Patent Application
20230381458
The present invention relates generally to a device for use in medical procedures to stabilize and support, and facilitate arterial catherization of, an umbilical cord, as may be needed for neonatological purposes and/or procedures.
In humans (and animals), the umbilical cord interconnects the fetus' circulatory system with the placenta, and acts to deliver nutrients such as oxygen, glucose and protein via the umbilical cord. Shortly after birth, the umbilical cord is typically clamped and cut, ultimately leaving the baby with an umbilical stump.
It is sometimes desirable to catheterize an artery of the umbilical cord for treatment of the baby. By way of example, umbilical arterial catherization may be used to allow for easier sampling of the baby's blood, for continuous blood pressure monitoring, for administration of medications and/or fluids, and/or for monitoring of arterial gas pressure. It has been estimated that about two percent of the babies born in the United States require an umbilical arterial catherization.
Performing the arterial catheterization can be challenging for several reasons. First, the umbilical cord itself is relatively flaccid and difficult to stabilize. Often, one hand of the physician is devoted to stabilizing the umbilical cord, leaving only one had to perform the catherization, which is difficult. Second, the arterial lumen is quite small, often approximately 1 mm or less in diameter or crosswise dimension. Accordingly, even when using both hands, with assistance of another person to stabilize the umbilical cord, it is difficult to properly identify the arterial lumen and to properly place the catheter in the arterial lumen. Thus, attempts at catherization are difficult and often time-consuming. It has been estimated that approximately 11% to 38% of umbilical arterial catheterization attempts are unsuccessful. If the attempt is unsuccessful, one or more subsequent attempts are required, which is further time-consuming. Delays in successful catherization can result in and/or contribute to increased utilization of high-skilled staff, increased time consumption in an acute unit, a lack of central access to better monitor acutely ill infants, increased risk for arterial perforation with increased attempts, and overall decreased survival rates with failed catheterizations, all of which are undesirable.
What is needed is a device that facilitates umbilical arterial catherization, to increase the catheterization success rate and save time, allowing doctors and facilities to meet the needs of more patients, and increase infant survival rates.
The present invention provides an umbilical arterial catherization device that facilitates umbilical arterial catherization, to increase the catheterization success rate and save time, allowing doctors and facilities to meet the needs of more patients, and increase infant survival rates. The device comprises a brace having a body adapted to support and stabilize the cut end of an umbilical cord. The device further comprises a dilator having a hook having a tip dimensioned for receipt within a lumen of an artery of the umbilical cord, and a catch joined to said hook and operable to fix said dilator in a desired position relative to said brace to maintain the artery in a dilated position. Optionally, the device may further include a lighting element operable to provide illumination to a free end of an umbilical cord, when supported in the device, to aid in the visualization of the arterial lumen and thus facilitate proper placement of the catch within the arterial lumen.
An understanding of the following description will be facilitated by reference to the attached drawings, in which:
The present invention relates to an umbilical arterial catheterization device that facilitates umbilical arterial catherization, to increase the catheterization success rate and increase the efficiency of utilization of neonatological medical staff and medical facilities. By way of non-limiting illustrative example, an exemplary umbilical arterial catheterization device in accordance with the present invention is discussed below with reference to the exemplary embodiment shown in
The umbilical arterial catherization device 100 has two principal components, which in this exemplary illustrative embodiment, namely, a brace 40 and a dilator 80. In this exemplary embodiment, these components are formed as two discrete components. However, in other embodiments, these components may be incorporated into a greater or lesser number of components.
Referring now to
The fastener 44 is structured to allow for securing/fixing the body 42 in the desired position relative to the umbilical cord. In this embodiment, the fastener 44 is provided as a longitudinally elongated strap 48, which may be fixed to, releasably mountable to, or separate from, the body 42. In certain embodiments, the fastener 44 includes one or more fields of hook-type and/or loop-type fasteners of a hook-and-loop fastener system. In a preferred embodiment, the fastener 44 is provided as a strap having a first continuous field of hook-type (or loop-type) fasteners on one side (e.g., to mate with complementary loop-type (or hook-type) fasteners on the body 42), and having a second continuous field of complementary loop-type (or hook-type) fasteners on its opposite side. In this manner, the fastener 44 may be fixed to the body 42, and the body 42 and fastener 44 may be collectively wrapped around the umbilical cord and the fastener 44 may be secured to itself in a range of longitudinal positions (to accommodate umbilical cords of different sizes) to secure/fix the body 42/brace 40 in the desired position relative to the umbilical cord. Additionally, this configuration leaves a field of hook-and-loop type fasteners exposed on an outer surface of the fastener 44, which is advantageous for reasons discussed below. It will be appreciated by those skilled in the art that the fastener may have any suitable structure.
