Abstract:
This invention concerns a catheter protective device useful for a Y-adaptor, where a tubular member is positioned at the proximal end of the Y-adaptor The tubular member protects a catheter from being crushed by a fastener on the Y-adaptor and minimizes blood bleed-back.

Description:
FIELD OF THE INVENTION 
     This invention is directed to a catheter protective device. More particularly, this invention is directed to a device for protecting the proximal sections of catheters and minimizing blood loss during catheter exchanges. 
     BACKGROUND OF THE INVENTION 
     During certain invasive intravascular procedures such as percutaneous transluminal coronary angioplasty (PTCA), a number of devices are inserted into and removed from the patient&#39;s cardiovascular system through an opening, for example, in the femoral artery. In a typical procedure, a guide catheter with a diameter of approximately 8 French will be advanced distally within the patient&#39;s arterial system and then a guidewire will be advanced within the guide catheter, to the point that the distal portion of the guidewire will be maneuvered to a point distal to the distal end of the guide catheter. Then, dependent upon the particular procedure being performed, one or more different catheters will be advanced over the guidewire, including situations where one catheter may be “exchanged” for another over the guidewire. 
     Typically at the proximal end of the guide catheter there will be a “Y” adaptor having two or more manifolds or ports for the introduction of and removal of guidewires, catheters, and the like. In some instances an additional Y-adaptor may be linked to another Y-adaptor. 
     One characteristic of the Y-adaptors is that they are preferably able to tighten, that is, “clamp down”, onto a device such as a catheter to be inserted, to hold the catheter in position as well as to minimize blood leakage and to allow simultaneous monitoring of blood pressure. Existant Y-adaptors have the drawback that they sometimes will damage expensive, mechanically fragile catheters when the clamp is tightened or inhibit intracatheter movement. In addition, there may be a significant blood loss, particularly during certain catheter exchanges. 
     In recognition of the aforementioned problems at least one company has developed a modified Y-adaptor that has an O-ring arrangement. However, that arrangement is specific to that one particular company&#39;s Y-adaptor. Also, some cardiologists have adopted commercially available Y-adaptors by adding additional O-rings to minimize bleed-back during catheter exchanges. However, this is a cumbersome and unacceptable procedure. 
     OBJECT OF THE INVENTION 
     It is an object of this invention to provide a catheter protective device. 
     It is also an object of this invention to provide a device for minimizing damage to catheters that are secured by Y-adaptors in vascular procedures. 
     It is a further object of this invention to minimize blood loss during certain intravascular procedures. 
     It is a yet further object of the converter to provide a simple device for modifying existant Y-adaptors to reduce blood loss and to minimize catheter damage. 
     These and other objects of the invention will become more apparent from the description above. 
     SUMMARY OF THE INVENTION 
     This invention is directed to a device for protecting catheters, particularly during invasive cardiological procedures. According to the invention, a device is designed to be positioned by control of the proximal portion of a guide catheter. The device comprises a tubular member to be positioned within the proximal portion of a Y-adaptor as well as a Y-adaptor containing such a tubular member. The tubular member is held in position by an annular valvular or locking mechanism. Preferably there is an O-ring or a one-way valve in the annular space between the tubular member and the proximal portion of the Y-adaptor. It is also preferable that the lumen of the tubular member will contain a hemostatic valvular mechanism. Further, preferably the tubular member will comprise a reasonably stiff material that will resist crushing of any catheter or other device that might be inserted through the lumen of the tubular member. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 comprises a schematic, partially cross-sectional view of an embodiment of the invention; 
     FIG. 2 is a cross-sectional view along line  2 — 2  of the embodiment of FIG. 1; and 
     FIG. 3 is a partial, cross-sectional view of another embodiment of the invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention can perhaps be better appreciated by making reference to the drawings. In FIG. 1, a conventional Y-adaptor  10  comprises a manifold accepting member  12 , an inner lumen  14 , a connector  16 , such as a LUER LOK connector, for connecting to a guide catheter  18 , a fastener  20 , and a proximal opening  22 . Fastener  20  typically has a rotable member  24  for reducing the opening  22  to grip a catheter, guidewire, or other device  26  that is inserted into opening  22  and advanced through guide catheter  18 . 
     According to the invention a tubular member  28  is positioned within the proximal portion  30  of Y-adaptor  10 . The tubular member  28  extends proximally and distally of a lumen  32  formed within fastener  20 . An annular sealing member  34  is positioned in the annular space between tubular member  28  and the interior surface  36  of fastener  20 , as shown in a different view in FIG.  2 . Optionally, or alternatively, there may be an annular sealing member  38  in the annular space between the interior surface  40  of Y-adaptor  10  and tubular member  18 . A flange  41  rests against fastener  20  and prevents distal movement of tubular member  28 . 
