This invention relates generally to the use of catheters and more particularly concerns the materials and methods used to retain an inserted catheter in a physically stable position in the anatomy of a patient.

Different surfaces of the human anatomy involve different motions, contours and textures that impact their reliability as a support for medical appliances and devices. For example, catheters are used to administer healing fluids to, or to evacuate damaging fluids from, various cavities in the human anatomy. Each use involves a different point of penetration into the anatomy and each penetration point has a different set of surrounding conditions. For example, a patient’s neck has a greater range-ofmotion, a smaller diameter and different body-orifice and hair proximities than a patient’s torso.

For decades, neither the materials nor the practices of catheter installation have changed significantly. Known procedures employ .materials ill-suited to effective catheter installation and require performance of awkward inconsistently-performable steps in accomplishing the catheter installation. Arbitrary lengths of adhesive tape are torn from a roll and applied to the patient’s skin in an arbitrary overlapping pattern to form a base adhered to a broad area surrounding the point of penetration of the catheter into the anatomy. The exposed portion of the catheter is extended radially away from the point of penetration across the base lengths of tape. At least one other arbitrary length of tape is torn from the roll and cut or torn part-way into its width to form a slit. The slit is aligned transverse to the overlapping pattern and straddled on the catheter at the point of penetration with the closed end of the slit against, or as close as possible to, the catheter outer wall at the point of penetration. The half- width of the tape that does not overlie the exposed portion of the catheter is adhered to the base set the alignment of the split tape. The other half- width of the tape is manipulated under the exposed portion of the catheter and adhered to the base with the slit as closed as possible. Additional lengths of tape are torn from the roll and adhered as a cover for the base, the portion of the exposed catheter lying on the base, and the area surrounding the point of entry. If more than one length of slit tape is used, they are normally applied with their slits arranged at different angles. For example, two such slits would be at approximately right angles to each other.

Any catheter .installation requires an incision at the point of catheter penetration, resulting in leakage of body fluids. The above-described steps are generally accomplished using nou-sterile off-the-shelf adhesive tape, risking compromise of the sterility of the area and the possibility of acquired infections. This is especially of concern in connection with neck and face related catheters because of the proximity to the mouth and its “biologically dirty” oral secretions. Also, any strip of adhesive tape, once applied, blocks all visual observation and monitoring of the covered area, including the location of length markings on the catheter during and after, and any evidence of leakage or infection after, the installation. The arbitrary positioning of the strips of tape during installation and the associated deficiencies in permanent and smooth adherence of the tape to the skin or to the surfaces of already applied tape compromises, to varying degrees, the quality ⁷ , durability and effectiveness of the installation. Such deficiencies increase the likelihood of migration of the catheter into and out of, and the expansion of the incision at, the point of penetration. They also tend to reduce the effective life of the installation, increasing the risks of complication and the costs associated with the replacement of the catheter.

As a result of the materials and methods presently employed, the resulting catheter -to- anatomy attachment structure is imperfect, imprecise, inaccurate and inadequate.

It is, therefore, a primary object of the invention to provide a catheter stabilizer and a method for installing the stabilizer which are especially suited to retaining a catheter in its position of insertion into the body of a patient It is also an object of the invention to provide a catheter stabilizer and a method for installing the stabilizer which reduce the preparation-of-materials steps required for installation. Another object of the invention is to provide a catheter stabilizer and a method for installing the stabilizer which eliminate the need for performance of arbitrary, awkward or inconsistently-performable installation steps, A further object of the invention is to provide a catheter stabilizer and a method for installing the stabilizer which result in predictably effective catheter-to-patient connections. Yet another object of the invention is to provide a catheter stabilizer and a method for installing the stabilizer which mitigate against the likelihoods of migration of the catheter out of the incision or expansion of the length of the incision during and after installation. Still another object of the invention is to provide a catheter stabilizer and a method for installing the stabilizer which create a sterile environment to the area surrounding the point of penetration of the catheter into the anatomy. Yet a further object of the invention is to provide a catheter stabilizer and a method for installing the stabilizer which extend the effective life of the installation, thereby reducing the risks of complications and costs associated with replacement of a catheter. And it is an object of the invention to provide a catheter stabilizer and a method for installing the stabilizer which enable a rapid and sound installation.

