Abstract:
A catheter retaining clip ( 100 ) including first and second generally straight body portions ( 104,106 ), each of which extends along a longitudinal axis parallel to the other and includes a retention section. The generally straight body portions are connected by an extension piece ( 116  or  240 ) that extends generally from one generally straight body portion to the other generally straight body portion. The extension piece ( 116 ) may extend around a 180° curve that defines the curve of the catheter to be inserted into the clip, and a U-shaped channel ( 120 ) extends through the first and second generally straight body portions and the extension piece; the clip is installed onto a catheter ( 50 ) so that the catheter lies in the U-shaped channel and is retained therein by two or three retention sections or locking clasps ( 130 ). The present invention also provides methods of installing a catheter within the clip and methods of removing a catheter from within the clip.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     The present application claims priority from Provisional patent application Ser. No. 60/604,228 filed Aug. 25, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to medical devices and more specifically to pre-curved catheters and the use of a device to properly maintain the shape of a pre-curved catheter and to protect the catheter from damage during sterilization and packaging.  
       BACKGROUND OF THE INVENTION  
       [0003]     In the manufacture of certain catheters, it is desirable to provide a curved shape thereto between the proximal and distal ends. When a stylet is installed into such a catheter assembly during manufacture to later assist in the insertion of the catheter into a patient, the stylet is sufficiently stiff that it tends to try to straighten the curvature of the catheter assembly that is desired. Therefore, it is desired to provide for maintaining the curvature of the catheter assembly during sterilization, packaging and shipping.  
       SUMMARY OF THE INVENTION  
       [0004]     The present invention is a removable clip for being secured to a catheter assembly at the curvature of the catheter, to maintain the curvature thereof during sterilization, packaging and shipping until it is removed therefrom immediately prior to insertion of the catheter assembly into a patient. The clip includes first and second generally straight portions that are spaced apart and generally coextend parallel to each other, joined together by an extension piece. At least the first and second generally straight portions have retention sections such as locking clasps above U-shaped channels therethrough into which the catheter is insertable and securable, with the curved portion of the catheter isolated on one side of the clip while the remainder of the distal and proximal catheter portions are on the opposite side of the clip.  
         [0005]     In one embodiment of the present invention, the extension portion extends around a curve that defines the desired curve of the catheter to be maintained, in which case the U-shaped channel extends continuously from the first generally straight portion through the extension to the second generally straight portion, and the extension piece may include an additional locking clasp. In another embodiment, the extension piece extends directly between the first and second generally straight portions, and the catheter is not disposed along the extension piece.  
         [0006]     The methods of the present invention for installing the catheter into the clip comprise: forcing respective catheter lumen portions past respective retention sections at least on the first and second generally straight portions of the clip until the catheter lumen portions are secured to the clip. The methods for catheter removal comprise either: forcing the catheter lumens past the retention sections in a common direction away from the clip; or, pulling the catheter through the U-shaped channel of the clip until the distal end passes therethrough and outwardly from the second generally straight portion.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]     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:  
         [0008]      FIG. 1  is a perspective view of a pre-curved catheter clip according to a first preferred embodiment of the present invention;  
         [0009]      FIG. 2  is a top plan view of a catheter without the aid of the pre-curved catheter clip of  FIG. 1 ;  
         [0010]      FIG. 3  is a top plan view of the pre-curved catheter clip of  FIG. 1 , with a catheter disposed therein;  
         [0011]      FIG. 4  is a front profile view of the pre-curved catheter clip of  FIG. 1 ;  
         [0012]      FIG. 5  is an enlarged top plan view of the pre-curved catheter clip of  FIG. 3 ;  
         [0013]      FIG. 6  is a perspective view of a pre-curved catheter clip according to a second preferred embodiment of the present invention; and  
         [0014]      FIG. 7  is a perspective view of the clip of  FIG. 6 , with a catheter inserted therein. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0015]     In the drawings, like numerals indicate like elements throughout. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention. As used herein, the word “distal” is defined as being close to the insertion end of a catheter, and the word “proximal” is defined as being close to the end of the catheter that generally remains outside of the body.  
         [0016]     Referring to  FIG. 1 , a pre-curved catheter clip  100  according to a first embodiment of the present invention is shown. The pre-curved catheter clip  100  is used to protect, and maintain the curved shape of a pre-curved catheter during sterilization, packaging, and shipping. Typically, a pre-curved catheter  50  having a proximal end  52  and a distal end  54 , as shown in  FIG. 2 , has a curved lumen portion  56  extending between the proximal end  52  and the distal end  54  that is formed during catheter manufacture. The catheter  50  is preferably a dual lumen catheter having two lumens, such as side-by-side or co-axial lumens, although those skilled in the art will recognize that the catheter  50  may be a single lumen catheter or a catheter having more than two lumens.  
