# US 2014/0193381 A1 · Fluid Exchange Methods and Devices

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- Number: US 2014/0193381 A1
- Document ID: US20140193381A1
- Status: Published application
- Kind: A1
- Application number: 14/237,857
- Filed: 2012-09-28
- Published: 2014-07-10
- Earliest claimed: 2011-09-30
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Brian David Warner; John Dunne
- Web page: https://patentgrep.com/patent/US20140193381A1

## CPC

- A61J 3/00: Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J 1/10: Bag-type containers
- A61J 1/2003: {Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting}
- A61J 1/2089: {Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- A61M 1/3678: {Separation of cells using wave pressure; Manipulation of individual corpuscles}
- A61M 1/3692: {Washing or rinsing blood or blood constituents}
- A61M 1/3693: {using separation based on different densities of components, e.g. centrifuging}
- A61M 5/1407: {Infusion of two or more substances}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/19: having more than one chamber
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- C12N 13/00: Treatment of microorganisms or enzymes with electrical or wave energy, e.g. magnetism, sonic waves
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61M 2205/10: with powered movement mechanisms
- 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
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Methods and devices for exchanging therapeutic agents, such as cells, from one liquid medium to another liquid medium are provided. Aspects of embodiments of the methods include transferring a therapeutic agent from a first medium, such as a freezing, storage or shipping buffer, into a second medium, such as a sterile physiologically compatible buffer. In certain aspects, the transfer of the therapeutic agent from a first medium to a second medium involves the use of acoustic-focusing, or acoustophoresis. Embodiments of the subject methods may facilitate the transfer of a therapeutic agent from a storage medium to an infusion medium, and in certain embodiments include administering the therapeutic agent contained in the infusion medium to the subject. Also provided by the present disclosure are devices for practicing the subject methods.

## Claims

### Claim 1

A method of preparing a particulate infusion composition, the method comprising:
combining a first liquid comprising a therapeutic agent in a storage medium and a second liquid infusion medium in a manner sufficient to produce a laminar flow of the first and second media; and
acoustophoretically moving the therapeutic agent from a first liquid medium into the second liquid medium.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the method further comprises infusing the second liquid medium into a subject.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the subject is human.

### Claim 4 (depends on 2)

The method according to claim 2, wherein the therapeutic agent was obtained from the subject.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the therapeutic agent comprises cells.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the first liquid medium comprises a cryoprotectant.

### Claim 7 (depends on 1)

The method according to claim 1, wherein combining the first and second media comprises gravimetric fluid flow.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the method is performed under sterile conditions.

### Claim 9

A device for transferring a therapeutic agent, the device comprising:
a first container providing the therapeutic agent suspended in a first medium;
a second container providing a second medium;
an acoustophoresis device in fluidic communication with the first and second containers and configured to exchange the second medium for the first medium, to produce the therapeutic agent suspended in the second medium.

### Claim 10 (depends on 9)

The device according to claim 9, further comprising a channel in fluidic communication with the acoustophoresis device and configured to receive the therapeutic agent suspended in the second medium and administer the therapeutic agent suspended in the second medium to a patient.

### Claim 11 (depends on 10)

The device according to claim 10, comprising at least one pump to control a flow rate of the first medium or the second medium through the acoustophoresis device.

### Claim 12 (depends on 10)

The device according to claim 10, wherein the acoustophoresis device comprises 2 or more separation channels.

### Claim 13 (depends on 10)

The device according to claim 10, wherein the device is sterile.

### Claim 14

A kit comprising:
an acoustophoresis device configured to connect with two or more containers; and
a container providing a sterile physiologically compatible buffer.

### Claim 15

An acoustophoresis device configured to connect with a first container comprising a therapeutic agent in a storage medium and a second container comprising infusion medium; and configured to acoustophoretically move the therapeutic agent from the medium into the infusion medium.
