US-12623058-B2 - Integrated catheter with stabilized near-patient port extension set architecture

US12623058B2US 12623058 B2US12623058 B2US 12623058B2US-12623058-B2

Abstract

An integrated catheter includes a catheter adapter having a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature. The integrated catheter also includes a near-patient access port having a first port at a first end and a female luer connector at a second end, as well as intermediate tubing extending between the inlet of the catheter adapter and the first port of the near-patient access port. Additionally, the integrated catheter includes a stabilization platform configured to stabilize at least the near-patient access port on a patient's skin.

Inventors

Jonathan Karl Burkholz

Assignees

BECTON, DICKINSON AND COMPANY

Dates

Publication Date: 20260512
Application Date: 20221128

Claims (15)

1 . An integrated catheter comprising: a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature; a near-patient access port having a first port at a first end and a female luer connector at a second end; intermediate tubing extending between the inlet of the catheter adapter and the first port of the near-patient access port; a needle free connector removably couplable to the female luer connector of the near-patient access port; and a stabilization platform configured to stabilize at least the near-patient access port on a patient's skin, wherein the stabilization platform is coupled to or integrally formed with the needle free connector.
2 . The integrated catheter of claim 1 , wherein the near-patient access port further comprises a side port extending therefrom.
3 . The integrated catheter of claim 2 , wherein the side port extends 90° relative to an axis of the first port and the female luer connector of the near-patient access port.
4 . The integrated catheter of claim 2 , further comprising extension tubing extending from the side port of the near-patient access port.
5 . The integrated catheter of claim 4 , further comprising a medical component positioned at an end of the extension tubing.
6 . The integrated catheter of claim 1 , wherein the stabilization platform is coupled to the needle free connector.
7 . The integrated catheter of claim 1 , wherein the stabilization platform is integrally formed with the needle free connector.
8 . The integrated catheter of claim 1 , wherein the needle free connector comprises a t-extension set removably couplable to the female luer connector of the near-patient access port.
9 . The integrated catheter of claim 8 , wherein the t-extension set comprises a side port coupled to a second extension tube, wherein the second extension tube is coupled to a second medical component.
10 . The integrated catheter of claim 8 , wherein the stabilization platform is coupled to the t-extension set.
11 . The integrated catheter of claim 8 , wherein the stabilization platform is integrally formed with the t-extension set.
12 . The integrated catheter of claim 1 , wherein the stabilization platform comprises opposing first and second stabilizing wings.
13 . An integrated catheter comprising: a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature; a near-patient access port having a first port at a first end and a female luer connector at a second end; intermediate tubing extending between the inlet of the catheter adapter and the first port of the near-patient access port; and a stabilization platform configured to stabilize at least the near-patient access port on a patient's skin, wherein the stabilization platform is positioned on the near-patient access port, with the stabilization platform formed separate from and connected to the near-patient access port or formed integrally with the near-patient access port.
14 . An integrated catheter comprising: a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature; a near-patient access port having a first port at a first end and a female luer connector at a second end; intermediate tubing extending between the inlet of the catheter adapter and the first port of the near-patient access port; a needle free connector coupled to the female luer connector of the near-patient access port, wherein the needle free connector is removably couplable to the female luer connector; and a stabilization platform configured to stabilize at least the needle free connector on a patient's skin, wherein the stabilization platform is positioned on the needle free connector.
15 . The integrated catheter of claim 14 , wherein the needle free connector and the stabilization platform are removable from the female luer connector of the near-patient access port.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application claims priority to U.S. Provisional Patent Application Ser. No. 63/284,129, entitled “Integrated Catheter with Stabilized Near-Patient Port Extension Set Architecture”, filed Nov. 30, 2021, the entire disclosure of which is hereby incorporated by reference in its' entirety. BACKGROUND OF THE INVENTION Field of the Invention The present disclosure relates to an integrated catheter having a stabilized near-patient access port extension set architecture configured for use with a blood draw device. Description of Related Art Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient. A common type of catheter is an over-the-needle peripheral intravenous (“IV”) catheter (“PIVC”). The over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from a skin surface of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into the vasculature of the patient. In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion. Blood withdrawal using a peripheral IV catheter may be difficult for several reasons, particularly when an indwelling time of the catheter is more than one day. For example, when the catheter is left inserted in the patient for a prolonged period of time, the catheter or vein may be more susceptible to narrowing, collapse, kinking, blockage by debris (e.g., fibrin or platelet clots), and adhering of a tip of the catheter to the vasculature. Due to this, catheters may often be used for acquiring a blood sample at a time of catheter placement but are much less frequently used for acquiring a blood sample during the catheter dwell period. Accordingly, blood draw devices have been developed to collect blood samples through an existing PIVC. Blood draw devices attach to the PIVC and include a flexible flow tube that is advanced through the PIVC, beyond the catheter tip, and into a vessel to collect a blood sample. After blood collection, the blood draw device is removed from the PIVC and discarded. One example of such a blood draw device, known as PIVO™ from Velano Vascular, Inc., is shown and described in U.S. Pat. No. 11,090,461, which is hereby incorporated by reference in its entirety. As described in U.S. Pat. No. 11,090,461, the blood draw device includes an introducer having an actuator slidably coupled thereto, with the actuator being configured to selectively advance the flexible flow tube through the PIVC. The introducer is couplable to, e.g., an integrated needle free connector (NFC) of a near-patient access port by way of a lock positioned on a distal end portion of the introducer. However, in certain circumstances, undesirable movement and/or angulation of the near-patient access port or associated tubing may adversely affect the smooth advancement (or retraction) of the flexible flow tube and/or the collection of blood through the flexible flow tube of the blood draw device. Furthermore, the use of an integrated (i.e., non-removable) needle free connector may complicate the flushing of the near-patient access port after a blood draw procedure. SUMMARY OF THE INVENTION Accordingly, there is a need to provide an integrated catheter coupled to a stabilized near-patient access port for improved blood draw via, e.g., a PIVO™ blood draw device. Additionally, there is a need for a system utilizing a removable NFC for improved flushing characteristics of the near-patent access port. In accordance with an aspect of the present disclosure, an integrated catheter is disclosed. The integrated catheter includes a catheter adapter having a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature, and a near-patient access port having a first port at a first end and a female luer connector at a second end. The integrated catheter also includes intermediate tubing extending between the inlet of the catheter adapter and the first port of the near-patient access port, and a stabilization platform configured to stabilize at least the near-patient access port on a patient's skin. In some embodiments, the near-patient access port further includes a side port e