# US 9,039,679 B2 · Systems and methods for sustained medical infusion and devices related thereto

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- Number: US 9,039,679 B2
- Document ID: US9039679B2
- Status: Granted
- Kind: B2
- Application number: 14/057,840
- Filed: 2013-10-18
- Published: 2014-02-27
- Granted: 2015-05-26
- Earliest claimed: 2005-11-07
- Assignees: Roche Diagnostics Operations, Inc.
- Applicants: Roche Diagnostics Operations, Inc.
- Inventors: Ofer Yodfat; Avi Neta; Gavriel J. Iddan
- Web page: https://patentgrep.com/patent/US9039679B2

## CPC

- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/14232: {Roller pumps}
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/172: electrical or electronic
- A61M 5/16854: {by monitoring line pressure}
- A61M 2005/14252: {with needle insertion means}
- A61M 2005/14268: {with a reusable and a disposable component}
- 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 2209/01: Remote controllers for specific apparatus
- 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)}

## Abstract

Embodiments of the invention are directed to systems, methods and devices for sustained medical infusion with controlled rate injection of a fluid into a body. Such a system may include a first separate reusable unit, a second separate depletable unit a third separate disposable unit having a cannula, and may include a fourth separate remote control unit. Emission of appropriate instructions from the fourth unit, when the first unit, the second unit, and the third unit are coupled together in associative operation and disposed on the skin, power is supplied to an engine for generating motion to a fluid transfer system, and when the cannula is inserted in the body, fluid is transferred from the reservoir to the body, via the tube and the cannula.

## Claims

### Claim 1

A medical device for delivering therapeutic fluid to a body of a patient, the device comprising:
a first unit comprising a first portion of a fluid transfer system;
a second unit coupleable to the first unit, the second unit comprising a reservoir for holding the therapeutic fluid, and a second portion of the fluid transfer system coupleable to the first portion of the fluid transfer system when the first unit is coupled to the second unit;
a cradle configured for releasably receiving the first unit, the cradle comprising a releasable mechanism for coupling both the first and second units when engaged; and
a cannula unit coupleable to the second unit, the cannula unit comprising a cannula for insertion into the body of the patient;
wherein upon coupling the first, second, and cannula units, and insertion of the cannula into the body of the patient, fluid communication is established from the reservoir to the body, via the cannula, without the use of tubing external to the coupled first and second units.

### Claim 2 (depends on 1)

The device according to claim 1, wherein at least one of the first and second units comprises a flexible, skin-compliant envelope.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the first unit is coupleable to a different second unit.

### Claim 4 (depends on 3)

The device according to claim 3, wherein the different second unit comprises a different reservoir for holding a different therapeutic fluid.

### Claim 5 (depends on 3)

The device according to claim 3, wherein the reservoir of the second unit has a first reservoir size, and the different second unit comprises a different reservoir having a second reservoir size different from the first reservoir size.

### Claim 6 (depends on 3)

The device according to claim 3, wherein the second unit comprises an energy source having a first size, and the different second unit comprises a different energy source having a second size different from the first size.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the cannula is configured for insertion into the body at any desired angle.

### Claim 8 (depends on 1)

The device according to claim 1, further comprising:
a pumping mechanism for delivering the therapeutic fluid from the reservoir to the body of the patient;
one or more sensors for monitoring the fluid delivery; and
a controller connected to the one or more sensors and the pumping mechanism for controlling the pumping mechanism based on one or more signals generated by the one or more sensors.

### Claim 9 (depends on 8)

The device according to claim 8, wherein the one or more sensors comprise a flow sensor.

### Claim 10 (depends on 8)

The device according to claim 8, wherein the one or more sensors comprise a rotation sensor for sensing a rotation of the pumping mechanism.

### Claim 11 (depends on 8)

The device according to claim 8, wherein the one or more sensors comprise a pressure sensor for sensing a pressure of the fluid transfer system.

### Claim 12 (depends on 11)

The device according to claim 11, wherein the controller is configured to detect an occlusion or a leak based on a pressure signal generated by the pressure sensor.

### Claim 13 (depends on 11)

The device according to claim 11, wherein the one or more sensors further comprises a fluid flow sensor.

### Claim 14 (depends on 1)

The device according to claim 1, wherein the cannula unit does not increase a width of the device when coupled to the second unit.

### Claim 15 (depends on 1)

The device according to claim 1, wherein the cannula unit does not increase a height of the device above the body of the patient when coupled to the second unit.

### Claim 16 (depends on 1)

The device according to claim 1, wherein the reservoir comprises a collapsible bladder.

### Claim 17 (depends on 1)

The device according to claim 1, wherein the reservoir comprises a self-sealing port.

### Claim 18 (depends on 1)

The device according to claim 1, wherein the reservoir is pre-filled with the therapeutic fluid.

### Claim 19 (depends on 1)

The device according to claim 1, wherein the second unit defines a well through which the cannula unit is coupleable thereto.

### Claim 20 (depends on 19)

The device according to claim 19, further comprising a removable seal for sealing the well of the second unit before coupling the cannula unit to the second unit.

### Claim 21 (depends on 19)

The device according to claim 19, further comprising a vent tube configured to provide fluid communication from the well to an exterior of the second unit.

### Claim 22 (depends on 1)

The device according to claim 1, wherein at least one of the first and second units further comprises an adhesive layer for adhering the device to the patient's body.

### Claim 23 (depends on 22)

The device according to claim 22, wherein at least one of the first and second units further comprises a removable cover layer for covering the adhesive layer prior to adhering the device to the patient's body.

### Claim 24 (depends on 1)

The device according to claim 1, further comprising a transceiver for communicating with an external device.

### Claim 25 (depends on 1)

The device according to claim 1, wherein the first unit is reusable and the second unit is disposable.
