Sterile catheter securement device

This invention pertains to the construction and use of a sterile securement device for retaining an inserted and placed catheter and a connected tubular conductor in an assembled condition. This securement device in retaining condition maintains this assembly by this adhesively-coated film which is tightly pressed to the skin of a patient. A frame of sheet material has at least three outer-edge portions providing therebetween a determined interior space or area. This retaining film is a bottom member of film adhesively coated on one side and is attached by the adhesive to one side of this frame. The film within the frame has a flexible release sheet applied to the adhesive surface of this film. An additional protector sheet having a sealable surface is configured to be secured to both the frame and release sheet and has a tab means for removal of this protector and release sheet at time of use. The assembled package is sterilized before shipment and storage. Storage in packages for several devices is contemplated.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
With reference to the classification of art as established in and by the U. 
S. Patent Office, the present invention is believed to be found in the 
medical field and, more particularly, to a securing device for adhesively 
attaching and retaining a catheter and connected tubing for medication 
and/or fluids fed from an IV line into a catheter in a patient. This 
securement device is initially sterilized and with a protective and 
removable member when removed exposes an adhesively-coated and flexible 
plastic portion which is utilized for retention of the catheter and 
connected tubing to the skin of a patient. 2. Description of the Prior Art 
The use of an adhesive coating on plastics, particularly thin and flexible 
plastic film, is very well known. Adhesive tape is and has been used with 
catheters and the securing of these members to the body parts of the 
patient being treated. Among U. S. patents of interest is No. 3,046,984 to 
EBY, as issued July 31, 1962. The retaining member is suggested to be of 
aluminum foil with an adhesive surface. Retention of a secondary conductor 
and needle is with a slot and viewing of the flow in the flexible tubing 
is through a rectangular opening. Also of note is U.S. Pat. No. 3,430,300, 
as issued to DOAN on Mar. 4, 1969. This patent shows a strip of flexible 
material with an adhesive surface and a release paper used therewith. The 
retention of a tube is with a loop formed around the tube and with 
extending wings of an aperture and wing members inserted through the 
aperture to secure the tube. Also noted is U.S. Pat. No. 3,918,446 to 
BUTTARAVOLI, as issued Nov. 11, 1975. This patent depicts a foldover 
device with appropriate cutouts for guiding the hookup connection and the 
tubing and to effect a retained and positioned placement. An additional 
adhesive is provided for securing the device to the skin of the patient. 
This device is for retaining the IV hookup to and into the vein or artery 
of a patient. This device does not show or suggest a thin, transparent 
plastic sheet with peripheral frames to permit ready removal from the 
added inserting site. BUTTARAVOLI also addressed this securement problem 
with another U.S. Patent, No. 4,324,237, as issued Apr. 13, 1982. Another 
U.S. Patent is No. 4,120,304 to MOOR, as issued Oct. 17, 1978, which shows 
an adhesive member of flexible material and an added clamp member of 
molded material. 
Securing of catheters and connected tubing is also shown in other U.S. 
Patents, such as No. 3,574,306 to ALDEN, as issued Apr. 13, 1971; No. RE 
27,519 to SHEPHERD et al, as issued Oct. 31, 1972; No. 3,973,565 to STEER, 
as issued Aug. 10, 1976; No. 4,059,105, as issued to CUTRUZZULA et al on 
Nov. 22, 1977; No. 4,149,534 to TENCZAR, as issued Apr. 17, 1979; No. 
4,221,215 to MANDELBAUM, as issued Sept. 9, 1980; No. 4,390,105, as issued 
to CUMMINGS on June 28, 1983, and No. 4,534,762 to HEYER, as issued Aug. 
13, 1985. The above-noted patented examples and other devices known to the 
Applicant do not teach or contemplate a securement device that has an 
additional protective member to maintain an initial sterilized condition 
through storage, shipment and until the attendant prior to immediate use 
removes this additional protective member to apply the securement device. 
The readied device is utilized by the attendant to hold a catheter and 
connected tubular member in position and to the prepped skin of the 
patient. This (these) release sheet(s) must be removed by the attendant 
from the securement device prior to use of the securement device. 
In brief, and to be more fully described hereinafter, this invention is 
directed to overcoming these difficulties in providing an initially 
sterile retainer in which the exposed film is adhesively-coated and 
provides a securement of the placed catheter and a connected IV tubing and 
the like. The securement device is shown in two configurations. In a first 
embodiment, a frame portion is made with three sides and with a fourth 
side having no frame. In the other embodiment, the securement device has a 
four-edge frame. In both devices, a flexible film having one face coated 
with an adhesive is attached to the frame and also to a release sheet. 
