# US 2014/0194816 A1 · Adhesive and Peripheral Systems and Methods for Medical Devices

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- Number: US 2014/0194816 A1
- Document ID: US20140194816A1
- Status: Published application
- Kind: A1
- Application number: 13/975,770
- Filed: 2013-08-26
- Published: 2014-07-10
- Earliest claimed: 2006-02-09
- Assignees: DEKA Products Limited Partnership
- Inventors: Larry B. Gray; Eric Yeaton
- Web page: https://patentgrep.com/patent/US20140194816A1

## CPC

- A61M 5/14248: {of the skin patch type}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150175: {Adjustment of penetration depth}
- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap}
- 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}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/14212: {Pumping with an aspiration and an expulsion action}
- A61M 5/14232: {Roller pumps}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/14586: {pressurised by means of a flexible diaphragm}
- A61M 5/148: flexible (A61M5/155 takes precedence)
- A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
- A61M 5/16804: {Active flow controllers}
- A61M 5/16809: {by repeated filling and emptying of an intermediate volume}
- 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)}
- A61M 5/3287: {Accessories for bringing the needle into the body; Automatic needle insertion (A61M5/20, A61M5/31525 take precedence)}
- B23P 15/00: Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
- F04B 7/00: Piston machines or pumps characterised by having positively-driven valving
- F04B 43/02: having plate-like flexible members, e.g. diaphragms (F04B43/14 takes precedence)
- F04B 43/09: Pumps having electric drive
- G01F 22/00: Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
- G05D 7/0676: {by action on flow sources (G05D7/0688, G05D7/0694 take precedence)}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/1427: {Multiple blood sampling, e.g. at periodic or pre-established intervals}
- A61B 5/15107: {Piercing being assisted by a triggering mechanism}
- A61B 5/15119: {comprising shape memory alloys}
- A61B 5/15121: {comprising piezos}
- A61B 5/15123: {comprising magnets or solenoids}
- A61B 5/15125: {comprising a vacuum or compressed fluids}
- A61B 5/6833: {Adhesive patches}
- A61B 2560/0412: Low-profile patch shaped housings
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61M 5/141: {with capillaries for restricting fluid flow}
- A61M 5/14216: {Reciprocating piston type}
- A61M 5/14224: {Diaphragm type}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/152: pressurised by contraction of elastic reservoirs
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 5/16813: {by controlling the degree of opening of the flow line}
- A61M 5/16863: {Occlusion detection}
- A61M 5/16886: {for measuring fluid flow rate, i.e. flowmeters}
- A61M 5/172: electrical or electronic
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/365: {Air detectors (A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626)}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 2005/1402: {Priming}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14268: {with a reusable and a disposable component}
- A61M 2005/14506: {mechanically driven, e.g. spring or clockwork}
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1583: {Needle extractors}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/0266: Shape memory materials
- A61M 2205/0294: Piezoelectric materials
- A61M 2205/04: implanted
- A61M 2205/16: with back-up system in case of failure
- A61M 2205/18: with alarm
- A61M 2205/3303: Using a biosensor
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3341: stabilising pressure or flow to avoid excessive variation
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3389: Continuous level detection (A61M2205/3393 takes precedence)
- A61M 2205/3523: using telemetric means
- A61M 2205/3546: Range
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/8206: battery-operated
- A61M 2205/8237: Charging means
- A61M 2206/22: eliminating pulsatile flows, e.g. by the provision of a dampening chamber
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2209/045: for filling, e.g. for filling reservoirs
- A61M 2230/201: Glucose concentration
- F04B 43/1253: {by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing}
- F04C 2230/60: Assembly methods
- G05B 23/02: Electric testing or monitoring
- G05D 7/0647: {the plurality of throttling means being arranged in series}
- G08C 17/02: using a radio link
- H04B 7/2609: {Arrangements for range control, e.g. by using remote antennas}
- Y10T 29/49236: Fluid pump or compressor making
- Y10T 29/494: Fluidic or fluid actuated device making
- Y10T 29/49412: with assembly, disassembly or composite article making
- Y10T 29/49826: Assembling or joining
- Y10T 29/49828: Progressively advancing of work assembly station or assembled portion of work
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B23P: METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS (arrangements for copying or controlling B23Q)
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- G05D: SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G08C: TRANSMISSION SYSTEMS FOR MEASURED VALUES, CONTROL OR SIMILAR SIGNALS (fluid pressure transmitting systems F15B; mechanical means for transferring the output of a sensing member into a different variable G01D5/00; mechanical control systems G05G)
- H04B: TRANSMISSION
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

An inserter system for insertion of an infusion device in fluid-flow communication with the inlet or outlet port of a reservoir and for insertion of a sensor, the insertion system comprising:
a bridge comprising a cover for the infusion device and a cover for the sensor;
an infusion device introduction needle and a sensor introduction needle supported by the bridge for movement between a retracted position and an extended position;
an inserter housing for accommodating the bridge and for movement of the infusion device introduction needle and the sensor introduction needle between the retracted position and the extended position;
an infusion device about the infusion device introduction needle and moveable with the infusion device introduction needle between the retracted position and the extended position;
a sensor about the sensor introduction need and moveable with the sensor introduction needle between the retracted position and the extended position;
an infusion device release located on the bridge for releasing the infusion device in the extended position upon the infusion device introduction needle and infusion device being moved to the extended position; and
a sensor release located on the bridge for releasing the sensor in the extended position upon the sensor introduction needle and sensor being moved to the extended position.

### Claim 2 (depends on 1)

The inserter system of claim 1, wherein the cover further comprising a needle passage through which the infusion device introduction needle and a sensor introduction needle extends when the infusion device introduction needle and a sensor introduction needle are in the retracted position and moving toward the extended position.

