Sterile Guidewire Exchange System

Intravascular catheters commonly become colonized with bacteria and/or fungi during the indwelling period. The longer a catheter is allowed to remain in place the greater the probability of colonization and secondary infection of the patient. This is particularly common with multilumen catheters entering either the subclavian or internal jugular veins. Since the probability of colonization is a function of the indwelling time, these catheters are commonly exchanged with a new sterile catheter through the same site over a guidewire. Present techniques for guidewire exchange, however, are cumbersome and are difficult to perform while maintaining sterility.

The technique for guidewire exchange involves the preparation of the old catheter site at the point of entrance of the catheter into the patient. Using the fingers and commonly utilizing a stiff guide covering the distal portion of a J-tipped catheter, the guidewire is inserted from a guidewire container through the distal port of a multilumen catheter until the guidewire extends well into the catheter. The catheter is then withdrawn over the guidewire. Subsequent to this, a new sterile catheter is inserted over the guidewire in the old catheter's place. The guidewire is then removed and the catheter is attached to a fluid system.

Unfortunately, it is common for the old catheter to contaminate the physician's gloves during the procedure and, therefore, contaminate the new catheter by transfer of these bacteria during the insertion process (conventional multilumen catheters are generally 20-30 cm in length). A variety of techniques utilizing multiple drapes and multiple sets of sterile gloves are well known in the art. These techniques remain cumbersome and unreliable. It is particularly difficult to maintain a sterile field for the guidewire which remains within the insertion site at the time the old catheter is removed. This guidewire is flexible and a large portion of this guidewire must remain out of the patient to avoid excessive penetration into the patient which could result in cardiac or vascular injury. It is very difficult for the physician to maintain the sterility of this flexible guidewire within a sterile field which is commonly contaminated by the old catheter which has been removed and may have contacted the surrounding environment in juxtaposition with the guidewire. In fact, a recent study has shown that guidewire exchange may not be associated with a reduction in infection-related complications. This failure to reduce infection may be due to the fact that many of the sterile catheters which are exchanged over guidewires are contaminated during the exchange process.

For these reasons, there has long been a critical need to provide an inexpensive over-the guidewire catheter exchange system which eliminates the potential for contamination of the new catheter during catheter exchange.

The present invention comprises an enclosed guidewire exchange system and method which utilized a flexible sterile barrier which is preferably tubular and folded or rolled prior to use. The barrier functions to enclose the old catheter as it is being withdrawn from the patient, the system further providing a sterile barrier for enclosure of the guidewire upon removal of the old catheter from over the guidewire.

The system preferably includes a guidewire container containing a flexible guidewire. The container includes a connector which may be a threaded female end for attachment to the pilot tube luer of the distal port of the multilumen catheter or other indwelling catheter. The guidewire container preferably includes an interrupted portion such as a window to allow the physician to contact the guidewire within the container so as to advance the guidewire into the catheter once the container has been connected to the luer of the catheter. The sterile barrier enclosure is provided, which is preferably attached to the guidewire container proximal to the female connector and unfolds or unrolls to provide a sterile cavity distal to the guidewire container. The sterile barrier can include a proximal catheter barrier portion and a distal guidewire barrier portion and a tear point or region intermediate the portions. The system further includes a sterile catheter for replacement over the guidewire.

In operation, the site surrounding the entry of the catheter into the skin is sterilely prepped. The connector of the guidewire container is then attached to the luer of the distal port of the catheter. The physician then puts on sterile gloves and grasps the guidewire through the guidewire container windows and advances the guidewire to a predetermined point. The sterile barrier is then unfolded or unrolled and advanced partly over the old catheter. Once the proximal portion of the old catheter is enclosed, the old catheter is then retracted completely into the sterile barrier until a small portion of the guidewire extends beyond the distal tip of the catheter into the insertion site. At this point, the catheter barrier is fully extended to the tip of the old catheter. The physician then advances as by unrolling or unfolding the guidewire barrier slightly over the guidewire. The physician then grasps the distal portion of the guidewire barrier against the guidewire to prevent further retraction of the guidewire out of the patient. With the other hand, the physician grasps the old catheter through the catheter barrier and pulls the old catheter off the guidewire. As this maneuver is accomplished, the guidewire barrier expands from its previously compressed position to entirely cover that portion of the guidewire extending outside the patient from which the old catheter has now been removed. The physician now has a sterile guidewire extending from the patient which is completely covered by the guidewire barrier portion which is continuous with the catheter barrier portion which contains the old catheter. The physician grasps the distal portion of the catheter barrier in one hand and the proximal portion of the guidewire barrier in the other hand and separates the two barriers, thereby removing the catheter barrier with its contained contaminated catheter from the guidewire barrier. The physician then grasps the proximal portion of the guidewire through the guidewire barrier and slides the guidewire barrier downward toward the patient to exposure approximately 1 cm of the end of the guidewire. With the other hand, the physician grasps the new multilumen catheter and inserts the tip over the guidewire and advances the catheter through the guidewire barrier, over the guidewire, and into the patient to the proper position. The guidewire barrier is then removed from around the multilumen catheter and the catheter is sutured in place. With this system, the entire process can be accomplished without the risk of contact contamination of either the guidewire or the new catheter.

