Method and system for colloid exchange therapy

• US 7,520,992 B2
• Filed: 03/23/2006
• Issued: 04/21/2009
• Est. Priority Date: 05/16/2000
• Status: Expired due to Term

• Current Assignee: Immunocept Medical Products, LLC (LMF Acquisition Opportunities, Inc.)
• Original Assignee: Imunocept LLC
• Inventors: Matson, James R., Lee, Patrice A., Radunsky, David
• Primary Examiner(s): Drodge; Joseph W
• Application Number:
  US11/387,556
• Publication Number:
  US 20060163138A1
• Time in Patent Office: 1,125 Days
• Field of Search: 210/321.6, 210/645, 210/650, 210/651, 210/195.2, 210/805, 604/4.01, 604/5.01, 604/5.02, 604/5.04, 604/6.09, 604/19, 604/6.08, 514/21, 514/23, 514/832, 424/140.1, 424/192.1, 424529-531, 530/300, 530/350, 530362-364, 530/369, 530380-382
• US Class Current: 210/645
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3472 with treatment of the filtrate
• CPC Class Codes: A61M 1/3486 Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: B01D 61/46 Apparatus therefor
• CPC Class Codes: B01D 61/48 having one or more compartments filled with ion-exchange material , e.g. electrodeionisation
• CPC Class Codes: B01D 61/50 Stacks of the plate-and-frame type
• CPC Class Codes: B01D 61/52 Accessories; Auxiliary operation
• CPC Class Codes: B01D 61/54 Controlling or regulating
• CPC Class Codes: B01D 69/00 Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor

Abstract

The present invention relates to a method and system for using a hemofilter to treat IMRD, hepatic failure, exogenous intoxication and other conditions associated with toxins in a patient'"'"'s blood. One treatment includes the use of a very large pore hemofilter to remove target complex molecules and/or target molecules from a patient'"'"'s blood and to infuse a replacement fluid into the patient'"'"'s blood to maintain a prescribed albumin concentration in the patient'"'"'s blood.

Claims

1. A very large pore hemofiltration system for removing target molecules and target complex molecules from a patient'"'"'s blood, comprising:

a blood flow circuit operable to remove a portion of the patient'"'"'s blood to a very large pore hemofilter and return an unsieved portion of the patient'"'"'s blood;

the very large pore hemofilter operably coupled with the blood flow circuit to allow the portion of the patient'"'"'s blood to flow therethrough;

the very large pore hemofilter having a molecular weight cutoff of between about 150,000 Daltons and about 1,000,000 Daltons and selected to avoid removal of significant amounts of immunoglobins and operable to form the unsieved filtered bloodstream portion and an ultrafiltrate stream containing the target molecules and the target complex molecules removed from the portion of the patient'"'"'s blood flowing through the very large pore hemofilter;

a fluid source operable to supply a plasma colloid replacement fluid to the patient'"'"'s blood;

the plasma colloid replacement fluid comprising clean target receptor molecules, clean carrier molecules and/or clean receptor molecules to adequately replenish ongoing losses in the form of target complex molecules removed from the portion of the patient'"'"'s blood flowing through the very large pore hemofilter;

the clean target receptor molecules, clean carrier molecules and/or clean receptor molecules operable to combine with additional inflammatory mediators and toxins from tissue spaces and tissue binding sites in the patient when the filtered bloodstream is transferred to the patient;

whereby the clean target receptor molecules, clean carrier molecules and/or clean receptor molecules combine with the additional inflammatory mediators and toxins to form target complex molecules which may be removed by the very large pore hemofilter from the portion of the patient'"'"'s blood flowing therethrough; and

the replacement fluid operable to provide sufficient clean albumin to maintain adequate plasma oncotic pressure at ultrafiltration rates between approximately one liter per hour and twenty liters per hour.

2. The system of claim 1 wherein the plasma colloid replacement fluid comprises a pharmaceutical grade balanced salt solution with a concentration of albumin greater than approximately 0.5 grams per one hundred milliliters.

3. The system of claim 1 wherein the plasma colloid replacement fluid comprises a pharmaceutical grade balanced salt solution with a concentration of albumin less than approximately twenty grams per one hundred milliliters.

4. The system of claim 1 wherein the plasma colloid replacement fluid comprises a pharmaceutical grade balanced salt solution with a plurality of clean target receptor molecules corresponding with a plurality of target receptor molecules contaminated with more than one toxin removed from the patient'"'"'s blood by the very large pore hemofilter.

5. The system of claim 1 wherein the very large pore hemofilter further comprises a nominal molecular weight cutoff sufficiently large to sieve more than a nominal amount of target complex molecules during hemofiltration and the nominal molecular weight cutoff less than approximately 500,000 Daltons.