Preferably the release sheet is die-cut as the frame is cut, with the 
cutout portion of the frame providing the release sheet which is not 
removed during assembly. This adhesively-coated film is adapted to be 
attached to the skin of the patient to retain the catheter and a tubular 
connection. An additional protective member of adhesively-coated film or 
paper is applied to fully cover the other side of the release sheet until 
used. One portion of this protective member covers the frame except for an 
outer portion which is absent adhesive or is covered to make a tab which 
provides means for insertion of a fingernail or the like. After assembly, 
the device is sterilized and, after sterilization, this protective member 
together with the adhesively-coated film provides and maintains internal 
sterility until time of application. 
The skin of the patient is "prepped" for blood vessel puncture, then a 
catheter is inserted into the vein or artery of said patient. The 
protective cover of the securement device is removed by gripping the tab 
and adjacent frame, a one-step procedure. The securement device is ready 
for placement over the puncture site to secure the catheter and protect 
the catheter skin entrance site from contamination. The device of this 
application is shown in two embodiments and, in both, sterility is 
established and maintained until the protective member is removed just 
before application. The adhesive has been subjected to sterilization and 
has been selected from those which are acceptable for use on the human 
skin. This application is not directed to the composition of adhesive, per 
se, but to a simple-to-use, economical securement device for retaining a 
catheter and connected tubing in a substantially near-sterile condition. 
SUMMARY OF THE INVENTION 
This invention may be summarized, at least in part, with reference to its 
objects. it is an object of this invention to provide, and it does 
provide, a securement device utilizing a thin, transparent plastic film 
coated on one side with a substantially non-irritating adhesive having at 
least a partial border frame along three sides, with said frame portions 
on their exposed surfaces absent adhesive. 
A further object of this invention is to provide, and it does provide, a 
one-step procedure for removing a sterile securement device from its 
package (protective film or paper) and ready for placement. Although the 
film is somewhat flimsy, the frame provides rigidity and ease of 
placement. 
A further object of this invention is to provide, and it does provide, a 
securement device that is adaptable to automatic production equipment. 
In addition to the above summary, the following disclosure is detailed to 
insure adequacy and aid in understanding of the invention. This 
disclosure, however, is not intended to cover each new inventive concept 
no matter how it may later be disguised by variations in form or additions 
of further improvements. For this reason, there have been chosen two 
specific embodiments of a sterile catheter securement device as adopted 
for use in retaining a placed catheter and connector and showing a 
preferred means for construction, assembly and use. These specific 
embodiments have been chosen for the purposes of illustration and 
description as shown in the accompanying drawings wherein:

EMBODIMENT OF FIGS. 1 A THROUGH 1 L 
Referring next to the drawings and one of the embodiments shown in the 
drawings, there is depicted a sterile catheter securement device in which 
sterility is retained until just before application by an attendant. A 
bottom member 10 of film has an adhesive 11 applied to one surface of this 
film member. A frame member 12 is secured to this adhesive surface. This 
frame is of thin material which is preferably die-cut to shape. The 
material for the frame may be made of surgical grade kraft paper stock and 
have a thickness (such as a thickness of four- to ten-thousandths of an 
inch) or may be of plastic of a few thousandths of an inch in thickness. 
The bottom member 10 may be of polyurethane, vinyl or other plastic films 
that are supple and sufficiently flexible to conform to the skin of a 
patient. The adhesive 11 is a coating which may be an acrylate or other 
pressure-sensitive emulsion or melt adhesive which is non-irritating to 
the patient's skin. As reduced to practice, the film 10 is usually from 
one-half to four-thousandths of an inch in thickness, but this is a matter 
of selection, with consideration being made to the composition of film and 
adhesive. The adhesive coating is a commercial product and is usually from 
one-half to four-thousandths of an inch in thickness. 
As seen in FIGS. 1 B and 1 D, the film 10 with the adhesive coating 11 and 
frame 12 are made the same size and are in coincidence. As depicted, the 
frame 12 is made with sides 14 and 15 of about one-quarter of an inch or 
less in width. An end portion 16 is provided with a similar or wider 
width, although these dimensions are merely a matter of choice. The extent 
of film interior of the frame portions 14, 15 and 16 has a release-sheet 
portion 18 which is adapted to substantially cover the film area interior 
of the frame. This release-sheet portion may be and usually is of the same 
material as provided for the frame 12. A protective sheet 20 is also 
provided. This protective sheet is usually of film or paper or, even if 
not, is intended to be impervious to passage therethrough of bacteria and 
the like. 
