# US 10,369,079 B2 · Drug refill applicator system and method of use

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- Number: US 10,369,079 B2
- Document ID: US10369079B2
- Status: Granted
- Kind: B2
- Application number: 14/579,231
- Filed: 2014-12-22
- Published: 2015-06-25
- Granted: 2019-08-06
- Earliest claimed: 2011-03-14
- Assignees: MiniPumps, LLC
- Applicants: Andres Rodriguez; Pedrum Minaie; Tun Min Soe; Jason Shih; Andrew Dunn; Andrew Urazaki; Bin Wang; Fukang Jiang
- Inventors: Andres Rodriguez; Pedrum Minaie; Tun Min Soe; Jason Shih; Andrew Dunn; Andrew Urazaki; Bin Wang; Fukang Jiang
- Web page: https://patentgrep.com/patent/US10369079B2

## CPC

- A61J 1/22: with means for metering the amount of fluid
- A61M 5/14276: {specially adapted for implantation}
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- A61J 1/201: {having one piercing end}
- A61M 2005/14268: {with a reusable and a disposable component}
- 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
- 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)}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

Embodiments of the present invention involve a refill apparatus comprising at least one pump, a plurality of reservoirs, a plurality of reservoir fluid channels each associated with one of the reservoirs, a plurality of valves, each having a cracking pressure, for fluidically sealing the reservoir fluid channels and the outlet fluid channel, an outlet fluid channel fluidically connected to the reservoir fluid channels, and a needle having a lumen in fluid communication with the outlet fluid channel. A parameter such as a pressure level is monitored, and one or more pumps and various ones of the valves are actuated in accordance with a protocol comprising a sequence of steps whereby fluidic pathways are opened between different ones of the reservoirs and the needle in a washing and filling sequence, each of the steps being associated with an expected pressure level.

## Claims

### Claim 1

Apparatus for refilling a reservoir, the apparatus comprising:
a plurality of reservoirs;
a plurality of reservoir fluid channels each associated with one of the reservoirs;
an outlet fluid channel fluidically connected to the reservoir fluid channels;
a plurality of valves, each having a cracking pressure, for fluidically sealing the reservoir fluid channels and the outlet fluid channel;
at least one pressure sensor for monitoring pressure in the reservoir fluid channels and the outlet fluid channel;
at least one actuation mechanism;
a needle having a lumen in fluid communication with the outlet fluid channel, the needle being configured for insertion into a drug-delivery port of an implantable medical device; and
a controller for actuating the at least one actuation mechanism and various ones of the valves in accordance with the monitored pressure and a protocol comprising a sequence of steps whereby fluidic pathways are opened between different ones of the reservoirs and the needle in a washing and filling sequence, each of the steps being associated with an expected pressure level.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the controller is configured to execute a step in the sequence upon detection, via the sensor, of the expected pressure level.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein at least some of the valves are active valves.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein at least some of the valves are passive valves.

### Claim 5 (depends on 1)

The apparatus of claim 1, further comprising at least one flow sensor.

### Claim 6 (depends on 1)

The apparatus of claim 1, further comprising at least one biosensor.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the controller is configured to control the actuation mechanism so as to maintain a pressure through the outlet fluid channel below a pressure causing damage to an implantable device connected to the needle.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the controller is configured to control the actuation mechanism so as to maintain a pressure through the outlet fluid channel below a pressure causing an implantable device connected to the needle to expel material.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein the controller is configured to control the actuation mechanism so as to maintain, during a filling or aspiration step, a pressure through the outlet fluid channel above the cracking pressure of each one of the check valves in each one of the reservoir fluid channels operatively used during the filling or aspiration step.

### Claim 10 (depends on 1)

The apparatus of claim 1, wherein the controller (i) comprises a memory for storing a plurality of expected pressure levels and expected intervals therebetween and (ii) is configured to monitor the at least one pressure sensor and, upon detection of an expected pressure level following an expected interval, to initiate or terminate a protocol step.

### Claim 11 (depends on 1)

The apparatus of claim 1 further comprising at least one sensor for a parameter other than pressure, wherein the controller (i) comprises a memory for storing a temporal profile of expected parameter values including pressure values and (ii) is configured to monitor the sensors and, upon detection of a deviation from the stored profile, report an error condition.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the parameter values comprise at least one of a detected flow rate, cumulative flow, pressure slope change, duration of a specific pressure, or plateauing within specific pressure ranges.

### Claim 13

A method of refilling an implantable device having a drug chamber, the method comprising the steps of:
providing a refill apparatus comprising at least one pump, a plurality of reservoirs, a plurality of reservoir fluid channels each associated with one of the reservoirs, a plurality of valves, each having a cracking pressure, for fluidically sealing the reservoir fluid channels and an outlet fluid channel, the outlet fluid channel fluidically connected to the reservoir fluid channels, and a needle having a lumen in fluid communication with the outlet fluid channel;
monitoring a pressure level;
inserting the needle into a drug-delivery port of the implantable device; and
actuating at least one said pump and various ones of the valves in accordance with the monitored pressure level and a protocol comprising a sequence of steps whereby fluidic pathways are opened between different ones of the reservoirs and the needle in a washing and filling sequence, each of the steps being associated with an expected pressure level.

### Claim 14 (depends on 13)

The method of claim 13, wherein the washing and filling sequence comprises flushing a drug chamber of the implantable device by (i) causing a first fluid from a first one of the reservoirs to enter the drug chamber via the needle at a pressure not exceeding a specific pressure threshold, (ii) removing the first fluid from the drug chamber, and (iii) causing a drug-containing liquid to enter at a pressure not exceeding the specific pressure threshold.

### Claim 15 (depends on 14)

The method of claim 14, wherein the specific pressure threshold is less than a pressure causing damage to the implantable device.

### Claim 16 (depends on 14)

The method of claim 14, wherein the specific pressure threshold is less than a pressure causing flow through the implantable device.

### Claim 17 (depends on 13)

The method of claim 13, further comprising the step of monitoring at least one parameter other than pressure and, upon detection of a parameter value matching a stored trigger value, initiating or terminating a step in the sequence.

### Claim 18 (depends on 17)

The method of claim 17, wherein the trigger values comprise or consist of at least one of a detected flow rate, cumulative flow, pressure slope change, duration of a specific pressure, or plateauing within specific pressure ranges.

### Claim 19 (depends on 13)

The method of claim 13 further comprising monitoring at least one parameter other than and in addition to pressure, and further comprising the steps of:
storing a temporal profile of expected parameter values including pressure values; and
based on the monitored parameters, reporting an error condition upon detection of a deviation from the stored profile.