Abstract:
A device for introducing a guide wire into a catheter comprising a housing having at least one lumen for permitting the passage of a guide wire therethrough. The lumen has an axial single seam positioned longitudinally along the lumen that is defined by opposite lateral ends of the housing. The seam comprises a gap that is dimensioned less than the diameter of the guide wire to be passed therethrough for preventing lateral removal of the guide wire from said device during use. The housing further comprises a plurality of gripping surfaces distinct from the seam for permitting a user to widen the seam to facilitate removal of a guide wire. The housing may further include an axial notch positioned generally about 180 degrees opposite from the seam to facilitate widening of the seam when it desired to remove the guide wire. The join may comprise a longitudinal groove on the housing. The gripable surfaces may each comprise a tab, or may comprise an indentation in the housing.

Description:
RELATED APPLICATIONS  
       [0001]     The present application is a continuation of U.S. application Ser. No. 10/272,209 filed Oct. 15, 2002, which claims priority 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/343,627 filed Oct. 22, 2001, the disclosures of which are incorporated by reference herein in their entirety. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a device for facilitating the insertion of a guide wire into a catheter lumen in a manner that the device can be removed from the guide wire while the guide wire remains loaded into the catheter.  
       BACKGROUND OF THE INVENTION  
       [0003]     In the treatment of human diseases and disorders, clinicians and interventionalists often routinely use some form of catheter based treatment system, whether for the aspiration or infusion of fluids, or for more elaborate procedures such as angioplasty. To advance a catheter or other tubular member within a patient&#39;s vasculature or other systemic lumen, it is often desired to use a guide wire pre-inserted into the patient to first locate and then preserve the pathway for the catheter. The catheter is advanced over the guide wire to a desired distal location, at which point the guide wire may be left in place or removed.  
         [0004]     A difficulty encountered in the use of a guide wire and catheter treatment system is inserting the guide wire through the lumen of the catheter. The internal lumen of catheters used in many different applications tends to be rather small, as small as 0.010 inches. In contrast, guide wires tend to have a diameter only a few thousands of an inch smaller than the intended lumen. Coupled with the fact that the distal end of a catheter is often tapered, the insertion of the proximal end of the guide wire into the distal end of the catheter or other tubular member is difficult at best. The resiliency of the catheter material adds to the difficulty. In the circumstances of medical intervention, such as a catheterization lab, where the lighting may be poor, intentionally or unintentionally, the difficulty of guide wire insertion is exacerbated.  
         [0005]     There have been efforts made to address this difficulty. For example, U.S. Pat. No. 5,320,613 to Houge et al. discloses a device that facilitates insertion of a guide wire into a catheter lumen. However, the Houge et al. device is flawed in that a longitudinal groove or slot is provided along the length of the device that has a width that is greater than the guide wire to permit the lateral removal of the guide wire from the device. The slot requires that the clinician hold his/her thumb over the slot to permit the guide wire insertion process to proceed. An alternative embodiment disclosed by Houge et al. adds a rotatable cover sleeve that covers the slot during use and, when rotated to expose the slot, permits removal of the guide wire after use.  
         [0006]     U.S. Pat. No. 5,978,699 to Fehse et al. also discloses a device that facilitates insertion of a guide wire into a catheter lumen. However, the Fehse et al. device is also flawed in that it presents a large cumbersome configuration that relies upon a hinged format to create a longitudinal slot through which the guide wire may be removed after use.  
         [0007]     The present invention reflects an improvement over the prior art by providing a self-contained guide wire insertion tool that is streamlined in configuration and avoids the need for an additional cover sleeve or the need for the clinician to hold his/her thumb over a removal slot.  
       SUMMARY OF THE INVENTION  
       [0008]     The present invention comprises a device for introducing a guide wire into a catheter, where the device comprises a housing having at least one lumen for permitting the passage of a guide wire therethrough. The lumen has an axial single seam positioned longitudinally along the lumen that is defined by opposite lateral ends of the housing. The seam comprises a gap that is dimensioned less than the diameter of the guide wire to be passed therethrough for preventing lateral removal of the guide wire from said device during use. The housing further comprises a plurality of gripping surfaces distinct from the seam for permitting a user to widen the seam to facilitate removal of a guide wire. The housing may further include an axial notch positioned generally about 180 degrees opposite from the seam to facilitate widening of the seam when it desired to remove the guide wire. The join may comprise a longitudinal groove on the housing. The gripable surfaces may each comprise a tab, or may comprise an indentation in the housing.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  is a side schematic view of the present invention insertion tool.  
         [0010]      FIG. 2  is an end schematic view of the device of  FIG. 1  taken along lines  2 - 2 .  
