Abstract:
A hub device and a method for reception of a flexible elongate device therethrough are provided. The hub device includes a proximal portion having a substantially cylindrical opening defined in the proximal portion, a first connector at a proximal end of the proximal portion for connecting to a medical device and a distal portion connectable to an elongate shaft. The hub device further includes a lumen extending from the cylindrical opening in the proximal portion to a non-cylindrical cross-sectional lumen portion in the distal portion of the hub device, the lumen including a distal tapered portion tapering to the non-cylindrical cross sectional lumen portion. The distal tapered portion includes a first pair of longitudinal loop guides positioned on opposite sides of the lumen and configured to receive and collapse a loop of an elongate device received and distally advanced through the lumen.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/320,856, filed Apr. 5, 2010, which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    This invention relates to hubs for reception of wire guides used in the placement of medical devices, and more particularly to hubs for reception of wire guides having a loop tip. 
         [0004]    2. Background Information 
         [0005]    Wire guides are elongate flexible members used to provide a path along which another medical device can be moved. The path provided by the wire guide can be used to navigate another medical device, such as a catheter through a body vessel. The wire guide provides an established path for placing other devices and eliminates the need for performing delicate navigation procedures for each device passed into the body lumen, for example when additional procedures are performed. 
         [0006]    During placement of the wire guide, an operator must navigate the wire guide through a tortuous pathway in the body lumen due to the presence of natural bends and/or curves, or unnatural impediments, such as tumors, build-ups, and/or strictures. The operator may chose to navigate the lumen with a standard wire guide having a generally straight distal tip or a loop tip wire guide having a deformable loop at the distal tip. Loop tip wire guides are beneficial in navigating tortuous pathways to avoid having the end of the wire guide trapped in a pocket or sharp curve. The loop tip flexes against the pathway to move the wire guide distally to the treatment site. 
         [0007]    Several types of catheters, including treatment devices, are used in endoscopic procedures that are delivered to the treatment site over the wire guide. These catheters typically include a hub connected the proximal end of the catheter through which the wire guide is inserted and extended out of the distal end of the catheter for navigation of the wire guide through the pathway. Conventional hubs typically include a luer connector at a proximal end of the hub and are connected to the catheter at a distal end of the hub. A loop tip wire guide is generally not designed to work with the conventional hub provided on the catheter. The loop portion deforms when the loop is advanced into the hub in such a way that the loop is not properly compressed at the loop portion so that the tip of the loop is narrowed for advancement into the narrower lumen of the catheter. Insertion of the loop tip wire guide into a conventional hub may deform the loop so that the loop widens and resists insertion in to the narrower lumen of the catheter. 
         [0008]    What is needed is a hub for the reception of a wire guide that is suitable for receiving a conventional wire guide and a loop tip wire guide so that the wire guide is advanceable into the lumen of the catheter. 
       BRIEF SUMMARY 
       [0009]    The various preferred embodiments provide improvements and advantages over conventional hubs configured for receiving straight wire guide tips. 
         [0010]    According to one aspect of the present invention, a hub device for reception of a flexible elongate device therethrough is provided. The hub device includes a proximal portion having a substantially cylindrical opening defined in the proximal portion, a first connector at a proximal end of the proximal portion for connecting to a medical device and a distal portion connectable to an elongate shaft. The hub device further includes a lumen extending from the cylindrical opening in the proximal portion to a non-cylindrical cross-sectional lumen portion in the distal portion of the hub device, the lumen including a distal tapered portion tapering to the non-cylindrical cross-sectional lumen portion. The distal tapered portion includes a first pair of longitudinal loop guides positioned on opposite sides of the lumen and configured to receive and collapse a loop of an elongate device received and distally advanced through the lumen. 
