Abstract:
An introducer of the type employing an elongated introducer sleeve for receiving a catheter or lead body and an associated hemostasis clamp including a clamping member configured to engage the outer circumference of the introducer sleeve. The clamp is provided with a mechanism for maintaining the clamping member in engagement with said outer circumference of the sleeve to compress the outer circumference of the sleeve around a catheter or lead body inserted therethrough. In some embodiments the clamp takes the form of a hinged clamp provided with two jaws each having a recess adapted to engage a portion of the other circumference of the introducer sleeve. In other embodiments the clamp takes the form of interacting ramped members. The clamp is maintained in engagement with the sleeve either resiliently or by means of a latch.

Description:
BACKGROUND OF THE INVENTION 
     Introducers for implantable leads and catheters typically include a dilator and an associated introducer sleeve, through which the lead or catheter is to be inserted. Conventional designs of lead and catheter introducers are disclosed in U.S. Pat. No. 4,306,562 issued to Osborne, U.S. Pat. No. 4,596,559 issued to Fleischhacker and U.S. Pat. No. 4,166,469 issued to Littleford. In conjunction with such introducers, it has become common to include a hemostasis valve. Introducers including hemostasis valves are illustrated in U.S. Pat. No. 5,672,158 issued to Okada et al., U.S. Pat. No. 5,098,393 issued to Amplatz et al. and U.S. Pat. No. 5,312,355 issued to Lee. In all such cases, the hemostasis valve engages the circumference of the lead or catheter to be introduced. 
     SUMMARY OF THE INVENTION 
     The present invention is directed toward a substantially simplified lead or catheter introducer including an external hemostasis clip as a substitute for the more conventional hemostasis valve. The hemostasis clip, rather than engaging the circumference of the lead or catheter compresses the introducer sleeve around the external circumference of the lead or catheter. In its preferred embodiments, the clip is configured so that it may be removed from the sleeve, prior to the sleeve being removed from the catheter or lead body by means of either slitting or tearing the introducer sleeve. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a plan view of an introducer including the hemostasis clip according to the present invention. 
     FIG. 2 is an end plan view of an introducer clip according to the present invention. 
     FIG. 3 is a bottom plan view of a first embodiment of an introducer clip according to the present invention. 
     FIG. 4 is a side plan view of an introducer, including the hemostasis clip of the present invention, impressing the introducer around the body of a lead or catheter passing through the introducer sleeve. 
     FIG. 5 is a cross-sectional view through the introducer and lead combination of FIG. 4, showing compression of the introducer sleeve around the lead body. 
     FIG. 6 is a perspective view of an alternative embodiment of a hemostasis clip according to the present invention. 
     FIG. 7 is a perspective view of a second alternative hemostasis clip according to the present invention. 
     FIG. 8 is a side plan view of an alternative embodiment of an introducer according to the present invention employing a hemostasis clip which includes compression members mounted permanently to the introducer sleeve. 
     FIG. 9 is a sectional view through the introducer of FIG. 8 illustrating the configuration of the compression members and an associated compression ring employed to compress the introducer sleeve around a lead body or catheter body passed therethrough. 
     FIGS. 10 a  and  10   b  are cross-sectional views through alternative embodiments of the compression ring illustrated in FIG.  9 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 is a plan view of the first embodiment of an introducer and associated hemostasis clip according to the present invention. The introducer includes an introducer sleeve  10  which is provided with weakened zones  16  extending the length of the introducer sleeve on opposite sides of the sleeve, allowing the sleeve to be separated into two pieces and removed from the catheter or lead passed therethrough as disclosed in U.S. Pat. No. 4,166,469 issued to Littleford, and incorporated herein by reference in its entirety. At the proximal end of sleeve  10  are mounted handles  14  which are employed to separate the sleeve  10  so that it may be removed from the lead or catheter passed therethrough. Handles  14  are molded of a single plastic component provided with weakened zones  18  on either side of the handle assembly, facilitating separation of handles  14 . A dilator  12  is illustrated inserted into sleeve  10 . A luer lock fitting  20  is mounted to the proximal end of the dilator. 
     A hemostasis clip  22  is coupled to one of the handles  14  by means of a plastic lanyard  24 . Clip  22  and handles  14  and lanyard, may all be molded of a single piece of plastic or may be assembled of multiple plastic components. Clip  22  in general resembles a tubing clamp of the type typically employed to clamp off medical tubing, and includes upper and lower jaw members  28  and  30 , connected by means of a recessed area  34 . At one end of the upper jaw  28  is located a first latching member  26  which engages a corresponding latching member  27  coupled to lower jaw  30  by means of a second recessed area  32 . In use, the sleeve  10  is clamped between upper and lower jaws  28  and  30 , and passes through recessed areas  32  and  34 . The structure in operation of clamp  22  is discussed in more detail below. 
     FIG. 2 is a proximal end view of clamp  22 . In this view, the proximal surface of the second latching member  27  is visible along with the configuration of the first recessed area  32 , through which the introducer sleeve  10  (FIG. 1) will pass. In this view, it can be seen that upper and lower jaw members  28  and  30  are each provided with a recess,  38  and  36 , which are intended to engage the sleeve  10  (FIG. 1) around its outer circumference. 
     FIG. 3 is a bottom plan view of hemostasis clip  22 , further illustrating the configuration of recessed areas  32  and  34  through which the introducer sleeve  10  passes. The lower surfaces of latching members  26  and  27  and lanyard  24  are also visible in this view. 
