MICROFABRICATED ARTIFICIAL LUNG ASSIST DEVICE, AND METHODS OF USE AND MANUFACTURE THEREOF

• US 20110290113A1
• Filed: 05/26/2011
• Published: 12/01/2011
• Est. Priority Date: 05/26/2010
• Status: Active Grant

• Current Assignee: Charles Stark Draper Laboratory Incorporated
• Original Assignee: Charles Stark Draper Laboratory Incorporated
• Inventors: Hsiao, James Ching-Ming, Kniazeva, Tatiana, Borenstein, Jeffrey T., Charest, Joseph L.
• Granted Patent: US 8,647,410 B2
• Time in Patent Office: Days
• US Class Current: 95/54
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: B01D 63/081 Manufacturing thereof
• CPC Class Codes: B01D 63/082 comprising a stack of flat membranes
• CPC Class Codes: B01D 63/0821 Membrane plate arrangements for submerged operation
• CPC Class Codes: B01D 63/084 at least one flow duct intersecting the membranes
• CPC Class Codes: B01D 63/088 Microfluidic devices comprising semi-permeable flat membranes
• CPC Class Codes: B01D 71/70 Polymers having silicon in the main chain, with or without sulfur, nitrogen, oxygen or carbon only
• CPC Class Codes: B01D 71/701 Polydimethylsiloxane
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y02C 20/40 of CO2

Abstract

The invention provides systems and methods for exchanging gas in an oxygenator device, and methods for preparing and using such oxygenator devices. The systems and methods can be used to transfer oxygen to blood to assist lung function in a patient.

Claims

1. An extracorporeal membrane oxygenator device, comprising a plurality of bi-layer structures arranged in a stack, each bi-layer structure comprising:

(i) a first micropatterned polymer layer defining a microvascular network for blood flow therethrough;

(ii) a second micropatterned polymer layer defining channels for gas supply; and

(iii) a gas-permeable polymer membrane located between and bonding the first micropatterned polymer layer to the second micropatterned polymer layer.

2. The device of claim 1, wherein the gas-permeable membrane has a thickness of about 25 μ

m to about 35 μ

m.

3. The device of claim 1, wherein the gas-permeable membrane has a thickness of no more than 10 μ

m.

4. The device of claim 1, wherein the gas-permeable polymer membrane is made of polydimethylsiloxane.

5. The device of claim 1, wherein the microvascular network forms channels having a height of not more than 120 μ

m.

6. The device of claim 1, wherein the microvascular network forms channels having a height of about 40 μ

m to about 60 μ

m.

7. The device of claim 1, wherein the microvascular network forms channels having a length of about 500 μ

m to about 3 cm.

8. The device of claim 1, wherein the microvascular network is biomimetic.

9. The device of claim 1, wherein channels in the microvascular network are rectangular.

10. The device of claim 1, wherein channels in the microvascular network have round corners and round edges.

11. The device of claim 1, wherein at least one channel in the second micropatterned polymer layer has a width spanning at least 10 channels in the microvascular network of the first micropatterned polymer layer.

12. The device of claim 1, wherein at least one channel in the second micropatterned polymer layer comprises an arrangement of polymer posts.

13. The device of claim 1, wherein the first micropatterned polymer layer and the second micropatterned polymer layer each independently have a thickness of less than about 150 μ

m.

14. The device of claim 1, wherein the first micropatterned polymer layer has a thickness of about 90 μ

m to about 150 μ

m, the second micropatterned polymer layer has a thickness of about 90 μ

m to about 200 μ

m, and the microvascular network forms channels having a height of about 40 μ

m to about 60 μ

m.

15. The device of claim 1, wherein the first micropatterned polymer layer and the second micropatterned polymer layer are made of polydimethylsiloxane.

16. The device of claim 1, further comprising a third micropatterned polymer layer defining at least one channel for gas supply, wherein said third micropatterned polymer layer is attached to the surface of the first micropatterned polymer layer located opposite the surface attached to the gas-permeable polymer membrane.

17. The device of claim 16, wherein the first micropatterned polymer layer has a thickness of about 90 μ

m to about 150 μ

m, the microvascular network forms channels having a height of about 40 μ

m to about 60 μ

m, the second micropatterned polymer layer has a thickness of about 90 μ

m to about 200 μ

m; and

each of the first micropatterned polymer layer, the second micropatterned polymer layer, and the third micropatterned polymer layer are made of polydimethylsiloxane.

18. The device of claim 1, wherein the device comprises from about 5 to about 100 bi-layer structures arranged in a stack.

20. The device of claim 1, further comprising a distribution system for delivering gas to any channel for gas flow, and delivering blood to any microvascular network for blood flow.

23. The device of claim 1, having a blood prime volume not exceeding 10 mL.

24. The device of claim 1, wherein the device is adapted to transfer oxygen between the microvascular network of first micropatterned polymer layers and the gas-supply channels of the second micropatterned polymer layers at a rate of at least 4 mL/min.

25. The device of claim 1, wherein the device is adapted to transfer oxygen between the microvascular network of first micropatterned polymer layers and the gas-supply channels of the second micropatterned polymer layers at a rate of at least 4 mL/min when blood is passed through the device at a rate of about 100 mL/min.

27. A method for transferring a gas to blood, comprising passing blood through a device of claim 1 having a gas in at least one channel for gas flow, to thereby transfer said gas to said blood.

19. (canceled)

21. (canceled)

22. (canceled)

26. (canceled)

28-32. -32. (canceled)

33. A method of manufacturing a bi-layer structure for use in an extracorporeal membrane oxygenator device, the structure including first and second micropatterned polymer layers and a gas-permeable polymer membrane therebetween, the method comprising:

spin-coating a prepolymer mixture onto a silicon wafer so as to form the polymer membrane, the polymer membrane being attached to the silicon wafer at a first side of the polymer membrane;

bonding the first micropatterned polymer layer to a second side of the polymer membrane;

releasing the polymer membrane from the silicon wafer; and

bonding the second micropatterned polymer layer to the first side of the polymer membrane.

34-39. -39. (canceled)

40. A method of manufacturing a bi-layer structure for use in an extracorporeal membrane oxygenator device, the structure including first and second micropatterned polymer layers and a gas-permeable polymer membrane therebetween, the method comprising:

spin-coating a prepolymer mixture onto a micropatterned silicon wafer so as to fill recessed features of the micropatterned silicon wafer and form a thin, continuous polymer layer thereover, thereby forming an integrated structure including the first micropatterned polymer layer and the gas-permeable polymer membrane;

releasing the integrated structure from the silicon wafer; and

bonding the second micropatterned polymer layer to the exposed side of the gas-permeable polymer membrane.