# US 10,369,263 B2 · Blood processing cartridges and systems, and methods for extracorporeal blood therapies

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- Number: US 10,369,263 B2
- Document ID: US10369263B2
- Status: Granted
- Kind: B2
- Application number: 14/671,186
- Filed: 2015-03-27
- Published: 2015-11-05
- Granted: 2019-08-06
- Earliest claimed: 2014-03-29
- Assignees: Novaflux Inc.
- Applicants: Princeton Trade & Technololgy, Inc.
- Inventors: Mohamed E. Labib; Stanislav S. Dukhin
- Web page: https://patentgrep.com/patent/US10369263B2

## CPC

- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome}
- A61M 1/3403: {Regulation parameters}
- A61M 1/341: {by measuring the filtrate rate or volume}
- B01D 63/0241: {being U-shaped}
- B01D 63/031: {Two or more types of hollow fibres within one bundle or within one potting or tube-sheet}
- B01D 69/084: {Undulated fibres}
- A61M 2205/3331: Pressure; Flow
- B01D 2313/10: Specific supply elements
- B01D 2313/12: Specific discharge elements
- B01D 2313/16: Specific vents
- B01D 2313/201: Closed housing, vessels or containers
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)

## Abstract

In embodiments of the invention, there is provided a dialyzer or filter comprising hollow fibers, in which blood flows on the exterior of the hollow fibers, and dialysate or filtrate may flow on the inside. The external surfaces of the hollow fibers may have properties of smoothness and hemocompatibility. The fiber bundle may have appropriate packing fraction and may have wavy fibers. Optimum shear rates and blood velocities are identified. Geometric features of the cartridge, such as pertaining to flow distribution of the blood, may be different for different ends of the cartridge. Air bleed and emboli traps may be provided. Lengthened service life may be achieved by combinations of these features, which may permit additional therapies and applications or better economics.

## Claims

### Claim 1

A method of treating blood with dialysate comprising:
(a) providing a blood processing system comprising a blood processing cartridge comprising:
a housing having a housing interior, a housing blood supply port, a housing blood discharge port, and wherein said housing interior includes a housing midsection interior region;
a plurality of fibers contained inside said housing, at least some of said fibers being hollow fibers and being made of semi-permeable membranes having respective fiber interiors and fiber exteriors, said fibers being parallel or almost parallel to each other over at least a substantial portion of their lengths;
a first end barrier that joins with said fibers at first ends of said fibers and joins with said housing interior of said housing and bounds a first end plenum and separates said first end plenum from said housing midsection interior region;
a second end barrier that joins with said fibers at second ends of said fibers and joins with said housing interior and bounds a second end plenum and separates said second end plenum from said housing midsection interior region;
a fluid flow compartment comprising said first end plenum, said fiber interiors, and said second end plenum, said first end plenum, said fiber interiors, and said second end plenum being in fluid communication with each other; and
a blood flow compartment comprising an inter fiber space defined by said fiber exteriors and an interior housing surface along said housing midsection interior region, said housing blood supply port and said housing blood discharge port, said inter fiber space, said housing supply port, and said housing discharge port being in fluid communication with each other;
wherein at least some of said fibers have external surfaces that are hydrophilic, and said external surfaces have root-mean-square roughness values of less than 100 nanometers;
wherein at least a part of said interior housing surface along said housing midsection interior region comprises a coating or surface treatment to increase hemocompatibility; and
wherein the blood processing cartridge is constructed to receive blood in the blood flow compartment so that the blood flows into the blood flow compartment via the housing supply port, in contact with said external surfaces of said fibers, and out of the blood flow compartment via the housing discharge port;
(b) connecting said blood processing system to a patient; and
(c) flowing blood from the patient through the blood flow compartment along said inter fiber space and returning the blood from the blood flow compartment to the patient, and flowing dialysate through said hollow fibers.

### Claim 2

A method of treating blood with dialysate comprising:
(a) providing a blood processing system comprising:
a blood flow system comprising a blood inlet line, a blood processing cartridge, and a blood outlet line; and
said blood processing cartridge comprises:
a housing having a housing supply port and a housing discharge port;
a plurality of fibers contained inside said housing, at least some of said fibers being hollow and being made of semi-permeable membranes having respective fiber interiors and fiber exteriors, said fibers having an external surface that is hydrophilic and has a root-mean-square surface roughness that is smaller than 100 nanometers;
a first end barrier that joins with said fibers at first ends of said fibers and joins with a housing interior of said housing and bounds a first end plenum and separates said first end plenum from a housing midsection interior region;
a second end barrier that joins with said fibers at second ends of said fibers and joins with said housing interior of said housing and bounds a second end plenum and separates said second end plenum from said housing midsection interior region;
a fluid flow compartment comprising said first end plenum, said fiber interiors, and said second end plenum, said first end plenum, said fiber interiors, and said second end plenum being in fluid communication with each other; and
a blood flow compartment comprising an inter fiber space defined by said fiber exteriors and an interior housing surface along said housing midsection interior region, said housing supply port connected to said blood inlet line, said housing discharge port connected to said blood outlet line, and said inter fiber space, said housing supply port, and said housing discharge port being in fluid communication with each other;
wherein said blood flow system is constructed to introduce blood through said blood inlet line and through said housing supply port and into said blood flow compartment and remove said blood from said housing discharge port and through said blood outlet line, and wherein said blood flows in contact with the external surface of said fibers;
(b) connecting said blood processing system to a patient; and
(c) flowing blood from the patient into said blood inlet line and said housing through said housing supply port, along the external surface of said fibers, and out of said housing through said housing discharge port and into said blood outlet line, and flowing dialysate through said hollow fibers.

