Stabilization device for intravascular catheters

A stabilization device for intravascular catheters comprises a sheet of fiber reinforced material defined by first and second spaced sheet members. The first and second sheet members each have a predetermined size and shape and the same or different thickness dimension. A pair of fiber reinforced side bolsters bridge the first and second sheet members and provide a connection therebetween. The side bolsters have a thickness dimension that is greater than the thickness dimension of both the first and second sheet members to provide lateral support for an intravascular catheter. The sheet members and the side bolsters cooperate to define a framing window to facilitate unobstructed observation of the percutaneous insertion site of the intravascular catheter.

BACKGROUND--FIELD OF INVENTION 
This invention relates to medical products, specifically stabilization of 
intravascular catheters. 
BACKGROUND--DISCUSSION OF PRIOR ART 
Most of the time, intravascular catheters are inserted into flexible body 
areas (e.g. wrist, neck, groin and elbow). These catheters are usually 
covered with unsterile tape and on top of the tape is placed a sterile 
clear plastic bandage. The purpose of the sterile clear plastic bandage is 
to prevent contamination of the catheter site. However, when the unsterile 
tape is placed between the catheter and sterile plastic bandage, the 
catheter entry site is already contaminated, thus defeating the purpose of 
the sterile plastic bandage. 
Furthermore, neither the unsterile tape or the sterile clear plastic 
bandage acts to stabilize the catheter. Consequently, due to the necessary 
body placement and absence of stabilizing materials, the catheters often 
become dislodged or bent. 
If the catheter becomes dislodged or bent it can cause irritation of the 
surrounding tissues, infiltration of intravascular infusions into the 
surrounding body tissues, bleeding from the entry site and false readings 
from catheter transducers. The very least concern is that medical 
personnel will be unable to properly treat and diagnose the patients 
condition because of false readings from catheter transducers. Of more 
serious concern is the possibility that intravascular infusions infiltrate 
the body tissue resulting in amputation of the patient's extremity in 
which the catheter was inserted. The most severe consequence is the 
patient can bleed to death if an arterial catheter is totally dislodged 
from the entry site. 
Another problem with existing products is their inability to remain adhered 
to the patients skin when they become moist due to sweat, blood, bodily 
fluids, water or contact with infusion fluids. 
Dislodged catheters must be removed. Loose tape and bandages must be 
replaced. The more often a catheter is removed and a new one placed in 
another area of the body, the higher the risk of infection and 
complications. Also, the more often a catheter site is exposed when the 
tape and bandage are replaced, the higher the risk of infection. Not to 
mention, the increased cost to the patient, his insurance carrier or the 
public when catheters, tape and bandages are disposed and replaced with 
new ones. 
Materials do exist which will adhere to human skin under moist conditions. 
However, these materials, called wound closure strips, are not presently 
designed to secure and stabilize catheter entry sites. 
Existing products fail to maintain sterility, fail to stabilize the 
catheter and result in higher medical costs, higher risk of complications 
for the patient and consumes more materials and time than the proposed 
invention. 
OBJECTS AND ADVANTAGES 
The objects and advantages of our invention are: 
(a) To provide stabilization of intravascular catheter entry sites. 
(b) To permit visualization of the catheter entry site, while providing 
stabilization, so medical personnel may observe the entry site for 
infection or signs of infiltration. 
(c) To increase the amount of time any single catheter can stay in a 
patient's body before having to be replaced or relocated to another body 
area. 
(d) To decrease the risk of infection, infiltration, amputation of body 
extremities and death due to catheter dislodging and potential 
complications. 
(e) To increase to reliability of transducer readings emitted from a 
catheter transducer so medical personnel may more accurately treat and 
diagnose the patient's condition. 
(f) To decrease the cost of medical treatment for patients, their insurance 
carriers and the public taxpayers by increasing the longevity of catheters 
and the materials used to secure the catheters. 
(g) To decrease the cost of medical treatment by reducing the frequency of 
infection, infiltration and other complications caused by catheter 
dislodging. 
(h) To enhance medical personnel time management through reducing the 
frequency of catheter replacement and treatments associated with 
complications from catheter dislodging. 
Further advantages include better adhesion of the stabilizing device under 
moist conditions caused by sweat, blood, bodily fluids, water and infusion 
fluids. The invention is made of non-allergenic material which will reduce 
irritation to the patient's skin and is a sterile product alleviating the 
need to use unsterile tape. 
DRAWINGS--FIGURES 
FIG. 1A is an overall single dimensional top view showing the unique shape 
of the invention, the relative size and length of the parallel side 
bolsters and the catheter window. 
Fig 1B is a single dimensional horizontal end view showing sheet of fiber 
reinforced material which is coated with the pressure-sensitive adhesive, 
the protective backing and the side bolsters which act as the stabilizing 
mechanism of the structure. 
FIG. 1C is a perspective view showing the components of the invention and 
emphasizing the relative dimensions between the sheet of fiber reinforced 
material and the side bolsters. 
REFERENCE NUMERALS IN DRAWINGS 
1 Stabilizing side bolsters 
2 Catheter window 
3 Fiber reinforced material 
4 Pressure sensitive adhesive 
5 Protective backing material

DESCRIPTION 
A fiber reinforced material, 3 of FIG. 1A, with a protective backing 
material, 5 of FIG. 1B, is cut to a predetermined size and shape as shown 
in 3 of FIG. 1A. The fiber reinforced material is evenly coated on one 
side, as shown in 4 of FIG. 1B, with a pressure sensitive adhesive. A 
protective backing material covers the pressure-sensitive adhesive prior 
to utilization of the invention. 
FIG. 1B (horizontal view) shows the additional layered thickness of the 
fiber reinforced material which constitutes the stabilizing side bolsters 
shown as 1 of FIG. 1A and FIG. 1B. 
A catheter window of predetermined size and rectangular shape, 2 of FIG. 
1A, is formed during the cutting process of the fiber reinforced material 
and protective backing, 3 of FIG. 1A and 5 of FIG. 1B respectively. The 
stabilizing side bolsters, 1 of FIG. 1A and FIG. 1B, are attached to the 
fiber reinforced material. 
OPERATION 
The manner of using the stabilization device for intravascular catheters is 
to remove the protective backing, 5 of FIG. 1B, thus exposing the bottom 
side of the fiber reinforced material covered with the pressure sensitive 
adhesive, 4 of FIG. 1B. 
The stabilization device, FIG. 1A, is positioned over the intravascular 
catheter so that the catheter head is lodged in the catheter window, 2 of 
FIG. 1A, and between the stabilizing side bolsters, 1 of FIG. 1A and FIG. 
1B.