Apparatus and method for maintaining and/or restoring viability of organs

• US 8,431,385 B2
• Filed: 01/21/2011
• Issued: 04/30/2013
• Est. Priority Date: 09/29/1998
• Status: Expired due to Fees

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Owen, Donald R., Kravitz, David C., Brassil, John, Brockbank, Kelvin G. M., Burroughs, Andrew, Isaacs, Dickon, Schein, Douglas
• Primary Examiner(s): Beisner, William H
• Application Number:
  US12/929,410
• Publication Number:
  US 20110129908A1
• Time in Patent Office: 830 Days
• Field of Search: 435/1.2, 435/284.1
• US Class Current: 435/284.1
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A01N 1/0273 Transport containers A01N1/0268 takes precedence
• CPC Class Codes: G06F 16/955 using information identifiers, e.g. uniform resource locators [URL]
• CPC Class Codes: H04L 67/02 based on web technology, e.g. hypertext transfer protocol [HTTP]

Abstract

An organ perfusion apparatus and method monitor, sustain and/or restore viability of organs and preserve organs for storage and/or transport. Other apparatus include an organ transporter, an organ cassette and an organ diagnostic device. The method includes perfusing the organ at hypothermic and/or normothermic temperatures, preferably after hypothermic organ flushing for organ transport and/or storage. The method can be practiced with prior or subsequent static or perfusion hypothermic exposure of the organ. Organ viability is restored by restoring high energy nucleotide (e.g., ATP) levels by perfusing the organ with a medical fluid, such as an oxygenated cross-linked hemoglobin-based bicarbonate medical fluid, at normothermic temperatures. In perfusion, organ perfusion pressure is preferably controlled in response to a sensor disposed in an end of tubing placed in the organ, by a pneumatically pressurized medical fluid reservoir, providing perfusion pressure fine tuning, overpressurization prevention and emergency flow cut-off. In the hypothermic mode, the organ is perfused with a medical fluid, preferably a simple crystalloid solution containing antioxidants, intermittently or in slow continuous flow. The medical fluid may be fed into the organ from an intermediary tank having a low pressure head to avoid organ overpressurization. Preventing overpressurization prevents or reduces damage to vascular endothelial lining and to organ tissue in general. Viability of the organ may be automatically monitored, preferably by monitoring characteristics of the medical fluid perfusate. The perfusion process can be automatically controlled using a control program.

Claims

1. A sterilized disposable kit, comprising:

an organ cassette for independently holding an organ, the organ cassette including an organ supporting surface that supports the organ, the organ cassette being structured to be removably received by a portable organ perfusion apparatus;

at least one of tubing and a connector configured to allow connection of the organ in the organ cassette to tubing in a recirculating arrangement; and

a first lid attachable to the cassette and a second lid attachable to the cassette, wherein at least one of the first lid and the second lid is openable without exposing an interior of the cassette when the first lid and the second lid arc attached to the cassette.

2. A sterilized disposable kit according to claim 1, wherein the recirculating arrangement is configured to divert fluid flow into a perfusate bath surrounding an organ when perfusion pressure rises above a level suitable for an organ.

3. A sterilized disposable kit according to 1, wherein the organ cassette maintains uninterrupted sterile conditions inside the organ cassette when being removably received by the portable organ perfusion apparatus.

4. A sterilized disposable kit according to 1, wherein the second lid is configured to be interior to the first lid in use.

5. A sterilized disposable kit according to 1, wherein the first lid and the second lid are each configured to form a seal with the cassette.

6. A kit comprising:

a saleable package containing a portable housing, a set of tubes, an organ supporting surface, a first lid attachable to the portable housing, and a second lid attachable to the portable housing, wherein

at least one of the first lid and the second lid is openable without exposing an interior of the portable housing when the first lid and the second lid are attached to the portable housing,

the organ supporting surface is configured to support an organ within said portable housing,

the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes one or more openings configured to allow the set of tubes to be connected to the organ by way of the one or more openings in a recirculating arrangement, and

a bottom portion of the housing is liquid-tight.

7. A kit according to claim 6, wherein the recirculating arrangement is configured to divert fluid flow into a perfusate bath surrounding an organ when perfusion pressure rises above a level suitable for an organ.

8. A kit according to claim 6, wherein the portable housing is configured to maintain uninterrupted sterile conditions inside the portable housing when being removably received by at least one of the organ perfusion device, the organ transporter and the organ diagnostic device.

9. A kit according to claim 6, wherein the second lid is configured to be interior to the first lid in use.

10. A kit according to claim 6, wherein the first lid and the second lid are each configured to form a seal with the portable housing.