apparatus to dispense fluid according to claim 10 wherein the sensing microphone and loudspeaker are located to prevent the loudspeaker pressure waves from impacting the sensing microphone without passing through the measurement chamber.

12. The apparatus to dispense fluid according to claim 10 further comprising a flared aperture on at least one of the first and second ports, wherein the flared aperture is proximal to the measurement chamber.

13. The apparatus to dispense fluid according to claim 10 further comprising a dispensing spring, wherein the dispensing spring provides additional resilience to the dispensing chamber portion of the flexible membrane material.

14. The apparatus to dispense fluid according to claim 13 wherein the dispensing spring is part of the acoustic volume sensor.