# US 2026/0091202 A1 · Releasable safety catheter insertion assembly

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- Number: US 2026/0091202 A1
- Document ID: US20260091202A1
- Status: Published application
- Kind: A1
- Application number: 19/398,181
- Filed: 2025-11-24
- Published: 2026-04-02
- Earliest claimed: 2018-01-31
- Assignees: ICU Medical, Inc.
- Applicants: ICU Medical, Inc.
- Inventors: Gursel Akcay; Jay T. Breindel; Harsh D. Chheda; Kathryn Felicito; David J. Goral; Thomas T. Koehler; Christopher Roehl
- Web page: https://patentgrep.com/patent/US20260091202A1

## CPC

- A61M 25/0618: {having means for protecting only the distal tip of the needle, e.g. a needle guard}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- 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 safety catheter insertion assembly configured to inhibit access to the distal tip of a needle cannula prior to release of a catheter insertion assembly from a catheter hub. The safety catheter insertion assembly including a catheter assembly having an elastomeric blood control valve and a catheter insertion device having a safety clip, the safety clip movable between an expanded configuration in which a portion of the safety clip applies a compressive force to a portion of the elastomeric blood control valve, and a collapsed configuration in which the compressive force is reduced and release of the safety clip from the elastomeric blood control valve is enabled.

## Claims

### Claim 1

A safety clip for use with a catheter insertion assembly adapted to be configured in a ready position and a safe position, comprising:
a proximal wall having an opening through which a needle passes along a longitudinal axis;
a first guard arm extending distally from a top bend of the proximal wall along one longitudinal side of the needle, the first guard arm having a linear portion, a mid portion having a proximal end extending from a distal end of the linear portion downwardly towards the longitudinal axis from one side of the needle and a distal end connected to a proximal end of a distal wall that angles toward the longitudinal axis;
a second guard arm extending from a bottom bend of the proximal wall along other longitudinal side of the needle, the second guard arm having a linear portion, a mid section having a proximal end extending from a distal end of the linear portion upwardly towards the longitudinal axis from other side of the needle and a distal end connected to a proximal end of a distal wall that angles toward the longitudinal axis;
wherein the first guard arm and the second guard arm are non-intersecting; and
wherein the distal walls of the first and second guard arms each have a distal end, the respective distal ends of the distal walls biased away from each other by the needle passing therebetween when the safety clip is in the ready position.

### Claim 2 (depends on 1)

The safety clip of claim 1, wherein the mid portion of the first guard arm comprises a reduced width portion; and
wherein the mid portion of the second guard arm comprises a reduced width portion.

### Claim 3 (depends on 1)

The safety clip of claim 1, wherein the mid portion of the first guard arm comprises a downwardly curved portion; and
wherein the mid portion of the second guard arm comprises an upwardly curved portion.

### Claim 4 (depends on 3)

The safety clip of claim 3, wherein each of the downwardly and upwardly curved portions has a reduced width relative to the width of its corresponding linear portion such that each of the curved portions is adapted to at least partially conform to the outer diameter of the needle.

### Claim 5 (depends on 1)

The safety clip of claim 1, wherein the respective distal ends of the distal walls return to their respective unbiased state to enclose a distal tip of the needle when the distal tip is withdrawn to a position proximal the respective distal ends of the distal walls.

### Claim 6 (depends on 1)

The safety clip of claim 1, wherein the distal walls of the first and second guard arms each have a tab extending from a lateral side of the each distal wall configured to retain the needle in a safe position.

### Claim 7 (depends on 1)

The safety clip of claim 1, wherein the linear portion of the first guard arm and the linear portion of the second guard arm each are angled toward the longitudinal axis in a free or relaxed state.

### Claim 8 (depends on 3)

The safety clip of claim 3, wherein the linear portions are of different lengths such that one of the curved portions is closer to the proximal wall than the other of the curved portions.

