Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application is a Divisional of U.S. patent application Ser. No. 10/960,737, filed on Oct. 7, 2004, in turn a Continuation-in-Part of U.S. patent application Ser. No. 10/366,247, filed on Feb. 13, 2003, which claims priority from U.S. Provisional Patent Application Ser. No. 60/434,262, filed on Dec. 18, 2002. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a catheter guidewire and a method of retaining a catheter guidewire in a guidewire tube. 
       BACKGROUND OF THE INVENTION 
       [0003]    Catheter guidewires are used to facilitate introduction of a catheter into a patient. In a typical catheter installation, an insertion site is located, and an incision is made by the inserting physician at the insertion site. A syringe is inserted into the patient through the incision to locate the blood vessel, such as a vein, to be catheterized. A flexible metal guidewire is typically inserted through the syringe and into the blood vessel to further enable the inserting physician to insert the catheter into the patient. The guidewire typically has a “J-shaped” distal end, so as not to tear into the patient&#39;s blood vessel during insertion. The guidewire is quite flexible so that it can bend with the contours of the blood vessel, but the flexibility of the guidewire, along with the “J-shape”, can make it difficult for the physician to insert the distal end of the guidewire into the syringe. Guidewire straighteners are used to straighten out the “J-shape” and to assist the physician in inserting the distal tip of the guidewire into the syringe for advancement into the blood vessel. 
         [0004]    A guidewire is typically stored in a coiled plastic tube, both for ease of physician use and for sterility. However, during shipping, the guidewire can work its way out of the tube, making the guidewire more difficult to handle and potentially compromising the sterility of the guidewire. 
         [0005]    A known guidewire straightener is disclosed in U.S. Pat. No. 5,125,905. This guidewire straightener utilizes a cantilevered extension at the proximal end of the straightener to grasp a guidewire and retain the guidewire in its tube. It is believed by the inventors that the prior art design does not provide sufficient gripping between the straightener and the guidewire. It is also believed by the inventors that the prior art design may be prone to breakage from fatigue. 
         [0006]    It would be beneficial to provide a guidewire straightener that provides increased gripping between the straightener and the guidewire so that the guidewire does not work its way out of the tube, as well as a guidewire straightener that is less prone to breakage from fatigue. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    Briefly, the present invention provides a guidewire straightener assembly. The assembly comprises a guidewire tube including a tubular passage having a first diameter and a distal end including a collar having a second diameter, larger than the first diameter. The assembly also includes a guidewire straightener having a distal end, a proximal end having an exterior surface with a diameter sized to fit within the guidewire tube, and a longitudinal passageway sized to accept the guidewire, the passageway extending between the proximal end and the distal end. The assembly further includes a guidewire having a third diameter, smaller than the first diameter, wherein the guidewire is disposed within the tubular passage and the longitudinal passageway. The proximal end of the guidewire straightener further includes at least one finger extending therefrom such that, when the guidewire straightener is disposed within the guidewire tube in a first position in the tubular passage, the at least one finger is biased by the tubular passage into frictional engagement with the guidewire. When the guidewire straightener is disposed within the guidewire tube in a second position in the collar, the at least one finger is disposed away from frictional engagement with the guidewire. 
         [0008]    The present invention also provides a catheter guidewire tube comprising a body having a distal end, a proximal end, and a tube passageway extending between the distal end and the proximal end, wherein the tube has a first diameter. The assembly also includes a collar fixedly connected to the distal end, wherein the collar comprises a longitudinal passage having a second diameter, larger than the first diameter, and wherein the collar further comprises a distal opening having a third diameter, smaller than the second diameter. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0009]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: 
           [0010]      FIG. 1  is a perspective view of a catheter guidewire straightener according to an embodiment of the present invention. 
           [0011]      FIG. 2  is a side elevational view of the catheter guidewire straightener shown in  FIG. 1 . 
           [0012]      FIG. 3  is a sectional view of the catheter guidewire straightener taken along line  3 - 3  of  FIG. 2 . 
           [0013]      FIG. 4  is a plan view of a catheter guidewire assembly incorporating the catheter guidewire straightener shown in  FIGS. 1-3 . 
           [0014]      FIG. 5  is a sectional view of the catheter guidewire assembly taken along line  5 - 5  of  FIG. 4 . 
           [0015]      FIG. 6  is a schematic view showing operation of the catheter guidewire assembly during insertion of a guidewire into a patient. 
           [0016]      FIG. 7  is a side profile view of a catheter guidewire straightener assembly according to a second embodiment of the present invention. 
