Adhesive and peripheral systems and methods for medical devices

• US 9,492,613 B2
• Filed: 07/15/2013
• Issued: 11/15/2016
• 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.
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/942,051
• Publication Number:
  US 20130303991A1
• Time in Patent Office: 1,219 Days
• Field of Search: 128/205.16, 604/134, 604/136, 604/157, 604/164.08, 604/164.12, 604/192, 604/272
• 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

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 needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

a housing provided with an interior channel having a longitudinal, axial dimension and an opening extending through a wall of the housing to the channel and extending along at least a portion of the longitudinal length of the channel;

a hollow needle supported in the channel for movement relative to the housing between a start position, an extended position and a retracted position, the needle having a piercing end having an opening and an opposite, second end having an opening;

a fluid conduit connected to the opening on the second end of the hollow needle and moveable with the hollow needle, the fluid conduit being connectable to the outlet or inlet port of the reservoir;

a cannula supported on the needle, when the needle is in the start position, and moveable with the needle to the extended position of the needle;

a lever member connected in a fixed relation to the hollow needle and having an extension portion extending through the opening in the housing;

a first bias member arranged to impart a first bias force on the lever in a first direction, for moving the lever and the attached needle and the supported cannula from the start position to the extended position of the needle, free of manual input;

a lock structure for locking the cannula in a fixed position relative to the housing, when the needle and cannula are moved to the extended position of the needle;

a second bias member arranged to impart a second bias force on the lever in a second direction, opposite to the first direction, for moving the lever and the attached needle from the extended position to the retracted position, while leaving the cannula in the extended position;

wherein at least a portion of the first bias member is located outside the housing, and

wherein at least a portion of the second bias member is located outside the housing.

2. A device according to claim 1, wherein, in the retracted position, the piercing end of the needle is arranged in fluid flow communication with the cannula, to complete a fluid flow path from the fluid conduit to the cannula.

3. A device as recited in claim 1, further comprising a second lock structure for locking the first bias member in a state at which the first bias member is ready to impart a bias force on the lever member, but does not impart its full force on the lever and for selectively releasing the first bias member to impart its full force on the lever.

4. A device as recited in claim 3, wherein the first bias member is configured such that upon releasing the first bias member, the first bias member imparts a force on the lever member that overpowers the force of the second bias member, to move the lever member and attached needle from the start position to the extended position against the bias force of the second bias member.

5. A device as recited in claim 4, wherein, the lever member is configured to be released from the first bias member, upon the lever member being moved to the extended position, to allow the bias force of the second bias member to move the lever member and attached needle to the retracted position.

6. A device as recited in claim 5, wherein the lever member comprises a bendable or breakable portion that bends or breaks to disengage from the first bias member, upon the lever member being moved by the first bias member to the extended position.

7. A device as recited in claim 3, wherein the second lock structure is configured to selectively release the first bias member upon pivoting of the second lock structure.

8. A device as recited in claim 1, wherein the first bias member comprises a first spring and the second bias member comprises a second spring.

9. A device as recited in claim 8, wherein the housing has a pair of projection ears arranged to hold two ends of a length of each of the first and second springs.

10. A device as recited in claim 1, wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member outside of the housing.

11. A device as recited in claim 1, wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member outside of the housing.

12. A method of making a needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the method comprising:

providing a housing with an interior channel having a longitudinal, axial dimension and an opening extending through a wall of the housing to the channel, the opening extending along at least a portion of the longitudinal length of the channel;

supporting a hollow needle in the channel for movement relative to the housing between a start position, an extended position and a retracted position, the needle having a piercing end having an opening and an opposite, second end having an opening;

connecting a fluid conduit to the opening on the second end of the hollow needle for movement with the hollow needle, the fluid conduit being connectable to the outlet or inlet port of the reservoir;

supporting a cannula, when the needle is in the start position, for movement with the needle to the extended position of the needle;

connecting a lever member in a fixed relation to the hollow needle and extending an extension portion of the lever member through the slot-shaped opening in the housing;

arranging a first bias member to impart a first bias force on the lever in a first direction, for moving the lever and the attached needle and the supported cannula from the start position to the extended position of the needle, free of manual input;

providing a lock structure for locking the cannula in a fixed position relative to the housing, when the needle and cannula are moved to the extended position of the needle; and

arranging a second bias member to impart a second bias force on the lever in a second direction, opposite to the first direction, for moving the lever and the attached needle from the extended position to the retracted position, while leaving the cannula in the extended position;

wherein at least a portion of the first bias member is located outside the housing, and

wherein at least a portion of the second bias member is located outside the housing.

13. A method as recited in claim 12, further comprising providing a second lock structure for locking the first bias member in a state at which the first bias member is ready to impart a bias force on the lever member, but does not impart its full force on the lever and for selectively releasing the first bias member to impart its full force on the lever.

14. A method as recited in claim 13, wherein arranging the first bias member comprises arranging a bias member that is configured such that upon releasing the first bias member, the first bias member imparts a force on the lever member that overpowers the force of the second bias member, to move the lever member and attached needle from the start position to the extended position against the bias force of the second bias member.

15. A method as recited in claim 14, wherein the lever member is configured to be released from the first bias member, upon the lever member being moved to the extended position, to allow the bias force of the second bias member to move the lever member and attached needle to the retracted position.

16. A method as recited in claim 15, wherein the lever member comprises a bendable or breakable portion that bends or breaks to disengage from the first bias member, upon the lever member being moved by the first bias member to the extended position.

17. A method as recited in claim 13, wherein the second lock structure is configured to selectively release the first bias member upon pivoting of the second lock structure.

18. A method as recited in claim 12, wherein the first bias member comprises a first spring and the second bias member comprises a second spring.

19. A method as recited in claim 18, wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member outside of the housing.

20. A method as recited in claim 18, wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member outside of the housing.