Abstract:
A protective sleeve for a catheter having a distal end capable of (i) being disposed within and engaging a majority of existing hemostatic valves; and (ii) capable of being partially inserted into a patient, thus, securing the sleeve to the patient in a sheathless catheter insertion procedure.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to a universal catheter guard. More particularly, the invention relates to a protective catheter sleeve capable of engaging a majority of existing hemostatic valves having widely differing hub designs. 
     2. Description of the Prior Art 
     Intra-aortic balloon (IAB) catheters are used in patients with left heart failure to increase coronary artery perfusion, decrease the workload of the left ventricle, and allow healing of the injured myocardium. The catheters, approximately 1 meter long, have an inflatable and deflatable balloon at the distal end. The catheter is typically inserted into the femoral artery, through an insertion sheath, and moved up the descending thoracic aorta until the distal tip of the balloon is positioned just below or distal to the left subclavian artery. A passageway for inflating and deflating the balloon extends through the catheter and is connected at its proximal end to an external pump. The proximal end of the catheter remains outside of the patient&#39;s body. 
     The insertion sheath generally has a hemostatic valve at one end. The purpose of the hemostatic valve is to prevent blood from traveling up the annular space between the catheter and the insertion sheath and escaping from the proximal end of the insertion sheath. The hemostatic valve generally has a hub for connection with a collapsible polymeric protective sleeve. Said sleeve is disposed about the catheter, and in its extended state, spans from the proximal end of the insertion sheath to the proximal end of the intra-aortic balloon catheter. The distal end of the sleeve has a collar which when disposed about the hemostatic valve hub secures the distal end of the sleeve to the hemostatic valve. The purpose of the sleeve is to keep the catheter free of contamination so as to prevent infection. The area where the catheter exits the skin of the patient is particularly sensitive to infections or irritation because it is essentially an open wound. 
     As a result of recent design developments in the IAB catheter field, a long awaited 8 Fr. catheter is now available from Datascope Corp. (Montvale, N.J.). One valuable feature of the 8 Fr. catheter is that due to its reduced size it is capable of passing through an already inserted sheath used for a previous procedure, such as angiography or angioplasty, which generally utilize sheaths that accommodate 8 Fr. catheters. Thus, after an angioplasty procedure, for example, rather than removing the angioplasty insertion sheath and replacing it with an IAB catheter insertion sheath, the IAB catheter can now be inserted into the existing angioplasty insertion sheath. 
     Given the use of the 8 Fr. IAB catheter with multiple insertion sheaths, the need exists for a protective sleeve having a universal connector capable of connecting to a majority of similarly sized insertion sheaths. 
     In sheathless procedures, the protective sleeve cannot be connected to the proximal end of the insertion sheath. It is generally left hanging loose, adjacent the insertion site. As a result, the sleeve may move and expose a portion of the catheter, thus increasing the chances of infection. Therefore, the need exists for a protective sleeve capable of being locked in place adjacent the insertion site during sheathless insertion of an IAB catheter. 
     SUMMARY OF THE INVENTION 
     Accordingly, it is an object of the invention to produce a protective sleeve for a catheter capable of connecting at its distal end to a majority of existing hemostatic valves. 
     It is another object of the invention to produce a protective sleeve capable of being safely used in a sheathless IAB catheter insertion procedure. 
     It is still another object of the invention to produce a protective sleeve capable of being partially inserted into the patient, during a sheathless procedure, thus, preventing exposure of the catheter. 
     The invention is a protective sleeve for a catheter having a distal end capable of (i) being disposed within and engaging a majority of existing hemostatic valves; and (ii) capable of being partially inserted into a patient, thus, securing the sleeve to the patient in a sheathless catheter insertion procedure. 
     To the accomplishment of the above and related objects the invention may be embodied in the form illustrated in the accompanying drawings. Attention is called to the fact, however, that the drawings are illustrative only. Variations are contemplated as being part of the invention, limited only by the scope of the claims. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the drawings, like elements are depicted by like reference numerals. The drawings are briefly described as follows. 
     FIG. 1 is a longitudinal cross section of a prior art protective catheter sleeve connected to a hemostatic valve. 
