# US 12,109,383 B2 · Stabilizing connector devices for vascular access and methods of using the same

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- Number: US 12,109,383 B2
- Document ID: US12109383B2
- Status: Granted
- Kind: B2
- Application number: 17/517,368
- Filed: 2021-11-02
- Published: 2022-02-24
- Granted: 2024-10-08
- Earliest claimed: 2017-11-30
- Assignees: Velano Vascular, Inc.
- Applicants: Velano Vascular, Inc.
- Inventors: Brian Funk; Pitamber Devgon; Albert G. Burdulis, Jr.; Joseph W. Jackson, Jr.; Andrew Mazzotta; Dylan J. Paproski; Eric Sugalski
- Web page: https://patentgrep.com/patent/US12109383B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 5/1418: {Clips, separators or the like for supporting tubes or leads}
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/1033: {Swivel nut connectors, e.g. threaded connectors or bayonet-connectors}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0261: {Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body}
- A61M 2039/027: {having a particular valve, seal or septum}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2039/0276: {for introducing or removing fluids into or out of the body}
- A61M 2039/0285: {with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port}
- A61M 2209/088: on the body
- 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 stabilizing connector includes a connector portion and a stabilization portion. The connector portion is configured to couple to an access device. The connector portion defines at least one lumen that is configured to be placed in fluid communication with a lumen of the access device. The stabilization portion is coupled to the connector portion. The stabilization portion is configured to be placed in contact with a surface of a patient's skin to stabilize at least one of the stabilizing connector or the access device.

## Claims

### Claim 1

An apparatus, comprising:
a connector portion comprising:
a distal coupler,
a proximal coupler,
a flexible region positioned between the distal coupler and the proximal coupler, and
a lumen extending through the distal coupler, the flexible region, and the proximal coupler, the distal coupler configured to be coupled to a hub of an access device inserted, at least in part, into a patient at a predetermined angle relative to an insertion site of the patient, the lumen of the connector portion being placed in fluid communication with a lumen defined by the access device when the distal coupler is coupled to the hub; and
a stabilization portion integrally formed with at least a part of the connector portion, the stabilization portion configured to be in contact with the patient when the distal coupler is coupled to the hub of the access device to stabilize at least one of the connector portion or the access device, the connector portion being disposed at about the predetermined angle when the stabilization portion is in contact with the patient such that a common axis extends through the lumen defined by the connector portion and at least a portion of the lumen defined by the access device.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the proximal coupler includes a fluid flow control device.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the predetermined angle is an insertion angle of at least a portion of the access device.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the lumen of the connector portion is a first lumen, the connector portion defines a second lumen in fluid communication with the first lumen, the second lumen is substantially perpendicular to the first lumen.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the lumen of the connector portion is a first lumen, the connector portion includes a port defining a second lumen in fluid communication with the first lumen, the port being disposed in a position along the connector portion that is adjacent to the proximal coupler.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the access device includes an intravenous catheter configured to be at least partially disposed within a vein of a patient.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the access device includes an intravenous catheter configured to be at least partially disposed within a vein of a patient,
the stabilization portion has a base surface that forms a recess, a portion of the base surface is configured to be in contact with the insertion site of the patient when the distal coupler is coupled to the hub of the access device such that the recess is aligned with the vein and spaced apart from the insertion site of the patient.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein aligning the recess with the vein and spacing the recess apart from the insertion site reduces an amount of force exerted on the vein.

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein at least a portion of the flexible portion surrounds the lumen.

### Claim 10

An apparatus, comprising:
a connector portion comprising:
a distal coupler,
a proximal coupler,
a flexible region positioned between the distal coupler and the proximal coupler, and
a lumen extending through the distal coupler, the flexible region, and the proximal coupler, the distal coupler configured to be coupled to a hub of an access device inserted, at least in part, into a patient at a predetermined angle relative to an insertion site of the patient, the lumen of the connector portion being placed in fluid communication with a lumen defined by the access device when the distal coupler is coupled to the hub; and
a stabilization portion integrally formed with at least a part of the connector portion, the stabilization portion having a base surface, a portion of the base surface configured to be in contact with the patient when the distal coupler is coupled to the hub of the access device such that (1) the stabilization portion stabilizes at least one of the connector portion or the access device and (2) a common axis extends through the lumen defined by the connector portion and at least a portion of the lumen defined by the access device, the base surface forming a recess configured to be aligned with the vein and spaced apart from the patient when the portion of the base surface is in contact with the patient.

### Claim 11 (depends on 10)

The apparatus of claim 10, wherein the base surface has a proximal edge and a distal edge, the recess extends between the proximal edge and the distal edge.

### Claim 12 (depends on 10)

The apparatus of claim 10, wherein a portion of the access device is inserted into the vein at a predetermined angle relative to an insertion site of the patient, the stabilization portion configured to place the connector portion at about the predetermined angle relative to the insertion site when the distal coupler is coupled to the hub of the access device and the portion of the base surface is in contact with the patient.

### Claim 13 (depends on 10)

The apparatus of claim 10, wherein the proximal coupler is configured to be coupled to a fluid transfer device.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein the proximal coupler includes a needle free connector (NFC) valve, the NFC valve configured to transition from a closed configuration to an open configuration in response to the fluid transfer device being coupled to the proximal coupler.

### Claim 15

An apparatus, comprising:
a connector portion comprising:
a distal coupler,
a proximal coupler,
a flexible region positioned between the distal coupler and the proximal coupler, and
a lumen extending through the distal coupler, the flexible region, and the proximal coupler, the distal coupler configured to be coupled to a hub of an access device inserted, at least in part, into a patient at a predetermined angle relative to an insertion site of the patient, the lumen of the connector portion being placed in fluid communication with a lumen defined by the access device when the distal coupler is coupled to the hub; and
a stabilization portion integrally formed with at least a part of the connector portion, the stabilization portion having a base surface, a portion of the base surface configured to be in contact with the patient when the distal coupler is coupled to the hub of the access device to stabilize at least one of the connector portion or the access device, the base surface forming a recess configured to be spaced apart from the patient when the portion of the base surface is in contact with the patient,
the connector portion being disposed at a predetermined angle when the distal coupler is coupled to the hub of the access device and the portion of the base surface is in contact with the patient such that a common axis extends through the lumen defined by the connector portion and at least a portion of the lumen defined by the access device.

### Claim 16 (depends on 15)

The apparatus of claim 15, wherein the access device is a peripheral intravenous catheter configured to be at least partially disposed in a vein of the patient.

### Claim 17 (depends on 16)

The apparatus of claim 16, wherein the recess is configured to be aligned with the vein and spaced apart from the patient when the portion of the base surface is in contact with the patient to reduce an amount of force otherwise exerted on the vein by the base surface.

### Claim 18 (depends on 15)

The apparatus of claim 15, wherein the lumen of the connector portion is a first lumen, the connector portion includes a port defining a second lumen in fluid communication with the first lumen,
the port is disposed between the base surface of the stabilization portion and the proximal coupler.

### Claim 19 (depends on 15)

The apparatus of claim 15, wherein the proximal coupler is configured to be coupled to a fluid transfer device.

### Claim 20 (depends on 19)

The apparatus of claim 19, wherein the proximal coupler includes a needle free connector (NFC) valve, the NFC valve configured to transition from a closed configuration to an open configuration in response to the fluid transfer device being coupled to the proximal coupler.
