# US 10,245,390 B2 · Adhesive and peripheral systems and methods for medical devices

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- Number: US 10,245,390 B2
- Document ID: US10245390B2
- Status: Granted
- Kind: B2
- Application number: 15/350,606
- Filed: 2016-11-14
- Published: 2017-03-02
- Granted: 2019-04-02
- Earliest claimed: 2006-02-09
- Assignees: DEKA Products Limited Partnership
- Applicants: DEKA Products Limited Partnership
- Inventors: Dean Kamen; Larry B. Gray; Russell H. Beavis
- Web page: https://patentgrep.com/patent/US10245390B2

## 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 needle injector device for connection in fluid-flow communication with the inlet or outlet port of a reservoir, the needle injector comprising:
a housing;
a hollow needle supported in the housing 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;
a first bias member supported by the housing and arranged to impart a first bias force in a first direction on the attached needle from the start position to the extended position of the needle;
a second bias member arranged to impart a second bias force in a second direction, opposite to the first direction, for moving the attached needle from the extended position to the retracted 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.

### Claim 2 (depends on 1)

A device as recited in claim 1, further comprising:
a lever member connected in a fixed relation to the hollow needle and having an extension portion extending through the slot-shaped opening in the housing;
a lock structure for locking the first bias member in a first 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.

### Claim 3 (depends on 2)

A device as recited in claim 2, 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.

### Claim 4 (depends on 3)

A device as recited in claim 3, 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.

### Claim 5 (depends on 4)

A device as recited in claim 4, 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.

### Claim 6 (depends on 1)

A device as recited in claim 1, wherein the extension portion of the lever member is positioned to extend at least partially outside of the housing.

### Claim 7 (depends on 6)

A device as recited in claim 6, wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 8 (depends on 6)

A device as recited in claim 6, wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 9 (depends on 6)

A device as recited in claim 6,
wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing, and
wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 10 (depends on 5)

A device as recited in claim 5, wherein the bendable or breakable portion of the lever member is a breakable portion configured to break to disengage from the first bias member, upon the lever member being moved by the first bias member to the extended position.

### Claim 11 (depends on 1)

A device as recited in claim 1,
wherein the piercing end of the needle is positioned inside the housing when the needle is in the retracted position.

### Claim 12 (depends on 2)

A device as recited in claim 2,
wherein the lock structure is located outside the housing.

### Claim 13 (depends on 2)

A device as recited in claim 2,
wherein the lock structure comprises a pivotal lever pivotally coupled to the housing.

### Claim 14 (depends on 13)

A device as recited in claim 13,
wherein the first the pivotal lever is pivotal between first and second pivotal positions and is configured to hold the first bias member in its first state when the pivotal lever is in the first pivotal position and to release the first bias member when the pivotal lever is in the second pivotal position.

### Claim 15 (depends on 6)

A device as recited in claim 6,
wherein the extension portion of the lever member is positioned to extend at least partially outside of the housing throughout the motion of the needle between the retracted and extended positions.

### Claim 16 (depends on 6)

A device as recited in claim 6,
wherein the extension portion of the lever member extends outside the housing at a fixed distance relative to the needle.

### Claim 17 (depends on 1)

A device as recited in claim 1,
wherein, after retraction, the needle remains attached to the fluid conduit.

### Claim 18

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;
supporting a hollow needle in the housing 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;
arranging a first bias member supported by the housing to impart a first bias force in a first direction on the attached needle from the start position to the extended position of the needle; and
arranging a second bias member to impart a second bias force in a second direction, opposite to the first direction, for moving the attached needle from the extended position to the retracted 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.

### Claim 19 (depends on 18)

A method as recited in claim 18, further comprising:
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;
providing a 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.

### Claim 20 (depends on 19)

A method as recited in claim 19, 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.

### Claim 21 (depends on 20)

A method as recited in claim 20, 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.

### Claim 22 (depends on 21)

A method as recited in claim 21, 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.

### Claim 23 (depends on 18)

A method as recited in claim 18, wherein the extension portion of the lever member is positioned to extend at least partially outside of the housing.

### Claim 24 (depends on 23)

A method as recited in claim 23, wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 25 (depends on 23)

A method as recited in claim 23, wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 26 (depends on 23)

A method as recited in claim 23,
wherein the first bias member is arranged to impart the first bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing, and
wherein the second bias member is arranged to impart the second bias force on the extension portion of the lever member at a location on the extension portion that is outside of the housing.

### Claim 27 (depends on 26)

A method as recited in claim 26,
wherein the first the pivotal lever is pivotal between first and second pivotal positions and is configured to hold the first bias member in its first state when the pivotal lever is in the first pivotal position and to release the first bias member when the pivotal lever is in the second pivotal position.

### Claim 28 (depends on 18)

A method as recited in claim 18,
wherein the extension portion of the lever member is positioned to extend at least partially outside of the housing throughout the motion of the needle between the retracted and extended positions.

### Claim 29 (depends on 27)

A method as recited in claim 27,
wherein the extension portion of the lever member extends outside the housing at a fixed distance relative to the needle.

### Claim 30 (depends on 18)

A method as recited in claim 18,
wherein the piercing end of the needle is positioned inside the housing when the needle is in the retracted position.