### Claim 9 (depends on 3)

The safety clip of claim 3, wherein each curved portion of the first and second guard arms has a reduced width relative to the width of its corresponding linear portion such that the each curved portion is adapted to at least partially conform to the outer diameter of the needle.

### Claim 10 (depends on 3)

The safety clip of claim 3, wherein the downwardly curved portion has a proximal end and a distal end interconnecting the linear portion and the distal wall of the first guard arm; and
wherein the upwardly curved portion has a proximal end and a distal end interconnecting the linear portion and the distal wall of the second guard arm.

### Claim 11 (depends on 1)

The safety clip of claim 1, wherein the distal wall of the first guard arm comprises one hook at its distal end and the distal wall of the second guard arm comprises an other hook at its distal end; and
wherein the second guard arm is slightly shorter than the first guard arm such that the other hook is positioned proximal the one hook in the safe position.

### Claim 12 (depends on 1)

The safety clip of claim 1, wherein the safety clip is adapted to be positioned in a septum cavity defined by a cylindrical wall of a septum fitted inside a hub cavity of a catheter hub, the respective proximal end of the distal walls in frictional interfering contact with the wall of the septum to inhibit movement of the safety clip relative to the catheter hub when the needle passes between the distal walls in the ready position.

### Claim 13 (depends on 2)

The safety clip of claim 2, wherein the mid portion of the first guard arm comprises a tab portion forming a pair of tines separated by a notch to define guide surfaces for the needle.

### Claim 14 (depends on 13)

The safety clip of claim 13, wherein the tines each include a twist or partial rotation relative to the linear portion of the first guard arm; and
wherein the reduced width portion of the mid portion of the second guard arm comprises another pair of tines each include a twist or partial rotation relative to the lower linear portion.

### Claim 15 (depends on 1)

The safety clip of claim 1, wherein the first and second guard arms are integrally connected to the proximal wall such that the safety clip is a single integral clip.

### Claim 16

A safety clip for use with a catheter insertion assembly adapted to be configured in a ready position and a safe position, comprising:
a proximal wall having an opening through which a needle passes along a longitudinal axis;
a first guard arm extending distally from a top bend of the proximal wall along one longitudinal side of the needle, the first guard arm having a linear portion, a mid portion having two downwardly curved portions each having a proximal end extending from the distal end of the linear portion and a distal end connected to a proximal end of a distal wall that angles toward the longitudinal axis, a notch at the first guard arm separating the two downwardly curve portions extending from the distal end of the linear portion to the proximal end of the distal wall;
a second guard arm extending from a bottom bend of the proximal wall along other longitudinal side of the needle, the second guard arm having a linear portion, a mid section having two upwardly curved portions each having a proximal end extending from the distal end of the linear portion of the second guard arm, a notch at the second guard arm separating the two upwardly curved portions extending from the distal end of the linear portion to the proximal end of the distal wall that angles toward the longitudinal axis;
wherein the first guard arm and the second guard arm are non-intersecting; and
wherein the respective notches are configured to enable the needle to pass between the downwardly and upwardly curve portions.

### Claim 17 (depends on 16)

The safety clip of claim 16, wherein the distal walls of the first and second guard arms each have a distal end, the respective distal ends of the distal walls biased away from each other by the needle passing therebetween when the safety clip is in the ready position.

### Claim 18 (depends on 16)

The safety clip of claim 16, wherein the distal wall of each of the first and second guard arms comprises one or more tabs positioned on either lateral side of the distal wall.

### Claim 19 (depends on 16)

The safety clip of claim 16, wherein the distal wall of the first guard arm comprises one hook at its distal end and the distal wall of the second guard arm comprises an other hook at its distal end; and
wherein the second guard arm is slightly shorter than the first guard arm such that the other hook is positioned proximal the one hook when the safety clip is in a safe position.

### Claim 20 (depends on 16)

The safety clip of claim 16, wherein the first and second guard arms and the proximal wall are integrally connected to form a one piece integral safety clip.