### Claim 3 (depends on 2)

The method of treating blood of claim 2, wherein said blood has a shear rate that everywhere inside said cartridge is between 300 sec−1 and 2700 sec−1.

### Claim 4 (depends on 2)

The method of treating blood of claim 2, wherein said blood has a shear rate that everywhere inside said cartridge is between 300 sec−1 and 1000 sec−1.

### Claim 5 (depends on 2)

The method of treating blood of claim 2, wherein said blood has a local velocity that everywhere inside said cartridge is greater than 0.25 cm/sec.

### Claim 6 (depends on 2)

The method of treating blood of claim 2, wherein flow of said blood inside said housing occurs generally parallel to a lengthwise direction of said fibers.

### Claim 7 (depends on 2)

The method of treating blood of claim 2, wherein said blood flow system causes blood to flow through said cartridge at flowrate of between 75 and 300 mL/min.

### Claim 8 (depends on 1)

The method of treating blood of claim 1, wherein said hollow fibers are asymmetric membranes and comprise polyethersulfone or related polymers, in combination with polyvinylpyrrolidone or polyethylene glycols.

### Claim 9 (depends on 1)

The method of treating blood of claim 1, wherein said hollow fibers have internal surfaces having root-mean-square surface roughness values larger than 100 nanometers.

### Claim 10 (depends on 1)

The method of treating blood of claim 1, wherein said hollow fibers are symmetric membranes and comprise a material selected from the group consisting of: cellulose triacetate and other cellulosics; polyacrilonitrile; polymethylmethacrylate; and polyester polymer alloy.

### Claim 11 (depends on 1)

The method of treating blood of claim 1, wherein at least some of said fibers are wavy having a wavelength of waviness that is in the range of 0.4 centimeters to 1 centimeter.

### Claim 12 (depends on 1)

The method of treating blood of claim 1, wherein at least some of said fibers are wavy having a half-amplitude of waviness that is in the range of 0.1 millimeter to 1 millimeter.

### Claim 13 (depends on 1)

The method of treating blood of claim 1, wherein at least some of said fibers are straight.

### Claim 14 (depends on 1)

The method of treating blood of claim 1, wherein at least some of said fibers have an outside diameter that is in the range of 100 microns to 1,500 microns.

### Claim 15 (depends on 1)

The method of treating blood of claim 1, wherein said hydrophilic external surface has a hydrated surface layer whose thickness is greater than 48 nanometers.

### Claim 16 (depends on 1)

The method of treating blood of claim 1, wherein said semi-permeable membranes have pore sizes in the range of 2 nanometers to 7 nanometers.

### Claim 17 (depends on 1)

The method of treating blood of claim 1, wherein said semi-permeable membranes have a molecular weight cutoff of 50,000 Daltons or less.

### Claim 18 (depends on 1)

The method of treating blood of claim 1, wherein said fibers have an ultrafiltration coefficient of between 5 and 100 ml/hr/m2/mmHg.

### Claim 19 (depends on 1)

The method of treating blood of claim 1, wherein a total surface area of said fibers is between 0.03 m2 and 2.0m2.

### Claim 20 (depends on 1)

The method of treating blood of claim 1, wherein said blood has a shear rate that everywhere inside said cartridge is between 300 sec−1 and 2700 sec−1.

### Claim 21 (depends on 1)

The method of treating blood of claim 1, wherein said blood has a shear rate that everywhere inside said cartridge is between 300 sec−1 and 1000 sec−1.

### Claim 22 (depends on 1)

The method of treating blood of claim 1, wherein said blood has a local velocity that everywhere inside said cartridge is greater than 0.25 cm/sec.

### Claim 23 (depends on 1)

The method of treating blood of claim 1, wherein flow of said blood inside said housing occurs generally parallel to a lengthwise direction of said fibers.

### Claim 24 (depends on 1)

The method of treating blood of claim 1, wherein said blood flow system causes blood to flow through said cartridge at flowrate of between 75 and 300 mL/min.

