Adhesive and peripheral systems and methods for medical devices

• US 10,245,389 B2
• Filed: 05/16/2016
• Issued: 04/02/2019
• 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): Lee, Brandy S
• Application Number:
  US15/155,694
• Publication Number:
  US 20160256627A1
• Time in Patent Office: 1,051 Days
• 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 repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Claims

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

a disposable housing assembly adapted to be secured to a user'"'"'s skin;

a reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior;

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

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

a tubing connected to the base portion at the cannula port, the tubing in fluid communication with the reservoir cavity; and

a needle insertion device for inserting a cannula into the user'"'"'s skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position;

wherein the disposable housing assembly has a passage through which the introduction needle extends, and

wherein the cannula has a central passage through which the introduction needle extends.

2. The delivery device of claim 1, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

3. The delivery device of claim 2, the reusable housing assembly further comprising a latching mechanism for permitting selective engagement and disengagement with the disposable housing assembly.

4. The delivery device of claim 2, the reusable housing assembly further comprising a mechanism for attaching the housing structure to the user.

5. The delivery device of claim 1, wherein the tubing portion comprises a cannula port end and a cannula interface end, the cannula interface end configured to attach to a cannula.

6. The delivery device of claim 1, wherein the fluid path further comprises a series of regions exposed to the flexible membrane portion, at least one of the regions being a valve region.

7. The delivery device of claim 6, wherein the series of regions further comprises a pump chamber region.

8. The delivery device of claim 1, wherein the base portion and the flexible membrane portion constitute a fluidic assembly, and wherein the disposable housing assembly further comprises a disposable base into which the fluidic assembly fits.

9. The delivery device of claim 8, further comprising a pad coupled to a bottom of the disposable base, the pad for attaching the disposable housing assembly to the user.

10. The delivery device of claim 1, wherein the reservoir port in fluid communication with the reservoir cavity and the septum for penetration by a needle so as to fill the reservoir cavity with therapeutic fluid.

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

a disposable housing assembly adapted to be secured to a user'"'"'s skin comprising;

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

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

at least one flexible membrane portion forming at least one portion of the fluidic path portion and the reservoir;

a tubing attached to the outlet, the tubing adapted to connect to a cannula, wherein the reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior; and

a needle insertion device for inserting the cannula into the user'"'"'s skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position,

wherein the disposable housing assembly has a passage through which the introduction needle extends, and

wherein the cannula has a central passage through which the introduction needle extends.

12. The delivery device of claim 11, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

13. The delivery device of claim 11, wherein the reservoir further comprises a septum, whereby the septum for filling the reservoir with therapeutic fluid.

14. The delivery device of claim 11, wherein the tubing further comprises an outlet end and a cannula interface end, the outlet end attached to the outlet and the cannula interface end configured to attach to a cannula.

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

a disposable housing assembly adapted to be secured to a user'"'"'s skin comprising;

a reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior;

a substrate having flexible membrane material thereon, and incorporating therein the reservoir and a fluid channel, the reservoir having a septum, the fluid channel being part of a fluid path in the disposable housing assembly from the outlet port to a cannula port and comprising a series of regions exposed to the flexible membrane material, at least one of the regions being a valve region; and

a tubing portion connected to the cannula port of the disposable housing assembly; and

a needle insertion device for inserting a cannula into the user'"'"'s skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position;

wherein the disposable housing assembly has a passage through which the introduction needle extends, and

wherein the cannula has a central passage through which the introduction needle extends.

16. The delivery device of claim 15, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

17. The disposable unit of claim 16, further comprising a latching mechanism for permitting selective engagement and disengagement of the reusable housing assembly with the disposable assembly.

18. The delivery device of claim 15, wherein the tubing portion comprises a cannula port end and a cannula interface end, the cannula port end attached to the cannula port and the cannula interface end configured to attach to a cannula.

19. The delivery device of claim 15, wherein the fluid path further comprises a pump chamber region.

20. The delivery device of claim 15, wherein the tubing adapted to connect to a cannula.

21. The delivery device of claim 15, wherein the substrate and the flexible membrane material constitute a fluidic assembly, and wherein the disposable housing assembly further comprising a disposable base into which the fluidic assembly fits.

22. The disposable unit of claim 21, further comprising a pad coupled to a bottom of the disposable housing assembly for attaching the housing structure to the user.