     Sealing members  34  and  38  each preferably comprise an O-ring, a one-way hemostatic valve, or a multileaf valve to prevent blood or other fluid leakage or bleed-back. Lumen  42  of tubular member  18  preferably comprises a one-way hemostatic valve  44 . 
     Tubular member  28  comprises at least one lumen  42  through which a guidewire or an intravascular catheter, represented as  26 , could be inserted. Useful intravascular catheters include balloon dilatation catheters, ultrasound catheters, radiation catheters, atherectomy catheters, local drug or radiation delivery devices, and the like. 
     Another embodiment of the invention is shown in FIG. 3, where a tubular member  50  comprises distal section  52  and proximal section  54 . Distal section  52  is positioned within a proximal portion  56  of a Y-adaptor. Proximal portion  56  comprises a rotable fastener  58  having a lumen  60 , and distal section  52  extends longitudinally within lumen  60 . 
     An annular sealing member  62  is positioned in the annular space between the interior space surface of fastener  58  and distal section  52 . Sealing member  62  preferably comprises an O-ring, a one-way hemostatic valve, or a multileaf valve to prevent blood or other fluid leakage or bleedback. 
     Tubular member  50  comprises one or more one-way hemostatic valves, in either distal section  52  or proximal section  54 , and one or more lumens. Preferably tubular member  50  comprises one lumen with a one-way hemostatic valve  64 , as shown, or in proximal section  54 . In another preferred embodiment there is a one-way hemostatic valve in each of distal section  52  and proximal section  54 . 
     Proximal section  54 , which may have a larger diameter or effective diameter than that of distal section  52 , may be circular or non-circular in inner cross-section or outer geometry. In one preferred embodiment proximal section  54  will have a hexagonal or octagonal outer geometry, and a distal surface  68  of proximal section  54  will fit against or engage proximal surface  70  of fastener  58 . Proximal section  54  could optionally have a non-uniform shape, such as, for example, a funnel shape. 
     Tubular member  28  or  50  can be useful in two ways: First, the tubular member can be inserted into a conventional commercially available Y-adaptor, such as the PASSAGE™ Hemostatic Valve, available from Merit Medical Systems. Preferably the tubular member would be inserted into the proximal part of a Y-adaptor prior to initiation of a procedure, e.g., when placing an initial balloon catheter into device  10 , although it is possible that it could be inserted during the procedure. The tubular member could be inserted into the proximal port, and then fastener  20  or  58  would be tightened to hold the tubular member in position. 
     And second, a Y-adaptor could be adapted to integrate tubular member  28  or  50 . Such a Y-adaptor could have a tubular member already inserted and positioned within a fastener. optionally no fastener will be required if the tubular member is otherwise fixed in position and catheters, guidewires, and the like are inserted through a lumen of the tubular member and held in position by a hemostatic valve means. 
     The tubular number will preferably be comprised of one or more suitable physiological acceptable polymers or metals. A polymer for the distal section of the tubular member must have sufficient rigidity to prevent the crushing of a catheter or guidewire. Suitable polymeric materials useful according to the invention include, but are not limited to, polyethylene, polypropylene, and copolymers thereof. Suitable metals include, but are not limited to, stainless steel and nitinol. It is within the scope of the invention that the tubular member may comprise two or more different materials bonded together. For example, the inside might comprise a rigid material whereas the outside may comprise a “softer”, less rigid material. 
     The tubular member is preferably from about 0.5 cm to about 10 cm in length, with an inner diameter of from about 0.2 mm to about 1.0 cm and a wall thickness of from about 0.1 mm to about 5.0 mm. The tubular member can be substantially cylindrical or its diameter could vary from one end to the other. Preferably the end with the smaller diameter could be positioned distally. Where the distal and proximal sections of the tubular member are discontinuous, as in FIG. 3, the total length of the tubular member will be from about 2 cm to about 12 cm, with the ratio of the respective lengths of the distal and proximal sections ranging from about 1:4 to about 10:1. The inner diameter and wall thickness of the distal section will be as described hereinbefore, whereas the inner diameter of the proximal section will preferably be from about 0.5 mm to about 3.0 cm and the wall thickness could range from about 0.1 mm to about 3.0 mm. 
     Any O-ring or hemostatic valve would be comprised of conventional materials, including, but not limited to, suitable polymeric materials such as silicone or silicone polymer. 
     The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, however, that other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the spirit of the invention or the scope of the appended claims.