Claims for Patent: 8,535,536

Summary for Patent: 8,535,536

Title:	Cross-flow split-thin-flow cell
Abstract:	A split thin-flow separations device can include a fluid channel having an inlet zone, an outlet zone, and a transport region between the inlet zone and outlet zone. The inlet zone includes a sample inlet and a carrier fluid inlet which are fluidly separated by an inlet splitter to minimize mixing of fluids from respective inlets in the inlet zone. The transport region can be a substantially open channel. Similar to the inlet zone, the outlet zone can include a sample outlet and a carrier outlet which are fluidly separated by an outlet splitter to segregate portions of a fluid into each of the two outlets as the fluid enters the outlet zone. A plurality of cross-flow inducers can also be oriented along a wall of the fluid channel in the transport region. The cross-flow inducers are oriented to form a cross-flow field across the transport region.
Inventor(s):	Gale; Bruce K. (Taylorsville, UT), Sant; Himanshu (Salt Lake City, UT), Madhav; Venu (Salt Lake City, UT), Merugu; Srinivas (Salt Lake City, UT)
Assignee:	University of Utah Research Foundation (Salt Lake City, UT)
Application Number:	12/830,104
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,535,536
Patent Claims:	1. A split thin-flow separations device, comprising: a) a fluid channel having an inlet zone, an outlet zone, and a transport region between the inlet zone and outlet zone, said inlet zone including a sample inlet and a carrier fluid inlet which are fluidly separated by an inlet splitter to minimize mixing of fluids from respective inlets in the inlet zone, said transport region being a substantially open rectangular ribbon channel having a sample wall opposite a carrier wall and two side walls bridging the sample wall and carrier wall, said two side walls having a height substantially less than a width of each of the sample wall and carrier wall, so as to form an inlet fluid rich region proximate the sample inlet wall and a carrier fluid rich region proximate the carrier wall, and said outlet zone including a sample outlet and a carrier outlet which are fluidly separated by an outlet splitter to segregate portions of a fluid into each of the two outlets as the fluid enters the outlet zone; and b) at least one cross-flow inducer along a wall of the fluid channel in the transport region, said at least one cross-flow inducer is oriented to direct a cross-flow fluid into the transport region. 2. The device of claim 1, wherein the sample inlet, the sample outlet, and at least one cross-flow inducer are oriented on a sample side of the device. 3. The device of claim 2, wherein the carrier fluid inlet and carrier outlet are oriented on a carrier side of the device opposite the sample side. 4. The device of claim 1, wherein a ratio of the width to the height is about 3:1 to about 20:1. 5. The device of claim 1, wherein the transport region has an asymmetrical cross-section. 6. The device of claim 5, wherein the asymmetrical cross-section has a decreasing channel width from the inlet zone to the outlet zone. 7. The device of claim 1, wherein at least one of the inlet zone and the outlet zone include a plurality of baffles extending from either or both sides of the corresponding splitter and which are oriented to inhibit turbulent mixing between fluid in the transport region adjacent the inlet zone or outlet zone. 8. The device of claim 1, wherein the device is formed as a layered structure including: a) a carrier wall plate having the carrier fluid inlet and carrier fluid outlet therein; b) a carrier side channel plate oriented adjacent the carrier wall plate having a first open region; c) a splitter plate oriented adjacent the carrier side channel plate and forming the inlet splitter and the outlet splitter and a second open region there between; d) a sample side channel plate oriented adjacent the splitter plate having a third open region; and e) a sample wall plate having the sample inlet and sample outlet therein such that the first open region, the second open region and the third open region collectively form the fluid channel. 9. The device of claim 1, further comprising an electric field source electrically associated with the fluid channel to allow an electric field to be applied across the fluid channel. 10. A method of separating components of a fluid using a split thin-flow process, comprising: a) passing a sample fluid and a carrier fluid into a fluid channel under diffusional split-flow thin cell conditions such that a first component of the sample fluid preferentially flows into a carrier fluid outlet, wherein the sample fluid includes the first component which has a lower molecular weight than a second component in the sample fluid, and wherein the fluid channel comprises an inlet zone, an outlet zone, and a transport region between the inlet zone and outlet zone, said inlet zone including a sample inlet through which the sample fluid passes and a carrier fluid inlet through which the carrier fluid passes, the sample inlet and carrier fluid inlet being fluidly separated by an inlet splitter to minimize mixing of the sample fluid with the