# US 10,245,392 B2 · Oxygen concentrating device, wound care apparatus, and treatment methods

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- Number: US 10,245,392 B2
- Document ID: US10245392B2
- Status: Granted
- Kind: B2
- Application number: 15/050,371
- Filed: 2016-02-22
- Published: 2016-06-16
- Granted: 2019-04-02
- Earliest claimed: 2014-08-08
- Assignees: Neogenix, LLC
- Applicants: Neogenix, LLC
- Inventors: Srinivasan Sarangapani; Lawrence J. Cali
- Web page: https://patentgrep.com/patent/US10245392B2

## CPC

- A61M 35/30: {Gas therapy for therapeutic treatment of the skin}
- A61M 1/94: {with gas supply means}
- A61M 1/96: {Suction control thereof}
- A61M 1/962: {having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction}
- A61M 1/98: {Containers specifically adapted for negative pressure wound therapy}
- A61M 13/003: {Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing}
- A61F 13/05: specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
- A61F 2013/0017: {possibility of applying fluid}
- A61M 1/602: {Mechanical means for preventing flexible containers from collapsing when vacuum is applied inside, e.g. stents}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61M 1/984: {portable on the body}
- A61M 2202/0208: Oxygen
- A61M 2205/42: Reducing noise
- A61M 2205/6063: Optical identification systems
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A wound care device for delivering topical oxygen therapy, negative pressure wound therapy, and a low intensity vacuum therapy for treatment of a wound. The wound care device may include an oxygen supply MEA, an oxygen consuming MEA, a vacuum pump and motor, a pressure sensor, and a power supply and electronic controls. A dressing may be connected to the wound care device for administering topical continuous oxygen therapy and simultaneous negative pressure wound therapy to a wound. A canister or exudate trap may be positioned between the dressing and the vacuum supply port of the vacuum pump to collect and store exudates from the wound. The canister may be combined with the dressing.

## Claims

### Claim 1

A wound care device comprising:
an oxygen port for supplying oxygen gas for wound care;
an oxygen concentrating device fluidly connected to the oxygen port, the oxygen concentrating device including:
a first membrane electrode assembly (MEA) for the production of oxygen gas from air, which comprises:
a first electrode fluidly connected to a source of ambient air;
a cover disposed between the first electrode and the source of ambient air, the cover including at least one passage which fluidly connects the first electrode to the source of ambient air such that the cover restricts moisture loss from the first electrode,
a second electrode spaced from the first electrode, the second electrode being fluidly connected to a first basin such that the first basin is fluidly connected to the oxygen port, and
a first ion conducting membrane positioned between the first and second electrodes, which comprises:
a first conductive wire connected to the first electrode, and
a second conductive wire connected to the second electrode, such that the application of a substantially constant flow of electrical current through the first conductive wire and the second conductive wire electrochemically produces oxygen on the second electrode from ambient air adjacent the first electrode, and such that when the source of ambient air has an ambient relative humidity which is equal to or less than 30%, the voltage across the first electrode and the second electrode increases less than 25% after 15 days of electrochemically producing oxygen on the second electrode as the result of the application of the substantially constant flow of electrical current;
wherein the at least one passage has a radius that is equal to or greater than 0.159 mm.

### Claim 2 (depends on 1)

The device of claim 1, further comprising:
a vacuum port for providing a vacuum for wound care; and
a mechanical pump which comprises:
a pump intake fluidly connected to the vacuum port, and
a motor for driving the mechanical pump such that the motor drives the mechanical pump to evacuate a gaseous mixture at a temperature ranging from 60° F. to 100° F. and a pressure ranging from 560 mmHg absolute to 760 mmHg absolute at a volumetric flow rate ranging from 1 cc/min to 2,500 cc/min while maintaining a vacuum at the pump intake, the vacuum ranging from 100 mmHg to 500 mmHg.

### Claim 3 (depends on 2)

The device of claim 2, further comprising an oxygen consuming device fluidly connected to the oxygen port, the oxygen consuming device comprises:
a second MEA for the removal of oxygen from a gaseous mixture, which comprises:
a third electrode fluidly connected to the first basin,
a fourth electrode spaced from the third electrode,
a second ion conducting membrane positioned between the third and fourth electrodes,
a third conductive wire connected to the third electrode, and
a fourth conductive wire connected to the fourth electrode, such that the application of a constant voltage across the third conductive wire and the fourth conductive wire electrochemically consumes oxygen from the first basin at the third electrode.

### Claim 4 (depends on 3)

The device of claim 3, further comprising a pressure sensor and a microcontroller electrically connected to the first MEA, the second MEA, the motor, and the pressure sensor, the microcontroller being configured to regulate operation of the wound care device in a plurality of operational modes which comprise:
a first operational mode in which the first MEA delivers oxygen gas to the oxygen port at a rate ranging from 1 ml oxygen/hr to 10 ml oxygen/hr at a temperature ranging from 60° F. to 100° F. and a pressure of 760 mmHg; and
a second operational mode in which the second MEA consumes oxygen from the oxygen port, and
a third operational mode in which the mechanical pump evacuates a gaseous mixture from the vacuum port at a volumetric flow rate ranging from 1 cc/min to 2,500 cc/min while maintaining a pressure ranging from 560 mmHg to 680 mmHg at a wound site which is fluidly connected to the vacuum port.