Summary of the Invention:

In accordance with the invention, a stabilizer retains a catheter in an inserted condition into the anatomy of a patient. In this condition, the catheter extends radially from its penetration point and along the anatomy. The stabilizer is a laminate of a layer of clear film and a layer of double- backed adhesive. A slit divides the laminate into a main body and an integral independently manipulable wing. The layer of double-backed adhesive defines a window through the main body. The window is sized and oriented so that the point of penetration and a portion of the catheter radially extending from the point of penetration are visible when the layer of double-backed adhesive is adhered to the anatomy with the nianipulable wing extending transversely under the radially extending portion of the catheter. Preferably, the closed end of the slit defines an over- under aperture securing the catheter in place when the main body and the manipulable wing are adhered to the anatomy. Preferably, the laminate has a layer of peel-off release paper shielding an exposed face of the layer of double-backed adhesive prior to the adhering of the laminate to the anatomy.

For laminates having a front layer of clear film, an intermediate layer of double-backed adhesive and a rear layer of release papers, a first release paper covers the main body to a reference plane extending across the main body parallel to the slit and a second release paper covers the manipulable wing and the remainder of the main body to the reference plane. The window defined through the main body by the intermediate layer of double-backed adhesive is sized and oriented to permit the point of penetration and a portion of the catheter extending radially from the point of penetration to be visible when the layer of double-backed adhesive is adhered to the anatomy with the manipulable wing extending transversely under the radially extending portion of the catheter.

Preferably, the laminate has a generally rectangular outer perimeter with long and short edges and the slit extends from approximately a quarter-point of one of the long edges toward an opposite edge of the laminate. Preferably, the laminate has lengthwise and widthwise reference planes respectively extending across and perpendicular to the laminate and dividing the laminate into quadrants. Preferably, the slit extends beyond the lengthwise reference plane to define the independently manipulable wing. Preferably, the window defined by the layer of double-backed adhesive is aligned on the lengthwise reference plane and extends between the slit and a distal short side of the laminate. Preferably, for the three layer laminate, the first release paper has a length extending from the distal short edge of the laminate to the widthwise reference plane and the second release paper has a length sufficient to extend from a proximal short edge of the laminate to the widthwise reference plane. Also preferably, each release paper has a fold coincident with the widthwise reference plane and extending beyond the fold to form a flap of sufficient length to be fingertip gripped, the folds being coincident with the widthwise reference plane. The window may overlap the widthwise reference plane and the flaps when the flaps are folded back against their respective release papers.

Also in accordance with the invention, in the method for installing the stabilizer, the stabilizer is aligned approximately on a vertical lengthwise plane through an exposed portion of the catheter extending radially from the point of penetration toward a closed end of the slit. The aligned stabilizer is simultaneously smoothed and pressed to adhere a main body portion of the laminate against an underlying portion of the anatomy The independently manipulable wing of the laminate is slipped under the catheter with the catheter seated in the closed end of the slit. The unadhered portions of the stabilizer are then simultaneously smoothed and pressed to adhere the unadhered portion of the main body of the laminate and the independently manipulable integral wing of the laminate against underlying portions of the anatomy and against the exposed portion of the catheter. If the adhesive layer has a window through the main body, as the stabilizer is aligned the window is also aligned to display the point of penetration of the catheter into the anatomy of the patient and the exposed portion of the catheter radially extending from the po int of penetration along the vertical lengthwise plane toward a closed end of the slit.

If the adhesive layer has a window through the main body and the laminate includes a rear layer of release papers, the stabilizer is aligned approximately on a vertical lengthwise plane through the exposed radially extending portion of the catheter with the window positioned to display the point of penetration and the exposed portion of the catheter extending radially from the point of penetration toward a closed end of the slit. A first release paper of the releasable paper layer is peeled to reveal the double backed adhesive lying under the first release paper and to at least partly open the windo w so as to display at least the point of penetration of the catheter and a portion of the exposed portion of the catheter radially extending from the point of penetration. The aligned stabilizer is simultaneously smoothed and pressed to adhere the first-revealed double- backed adhesive against an underlying portion of the anatomy. The independently manipulable wing of the laminate is slipped under the catheter with the catheter seated in the closed end of the slit. A second release paper of the releasable paper layer is peeled to reveal the double-backed adhesive lying under the second release paper and to fully open the window to display more of the exposed portion of the catheter extending radially from the point of penetration. The unadhered portions of the stabilizer are then simultaneously smoothed and pressed to adhere the second revealed double-backed adhesive against an underlying portion of the anatomy and against the exposed portion of the catheter to complete the installation of the stabilizer.

