# US 11,439,794 B2 · Catheter insertion device with improved flashback response

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- Number: US 11,439,794 B2
- Document ID: US11439794B2
- Status: Granted
- Kind: B2
- Application number: 16/811,714
- Filed: 2020-03-06
- Published: 2020-09-10
- Granted: 2022-09-13
- Earliest claimed: 2019-03-07
- Assignees: Smiths Medical ASD, Inc.
- Applicants: Smiths Medical ASD, Inc.
- Inventors: Timothy Ebner; Kathryn Felicito; Harsh Chheda
- Web page: https://patentgrep.com/patent/US11439794B2

## CPC

- A61M 25/0693: {Flashback chambers}
- A61B 5/15003: {for venous or arterial blood}
- 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 25/0618: {having means for protecting only the distal tip of the needle, e.g. a needle guard}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- 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

In various embodiments, an improved catheter insertion device is described that provides an improved flashback response and use for deep vein access. In various embodiments, the improved flashback response comprises two separate and distinct flash events, the first indicating insertion of a cannula in a blood vessel, and a second indicating insertion of a catheter in the blood vessel. The two flash responses are made possible by a combination of features provided on the cannula, such as including a view window in the cannula and a flat relief portion on the outer surface of the cannula at the distal opening.

## Claims

### Claim 1

A catheter insertion device comprising:
a catheter hub comprising a catheter extending distally from the catheter hub to a distal end, the catheter having an outer surface and an inner surface defining a fluidic passageway therethrough, the catheter hub comprising an interior cavity and a septum contained therein;
a cannula axially movable through the septum and the catheter, the cannula having an outer surface, an inner surface defining a central bore therethrough, and a distal opening in the shape of a bevel having a length D4 and ending distally at a sharp distal tip; and
a fenestration radially disposed through a wall of the cannula into the central bore of the cannula, the fenestration having a proximal edge and a distal edge on the outer surface of the cannula defining an axial length of the fenestration,
wherein an annular space is present between the inner surface of the catheter and the outer surface of the cannula when the cannula is within the fluidic passageway of the catheter;
wherein the distal end of the catheter is tapered such that a circumferential seal is present between the inner surface of the catheter and the outer surface of the cannula at the distal end of the catheter when the distal opening of the cannula extends distally beyond the distal end of the catheter;
wherein the cannula further comprises a flat relief portion extending proximally on the cannula by a length D3 beginning from a position proximal to the distal opening of the cannula and configured to provide a fluidic pathway under said circumferential seal for blood to flow proximally into the annular space, and a circumferentially enlarged portion positioned between a proximal end of the flat relief portion and the distal edge of the fenestration providing a seal within the annular space around the circumferentially enlarged portion;
wherein a distance D1 between the sharp distal tip of the cannula and the proximal edge of the fenestration is greater than a length of the septum; and
wherein a distance D2 between the sharp distal tip of the cannula and the distal edge of the fenestration is less than a length of the septum.

### Claim 2 (depends on 1)

The catheter insertion device of claim 1, wherein D1 is less than or equal to 150% of the septum length, and D2 is greater than D4 such that the distance D1 remains less than or equal to 150% of the septum length.

### Claim 3 (depends on 1)

The catheter insertion device of claim 1, wherein the septum comprises a self-sealing septum.

### Claim 4

A catheter insertion device, comprising:
a catheter hub having an open end and a distal end, an interior cavity defined in the catheter hub between the open end and the distal end, a catheter having a distal end and a proximal end connected to the distal end of the catheter hub to establish a through passage between the distal end of the catheter and the interior cavity of the catheter hub;
a septum having a given length fitted to the interior cavity of the catheter hub distal the proximal end of the catheter hub;
a cannula having a shaft defining a lumen, the shaft including a distal tip, the cannula axially movable through the septum into the interior cavity of the catheter hub and the catheter such that the distal tip of the cannula extends beyond the distal end of the catheter in a ready position, a fenestration at a wall of the cannula proximal the distal tip providing an opening to the lumen, the fenestration having a distal edge and a proximal edge;
wherein the distance between the distal tip of the cannula and the proximal edge of the fenestration is greater than the length of the septum, and the distance between the distal tip of the cannula and the distal edge of the fenestration is not greater than the length of the septum such that, as the cannula is withdrawn through the septum, the fenestration is partially occluded by the septum when the distal tip of the cannula is withdrawn into and sealed by the septum.