         [0011]      FIG. 3  is a side cross-sectional schematic view of the device of  FIG. 1  taken along lines  3 - 3 .  
         [0012]      FIG. 4  is a schematic view of the present invention insertion tool engaging a catheter through which it is desired to advance a guide wire.  
         [0013]      FIG. 5  is a cross-section schematic of the arrangement shown in  FIG. 4 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0014]     Referring to  FIGS. 1-3 , the invention comprises a guide wire insertion tool  10  that itself comprises a housing  12  having a proximal end  14 , a distal end  16 , and a mid-section  18  therebetween. Traversing longitudinally through the housing is a lumen  20  of sufficient diameter to permit the axial passage of a guide wire therethrough. Either of the proximal or distal end may be fitted with a Luer fitting (not shown) for engagement with a mating Luer fitting of a discrete piece. The insertion tool also includes a means for separating the insertion tool from a guide wire after use. In a first embodiment, the housing is configured in a rolled format so as to comprise one configuration of separating means: two lateral sides  24  and  26  spaced apart to define an already exposed seam  30 . The seam  30  of this first embodiment comprises a gap that is sufficiently small in its normal position to preclude the unintended removal of the guide wire from the housing during use.  
         [0015]     The housing  12  is preferably tapered radially outward from the mid-section  18  toward the proximal end  14  and distal end  16 , respectively so as to provide a funnel-like appearance. The large diameter ends define proximal and distal openings  32  and  34  that serve to permit easy feeding of a guide wire into the lumen  20 . Like the profile of the housing, the profile of the lumen  20  preferably has a taper extending radially outward from the mid-section  18  toward the proximal end  14  and distal end  16 . Having a tapered lumen facilitates effective engagement of the insertion tool  10  with a catheter during use, as explained more fully below. The interior surface of the lumen  20  is preferably smooth and untextured, although it is not necessary for effective operation. Within the mid-section, the lumen preferably has a diameter only slightly larger than the diameter of the guide wire to restrict undesired lateral movement of the guide wire, which permits greater control during advancement of the guide wire through the insertion tool. In one embodiment, for guide wires having diameters approximately 0.014 inches, it is contemplated that the interior diameter of lumen  20  within mid-section  18  would be approximately 0.017 inches, although other diameters would be effective.  
         [0016]     In the preferred embodiment, each of the proximal end  14  and distal end  16  includes a recess  38  that serves the purpose of directing the guide wire through seam  30  when it is desired to remove the guide wire from the insertion tool, although such a recess is not necessary for effective use. When removing the guide wire insertion tool  10  from a guide wire, the tool  10  may be angled in such a way that the guide wire is directed to one of the recesses  38  on the tool. Once the guide wire is at the notched location, the tool may continue to be angled in such a way that the guide wire is urged through seam  30 . In this manner, the tool may be removed from around the guide wire, using only tactile feel, without looking at the guide wire or tool.  
         [0017]     The separating means of housing  12  further comprises means for gripping the housing in a manner that permits widening the seam  30  to permit separation of the guide wire form the insertion tool  10 . In one embodiment, shown in  FIGS. 1 and 2 , the gripping means comprises separator tabs  40  extending radially outward from the housing surface. The tabs  40  are joined to the housing  12  at opposite sides of the seam  30  to permit a user to grip the tabs  40  and pull them apart. Doing so results in the seam gap widening sufficiently to permit removal of the guide wire. The tabs may be positioned directly across from each other, or may be positioned longitudinally offset from each other. In the former case, the separator tabs  40  should be spaced apart to permit the user to effectively grasp the tabs. Other arrangements for the tab are also contemplated, so long as they permit the user to grip the tabs and widen the seam  30  for guide wire separation. The tabs  40  may be made integral with the housing or may be discrete components attached to the housing. In another embodiment of the separating means, the gripping means may comprise indentations in the housing at the already exposed seam that permit the user to grip opposing lateral sides  24  and  26  of the housing to widen the seam gap.  
         [0018]     The insertion tool may optionally further comprise means for facilitating widening of the seam  30 . In the preferred embodiment, the facilitating means comprises a longitudinally extending notch  44 , as shown more clearly in  FIG. 2 . Given housing material that is sufficiently pliable, the notch  44  facilitates widening of the housing seam  30  by reducing the thickness of the housing wall at a point radially opposite of the seam  30 . That reduced wall thickness results in a weaker resistance to radial bending of the housing  12 , thus facilitating widening of the seam  30 . In effect, the notch  44  presents a living hinge-like arrangement. In an alternative embodiment, the housing material is sufficiently rigid that the housing intentionally breaks at the notch. In that embodiment, widening of the seam is not the goal. Other configurations for the facilitating means are also contemplated, including longitudinal scoring that results in a weakened housing portion, and other means known to persons of ordinary skill in the art. Indeed, no notch or scoring is necessary if it is desired nearly to have the facilitating means comprise a thinner wall that permits resilient bending of the wall at the thinner wall area.  