Brief Description of the Drawings:

Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:

Figure 1 is a front view of a catheter stabilizer in accordance with the invention;

Figure 2 is a right edge view of the catheter stabilizer of Figure 1;

Figure 3 is a rear view of the catheter stabilizer of Figure .1;

Figure 4 is a front view of the front cover film of the catheter stabilizer of Figure I ;

Figure 5 is a rear view of the double-backed adhesive of the catheter stabilizer of Figure 1 ; Figure 6 is a front view of a first release paper of the catheter stabilizer of Figure 1;

Figure 7 is a right edge view of the first release paper of Figure 6;

Figure 8 is a front view of a second release paper of the catheter stabilizer of Figure 1;

Figure 9 is a right edge view of the second release paper of Figure 8;

Figure 10 is a perspective view of the catheter stabilizer of Figure 1;

Figure 11 is a perspective view illustrating the catheter stabilizer of Figure I ready for installation;

Figure 12 is a perspective view illustrating a catheter inserted into and extended across a patient’s anatomy in preparation for installation of the catheter stabilizer of Figure 11;

Figure 13 is a perspective view illustrating the peeling of the first release paper of Figure 6 from the catheter stabilizer of Figure 11 ; Figure .14 is a perspective view illustrating the first revealed portion of the double-backed adhesive being applied to the base of the catheter stabil izer of Figure 11;

Figure 15 is a perspective view illustrating the peeling of the second release paper of Figure 8 from the catheter stabilizer of Figure .1.1; and Figure 16 is a perspective view illustrating the second revealed portion of the double- backed adhesive applied to the base of the catheter stabilizer of Figure 11, completing the installation of the catheter stabilizer.

While the invention will be described in connection with a preferred embodiment and method thereof, it will be understood that it is not intended to limit the invention to that embodiment or method or to the details of the construction or arrangement of parts illustrated in the accompanying drawings.

Detailed Description:

Looking at Figures 1-16, a stabilizer S in accordance with the invention is described in conjunction with retaining a catheter C in a stable position in the anatomy A of a patient. Catheters include chest tubes and dialysis catheters, central lines in the subclavian, internal jugular, and femoral veins or arterial lines in the radial, ulnar, and femoral arteries. The shape, composition and installation of the stabilizer S remain unchanged, but the stabilizer S is sized according to its use, As seen in Figures 1-3, the stabilizer S is a lamination 10 of a front layer of clear film 30, an intermediate layer of double-backed adhesive 50 and a rear layer of side-by-side release papers 70/90. Preferably, the clear film 30 is polyurethane. Preferably, and as shown, the outer perimeter 11 of the lamination 10 is generally rectangular with rounded comers. It has long edges 13 of equal length, a short edge 15 and a shorter edge 17. For purposes of further description, length wise and widthwise reference planes 19 and 21 , respectively, are displayed across and perpendicular to the lamination 1.0, approximately dividing the lamination 10 into quadrants. A slit 23 extends from approximately a quarter-point of one of the long edges 1.3 toward, but short of, the opposi te long edge 13 of the lam ination 10. The slit 23 extends slightly beyond the lengthwise reference plane 19. Preferably, and as shown, the outer perimeter 1 1 of the lamination 10 rounds into the slit 23. The slit 23 divides the lamination 10 into a main body 25 and an integral independently manipulable wing 27 with a rounded corner 29 at the shorter edge 17 of the lamination 10.

Moving on to side-by-side Figures 4 and 5, the front face 31. of the clear film 30 and the rear face 51 of the double-backed adhesive 50 are mirror images. Looking again at Figure 2, the front face 53 of the double-backed adhesive 50 is applied to the rear face 33 of the clear film 30. Returning to Figures 4 and 5, preferably, and as shown, the double-backed adhesive 50 covers all of the rear face 33 of the clear film 30 except for a rectangular window 55 through the double- backed adhesive 50. Preferably, and as shown, the window 55 is symmetrically aligned on the lengthwise reference plane 19 and extends between the slit 23 and the short edge 15 of the lamination 10. When the front face 53 of the double-backed adhesive 50 is applied to the rear face 33 of the clear film 30, the rectangular window 55 through the double-backed adhesive 50 is coincident with a phantom rectangular delineation 35 of the window 55 on the clear film 30,

Looking at Figures 6-7, first release paper 70 has a length 71 sufficient to extend from the short edge 15 of the lamination 10 to the widthwise reference plane 21, Preferably, and as shown, the first release paper 70 has a fold 73 coincident with the widthwise reference plane 19 and extends beyond the fold 73 to form a flap 75 of sufficient length to provide a fingertip grip.

Looking at Figures 8-9, the second release paper 90 has a length 91 sufficient to extend from the shorter edge 17 of the lamination 10 to the widthwise reference plane 21. Preferably, and as shown, the release paper 90 has a fold 93 coincident with the widthwise reference plane 21 and extends beyond the fold 93 to form a flap 95 of sufficient length to provide a fingertip grip.

