ADHESIVE AND PERIPHERAL SYSTEMS AND METHODS FOR MEDICAL DEVICES

• US 20120150115A1
• Filed: 02/13/2012
• Published: 06/14/2012
• 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.
• Granted Patent: US 8,998,850 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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

Fill stations and base stations are provided for personal pump systems. The fill stations may be opened and closed to accept a reservoir and to allow fluid to be introduced into the reservoir for use with personal pump systems. The fill stations may hold the reservoir at a tilt relative to an underlying surface and may discourage overfilling of the reservoir. The filling stations may also include viewing windows having fluid lines marked thereon for indicating volume of fluid within the reservoir.

Claims

1. A method of filling a reservoir with a liquid therapeutic, the method comprising:

providing a fill station having

a substantially rigid fill-station base for holding the reservoir at a tilt, and

a substantially rigid fill-station cover attached to the fill-station base, the fill-station cover having a filling aperture for receiving fluid from a syringe, the fill-station cover and the fill-station base defining a volume so as to prevent over-filling of the reservoir;

placing a reservoir in the fill station and closing the fill-station cover over the reservoir;

applying a syringe containing the liquid therapeutic to the filling aperture; and

ejecting the liquid therapeutic from the syringe through the filling aperture into the reservoir.

2. A method according to claim 1, further comprising removing any remaining air in the reservoir after injecting a desired amount of liquid therapeutic into the reservoir.

3. A method according to claim 1, further comprising viewing the amount of liquid in the reservoir through a window in the fill station cover.

4. A method according to claim 3, further comprising estimating the amount of liquid by comparing the liquid level viewed through the window to a fluid-level indicia.

5. A disposable unit for a therapeutic fluid delivery device, the disposable unit comprising:

a base portion comprising a reservoir cavity and a fluid path, the reservoir cavity comprising a reservoir port and a septum, said fluid path comprising a fluid channel from said reservoir port to a cannula port;

at least one flexible membrane portion attached onto said base portion and forming a top of said reservoir cavity and a top of said fluid channel; and

a tubing connected to said base portion at said cannula port, said tubing in fluid communication with said reservoir cavity.

6. The disposable unit of claim 5 wherein said tubing portion comprising a cannula port end and a cannula interface end, the cannula interface end configured to attach to a cannula.

7. The disposable unit of claim 5 wherein the fluid path further comprising a series of regions exposed to the flexible membrane portion, at least one of said regions being a valve region.

8. The disposable unit of claim 7 wherein said series of regions further comprising a pump chamber region.

9. The disposable unit of claim 5, wherein said base portion and said flexible membrane portion constitute a fluidic assembly, and wherein said disposable unit further comprising a disposable base into which the fluidic assembly fits.

10. The disposable unit of claim 9, further comprising a pad coupled to a bottom of said disposable base said pad for attaching said disposable unit to a patient.

11. The disposable unit of claim 5, wherein said reservoir port in fluid communication with said reservoir cavity and said septum for penetration by a needle so as to fill said reservoir cavity with therapeutic fluid.

12. The disposable unit of claim 5, further comprising a latching mechanism for permitting selective engagement and disengagement with a reusable unit.

13. The disposable unit of claim 5, further including a mechanism for attaching the disposable unit to a patient.

14. A disposable base for holding components of a device for delivering a therapeutic fluid, the disposable base comprising:

a bottom adapted for attachment to the skin of a patient;

a fluidic path portion having a reservoir, a pumping chamber and an outlet; and

a tubing attached to said outlet, said tubing adapted to connect to a cannula.

15. The disposable base of claim 14 wherein said reservoir further comprising a septum, whereby said septum for filling said reservoir with therapeutic fluid.

16. The disposable base of claim 14 wherein said tubing further comprising an outlet end and a cannula interface end, said outlet end attached to said outlet and said cannula interface end configured to attach to a cannula.

17. The disposable base of claim 14 further comprising at least one flexible membrane portion forming at least one portion of said fluidic path portion and said reservoir.