The present disclosure relates to an integrated intravenous catheter with a needle free connector (NFC) configured for use with a blood draw device.
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., a needle free connector (NFC) of a near-patient access port by way of a lock positioned on a distal end portion of the introducer. The lock may include, e.g., a proboscis (or nose) and a clip comprising a pair of deflectable arms. However, in certain circumstances, the lock may be incorrectly or incompletely coupled to the NFC, potentially leading to misalignment of the nose within the NFC. Such misalignment of the nose within the NFC may result in bowing and/or kinking of the flexible flow tube as it is advanced through the NFC, as the internal structure of the NFC may include “catch points” which can be contacted by the flexible flow tube if misalignment of the lock occurs. The bowing and/or kinking of the flexible flow tube in this way 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.
Accordingly, there is a need to provide a needle free connector (NFC) configured to accommodate and correctly align the lock of a blood draw device thereon. Additionally, there is a need for a NFC having improved flushing characteristics.
In accordance with an aspect of the present disclosure, an integrated intravenous catheter is disclosed, the integrated intravenous catheter including a catheter adapter having a catheter and an inlet, the catheter configured to be inserted into a patient's vasculature, and a needle free connector having a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, wherein the needle free connector further includes a main cavity portion having a tapered sidewall and a distal taper portion, and wherein the tapered sidewall gradually narrows in a direction of the distal taper portion. The integrated intravenous catheter also includes intermediate tubing extending between the inlet of the catheter adapter and the first port of the needle free connector, and extension tubing extending from the side port of the needle free connector.
In some embodiments, the needle free connector includes a body defining a flow path extending between the first port and the second port.
In some embodiments, the side port is offset from a center of the flow path.
In some embodiments, the side port is not offset from a center of the flow path.
In some embodiments, the body of the needle free connector further includes a lip portion extending 360° around the needle free connector, and the lip portion is configured to provide a latching surface for engagement with clip portions of a lock of a blood draw device when coupled to the needle free connector.
In some embodiments, a gap is formed between the lip portion and the side port.
In some embodiments, a medical connector is positioned at an end of the extension tubing.
In some embodiments, the needle free connector includes a body defining a longitudinal axis extending between the first port and the second port, and the side port extends from the body at an angle of 15-165 degrees relative to the longitudinal axis of the body.
In some embodiments, the main cavity portion of the needle free connector includes an internal structure configured to redirect fluid when fluid enters the needle free connector via the side port.
In some embodiments, the side port includes a fluid flow path, and an internal surface of the side port at a distal portion of the fluid flow path includes a fluid directing ramp.
In some embodiments, the fluid directing ramp is positioned on a lower internal surface of the side port and is configured to divert flow upward relative to a central plane of the main cavity portion of the needle free connector.
In some embodiments, the fluid directing ramp is positioned on an upper internal surface of the side port and is configured to divert flow downward relative to a central plane of the main cavity portion of the needle free connector.
In some embodiments, the side port includes a fluid flow path, and wherein a distal portion of the fluid flow path of the side port includes a flow splitter.
According to another aspect of the present disclosure, a needle free connector is disclosed. The needle free connector may include a body, a first port positioned at a first end portion of the body, a second port positioned at a second end portion of the body opposite the first port, and a side port positioned between the first port and the second port. The body includes a main cavity portion positioned between the first port and the second port, the main cavity portion having a tapered sidewall and a distal taper portion, and the tapered sidewall gradually narrows in a direction of the distal taper portion.
In some embodiments, the body further includes a lip portion extending 360° around the needle free connector, and the lip portion is configured to provide a latching surface for engagement with clip portions of a lock of a blood draw device when coupled to the needle free connector.
In some embodiments, a gap is formed between the lip portion and the side port.
In some embodiments, the side port includes a fluid flow path, and an internal surface of the side port at a distal portion of the fluid flow path of the side port includes a fluid directing ramp.
In some embodiment, the fluid directing ramp is positioned on a lower internal surface of the side port and is configured to divert flow upward relative to a central plane of the main cavity portion of the needle free connector.
In some embodiment, the fluid directing ramp is positioned on an upper internal surface of the side port and is configured to divert flow downward relative to a central plane of the main cavity portion of the needle free connector.
In some embodiments, the side port includes a fluid flow path, and wherein a distal portion of the fluid flow path of the side port includes a flow splitter.
The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.
Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention.
Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.
The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
As used herein, “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.