Preferably, the umbilical cord is pulled taut and the brace 40 is fastened to the cord in abutting relationship to the baby's abdomen, so that the body 42 provides an upwardly-acting friction force that serves to support and stabilize the umbilical cord.
The catch 94, when attached to the hook 84 as shown in
The catch 94 further includes a fastener for securing the catch 94 to the brace 40 after the arterial lumen has been dilated, so that the arterial lumen may be maintained in the dilated configuration by the umbilical arterial catheterization device 100.
In this exemplary embodiment, the catch 94 includes a field of hook-type (or loop type) fastener 96 of a hook-and-loop fastener system, preferably of a type complementary to the fastener 46 exposed on the outer surface of the fastener 44 of the brace 40.
In use, the umbilical arterial catheterization device 100 can be positioned with the body 42 of the brace 40 wrapped tightly around an umbilical cord X, such that the body 42 engages and embraces the umbilical cord, as shown in
Next, the physician/user may visualize an artery of the umbilical cord X. This may be challenging, since the artery may have a small lumen (e.g., approx. 1 mm or less in diameter or crosswise dimension) in a relaxed state, and further the artery may present in a closed state, with a diameter or crosswise dimension of approximately 0 mm), since the artery is surrounded by smooth muscle tissue that may contract when the cord is cut.
The physician/user may then manually grasp the catch 94, and manipulate the catch 94 to cause the point/tip 86 of the hook 84 to enter the arterial lumen and engage umbilical cord tissue. The physician/user may then pull the catch 94 laterally, to apply traction in a direction transverse to a direction of elongation of the artery, to stretch/open/dilate the open end of the artery. The physician/user may then press the catch 94 against the outer surface of the brace 40 to cause the catch's fastener 96 to engage the brace 40, e.g., to cause loop type fastener 96 on the catch 94 of the dilator 80 to engage hook-type fastener 46 on an outer surface of the fastener 44 of the brace 40. This fastens the dilator 80 to the brace 40, such that the physician/user may release his/her grasp of the catch 94, and have the umbilical arterial catheterization device 100 maintain the arterial lumen in the stretched/opened/dilated state, thereby freeing both of the physician/user's hands for other tasks. By way of example, the arterial lumen may be dilated to have a diameter/crosswise dimension of approximately 3.5 mm, in view of typical suitable catheters having diameters ranging in size from approx. 1.2 to approx. 1.7 mm in outer diameter.
The physician/user may then use both hands to advance a catheter Z into the dilated end of the umbilical artery.
After suitable placement of the catheter Z, the catch 94/dilator 80 may be decoupled from the brace 40, and the fastener 44 of the brace may be decoupled to permit removal of the brace 40 from engagement with the umbilical cord.
Referring now to
The lighting element may have any suitable configuration. In one embodiment, the lighting element may comprise one or more light sources, such as LEDs. The light sources may be operatively connected, e.g., via a wire, to a power source that may be remotely located from the device. By way of alternative example, on another embodiment, the lighting element may comprise a light pipe for transmitting light emitted from a light source. In this embodiment, the light pipe/lighting source is operatively connected to an LED or other suitable light source, which may be located remotely from the device.
In this exemplary embodiment, the body 42 of the brace 40 is provided with a recess 50 open to a surface 43 of the body 42/inner surface of the brace 40 when in an operative position. The recess 50 is sized and shaped to receive the desired lighting element. In the exemplary embodiment shown, the recess 50 is provided as a longitudinally-extending channel 52 for receiving a longitudinally-extending lighting element 60, such as a light pipe operatively connected to an LED or other suitable light source.
As will be appreciated from
While there have been described herein the principles of the invention, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation to the scope of the invention. Accordingly, it is intended by the appended claims, to cover all modifications of the invention which fall within the true spirit and scope of the invention.
This application claims the benefit of priority, under 35 USC 119(e), of U.S. Provisional Patent Application No. 63/114,176, filed Nov. 16, 2020, the entire disclosure of which is hereby incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/059364 | 11/15/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63114176 | Nov 2020 | US |