         [0017]     A stylet  60  is inserted through the catheter  50 . The stylet  60  provides stiffening support for the catheter  50  during insertion of the catheter  50  into a patient during catheterization of the patient. Ideally, the proximal end  52  and the distal end  54  of the catheter  50  are generally parallel to each other. However, as seen in  FIG. 2 , the proximal end  52  and the distal end  54  of the catheter  50  are approximately 45 degrees out of parallel. The stylet  60  is straight, and tends to at least partially straighten the catheter  50  after the stylet  60  is inserted thereinto, resulting in the approximate 45 degree angle of the distal end  54  of the catheter with respect to the proximal end  52  of the catheter  50 . The catheter clip  100  according to the present invention is used to maintain the proximal end  52  and the distal end  54  of the catheter  50  in a generally parallel relationship during packaging, sterilization, and shipping, as shown in  FIG. 3 .  
         [0018]     Referring back to  FIG. 1 , the pre-curved catheter clip  100  includes a body  102 . The body  102  includes a first straight portion  104  and a second straight portion  106 . The first straight portion  104  includes a first open end  108  and a first connection end  110 . The first straight portion  104  also includes a first longitudinal axis  111  extending therethrough. The second straight portion  106  includes a second open end  112  and a second connection end  114 , and also includes a second longitudinal axis  115  extending therethrough, generally parallel to the first longitudinal axis  111 . Preferably, the first and second straight portions  104 ,  106  are each approximately 1.27 cm (0.50 inches) long, although those skilled in the art will recognize that the first and second straight portions  104 ,  106  may be longer or shorter than 1.27 cm. A curved connecting portion  116  connects the first and second connection ends  110 ,  114 . Preferably, the connecting portion  116  has a bend radius of approximately 1.60 cm (0.63 inches) in order to maintain curvature of a pre-curved catheter installed in the clip  100 , but without kinking the catheter.  
         [0019]     A channel  120  extends through the body  102  from the first open end  108 , through the first straight portion  104 , the connecting portion  116  and the second straight portion  106 , to the second open end  112 . As seen in  FIG. 4 , the channel  120  is generally “U-shaped” in cross section. The channel  120  includes an outer wall  122  and an inner wall  124 . Bottom portions  122   a,    124   a  of each of the outer wall  122  and the inner wall  124  are connected to each other by a generally curved foundation  126 .  
         [0020]     At least one retention section is defined on each of the first and second generally straight portions  104 , 106 . The retention section may be a locking clasp or pair of cooperating locking clasps, or may be a force fit between opposing walls of each of portions  104 , 106 , or may be a latch arm or the like. Preferably, at least one locking clasp assembly  130  extends from each of the outer wall  122  and the inner wall  124 . However, those skilled in the art will recognize that more than one locking clasp assembly  130  may be used as part of the general principle of the invention.  FIG. 5  shows three locking clasp assemblies  130 , with the first locking clasp assembly  130  on the first straight portion  104 , the second locking clasp assembly  130  on the second straight portion  106 , and the third locking clasp assembly  130  on the connecting portion  116 , as a non-limiting example of the number and locations of locking clasp assemblies  130  mounted on the body  102 .  
         [0021]     Each locking clasp assembly  130  preferably includes a locking clasp  132  disposed on the outer wall  122  and a locking clasp  132  extending from the inner wall  124 . However, those skilled in the art will recognize that each locking clasp assembly  130  may consist of only one locking clasp  132  extending from either the outer wall  122  or the inner wall  124 , with a corresponding locking clasp  132  on the inner wall  124  or the outer wall  122  being omitted.  
         [0022]     Referring back to  FIG. 4 , each locking clasp includes a tapered portion  134  that extends upward from bottom portion of its respective outer wall  122  or inner wall  124  into the channel  120 . A cantilevered portion  136  extends from the tapered portion  134  into the channel  120 . A cutout  138  is formed in the foundation  126  directly below each locking clasp assembly  130 . The cutout  138  facilitates insertion and removal of the catheter  50  from the clip  100  by allowing the clip  100  to flex in the proximity of the cutout  138 .  
         [0023]     Preferably, the channel  120  has a diameter sufficient to accept a catheter of varying sizes, and the locking clasp assembly  130  is able to retain such catheters within the channel  120 . Preferably, the clip  100  may be used on catheters varying between 12 and 16 French, although those skilled in the art will recognize that the dimensions of the clip may be modified to accept and retain larger or smaller catheters.  
         [0024]     Preferably, the pre-curved catheter clip  100  is constructed from a polymer, such as polypropylene. However, the use of any other polymer or similar material of a life strength and composition is also within extent of the present invention.  
