US-12623060-B2 - Catheter insertion device with improved flashback response

US12623060B2US 12623060 B2US12623060 B2US 12623060B2US-12623060-B2

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.

Inventors

Timothy Ebner
Kathryn Felicito
Harsh Chheda

Assignees

ICU MEDICAL, INC.

Dates

Publication Date: 20260512
Application Date: 20220505

Claims (8)

1 . A catheter insertion device, comprising: a catheter hub including an open proximal end and a distal end having connected thereto a catheter having a distal open end, a through passageway defined by the catheter extends to an interior cavity defined in the catheter hub, the catheter having a circumferential inner wall; a septum having a given length having a distal end and a proximal end fitted to the interior cavity of the catheter hub between the distal and proximal ends of the catheter hub; a cannula having a beveled distal tip and a circumferential wall defining a lumen an opening at the 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 open end of the catheter in a ready position, a fenestration at the circumferential wall of the cannula proximal the distal tip providing an aperture between the lumen and the inner circumferential wall of the catheter, the fenestration having a distal edge and a proximal edge, a distance between the distal tip of the cannula and the proximal edge of the fenestration being greater than the given length of the septum and an other distance between the distal tip of the cannula and the distal edge of the fenestration being greater than a length of the beveled distal tip and less than the given length of the septum; a flat relief portion at the cannula extending proximally from the beveled distal tip to a distance distal of the fenestration; wherein when the cannula is inserted into a patient and the distal tip of the cannula enters into a vein of the patient, blood flows into the lumen and through the aperture into an annular space defined between the circumferential wall of the cannula and the inner circumferential wall of the catheter to provide a first flashback response, and wherein when the catheter enters the vein, blood flows into a space between the inner diameter of the catheter and the outer diameter of the flat relief portion to provide a second flashback response.
2 . The catheter insertion device of claim 1 , wherein the fenestration is partially occluded by the septum when the opening at the distal tip of the cannula is moved to within the septum.
3 . The catheter insertion device of claim 1 , wherein the proximal edge of the fenestration is proximal the proximal end of the septum and the distal end of the fenestration is inside the septum when the opening at the distal tip of the cannula is within the septum.
4 . The catheter insertion device of claim 1 , wherein the distance between the distal tip of the cannula and the proximal edge of the fenestration is less than or equal to 150% of the given length of the septum.
5 . The catheter insertion device of claim 1 , wherein the distance between the proximal edge of the fenestration and the distal tip is about 10 mm to about 50 mm.
6 . The catheter insertion device of claim 1 , wherein the cannula comprises a bump out between the distal tip and the fenestration of the cannula.
7 . The catheter insertion device of claim 6 , wherein the bump out provides an enlarged transition between the fenestration and the distal tip of the cannula such that blood in the annular space between the circumferential wall of the cannula and the inner circumferential wall of the catheter is blocked from moving distally past the enlarged transition.
8 . The catheter insertion device of claim 1 , wherein when the cannula is moved proximally relative to the septum such that the distal tip of the cannula is proximal the distal end of the septum, a portion of the fenestration distal its proximal edge is proximal from the proximal end of the septum and another portion of the fenestration proximal its distal edge remains within the septum.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/811,714 filed Mar. 6, 2020, now U.S. Pat. No. 11,439,794B2 issued Sep. 13, 2022, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 62/815,066 filed Mar. 7, 2019 and entitled “Catheter Insertion Device with Improved Flashback Response.” The respective disclosures of the '714 application and the '066 provisional application are incorporated herein by reference in its entirety for all purposes. FIELD OF INVENTION The present disclosure generally relates to intravenous (IV) catheters and more particularly to catheter insertion devices that provide an improved blood flashback response during deep vein access. BACKGROUND OF INVENTION Clinical evidence regarding peripheral intravenous catheters has shown the adoption of closed system catheters (with an integrated extension set) may reduce complications, extend catheter indwell, and reduce the cost of care. As clinicians adopt closed system catheters it's desirable that new devices include features and functions that are known to be useful in connection with successful peripheral IV catheter (PIVC) insertion. One such feature is early indication of vascular entry. While PIVCs can include a flash chamber, it takes time for blood to flow through the length of the cannula and into the flash chamber. For this reason, PIVCs today may include a more distally oriented flashback feature that provides earlier indication of entry within the catheter tube. A common method to provide this functionality is to create a window, or fenestration, through the wall of the cannula to visualize blood before it becomes visible in the flash chamber. Intuitively, the distance between the cannula fenestration and the distal opening of the cannula is minimized to provide the fastest flashback response. Additionally, the cannula fenestration may be positioned in proximity to the distal opening of the cannula to reduce the likelihood of blood leakage, especially when the cannula is withdrawn from the catheter through a blood control seal or self-sealing septum. However, distal placement of a cannula fenestration creates a challenge when clinicians place an IV into a deep vein, or in an obese patient, as it can be difficult to see the flash in the cannula fenestration when the catheter is inserted deep under the skin. Therefore, there continues to be an ongoing need for new catheter devices that balance the speed of the flashback response, the risk of blood leakage, and the proximal visibility of the flashback response for deep vein access. SUMMARY OF INVENTION In various embodiments of the present disclosure, a catheter insertion device comprises a cannula having distally oriented features that operate in combination to provide two consecutive and visible flashback responses, separate from the flash visible in the flash chamber. The first flashback response upon entry of the cannula bevel into a blood vessel and the second flashback response upon entry of the catheter into the blood vessel. These features may be applied to a device with or without an additional flash chamber The catheter insertion device is usable with both closed system catheters and open system catheters having a blood control seal. In various embodiments, a catheter insertion device comprises: 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 ending distally at a sharp distal tip; and a view window in the cannula, the view window comprising a fenestration in the cannula through to the central bore and a transparent seal member fit over the fenestration, 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. In various embodiments, the transparent seal member is selected from a transparent film, transparent insert, transparent sleeve or transparent cover. In various embodiments, the cannula further comprises a narrower diameter portion surrounding the fenestration such that the transparent seal member fit therein provides a viewing capsule capable of filling with fluid present in the cannula. In various embodiments, the transparent seal member comprises a glass or plastic sleeve having substantially similar dimensions to the narrower diameter portion, and wherein the outer diameter of the cannu