         [0011]    According to another aspect of the present invention, a medical device for reception of a flexible elongate device therethrough is provided. The medical device includes an elongate shaft and a hub device connected to a proximal portion of the elongate shaft. The hub device includes a proximal portion and a distal portion; and a lumen extending from the proximal portion to the distal portion. The lumen includes a non-cylindrical cross-sectional lumen portion in the distal portion, a distal tapered portion tapering to the non-cylindrical cross-sectional lumen portion, and a first pair of longitudinal loop guides defined in the distal tapered portion and positioned on opposite sides of the lumen and configured to receive and collapse a loop of an elongate device received and distally advanced through the lumen and into a lumen of the elongate shaft. 
         [0012]    According to another aspect of the invention, a method of advancing a flexible elongate device through a hub device and into an elongate shaft is provided. The method includes inserting a loop tip of a flexible elongate device into a hub device. The hub device includes a proximal portion having a substantially cylindrical opening defined in the proximal portion and a distal portion connected to an elongate shaft. The hub device further includes a lumen extending from the cylindrical opening in the proximal portion to a non-cylindrical cross-sectional lumen portion in the distal portion, the lumen having a distal tapered portion tapering to the non-cylindrical cross-sectional lumen portion and the distal tapered portion comprising a first pair of longitudinal loop guides positioned on opposite sides of the lumen. The method further includes distally advancing the loop tip from the cylindrical opening to a distal tapered portion, engaging loop portions of the loop tip with the first pair of longitudinal loop guides to orient the loop, and compressing the loop against the first pair of loop guides as the loop advances distally to the non-cylindrical cross-sectional portion and into a lumen of the elongate shaft. 
         [0013]    The foregoing paragraphs have been provided by way of general introduction, and are not intended to limit the scope of the following claims. The presently preferred embodiments, together with further advantages will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Embodiments of the present invention will now be described by way of example with reference to the accompanying drawings, in which: 
           [0015]      FIG. 1  is a partial perspective view of a wire guide hub connected to a catheter according to an embodiment of the present invention; 
           [0016]      FIG. 2  is an end view of an embodiment of the hub shown in  FIG. 1 ; 
           [0017]      FIG. 3  is a perspective view of the interior of the hub shown in  FIG. 2 ; 
           [0018]      FIG. 4  is a side view of the hub shown in  FIG. 3 ; 
           [0019]      FIG. 5  is a side view of the hub shown in  FIG. 4  rotated 90° C.; 
           [0020]      FIGS. 6A-6F  illustrate cross-sectional views through the lumen portion of the hub  10 ; 
           [0021]      FIG. 7  is a side view of an alternative embodiment of a wire guide hub; 
           [0022]      FIGS. 8A-8D  illustrate distal portions of wire guides; and 
           [0023]      FIGS. 9A-9C  illustrate a wire guide being inserted, oriented and narrowed by the hub in accordance with the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention as described below are by way of example only, and the invention is not limited to the embodiments illustrated in the drawings. It should also be understood that the drawings are not to scale and in certain instances details have been omitted, which are not necessary for an understanding of the present invention, such as conventional details of fabrication and assembly. 
         [0025]    As used in the specification, the terms proximal and distal should be understood as being in the terms of a physician using the wire guide in the hub device. Hence the term distal means the portion of the wire guide hub which is farthest from the physician and the term proximal means the portion of the wire guide hub which is nearest to the physician. 
         [0026]      FIG. 1  illustrates a perspective view of a hub  10  according to an embodiment of the invention. The hub  10  is shown connected to a catheter  20 , however, the hub  10  may be connected to any type of device through which a wire guide may be inserted. The hub  10  may be removably or non-removably connected to the catheter  20 . The hub  10  includes a proximal portion  22  and a distal portion  24 . The proximal portion  22  of the hub  10  may include a connector  26 . The connector  26  may comprise a thread, flange, protrusion or rib for removably interlocking with a syringe (not shown). By way of non-limiting example, the connector  26  may be a luer connector. The hub  10  may further include a gripping portion  28  that facilitates operation, handling, manipulation and/or movement of the hub  10  by the physician. The gripping portion  28  may have any shape to provide a gripping surface, for example square, hexagonal, or textured and the like. In some embodiments, a setoff  32  may be included distal to the connector  26  and proximal to the gripping portion  28  to facilitate connection of the syringe or other device to the connector  26  without interference with the gripping portion  28 . A second connector  34  may be provided at the distal portion  24  of the hub  10  for connecting the hub  10  to an outer catheter or other device (not shown). The second connector  24  may comprise a thread, flange, protrusion or rib for removably interlocking with the second device. 
