Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-06
2003-03-25
Hayes, Michael J (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S167030, C604S535000
Reexamination Certificate
active
06537254
ABSTRACT:
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'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.
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Frisch Frank
Marques Manuel
McGinley Jeffrey
Schock Robert B.
Datascope Investment Corp.
Hayes Michael J
Ronai Abraham
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