It is the purpose of this invention to provide an over-the-guidewire catheter exchange system which reduces the risk of contact contamination of either the guidewire or the catheter during the insertion process. It is further the purpose of this invention to provide a simplified method of sterile catheter exchange. Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be evident from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized by means of the instrumentalities and combinations particularly pointed out in the appended claims.

FIG. 1 is a top view of the system showing the assembly within a vacuformed package and the exchange barrier in a rolled position.

FIG. 2 illustrates the operation of the assembly, showing the exchange barrier extended over the catheter with the barrier against the patient's skin and the guidewire extending into the patient's blood vessel.

FIG. 3 illustrates the operation of the assembly, showing the guidewire being grasped through the guidewire barrier.

FIG. 4 illustrates the operation of the assembly wherein the physician has grasped the catheter and retracted it from over the guidewire.

FIG. 5 demonstrates the guidewire barrier in its fully expanded position after the catheter has been completely retracted from over the guidewire.

FIG. 6 illustrates separation of the catheter barrier and the guidewire barrier along the weakened portion.

FIG. 7 illustrates placement of a new sterile catheter over the indwelling guidewire.

FIG. 1 shows generally a over-the-guidewire sterile catheter exchange system 10 including exchange assembly 12, having a guidewire container 14 containing J-tipped guidewire 15. The guidewire container 14 includes finger contact windows 16. The guidewire container 14 has clips 17 and 18. The guidewire container 14 further has a female threaded connector 24 at its distal end 25 for connection to the male luer 26 of the distal port 27 of pilot tube 28 of a conventional central venous catheter 29. The guidewire container is held together by fasteners 30. Catheter 29 is shown with additional proximal tube 31 and middle tube 32. An exchange barrier 33 is provided (shown rolled in FIG. 1). The exchange barrier 33 has a proximal old catheter barrier portion 34 and the more distal guidewire barrier portion 36 (shown unrolled in FIG. 2). The two barrier portions are connected along a weakened portion 38, the two barrier portions can be disengaged at the weakened area 38 as will be discussed below. The exchange barrier 33 is connected, as by adhesive, near its proximal end 42 about the guidewire container 14 at barrier connection site 44. Prior to operation, the catheter barrier 34 is rolled into a relatively tight roll (FIG. 1) in juxtaposition with its connection 44 with the guidewire container 14. The catheter barrier 34 is preferably longer than the catheter 29 and is preferably greater than 20 cm in length. In this position, before use, the distal guidewire barrier portion 36 (shown unrolled in FIG. 2) is folded and rolled within the outer rolled catheter barrier portion 34. The guidewire barrier 36 is preferably greater than 20 cm in length.

The entire assembly 12 is preferably provided within a vacuformed sterile package 45 having a conventional lid (not shown) attached as by adhesive along rim 46. A guidewire container recess 47 and a catheter recess 48 are included. A sterile catheter 49 is included within the catheter recess 48. The catheter injection caps are held in an upright position by vacuformed cap holders 52 to allow one handed injections through the caps 51 for flushing catheter 29. The distance separating the capholders is slightly less than the diameter of the caps, thereby tightly holding the caps in a vertical position.