           [0017]      FIG. 8  is an enlarged sectional view of the guidewire straightener assembly of  FIG. 7 , taken along lines  8 - 8  of  FIG. 9 . 
           [0018]      FIG. 9  is an enlarged sectional view of the guidewire straightener assembly of  FIG. 7 , taken along lines  9 - 9  thereof. 
           [0019]      FIG. 10  is an enlarged sectional view of the guidewire straightener assembly of  FIG. 7 , with the guidewire straightener removed from the guidewire tube. 
           [0020]      FIG. 11  is a sectional view of a catheter guidewire straightener assembly according to a third embodiment of the present invention. 
           [0021]      FIG. 12  is a sectional view of the catheter guidewire straightener assembly shown in  FIG. 11 , with the guidewire straightener removed from the guidewire tube. 
           [0022]      FIG. 13  is a sectional view of a guidewire straightener assembly according to a fourth embodiment of the present invention. 
           [0023]      FIG. 14  is a sectional view of the guidewire straightener assembly of  FIG. 13 , with the guidewire straightener disconnected from the guidewire tube. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0024]    In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The words “proximal” and “distal” refer to directions away from and closer to, respectively, the insertion tip of the guidewire in the guidewire assembly according to the present invention. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the invention. However, it should be understood based on this disclosure, that the invention is not limited by the preferred embodiment described herein. 
         [0025]    A catheter guidewire straightener  10  according to an embodiment of the present invention is shown in  FIGS. 1-3 . The guidewire straightener  10  is comprised of a generally frusto-conically shaped distal end  12  and a generally cylindrically shaped proximal end  14 . A stop collar  16  is disposed between the distal end  12  and the proximal end  14 . A straightener passageway  18  extends through the guidewire straightener  10  between the distal end  12  and the proximal end  14 . The straightener passageway  18  is sized to allow a guidewire  52 , shown in a guidewire assembly  50  in  FIG. 4 , to pass through the straightener passageway  18  with little or no interference. A standard guidewire has a diameter of approximately 0.038 inches (approximately 0.97 mm), and the straightener passageway  18  has a diameter of approximately 0.05 inches (approximately 1.27 mm). Therefore, when the guidewire  52  is inserted into the straightener passageway  18 , a clearance of approximately 0.012 inches (approximately 0.30 mm) is provided between the guidewire  52  and the guidewire straightener  10 . 
         [0026]    Referring back to  FIGS. 1-3 , the proximal end  14  of the straightener  10  includes first and second diametrically opposed biasing assemblies  20 ,  22 , which are each comprised of a lug  24  disposed on a biasing member  26 , such as a leaf spring. A distance between free ends of each lug  24  on the biasing assemblies  20 ,  22 , as shown in  FIG. 2 , is defined as a diameter “D”. 
         [0027]    Each biasing assembly  20 ,  22 , extends longitudinally along the proximal end  14  of the straightener  10 , with channels  28 ,  30  disposed on either side of the biasing assemblies  20 ,  22 . The channels  28 ,  30  allow the lugs  24  and the biasing members  26  to deflect toward the straightener passageway  18  when force is applied on the lugs  24  toward the straightener passageway  18 . The biasing members  26  resist such force and bias the lugs  24  away from the straightener passageway  18 . 
         [0028]    Preferably, the guidewire straightener  10  is constructed from a polymer, such as polypropylene, although those skilled in the art will recognize that other, suitable materials may be used. 
         [0029]    A guidewire assembly  50  incorporating the guidewire straightener  10  of the present invention is shown in  FIGS. 4 and 5 . The guidewire assembly  50  is comprised of a guidewire  52  disposed within a tube passageway  54  of a guidewire tube  56 . The guidewire  52  has a “J-shaped” distal end  53 . The tube passageway  54  has an inner diameter “d”. The guidewire tube  56  is connected to the proximal end  14  of the guidewire straightener  10 . 
         [0030]    The guidewire tube  56  is preferably coiled as shown for the ease of the user. The guidewire  52  is typically approximately 24 inches (61 cm) long and, by coiling the guidewire  52  along with the guidewire tube  56 , the user can more readily handle the guidewire  52  and advance the guidewire  52  into the patient. 
         [0031]    The guidewire tube  56  includes an open distal end  58 , through which the guidewire  52  is advanced, the distal end  58  having a collar with an inner diameter larger than tube passageway diameter “d”. The distal end  58  of the guidewire tube  56  is inserted over the proximal end  14  of the guidewire straightener  10 , so that the distal end  58  of the guidewire tube  56  and the proximal end of the guidewire straightener  10  engage each other with a press fit. 