Referring to
The intermediate tubing 18 extends between the inlet 22 of the catheter adapter 12 and the first port 24 of the needle free connector 16. The extension tubing 20 extends from the side port 28 of the needle-free connector 16. The intermediate tubing 18 is configured to provide flexibility when inserting and dressing the catheter 14 and also when manipulating the needle free connector 16 for flushing, blood draw, and/or other procedure without disturbing the catheter insertion site.
Referring still to
In some embodiments, at least a portion of the needle free connector 16 is transparent. The connector components of the integrated catheter 10 may be transparent, opaque, and/or colored. In one aspect or embodiment, the needle free connector 16 includes an anti-reflux valve.
In some embodiments, the medical component 36 at the end of the extension tubing 20 is a single port or dual port connector and may include a variety of connectors, including needle free connectors or needle access connectors, such as a PRN. The extension tubing 20 may be left or right facing. In some embodiments, in addition to a vent plug, the medical component 36 may be a removable or non-removable needle free connector or needle access connectors, such as a PRN, that is attached to a female luer connection provided on the extension tubing 20. In some embodiments, a dual female luer port may be bonded or otherwise attached to the extension tubing 20 instead of a single luer connector.
Next, referring to
Blood draw device 200 may include an introducer 210, a lock 240, a secondary catheter 265, and an actuator 270. The introducer includes a proximal end portion 211 and a distal end portion 212, with the lock 240 being located adjacent the distal end portion 212. The secondary catheter 265 includes the proximal end portion 266 which is coupled to and/or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidically couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, fluid source, syringe, evacuated container holder (e.g., having a sheathed needle or configured to be coupled to a sheathed needle), pump, and/or the like.
In accordance with some embodiments, a user may manipulate the blood draw device 200 to couple the lock 240 to, e.g., the catheter adapter 12 of integrated intravenous catheter 10. For example, in some embodiments, the user can exert a force sufficient to pivot the first and second clip arms of the lock 240 such that a portion of the catheter adapter 12 can be inserted into the space defined between the arms of the lock 240 and, for example, a nose 242 extending distally from the lock 240. In some embodiments, the nose 242 can be inserted into, e.g., the needle free connector 16 of the catheter adapter 12 when the lock 240 is coupled thereto, while the first and second clip arms of the lock 240 may latch onto an exterior surface (or surfaces) of the needle free connector 16 to hold the blood draw device 200 in place relative to the catheter adapter 12. The nose 242 is sufficiently long to dispose at least a portion of the nose 242 within the needle free connector 16, thereby providing a path for the flexible flow tube to pass from the blood draw device 200 through the catheter adapter 12 of the integrated catheter 10. In some embodiments, the needle free connector 16 is a split septum-type needle free connector.
Next, referring to
The body 62 of the needle free connector 16 defines a longitudinal axis L extending between the first port 24 and the second port 26, with the side port 28 extending from the body 62 at an angle A of e.g., 15°-165° relative to the longitudinal axis L of the body 62. In one embodiment, the side port 28 extends from the body 62 at an angle of 60° relative to the longitudinal axis L of the body 62. The side port 28 extends at the angle A toward the second port 26, although other suitable arrangements may be utilized. The body 62 of the needle free connector 16 includes a first portion 70 and a second portion 72 connected to the first portion 70. In some embodiments, the first portion 70 of the body 62 is fixedly secured to the second portion 72 of the body 62.
Referring to
Additionally, referring to
Next, referring to
In some embodiments, the side port 128 may be utilized to introduce a flushing fluid into the needle free connector 100. As shown in
Referring to
Referring to
Although described with respect to needle free connectors used with integrated intravenous catheters, it is to be understood that the concepts described herein may be applicable to any medical device fluid junction having fluid inlets or outlets with different central axes. The fluid junction may be an optimization of one or more of side fluid path entrance angle, central or planar offset, side port flow directing ramp(s), and/or optimized position of proximal flow diverting feature(s). For example, catheter adapters may include the concepts described herein, wherein a first port may be coupled to a catheter, a second port may include a non-luer accessible septum, and a side port is provided having a different central axes to the first port and the second port.
Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
The present application claims priority to U.S. Provisional Patent Application Ser. No. 63/284,118, entitled “Split Septum Needle Free Connector Alignment and Flushing Features” filed Nov. 30, 2021, the entire disclosure of which is hereby incorporated by reference in its' entirety.
Number | Date | Country | |
---|---|---|---|
63284118 | Nov 2021 | US |