Patch-sized fluid delivery systems and methods

• US 9,907,903 B2
• Filed: 03/28/2016
• Issued: 03/06/2018
• 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., Yeaton, Eric
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US15/082,535
• Publication Number:
  US 20160206808A1
• Time in Patent Office: 708 Days
• Field of Search: 604 19
• 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: 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 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 5/148 : flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

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 method of making a delivery device, the method comprising:

providing a first housing portion;

providing a second housing portion configured to selectively engage with and disengage from the first housing portion;

supporting a rotatable rotor for rotation, the rotor having at least one pad or roller for movement in an annular path with the rotation of the rotor;

providing a conduit having a flexible portion;

coupling an interior volume of a reservoir in fluid flow communication with the conduit, the interior volume of the reservoir for containing a fluid;

supporting the flexible portion of the conduit on the first housing portion and arranging the flexible portion of the conduit within at least a portion of the annular path of the at least one pad or roller to be engaged at locations along the annular path by the at least one pad or roller when the second housing portion and the first housing portion are engaged, the flexible portion of the conduit being resiliently collapsible at the locations of engagement of the at least one pad or roller to provide a pumping action as the rotor rotates while the first and second housing portions are engaged, the conduit being connectable in fluid flow communication with an injection site, wherein supporting the flexible portion of the conduit comprises supporting the flexible portion of the conduit on a flat support surface;

supporting a drive device on the second housing portion; and

operatively coupling the drive device to the rotor for selectively rotating the rotor to provide the pumping action while the first and second housing portions are engaged.

2. A method according to claim 1, wherein supporting a rotatable rotor comprises supporting the rotatable rotor on the second housing portion.

3. A method according to claim 1, wherein:

providing a second housing portion further comprising providing a housing structure with an internal volume;

supporting a rotatable rotor comprises supporting a rotor on the second housing portion, outside of the internal volume; and

operatively coupling the drive device to the rotor comprises extending a rotor shaft having a longitudinal axis into the interior volume of the second housing portion, operatively coupling the rotor shaft to the rotor and to the drive device to transfer drive force from the drive device to the rotor.

4. A method according to claim 3, wherein extending a rotor shaft comprises extending the rotor shaft through an aperture in a wall of the second housing portion.

5. A method according to claim 4, further comprising arranging a seal around the aperture in the wall of the second housing portion.

6. A method according to claim 3, wherein supporting a rotatable rotor comprises supporting a rotor within a recess in a wall of the second housing portion.

7. A method according to claim 1, wherein supporting a rotatable rotor comprises supporting a rotary wheel and wherein the at least one pad or roller is supported by the rotary wheel.

8. A method according to claim 1, wherein supporting the flexible portion of the conduit on a flat support surface comprises supporting the flexible portion of the conduit on a flat surface of the reservoir.

9. A method according to claim 1, wherein supporting the flexible portion of the conduit comprises supporting the flexible portion of the conduit on a curved support surface.

10. A method according to claim 9, wherein supporting the flexible portion of the conduit on a curved support surface comprises supporting the flexible portion of the conduit on a curved surface of the reservoir.

11. A method according to claim 1, wherein arranging the flexible portion of the conduit that is arranged within at least a portion of the annular path of the at least one pad or roller comprises arranging a portion of the conduit in at least a partial coil around a generally annular path.