As shown in FIGS. 1 C and 1 F, the protective cover 20 retains release 
sheet 18 in a desired position. An additional sealable material, which may 
be the cover itself or a coating on sheet 20, is conventionally provided 
to secure portion 18 to the cover 20. This surface, identified as 22, is 
at least sealably coated sufficiently to retain the cover member 20 to at 
least the frame portion adjacent the inner-edge portions of the frame. As 
shown in FIG. 1 I, the cover film 20 has the sealable material 22 stopped 
short of the end to provide a tab portion 24 that is absent a seal coating 
so that when the device is assembled this tab portion 24 lies adjacent and 
facing the end 16 of the frame 12. This tab portion 24 is thus void of a 
sealable coating. 
In FIG. 1 L, an alternate tab structure is shown. The film 20, as 
conventionally provided in this embodiment, has a sealable coating 22 
applied to all of one surface and a thin piece of paper or film, 
identified as 124, is secured to this sealable coating surface to render 
this portion ineffective and provide manipulating means for inserting a 
fingernail or the like between tab 24 (FIG. 1 I) or tab 124 (FIG. 1 L) and 
the frame portion 16 so as to grasp and lift the cover 20 and release 
sheet 18 from the securement member so that this film 10 may be used to 
secure a placed catheter. 
When pulling the cover sheet from the securement device, a fiber tear bond 
or other discernible seal breakage becomes noticeable between the cover 20 
and frame portions 14, 15 and 16. In this manner the user is assured the 
seal between the frame and cover was not tampered with previously. Any 
tampering of the supple film and release sheet surface results in film 
distortion such as creases or air pockets. Thus, until the time of use, it 
is quite difficult to disturb the seals without their being noticed. 
USE AND OPERATION OF ASSEMBLY OF FIGS. 1 A THROUGH 1 L 
The drawings particularly illustrate the assembly of the device and 
preparing the device for shipment, storage and use. This device is 
anticipated to be used mainly in the hospital and doctor's office where 
catheters are inserted into a patient. Sterility is important and desired 
where invasion of a patient's skin is present. This device is anticipated 
as being inexpensively produced from assembly to sterility procedures and 
use. By and with both the film 10 and adhesive 11 cut to size and shape by 
die means and with frame 12 also produced from sheet stock and die-cutting 
also contemplated, the aligning and assembly are by automatic, high-speed 
machinery. If desired, the release-sheet portion 18 may be placed in 
position at this time period and assembly procedure, with the release 
sheet 18 nearly filling the available space interior of the frame 10. The 
protector cover member 20, having a determined adhesive coating, is 
provided with a tab portion 24 which as a film portion absent a sealable 
coating provides means for insertion of a fingernail or the like (FIG. 1 
I), or as an added member portion 124 is first secured and then this cover 
member assembly is placed and pressed into position as in FIG. 1 A. 
It is to be noted that the sealable surface on cover member 20 extends at 
least partly over the separation of the frame and release sheet. The tab 
portion 24, although extending above the frame portion 16 as seen in FIG. 
1 G, has the inner portion of cover member 20 securely attached to the 
frame 12. The cover 20 is sufficiently flexible to produce bending while 
making separation. Prior to shipping, the package as in FIG. 1 A is 
sterilized by a commercial and known method. 
The sterile securing devices are grouped into stacks of like packages and 
sterilized. The cover 20 provides an inviolate barrier at the separation 
line interior of the frame 12 and the release sheet 18. After shipping, 
the packaged device is brought to the point of use. After placement of the 
catheter and hookup with a supply line, the patient's skin is prepped for 
securing the catheter in place. The device is as in FIG. 1 J, after which 
the cover 20 is removed. As seen in FIG. 1 K, tab 24, or tab 124 seen in 
FIG. 1 L, is grasped and cover 20 is peeled back from the frame 12. Since 
the release sheet is prepared for removal from the film 10 and its 
adhesive coating 11, it is anticipated that cover 20 and the release sheet 
18 will be removed as a unit. 