carrier fluid in the inlet zone, said transport region being a substantially open rectangular ribbon channel having a sample wall opposite a carrier wall and two side walls bridging the sample wall and carrier wall, said two side walls having a height substantially less than a width of each of the sample wall and carrier wall, so as to form an inlet fluid rich region proximate the sample inlet wall and a carrier fluid rich region proximate the carrier wall and said outlet zone including a sample outlet and the carrier fluid outlet which are fluidly separated by an outlet splitter to segregate portions of the sample fluid and carrier fluid into each of the two outlets as the sample fluid and carrier fluid enter the outlet zone; and b) inducing a cross-flow field transversely across the fluid channel under conditions sufficient to augment separation of the first component from the sample fluid while minimizing transfer of the second component into the carrier fluid outlet, said cross-flow field being induced by at least one cross-flow inducer along a wall of the fluid channel in the transport region, said at least one cross-flow inducer directing a cross-flow fluid into the transport region. 11. The method of claim 10, wherein the sample fluid is blood. 12. The method of claim 11, wherein the first component includes at least one of .beta.2 microglobulin, parathyroid hormone, overdose drugs, small proteins, and toxins. 13. The method of claim 11, wherein the second component is human serum albumin. 14. The method of claim 10, wherein the sample fluid is plasma, biological fluid, environmental monitoring sample, or clinical diagnostic sample. 15. The method of claim 10, wherein the carrier fluid is phosphate buffered saline or dialysate fluid. 16. The method of claim 10, wherein the fluid channel is a rectangular ribbon channel. 17. The method of claim 10, wherein the fluid channel is an asymmetrical channel. 18. The method of claim 10, wherein the sample fluid and the carrier fluid have a combined inlet flow rate which is about 1 to about 10 times a flow rate of the cross-flow fluid. 19. The method of claim 10, further comprising applying an electric field across the fluid channel sufficient to reduce diffusion of the second component across the fluid channel. 20. The method of claim 10, wherein the step of injecting the cross flow fluid is a reverse cross-flow from the carrier side to the sample side. 21. The method of claim 10, wherein the sample fluid is blood, and the method further comprises performing hemodialysis on the blood prior to the step of passing the sample fluid and then returning the sample fluid to a patient subsequent to the steps of passing and injecting. 22. A split thin-flow separations device, comprising: a) a fluid channel having an inlet zone, an outlet zone, and a transport region between the inlet zone and outlet zone, said inlet zone including a sample inlet and a carrier fluid inlet which are fluidly separated by an inlet splitter to minimize mixing of fluids from respective inlets in the inlet zone, said transport region being a substantially open channel having an asymmetrical cross-section, and said outlet zone including a sample outlet and a carrier outlet which are fluidly separated by an outlet splitter to segregate portions of a fluid into each of the two outlets as the fluid enters the outlet zone; and b) at least one cross-flow inducer along a wall of the fluid channel in the transport region, said at least one cross-flow inducer is oriented to direct a cross-flow fluid into the transport region. 23. A split thin-flow separations device, comprising: a) a fluid channel having an inlet zone, an outlet zone, and a transport region between the inlet zone and outlet zone, said inlet zone including a sample inlet and a carrier fluid inlet which are fluidly separated by an inlet splitter to minimize mixing of fluids from respective inlets in the inlet zone, said transport region being a substantially open channel, and said outlet zone including a sample outlet and a carrier outlet which are fluidly separated by an outlet splitter to segregate portions of a fluid into each of the two outlets as the fluid enters the outlet zone; and b) at least one cross-flow inducer along a wall of the fluid channel in the transport region, said at least one cross-flow inducer is oriented to direct a cross-flow fluid into the transport region; wherein the device is formed as a layered structure including: a carrier wall plate having the carrier fluid inlet and carrier fluid outlet therein; a carrier side channel plate oriented adjacent the carrier wall plate having a first open region; a splitter plate oriented adjacent the carrier side channel plate and forming the inlet splitter and the outlet splitter and a second open region there between; a sample side channel plate oriented adjacent the splitter plate having a third open region; and a sample wall plate having the sample inlet and sample outlet therein such that the first open region, the second open region and the third open region collectively form the fluid channel.

Details for Patent 8,535,536

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2029-07-04