### Claim 5 (depends on 4)

The device of claim 4, wherein the microcontroller regulates simultaneous operation of the first operational mode and the third operational mode.

### Claim 6 (depends on 4)

The device of claim 4, wherein the microcontroller regulates operation of the second operational mode after regulating operation of the first operational mode.

### Claim 7 (depends on 4)

The device of claim 4, further comprising an enclosure for housing the first MEA, the second MEA, and the mechanical pump.

### Claim 8 (depends on 7)

The device of claim 7, wherein the enclosure comprises a cover section and a base section.

### Claim 9 (depends on 8)

The device of claim 8, wherein the first MEA and the second MEA are secured to the cover section.

### Claim 10 (depends on 9)

The device of claim 9, wherein the mechanical pump is connected to the base section.

### Claim 11 (depends on 10)

The device of claim 10, wherein the oxygen port is connected to the cover section and the vacuum port is connected to the base section.

### Claim 12 (depends on 8)

The device of claim 8, wherein the first basin comprises a recess in the cover section.

### Claim 13 (depends on 12)

The device of claim 12, further comprising a second basin adjacent the first basin.

### Claim 14 (depends on 13)

The device of claim 13, further comprising an intermediate passage fluidly connecting the first basin and the second basin.

### Claim 15 (depends on 14)

The device of claim 14, wherein the second basin is opposite the second MEA.

### Claim 16 (depends on 15)

The device of claim 15, further comprising a plurality of LEDs connected to the microcontroller for signaling a status of one or more operating parameters.

### Claim 17 (depends on 16)

The device of claim 16, wherein the device further comprises a replaceable power supply for operating the motor.

### Claim 18 (depends on 16)

The device of claim 16, wherein the device further comprises a rechargeable power supply for operating the motor.

### Claim 19 (depends on 2)

The device of claim 2, wherein the pressure sensor is fluidly connected to the vacuum port at a location between the mechanical pump and the vacuum port.

### Claim 20 (depends on 2)

The device of claim 2, wherein the pressure sensor is fluidly connected to the oxygen port at a location between the first MEA and the oxygen port.

### Claim 21 (depends on 2)

The device of claim 2, further comprising a trap for storing wound care exudates, the trap being fluidly connected to the pump intake.

### Claim 22 (depends on 1)

The device of claim 1, wherein the at least one passage is a plurality of passages which fluidly connect the first electrode to the source of ambient air.

### Claim 23 (depends on 22)

The device of claim 22, wherein the plurality of passages each have a cross-sectional area of approximately 0.01 cm2.

### Claim 24 (depends on 22)

The device of claim 22, wherein four passages fluidly connect the first electrode to the source of ambient air.

### Claim 25 (depends on 1)

The device of claim 1, wherein the substantially constant flow of electrical current is approximately 13.5 mA.

### Claim 26 (depends on 1)

An apparatus for treating a wound comprising:
a wound care device of claim 1, and
a dressing for administering treatment to a wound, the dressing comprising an oxygen delivery zone fluidly connected to the oxygen port.

### Claim 27 (depends on 2)

An apparatus for treating a wound comprising:
a wound care device of claim 2; and
a dressing for administering treatment to a wound, the dressing comprising:
an oxygen delivery zone fluidly connected to the oxygen port, and
a gaseous mixture and exudates removal zone fluidly connected to the vacuum port.

### Claim 28 (depends on 27)

The apparatus of claim 27, further comprising a trap for storing wound care exudates, the trap being fluidly connected to the gaseous mixture and exudates removal zone and the pump intake, and the trap is located between the pump intake and the vacuum port.

### Claim 29 (depends on 27)

The apparatus of claim 27, further comprising a trap for storing wound care exudates, the trap being fluidly connected to the gaseous mixture and exudates removal zone and the pump intake, and the trap is located in the dressing.

### Claim 30 (depends on 27)

The apparatus of claim 27, further comprising a trap for storing wound care exudates, the trap being fluidly connected to the gaseous mixture and exudates removal zone and the pump intake, the trap including a container that is located between the vacuum port and the dressing.

### Claim 31 (depends on 2)

A method of treating a wound comprising:
providing a wound care device of claim 2;
positioning a dressing over a wound to form a wound care environment for administering topical continuous oxygen therapy and negative pressure wound therapy;
connecting the dressing to the wound care device;
activating operation of the wound care device;
supplying oxygen concentrated by the wound care device to the wound care environment via the dressing; and
applying a vacuum produced by the wound care device to the wound care environment via the dressing.

### Claim 32 (depends on 31)

The method of claim 31, wherein activating operation of the wound care device initiates a seven-day treatment cycle that comprises simultaneous topical continuous oxygen therapy and negative pressure wound therapy.

### Claim 33 (depends on 31)

The method of claim 31, wherein activating operation of the wound care device initiates a seven-day treatment cycle that comprises topical continuous oxygen therapy and intermittent negative pressure wound therapy.
