# US 12,214,092 B2 · Systems and methods for treating biological fluids

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- Number: US 12,214,092 B2
- Document ID: US12214092B2
- Status: Granted
- Kind: B2
- Application number: 18/084,344
- Filed: 2022-12-19
- Published: 2023-07-20
- Granted: 2025-02-04
- Earliest claimed: 2017-12-29
- Assignees: Cerus Corporation
- Applicants: Cerus Corporation
- Inventors: Daniel Church; Peter Bringmann; Grace Castro; Thea Lu; Shelby Reinhardt; Felicia Santa Maria; Adonis Stassinopoulos
- Web page: https://patentgrep.com/patent/US12214092B2

## CPC

- A61L 2/10: Ultraviolet [UV] radiation
- A01N 1/124: Disinfecting agents, e.g. antimicrobials
- A01N 1/168: using electromagnetic fields or radiation; using acoustic waves or corpuscular radiation
- A61K 31/37: Coumarins, e.g. psoralen
- A61K 41/17: by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
- A61L 2/088: using photocatalysts or photosensitisers
- A61L 2/26: Accessories
- A61M 1/3683: {using photoactive agents}
- B01J 19/123: {Ultraviolet light}
- H10W 90/00: Package configurations
- A61L 2/24: Apparatus using programmed or automatic operation
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/09: Blood or products thereof
- A61L 2202/11: Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
- A61L 2202/122: Chambers for sterilisation
- A61L 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- A61M 2202/0415: Plasma
- A61M 2202/0427: Platelets; Thrombocytes
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)}
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- H10W: GENERIC PACKAGES, INTERCONNECTIONS, CONNECTORS OR OTHER CONSTRUCTIONAL DETAILS OF DEVICES COVERED BY CLASS H10

## Abstract

Provided are systems and methods for treating a biological fluid, e.g., to inactivate pathogens.

## Claims

### Claim 1

A method for treating a biological fluid comprising:
providing a biological fluid in admixture with a photoactive pathogen inactivation compound; and
illuminating the biological fluid with ultraviolet light with a first peak wavelength of from about 315 nm to about 350 nm emitted by a set of one or more first light sources, wherein each of the one or more first light sources emits light has a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers, and
wherein illuminating the biological fluid occurs for a duration and at an intensity sufficient to inactivate a pathogen in the biological fluid when present.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first peak wavelength is from about 315 to about 335 nm.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first peak wavelength is from about 330 nm to about 350 nm.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first peak wavelength is a peak wavelength of one first light source of the set of one or more first light sources.

### Claim 5 (depends on 4)

The method of claim 4, wherein the first peak wavelength is a peak wavelength of each of a plurality of first light sources of the set of one or more first light sources.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first peak wavelength is an average peak wavelength of the set of one or more first light sources.

### Claim 7 (depends on 1)

The method of claim 1, further comprising illuminating the biological fluid with ultraviolet light with a second peak wavelength emitted by a set of one or more second light sources, wherein each of the one or more second light sources emits light has a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers, and wherein the second peak wavelength differs from first peak wavelength by at least 5 nm.

### Claim 8 (depends on 7)

The method of claim 7, wherein the second peak wavelength is a peak wavelength of one second light source of the set of one or more second light sources.

### Claim 9 (depends on 8)

The method of claim 8, wherein the second peak wavelength is a peak wavelength of each of a plurality of second light sources of the set of one or more second light sources.

### Claim 10 (depends on 7)

The method of claim 7, wherein the second peak wavelength is an average peak wavelength of the set of one or more second light sources.

### Claim 11 (depends on 1)

The method of claim 1, wherein the set of one or more first light sources comprises one or more LEDs.

### Claim 12 (depends on 1)

The method of claim 1, wherein the biological fluid is contained within a container, and wherein the set of one or more first light sources is disposed as an array of light sources, the set of one or more first light sources facing only one side of the container.

### Claim 13 (depends on 1)

The method of claim 1, wherein the photoactive pathogen inactivation compound is a psoralen.

### Claim 14 (depends on 13)

The method of claim 13, wherein the photoactive pathogen inactivation compound is amotosalen.

