Adhesive and peripheral systems and methods for medical devices

• US 9,278,174 B2
• Filed: 03/12/2010
• Issued: 03/08/2016
• 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.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US12/723,135
• Publication Number:
  US 20120209244A1
• Time in Patent Office: 2,188 Days
• Field of Search: 604/21, 604/65, 604/66, 604/503, 604/504, 604/890.1, 604/164.04
• US Class Current: 1/1
• 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

An apparatus for inserting an infusion device for supplying a fluid to a body of a user, and a sensor for monitoring a body characteristic of the user, the apparatus including a bridge including a rigid body and comprising an infusion device end and a sensor end, the bridge further including an infusion device introduction needle attached to the infusion device end, a sensor introduction needle, the sensor introduction needle attached to the sensor end, an infusion device, operatively coupled to the infusion device introduction needle, for infusing a fluid to an infusion site, and a sensor introduction needle operatively coupled to an electrochemical sensor having a sensor electrode for determining at least one body characteristic of the patient at a sensor placement site, an infusion device release for releasing the infusion device from the infusion device introduction needle, and a sensor release for releasing the sensor from the sensor introduction needle.

Claims

1. A method for insertion of an infusion device and an electrochemical sensor that monitors a body characteristic of a user, the method comprising using an insertion apparatus comprising:

a bridge comprising a rigid body, the bridge further comprising;

an infusion device introduction needle attached to and extending from the bridge, wherein the infusion device introduction needle is removably coupled to an infusion device for infusing a fluid to an infusion site

a sensor introduction needle attached to and extending from the bridge and removably coupled to an electrochemical sensor having a sensor electrode for determining at least one body characteristic of the user at a sensor placement site;

an infusion device release for releasing the infusion device from the infusion device introduction needle; and

a sensor release for releasing the electrochemical sensor from the sensor introduction needle,

wherein the infusion device and the sensor are disposed on the bridge wherein they operatively engage and disengage from the bridge.

2. An apparatus for inserting both an infusion device for supplying a fluid to a body of a user, and a sensor for monitoring a body characteristic of the user, the apparatus comprising:

a bridge comprising a rigid body and comprising an infusion device end and a sensor end, the bridge further comprising;

an infusion device introduction needle attached to the infusion device end;

a sensor introduction needle, the sensor introduction needle attached to the sensor end;

an infusion device, operatively coupled to the infusion device introduction needle, for infusing a fluid to an infusion site;

a sensor having a sensor electrode for determining at least one body characteristic of the patient at a sensor placement site operatively coupled to the sensor introduction needle;

an infusion device release for releasing the infusion device from the infusion device introduction needle; and

a sensor release for releasing the sensor from the sensor introduction needle,

wherein the infusion device and the sensor are disposed on the bridge wherein they operatively engage and disengage from the bridge.

3. The apparatus of claim 2, wherein the infusion device introduction needle and the sensor introduction needle are coupled to the bridge in an orientation such that when the infusion device introduction needle and the sensor introduction needle are inserted into a patient, the infusion site and the sensor electrode are separated by at least 7 millimeters of tissue.

4. The apparatus of claim 2, wherein the infusion device introduction needle and sensor introduction needle remain attached to the bridge.

5. The apparatus of claim 2, wherein the infusion device introduction needle and the sensor introduction needle are metal needles.

6. The apparatus of claim 2, further comprising an infusion set tubing adapted to connect to the infusion device.

7. The apparatus of claim 6, further comprising an infusion pump adapted to connect to the infusion set tubing.

8. The apparatus of claim 2, wherein the apparatus is in a modular configuration that allows the infusion device and the sensor to be replaced independently of other components of the apparatus.

9. An apparatus for inserting both an infusion device for supplying a fluid to a body of a user, and a sensor for monitoring a body characteristic of the user, the apparatus comprising:

a bridge comprising a rigid body and comprising an infusion device end and a sensor end, the bridge further comprising;

an infusion device introduction needle attached to the infusion device end;

a sensor introduction needle, the sensor introduction needle attached to the sensor end;

an infusion device, operatively coupled to the infusion device introduction needle, for infusing a fluid to an infusion site;

a sensor having a sensor electrode for determining at least one body characteristic of the patient at a sensor placement site operatively coupled to the sensor introduction needle;

an infusion device release for releasing the infusion device from the infusion device introduction needle; and

a sensor release for releasing the sensor from the sensor introduction needle,

wherein the infusion device and the sensor are disposed on the bridge wherein they operatively engage and disengage from the bridge, and

wherein the infusion device introduction needle and sensor introduction needle remain attached to the bridge.

10. The apparatus of claim 9, wherein the infusion device introduction needle and the sensor introduction needle are coupled to the bridge in an orientation such that when the infusion device introduction needle and the sensor introduction needle are inserted into a patient, the infusion site and the sensor electrode are separated by at least 7 millimeters of tissue.

11. The apparatus of claim 9, wherein the infusion device introduction needle and the sensor introduction needle are metal needles.

12. The apparatus of claim 9, further comprising an infusion set tubing adapted to connect to the infusion device.

13. The apparatus of claim 12, further comprising an infusion pump adapted to connect to the infusion set tubing.

14. The apparatus of claim 9, wherein the apparatus is in a modular configuration that allows the infusion device and the sensor to be replaced independently of other components of the apparatus.