Abstract:
A retainer for maintaining a tubular sheath used to store a catheter guide wire in a coiled configuration includes a body having a bottom defining a plurality of substantially parallel channels. Each channel is designed to closely receive a coil of the tubular sheath. A loop is affixed to and extends adjacently above the body and defines an aperture therethrough for receiving and guiding the catheter guide wire after removal of the guide wire from the tubular sheath.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to medical devices in general and more particularly to packaging for a catheter guide wire. 
     2. Discussion of the Related Art 
     Catheters are used in the medical field for a number of purposes. For example in angiographic techniques, a catheter having an inflatable balloon at its distal end is inserted into a patient. In order to accurately position the catheter, a guide wire is first inserted into the patient, often at a remote site such as the femoral artery and the end of the guide wire is moved towards the target site. In order to achieve this, a guide wire is used which is sufficiently rigid to enable it to be pushed along the blood vessels of the patient and yet sufficiently flexible in order to make the necessary turns along its path within the body. 
     The guide wire is often formed with a curved tip such that the tip may be used to control the path of the distal end of the guide wire. In order to do this, the wire is rotated by the operator. The wire is sufficiently rigid to transmit torque along the length of the wire so as to cause the orientation of the wire, and in particular the orientation of the curved section at the distal end, to rotate in order that the wire can be guided. Once the distal end of the wire is in the target region, a catheter is then slid along the wire in order to carry out whichever medical procedure is involved. 
     The typical guide wire is from about 135 centimeters to 195 centimeters in length. Since the guide wire is for introduction into a patient&#39;s body, the wire must be in a sterile condition as it is brought to area of the medical procedure. Because of its length, the guide wire is often transported in a coiled sterile sheath. However, prior to introduction into the patient, the guide wire must be removed from the sheath. The guide wire, being flexible and of such length, requires a dedicated medical professional such as a nurse to monitor and support the wire to ensure it remains in a sterile condition throughout the procedure. 
     Thus what is desired is a medical device that is readily sterilized and can be used. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a retainer for use with catheter guide wire packaging such as a coiled tubular sheath that satisfies the need to support a catheter guide wire during a medical procedure and maintain the guide wire in a sterile condition without requiring a dedicated medical professional to perform the task. A retainer for maintaining a tubular sheath used to store a catheter guide wire in a coiled configuration includes a body having a bottom defining a plurality of substantially parallel channels. Each channel is designed to closely receive a coil of the tubular sheath. A loop is affixed to and extends adjacently above the body and defines an aperture therethrough for receiving and guiding the catheter guide wire after removal of the guide wire from the tubular sheath. It is understood the channels can alternately be located on a top of the body. 
     Another aspect of the present invention is a packaging for a catheter guide wire comprising at least a first retainer having a body with a bottom defining a plurality of parallel channels therein. A loop is affixed to and extends adjacently above the body and further defines an aperture therethrough for receiving and guiding the catheter guide wire after removal of the guide wire from the tubular sheath. A tubular sheath is arranged in a plurality of coils wherein each of the coils is closely received in one of the parallel channels of the first retainer. 
     Yet another aspect of the present invention is a method of supporting a catheter guide wire during introduction of the guide wire into a patient&#39;s body. The method includes placing proximate to a patient, a sterilized catheter guide wire packaging containing a catheter guide wire, wherein the packaging is of the type having a tubular sheath arranged in a coiled configuration, each coil of the sheath received in a channel of first and second diametrically opposed retainers, each retainer including a slotted loop defining an aperture therethrough and further including at least a third retainer having a clamp for clamping to a surgical drape. The packaging is then oriented substantially align the apertures of the loops of the first and second retainers with the site on the patient&#39;s body designated for insertion of the catheter guide wire. The packaging is secured to the surgical drape with the clamp of the third retainer. Once the packaging is secured in place, the catheter guide wire is withdrawn from the coiled tubular sheath to an extended uncoiled configuration and then inserted into the loop apertures through the slots defined by the loops. The catheter guide wire is then introduced into the patient. 
     These and other features, aspects, and advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a fuller understanding of the nature of the present invention, reference should be made to the accompanying drawings in which: 
         FIG. 1  is a perspective view of a catheter guide wire sheathed in packaging embodying the present invention, wherein the guide loops are in a stowed position; 
         FIG. 2  is a perspective view of a catheter guide wire sheathed in packaging embodying the present invention, wherein the guide loops are in a raised position; 
         FIG. 3  is a perspective view of the catheter guide wired removed from the tubular sheath and being supported by the guide loops of the packaging; 
         FIG. 4  is an enlarged perspective view of the sheathing retainer and guide loop of  FIG. 1 ; 
         FIG. 5  is a perspective view of a patient undergoing a catheterization wherein the catheter guide wire is being partially supported by the guide loops; 
         FIG. 6  is an enlarged perspective view of an alternate embodiment sheathing retainer and guide loop. 
     
    
    
     Like reference numerals refer to like parts throughout the several views of the drawings. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     For purposes of description herein, the terms “upper”, “lower”, “left”, “rear”, “right”, “front”, “vertical”, “horizontal”, and derivatives thereof shall relate to the invention as oriented in  FIGS. 1 and 4 . However, one will understand that the invention may assume various alternative orientations and step sequences, except where expressly specified to the contrary. Therefore, the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise. 