### Claim 15 (depends on 1)

The method of claim 1, further comprising, prior to illuminating the biological fluid with the ultraviolet light with the first peak wavelength:
introducing the biological fluid in admixture with the photoactive pathogen inactivation compound into a treatment chamber, the treatment chamber comprising one or more light sensors configured to detect light in the treatment chamber and a first array of light sources configured to illuminate the biological fluid in the treatment chamber, wherein the first array of light sources comprises a first light source channel comprising the set of one or more first light sources,
wherein illuminating the biological fluid comprises emitting light with the first peak wavelength from the first light source channel for a first duration and at a first intensity sufficient to inactivate a pathogen in the biological fluid when present.

### Claim 16 (depends on 15)

The method of claim 15, wherein each light source of the first light source channel is configured to emit ultraviolet light with a first peak wavelength between about 315 nm and about 350 nm.

### Claim 17 (depends on 15)

The method of claim 15, further comprising,
determining a set of characteristics of the biological fluid;
determining a treatment profile based on the set of characteristics of the biological fluid; and
adjusting or setting a set of parameters of the treatment chamber in accordance with the treatment profile.

### Claim 18 (depends on 17)

The method of claim 17, wherein illuminating the biological fluid is performed in accordance with the treatment profile, and wherein the first duration and the first intensity sufficient to inactivate the pathogen are determined from the treatment profile.

### Claim 19 (depends on 15)

The method of claim 15, wherein the first array of light sources comprises a second light source channel configured to emit light of a second peak wavelength.

### Claim 20 (depends on 19)

The method of claim 19, wherein the second peak wavelength differs from the first peak wavelength by at least 5 nm.

### Claim 21 (depends on 19)

The method of claim 19, wherein the second peak wavelength is in an ultraviolet A, ultraviolet B, or ultraviolet C spectrum.

### Claim 22 (depends on 19)

The method of claim 19, wherein the second light source channel comprises a set of one or more second light sources, wherein each of the one or more second light sources emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers.

### Claim 23 (depends on 17)

The method of claim 17, wherein the set of characteristics of the biological fluid includes one or more of a group comprising: a volume of the biological fluid, a type of the biological fluid, and a temperature of the biological fluid.

### Claim 24 (depends on 17)

The method of claim 17, wherein determining the treatment profile based on the set of characteristics of the biological fluid comprises determining the first intensity of light with the first peak wavelength or determining the first duration of emission of light with the first peak wavelength.

### Claim 25 (depends on 15)

The method of claim 15, wherein the treatment chamber further comprises a first platform positioned in the treatment chamber, the first platform carrying the biological fluid.

### Claim 26 (depends on 25)

The method of claim 25, wherein adjusting or setting a set of parameters of the treatment chamber comprises adjusting or setting a distance between the first array of light sources and the first platform.

### Claim 27 (depends on 1)

The method of claim 1, further comprising agitating the biological fluid.

### Claim 28 (depends on 1)

The method of claim 1, wherein a total dose of the ultraviolet light illuminating the biological fluid is about 0.5 J/cm2 to about 50 J/cm2.

### Claim 29 (depends on 28)

The method of claim 28, wherein the total dose of the ultraviolet light illuminating the biological fluid emitted by the set of one or more first light sources is about 0.5 J/cm2 to about 50 J/cm2.

### Claim 30 (depends on 1)

The method of claim 1, wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid after illuminating is suitable for infusion into a subject without further processing to remove residual pathogen inactivation compound or photoproduct(s) thereof.

### Claim 31 (depends on 1)

The method of claim 1, wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid after illuminating is suitable for infusion into a subject without subjecting the biological fluid to a compound removal step to remove residual pathogen inactivation compound or photoproduct(s) thereof.

### Claim 32 (depends on 1)

The method of claim 1, wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid comprises 5 μM or less of the photoactive pathogen inactivation compound after illuminating.

### Claim 33 (depends on 1)

The method of claim 1, wherein the method for treating is sufficient to inactivate at least 1 log of a pathogen in the biological fluid when present, and wherein the biological fluid comprises 2 μM or less of the photoactive pathogen inactivation compound after illuminating.

### Claim 34 (depends on 1)

The method of claim 1, wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating is at least about 10 μM or at least about 50 μM.

### Claim 35 (depends on 1)

The method of claim 1, wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating is about 15 μM to about 150 μM.

### Claim 36 (depends on 1)

The method of claim 1, wherein a concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid after illuminating is at least 3-fold less than the concentration of the photoactive pathogen inactivation compound in admixture with the biological fluid prior to illuminating.

### Claim 37 (depends on 1)

The method of claim 1, wherein the method for treating is sufficient to inactivate at least 4 log of a pathogen in the biological fluid when present.