In the above-described securement device, FIG. 1 A shows a side view of an 
assembled product, with the left end of the product shown in an enlarged 
scale in FIG. 1 F. The other end of this assembled product is 
fragmentarily shown in the enlarged view of FIG. 1 G. The film 10 and 
frame 12 with adhesive 11 are shown in FIG. 1 D and an enlarged showing is 
fragmentarily illustrated in FIG. 1 H. The covering 20 and release sheet 
18 with tab 24 secured thereto are shown in FIG. 1 C and in a side view in 
FIG. 1 E, with an enlarged fragmentary illustration provided in FIG. 1 E. 
FIG. 1 J shows the preferred construction of the device and FIG. 1 K shows 
a partial peeling of cover 20 from the frame 12 and film 10. FIG. 1 L 
shows an alternate tab construction. 
EMBODIMENT OF FIGS. 2 A THROUGH 2 K 
This embodiment is very like that of FIG. 1 A through 1 L, but the frame 
rather than three-sided is made as a four-sided member. It is, of course, 
realized that the fourth side may be made incomplete or with a portion of 
this fourth member severed or as two portions attached to the two longer 
side portions. Except for a change in the frame structure, this device is 
identical to or very near to the above-described device. 
In FIGS. 2 A and 2 B, the film 10 and adhesive 11 are as identified above. 
A frame member 30 is depicted as having four outer closed portions 32, 33, 
34 and 35 which are integrally secured and conventionally integral with 
the frame member made of sheet material. The release-sheet portion 18 is 
made of a size and configuration to fit within and extend substantially to 
the inner edge portions of said frame 30. The protective cover 20 is sized 
to extend substantially to the outer extents of the frame and a tab 
portion 24 of cover 20 or tab 124 is attached to said cover. The 
inwardly-directed surface of cover member 20 is also provided with a 
sealable surface 22 as above. 
USE AND OPERATION OF EMBODIMENT OF FIGS. 2 A THROUGH 2 K 
The assembly of the device of FIGS. 2 A through 2 K is substantially the 
same as for the device of FIGS. 1 A through 1 K above except that the 
frame has four outer portions. The assembly, sterilization and use are 
identical or very similar to that described above. It is to be noted in 
both devices that the release-sheet portion 18 is sufficiently flexible to 
permit a peeling action after the tab 24 is grasped and manipulated. This 
is particularly depicted in FIG. 2 K. 
EMBODIMENT OF FIG. 3 
In FIG. 3, the sterile catheter securing device is shown in use. The 
showing is with the device of FIG. 1 A in that the frame is three-sided. 
Whether with a frame with three sides or with a four-side arrangement as 
in FIG. 2 A, the sterile attachment device is brought to the site and in 
this view the protector 20, and the release sheet 18 have been removed to 
expose the adhesive surface of film 10. The site of the patient's skin has 
been prepped so as to bring the skin to the practical and lowest level of 
bacteria contamination. A catheter 40 is inserted into a patient 42 and a 
connecting end 43 of a conductor 44 is hooked up to said catheter. With 
the removal of protector 20 and release sheet 18, the adhesively-coated 
film 10 is positioned and tightly pressed to the skin of the patient to 
retain the catheter 40 and conductor 44 in the placed position. It is 
noted that the film 10 has been configured to tightly secure the connected 
portions. This adhesively-coated film provides (a) a bacteria barrier, (b) 
a securement device for securing the catheter and connecting tube to the 
patient's skin, and (c) by using a clear plastic film 10 provides a very 
visible window through which the catheter placement site during use may be 
observed. 
It is to be noted that the frame 12, since it is absent any adhesive, may 
be used as a lift assist for removal of the securement device from the 
skin of the patient 42. The adhesive film 10 tightly secures the catheter 
40 and connector tubing 44 and prevents contamination from the 
environment. 
The cover film edge 24 is not coated. In this manner, a flap or tab is 
created which may be used for grasping and removal of the cover film with 
release sheet from the securement device. Tab 24 when of uncoated film, or 
tab 124 when of paper or like material added to the adhesive surface of 
the cover 20, may be thinner than the frame material. The tab 24 or 124 is 
shown as a full width, but this length is not required as tab extent need 
be only sufficient to allow a comfortable insertion of a fingernail 
between the frame and tab. Whether with a frame (three-sided) as in FIGS. 