6. A very large pore hemofiltration system for removing target molecules and target complex molecules from a patient'"'"'s blood, comprising:

an extracorporeal blood circuit operable to remove portion of the patient'"'"'s blood to a very large pore hemofilter and return an unsieved portion of the patient'"'"'s blood;

the very large pore hemofilter operably coupled with the blood circuit to allow the portion of the patient'"'"'s blood to flow therethrough without being sieved and having a molecular weight cutoff of between 150,000 Daltons and 1,000,000 Daltons;

the very large pore hemofilter operable to form a filtered bloodstream comprising an unsieved portion and an ultrafiltrate stream;

the ultrafiltrate stream containing the target molecules and the target complex molecules removed from the portion of the patient'"'"'s blood flowing through the very large pore hemofilter and the ultrafiltrate stream not containing significant amounts of immunoglobulins;

the extracorporeal blood circuit operable to remove an initially high volume ultrafiltrate stream of at least approximately two liters per hour;

a replacement fluid kit attached to the extracorporeal blood circuit during hemofiltration of the portion of the patient'"'"'s blood;

the replacement fluid kit having a reservoir source operable to supply plasma colloid replacement fluid to the patient'"'"'s blood circulatory system;

the reservoir having at least one port operable to communicate the replacement fluid from the reservoir source;

a coupling operable to allow flow of the replacement fluid from the port to the extracorporeal blood circuit;

the replacement fluid including a pharmaceutical grade balanced salt solution and clean target receptor molecules suitable for infusion into the patient'"'"'s blood circulatory system;

the clean target receptor molecules selected to replace the target molecules and target complex molecules disposed in the ultrafiltrate stream; and

the replacement fluid having a concentration of albumin at least sufficient to maintain a prescribed albumin concentration in the patient'"'"'s blood circulatory system.

7. An extracorporeal blood circuit for the filtration of a patient'"'"'s blood, the circuit comprising:

the blood circuit operable to remove a portion of the patient'"'"'s blood to a blood filter and to return a an unsieved portion of the patient'"'"'s blood from a blood source;

the blood filter operably coupled with the blood circuit to allow the portion of the patient'"'"'s blood to flow therethrough without being sieved;

the blood filter having an effective molecular weight cutoff of between 150,000 Daltons and 1,000,000 Daltons and sufficiently large to sieve an ultrafiltrate stream having more than a nominal amount of target complex

molecules from the portion of the patient'"'"'s blood and adapted to avoid removal of significant amounts of immunoglobulins as part of the ultrafiltrate stream;

an ultrafiltrate line operable to allow the ultrafiltrate stream to flow from the blood filter through the ultrafiltrate line at a rate between at least two liters per hour and five liters per hour;

a waste reservoir in fluid communication with the ultrafiltrate line so as to receive at least a portion of the ultrafiltrate stream and to hold the ultrafiltrate separate from the blood source; and

an albumin source operable to infuse albumin and optionally other clean target receptor molecules into a filtered bloodstream exiting from the blood filter to maintain a serum albumin sufficient to preserve adequate plasma oncofic pressure for the patient and to replenish ongoing losses from the patient'"'"'s blood.

8. An extracorporeal blood circuit for filtration of a patient'"'"'s blood to remove target molecules and target complex molecules, the circuit comprising:

the circuit operable to remove a portion of the patient'"'"'s blood to a very large pore hemofilter and to return an unsieved portion of the patient'"'"'s blood from a blood source;

the very large pore hemofilter operably coupled with the circuit to allow the portion of the patient'"'"'s blood to flow therethrough without being sieved;

the very large pore hemofilter having a molecular weight cutoff greater than 150,000 Daltons to sieve more than a nominal amount of the target complex molecules from the portion of the patient'"'"'s blood;

the molecular weight cutoff less than approximately 500,000 Daltons to avoid removal of undesired amounts of immunoglobulins to prevent increasing the risk of opportunistic infection;

a fluid source having a fluid reservoir containing a replacement fluid with clean target receptor molecules selected to replace target receptor molecules contaminated with at least one inflammatory mediator removed from the portion of the patient'"'"'s blood during the very large pore hemofiltration; and

the circuit operable to remove an ultrafiltrate stream of at least one liter per hour from the very large pore hemofilter and to isolate at least a portion of the ultrafiltrate stream from the blood source for disposal.

9. The circuit of claim 8 wherein the replacement fluid further comprises a concentration of albumin greater than approximately 0.5 grams per one hundred milliliters.

10. An extracorporeal blood circuit operable to remove target molecules and target complex molecules from a portion of a patient'"'"'s blood flowing through the blood circuit to a very large pore hemofilter and return an unsieved portion of the filtered blood to the patient comprising:

the very large pore hemofilter operably coupled with the blood circuit to allow the unsieved portion of the patient'"'"'s blood to flow therethrough;

the very large pore hemofilter having a molecular weight cutoff of between about 150,000 Daltons and about 1,000,000 Daltons and operable to sieve the target molecules and target complex molecules from the bloodstream and the molecular weight cutoff operable to avoid removal of significant amounts of immunoglobulin to prevent increasing the risk of opportunistic infection;

the circuit containing a valve for controlling discard of an ultrafiltrate stream between at least two liters per hour and twenty liters per hour;

the ultrafiltrate stream containing target molecules and target complex molecules removed from the bloodstream using the very large pore hemofilter;

an ultrafiltrate tubing operable to flow the ultrafiltrate from the very large pore hemofilter to the valve;

a return tubing operable to return the unsieved portion of the patient'"'"'s blood to the patient;

a source of replacement fluid having clean target receptor molecules operable to replenish ongoing losses from the portion of the patient'"'"'s blood flowing through the very large pore hemofilter including sufficient clean albumin to maintain adequate plasma oncotic pressure; and

the clean target receptor molecules operable to attract additional inflammatory mediators and toxins from tissue spaces and tissue binding sites in the patient.