         [0032]    The diameter “D” of the lugs  24  is larger than the diameter “d” of the tube passageway  54  so that, as is seen in  FIG. 5 , the distal end collar of guidewire tube  56  biases the lugs  24  and the biasing members  26  into the straightener passageway  18 . Each lug  24  biases its respective biasing member  26  against the guidewire  52  so that the guidewire  52  is longitudinally engaged along a length of the guidewire  52  by the biasing members  26 . The biasing members  26 , in turn, bias the lugs  24  against the tube&#39;s collar to releasably retain the straightener  10  in the tube  56 . 
         [0033]    Referring now to the guidewire insertion procedure of  FIG. 6  during a catheter insertion procedure, an incision  110  is initially made near an insertion site  112  which is to be aspirated with a syringe or other introducer apparatus near or proximate the area to be catheterized. If the catheter is used for hemodialysis and the area to be catheterized is the internal jugular vein  116 , the incision  110  is made in the clavicular triangle region, as shown for example, in  FIG. 6 . The exact location of the incision  110  can be varied by the physician. In accordance with the Seldinger technique, a narrow needle  114  connected to the syringe is inserted through the incision  110  and into the vein  116 , and the vein  116  is aspirated. The syringe is disconnected from the needle  114 , leaving the needle  114  in the vein  116 . 
         [0034]    The guidewire  52  is next inserted into the vein  116  through the needle  114 . To insert the guidewire  52  into the vein  116 , the proximal end  14  of the straightener  10  is removed from the tube  56 . The biasing members  26  bias away from the straightener passageway  18 , releasing the guidewire  52  from between the biasing members  26 . The distal end  53  (see  FIGS. 4 and 5 ) of the guidewire  52  is then retracted into the straightener  10  so that the “J-shaped” distal end  53  of the guidewire  52  is disposed within the straightener  10 . The distal end  12  of the straightener  10  is then inserted into the proximal end of the needle  114 . The preferably frusto-conical shape of the distal end  12  facilitates insertion of the distal end  12  into the needle  114 . 
         [0035]    Using thumb  118  and forefinger  120  on the guidewire  52  between the straightener  10  and the tube  56 , the physician advances the guidewire  52  through the needle  114  and into the vein  116 . Once the guidewire  52  is in place, the tube  56  and the straightener  10  are removed by advancing each of the tube  56  and the straightener  10  along the guidewire  52  away from the distal end  53  of the guidewire  52  and then off the proximal end of the guidewire  52 . Next, the needle  114  is removed by advancing the needle  114  along the guidewire  52  away from the distal end  53  of the guidewire  52  and then off the proximal end of the guidewire  52 . A dilator (not shown) and a tearable sheath (not shown) are introduced over the guidewire  52  and partially into the vein  116 . The insertion site  112  is now ready to accept a catheter assembly (not shown). At least one catheter lumen is disposed over the proximal end of the guidewire  52  and advanced toward the distal end  53  of the guidewire  52  and into the vein. 
         [0036]    An alternate embodiment of a guidewire straightener assembly  200  is shown in  FIG. 7 . The assembly  200  includes a straightener  210  and a guidewire tube  250 . The straightener  210  is partially disposed in the tube  250  and is used to assist the inserting physician in advancing a guidewire  202  from the tube  250  during catheter insertion. 
         [0037]    Referring to  FIG. 8 , the straightener  210  includes a distal end  212  that is generally conically or frusto-conically shaped. The distal end  212  is shaped to facilitate insertion of the distal end  212  into an introducer device, such as an introducer needle (not shown). The straightener  210  also includes a proximal end  214  that includes a biasing member  216 . A longitudinal axis  217  extends through the straightener  210 . A straightener passageway  218  extends along the longitudinal axis  217  through the straightener  210  between the distal end  212  and the proximal end  214 . The passageway  218  has a diameter D 1  that is sized to allow the guidewire  202  to be able to be translated therethrough with a minimal force during insertion of the guidewire  202  into the patient. 
         [0038]    The biasing member  216  includes a plurality of fingers  220  that extend in a proximal direction. While eight fingers  220  are shown in  FIG. 9 , those skilled in the art will recognize that more or less than eight fingers  220  may be used. Each finger  220  has a connected end  222  that is connected to the proximal end  214  and a free end  224  that freely extends away from the proximal end  214 . Each finger  220  has a body portion  226  between the connected end  222  and the free end  224  that is biased away from the longitudinal axis  217 . The biasing member  216  is dimensioned such that, when the biasing member  216  is disposed within the guidewire tube  250 , the interior wall of the guidewire tube  250  biases the biasing member  216  against the guidewire  202 . 
