ADHESIVE AND PERIPHERAL SYSTEMS AND METHODS FOR MEDICAL DEVICES

• US 20120209204A1
• Filed: 03/22/2011
• 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 B., Yeaton, Eric
• Granted Patent: US 11,406,753 B2
• Time in Patent Office: Days
• US Class Current: 604/164.12
• 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 needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:

abuse structure for arranging adjacent a user'"'"'s skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one pivotal arm supported on the moveable carriage for pivotal motion relative to the base, between a first pivot position and a second pivot position;

a moveable needle supported by the base structure for movement between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user'"'"'s skin when the base structure is arranged adjacent the user'"'"'s skin and the moveable needle is moved to the extended position, wherein the needle shaft has a sufficient length to extend through the cannula to extend the piercing end of the needle out one end of the cannula and move with the cannula between the retracted position and the extended position;

a first spring arranged to provide a first bias force at least when the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second spring arranged to be held in a compressed state by the at least one pivotal arm, when the at least one pivotal arm is in the first pivot position and the moveable needle is moved to the extended position and, from that state, to be released to expand toward its natural state of uncompression upon the at least one pivotal arm moving to the second pivot position;

wherein, when (i) the base structure is arranged adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second spring is released from its compressed state and expands toward its natural state of uncompression, a second bias force is provided on the needle by the second spring to move the needle from an extended position to a retracted position, while leaving the cannula in the user'"'"'s skin.

2. A device according to claim 1, wherein the base structure has an opening through which the needle moves as the needle is moved between the retracted and extended positions.

3. A device according to claim 2, wherein the first and second springs comprise first and second coil springs, respectively, and wherein the first and second coil springs are arranged with their coils around the opening in the base structure.

4. A device according to claim 1, wherein the first and second springs comprise first and second coaxially arranged coil springs, respectively, and wherein the needle is supported for movement within the first and second coil springs.

5. A device according to claim 4, wherein the needle is arranged to extend along the common axis of the first and second coil springs.

6. A device according to claim 1, further comprising a flange member arranged to abut the at least one pivotal arm, needle and the second spring when (i) the at least one pivotal arm is in the first pivot position, (ii) the second spring is in its compressed state, and (iii) the needle is in the extended position, and to move with the needle toward the retracted position of the needle when the at least one pivotal arm is moved to the second pivot position to release the second spring.

23. A device according to claim 1, in which the moveable needle has a needle head, and the second spring is arranged between the moveable carriage and the needle head.

24. A device according to claim 1, further comprising:

a fluid passage on the base structure and having a port, the fluid passage for conveying fluid between a reservoir and the port; and

a connection structure arranged to connect the cannula in fluid flow communication with the port of the fluid passage when the moveable carriage is in the extended position and to disconnect the cannula from the port of the fluid passage when the moveable carriage is in the retracted position.

25. A device according to claim 24, wherein the connection structure is supported on the moveable carriage.

29. A device according to claim 1, wherein the second spring is arranged to be held in a state to store energy for the second bias force when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.

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

a base structure for arranging adjacent a user'"'"'s skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one moveable locking member supported on the moveable carriage for motion relative to the base, between at least one first position and at least one second position;

a moveable needle supported by the base structure for movement with the moveable carriage between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user'"'"'s skin when the base structure is arranged adjacent the user'"'"'s skin and the moveable needle is moved to the extended position,

a first bias member arranged to provide a first bias force on the needle at least When the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second bias member arranged to be held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle is moved to the extended position and the at least one moveable locking member is in one of the first positions and, from that state, to a state at which the stored bias energy is released to apply a force on the needle to move the needle toward the retracted position, when the at least one moveable locking member is moved to one of the second positions; and

the second bias member being held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle and the carriage are both in the retracted position.

8. A device according to claim 7, wherein the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, white supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user'"'"'s skin, when (i) the base structure is arranged adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second bias member is released from its bias energy storing state and moves the needle from its extended position toward its retracted position.

9. A device according to claim 7, wherein the at least one moveable locking member comprises at least one pivotal arm.

10. A device according to claim 7, wherein the at least one moveable locking member comprises a plurality of pivotal arms.