### Claim 3 (depends on 1)

The inserter system of claim 1, wherein the infusion device further comprising a central passage through which the infusion device introduction needle extends when the infusion device introduction needle is in the retracted position and moving toward the extended position.

### Claim 4 (depends on 1)

The inserter system of claim 1, wherein the sensor further comprising a central passage through which the sensor introduction needle extended when the sensor introduction needle is in the retracted position and moving toward the extended position.

### Claim 5 (depends on 1)

The inserter system of claim 1, wherein the infusion device introduction needle and the sensor introduction needle remain attached to the bridge.

### Claim 6 (depends on 1)

The inserter system of claim 1, wherein the infusion device is located in a position adapted to extend into a user's when the infusion device introduction needle and infusion device are locked in the extended position.

### Claim 7 (depends on 1)

The inserter system of claim 1, wherein the infusion device introduction needle is located in a position adapted to pierce a user's skin wherein the infusion device introduction needle is moved to the extended position, and wherein the infusion device introduction needle is located in a position external to a user's skin, when the infusion device introduction needle is in the retracted position.

### Claim 8 (depends on 1)

The inserter system of claim 1, wherein the inserter housing a spring.

### Claim 9 (depends on 1)

The inserter system of claim 1, wherein the bridge configured to be removably attached to the inserter housing wherein the inserter housing for imparting a force on the bridge in a direction for moving the infusion device introduction needle and the sensor introduction needle from the retracted position to the extended position.

### Claim 10 (depends on 1)

The inserter system of claim 1, wherein:
The inserter housing comprising an actuation lever for releasing a spring to impart a force on the bridge and wherein the force moves the infusion device introduction needle and the sensor introduction needle in a direction for moving the infusion device introduction needle and the sensor introduction needle from the retracted position to the extended position.

### Claim 11 (depends on 1)

The inserter system of claim 1, wherein the inserter device configured to actuate the infusion device release and the sensor release when the infusion device introduction needle and the sensor introduction needle are in the extended position.

### Claim 12 (depends on 1)

The inserter system of claim 1, wherein the infusion device release and the sensor release are actuated through apertures and release the infusion device and the sensor device from the bridge when the infusion device introduction needle and the sensor introduction needle are moved to the extended position.

### Claim 13 (depends on 1)

The inserter system of claim 1, wherein the bridge comprises:
a body having two ends, an infusion device end and a sensor end, wherein the infusion device and the sensor removably attach to the infusion device end and the sensor end respectively; and
the infusion device introduction needle and the sensor introduction attached to the needle infusion device end and the sensor end respectively.

### Claim 14 (depends on 1)

The inserter system of claim 1, wherein the inserter housing further comprising an actuation lever operable from outside of the inserter housing, for selectively releasing the bridge to move under the force of a spring from the retracted position to the extended position.

### Claim 15 (depends on 14)

The inserter system of claim 14, wherein the inserter housing further comprising a cocking lever connecting cocking linkages to a hammer cocking slide, wherein the cocking lever moves the cocking slide to a charged position.

### Claim 16 (depends on 15)

The inserter system of claim 15, wherein the inserter housing further comprising a power spring connected to the hammer cocking slide to a trigger, wherein the trigger, when compressed, provides downward force for moving the bridge from the retracted position to the extended position.

### Claim 17 (depends on 16)

The inserter system of claim 16, wherein the inserter housing further comprising a trigger hammer disposed under the hammer cocking slide and between a pair of cocking linkages, wherein the trigger hammer transmits energy released from the power spring when the trigger is released and the trigger hammer impacts a bridge bolt, linked to the bridge.

### Claim 18 (depends on 1)

A delivery device for delivery of infusion medium, the delivery device comprising:
a reservoir for containing an infusion medium and having an outlet port;
a fluid conduit connected in fluid flow communication with the outlet port of the reservoir; and
a drive device operatively connectable to the reservoir, for selectively driving the infusion medium from the reservoir and an inserter system according to claim 1, wherein the infusion device is connected in fluid flow communication with the fluid conduit when the infusion device introduction needle the infusion device are in the extended position.

### Claim 19

An inserter system for insertion of an infusion device in fluid-flow communication with the inlet or outlet port of a reservoir and for insertion of a sensor, the insertion system comprising:
a bridge comprising:
a body having two ends, an infusion device end and a sensor end, wherein the infusion device and the sensor removably attach to the infusion device end and the sensor end respectively;
the infusion device introduction needle and the sensor introduction attached to the needle infusion device end and the sensor end respectively; and
a cover for the infusion device and a cover for the sensor;
an infusion device introduction needle and a sensor introduction needle supported by the bridge for movement between a retracted position and an extended position;
an inserter housing for accommodating the bridge and for movement of the infusion device introduction needle and the sensor introduction needle between the retracted position and the extended position;
an infusion device about the infusion device introduction needle and moveable with the infusion device introduction needle between the retracted position and the extended position;
a sensor about the sensor introduction need and moveable with the sensor introduction needle between the retracted position and the extended position;
an infusion device release located on the bridge for releasing the infusion device in the extended position upon the infusion device introduction needle and infusion device being moved to the extended position; and
a sensor release located on the bridge for releasing the sensor in the extended position upon the sensor introduction needle and sensor being moved to the extended position.

### Claim 20 (depends on 19)

A delivery device for delivery of infusion medium, the delivery device comprising:
a reservoir for containing an infusion medium and having an outlet port;
a fluid conduit connected in fluid flow communication with the outlet port of the reservoir; and
a drive device operatively connectable to the reservoir, for selectively driving the infusion medium from the reservoir and an inserter system according to claim 19, wherein the infusion device is connected in fluid flow communication with the fluid conduit when the infusion device introduction needle the infusion device are in the extended position.