In operation, the area of the insertion site of the patient's skin 53 around the old indwelling central venous catheter 29 is prepped with an antiseptic solution. The package 45 is then placed near the distal port 27 of the old multilumen catheter 29. The sterile lid from the package 45 is then removed and the physician attaches the female connector 24 of the guidewire container 14 to the luer of the distal port 27 of the pilot tube 28 while leaving the assembly 12 within the package 45. The physician then clips the proximal and middle port tubes (31 and 32) into their respective clips 17 and 18 near the end portion of the guidewire container 14 so that all three pilot tubes are in relative alignment with the guidewire container 14. Alternatively, the three pilot tubes (31,28, and 32) may be clipped together by clip 54 (as shown in FIG. 2). During this time, the physician avoids touching the proximal portion 55 of the assembly 12 which is still resting in the package 45. The physician then puts on sterile gloves and advances the guidewire 15 by grasping the guidewire 15 through the guidewire contact windows 16. The guidewire 15 is advanced until the proximal end 56 of the guidewire 15 reaches a preselected mark 57 on the guidewire container 14. The physician then grasps the proximal portion 55 of the assembly 12 and elevates the assembly 12 out of the package 45 and holds the assembly 12 with its attached catheter 29 in an elevated position. With the other hand, the physician rolls the catheter barrier 34 over the pilot tubes (28, 31, and 32) and the proximal portion of the catheter 29. After a portion of the catheter 29 has been received within the barrier 34 , the physician gently withdraws the catheter 29 from the patient while rolling the catheter barrier 34 over the catheter 29 until the catheter 29 is completely removed from the patient and approximately 2.5-3 cm of guidewire 15 is exposed between the distal tip 60 of the catheter 29 and the patient. The remainder of the distal guidewire portion 15 extends beneath the patient's skin 53 into the blood vessel 64 (FIG. 2). At this point, the catheter barrier 34 is fully extended to the distal tip 60 of the catheter 29 and the physician unrolls the attached folded and compressed guidewire barrier 36 from its formerly enclosed position, rolled within catheter barrier 34 (FIG. 1) to a position over the exposed guidewire 15 (FIG. 2). Adhesive may be included on the inner surface of the distal skin contact portion 66 of the guidewire barrier. At this point, the physician grasps the distal portion of the guidewire barrier 36 and holds the guidewire 15 tightly through the distal portion of the barrier 36, leaving the proximal compressed portion of the guidewire barrier 36 free in its compressed form (FIG. 3). The physician then, with the other hand (FIG. 4), pulls the catheter 29 upward and outward until the catheter 29 is completely removed from over the guidewire 15. Since the physician is holding the distal end of the compressed guidewire barrier 36 during this maneuver, the length of the remainder of the guidewire barrier 36 expands from its compressed form to cover the entire length of the guidewire 15. At this point, the guidewire barrier 36 is fully extended (FIG. 5) and the catheter 29 is within the catheter barrier 34 and the guidewire 15 within the guidewire barrier 36. The physician then grasps both barriers 34 and 36 near the weakened portion 38 with both hands and separates the barriers along its weakened portion 38 (FIG. 6). To that end, the weakened portion 38 preferably has a tear region that is facilitate barrier separation. With one hand, the physician then sets aside the catheter barrier 34 containing the catheter 29 so that the tip 60 of the catheter 29 may later be removed for culture. With one hand (FIG. 7), the physician holds the guidewire barrier 36 upward in a stable position and pushes the guidewire barrier 36 downward to expose approximately 1-2 cm of the proximal end 72 of the guidewire 15. With the other hand, the physician reaches into the sterile package 45 and grasps the new prepared catheter 75. The tip 76 of new sterile catheter 75 is then advanced over the guidewire 15 into the guidewire barrier 36 and then into the patient at the insertion site 53. Once the catheter has been advanced the proper distance (generally 8-12 cm) into the patient, the guidewire 15 is removed from the catheter 75 and the new catheter 75 is secured and dressed in the usual fashion. The entire guidewire exchange process can, therefore, be carried out simply, with considerable speed, and without the potential risk of contact contamination of the new catheter. It is clear that many modifications can be made within the scope of the present invention. For example, the catheter and guidewire barrier may initially be separate parts from the guidewire container and assembled at the time of use. Although the cylindrical configuration of the catheter and the guidewire barriers is presently preferred, other configurations are possible. For example, these barriers could be planar, having a perforation for being received over and connecting to the guidewire container and then subsequently unfolded over the catheter and guidewire.

Although the preferred embodiments of this invention has been described, it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the invention. Therefore, the claims are intended to include all such changes and modifications may be made therein without departing from the invention. Therefore, the claims are intended to include all such changes and modifications that fall within the true spirit and scope of the invention.