DEVICE AND METHOD FOR REMOVAL OF BLOOD-BORNE PATHOGENS, TOXINS AND INFLAMMATORY CYTOKINES

• US 20140012097A1
• Filed: 08/13/2013
• Published: 01/09/2014
• Est. Priority Date: 02/15/2011
• Status: Active Grant

• Current Assignee: ExThera Medical Corporation
• Original Assignee: ExThera Medical Corporation
• Inventors: McCrea, Keith, Ward, Robert S., Pitarra, George Jr.
• Granted Patent: US 10,537,280 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/206 Viruses
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: B01J 20/321 : consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/3212 : consisting of a polymer obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/3251 : comprising at least two different types of heteroatoms selected from nitrogen, oxygen or sulphur

Abstract

The present invention is directed to an integrated system and a method for utilizing the system to detect and remove blood-borne factors of interest, such as pathogens and/or toxins and/or cytokines, from blood or serum (blood) by contacting the blood with a solid, essentially nonporous substrate which has been surface treated with molecules or chemical groups (the adsorbent media or media) having a binding affinity for the pathogens and/or toxins to be removed (the adsorbents). The invention can be used to remove virulence factors, e.g. toxins, that are released from various pathogens. In one aspect, the invention is for the treatment of sepsis and infection, such as infections associated with battle field trauma.

Claims

1. A system for broad-spectrum whole-blood separation of blood-borne factors of interest comprising:

a solid substrate or cartridge and a biosensor.

3. The system of claim 1 wherein the solid substrate comprises covalently-bonded heparin on a high-surface-area polymer substrate.

4. The system of claim 1 wherein the solid substrate is disposable.

5. The system of claim 1 where said biosensor(s) is at least one member selected from the group consisting of a blood pressure sensor, a temperature sensor, a blood glucose sensor, a blood gas sensor, or a sensor which detects nitric oxide (NO) or its metabolites, a sensor that detects cytokines, a sensor that detected bacteria or bacteria toxins, a sensor that detects viruses, a sensor that detects parasites, a sensor that detects fungi, a sensor that detects coagulation factors, a sensor that detects organ dysfunction proteins, a sensor that detects acute phase proteins, a sensor that detects complement factors, or a com

6. The system of claim 5, wherein the biosensor quantifies the amount of biomarker in blood.

7. The system of claim 1, wherein the biosensor amperometrically detects blood-borne factors.

8. The system of claim 1, wherein the biosensor chemometrically analyzes the presence and amount of blood-borne factors.

9. The system of claim 1, wherein the pump is a roller pump.

10. The system of claim 1 further comprising a power source.

11. The system of claim 1 comprising a means for providing caregiver feedback on a patient condition.

12. The system of claim 1, further comprising a means for measuring pressure drop over the solid substrate, biosensor output, patient data or system data.

13. The system of claim 12, comprising alarms correlated to cartridge pressure drop, biosensor output, patient data or system data.

14. The system of claim 1, further comprising means for telemetry of measurements.

15. The system of claim 1, comprising means for automatic replacement or bypassing of cartridges and/or biosensors.

2. A system for broad-spectrum whole-blood separation of blood-borne factors of interest comprising:

a broad-spectrum, anti-thrombogenic cartridge

a biosensor

a pump, and

a patient monitor.

16. A method for broad-spectrum whole-blood separation of blood-borne factors comprising:

(a) detecting the presence or amount of a blood-borne factor of interest using a biosensor,

(b) bringing a sample of blood in contact with a broad-spectrum, anti-thrombogenic cartridge, and

(c) separating the sample from said broad-spectrum, anti-thrombogenic cartridge whereby said blood-borne factor is at least partially retained on said cartridge and the removed sample has a reduced amount of blood-borne factor.

17. The method of claim 16, wherein the biosensor detects an elevation in a biomarker.

18. The method of claim 16, wherein the biosensor detects levels of biomarkers in a patient at two or more time points.

19. The method of claim 16, wherein the biosensor continuously detects levels of biomarkers.

20. The method of claim 16, wherein the biosensor detects a decrease in blood pressure.

21. The method of claim 16, where the blood-borne factors are separated without the prior identification of specific pathogens.

22. A method for treating a patient suspected of having sepsis comprising:

(a) detecting the presence or an increase in at least one biomarker,

(b) contacting a sample of blood with a broad-spectrum, anti-thrombogenic cartridge, and

(c) separating the sample from said broad-spectrum, anti-thrombogenic cartridge whereby one or more blood-borne factors of interest is at least partially retained on said cartridge and the removed sample has a reduced amount of blood-borne factor(s).