# US 10,478,609 B2 · Blood control catheter valve employing actuator with flexible retention arms

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- Number: US 10,478,609 B2
- Document ID: US10478609B2
- Status: Granted
- Kind: B2
- Application number: 15/413,211
- Filed: 2017-01-23
- Published: 2017-05-11
- Granted: 2019-11-19
- Earliest claimed: 2013-07-30
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Weston F. Harding; S. Ray Isaacson
- Web page: https://patentgrep.com/patent/US10478609B2

## CPC

- A61M 39/221: {Frangible or pierceable closures within tubing (A61M39/14 takes precedence; frangible closures for containers A61J1/14)}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 39/0606: {without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)}
- A61M 39/0693: {including means for seal penetration}
- A61M 39/10: Tube connectors or tube couplings
- A61M 2039/062: {used with a catheter}
- A61M 2039/0653: {Perforated disc}
- A61M 2039/1072: {with a septum present in the connector}
- A61M 2039/1077: {Adapters, e.g. couplings adapting a connector to one or several other connectors}
- 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

The present invention extends to a blood control catheter valve for use in a catheter adapter. The blood control catheter value employs an actuator for bypassing a septum to open the blood control catheter valve. The actuator includes flexible retention arms positioned on one end which retract into the body of the actuator while the end of the actuator passes through the septum, and then expand outwardly to maintain the actuator positioned within the septum. This design facilitates the manufacturing of catheter adapters (as well as blood control catheter valves and other components that attach to the catheter adapter) because the design can reduce the tolerance requirements of such components. Further, the design provides a reliable blood control catheter valve that does not require the catheter adapter to be increased in size to accommodate the valve.

## Claims

### Claim 1

A catheter assembly comprising:
a catheter adapter;
a septum configured to be retained within the catheter adapter; and
an actuator configured to pass partially through the septum to open the septum, wherein the actuator comprises a plurality of proximally-facing flexible retention arms that are biased in an outward position, the actuator further comprising a plurality of channels disposed in an outer surface of the actuator, wherein the flexible retention arms fold inwardly into the plurality of channels and are flush with the outer surface as the actuator moves distally through the septum and return to the outward position after the flexible retention arms have moved distally through the septum thereby retaining the actuator within the septum.

### Claim 2 (depends on 1)

The catheter assembly of claim 1, wherein, prior to the actuator passing partially through the septum, the flexible retention arms are biased outwardly into one or more recesses formed in an internal wall of the catheter adapter thereby retaining the actuator within the catheter adapter.

### Claim 3 (depends on 1)

The catheter assembly of claim 1, wherein the actuator is configured to pass partially through the septum to open the septum when a separate device is inserted distally into the catheter adapter, wherein the separate device has a male luer connector that inserts into the catheter adapter to contact and force the actuator partially through the septum as the separate device is connected to the catheter adapter.

### Claim 4 (depends on 1)

The catheter assembly of claim 1, wherein the actuator has a length that is less than a first length of the catheter adapter, the first length being the length between a proximal end of the catheter adapter and the position of the septum within the catheter adapter.

### Claim 5 (depends on 1)

The catheter assembly of claim 1, wherein the flexible retention arms comprise two flexible retention arms formed on opposite sides of the actuator.

### Claim 6 (depends on 1)

The catheter assembly of claim 1, wherein the catheter adapter is an intravenous catheter adapter.

### Claim 7

An intravenous catheter assembly comprising:
a catheter adapter;
a septum contained within the catheter adapter; and
an actuator configured to pass partially through the septum to open the septum, wherein the actuator comprises a plurality of channels formed in an exterior surface of the actuator, wherein the actuator further comprises a plurality of flexible retention arms biased in an outward position, wherein the plurality of channels are configured to receive the flexible retention arms when the flexible retention arms are folded inwardly.

### Claim 8 (depends on 7)

The catheter assembly of claim 7, wherein the actuator further comprises an internal channel that extends through a length of the actuator, the internal channel forming a path for fluid flow through the actuator.

### Claim 9 (depends on 8)

The catheter assembly of claim 8, further comprising:
a needle contained within the catheter adapter, the needle passing through the internal channel of the actuator and through the septum.

### Claim 10 (depends on 7)

The catheter assembly of claim 7, further comprising:
a needle shield attached to the catheter adapter, the needle shield configured to retain a needle after the needle is retracted from the catheter adapter.

### Claim 11 (depends on 7)

The catheter assembly of claim 7, wherein the septum is configured to reseal after a needle is retracted from the catheter adapter thereby preventing fluid flow through the catheter adapter until the actuator passes partially through the septum.

### Claim 12 (depends on 7)

The catheter assembly of claim 7, wherein, prior to the actuator passing partially through the septum, the flexible retention arms are biased outwardly into one or more recesses formed in an internal wall of the catheter adapter thereby retaining the actuator within the catheter adapter.

### Claim 13 (depends on 7)

The catheter assembly of claim 7, wherein a separate device has a male luer connector that inserts into the catheter adapter to contact and force the actuator partially through the septum as the separate device is connected to the catheter adapter.

### Claim 14

A catheter assembly comprising:
a catheter adapter;
a septum configured to be retained within the catheter adapter; and
an actuator positioned entirely within the catheter adapter and configured to pass partially through the septum to open the septum, the actuator comprising a proximally-facing flexible retention arm biased in an outward position and foldable inwardly, wherein the actuator comprises an internal channel that extends through a length of the actuator, the internal channel forming a path for fluid flow through the actuator, wherein in response to the actuator passing partially through the septum such that the proximally-facing flexible retention arm is disposed on a distal side of the septum and a proximal end of the actuator is disposed on a proximal side of the septum, the actuator is retained within the septum by the flexible retention arm disposed in the outward position.

### Claim 15 (depends on 14)

The catheter assembly of claim 14, wherein a proximal end of the actuator comprises multiple protrusions extending radially from a body of the actuator, wherein the actuator passes partially through the septum in response to another component contacting the multiple protrusions.

### Claim 16 (depends on 14)

The catheter assembly of claim 14, wherein the actuator further comprises multiple flexible retention arms, wherein in response to the actuator passing partially through the septum, the actuator is retained within the septum by the flexible retention arms.