### Claim 25 (depends on 1)

The method of treating blood of claim 1, wherein the method comprises hemodialysis or hemodiafiltration.

### Claim 26 (depends on 2)

The method of treating blood of claim 2, wherein the method comprises hemodialysis or hemodiafiltration.

### Claim 27

A method of ultrafiltration of blood comprising:
(a) providing a blood processing system comprising a blood processing cartridge comprising:
a housing having a housing interior, a housing blood supply port, a housing blood discharge port, and wherein said housing interior includes a housing midsection interior region;
a plurality of fibers contained inside said housing, at least some of said fibers being hollow fibers and being made of semi-permeable membranes having respective fiber interiors and fiber exteriors, said fibers being parallel or almost parallel to each other over at least a substantial portion of their lengths;
a first end barrier that joins with said fibers at first ends of said fibers and joins with said housing interior of said housing and bounds a first end plenum and separates said first end plenum from said housing midsection interior region;
a second end barrier that joins with said fibers at second ends of said fibers and joins with said housing interior and bounds a second end plenum and separates said second end plenum from said housing midsection interior region;
a fluid flow compartment comprising said first end plenum, said fiber interiors, and said second end plenum, said first end plenum, said fiber interiors, and said second end plenum being in fluid communication with each other; and
a blood flow compartment comprising an inter fiber space defined by said fiber exteriors and an interior housing surface along said housing midsection interior region, said housing blood supply port and said housing blood discharge port, said inter fiber space, said housing supply port, and said housing discharge port being in fluid communication with each other;
wherein at least some of said fibers have external surfaces that are hydrophilic, and said external surfaces have root-mean-square roughness values of less than 100 nanometers;
wherein at least a part of said interior housing surface along said housing midsection interior region comprises a coating or surface treatment to increase hemocompatibility; and
wherein the blood processing cartridge is constructed to receive blood in the blood flow compartment so that the blood flows into the blood flow compartment via the housing supply port, in contact with said external surfaces of said fibers, and out of the blood flow compartment via the housing discharge port;
(b) connecting said blood processing system to a patient; and
(c) flowing blood from the patient through the blood flow compartment and returning the blood from the blood flow compartment to the patient, and collecting filtrate from said hollow fibers.

### Claim 28 (depends on 27)

The method of ultrafiltration of claim 27, wherein said fibers have a pore size of about 0.2 nanometers to 5 nanometers.

### Claim 29 (depends on 27)

The method of ultrafiltration of claim 27, wherein a majority of said fibers have a molecular weight cutoff of less than about 50,000 Daltons.

### Claim 30

A method of ultrafiltration of blood comprising:
(a) providing a blood processing system comprising:
a blood flow system comprising a blood inlet line, a blood processing cartridge, and a blood outlet line; and
said blood processing cartridge comprises:
a housing having a housing supply port and a housing discharge port;
a plurality of fibers contained inside said housing, at least some of said fibers being hollow and being made of semi-permeable membranes having respective fiber interiors and fiber exteriors, said fibers having an external surface that is hydrophilic and has a root-mean-square surface roughness that is smaller than 100 nanometers;
a first end barrier that joins with said fibers at first ends of said fibers and joins with a housing interior of said housing and bounds a first end plenum and separates said first end plenum from a housing midsection interior region;
a second end barrier that joins with said fibers at second ends of said fibers and joins with said housing interior of said housing and bounds a second end plenum and separates said second end plenum from said housing midsection interior region;
a fluid flow compartment comprising said first end plenum, said fiber interiors, and said second end plenum, said first end plenum, said fiber interiors, and said second end plenum being in fluid communication with each other; and
a blood flow compartment comprising an inter fiber space defined by said fiber exteriors and an interior housing surface along said housing midsection interior region, said housing supply port connected to said blood inlet line, said housing discharge port connected to said blood outlet line, and said inter fiber space, said housing supply port, and said housing discharge port being in fluid communication with each other;
wherein said blood flow system is constructed to introduce blood through said blood inlet line and through said housing supply port and into said blood flow compartment and remove said blood from said housing discharge port and through said blood outlet line, and wherein said blood flows in contact with the external surface of said fibers;
(b) connecting said blood processing system to a patient; and
(c) flowing blood from the patient into said blood inlet line and said housing through said housing supply port, along the external surface of said fibers, and out of said housing through said housing discharge port and into said blood outlet line, and collecting filtrate from said hollow fibers.

### Claim 31 (depends on 30)

The method of ultrafiltration of claim 30, wherein said fibers have a pore size of about 0.2 nanometers to 5 nanometers.

### Claim 32 (depends on 30)

The method of ultrafiltration of claim 30, wherein a majority of said fibers have a molecular weight cutoff of less than about 50,000 Daltons.