Patent Application
20180207398
Disclosed herein is a closed system for umbilical vein catheterization and infusion.
In the situation of a pre-term, premature, or new born human baby, it can be difficult to obtain reliable vascular access and it can be particularly difficult to obtain central venous access. A newborn's umbilical vein is often used to gain vascular access using an umbilical vein catheter as the umbilical vein has a relatively convenient size for insertion of such a catheter.
However, conventional umbilical vein catheters are open ended and are therefore susceptible to infection. That is, such conventional umbilical vein catheters have proximal hubs that communicate with an internal lumen of the catheter and that are open to the environment. Consequently, the opens hubs make the catheters prone to intraluminal infection, air embolism, and bleeding due to accidental disconnect with the catheter.
In view of the foregoing, there is a need for improved systems that provide access to an umbilical vein of a pre-term, premature, or new born human baby.
The disclosed system is a closed system umbilical vein catheter with a relatively low profile and relatively small footprint that facilitate insertion of the catheter into an umbilical vein. The umbilical vein catheter includes a proximal access port that is closed with a septum. The septum provides a sealed, closed system to reduce the risk of air embolism and intraluminal infection via the catheter. Unlike a regular implantable port, the port in the disclosed system remains outside the patient's body for ease of access after the catheter has been coupled to the umbilical vein. Further, the port of the system is pre-connected instead of requiring attachment during the procedure.
Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the disclosure.
Disclosed are methods, systems, and devices for accessing an umbilical vein of a human. The umbilical vein catheter includes a proximal access port that is closed with a septum. The septum provides a closed system to reduce the risk of air embolism and intraluminal infection via the catheter.
With reference still to
The cap 210 and base 205 couple to the septum 215 such that the septum 215 is captured between the cap 210 and the base 205. The reservoir is an internal cavity inside the housing formed by the cap 210 and the base 205. The cap 210 may include an opening through which a portion of the septum 215 extends and the base 205 may include a recess in which at least a portion of the septum 215 is seated. The septum is configured to be pierced by a cannula such that fluid may be injected into the reservoir via the cannula. In this manner, fluid can be injected into the blood vessel to which the catheter 110 is attached via the access port.
The dimensions of the system may vary. In a non-limiting example, the catheter 110 is less than 5 French in outer diameter and is made of polyurethane. The port may have dimensions of about 23 mm length×17.8 width mm×10 mm height. In another embodiment, the port has dimensions of about 24 mm length×20.5 width mm×10.3 mm height. It should be appreciated that these dimensions are examples and that the dimensions of the system may vary.
There is now described a non-limiting, example process of inserting the catheter 110 into an umbilical vein of an infant. In an initial step, a clinician places a suture on the base of an umbilical cord and ties the umbilical cord to prevent excess bleeding upon cutting of the umbilical cord. The clinician then cuts the umbilical cord and inspects the anatomy to identify the blood vessels in the cut umbilical cord.
The clinician then stabilizes and exposes the vessels. Using a fine dilator, the clinician then eases the vessel open and cannulates the vessel toward the lower body. In an embodiment, the use of the catheter is optional and the clinician can insert the catheter directly into the open vein. The clinician then applies gentle, steady pressure to insert the catheter 110 into the blood vessel. The clinician can then aspirate to ensure a “flashback” arterial blood from the UAC. The umbilical venous catheter 110 is inserted into the umbilical vein such that a desired length of a distal region of the catheter is inside the umbilical vein. In this state, the catheter 110 provides access to the vein via the port 115 and the internal lumen of the catheter 110. The catheter 110 can be sutured separately and fixed in place.
The clinician can aspirate, infuse or inject material from or into the catheter using the access port 115. In this regard, the clinician can insert a cannula through the septum of the access port such that the cannula communicates with the reservoir of the access port 115. The clinician can then use the cannula to aspirate or infuse fluid from or into the catheter via the access port 115.
As mentioned, the port 115 remains outside the infant's body (and/or outside the mother's body) after the catheter 110 has been coupled to the umbilical vein. Because the port 115 is sealed, there is a reduced likelihood of infectious material being introduced into the umbilical vein via the catheter. The catheter 110 may remain coupled to the umbilical vein for a period of time, such as for about ten days. The duration for which the catheter remains coupled to the umbilical vein can be as needed and can also be dictated by the clinician.
While this specification contains many specifics, these should not be construed as limitations on the scope of an invention that is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results.
Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.