1 A through 1 L or the frame (four-sided) as in FIGS. 2 A through 2 K, the 
film 10 is contemplated to be sufficiently flexible so that with adhesive 
cementing 11 may be tightly pressed around the catheter 40 and tubular 
portion 44 where and when connected by the connected end 43. Whether a 
three-sided frame or a four-sided frame, the extent of adhesively-coated 
film 10 is sufficient to insure a retention of this connection. The frame 
provides an easy means for the attendant to remove the securement device 
after a determined period of time. 
The sterile catheter securement device, although utilizing few components, 
is contemplated to be made in and with automatic high-speed apparatus. The 
resulting product, when assembled as in FIGS. 1 A or 2 A, contemplates a 
subsequent sterilizing procedure before final packaging for shipment. The 
resulting accumulation may be in a box-like retainer (not shown) in which 
a quantity such as fifty or one hundred, or some other selected quantity 
is packaged. As this product is conventionally used in a hospital, 
doctor's office or the like, with the catheter 40 inserted into the 
patient 42 and hooked up to the tubular conductor 44 in the usual manner, 
the surrounding skin area of the patient is now prepped. A securement 
device is now removed, one at a time, from the storage container and still 
in a sterile condition the tab portion 24 or 124 is manipulated in 
conjunction with an adjacent frame member and the cover 20 and 
release-sheet portion 18 are removed. Securing and use of this device in 
the desired mounted condition are depicted in FIG. 3. 
The frame and release sheet are conventionally produced by a die-cutting 
operation and this representation in the drawings described above is as a 
line, with these two edges very contiguous. A very few thousandths of an 
inch spacing may occur at this die-cut, but when a peeling actuation is 
performed a separation of the frame and tab is easily achieved. The tab 24 
or portion 124 is positioned at one end of the frame, which is a preferred 
location, but this is not to preclude placing the tab at the sides of the 
device. The tab 24 or a tab 124 is also shown as at or approximately at or 
in coincidence with the end of the frame, but this is also a matter of 
preference as long as the protector sheet 20 covers the inside of the 
frame and adjacent release sheet 14. This sheet protector insures that the 
adhesively-coated inside of the bottom film member 10 is kept inviolate 
until the device is used. 
The frame and associated components as illustrated are depicted as 
rectangluar - which is easily and most economically produced by 
die-cutting, but it is to be understood that such showing is merely for 
the purpose of illustration. Other configurations - such as hexagonal, 
octagonal, oval and circular - are contemplated and may be provided within 
the scope of this invention. Shape and size is merely a matter of design 
and is not considered limiting. 
The above invention as shown and described is believed to provide a basis 
for a method of constructing, assembling and using the sterile securement 
device for retaining an inserted and placed catheter and a connected 
tubular conductor to and from an IV supply and the like, this sterile 
securement device adapted for retaining and maintaining this assembled 
connection condition by an adhesively-coated film pressed to the skin of 
the patient, this method including the steps of: 
providing a frame of sheet material having at least three outer-edge 
portions and establishing interior thereof and therebetween a determined 
space or area; 
supplying a bottom film member which is sized to extend substantially to 
the outer edges or extents of said frame, this bottom film member very 
thin and flexible, and coating one surface of said bottom film member on 
one surface with an adhesive acceptable for contact attachment to the skin 
of a patient, and securing this film by this adhesive to said frame; 
securing a flexible release sheet which is sized so as to extend to 
substantially the inner edges of the outer-edge portions of the frame, 
with this release sheet when in secured position protecting the adhesive 
surface of that bottom film interior of said frame-edge portions; 
supplying and applying to said frame and said release sheet a protective 
sheet member of flexible composition and having a sealable material on one 
surface, said protective sheet member sized to extend substantially to the 
outer portions of said frame and enclose said release sheet, and 
supplying one edge of the protective sheet minus sealable means to form a 
tab member which provides means for separating the protective member from 
the frame and when said protective sheet member is sealably secured to the 
frame and release sheet, this protective sheet providing a covering of 
that space between the release sheet and frame-edge portions so that said 
spacing is protected from the environment, and after the protector is 
secured in place a sterilization of the assembled device is conventionally 
made. 
Terms such as "left," "right," "up," "down," "bottom," "top," "front," 
"back," "in," "out" and the like are applicable to the embodiments shown 
and described in conjunction with the drawings. These terms are merely for 
the purposes of description and do not necessarily apply to the position 
in which the sterile catheter securement device may be constructed or 
used. 
While particular embodiments of the securement device and initial 
construction and assembly have been shown and described, it is to be 
understood that the invention is not limited thereto and protection is 
sought to the broadest extent the prior art allows.