# US 11,305,097 B2 · Support devices for bodily fluid transfer systems and methods of using the same

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- Number: US 11,305,097 B2
- Document ID: US11305097B2
- Status: Granted
- Kind: B2
- Application number: 16/233,801
- Filed: 2018-12-27
- Published: 2019-07-04
- Granted: 2022-04-19
- Earliest claimed: 2017-12-27
- Assignees: Velano Vascular, Inc.
- Applicants: Velano Vascular, Inc.
- Inventors: Brian Funk; Pitamber Devgon
- Web page: https://patentgrep.com/patent/US11305097B2

## CPC

- A61M 25/0662: {Guide tubes}
- A61B 5/15003: {for venous or arterial blood}
- 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}
- A61B 5/153: {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61M 25/0075: {Valve means}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- A61M 2025/0079: {Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2202/0413: Blood
- A61M 2210/12: Blood circulatory system
- 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

A method includes disposing a lumen-defining device within a portion of a vein of a patient. A support member is inserted into a lumen of the lumen-defining device and advanced through at least a portion of the lumen of the lumen-defining device. At least a portion of the lumen-defining device is supported via the support member such that the support member limits complete occlusion of the lumen in response to a force exerted on the lumen-defining device. A volume of bodily fluid is withdrawn from the patient via the lumen-defining device when the support member is disposed in the lumen-defining device.

## Claims

### Claim 1

A method, comprising:
disposing a lumen-defining device within a portion of a vein of a patient;
inserting a support member into a lumen of the lumen-defining device, wherein the lumen-defining device is a catheter having an inner diameter and the support member is a filament having an outer diameter less than the inner diameter;
advancing the support member through at least a portion of the lumen of the lumen-defining device;
supporting, via the support member, at least the portion of the lumen-defining device such that the support member is configured to limit complete occlusion of the lumen in response to a force exerted on the lumen-defining device; and
withdrawing a volume of bodily fluid from the patient via the lumen-defining device when the support member is disposed in the lumen-defining device.

### Claim 2 (depends on 1)

The method of claim 1, wherein the lumen-defining device has a first stiffness and the support member has a second stiffness greater than the first stiffness.

### Claim 3 (depends on 1)

The method of claim 1, wherein the force exerted on the lumen-defining device is a force applied to an exterior surface of the lumen-defining device.

### Claim 4 (depends on 1)

The method of claim 1, wherein the force exerted on the lumen-defining device is a suction force within the lumen of the lumen-defining device.

### Claim 5 (depends on 1)

The method of claim 1, wherein the advancing of the support member includes advancing the support member to a distal position such that at least a distal end portion of the support member is disposed within the vein and distal to the lumen-defining device.

### Claim 6 (depends on 1)

The method of claim 1, wherein the advancing of the support member includes advancing the support member to a distal position such that at least a distal end portion of the support member is disposed within the vein and distal to the lumen-defining device, the method further comprising:
transitioning an anatomic valve within the vein from a substantially closed state to a substantially open state when support member is in the distal position.

### Claim 7 (depends on 1)

The method of claim 1, wherein the advancing of the support member includes advancing the support member to a distal position such that at least a distal end portion of the support member is disposed within the vein and distal to the lumen-defining device, the method further comprising:
transitioning at least the distal end portion of the support member from a first configuration to a second configuration when the support member is in the distal position; and
transitioning an anatomic valve within the vein from a substantially closed state to a substantially open state when the support member is in the distal position and in the second configuration.

### Claim 8

A method, comprising:
establishing fluid communication between a lumen-defining device and a fluid source;
coupling a support member to a hub of the lumen-defining device such that a portion of the support member is disposed in a lumen of the lumen-defining device, wherein the lumen-defining device is a catheter having an inner diameter and the support member is a filament having an outer diameter less than the inner diameter;
supporting, via the support member, at least a portion of the lumen-defining device such that the support member is configured to limit complete occlusion of the lumen in response to a force exerted on the lumen-defining device;
coupling a fluid transfer device to the hub of the lumen-defining device; and
withdrawing a volume of fluid from the fluid source into the fluid transfer device via the lumen-defining device when the support member is disposed in the lumen-defining device.

### Claim 9 (depends on 8)

The method of claim 8, wherein the lumen-defining device has a first stiffness and the support member has a second stiffness greater than the first stiffness.

### Claim 10 (depends on 8)

The method of claim 8, wherein the force exerted on the lumen-defining device is a force applied to an exterior surface of the lumen-defining device.

### Claim 11 (depends on 8)

The method of claim 8, wherein the force exerted on the lumen-defining device is a suction force within the lumen of the lumen-defining device operable to withdraw the volume of fluid from the fluid source into the fluid transfer device.

### Claim 12 (depends on 8)

The method of claim 8, wherein the fluid source is a vein of a patient, the lumen-defining device includes a catheter coupled to the hub, the establishing of fluid communication includes at least partially disposing the catheter in the vein.

### Claim 13 (depends on 8)

The method of claim 8, wherein the coupling of the support member to the hub of the lumen-defining device such that the portion of the support member is disposed in the lumen of the lumen-defining device includes dislodging debris from a portion of the lumen-defining device in response to the support member being disposed in the lumen.

### Claim 14

A method, comprising:
disposing a lumen-defining device within a portion of a vein;
inserting a support member into a lumen of the lumen-defining device;
advancing the support member through the lumen of the lumen-defining device to a distal position such that at least a portion of the support member is disposed within the vein and distal to the lumen-defining device;
transitioning the support member from a first configuration to a second configuration after the support member is placed in the distal position; and
transitioning an anatomic valve within the vein from a substantially closed state to a substantially open state when the support member is in the distal position and in the second configuration,
wherein a central axis extending through a distal end surface of the support member extends in a first direction when the support member is in the first configuration,
the transitioning of the support member from the first configuration to the second configuration is such that the central axis extends in a second direction different from the first direction when the support member is in the second configuration.

### Claim 15 (depends on 14)

The method of claim 14, wherein the lumen-defining device has a first stiffness and the support member has a second stiffness greater than the first stiffness.

### Claim 16 (depends on 14)

The method of claim 14, further comprising:
supporting, via the support member, at least a portion of the lumen-defining device such that the support member is configured to limit complete occlusion of the lumen in response to a force applied to an exterior surface of the lumen-defining device.

### Claim 17 (depends on 14)

The method of claim 14, further comprising:
supporting, via the support member, at least a portion of the lumen-defining device such that the support member is configured to limit complete occlusion of the lumen in response to a suction force within the lumen of the lumen-defining device.

### Claim 18 (depends on 14)

The method of claim 14, wherein the transitioning of the support member from the first configuration to the second configuration includes deforming at least a distal end portion of the support member.

### Claim 19 (depends on 14)

The method of claim 14, wherein a distal end portion of the support member defines a first area when the support member is the first configuration,
the transitioning of the support member from the first configuration to the second configuration is such that the distal end portion of the support member defines a second area greater than the first area when the support member is in the second configuration.
