# US 11,998,675 B2 · Systems, assemblies, and methods of trauma management

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- Number: US 11,998,675 B2
- Document ID: US11998675B2
- Status: Granted
- Kind: B2
- Application number: 18/381,948
- Filed: 2023-10-19
- Published: 2024-04-25
- Granted: 2024-06-04
- Earliest claimed: 2022-10-19
- Assignees: Lazarus Technologies LLC
- Applicants: Lazarus Technologies LLC
- Inventors: Tom Bozzay
- Web page: https://patentgrep.com/patent/US11998675B2

## CPC

- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/1698: {Blood oxygenators with or without heat-exchangers (intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00)}
- A61M 1/3603: {in the same direction}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/362263: {Details of incorporated filters}
- A61M 1/362265: {Details of valves}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/3623: {Means for actively controlling temperature of blood}
- A61M 1/3624: {Level detectors; Level control}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 1/365: {through membranes, e.g. by inverted trans-membrane pressure [TMP]}
- A61M 1/3666: {Cardiac or cardiopulmonary bypass, e.g. heart-lung machines}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- A61M 1/369: {Temperature treatment}
- A61M 2202/0021: removed from and reintroduced into the body, e.g. after treatment
- A61M 2202/0208: Oxygen
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2202/0413: Blood
- A61M 2205/103: rotating
- A61M 2205/3303: Using a biosensor
- A61M 2205/3327: Measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3606: cooled
- A61M 2205/3673: thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
- A61M 2205/50: with microprocessors or computers
- A61M 2205/7545: for solid matter, e.g. microaggregates
- A61M 2205/8206: battery-operated
- A61M 2209/088: on the body
- A61M 2230/20: Blood composition characteristics
- A61M 2230/202: partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/50: Temperature
- 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)}

## Abstract

A system for performing extracorporeal blood treatment of recovered blood can include a reservoir to receive a first portion of the recovered blood from a subject, an inline pump coupled the reservoir to regulate a flow rate of at least the first portion of the recovered blood, and an extracorporeal blood conditioner including at least one of an oxygenator to reoxygenate hemoglobin included in the recovered blood for at least intravenous delivery back to the subject or a temperature regulator configured to selectively control a temperature of the recovered blood.

## Claims

### Claim 1

A device for performing extracorporeal blood treatment of recovered blood, the device comprising:
a first fluid inlet configured for drawing a first portion of the recovered blood, the first portion received from a body cavity of a subject;
a reservoir fluidly coupled to the first fluid inlet, the reservoir fluidly sealed relative to an external ambient environment and configured to maintain a negative internal pressure relative to the external ambient environment;
an inline pump fluidly coupled to an outlet of the reservoir, the inline pump configured to regulate a flow rate of at least the first portion of the recovered blood, received from the first fluid inlet or the reservoir, through an outlet of the pump;
an extracorporeal blood conditioner connected to the outlet of the pump, the conditioner configured to condition the recovered blood via at least one of:
a temperature regulator configured to selectively control a temperature of the recovered blood; or
an oxygenator configured to reoxygenate hemoglobin (Hb) included in the recovered blood, received from at least the reservoir, for at least intravenous delivery back to the subject via at least a first fluid outlet;
a blood state sensor, configured to measure an indication of blood lactate concentration of at least the first portion of the recovered blood received via at least the first fluid inlet; and
processing circuitry configured to monitor the measured indication of blood lactate concentration over time and to control operation of the device between:
an assist mode, wherein the temperature regulator is configured to regulate the blood at a first temperature and configured to deliver reoxygenated blood back intravenously to the subject via the first fluid outlet after reoxygenation via the oxygenator; and
a controlled preservation mode, configured to temporarily slow biological function of the subject to help preserve organ tissue, wherein the temperature regulator cools the recovered blood toward a second temperature lower than the first temperature before at least intraarterial delivery of the cooled blood back to the subject;
wherein the controlling of the operation of the device between the assist mode and the controlled preservation mode is determined at least in part based on the monitored blood lactate concentration.

### Claim 2 (depends on 1)

The device of claim 1, wherein the blood state sensor is configured to measure an indication of blood state including at least one of blood volume, or arterial blood gas (ABG) of at least the first portion of the recovered blood received via at least the first fluid inlet;
wherein the processing circuitry is configured to:
monitor the measured indication of blood state from the blood state sensor overtime; and
establish or adjust at least one operating parameter of the oxygenator or at least one operating parameter of the temperature regulator based at least in part on the monitored blood state.

### Claim 3 (depends on 1)

The device of claim 1, wherein the extracorporeal blood conditioner includes both the oxygenator and the temperature regulator, arranged such that the temperature regulator is configured to preheat the blood before the reoxygenating hemoglobin (Hb) via the oxygenator.