     Turning to the drawings,  FIG. 1  shows a packaging  20  for a catheter guide wire  16 , which is one of the preferred embodiments of the present invention and illustrates its various components. Packaging  20  has a tubular sheath  22  arranged in a plurality of coils  24  which are secured in a coiled fashion by a plurality of retainers such as first and second retainers  30  and by third and fourth retainers  60 . Tubular sheath  22  retains a catheter guide wire  16  within its coiled tubular structure to shield guide wire  16  from contamination and to prevent accidental permanent deformation of guide wire  16  prior to use. 
     Turning to  FIG. 4 , retainer  30  has a body  32 , which is typically formed from a resilient moldable material. Body  32  has a bottom  36 , which defines a plurality of parallel channels  34 . It is understood the plurality of parallel channels  34  can be disposed upon a top of the body as an equivalent configuration. Each channel  34  is sized to closely receive and retain therein one of the coils  24  of tubular sheath  22 . A loop  40  is affixed to body  32  and positioned adjacent to a top  38  of body  32 . Loop  40  can be of any cross sectional configuration such as square, circular, rectangular, or hexagonal and defines an aperture  42 . Loop  40  is hinged at  46  with body  32  to permit loop  40  to be selectively raised as illustrated or lowered as illustrated in phantom by  48  to create a lower profile for storage purposes. Loop  40  also defines a slot  44  therethrough. Slot  44  has a width greater than the thickness of guide wire  16  to permit guide wire  16  to be introduced into aperture  42  by translating a mid-portion of guide wire  16  through slot  44  into aperture  42 . Slot  44  is preferably non-linear or S-shaped to inhibit guide wire  16  from accidentally disengaging from aperture  42  through slot  44  during introduction of guide wire  16  into a patient. Loop  40  is configured such that in its raised position, aperture  42  is as close to body  32  as possible. 
     Turning to  FIG. 6 , an alternate embodiment retainer  130  is illustrated and can be used in place of retainer  30 . Retainer  130  includes a body  132  typically molded of a resilient material. Body  132  has a bottom  136  defining a plurality of parallel channels  134  and  135 . It is understood the plurality of parallel channels  134  and  135  can alternately be disposed on a top of the body  132 . Channels  134  are sized to accept and closely receive a coil  24  of sheath  22 . Channel  135  pivotally receives a portion of loop  140  such that loop  140  can be selectively raised and lowered by rotating loop  140  within channel  135 . Loop  140  in combination with top  138  of body  132  defines an aperture  142  therethrough. Loop  140  also defines a slot  144  therethrough. Slot  144  has a width slightly greater than the thickness of guide wire  16  to permit guide wire  16  to be introduced into aperture  142  by translating a mid-portion of guide wire  16  through slot  144  into aperture  142 . Slot  144  is preferably non-linear or S-shaped to inhibit guide wire  16  from accidentally disengaging from aperture  142  through slot  144  during introduction of guide wire  16  into a patient. 
     Retainer  60  generally comprises a body  62  similar to body  32  of retainer  30  wherein body  62  defines a plurality of parallel channels to receive coils  24  of tubular sheath  22 . Each retainer  60  includes a clamp  64  flexibly affixed to body  32  such as with a length of chain  66 . 
     As illustrated in  FIGS. 1 and 2 , packaging  20  includes first and second retainers  30  securing coils  24  of sheath  22  in their respective channels  34 . First and second retainers  30  are oriented in a diametrically opposed manner about the periphery of coiled sheath  22  such that when loops  40  are raised to an upright position, apertures  42  are substantially in alignment one with the other. At least a third retainer  60  and most preferably also a fourth retainer  60  are positioned intermediate to first and second retainers  30  and approximately equidistant thereto such that retainer  30 ,  60  are positioned at each quadrant of coiled sheath  22 . 
     In use, and referring now to  FIGS. 3 and 5 , packaging  20  is utilized to transport guide wire  16  to the operating theater and to support wire  16  during introduction of the guide wire into the body of patient  12 . The sterilized guide wire  16  and packaging  20  is placed proximate to patient  12  in the vicinity of the body site where the catheter is to be introduced. For example, as shown in  FIG. 5 , guide wire is to be introduced in a femoral vein, thus packaging  20  is placed between the legs of patient  20  on a drape  15  covering operating table  14 . Packaging  20  is then oriented to substantially align apertures  44  of loops  44  of first and second retainers  30  with the site on the patient&#39;s body designated for introduction of catheter guide wire  16 . Packaging  20  is secured to surgical drape  15  with clamps  64  of third and fourth retainers  60 . Once packaging  20  is secured in place, catheter guide wire  16  is withdrawn from end  26  of coiled tubular sheath  22  to an extended uncoiled configuration. Guide wire  16  is then inserted into loop apertures  44  by translating a mid-portion of guide wire  16  through slots  44  defined by loops  40 . Guide wire  16  is thus supported without requiring a healthcare professional dedicated to the task of supporting guide wire  16 . Once guide wire  16  has been inserted into apertures  44 , loops  40  can be rotated to a lowered position (such as shown in  FIG. 6  with loop  140 ) to further secure and stabilize guide wire  16  in its orientation with respect to patient  12 . Catheter guide wire  16  is then introduced into the patient by the responsible health care professional. 
     The above description is considered that of the preferred embodiments only. Modifications of the invention will occur to those skilled in the art and to those who make or use the invention. Therefore, it is understood that the embodiments shown in the drawings and described above are merely for illustrative purposes and are not intended to limit the scope of the invention, which is defined by the following claims as interpreted according to the principles of patent law, including the doctrine of equivalents.