         [0019]     As described above, the already exposed seam  30  through which the guide wire may be separated from the insertion tool  10  is preferably defined by opposing lateral sides of the housing  12 . Other means for separating the guide wire from the housing are contemplated. For example, instead of an exposed seam, the housing may comprise a longitudinally arranged set of perforations that permit the user to break the housing wall at the perforations for guide wire separation. Such an arrangement would further comprise gripping means that may be similar to that described above, or some other effective gripping means. Yet another alternative embodiment of separating means comprises a tearable housing wall portion that would permit a user, by gripping a tab or other like grabable protrusion, to remove a longitudinal section of the housing wall from proximal end to distal end (or vice versa), thereby exposing a seam for separation of the guide wire from the insertion tool. No gripping means for widening the seam would be necessary with such an arrangement. With at least some of these alternative arrangements, means for facilitating widening of the seam may be used if so desired.  
         [0020]     Referring to  FIGS. 4 and 5 , the present invention also comprises one or more methods of using the inventive insertion tool  10  in which one method comprises the step inserting the distal end of a catheter  60  into the proximal end  14  of the housing  12  to permit fairly tight engagement of the catheter tip with the interior tapered portion of lumen  20 . Often distal tips of catheters are themselves tapered, permitting more effective engagement with the tapered portion of lumen  20 , as shown more clearly in  FIG. 5 . The method further comprises the steps of inserting a guide wire  70  into the distal end  16  of the housing and advancing the guide wire through the lumen  20  into the mid-section  18 . Continued advancement of the guide wire  70  results in the guide wire  70  being smoothly directed into the distal end of catheter  60 . Once the guide wire  70  is sufficiently advanced within the catheter, the insertion tool  10  is no longer needed and may be separated from the guide wire following the inventive steps. With one embodiment described herein, the method further comprises gripping the gripping means, in one case tabs  40 , to widen the seam  30  and permit removal of the guide wire from lumen  20 . Once the insertion tool  10  is separated, the clinician may then proceed with further treatment of the patient by advancing the catheter  60  along the guide wire  70  into the patient. Alternative methods comprise the alternative step of using an insertion tool that employs indentations rather than gripping tabs, that permit a user to grip the housing in such a away as to widen the seam. Alternative steps include gripping a pull tab longitudinally along the housing to expose a seam that is sufficiently wide to permit separation of the guide wire.  
         [0021]     It is contemplated that the present inventive insertion tool  10  be made of material that is sufficiently rigid and stable to permit insertion and advancement of a guide wire into the housing  12 , yet sufficiently resilient to permit opening of the seam to remove the guide wire. In one preferred embodiment, the housing  12  is made of a thermoplastic rubber (TPR) such as that sold under the brand name Santoprene®, for example. Other medical grade materials may also be used as well, including metals, metal alloys, silicone, polymers such as polycarbonate, polyethylene, polyester, polypropylene, polyurethane, fluoropolymers, PVC or other polymers, including those sold under the trade names Pebax® and Surlyn®. The contemplated hardness is preferably approximately 70-100 on the Shore A scale and approximately 20-50 on the Shore D scale. It should be recognized that materials having a finished hardness outside this range would also be effective for the application described herein. The insertion device of the present invention may incorporate a biocompatible fluorescing feature, making the device easier to see in the clinical setting. The florescence may be realized by using a coating, or by including fluorescing materials during the compounding or molding (or other) manufacturing processes. Also, the external surface of the housing may be textured to provide better gripping by the clinician.  
         [0022]     Contemplated methods of manufacture include injection molding, casting, machining, extrusion, a combination of any of these, or some other suitable manufacturing method. The insertion tool may be made of unitary construction, or a combination of assembled components.  
         [0023]     One anticipated advantage of the present inventive insertion tool is that is may be reusable during multiple catheter insertions for a single patient. By employing a living hinge in the design, i.e., the longitudinal notch that permits the seam to be widened without breaking the housing, the present invention is reusable, provided adequate sterilization procedures are applied. Being reusable for a single patient reduces the incremental cost per procedure and further increases the speed and ease of use. Since multiple wire exchanges are done on a single patient, being able to reuse cuts down on the incremental time to open additional packages associated with incremental wire exchanges.  
         [0024]     It should be noted that the present invention insertion tool may also be used outside the clinical context for the feeding of any thin object into a correspondingly thin opening. It is also contemplated that a set of insertion tools may be provided, each with a different diameter lumen for guiding differently sized objects therethrough, where removal of the tool from around the side is useful.