         [0039]    The guidewire advancer  210  also includes a generally elongated portion  230  that extends between the distal end  212  and the proximal end  214 . The generally elongated portion  230  extends below the guidewire  202  and is open so that the guidewire  202  is accessible. A generally convex raised portion  232  extends from the generally elongated portion  230  and provides a thumb rest for advancing the guidewire  202  distally through the advancer  210 . 
         [0040]    The guidewire tube  250  includes a distal end  252  that engages the straightener  210 . The guidewire tube  250  has an inner diameter D 2  that is sized to allow the proximal end  214  of the straightener  210  to be inserted into the guidewire tube  250 . The guidewire tube  250  also has an outer diameter D 3 . A cylindrical collar  260  is fixedly connected to the distal end  252  of the tube  250 . 
         [0041]    The collar  260  is preferably constructed from a polymer, such as polypropylene, or some other suitable material. Those skilled in the art will recognize that the collar  260  may be a separate piece from the tube  250 , or the collar  260  may be integrally formed with the tube  250 . If the collar  260  is a separate piece from the tube  250 , the collar  260  is fixedly connected to the tube  250  by known methods, such as by an adhesive, by ultrasonic welding, or other means known in the art for connecting the collar  260  to the tube  250 . 
         [0042]    The collar  260  includes a proximal collar end  262  that fits over the exterior of the distal end  252  of the tube  250 . The collar  260  also includes a distal collar end  264  that has an inner diameter D 4  that is larger than the outer diameter D 3  of the tube  250 . The distal collar end  264  includes an opening  265  along the longitudinal axis  217  that is sized to allow the proximal end  214  of the straightener  210  to be inserted into the opening  265 . The inner diameter D 4  of the distal collar end  264  is sufficiently large to allow the biasing member  216  to expand within the interior of the distal collar end  264  to allow the biasing member  216  to expand and release the guidewire  202 . However, it is preferred that the distal opening  265  is sufficiently small such that the biasing member  216  cannot be easily pulled through the distal opening  265  and out of the collar  260 . 
         [0043]    The collar  260  also includes a tapered portion  266  that tapers from the proximal collar end  262 , outward to the distal collar end  264 . Preferably, the tapered portion  266  begins at the distal end  252  of the tube  250 , although those skilled in the art will recognize that the tapered portion  266  may begin either proximally or distally of the distal end  252  of the tube  250 . 
         [0044]    The assembly  200  is provided with the straightener  210  fully inserted into the tube  250 , as shown in  FIGS. 7 and 8 . In use, the straightener  210  is partially removed from the tube  250  by advancing the straightener  210  in a distal direction relative to the tube  250 . The biasing means  216  moves distally from the interior of the tube  250  to the interior of the collar  260  to the position shown in  FIG. 10 . When the plurality of fingers  220  enter the interior of the collar  260 , the fingers  220  spring away from the guidewire  202 , allowing the guidewire  202  to be freely advanced from the distal end  212  of the straightener  210  according to known methods. The straightener  210 , however, is not sufficiently moved relative to the tube  250  so as to pull the proximal end  214  of the straightener  210  through the distal opening  265  of the collar  260 . 
         [0045]    After the guidewire  202  is inserted a desired distance into the patient, the guidewire straightener assembly  200  is removed from the guidewire  202  by sliding the assembly  200  proximally along the guidewire  202  until the guidewire  202  exits the assembly  200 . The assembly  200  is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. 
         [0046]    While the guidewire assembly  200  with the collar  260  fixed to the distal end  252  of the tube  250  is preferred, those skilled in the art will recognize that a guidewire assembly  300 , shown in  FIG. 11 , that omits the collar may be used. The straightener  210  is inserted into the tube  250  as shown in  FIG. 11 , with the fingers  220  biased against the guidewire  202 . 
         [0047]    In use, the straightener  210  is advanced distally with respect to the tube  250  until the proximal end  214  of the straightener  210  is removed from the tube, as show in  FIG. 12 . The fingers  220  spring away from the guidewire  202 , allowing the guidewire  202  to be freely advanced from the distal end  212  of the straightener  210 . The user biases the guidewire  202  against the generally convex raised portion  232  and advances his/her thumb in a distal direction, using friction to distally advance the guidewire  202  as well. 
         [0048]    After the guidewire  202  is inserted a desired distance into the patient, the guidewire straightener assembly  300  is removed from the guidewire  202  by sliding the assembly  300  proximally along the guidewire  202  until the guidewire  202  exits the assembly  200 . The assembly  300  is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. 
