Patch-sized fluid delivery systems and methods

• US 9,623,198 B2
• Filed: 02/27/2009
• Issued: 04/18/2017
• 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., Yeaton, Eric
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/395,036
• Publication Number:
  US 20120209179A1
• Time in Patent Office: 2,972 Days
• Field of Search: 604 86, 604 88, 604131, 604151, 60416702, 604203, 604216, 60428802, 604506
• 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
• 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 system, comprising:

a flexible reservoir for holding an infusion medium comprising a septum;

a syringe comprising a needle attached thereto and a piston disposed at least partially within the syringe, the piston being moveable within the syringe, the piston comprising a piston body for forcing the infusion medium out of the syringe; and

a fill apparatus, the fill apparatus comprising;

a filling aperture for engaging with a portion of the syringe;

a base portion; and

a cover portion hingedly attached to the base portion wherein the reservoir is located between the base portion and the cover portion;

wherein the filling aperture provides a path for transferring the infusion medium from an infusion medium container to the reservoir when a needle has pierced the septum,

wherein the septum capable of being pierced by the syringe to allow the infusion medium to be filled into the reservoir through the septum, and

wherein the filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing the path to allow the infusion medium to be transferred from the syringe to the reservoir.

2. The system of claim 1, wherein the piston is moveable to allow the infusion medium to be filled into the reservoir.

3. The system of claim 1, wherein the reservoir has an outlet port that is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of a user.

4. The system of claim 1, wherein the septum is located within an opening in the reservoir.

5. The system of claim 1, wherein the septum covers the opening in the reservoir.

6. The system of claim 1, wherein the septum is a self sealing septum so as to allow for keeping the infusion medium within the reservoir when the septum is not being pierced.

7. The system of claim 1, further comprising:

a disposable housing for housing the reservoir and for being secured to a user.

8. The system of claim 1, wherein the reservoir has a degassing portion that comprises a hydrophobic material for allowing gases to escape from the reservoir while keeping the infusion medium within the reservoir.

24. The system of claim 1, further comprising:

a disposable housing for housing the reservoir and for being secured to a particular user.

9. A system, comprising:

a flexible reservoir for holding an infusion medium, the reservoir comprising a septum;

a syringe comprising a needle attached thereto and a plunger disposed at least partially within the syringe, the plunger being moveable within the syringe, the plunger comprising a plunger body for forcing the infusion medium out of the syringe;

a fill apparatus, the fill apparatus comprising;

a filling aperture for engaging with a portion of the syringe;

a base portion; and

a cover portion hingedly attached to the base portion wherein the reservoir is located between the base portion and the cover portion;

wherein the filling aperture provides a path for transferring the infusion medium from an infusion medium container to the reservoir when a needle has pierced the septum,

wherein the septum capable of being pierced to allow the infusion medium to flow out of the syringe through an opening in the reservoir; and

a filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing a path to allow the infusion medium to be transferred from the syringe to the reservoir,

wherein the filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing the path to allow the infusion medium to be transferred from the syringe to the reservoir.

10. A system, comprising:

an infusion medium container for holding an infusion medium;

a syringe comprising a needle attached thereto and a plunger disposed at least partially within the syringe, the plunger being moveable within the syringe, the plunger comprising a plunger body for forcing the infusion medium out of the syringe;

a flexible reservoir for holding the infusion medium, the reservoir having a port for receiving the infusion medium;

a reservoir septum capable of being pierced to allow the infusion medium to flow out of the syringe through the reservoir septum and into the reservoir;

a fill apparatus, the fill apparatus comprising;

a filling aperture for engaging with a portion of the syringe;

a base portion; and

a cover portion hingedly attached to the base portion wherein the reservoir is located between the base portion and the cover portion;

wherein the filling aperture provides a path for transferring the infusion medium from an infusion medium container to the reservoir when a needle has pierced the septum; and

a filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing a path to allow the infusion medium to be transferred from the syringe to the reservoir

wherein the filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing the path to allow the infusion medium to be transferred from the syringe to the reservoir.

11. The system of claim 10, wherein the infusion medium container comprises a vial.

12. The system of claim 10, wherein the transfer element comprises a needle.

13. The system of claim 12,

wherein the transfer guard has a guard portion that is capable of at least partially surrounding a needle.

14. The system of claim 10, wherein the reservoir septum is a self sealing septum that is able to seal after being pierced.

15. The system of claim 10, wherein the port of the reservoir is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of a user.

16. The system of claim 10, wherein the reservoir has a degassing portion that comprises a hydrophobic material for allowing gases to escape from the reservoir while keeping the infusion medium within the reservoir.

17. The system of claim 10, further comprising:

a disposable housing for housing the reservoir.

18. The system of claim 17, wherein the disposable housing is able to be secured to a user.

19. The system of claim 17,

wherein the disposable housing is able to be secured to a user.

20. A system, comprising:

a syringe for holding an infusion medium comprising a needle attached thereto;

a piston disposed at least partially within the syringe, the piston being moveable to allow the infusion medium to fill into a flexible reservoir and to force the infusion medium out of the reservoir;

a plunger shaft connected to the piston for driving the plunger shaft so as to move the piston to force the infusion medium out of the syringe into a reservoir; and

a fill apparatus, the fill apparatus comprising;

a filling aperture for engaging with a portion of the syringe;

a base portion; and

a cover portion hingedly attached to the base portion wherein the reservoir is located between the base portion and the cover portion;

wherein the filling aperture provides a path for transferring the infusion medium from an infusion medium container to the reservoir when a needle has pierced the septum, and

wherein the filling aperture having a transfer element for guiding a needle connected to the syringe to pierce the septum and for providing the path to allow the infusion medium to be transferred from the syringe to the reservoir.

21. The system of claim 20,

wherein the reservoir has a port that is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of a particular user.

22. The system of claim 20, further comprising:

a base adapted to be secured to a particular user;

wherein the reservoir is connected to the base or is integrated into the base.

23. The system of claim 22, wherein the reservoir is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of the particular user through an opening in the base.

25. The system of claim 20, wherein the reservoir has a degassing portion that comprises a hydrophobic material for allowing gases to escape from the reservoir while keeping the infusion medium within the reservoir.