Adhesive and Peripheral Systems and Methods for Medical Devices

• US 20140207067A1
• Filed: 03/21/2014
• Published: 07/24/2014
• Est. Priority Date: 02/09/2006
• Status: Active Application

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Gray, Larry B., Beavis, Russell H.
• Application Number:
  US14/221,979
• Publication Number:
  US 20140207067A1
• 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

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 having a generally cylindrical interior surface surrounding a generally cylindrical hollow interior volume, the generally cylindrical interior surface having a central axis, an inner circumference, a first groove forming a generally spiral path around at least a portion of the inner circumference and a second groove extending in a generally linear path that is generally parallel to the central axis; and

a moveable cam member supported for movement within the interior volume of the housing between a retracted position and an extended position, the cam member having an outer cam portion for extending into the first and second grooves and an inner cam portion disposed within the outer cam portion, the inner cam portion for supporting a needle for movement with the cam member between the retracted position and extended position, the outer cam portion being rotatably connected to the inner cam portion, to rotate relative to the inner cam portion;

wherein, when the moveable cam member is in the retracted position, the moveable cam member is arranged relative to the generally cylindrical interior surface, to be selectively moved from the retracted position to the extended position, in a rotary direction around the central axis and simultaneously in a direction generally parallel to the central axis, while the outer cam portion follows the spiral path of the first groove; and

wherein, when the moveable cam member is in the extended position, the moveable cam member is arranged relative to the generally cylindrical interior surface, to be moved from the extended position toward the retracted position, in a generally linear direction that is generally parallel to the central axis, while the outer cam portion follows the generally linear path of the second groove.

2. A device according to claim 1, further comprising a guide structure for engaging the inner cam portion for inhibiting rotation of the inner cam portion, as the outer cam portion engages the first groove and is moved from a retracted position to an extended position.

3. A device according to claim 2, wherein the guide structure comprises at least one strut extending within the housing, in a direction generally parallel to the central axis, the at least one strut for engaging the inner cam portion.

4. A device according to claim 3, wherein the inner cam portion has at least one opening through which the at least one strut extends through.

5. A device according to claim 1, wherein the housing has a first end and a second end and wherein the generally linear path connects to the generally spiral path adjacent the first end and adjacent the second end of the housing.

6. A device according to claim 1, further comprising a needle having a shaft having a piercing end, the needle supported for movement with the cam member such that the piercing end of the needle extends out of the housing, when the cam member is in the extended position.

7. A device according to claim 1, wherein:

the housing has a base end for arranging adjacent a user'"'"'s skin; and

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, while 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 end of the housing is arranged adjacent the user'"'"'s skin;

(ii) the moveable needle and cannula are in the extended position; and

(iii) the moveable cam member is moved from the extended position toward the retracted position, while the cam projection follows the generally linear path of the second groove.

8. A needle inserter device comprising:

a base structure;

a cap member configured to engage the base structure and move in a first direction relative to the base housing while engaging the base structure; and

a needle support structure for supporting a needle, the needle support structure being moveably supported within the interior of the base housing between a retracted position and an extended position,

wherein the needle support structure moves at an angle greater than 0 degrees relative to the first direction of movement of the cap member relative to the base structure as the needle support structure moves from its retracted position to its extended position.

9. A device according to claim 8, further comprising a bias mechanism arranged to bias the cap member in a direction opposite to the first direction relative to the base structure.

10. A device according to claim 8, wherein the cap member includes a surface for receiving a manual force for moving the cap member in the first direction relative to the base structure.

11. A device according to claim 8, wherein:

the base structure has an interior, a first side surface having a first slot, the first slot having a length dimension longer than its width dimension;

the cap member has a first side surface provided with a second slot, the second slot having a length dimension longer than its width dimension; and

the needle support structure comprises a slide structure having an arm extending through the first slot in the first side surface of the base structure and through the second slot in the first side surface of the cap member;

wherein, the arm of the slide structure is engaged by an edge of the second slot to move the slide structure from its retracted position to its extended position as the cap member is moved in the first direction relative to the base structure.

12. A device according to claim 11, wherein the longitudinal dimension of the first slot in the base housing is arranged in a first direction and wherein the longitudinal dimension of the second slot in the cap member is arranged at an angle greater than 0 degrees relative to the longitudinal dimension of the first slot, when the cap member is engaged with the base housing.

13. A device according to claim 11, further comprising:

a first gear having a first gear surface arranged at an angle greater than 0 degrees relative to the first direction, the first gear supported by the base structure for movement relative to the base structure between a retracted position and an extended position; and

a second gear having a second gear surface and supported by the cap member with the second gear surface arranged generally in the first direction, the second gear surface being operatively coupled to the first gear surface; and

wherein the needle support structure is connected to the first gear for movement with the first gear between the retracted and extended positions;

wherein upon movement of the cap member relative to the base structure in the first direction, the second gear moves generally in the first direction with the cap member and causes the first gear to move relative to the base structure from the retracted position toward the extended position.

14. A device according to claim 13, wherein the first and second gear surfaces are generally linear.

15. A device according to claim 14, further comprising a linkage gear operatively connecting the first gear surface to the second gear surface.

16. A needle inserter device comprising:

a base structure;

a cap member configured to engage the base structure and move in a first direction relative to the base housing while engaging the base structure;

a bias mechanism arranged to bias the cap member in a direction opposite to the first direction relative to the base structure; and

a needle support structure for supporting a needle, the needle support structure being moveably supported within the interior of the base housing between a retracted position and an extended position,

wherein the needle support structure moves at an angle greater than 0 degrees relative to the first direction of movement of the cap member relative to the base structure as the needle support structure moves from its retracted position to its extended position.

17. A device according to claim 16, wherein the cap member includes a surface for receiving a manual force for moving the cap member in the first direction relative to the base structure.

18. A device according to claim 16, wherein:

the base structure has an interior, a first side surface having a first slot, the first slot having a length dimension longer than its width dimension;

the cap member has a first side surface provided with a second slot, the second slot having a length dimension longer than its width dimension; and

the needle support structure comprises a slide structure having an arm extending through the first slot in the first side surface of the base structure and through the second slot in the first side surface of the cap member;

wherein, the arm of the slide structure is engaged by an edge of the second slot to move the slide structure from its retracted position to its extended position as the cap member is moved in the first direction relative to the base structure.

19. A device according to claim 18, wherein the longitudinal dimension of the first slot in the base housing is arranged in a first direction and wherein the longitudinal dimension of the second slot in the cap member is arranged at an angle greater than 0 degrees relative to the longitudinal dimension of the first slot, when the cap member is engaged with the base housing.

20. A device according to claim 18, further comprising:

a first gear having a first gear surface arranged at an angle greater than 0 degrees relative to the first direction, the first gear supported by the base structure for movement relative to the base structure between a retracted position and an extended position; and

a second gear having a second gear surface and supported by the cap member with the second gear surface arranged generally in the first direction, the second gear surface being operatively coupled to the first gear surface; and

wherein the needle support structure is connected to the first gear for movement with the first gear between the retracted and extended positions;

wherein upon movement of the cap member relative to the base structure in the first direction, the second gear moves generally in the first direction with the cap member and causes the first gear to move relative to the base structure from the retracted position toward the extended position.