     FIG. 2 is a longitudinal cross section of the protective catheter sleeve of the present invention engaging a hemostatic valve. 
     FIG. 3 is a side view of the protective catheter sleeve of the present invention being used in a sheathless procedure. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Note that the proximal and distal directions, as herein used, are relative to the heart of patient. Therefore, the further distal a portion of a catheter is, the closer it is to the heart after insertion of the catheter. 
     FIG. 1 illustrates a longitudinal cross section of a catheter  10  inserted percutaneously through an insertion sheath  12  into a blood vessel  14  of a patient  16 . A hemostatic valve  24  has a hub  26  and is connected to or integrally formed with the insertion sheath  12 . The sleeve  20  is disposed about the catheter  10  and is made from a collapsible polymeric material. A sheath seal  18 , fixedly connected to a distal end  11  of a prior art protective catheter sleeve  20 , is removably connected to a proximal end  22  of the hemostatic valve  24 . More specifically, the sheath seal  18  is disposed about the hemostatic valve hub  26  and either frictionally engages or snaps onto said hub  26 . Alternatively, for insertion sheaths without a hemostatic valve, sheath seal  18  is disposed about a distal end of the insertion sheath  12 . An inner surface  17  of the hemostatic valve  24  defines hemostatic valve lumen  15 . A diaphragm  19 , projecting from the inner surface  17  of the hemostatic valve  24  into the hemostatic valve lumen  15 , creates a seal between the hemostatic valve  24  and the catheter  10 . A valve  13 , projecting from an inner surface  29  of the sheath seal body  30 , creates a seal between catheter  10  and sheath seal body  30 . 
     It is clear from FIG. 1 that the prior art protective catheter sleeve  20  is limited in that it can only be connected to hemostatic valves having hubs or ends specifically designed to mate with sheath seal  18 . 
     FIG. 2 illustrates a longitudinal cross sectional view of an improved catheter protective sleeve  20  fixedly attached to a tip portion or sheath seal body  30 . The sleeve  20  is shown independent of the patient  16  (FIG. 1) and the catheter  10  (FIG. 1) for clarity. A distal portion  18  of the sheath seal body  30  frictionally engages hemostatic valve diaphragm  19 . A distal end  9  of the distal portion  18  is preferably tapered. A middle portion  11  of the sheath seal body  30  has a taper which mates with and fits snugly in an internal taper on a proximal end of inner surface  17 . The sheath seal body  30  may have suture pads  25  for securing the sleeve  20  to the patient. The sleeve  20  is preferably made from a collapsible “crunchable” polymeric material which allows the sleeve  20  to be used with catheters of various lengths. Valve  13 , projecting from an inner surface  29  of the sheath seal body  30 , creates a seal between catheter  10  and sheath seal body  30 . 
     In an alternate embodiment of the invention, an elevation (not shown) projecting from an outer surface  28  of the sheath seal body  30  may frictionally engage inner surface  17  of the hemostatic valve hub  26  to secure the connection between the sleeve  20  and the hemostatic valve  24 . Sheath seal body  30  may engage hemostatic valve  24  by any means known in the art to engage two, at least partially, telescoping bodies. 
     Note that use of the sleeve  20  of the present invention is anticipated with an insertion sheath without a hemostatic valve  24 . In such a situation the sheath seal body  30  of the sleeve  20  would engage a proximal portion of the inner surface of the insertion sheath. Note further that a strain relief device (not shown) may be incorporated into the design of the sheath seal body  30 . 
     In sheathless procedures, a portion of the distal portion  18  of the sheath seal body  30  may be inserted directly into the patient  16  at the insertion site  32  of the catheter  10  so as to hold the sheath seal body  30  in place, as illustrated in FIG.  3 . Securing the sheath seal body  30  in this manner assures that the catheter remains covered, and thus, reduces the chance of infection. The distal portion  18  of the sheath seal body  30  does not enter the blood vessel  14  of the patient  16 . 
     Note that although the protective sleeve of the present invention is illustrated for use with an intra-aortic balloon catheter, use of the protective sleeve is anticipated with other types of catheters.