Patch-sized fluid delivery systems and methods

• US 8,617,107 B2
• Filed: 02/27/2009
• Issued: 12/31/2013
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Gray, Larry B.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/395,168
• Publication Number:
  US 20120209239A1
• Time in Patent Office: 1,768 Days
• Field of Search: 604/131, 604/151, 604/216, 604/506
• US Class Current: 604/131
• 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

A patch-sized fluid delivery device 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. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Claims

1. A delivery device for delivering an infusion medium to a user, the device comprising:

a first housing portion adapted to be secured to a user;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a pumping assembly;

a shape-memory alloy operatively connected to the pumping assembly, to selectively move the pumping assembly;

a dispensing assembly downstream from the pumping assembly, and in fluid communication with the reservoir by a flow line, the dispensing device comprising;

a variable volume metering chamber; and

a sensor; and

an exit assembly downstream from the dispensing assembly, the exit assembly in fluid communication with a pump exit, wherein the exit assembly further comprising a first one-way valve wherein the first one-way valve inhibits fluid flow from the dispensing assembly to the pump exit.

2. A delivery device according to claim 1, wherein the one-way valve comprises a duckbill valve structure.

3. A delivery device according to claim 1, further comprising a reservoir having an interior volume for containing an infusion medium and the flow line connecting the interior volume of the reservoir to the dispensing assembly.

4. A delivery device according to claim 3, wherein the reservoir is supported by the first housing portion.

5. A delivery device according to claim 3, further comprising a second one-way valve downstream to the reservoir and upstream to the dispensing assembly.

6. A delivery device according to claim 1, wherein:

the dispensing housing further comprising a variable volume metering chamber;

the second housing portion comprises a housing structure having an interior volume in which the sensor is located; and

the variable volume metering chamber is located in the first housing assembly.

7. A delivery device according to claim 6, wherein the variable volume metering chamber further comprising a resilient fluid diaphragm wherein the variable volume metering chamber expands and contracts with the flow of fluid into and out of the variable volume metering chamber.

8. A delivery device according to claim 1, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the shape-memory alloy for delivery of fluid from a reservoir to the user when the first housing portion and the second housing portion are engaged.

9. A delivery device according to claim 1, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

10. A delivery device according to claim 1, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the pump exit.

11. A delivery device according to claim 1, wherein the exit assembly further comprising a high-impedance flow restrictor.

12. A delivery device for delivering an infusion medium to a user, the device comprising:

a first housing portion adapted to be secured to a user;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a pumping assembly;

a shape-memory alloy operatively connected to the pumping assembly, to selectively move the pumping assembly;

a dispensing assembly downstream from the pumping assembly, and in fluid communication with the reservoir by a flow line, the dispensing device comprising;

a variable volume metering chamber; and

a sensor; and

an exit assembly downstream from the dispensing assembly, the exit assembly in fluid communication with a pump exit, wherein the exit assembly comprising a high-impedance flow restrictor.

13. A delivery device according to claim 12, wherein the exit assembly further comprising a first one-way valve wherein the first one-way valve inhibits fluid flow from the dispensing assembly to the pump exit.

14. A delivery device according to claim 13, wherein the one-way valve comprises a duckbill valve structure.

15. A delivery device according to claim 12, further comprising a reservoir having an interior volume for containing an infusion medium and the flow line connecting the interior volume of the reservoir to the dispensing assembly.

16. A delivery device according to claim 15, wherein the reservoir is supported by the first housing portion.

17. A delivery device according to claim 15, further comprising a second one-way valve downstream to the reservoir and upstream to the dispensing assembly.

18. A delivery device according to claim 12, wherein:

the dispensing housing further comprising a variable volume metering chamber;

the second housing portion comprises a housing structure having an interior volume in which the sensor is located; and

the variable volume metering chamber is located in the first housing assembly.

19. A delivery device according to claim 18, wherein the variable volume metering chamber further comprising a resilient fluid diaphragm wherein the variable volume metering chamber expands and contracts with the flow of fluid into and out of the variable volume metering chamber.

20. A delivery device according to claim 12, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the shape-memory alloy for delivery of fluid from a reservoir to the user when the first housing portion and the second housing portion are engaged.

21. A delivery device according to claim 12, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

22. A delivery device according to claim 12, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the pump exit.

23. A delivery device for delivering an infusion medium to a user, the device comprising:

a first housing portion adapted to be secured to a user;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a pumping assembly;

a shape-memory alloy operatively connected to the pumping assembly, to selectively move the pumping assembly;

a dispensing assembly downstream from the pumping assembly, and in fluid communication with the reservoir by a flow line, the dispensing device comprising;

a variable volume metering chamber; and

a sensor;

a reservoir, supported by the first housing portion, having an interior volume for containing an infusion medium, wherein the flow line connecting the interior volume of the reservoir to the dispensing assembly; and

an exit assembly downstream from the dispensing assembly, the exit assembly in fluid communication with a pump exit.