### Claim 5 (depends on 4)

The catheter insertion device of claim 4, wherein the cannula comprises a bump out feature distal the fenestration.

### Claim 6 (depends on 4)

The catheter insertion device of claim 4, wherein the septum is a part of a closed system catheter whereby the septum is fitted in the interior cavity away from the distal end of the catheter hub to seal the open end of the catheter hub.

### Claim 7 (depends on 4)

The catheter insertion device of claim 4, further comprising a cannula hub whereto a proximal end of the cannula is attached, the cannula hub adapted to be associated with a proximal portion of the catheter hub.

### Claim 8 (depends on 4)

The catheter insertion device of claim 4, wherein the cannula further comprises a flat relief portion extending from the distal tip of the cannula to a distance distal of a bump out feature distal the fenestration.

### Claim 9 (depends on 4)

The catheter insertion device of claim 4, wherein the wall of the cannula is defined by an outer surface and an inner surface, the catheter having an inner surface defining a bore wherethrough the cannula is axially movable, an annular space defined between the inner surface of the catheter and the outer surface of the cannula adapted to be in fluid communication with the lumen of the cannula through the fenestration when at least a portion of the fenestration is distal of the septum.

### Claim 10 (depends on 9)

The catheter insertion device of claim 9, wherein the length of the septum and the respective distances between the distal tip of the cannula and the proximal and distal edges of the fenestration are such that blood from the lumen continues to flow out of the un-occluded portion of the fenestration into the annular space to improve blood flashback visibility as the fenestration is partially occluded by the septum while the cannula is withdrawn through the septum.

### Claim 11

A method of making a catheter insertion device, comprising the steps of:
providing a catheter hub having an open end and a distal end, and an interior cavity between the open end and the distal end;
connecting a proximal end of a catheter to the distal end of the catheter hub to establish a through passage between the distal end of the catheter and the interior cavity of the catheter hub, the catheter having a distal end;
fitting a septum having a given length to the interior cavity of the catheter hub distal the proximal end and spaced from the distal end of the catheter hub;
extending a cannula having a lumen and a distal tip through the septum into the interior cavity of the catheter hub and the catheter such that the distal tip of the cannula extends beyond the distal end of the catheter in a ready position, a fenestration having a distal edge and a proximal edge at a wall of the cannula proximal the distal tip providing an opening to the lumen;
effecting the distance between the distal tip of the cannula and the proximal edge of the fenestration to be greater than the length of the septum; and
effecting the distance between the distal tip of the cannula and the distal edge of the fenestration to be not greater than the length of the septum;
wherein when the cannula is withdrawn proximally from the catheter hub, the cannula is axially moved through the septum and the catheter such that the fenestration is partially occluded by the septum when the distal tip of the cannula is withdrawn into and sealed by the septum.

### Claim 12 (depends on 11)

The method of claim 11, wherein the wall of the cannula is defined by an outer surface and an inner surface, and wherein the catheter has an inner surface defining a bore wherethrough the cannula is axially movable, further comprising the step of:
effecting an annular space between the inner surface of the catheter and the outer surface of the cannula adapted to be in fluid communication with the lumen of the cannula through the fenestration when at least a portion of the fenestration is distal of the septum.

### Claim 13 (depends on 11)

The method of claim 11, further comprising the step of:
effecting a bump out feature on the cannula distal the fenestration.

### Claim 14 (depends on 11)

The method of claim 11, further comprising the step of:
fitting the septum in the interior cavity away from the distal end of the catheter hub to seal the open end of the catheter hub as a part of a closed system catheter.

### Claim 15 (depends on 11)

The method of claim 11, further comprising the step of:
providing a cannula hub whereto a proximal end of the cannula is attached, the cannula hub adapted to be associated with a proximal portion of the catheter hub.

### Claim 16 (depends on 11)

The method of claim 11, further comprising the step of:
effecting a flat relief portion on the cannula to extend from the distal tip of the cannula to a distance distal of a bump out feature distal the fenestration.