11. A device according to claim 7, wherein the first bias member comprises a spring.

12. A device according to claim 11, wherein the second bias member comprises a spring.

13. A device according to claim 7, wherein the first and second bias members comprise first and second coil springs, respectively.

14. A device according to claim 7, wherein the first and second bias members comprises first and second coaxially arranged coil springs, respectively.

15. A device according to claim 7, wherein the first and second bias members are supported by the base structure.

16. A device according to claim 7, wherein the first and second bias members are supported by the base structure and the first and second bias members comprises first and second coaxially arranged coil springs, respectively, and wherein the needle is supported for movement within the first and second coil springs.

17. A device according to claim 16, wherein the needle is arranged to extend along the common axis of the first and second coil springs.

26. A device according to claim 7, in which the moveable needle has a needle head, and the second bias member is arranged between the moveable carriage and the needle head.

27. A device according to claim 7, further comprising:

a fluid passage on the base structure and having a port, the fluid passage for conveying fluid between a reservoir and the port; and

a connection structure having a fluid flow channel that is separate from and independent of the moveable needle and is arranged to connect a cannula supported by the moveable carriage in fluid flow communication with the port of the fluid passage when the moveable carriage is in the extended position and to disconnect the cannula from the port of the fluid passage when the moveable carriage is in the retracted position.

28. A device according to claim 27, wherein the connection structure is supported on the moveable carriage.

30. A device according to claim 7, wherein the second bias member is arranged to be held in a state to store a bias energy when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.

32. A device according to claim 27, wherein, when the moveable needle is in the extended position, the second bias member imparts a force to move the moveable needle from the extended position to a position at which the needle is outside of the fluid flow channel that connects the cannula fluid flow communication with the port.

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

a housing structure, the housing structure having an injection site portion;

a reservoir supported by the housing structure, the reservoir having an interior for containing an infusion medium,

a needle injector supported by the injection site portion of the housing structure and connected in fluid flow communication with the interior of the reservoir, the needle injector comprising;

abuse structure for arranging adjacent a user'"'"'s skin;

a moveable carriage for supporting a hollow cannula for movement between a retracted position and an extended position;

at least one moveable locking member supported on the moveable carriage for motion relative to the base, between at least one first position and at least one second position;

a moveable needle supported by the base structure for movement with the moveable carriage between a retracted position and an extended position, the moveable needle having a shaft, the needle shaft having a piercing end for piercing the user'"'"'s skin when the base structure is arranged adjacent the user'"'"'s skin and the moveable needle is moved to the extended position,

a first bias member arranged to provide a first bias force on the needle at least when the needle is in the retracted position, the first bias force directed to bias the needle toward the extended position;

a second bias member arranged to be held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle is moved to the extended position and the at least one moveable locking member is in one of the first positions and, from that state, to a state at which the stored bias energy is released to apply a force on the needle to move the needle toward the retracted position, when the at least one moveable locking member is moved to one of the second positions; and

the second bias member being held by the at least one moveable locking member in a state at which the second bias member stores a bias energy when the moveable needle and the carriage are both in the retracted position.

19. A device according to claim 18, wherein the needle shaft has a sufficient length and width relative to a hollow cannula to extend through the hollow cannula and to extend the piercing end of the needle out one end of the cannula, white supporting the cannula on the needle for movement with the needle between the retracted position and the extended position, and to leave the cannula in the extended position in a user'"'"'s skin, when (i) the base structure is arranged adjacent the user'"'"'s skin, (ii) the moveable needle and cannula are in the extended position and (iii) the second bias member is released from its bias energy storing state and moves the needle from its extended position toward its retracted position.

20. A device according to claim 18, wherein the at least one moveable locking member comprises at least one pivotal arm.

21. A device according to claim 18, wherein the first and second bias members comprise first and second coil springs, respectively.

22. A device according to claim 21, wherein the first and second coil springs are arranged coaxially on the base structure.

31. A device according to claim 18, wherein the second bias member is arranged to be held in a state to store a bias energy when the moveable needle is in the retracted position and the at least one moveable locking member is in one of the first positions.