Catheter Assembly

It has long been recognized that catheters lose their sterility either in the process of insertion or thereafter. There have been many proposed solutions for the problem, an example of which is U.S. Pat. No. 3,894,540 to F. J. Bonner, Jr. dated July 15, 1975. That patent, and others, disclose the use of a collapsible protective sleeve surrounding the catheter, and while such devices have not been unsuccessful, they do require extremely skillful handling and are not particularly designed for adjustment after the initial insertion into the body of the patient. Such adjustments are particularly necessary when catheters are inserted into the heart for purposes of measuring its activity. It often happens that when the catheter is originally implanted, its tip lodges in an area of the heart which is not sufficiently sensitive. Consequently such cardiac catheters need to be moved about until the end within the heart lodges in a sufficiently responsive area. Such manipulations often require that the end be moved farther into the body, thus requiring that an additional length of catheter be utilized.

This invention provides a catheter assembly provided with a collapsible protective sleeve and so arranged that a flexible catheter may be easily advanced through a standard introducer without in any way exposing the catheter to contamination. Moreover, the assembly is also so arranged that the catheter may be further advanced into the body at any time, again without exposing the catheter to the risk of contamination. The assembly is provided with a relatively rigid hollow tube maintained in sealing relationship to the collapsible sleeve and dimensioned to receive and guide a catheter. As the catheter is passed through the introducer and into the body of the patient the sleeve collapses to the extent the catheter is moved into the body. Thereafter the rigid tube may be removed from the sleeve and the sleeve then automatically becomes sealed to the exterior of the catheter. This arrangement not only protects the catheter from contamination, but is extremely simple to use.

Other objects and advantages of this invention will be more readily understood and appreciated from the following detailed description of a preferred embodiment shown in the accompanying drawing:

FIG. 1 is a view in side elevation of the assembly of the invention prior to its connection to an introducer and prior to the addition of a catheter,

FIG. 2 is a view in side elevation of the catheter assembly showing the catheter in place and the assembly connected to an introducer, and

FIG. 3 is a view in side elevation of the catheter assembly subsequent to the removal of the guide tube.

As shown in the drawings the catheter assembly is organized about a cylindrical hollow tube 10 of metal, preferably stainless steel, having a socket 11 by means of which the tube 10 may be connected to an introducer 12. The introducer 12 is standard and those skilled in the art will readily understand that no detailed description of it is required. The introducer 12 has the usual side port 14.

Secured to the other end of the tube 10 is a collapsible sleeve 16 made of a waterproof material such as cellophane or other suitable transparent plastic. The sleeve 16 may be provided with accordion pleats to facilitate its ability to collapse or be extended. The sleeve 16 is secured to the tube 10 by means of a rubber O-ring 18, although any suitable means may be utilized, to secure the end of the tube 16 to the tube 10, such, for example, as a suitable adhesive.

At its other end the sleeve 16 carries another O-ring 20 which tightly grips and seals a hollow fairly rigid tube 22. The tube 22 is dimensioned to receive a catheter 24 which slides through the tube 22, through the sleeve 16, and then through the introducer, thus permitting insertion of the catheter into an artery or other organ of a patient under treatment.

As shown in FIG. 3 the tube 22, after the catheter has been inserted, may be removed by sliding it through the O-ring 20 and out onto the remaining body of the catheter 24. As the tube 22 leaves the O-ring 20, the O-ring contracts about the surface of the catheter 24 and is in sealing engagement with it. Consequently the catheter within the sleeve 16 is completely sealed and not subject to contamination. If it becomes necessary to reposition the catheter after its initial insertion, it is only necessary for the physician to grasp the catheter, preferably at the O-ring 20 and move it in or out as required. Again, the adjustment operation in no way exposes the catheter to contamination but maintains it in sterile condition.

When the tube 22 has been removed from the sleeve 16, it can be left in place upon the portion of the catheter which remains outside the sleeve 16. However, the tube 22 may be provided with a longitudinal slit so that it can be stripped off the catheter after it leaves the sleeve 16.

While the embodiment herein shown and described is presently considered to be preferred, it will be understood that various modifications and improvements may be made therein, and it is intended to cover in the appended claims all such modifications and improvements as fall within the true spirit and scope of the invention.