Granted Patent B2

US 12,478,923 · App. 18/406,886 · Granted Nov 25, 2025

Inventors: H. David Humes (Ann Arbor, MI); Deborah A. Buffington (Ann Arbor, MI); Christopher J. Pino (Saline, MI)

Assignee: Seastar Medical, Inc.

B01D63/02A61M1/3672A61M1/3675C12N5/0634A61M1/1698A61M1/3679A61M2202/0427A61M2202/0439B01D2313/44

Abstract

Claims (29)

1 . A method for processing an activated leukocyte, an activated platelet, or both an activated leukocyte and an activated platelet contained within a body fluid, the method comprising:

(a) providing a cartridge comprising

(i) a rigid housing defining an inner volume (IV), a fluid inlet port and a fluid outlet port, wherein the inner volume is in fluid flow communication with the fluid inlet port and the fluid outlet port; and

(ii) a solid support disposed within the housing and defining a fluid contacting surface with a surface area (SA) capable of sequestering an activated leukocyte and/or an activated platelet if present in a body fluid entering the housing via the fluid inlet port, wherein the cartridge has an SA/IV ratio ranging from greater than 150 cm −1 to 800 cm −1 ;

(b) introducing blood from a subject into the housing via the fluid inlet port under conditions that permit sequestration of an activated leukocyte and/or an activated platelet on the fluid contacting surface of the solid support; and

(c) treating the leukocyte and/or platelet sequestered in step (b) to inhibit release of a pro-inflammatory substance or to deactivate the leukocyte and/or the platelet.

2 . The method of claim 1 , wherein the leukocyte or the platelet is sequestered for a time sufficient to inhibit the release of the pro-inflammatory substance or to deactivate the leukocyte or the platelet.

3 . The method of claim 1 , further comprising the step of returning the leukocyte and/or the platelet produced in step (c) back to a subject.

4 . The method of claim 1 , wherein in step (c), a calcium chelator inhibits the release of the pro-inflammatory substance or deactivates the leukocyte or the platelet.

5 . A method for treating a subject having or at risk of developing an inflammatory condition, the method comprising:

(a) providing a cartridge comprising

(i) a rigid housing defining an inner volume (IV), a fluid inlet port and a fluid outlet port, wherein the inner volume is in fluid flow communication with the fluid inlet port and the fluid outlet port; and

(ii) a solid support disposed within the housing and defining a fluid contacting surface with a surface area (SA) capable of sequestering an activated leukocyte, if present in a body fluid entering the housing via the fluid inlet port, wherein the cartridge has an SA/IV ratio ranging from greater than 150 cm −1 to 800 cm −1 ;

(b) introducing a body fluid blood from a subject into the housing via the fluid inlet port under conditions that permit sequestration of an activated leukocyte and/or an activated platelet on the fluid contacting surface of the solid support; and

(c) treating the leukocyte and/or platelet sequestered in step (b) with a calcium chelator to inhibit the release of a pro-inflammatory substance from or to deactivate the leukocyte or platelet thereby to reduce the risk of developing inflammation associated with the inflammatory condition or to alleviate inflammation associated with the inflammatory condition.

6 . The method claim 1 , wherein the SA of the cartridge provided in step (a) is in the range of from 0.1 m 2 to 5.0 m 2 .

7 . The method of claim 1 , wherein the inner volume is in the range of from 10 cm 3 to 150 cm 3 .

8 . The method of claim 1 , wherein the solid support comprises a membrane or a hollow fiber.

9 . The method of claim 8 , wherein the solid support comprises a hollow fiber disposed within the housing at a packing density ranging from 20% to 65%.

10 . The method of claim 1 , wherein the cartridge has an SA/IV ratio ranging from 300 cm −1 to 800 cm −1 .

11 . The method of claim 1 , wherein the cartridge has an SA/IV ratio ranging from 200 cm −1 to 600 cm −1 .

12 . The method of claim 1 , wherein in step (c), a calcium chelator deactivates the leukocyte and/or the platelet.

13 . The method of claim 12 , wherein the calcium chelator is citrate.

14 . The method of claim 1 , wherein in the inner volume of the cartridge provided in step (a) is less than 300 cm 3 .

15 . The method of claim 1 , wherein the SA is in the range of from 0.1 m 2 to 0.4 m 2 , from 0.4 m 2 to 0.8 m 2 , from 0.8 m 2 to 1.2 m 2 , from 1.2 m 2 to 1.6 m 2 , from 1.6 m 2 to 2.0 m 2 , from 2.0 m 2 to 2.4 m 2 , from 2.4 m 2 to 2.8 m 2 , from 2.8 m 2 to 3.2 m 2 , from 3.2 m 2 to 3.6 m 2 , from 3.6 m 2 to 4.0 m 2 , from 4.0 m 2 to 4.4 m 2 , from 4.4 m 2 to 4.8 m 2 , from 4.8 m 2 to 5.2 m 2 , from 5.2 m 2 to 5.6 m 2 , from 5.6 m 2 to 6.0 m 2 , from 6.0 m 2 to 6.4 m 2 , from 6.4 m 2 to 6.8 m 2 , from 6.8 m 2 to 7.2 m 2 , from 7.2 m 2 to 7.6 m 2 , from 7.6 m 2 to 8.0 m 2 , from 8.0 m 2 to 8.4 m 2 , from 8.4 m 2 to 8.8 m 2 , from 8.8 m 2 to 9.2 m 2 , from 9.2 m 2 to 9.6 m 2 , or from 9.6 m 2 to 10.0 m 2 .

16 . The method of claim 3 , wherein in step (c), the sequestered leukocyte and/or platelet is treated with a calcium chelator to inhibit the release of the pro-inflammatory substance or deactivate the leukocyte and/or the platelet, where the calcium chelator is citrate, the solid support is a hollow fiber, and the platelet is sequestered for a time sufficient to inhibit the release of the pro-inflammatory substance or to deactivate the leukocyte or the platelet.

17 . The method of claim 16 , wherein in the inner volume of the cartridge provided in step (a) is less than 300 cm 3 .

18 . The method of claim 5 , wherein the calcium chelator is citrate, the solid support is a hollow fiber, and the platelet is sequestered for a time sufficient to inhibit the release of the pro-inflammatory substance or to deactivate the leukocyte or the platelet.

19 . The method of claim 18 , further comprising the step of returning the leukocyte and/or the platelet treated in step (c) back to the subject.

Assignments (5)

Continuity (5)

References Cited (400)