# US 2019/0314567 A1 · Intravascular Membrane Oxygenator Catheter Systems and Methods

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- Number: US 2019/0314567 A1
- Document ID: US20190314567A1
- Status: Published application
- Kind: A1
- Application number: 15/950,517
- Filed: 2018-04-11
- Published: 2019-10-17
- Earliest claimed: 2018-04-11
- Assignees: Duke University
- Applicants: Duke University
- Inventors: Tobias Straube; Ken Gall; Bruce Klitzman; Ira Cheifetz; Roy Glenn Morris; Travis Vesel; Jennifer Chien
- Web page: https://patentgrep.com/patent/US20190314567A1

## CPC

- 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 1/1678: {intracorporal (peritoneal dialysis A61M1/28)}
- A61M 1/363: {Degassing by using vibrations}
- A61M 2202/0208: Oxygen
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- A61M 2210/125: Heart
- 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

Intravascular membrane oxygenator catheter systems and methods are disclosed, along with methods of making and using the same. A catheter system includes a catheter shaft having a wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen, a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft, the hollow fiber membrane loops are nonporous with solid walls; a pneumatic source in pneumatic communication with the hollow fiber membrane loops. The pneumatic source provides a gas containing oxygen at a pressure sufficient to cause a diffusive flux of the gas containing oxygen from an interior of the hollow fiber membrane loops to a fluid exterior to the hollow fiber membrane loops in a region of interest of a subject.

## Claims

### Claim 1

A catheter system comprising:
a catheter shaft having a wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen;
a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft, the plurality of hollow fiber membrane loops are nonporous with solid walls; and
a pneumatic source in pneumatic communication with the plurality of hollow fiber membrane loops;
wherein the pneumatic source is configured to provide a gas containing oxygen at a pressure sufficient to cause a diffusive flux of the gas containing oxygen from an interior of the plurality of hollow fiber membrane loops to a fluid exterior to the plurality of hollow fiber membrane loops in a region of interest of a subject, wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 1 pounds per square inch (PSI).

### Claim 2 (depends on 1)

The catheter system of claim 1 further comprising a pneumatic control system in pneumatic communication with the pneumatic source and the plurality of hollow fiber membrane loops, the pneumatic control system having a controller configured to provide pressure, temperature, and flow rate control of the gas containing oxygen to the plurality of hollow fiber membrane loops.

### Claim 3 (depends on 1)

The catheter system of claim 1, wherein the pneumatic source is an oxygen source.

### Claim 4 (depends on 1)

The catheter system of claim 1, wherein the distal end of the catheter shaft is dimensioned for positioning in the region of interest of the subject.

### Claim 5 (depends on 1)

The catheter system of claim 1, wherein the catheter system is dimensioned for intravascular placement using a percutaneous approach.

### Claim 6 (depends on 1)

The catheter system of claim 1, wherein the region of interest is an inferior vena cava of the subject.

### Claim 7 (depends on 1)

The catheter system of claim 1, wherein the region of interest is a right atrium of the subject's heart.

### Claim 8 (depends on 1)

The catheter system of claim 1, wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure from 1 to 2400 pounds per square inch (PSI).

### Claim 9 (depends on 1)

The catheter system of claim 1, wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 2400 pounds per square inch (PSI).

### Claim 10 (depends on 1)

The catheter system of claim 1 further comprising a manifold within the lumen, the manifold receives the plurality of hollow fiber membrane loops and supports the plurality of hollow fiber membrane loops at constant distances within the lumen.

### Claim 11 (depends on 1)

The catheter system of claim 1, wherein the plurality of hollow fiber membrane loops comprise an amorphous fluoropolymer material.

### Claim 12 (depends on 1)

The catheter system of claim 1, wherein the plurality of hollow fiber membrane loops are arranged in parallel loops having an inlet side and a return side, each inlet and return side being potted in a manifold connected to the catheter shaft.

### Claim 13 (depends on 1)

The catheter system of claim 1, wherein the plurality of hollow fiber membrane loops comprise between 2 and 500 individual hollow fiber loops.

### Claim 14 (depends on 1)

The catheter system of claim 1, wherein the plurality of hollow fiber membrane loops are between 100 micrometers (μm) and 1800 micrometers (μm) in diameter and have a wall thickness of between 10 micrometers (μm) and 500 micrometers (μm).

### Claim 15 (depends on 1)

The catheter system of claim 1, wherein the catheter system is configured to deliver at least 0.15 mL of O2 per minute.

### Claim 16 (depends on 1)

The catheter system of claim 1, wherein the catheter system is configured to deliver between 100 ml of O2 per minute and 200 mL of O2 per minute.

### Claim 17 (depends on 1)

The catheter system of claim 1, wherein the plurality of hollow fiber membrane loops are configured to be subjected to vibration induced from external energies to reduce the accumulation and adherence of bubbles to the plurality of hollow fiber membrane loops allowing more oxygen to be dissolved.

### Claim 18

A method of intravascular oxygenation, the method comprising:
a) introducing a catheter system to a region of interest in a subject, the catheter system comprising
a catheter shaft having a tubular wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen;
a plurality of hollow fiber membrane loops each having a proximal portion positioned within the lumen of the catheter shaft and a distal portion extending beyond the lumen of the catheter shaft;
a pneumatic source in pneumatic communication with the plurality of hollow fiber membrane loops;
the plurality of hollow fiber membrane loops are nonporous; and
b) providing a gas containing oxygen at a pressure from the pneumatic source to the plurality of hollow fiber membrane loops, thereby creating a diffusive flux causing the gas containing oxygen to diffuse from an interior of the plurality of hollow fiber membrane loops to a fluid flowing past an exterior of the plurality of hollow fiber membrane loops in a region of interest of a subject, wherein the pressure is at least 1 pounds per square inch (PSI).

### Claim 19 (depends on 18)

The method of claim 18, wherein the pneumatic source of step a) is an oxygen source.

### Claim 20 (depends on 18)

The method of claim 18, the method further comprising: delivering at least 0.15 mL of O2 per minute to the subject via the catheter system.

### Claim 21 (depends on 1)

The catheter system of claim 1, wherein the pneumatic source is configured to provide the gas containing oxygen at a pressure at or above 25 pounds per square inch (PSI).