Figure 10 illustrates the preferred relationships of the layers of the laminate 10 as being separated from each other but aligned as parts of the laminate 10. However, Figure 1.0 is not an assembly drawing. The laminate 10 may be formed using steps differing from the steps suggested by the drawing. Rather, Figure .10 is intended to further illustrate the preferred inter-relationships of the front layer of clear film 30, the intermediate layer of double-backed adhesive 50 including the window 55, the rear layer of first and second side-by-side release papers 70/90, the lengthwise and widthwise reference planes 19 and 21 of the laminate 10 and the slit 23 in the laminate 10. Furthermore, in Figure 10, the first and second release papers 70/90 are shown in a separated condition rather than in the side-by-side condition of the laminate 10. And, looking at Figures 1- 3 and 10, when the flaps 75 and 95 are folded back against their respective first and second release papers 70/90, the window 55 overlaps the widthwise reference plane 21 and the flaps 75/95, the folds 73 and 93 are abutting and the flaps 75 and 95 do not come into contact with the double- backed adhesive 50.

Figure 11 illustrates the stabilizer S oriented in a ready to install state. Figure 12 illustrates the catheter C inserted into the anatomy A, particularly into the torso T at a point of penetration P. in an orientation and a condition ready for installation of the stabilizer S. Turning to Figures 13- 16, the method for installing the stabilizer S. as seen in Figure .11, on the patient's anatomy A with the catheter C in its inserted condition, as seen in Figure 12, can be understood.

In Figure 13, the flap 75 of the first release paper 70 has been gripped and peeled from the widthwise reference plane 21 until the release paper 70 is entirely detached from the lamination 10. The rear face 51 of the double-backed adhesive 50 has been revealed entirely from the widthwise reference plane 21 to the short edge 15 of the lamination 10 and a substantial portion 57 of the window 55 has been “opened.” A smaller portion 59 of the window 55 remains “closed” by the second release paper 90.

As seen in Figure 14, the longitudinal axis of the catheter C is in approximate alignment with the vertical lengthwise plane 19 of the lamination 10. The point of penetration P of the catheter C into the anatomy A is approximately centered in the window 55. The revealed portion of the rear face 51 of the double-backed adhesive 50 is lowered, smoothed and pressed over the catheter C and against the anatomy A of the patient to secure the corresponding portion of the stabilizer S in place and to partially secure the catheter C in proper alignment with the stabilizer S.

Moving on to Figure 15, with a substantial portion of the main body 25 of the stabilizer $ secured in place to hold the catheter C in proper alignment, the flap 95 of the second release paper 90 is peeled to reveal the remainder of the rear face 51 of the double-backed adhesive 50. As i t is being peeled, the newly revealed portion of the main body 25 is smoothed and pressed against the underlying portion of the anatomy A and the catheter C up to the closed end of the slit 23. The catheter C is then lifted against the portion of the main body 25 extending between the window 55 and the slit 23 that bridges is adhered to the catheter C. The independently manipulable wing 27 of the laminate 10 is then slipped under the catheter C and smoothed and pressed against the anatomy A, locking the catheter C in the over-under aperture 61 created by the bridging portion of the main body 25 adhered to the catheter C, the underlying portion of the wing 27 adhered to the anatomy A and the substantial rec losing of the slit 23. The final condition resulting at the completion of the installation of the stabilizer S is seen in Figure 16. The point of penetration P of the catheter C into the anatomy A and the alignment of the catheter C from the point of penetration P to proximate the aperture 61 can be observed through the window 55. The alignment of the catheter C from the aperture 6! along the extending port ion E of the catheter C is entirely exposed.

Preferably, the stabilizer is sterilized and packaged to decrease the risk that infection be acquired because of the installation. The combination of the clear cover and the window through the double-backed adhesive allows visual observation and monitoring of the area surrounding the incision site during and after installation of the stabilizer, including but not limited to the position of length markings on the catheter during and after installation of the stabil izer and evidence of leakage or infection after installation of the stabilizer. The stabilizer mitigates against the likelihood of migration of the catheter out of, and expansion of the incision at, the point of penetration. The effectiveness of the stabilizer allows the catheter to be left in longer, decreasing the risks of complication and the costs associated with replacement of the catheter.

Thus, it is apparent that there has been provided, in accordance with the invention, a stabilizer and a method for installing the stabilizer to retain a catheter in an inserted condition in the anatomy of a patient that fully satisfies the objects, aims and advantages set forth above. While the invention has been described in conjunction with a specific embodiment thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art and in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit of the appended claims.