         [0027]    A lumen  36  extends through the hub  10  from a proximal opening  38  to a distal opening  42  of the hub  10  and fluidly connects with the catheter  20 . An end view from the proximal portion  22  of the hub  10  is shown in  FIG. 2 .  FIGS. 2-5  are schematic drawings where the exterior features are not shown to improve clarity of the interior features depicted in these drawings. The proximal opening  38  tapers to the narrower distal opening  42 . As shown in  FIGS. 2 and 3 , the proximal opening  38  is circular and the lumen narrows through a distal tapered portion  44  to a lumen portion  46  having a non-circular cross sectional shape and to the distal opening  42 .  FIG. 3  illustrates the features of the interior of the hub  10  and omits the exterior features for clarity. The proximal opening  38  may be sized and shaped according to the conventional luer connection and connected to a proximal lumen portion  48  sized and shaped to receive a syringe or other connection. As shown in  FIG. 3 , the proximal lumen portion  48  may have a slight taper from the proximal opening  38  to the distal tapered portion  44  and have a generally circular cross sectional shape. The lumen  36  between the proximal opening  38  and the distal opening  42  is generally smooth so that a tip of the wire guide will pass through the lumen  36  without catching at any of the transitions from the proximal opening  38  to the proximal lumen portion  48 , the distal tapered portion  44 , the lumen portion  46  and the distal opening  42 . 
         [0028]      FIGS. 2-5  illustrate the distal tapered portion tapering to a rectangular cross-sectional shape at the lumen portion  46 .  FIG. 4  shows a side view of the interior features of the hub  10  with the distal tapered portion  44  tapering to a rectangular cross-sectional shape at the lumen portion  46  with a long side  47  of the rectangular lumen portion  46  is shown.  FIG. 5  shows a side view of the interior features of the hub  10  that has been rotated 90° from the view shown in  FIG. 4  so that a short side  49  of the rectangular lumen portion  46  is shown. As shown in  FIG. 7 , the lumen  36  may also have walls  50  that bow inward in the distal tapered portion  44 . The inward curve of the walls  50  may facilitate orientation and collapse of the loop tip of the wire guide within the hub to narrow and position the tip of the wire guide for insertion into the catheter. (The wire guide is shown in  FIGS. 8A-8D  and  9 A- 9 C.) 
         [0029]      FIGS. 6A-6F  illustrate exemplary non-circular cross sectional shapes of the lumen portion  46 . Each of the cross-sectional shapes shown in  FIGS. 6A-6F  includes at least one pair of loop guides  54  that are configured to engage the sides of the loop of the wire guide to compress and orient the loop for insertion of the tip of the loop into the catheter  20 . The loop guides  54  are formed in the distal tapered portion  44  and longitudinally extend along the distal tapered portion  44 . The pair of loop guides  54  are positioned on opposite sides of the lumen  36  for reception of the loop. The distal tapered portion  44  narrows to the lumen portion  46  to facilitate the narrowing of the distal tip of the wire guide. The lumen portion  46  may include more than one pair of loop guides, for example, as shown in  FIGS. 6A , and  6 C- 6 F. As shown in  FIG. 6A , the lumen portion  46  may have a generally rectangular cross-sectional shape that includes a first pair of loop guides  54   a  formed by the short side walls  49  of the rectangle positioned on opposite sides of the lumen  36 . The lumen portion  46  having a rectangular cross-sectional shape may also include a second pair and a third pair of loop guides  54   b ,  54   c  formed at the intersection of the short and long side walls  47 ,  49  of the rectangle. The pairs of loop guides  54   b ,  54   c  are preferably are sized to receive the loop of the guide wire without catching or otherwise restricting advancement of the wire guide through the lumen portion  46 . In some embodiments, the intersection of the short and long side walls  47 ,  49  of the rectangle may be curvilinear, for example, rounded, to facilitate advancement of the loop tip. (See  FIG. 6A ,  54   b .) 