         [0025]     To insert the catheter  50  into the clip  100 , the lumens of the catheter  50  are forced past each of the locking clasp assemblies  130  and into the channel  120 . The cutout  138  proximate to each locking clasp assembly  130  allows the body  102  of the clip  100  to flex sufficiently to allow the catheter  50  to be inserted into the channel  120 . Once the catheter  50  is secured within the pre-curved catheter clip  100 , the catheter  50  is ready for sterilization and packaging.  
         [0026]     When the catheter  50  is ready for use on a patient, the pre-curved catheter clip  100  must be removed from the catheter  50  before insertion. One method of removing the catheter  50  from the pre-curved catheter clip  100  involves forcing the lumens past the cantilevered portion  136  of each locking clasp  132 . Once the catheter  50  is fully removed from the locking clasps  132 , the catheter  50  is ready for insertion into a patient.  
         [0027]     Another method for the removal of the catheter  50  from the clip  100  is to pull the catheter lumens through the channel  120  from the proximal end  52  of the catheter  50 . The pulling of the lumens allows the distal end  54  of the catheter  50  to enter into the first open end  108  of the body  102 . The distal end  120  of the catheter then passes through the channel  120 , underneath of all of the locking clasp assemblies  130  and then exits the channel  120  through the second open end  112 . Upon removal of the catheter  50  from the clip  100 , the catheter  50  is now ready for insertion into the patient and the clip  100  is discarded.  
         [0028]     A second embodiment of a pre-curved catheter clip  200  of the present invention is shown in  FIGS. 6 and 7 . The clip  200  includes a body  202 . The body  202  includes a first generally straight portion  204  and a second generally straight portion  206 . The first generally straight portion  204  includes a first proximal end  208  and a first distal end  210 . The first generally straight portion  204  also includes a first longitudinal axis  211  extending therethrough. The second generally straight portion  106  includes a second proximal end  212  and a second distal end  214 , and also includes a second longitudinal axis  215  extending therethrough, generally parallel to the first longitudinal axis  211 . Preferably, the first and second generally straight portions  204 ,  206  are each approximately 1.27 cm (0.50 inches) long, although those skilled in the art will recognize that the first and second generally straight portions  204 ,  206  may be longer or shorter than 1.27 cm.  
         [0029]     The first generally straight body portion  204  and the second generally straight body portion  215  each have a generally “C-shaped” cross-section. The C-shape of the first generally straight body portion  204  fonns a first channel  220 . The C-shape of the second generally straight body portion  215  forms a second channel  222 . The first generally straight body portion  204  includes two juxtaposed edges  224 ,  226  across the longitudinal axis  211 . The second generally straight body member also includes two juxtaposed edges  228 ,  230  across the second longitudinal axis  215 . The first generally straight body portion  204  acts as a first locking clasp and the second generally straight body portion  206  acts as a second locking clasp. The C-shaped cross-sections retain a catheter within the channels  220 ,  222 . An extension brace  240  connects the first and second generally straight body portions  204 ,  206  and extends generally perpendicular to the first and second longitudinal axes  211 ,  215 .  
         [0030]     Preferably, the channels  220 ,  222  each have a diameter sufficient to accept a catheter of varying sizes. Preferably, the clip  200  may be used on catheters varying between 12 and 16 French, although those skilled in the art will recognize that the dimensions of the clip may be modified to accept and retain larger or smaller catheters.  
         [0031]     Preferably, the pre-curved catheter clip  200  is constructed from a polymer, such as polypropylene. However, the use of any other polymer or similar material of a life strength and composition is also within extent of the present invention.  
         [0032]     The catheter  50  described above with respect to the clip  100  may also be used in respect to the second embodiment of the clip  200 . To install the catheter  50  into the clip  200 , the catheter  50  is pressed against the two juxtaposed edges  224 ,  226  of the first generally straight body portion  204  and forced into the first channel  220 . The catheter  50  is then pressed against the two juxtaposed edges  228 ,  230  of the second generally straight body portion  206  and forced into the second channel  222 . The catheter  50  is now secured within the pre-curved catheter clip  200 , as shown in  FIG. 7 , and the catheter  50  is ready for packaging and sterilization.  
         [0033]     The catheter  50  must be removed from the clip  200  before the use of the catheter  50  on a patient. To remove the catheter  50  from the clip  200 , the catheter  50  is forced past the two juxtaposed edges  224 ,  226  of the first generally straight body portion  204  and the catheter  50  is removed from the first channel  220 . The catheter is then forced past the two juxtaposed edges  228 ,  230  of the second generally straight body portion  206  and the catheter  50  is removed from the second channel  222 .  
         [0034]     Another method of removing the catheter  50  from the clip  200  is to pull the distal end  54  of the catheter  50  from the first distal end  210 , through the first distal channel  220 , and out the first proximal end  208  of the first generally straight portion  204 . Then, the distal end  54  of the catheter  50  is pulled from the second distal end  214 , through the second distal channel  222 , and out of the second proximal end  212  of the second generally straight portion  206 .  
         [0035]     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.