### Claim 4 (depends on 1)

The device of claim 1, wherein the blood state sensor comprises at least one arterial blood gas (ABG) sensor to provide at least one ABG indication:
wherein:
the processing circuitry is configured to monitor the at least one ABG indication of the recovered blood after reoxygenation via the oxygenator; and
the controlling of the operation of the device between the assist mode and the controlled preservation mode is initiated at least in part based on the monitored ABG indication.

### Claim 5 (depends on 1)

The device of claim 1, wherein in the controlled preservation mode, the first temperature is selected to move an internal body temperature of the subject toward a target temperature between 10° C. and 20° C. to induce controlled hypothermic arrest of the subject.

### Claim 6 (depends on 1)

The device of claim 1, wherein:
the processing circuitry is configured to control operation of the device between the assist mode, the controlled preservation mode, and an acidosis mode wherein a flow rate of the pump is increased and a second portion of the recovered blood is received at the extracorporeal blood conditioner and from an intravenous cannulation of the subject; and
wherein the controlling of the operation of the device between the assist mode, the acidosis mode, and the controlled preservation mode is determined at least in part based on the monitored blood lactate concentration.

### Claim 7 (depends on 6)

The device of claim 6, wherein in the acidosis mode, the inline pump is configured to regulate a flow rate of the first portion and the second portion of the recovered blood.

### Claim 8 (depends on 1)

The device of claim 1, comprising an enclosed sac fluidly coupled to the extracorporeal blood conditioner and configured to receive conditioned blood therefrom, wherein the enclosed sac is configured to purge air from the conditioned, recovered blood.

### Claim 9 (depends on 8)

The device of claim 8, wherein the enclosed sac is further fluidly coupled to the reservoir, establishing an open loop hydraulic circuit with the recovered blood.

### Claim 10 (depends on 9)

The device of claim 9, comprising a valve located between the enclosed sac and the blood conditioner, the valve selectively operable to divert recovered blood exiting the sac toward a blood outlet for redistribution back to the subject.

### Claim 11 (depends on 8)

The device of claim 8, wherein the enclosed sac includes a permeable membrane configured to contain the conditioned, recovered blood within the sac while allowing air mixed with the conditioned, recovered blood to pass through the membrane.

### Claim 12 (depends on 1)

The device of claim 1, wherein the inline pump includes a magnetically levitated impeller pump configured to regulate the flow rate between 1 liter per minute (L/min) and 10 L/min.

### Claim 13 (depends on 1)

The device of claim 1, wherein the reservoir contains an anticoagulant including at least one of heparin, bivalirudin, or argatroban.

### Claim 14

A system for performing extracorporeal blood treatment of recovered blood, the system comprising:
a portable enclosure including:
a first fluid inlet configured for drawing a first portion of the recovered blood, the first portion received from a body cavity of a subject;
a reservoir fluidly coupled to the first fluid inlet, the reservoir fluidly sealed relative to an external ambient environment and configured to maintain a negative internal pressure relative to the external ambient environment;
an inline pump fluidly coupled to an outlet of the reservoir, the inline pump configured to regulate a flow rate of at least the first portion of the recovered blood, received from the first fluid inlet or the reservoir, through an outlet of the pump;
a blood state sensor, configured to measure an indication of blood state including blood lactate concentration, of at least the first portion of the recovered blood received via at least the first fluid inlet;
an extracorporeal blood conditioner connected to the outlet of the pump, the conditioner configured to condition the recovered blood via at least one of:
a temperature regulator configured to selectively control a temperature of the recovered blood; or
an oxygenator configured to reoxygenate hemoglobin (Hb) included in the recovered blood, received from at least the reservoir, for at least intravenous delivery back to the subject via at least a first fluid outlet configured for delivering blood at least intravenously back to the subject; and
a battery configured to power the inline pump and the blood conditioner;
processing circuitry configured to monitor the measured indication of blood lactate concentration over time and to control operation of the system between:
an assist mode, wherein the temperature regulator is configured to regulate the blood at a first temperature and configured to deliver reoxygenated blood back intravenously to the subject via the first fluid outlet after reoxygenation via the oxygenator; and
a controlled preservation mode, configured to temporarily slow biological function of the subject to help preserve organ tissue, wherein the temperature regulator cools the recovered blood toward a second temperature lower than the first temperature before at least intraarterial delivery of the cooled blood back to the subject:
wherein the controlling of the operation of the system between the assist mode and the controlled preservation mode is determined at least in part based on the monitored blood lactate concentration; and
wherein the system is configured to output conditioned blood from the reservoir via the first fluid outlet at a greater rate than 200 milliliters per minute (mL/min).

### Claim 15 (depends on 14)

The system of claim 14, wherein the blood state sensor is configured to measure an indication of blood state including at least one of blood volume, or arterial blood gas (ABG) of at least the first portion of the recovered blood received via at least the first fluid inlet;
wherein the processing circuitry is configured to:
monitor the measured indication of blood state from the blood state sensor overtime; and
establish or adjust at least one operating parameter of the oxygenator or at least one operating parameter of the temperature regulator based at least in part on the monitored blood state.