         [0030]      FIG. 6B  illustrates a lumen portion  46  having a generally oval cross-sectional shape including a pair of loop guides  54 . The loop guides  54  sized and shaped to receive the loop of the guide wire without catching or otherwise restricting advancement of the wire guide through the lumen portion  46 .  FIGS. 6C and 6D  illustrate additional cross-sectional shapes for the lumen portion  46  of the hub  10 .  FIGS. 6C and 6D  show a plurality of pairs of loop guides  54  that are substantially uniformly sized and shaped. The loop tip of the wire guide may be narrowed and advanced using any of the pairs of loop guides  54 . In some embodiments, for example as shown in  FIGS. 6E and 6F , one of the pairs of loop guides  54  may be more readily configured for reception of the loop tip of the wire guide for orientation and narrowing of the wire guide tip. As shown in  FIGS. 6E and 6F , the pair of loop guides  54   a  is configured to receive the loop tip, although it is possible for the pair of guides  54   b  to also receive the loop tip. Other non-circular shapes may also be used and the cross-section shapes shown in  FIGS. 6A to 6F  and provided as non-limiting examples. 
         [0031]      FIGS. 8A-8C  illustrate distal portions  66  of wire guides  70 .  FIG. 8A  illustrates the shape of a loop tip  72  of the wire guide  70  prior to insertion of the loop tip  72  into the hub  10 .  FIG. 8A  shows loop portions  74  that contact and are collapsed inward by the pair of loop guides  54  formed in the distal tapered portion  44  of the hub  10 .  FIG. 8B  illustrates the misshapen loop tip  72  of the wire guide  70  that may occur using a conventional hub to connect to the catheter for insertion of the loop tip  72  through the conventional hub and into the catheter.  FIG. 8C  illustrates the shape of the narrowed and oriented loop tip  72  of the wire guide  70  that has been inserted into the hub  10 .  FIG. 8D  illustrates a conventional wire guide  71  having a straight distal tip  76  that may also be inserted into the hub  10 . 
         [0032]      FIGS. 9A-9C  illustrate advancement, orientation and narrowing of the loop tip  72  of the wire guide  70  being inserted into the hub  10 .  FIG. 9A  illustrates the loop tip  72  of the wire guide  70  inserted into the lumen  36  of the hub  10  at the proximal opening  38 . The loop portions  74  of the loop tip  72  are advanced distally into the distal tapered portion  44  of the hub  10 . As the loop tip  72  is distally advanced into the distal tapered portion, the pair of loop guides  54  on opposite sides of the lumen  36  engage and collapse the loop portions  74 .  FIGS. 9B and 9C  illustrate further distal advancement of the loop tip  72  toward the distal portion  24  of the hub  10  so that the loop tip  72  is oriented and collapsed to exit the distal opening  42  and insert into the catheter  20 . 
         [0033]    Any other undisclosed or incidental details of the construction or composition of the various elements of the disclosed embodiment of the present invention are not believed to be critical to the achievement of the advantages of the present invention, so long as the elements possess the attributes needed for them to perform as disclosed. The selection of these and other details of construction are believed to be well within the ability of one of even rudimentary skills in this area, in view of the present disclosure. Illustrative embodiments of the present invention have been described in considerable detail for the purpose of disclosing a practical, operative structure whereby the invention may be practiced advantageously. The designs described herein are intended to be exemplary only. The novel characteristics of the invention may be incorporated in other structural forms without departing from the spirit and scope of the invention. Unless otherwise indicated, all ordinary words and terms used herein shall take their customary meaning as defined in  The New Shorter Oxford English Dictionary , 1993  edition . All technical terms shall take on their customary meaning as established by the appropriate technical discipline utilized by those normally skilled in that particular art area. All medical terms shall take their meaning as defined by  Stedman&#39;s Medical Dictionary , 27 th edition.    
         [0034]    It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.