     FIG. 4 illustrates the hemostasis clamp  22 , clamped around introducer sleeve  10 , compressing it around the body of catheter or lead  40 , passing therethrough. The introducer sleeve  10  is located within the recesses  36  and  38  (FIG. 2) and is compressed therein around the outer circumference of lead or catheter  40 . Latching members  26  and  27  maintain compression of the upper and lower jaws  28  and  30 , respectively. In this view it can also be seen how introducer sleeve  10  passes through recessed areas  32  and  34 . All other numbered elements correspond to those illustrated in FIG.  1 . 
     FIG. 5 is a cross-sectional view through the combination of the introducer and catheter or lead illustrated in FIG.  4 . In this view it can be seen how the introducer sleeve  10  is compressed around lead body  40  to provide a seal. While the seal is not air tight, it is sufficient to prevent any significant flow of blood proximally through the introducer sleeve  20 . All other labeled components correspond to those illustrated in FIGS. 2 and 4. In addition, the clamp  22  may also be employed to clamp the introducer sleeve  10  against itself to provide a seal, by clamping the sleeve in region  39 , between the linear portions of the jaws  28  and  30 . 
     FIG. 6 is a perspective view of an alternative embodiment of a hemostasis clamp appropriate for use with the present invention. The clamp  50  is coupled to an associated introducer sleeve by means of a lanyard  58  and includes upper and lower jaws  52  and  54  which carry corresponding recesses  60  and  62  for engaging the outer circumference of the associated introducer sleeve. The clamp is provided with two handle portions  53  and  55  which when compressed cause flexion of resilient hinge portion  56  of the clamp, allowing the clamp to be opened. Optionally, an additional spring may be provided located between handles  53  and  55  to assist in compression of the upper and lower jaws  54  and  52  around the introducer sleeve. 
     FIG. 7 is a perspective view of a second alternative embodiment of as hemostasis clip for use in conjunction with the present invention. Hemostasis clip  70  is attached to an associated introducer by means of lanyard  73  and includes upper and lower jaws  76  and  74 , respectively, which each include a corresponding recess  80  and  78 , respectively for engaging the outer surface of the associated introducer sleeve. The clamp is provided with latching members  72  and  74  corresponding to latching members  27  and  26 , respectively of the clamp illustrated in FIGS. 1 through 5. 
     The alternative embodiments illustrated in FIG.  6  and FIG. 7 work functionally precisely in the manner of the clamp illustrated in FIGS. 1 through 5 with the exception that the hinge mechanism connecting the two jaws of the clamps operates perpendicular of the hinging mechanism of the clamp illustrated in FIG.  4 . In use, after the lead is passed through the introducer sleeve, the associated clamp, according to any of the preceding three embodiments is simply clamped around the introducer sleeve to compress it against the lead or catheter body. When it is time for the introducer sleeve to be removed, the clamp is simply released and removed from the introducer sleeve allowing the introducer to be slit or torn in a conventional manner. 
     FIG. 8 is a plan view of an additional alternative embodiment of a clamping mechanism for use in conjunction with an introducer according to the present invention. In this embodiment, the introducer sleeve  100  is provided with two ramped, semi-conical members  116 , located on either side of the weaken zones  118 , on either side of the sleeve. Ramped members  116  are each provided with a circumferential groove  122  which engages a corresponding internal circumferential projection in clamping ring  120 . The interior surface of clamping ring  120  is provided with a corresponding conical, ramped surface which, on being slid proximally along ramped members  116  compresses introducer sleeve  100  around the circumference of a lead or catheter body inserted therethrough. The ramped members  116  and clamping ring  120  are configured so that a tight seal around the lead or catheter body is accomplished when the internal circumferential projection within clamping ring  120  engages grooves  122 . Clamping ring  120  can be detached from ramped members  116  by simply sliding it distally, disengaging the internal projection therein from grooves  122 . Clamping ring  122  is coupled to handles  114  by means of a lanyard  119 . Removal of clamping ring  120  from sleeve  100  prior to slitting or tearing of sleeve  100  may be accomplished by configuring anchoring ring  120  as a “C” shaped ring which may be expanded to allow removal from introducer sleeve  100  or by configuring anchoring ring  120  as a hinged ring with a latch, which may be unlatched and opened, allowing removal of clamping ring  120  from introducer sleeve  100 . The configurations of ramped members  116  and clamping ring  120  are discussed in more detail below. 
     FIG. 9 is a sectional view the portion of the introducer illustrated in FIG. 8, including ramped members  116  and clamping ring  120 . In this view the configuration of the internal, conically ramped surface  124  of clamping ring  120  and the configuration of the circumferential interior projection  126  is visible. In use, clamping ring  120  is simply slid proximally until internal projections  126  engage indentations  122 , holding introducer sleeve  100  clamps tightly around the catheter or lead body passing therethrough. 
     FIG. 10A is a cross-sectional view through a first embodiment of clamping ring  120 . In this embodiment, clamping ring  120 A is formed to provide an integral hinge  128  and a releasable latch  130 . On release of latch  130  by compression of clamping ring  120 A, the ring may be opened at hinged portion  128  and removed from the associated introducer sleeve. Internal projection  126 A is also visible in this view. 
     FIG. 10B is a cross-sectional view through a second embodiment of a clamping ring  120 B according to the present invention. In this embodiment, the clamping ring  120 B is formed as a “C” shaped ring, having a lateral opening  132 . Removal of the clamping ring  120 B from the associated introducer sleeve is accomplished by simply spreading apart the ends of the locking ring  120 B adjacent opening  132  and removing the ring from the introducer sleeve. Internal projection  126 B is also visible in this view. 
     In conjunction with the above disclosure, a number of specific alternative mechanisms for allowing compression of an introducer sleeve around a catheter or lead body inserted therethrough are disclosed to illustrate the present invention. These illustrated embodiments are intended to be merely exemplary of the invention, rather than limiting, in conjunction with the claims which follow.