24. A delivery device according to claim 23, wherein the exit assembly further comprising a first one-way valve wherein the first one-way valve inhibits fluid flow from the dispensing assembly to the pump exit.

25. A delivery device according to claim 24, wherein the one-way valve comprises a duckbill valve structure.

26. A delivery device according to claim 23, wherein:

the dispensing housing further comprising a variable volume metering chamber;

the second housing portion comprises a housing structure having an interior volume in which the sensor is located; and

the variable volume metering chamber is located in the first housing assembly.

27. A delivery device according to claim 26, wherein the variable volume metering chamber further comprising a resilient fluid diaphragm wherein the variable volume metering chamber expands and contracts with the flow of fluid into and out of the variable volume metering chamber.

28. A delivery device according to claim 23, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the shape-memory alloy for delivery of fluid from a reservoir to the user when the first housing portion and the second housing portion are engaged.

29. A delivery device according to claim 23, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

30. A delivery device according to claim 23, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the pump exit.

31. A delivery device according to claim 23, further comprising a second one-way valve downstream to the reservoir and upstream to the dispensing assembly.

32. A delivery device according to claim 23, wherein the exit assembly further comprising a high-impedance flow restrictor.

33. A delivery device for delivering an infusion medium to a user, the device comprising:

a first housing portion adapted to be secured to a user;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a pumping assembly;

a shape-memory alloy operatively connected to the pumping assembly, to selectively move the pumping assembly;

a dispensing assembly downstream from the pumping assembly, and in fluid communication with the reservoir by a flow line, the dispensing device comprising;

a variable volume metering chamber; and

a sensor;

a reservoir having an interior volume for containing an infusion medium, wherein the flow line connecting the interior volume of the reservoir to the dispensing assembly;

a second one-way valve downstream to the reservoir and upstream to the dispensing assembly; and

an exit assembly downstream from the dispensing assembly, the exit assembly in fluid communication with a pump exit.

34. A delivery device according to claim 33, wherein the exit assembly further comprising a first one-way valve wherein the first one-way valve inhibits fluid flow from the dispensing assembly to the pump exit.

35. A delivery device according to claim 34, wherein the one-way valve comprises a duckbill valve structure.

36. A delivery device according to claim 33, wherein the reservoir is supported by the first housing portion.

37. A delivery device according to claim 33, wherein:

the dispensing housing further comprising a variable volume metering chamber;

the second housing portion comprises a housing structure having an interior volume in which the sensor is located; and

the variable volume metering chamber is located in the first housing assembly.

38. A delivery device according to claim 37, wherein the variable volume metering chamber further comprising a resilient fluid diaphragm wherein the variable volume metering chamber expands and contracts with the flow of fluid into and out of the variable volume metering chamber.

39. A delivery device according to claim 33, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the shape-memory alloy for delivery of fluid from a reservoir to the user when the first housing portion and the second housing portion are engaged.

40. A delivery device according to claim 33, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

41. A delivery device according to claim 33, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the pump exit.

42. A delivery device according to claim 33, wherein the exit assembly further comprising a high-impedance flow restrictor.

43. A delivery device for delivering an infusion medium to a user, the device comprising:

a first housing portion adapted to be secured to a user;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a pumping assembly;

a shape-memory alloy operatively connected to the pumping assembly, to selectively move the pumping assembly;

a dispensing assembly downstream from the pumping assembly, and in fluid communication with the reservoir by a flow line, the dispensing device comprising;

a variable volume metering chamber; and

a sensor; and

an exit assembly downstream from the dispensing assembly, the exit assembly in fluid communication with a pump exit, wherein the exit assembly further comprising a first one-way valve wherein the first one-way valve inhibits fluid flow from the dispensing assembly to the pump exit, wherein the one-way valve comprises a duckbill valve structure.

44. A delivery device according to claim 43, further comprising a reservoir having an interior volume for containing an infusion medium and the flow line connecting the interior volume of the reservoir to the dispensing assembly.

45. A delivery device according to claim 44, wherein the reservoir is supported by the first housing portion.

46. A delivery device according to claim 44, further comprising a second one-way valve downstream to the reservoir and upstream to the dispensing assembly.

47. A delivery device according to claim 43, wherein:

the dispensing housing further comprising a variable volume metering chamber;

the second housing portion comprises a housing structure having an interior volume in which the sensor is located; and

the variable volume metering chamber is located in the first housing assembly.

48. A delivery device according to claim 47, wherein the variable volume metering chamber further comprising a resilient fluid diaphragm wherein the variable volume metering chamber expands and contracts with the flow of fluid into and out of the variable volume metering chamber.

49. A delivery device according to claim 43, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the shape-memory alloy for delivery of fluid from a reservoir to the user when the first housing portion and the second housing portion are engaged.

50. A delivery device according to claim 43, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

51. A delivery device according to claim 43, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the pump exit.

52. A delivery device according to claim 43, wherein the exit assembly further comprising a high-impedance flow restrictor.