PATCH-SIZED FLUID DELIVERY SYSTEMS AND METHODS

• US 20120209180A1
• Filed: 02/27/2009
• Published: 08/16/2012
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Gray, Larry Brian, Yeaton, Eric
• Granted Patent: US 9,295,780 B2
• Time in Patent Office: Days
• 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

1-178. -178. (canceled)

179. A delivery device comprising:

a first housing portion;

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

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

a conduit supported by the first housing portion and having a flexible portion arranged 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 roller or pad 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 roller or pad to provide a pumping action as the rotor rotates the at least one roller or pad along the annular path while the second housing portion and first housing portion are engaged, the conduit being connectable in fluid flow communication with an injection site;

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

a drive device supported by the second housing portion and operatively coupled to the rotor for selectively rotating the rotor.

180. A delivery device according to claim 179, wherein the rotatable rotor is supported for rotation by the second housing portion.

181. A delivery device according to claim 179, wherein:

the second housing portion has a housing structure with an internal volume;

the rotor is disposed outside of the internal volume; and

the delivery device further comprising a rotor shaft having a longitudinal axis, the rotor shaft coupled to the rotor and extending into the internal volume of the second housing portion and operatively coupled to the drive device.

182. A delivery device according to claim 181, wherein the rotor shaft extends through an aperture in a wall of the second housing portion.

183. A delivery device according to claim 182, further comprising a seal disposed around the aperture in the wall of the second housing portion.

184. A delivery device according to claim 181, wherein the rotor is disposed within a recess in a wall of the second housing portion.

185. A delivery device according to claim 179, wherein the rotor comprises a rotary wheel and wherein the at least one pad or roller is supported by the rotary wheel.

186. A delivery device according to claim 179, wherein the flexible portion of the conduit is supported on a flat support surface.

187. A delivery device according to claim 186, wherein the reservoir comprises a rigid container structure and wherein the support surface comprises a surface of the reservoir.

188. A delivery device according to claim 179, wherein the flexible portion of the conduit is supported on a curved support surface.

189. A delivery device according to claim 188, wherein the reservoir comprises a rigid container structure and wherein the support surface comprises a surface of the reservoir.

190. A delivery device according to claim 179, wherein 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 a portion of the conduit arranged in at least a partial coil around a generally annular path.

191. (canceled)

192. (canceled)

193. (canceled)

194. (canceled)

195. (canceled)

196. (canceled)

197. (canceled)

198. (canceled)

199. (canceled)

200. (canceled)

201. (canceled)

202. (canceled)

203. (canceled)

204. A delivery device comprising:

a rotatable rotor supporting at least one cam follower for movement in an annular path with the rotation of the rotor;

a camming surface having a first portion and a second portion, the camming surface arranged to abut the at least one cam follower as the cam follower is moved in the annular path, to move the at least one cam follower in a first direction, upon the first portion of the camming surface abutting the at least one cam follower and allowing the at least one cam follower to move in a second direction, opposite to the first direction, upon the second portion of the camming surface abutting the at least one cam follower;

a respective fluid chamber associated with each cam follower and having a volume arranged adjacent its associated cam follower;

a flexible membrane arranged between each cam follower and its associated fluid chamber, the flexible membrane arranged to flex in one direction to reduce the volume of a fluid chamber upon movement of the cam follower associated with that fluid chamber in the first direction;

an inlet channel provided in fluid flow communication with each fluid chamber when a cam follower is moved in the annular path to aligned with the inlet channel and moved in the second direction to increase the volume of the fluid chamber associated with the cam follower; and

an outlet channel provided in fluid flow communication with each fluid chamber when a cam follower is moved in the annular path to align with the outlet channel and moved in the first direction to decrease the volume of the fluid chamber associated with the cam follower;

wherein fluid is drawn through the inlet channel and into the fluid chamber associated with a cam follower upon movement of the cam follower in the second direction to increase the volume of the fluid chamber associated with the cam follower; and

wherein fluid is driven through the outlet channel and from the fluid chamber associated with a cam follower upon movement of the cam follower in the first direction to decrease the volume of the fluid chamber associated with the cam follower.

205. A delivery device according to claim 204, further comprising:

a first housing portion;

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

wherein the rotatable rotor is supported for rotation by the second housing portion and wherein a drive device is supported by the first housing portion in a position to operatively engage the rotatable rotor for driving the rotatable rotor, when the first and second housing portions are engaged.

206. A delivery device according to claim 205, wherein:

the second housing portion has a housing structure with an internal volume;

the rotor is disposed outside of the internal volume; and

the delivery device further comprising a rotor shaft having a longitudinal axis, the rotor shaft coupled to the rotor and extending into the internal volume of the second housing portion.

207. A delivery device according to claim 206, wherein the rotor shaft extends through an aperture in a wall of the second housing portion.

208. A delivery device according to claim 204, further comprising a reservoir having an interior volume for containing an infusion fluid, the reservoir coupled in fluid flow communication with the inlet channel.