# US 12,109,348 B2 · Medication infusion devices, systems, and methods

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- Number: US 12,109,348 B2
- Document ID: US12109348B2
- Status: Granted
- Kind: B2
- Application number: 17/119,423
- Filed: 2020-12-11
- Published: 2021-06-17
- Granted: 2024-10-08
- Earliest claimed: 2019-12-11
- Assignees: EpicentRx, Inc.
- Applicants: EpicentRx, Inc.
- Inventors: Bryan T. Oronsky; Scott Caroen
- Web page: https://patentgrep.com/patent/US12109348B2

## CPC

- A61M 1/3673: {Anticoagulant coating, e.g. Heparin coating}
- A61M 5/16827: {controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407)}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/38: Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion}
- A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves}
- A61M 5/1411: {Drip chambers (A61M5/1689, A61M5/40 take precedence)}
- A61B 5/150992: {Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves}
- A61M 2202/0007: introduced into the body
- A61M 2202/0216: Ozone
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2202/0427: Platelets; Thrombocytes
- A61M 2202/0429: Red blood cells; Erythrocytes
- A61M 2202/0439: White blood cells; Leucocytes
- A61M 2205/75: with filters
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices, systems, and methods for medication infusion are described herein. In some embodiments, a system includes a patient access subassembly, a first fluid reservoir, a second fluid reservoir, and an assembly. The assembly can have a first configuration in which the patient access subassembly is in fluid communication with the first fluid reservoir via a first tube, a second configuration in which the first fluid reservoir is in fluid communication with the second fluid reservoir, and a third configuration in which the first fluid reservoir is in fluid communication with the patient access subassembly via a second tube, the first fluid reservoir fluidically isolated from the first tube in the third configuration.

## Claims

### Claim 1

An apparatus for in-situ mixing, the apparatus comprising:
a patient access subassembly;
a first fluid reservoir comprising a first fluidic substance;
a second fluid reservoir comprising a second fluidic substance, wherein the second fluidic substance comprises a medicament;
a base fluidically coupled to the patient access subassembly, the first fluid reservoir, and the second fluid reservoir; and
an assembly comprising a processor adapted to control the base to:
receive a blood product from a patient;
mix the blood product with the first fluidic substance to form a third fluidic substance;
mix the third fluidic substance with the second fluidic substance to form a fourth fluidic substance; and
transfer the fourth fluidic substance to the patient access subassembly to expel the fourth fluidic substance from the patient access subassembly and back into the patient,
wherein the apparatus is configurable such that fluidic communication is achievable between any of the first fluid reservoir, the second fluid reservoir, and the patient access subassembly.

### Claim 2 (depends on 1)

The apparatus of claim 1, where the first fluidic substance comprises an anti-coagulant.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the base comprises a cassette/pumping assembly configured to:
draw a predetermined volume of the blood product from vasculature of the patient at a predetermined rate;
draw the first fluidic substance into a mixing module configured to mix the blood product with the first fluidic substance to form the third fluidic substance; and
draw the third fluidic substance into the mixing module configured to mix the third fluidic substance with the second fluidic substance to form the fourth fluidic substance.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the apparatus is automated or semi-automated.

### Claim 5 (depends on 1)

The apparatus of claim 1,
wherein the apparatus further comprises a filter, and
wherein the filter is configured to trap microbubbles and remove debris from the fourth fluidic substance prior to expelling the fourth fluidic substance from the patient access subassembly and back into the patient.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein the filter comprises a pore size in a range of about 150 microns to about 260 microns.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the processor of the assembly is further configured to control the base to:
manipulate the assembly such that the first fluid reservoir is fluidically isolated from the patient access subassembly and the first fluid reservoir is in fluidic communication with the second fluid reservoir;
transfer a portion of the third fluidic substance from the first fluid reservoir into the second fluid reservoir such that the portion of the third fluidic substance and the second fluidic substance form the fourth fluidic substance;
transfer the fourth fluidic substance from the second fluid reservoir into the first fluid reservoir such that a remainder of the third fluidic substance and the fourth fluidic substance form a fifth fluidic substance;
manipulate the assembly such that the first fluid reservoir is in fluidic communication with the patient access subassembly; and
transfer the fifth fluidic substance to the patient access subassembly to expel the fifth fluidic substance from the patient access subassembly and back into the patient.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the processor of the assembly is further configured to control the base to maintain the fifth fluidic substance in the first fluid reservoir for a time period prior to transferring the fifth fluidic substance to the patient access subassembly to expel the fifth fluidic substance from the patient access subassembly and back into the patient.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein the time period comprises at least two minutes.

### Claim 10 (depends on 3)

The apparatus of claim 3, wherein the cassette/pumping assembly is coupled to vasculature of the patient via a fluid line.

### Claim 11 (depends on 10)

The apparatus of claim 10, wherein the base comprises an air detector and a display screen.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the air detector is coupled to the fluid line and is configured to:
monitor the fluid line for air during the transfer of the fourth fluidic substance to the patient access subassembly to expel the fourth fluidic substance from the patient access subassembly and back into the patient; and
in response to a detection of the air during the transfer, transmit an alert to the display screen.

### Claim 13 (depends on 3)

The apparatus of claim 3, wherein the cassette/pumping assembly is configured to draw a predetermined volume of the blood product from vasculature of the patient at a predetermined rate.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein the predetermined rate is in a range of about 20 mL/min to about 100 mL/min.

### Claim 15 (depends on 3)

The apparatus of claim 3, wherein at least one cassette of the cassette/pumping assembly is disposable and replaceable.

### Claim 16 (depends on 3)

The apparatus of claim 3, wherein the blood product comprises a volume of about 125 mL of blood.

### Claim 17 (depends on 3)

The apparatus of claim 3, wherein the blood of the blood product comprises whole blood.

### Claim 18 (depends on 1)

The apparatus of claim 1, where the first fluidic substance comprises an antioxidant.

### Claim 19 (depends on 18)

The apparatus of claim 18, wherein the antioxidant comprises vitamin C or N-acetylcysteine.

### Claim 20 (depends on 2)

The apparatus of claim 2, wherein the anti-coagulant is selected from the group consisting of: ACD-A, ACD-B, EDTA, and heparin.

### Claim 21 (depends on 1)

The apparatus of claim 1, wherein the medicament is selected from the group consisting of: 2-Bromo-1-(3,3-dinitroazetidin-1-yl)ethanone, a derivative of 2-Bromo-1-(3,3-dinitroazetidin-1-yl)ethenone, a dinitroazetidine, propofol, nitric oxide, a nitric oxide donor, ozone, and a chemotherapy drug.

### Claim 22 (depends on 21)

The apparatus of claim 21, wherein the medicament comprises the chemotherapy drug.

### Claim 23 (depends on 22)

The apparatus of claim 22, wherein the chemotherapy drug is selected from the group consisting of: an antitumor platinum coordination complex, an antimetabolite, a mitotic inhibitor, an anticancer antibiotic, a topoisomerase I inhibitor, a topoisomerase II inhibitor, a proteasome inhibitor, a histone deacetylase inhibitor, a nitrogen mustard alkylating agent, a nitrosourea alkylating agent, a nonclassical alkylating agent, an estrogen antagonist, an androgen antagonist, a mTOR inhibitor, and a tyrosine kinase inhibitor.