         [0049]    Yet another embodiment of the present invention is shown in  FIGS. 13 and 14 . A guidewire straightener assembly  400  includes a guidewire straightener  410  and a guidewire tube  450  that are used to retain and dispense a guidewire  402 . A swivel lock assembly  460  releasably connects the straightener  410  and the tube  450  to each other. 
         [0050]    The straightener  410  includes a distal end  412  that is generally conically or frusto-conically shaped. The distal end  412  is shaped to facilitate insertion of the distal end  412  into an introducer device, such as an introducer needle (not shown). The straightener  410  also includes a proximal end  414  that includes a biasing member  416 . A longitudinal axis  417  extends through the straightener  410 . A straightener passageway  418  extends along the longitudinal axis  417  through the straightener  410  between the distal end  412  and the proximal end  414 . The passageway  418  has a diameter D 1  that is sized to allow the guidewire  402  to be able to be translated therethrough with a minimal force during insertion of the guidewire  402  into the patient. 
         [0051]    The biasing member  416  includes a plurality of fingers  420  that extend in a proximal direction. Similar to the biasing member  216  described above and shown in  FIG. 9 , the biasing member  416  preferably includes six fingers  420 . While six fingers  420  are preferred, those skilled in the art will recognize that more or less than six fingers  420  may be used. Each finger  420  has a proximal end  422  that is connected to the proximal end  414  and a distal end  424  that extends away from the proximal end  414 . Each finger  420  has a body portion  426  between the proximal end  422  and the distal end  424  that is biased away from the longitudinal axis  417 . The biasing member  416  is dimensioned such that, when the biasing member  416  is disposed within the guidewire tube  450 , the interior wall of the guidewire tube  450  biases the biasing member  416  against the guidewire  402 , restricting the movement of the guidewire  402  within the tube  450 . 
         [0052]    The straightener  410  includes an annular groove  430  disposed between the distal end  412  and the proximal end  414 . The groove  430  is sized and shaped to allow the distal end of the swivel lock assembly  460  to be rotatably attached to the straightener  410 , as will be described more in detail later herein. 
         [0053]    The guidewire tube  450  includes a distal end  452  that engages the straightener  410 . The guidewire tube  450  has an inner diameter D 2  that is sized to allow the proximal end  414  of the straightener  410  to be inserted into the guidewire tube  450 . The guidewire tube  450  also has an outer diameter D 3 . The swivel lock assembly  460  includes a cylindrical collar  462  that is fixedly connected to the distal end  452  of the tube  450  and a swivel lock  470  that is rotatably connected to the straightener  410 . 
         [0054]    The collar  462  is preferably constructed from a polymer, such as polypropylene, or some other suitable material. Those skilled in the art will recognize that the collar  462  may be a separate piece from the tube  450 , or the collar  462  may be integrally formed with the tube  450 . If the collar is a separate piece from the tube  450 , the collar  462  is fixedly connected to the tube  450  by known methods, such as by an adhesive, by ultrasonic welding, or other means known in the art for connecting the collar  462  to the tube  450 . Preferably, the collar  462  includes a stop  461  that limits the distance that the collar  462  may be advanced over the distal end  452  of the tube  450 . 
         [0055]    The collar  462  includes a distal collar end  464  that includes male threads  466 . The swivel lock  470  includes female threads  472  that threadingly engage with the male threads  466 . A distal end of the swivel lock  470  includes a lip  474  that rotates within the groove  430  in the straightener  410  to allow the swivel lock  470  to rotate about the longitudinal axis  417  with respect to the straightener  410 . 
         [0056]    The assembly  400  is provided with the straightener  410  fully inserted into the tube  450  and the swivel lock  470  connected to the collar  462 , as shown in  FIG. 13 . In use, the straightener  410  is removed from the tube  450  by rotating the swivel lock  470  relative to the collar  462  and unthreading the female threads  472  from the male threads  466 . When the swivel lock  470  is unthreaded from the collar  462 , the straightener  410  is advanced in a distal direction relative to the tube  450 . The biasing means  416  moves distally from the interior of the tube  450  to the position shown in  FIG. 14 . When the plurality of fingers  420  exits the distal end  452  of the tube  450 , the fingers  420  spring away from the guidewire  402 , allowing the guidewire  402  to be freely advanced from the distal end  412  of the straightener  410  according to known methods. 
         [0057]    After the guidewire  402  is inserted a desired distance into the patient, the guidewire straightener assembly  400  is removed from the guidewire  402  by sliding the assembly  400  proximally along the guidewire  402  until the guidewire  402  exits the assembly  400 . The assembly  400  is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. 
         [0058]    It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

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