# US 10,245,389 B2 · Adhesive and peripheral systems and methods for medical devices

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,245,389 B2
- Document ID: US10245389B2
- Status: Granted
- Kind: B2
- Application number: 15/155,694
- Filed: 2016-05-16
- Published: 2016-09-08
- Granted: 2019-04-02
- Earliest claimed: 2006-02-09
- Assignees: DEKA Products Limited Partnership
- Applicants: DEKA Products Limited Partnership
- Inventors: Larry B. Gray; Eric Yeaton
- Web page: https://patentgrep.com/patent/US10245389B2

## 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

A delivery device for delivering an infusion medium to a user, the device comprising:
a disposable housing assembly adapted to be secured to a user's skin;
a reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior;
a base portion comprising the reservoir, the base portion having a reservoir cavity, and a fluid path, the reservoir cavity comprising the outlet port and a septum, the fluid path comprising a fluid channel from the outlet port to a cannula port;
at least one flexible membrane portion attached onto the base portion and forming a top of the reservoir cavity and a top of the fluid channel; and
a tubing connected to the base portion at the cannula port, the tubing in fluid communication with the reservoir cavity; and
a needle insertion device for inserting a cannula into the user's skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position;
wherein the disposable housing assembly has a passage through which the introduction needle extends, and
wherein the cannula has a central passage through which the introduction needle extends.

### Claim 2 (depends on 1)

The delivery device of claim 1, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

### Claim 3 (depends on 2)

The delivery device of claim 2, the reusable housing assembly further comprising a latching mechanism for permitting selective engagement and disengagement with the disposable housing assembly.

### Claim 4 (depends on 2)

The delivery device of claim 2, the reusable housing assembly further comprising a mechanism for attaching the housing structure to the user.

### Claim 5 (depends on 1)

The delivery device of claim 1, wherein the tubing portion comprises a cannula port end and a cannula interface end, the cannula interface end configured to attach to a cannula.

### Claim 6 (depends on 1)

The delivery device of claim 1, wherein the fluid path further comprises a series of regions exposed to the flexible membrane portion, at least one of the regions being a valve region.

### Claim 7 (depends on 6)

The delivery device of claim 6, wherein the series of regions further comprises a pump chamber region.

### Claim 8 (depends on 1)

The delivery device of claim 1, wherein the base portion and the flexible membrane portion constitute a fluidic assembly, and wherein the disposable housing assembly further comprises a disposable base into which the fluidic assembly fits.

### Claim 9 (depends on 8)

The delivery device of claim 8, further comprising a pad coupled to a bottom of the disposable base, the pad for attaching the disposable housing assembly to the user.

### Claim 10 (depends on 1)

The delivery device of claim 1, wherein the reservoir port in fluid communication with the reservoir cavity and the septum for penetration by a needle so as to fill the reservoir cavity with therapeutic fluid.

### Claim 11

A delivery device for delivering an infusion medium to a user, the device comprising:
a disposable housing assembly adapted to be secured to a user's skin comprising:
a bottom adapted for attachment to the skin of the user;
a fluidic path portion having a reservoir, a pumping chamber and an outlet;
at least one flexible membrane portion forming at least one portion of the fluidic path portion and the reservoir;
a tubing attached to the outlet, the tubing adapted to connect to a cannula, wherein the reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior; and
a needle insertion device for inserting the cannula into the user's skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position,
wherein the disposable housing assembly has a passage through which the introduction needle extends, and
wherein the cannula has a central passage through which the introduction needle extends.

### Claim 12 (depends on 11)

The delivery device of claim 11, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

### Claim 13 (depends on 11)

The delivery device of claim 11, wherein the reservoir further comprises a septum, whereby the septum for filling the reservoir with therapeutic fluid.

### Claim 14 (depends on 11)

The delivery device of claim 11, wherein the tubing further comprises an outlet end and a cannula interface end, the outlet end attached to the outlet and the cannula interface end configured to attach to a cannula.

### Claim 15

A delivery device for delivering an infusion medium to a user, the device comprising:
a disposable housing assembly adapted to be secured to a user's skin comprising:
a reservoir having an interior for containing a fluidic medium, the reservoir having an outlet port and being operatively coupled to a pumping assembly to selectively drive fluid out the outlet port from the reservoir interior;
a substrate having flexible membrane material thereon, and incorporating therein the reservoir and a fluid channel, the reservoir having a septum, the fluid channel being part of a fluid path in the disposable housing assembly from the outlet port to a cannula port and comprising a series of regions exposed to the flexible membrane material, at least one of the regions being a valve region; and
a tubing portion connected to the cannula port of the disposable housing assembly; and
a needle insertion device for inserting a cannula into the user's skin, the needle insertion device comprising an introduction needle for movement between a retracted position and an extended position;
wherein the disposable housing assembly has a passage through which the introduction needle extends, and
wherein the cannula has a central passage through which the introduction needle extends.

### Claim 16 (depends on 15)

The delivery device of claim 15, further comprising a reusable housing assembly adapted to be secured to the disposable housing assembly, the reusable housing assembly comprising a volume sensing device, wherein the volume sensing device determines the volume of fluid delivered to the user.

### Claim 17 (depends on 16)

The disposable unit of claim 16, further comprising a latching mechanism for permitting selective engagement and disengagement of the reusable housing assembly with the disposable assembly.

### Claim 18 (depends on 15)

The delivery device of claim 15, wherein the tubing portion comprises a cannula port end and a cannula interface end, the cannula port end attached to the cannula port and the cannula interface end configured to attach to a cannula.

### Claim 19 (depends on 15)

The delivery device of claim 15, wherein the fluid path further comprises a pump chamber region.

### Claim 20 (depends on 15)

The delivery device of claim 15, wherein the tubing adapted to connect to a cannula.

### Claim 21 (depends on 15)

The delivery device of claim 15, wherein the substrate and the flexible membrane material constitute a fluidic assembly, and wherein the disposable housing assembly further comprising a disposable base into which the fluidic assembly fits.

### Claim 22 (depends on 21)

The disposable unit of claim 21, further comprising a pad coupled to a bottom of the disposable housing assembly for attaching the housing structure to the user.