### Claim 38 (depends on 1)

The method of claim 1, wherein the biological fluid after illuminating maintains sufficient biological activity so that the biological fluid is suitable for infusion into a subject.

### Claim 39 (depends on 1)

The method of claim 1, wherein the biological fluid comprises a blood product.

### Claim 40 (depends on 1)

The method of claim 1, wherein the biological fluid comprises a plasma composition.

### Claim 41 (depends on 40)

The method of claim 40, wherein a concentration of fibrinogen in the plasma composition after illuminating is at least 70% of the concentration of fibrinogen in the plasma composition prior to illuminating.

### Claim 42 (depends on 40)

The method of claim 40, wherein a concentration of factor VIII in the plasma composition after illuminating is at least 70% of the concentration of factor VIII in the plasma composition prior to illuminating.

### Claim 43 (depends on 1)

The method of claim 1, wherein the biological fluid comprises a platelet composition.

### Claim 44 (depends on 43)

The method of claim 43, wherein the biological fluid further comprises a platelet additive solution.

### Claim 45 (depends on 43)

The method of claim 43, wherein an amount of platelets in the platelet composition after illuminating is at least 80% platelet recovery.

### Claim 46 (depends on 43)

The method of claim 43, wherein the pH at 22° C. of the platelet composition after illuminating is at least 6.2.

### Claim 47 (depends on 1)

The method of claim 1, wherein the method comprises, prior to illuminating, incubating the biological fluid with the photoactive pathogen inactivation compound for a period of from 30 minutes to 24 hours.

### Claim 48 (depends on 3)

The method of claim 3, wherein the first peak wavelength is from about 340 nm to about 350 nm.

### Claim 49 (depends on 3)

The method of claim 3, wherein the first peak wavelength is 345±5 nm.

### Claim 50 (depends on 2)

The method of claim 2, wherein the first peak wavelength is from about 320 to about 330 nm.

### Claim 51 (depends on 2)

The method of claim 2, wherein the first peak wavelength is 325±5 nm.

### Claim 52 (depends on 7)

The method of claim 7, wherein the set of one or more second light sources comprises one or more LEDs.

### Claim 53 (depends on 1)

The method of claim 1, wherein the biological fluid is contained within a container, and wherein the set of one or more first light sources is disposed as a first array of light sources and a second array of light sources, the first array and the second array facing opposite sides of the container.

### Claim 54 (depends on 15)

The method of claim 15, wherein the treatment chamber further comprises a second array of light sources configured to illuminate the biological fluid in the treatment chamber, wherein the second array of light sources comprises a first light source channel of the second array of light sources comprising a set of one or more second light sources configured to emit light of a first peak wavelength of the second array, wherein illuminating the biological fluid comprises emitting light with the first peak wavelength of each of the first array of light sources and second array of light sources, for a first duration and at first intensity sufficient to inactivate a pathogen in the biological fluid when present.

### Claim 55 (depends on 54)

The method of claim 54, wherein the first peak wavelength of the second array of light sources is substantially the same as the first peak wavelength of the first array of light sources.

### Claim 56 (depends on 54)

The method of claim 54, wherein the second array of light sources comprises a second light source channel of the second array of light sources configured to emit light of a second peak wavelength, and wherein the second peak wavelength of the second array of light sources is substantially the same as the second peak wavelength of the first array of light sources.

### Claim 57 (depends on 1)

The method of claim 1, further comprising, prior to illuminating the biological fluid with the ultraviolet light with the first peak wavelength:
introducing the biological fluid in admixture with the photoactive pathogen inactivation compound into a system for treating the biological fluid, the system comprising:
a treatment chamber configured to receive the biological fluid;
one or more sensors configured to detect light in the treatment chamber;
a first array of light sources positioned to illuminate the biological fluid in the treatment chamber, wherein the first array of light sources comprises a first light source channel configured to emit ultraviolet light with a first peak wavelength of from about 315 nm to about 350 nm, and wherein the first light source channel comprises one or more light sources, each of which emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers; and
control circuitry, wherein the control circuitry comprises:
a memory;
one or more processors; and
one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs when executed by the one or more processors cause the processor to: illuminate the biological fluid in admixture with the photoactive pathogen inactivation compound by controlling the first array of light sources to illuminate light for a duration and at an intensity sufficient to inactivate a pathogen in the biological fluid when present; and
illuminating the biological fluid for the duration and at the intensity sufficient to inactivate the pathogen in the biological fluid when present.