Abstract:
A gripping surface is provided on an outer surface of a needle shield as incorporated into an intravenous catheter assembly. The gripping surface provides a gripping position nearer the catheter adapter, catheter and needle tip for improved balance and control of the catheter assembly during insertion of the catheter. Additionally, the gripping surfaces include a guard feature to prevent a user&#39;s unintended contact with various components of the catheter assembly whereby the contact may result in an undesirable “over the bevel” condition.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The current invention relates to infusion devices, such as intravenous needles, used in combination with over-the-needle peripheral intravenous (IV) catheters. Specifically, the present invention relates to methods configured to provide a feature on an outer surface of a needle while generally preserving the cross-sectioned profile of the inner surface of the needle. 
         [0002]    Intravenous (IV) needles are commonly used for a variety of infusion therapies. IV needles are commonly used in combination with an over-the-needle peripheral IV catheter. As its name implies, an over-the-needle catheter is mounted over an IV needle (i.e. an introducer needle) having a sharp distal tip. A portion of the outer surface of the needle is commonly crimped or otherwise modified to provide a feature on the needle, as shown in the PRIOR ART of  FIG. 1 . In  FIG. 1 , a portion of a needle  10  is crimped between an upper anvil  20  and a lower anvil  22 . Opposing, planar surfaces  30  and  32  contact a portion of the outer surface  12  of the needle  10  and inwardly compresses or pinches the needle  10  thereby providing feature  30 . Feature  30  generally comprises an outwardly extended portion of the outer surface  12  of the needle  10 . The outer surface  12  of the needle  10  is extended outwardly as the upper and lower anvils  20  and  22  pinch the needle  10  resulting in a partial occlusion of a cross-section of the inner lumen  14  of the needle  10 . While the PRIOR ART method provides a feature  30  on the outer surface  12  of the needle  10 , the inner lumen  14  of the needle  10  is partially or completely occluded resulting in decreased flow efficiency through the needle  10 . 
         [0003]    Thus, while methods exist for providing a feature on a needle, challenges still exist. Accordingly, there is a need in the art for a method that permits the creation of a feature on an outer surface of a needle while preserving a flow efficiency through the needle. Such a method is disclosed herein. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    In order to overcome the limitations discussed above, the present invention relates to various methods for providing a needle feature on an outer surface of a needle while generally preserving the cross-sectional shape of the needle&#39;s inner lumen. Furthermore, some methods of the present invention provide a needle feature on an outer surface of a needle while preserving a flow efficiency through the needle. 
         [0005]    Some methods of the current invention entail crimping a portion of an outer surface of a needle by compressing the portion of the needle between an upper anvil and a lower anvil. The upper and lower anvils include opposing recessed surfaces that are configured to receive upper and lower portion of the outer surface of the needle. As such, the process of compressing the needle between the upper and lower anvils prevents or limits contact between the outer surface of the needle and the recessed surfaces. The result is that the upper and lower portions of the outer surface of the needle are not affected by the crimping or compression of the upper and lower anvils. 
         [0006]    However, in some embodiments the width of the recessed surfaces is configured to be less than the outer diameter of the needle. As such, when the needle is compressed between the upper and lower anvils, a planar surface of the anvils contacts a side portion of the outer surface of the needle. This contact between the anvils and the outer surface of the needle plastically deforms the side portion of the needle to provide a needle feature. In some embodiments, the depth and width of the recessed surfaces is configured such that the anvils contact only the outer surface of the needle and do not disturb the cross-sectional profile of the inner lumen of the needle. Thus, the methods of the current invention provide external needle features without compromising a flow efficiency through the inner lumen of the needle. 
         [0007]    In other methods of the present invention, a stylet or mandrel is inserted into the inner lumen of the needle prior to compressing the needle between the opposing anvils. The mandrel generally includes a cross-sectional profile that is the same as the cross-sectional profile of the inner lumen. The mandrel is positioned within the inner lumen so as to overlap the portion of the needle that is compressed or crimped by the opposing anvils. The presence of the mandrel prevents plastic deformation of the inner lumen cross-sectional profile thereby ensuring that a flow efficiency of the needle is preserved. In some embodiments, a lubricant is applied to the outer surface of the mandrel prior to insertion of the mandrel within the inner lumen. In other embodiments, a lubricant is applied to the surface of the inner lumen prior to insertion of the mandrel therein. 
         [0008]    Finally, in some methods of the present invention the contact surfaces of the opposing anvils is configured to divot the outer surface of the needle. The contact surfaces of the opposing anvils may be configured to provide a variety of needle features. For example, the contact surfaces of the opposing anvils may be configured to provide a protruding feature, a recessed feature, a spiral feature, a set of alternating features, a textured feature, and combinations thereof. Additionally, the contact surfaces of the opposing anvils may be configured to provide a series of features having a plurality of dimensions, textures, shapes, and patterns, as determined useful by a user. The current methods may also be modified to work in conjunction with other components of a catheter assembly. For example, the needle feature may be configured for use in conjunction with a safety feature of a needle housing. The needle feature may also be configured to enable controlled passage of fluids between the outer surface of the needle and a catheter. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0009]    In order that the manner in which the above-recited and other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. These drawings depict only typical embodiments of the invention and are not therefore to be considered to limit the scope of the invention. 
           [0010]      FIG. 1  is a perspective view of a PRIOR ART method for crimping a needle. 
           [0011]      FIG. 2A  is a cross-section view of a needle following a crimping method of the present invention. 
           [0012]      FIG. 2B  is a perspective top view of a needle following a crimping method of the present invention. 
           [0013]      FIG. 3A  is a cross-section view of a needle and inserted stylet prior to being crimped according to a crimping method of the present invention. 
           [0014]      FIG. 3B  is a cross-section view of a crimped needle having been crimped according to a crimping method of the present invention. 
           [0015]      FIG. 4  is a cross-section view of a needle and inserted stylet following a crimping method of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]    The presently preferred embodiment of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention. 
         [0017]    Referring now to  FIG. 2A , a representative embodiment of crimping method in accordance with the present invention is shown. Generally, crimping methods of the present invention are configured to provide a 30 feature on an outer surface  12  of a needle  10  without compromising a flow efficiency of the needle  10 . For example, the needle  10  of  FIGS. 2A and 2B  have been crimped by a method of the present invention. The method by which the needle  10  of  FIGS. 2A and 2B  were crimped requires that an upper anvil  40  and a lower anvil  42  be modified over the prior art to include opposing, recessed surfaces  50  and  52 , respectively. Opposing planar surfaces  44  and  46  have been modified over the prior art to include inwardly projecting recesses  50  and  52  having profiles that generally mirror the outer surface  12  of the needle  10 . In some embodiments, the depth  60  of the recess  50  and/or  52  is selected to be greater than, or equal to one-half of the outer diameter of the needle  10 . Additionally, in some embodiments the width  62  of the recess  50  and/or  52  is selected to be less than the outer diameter of the needle  10 . As such, when the needle  10  is compressed, or pinched between the upper and lower anvils  40  and  42 , the recessed portions  50  and  52  of the anvils  40  and  42  do not contact the outer surface  12  of the needle  10 . Rather, the planar portions  44  and  46  of the anvils  40  and  42  contact the outer surface  12  of the needle  10  thereby pinching the outer surface  12  of the needle  10  proximal to the planar surfaces  44  and  46 . For these embodiments, the process of crimping the needle  10  between the upper and lower anvils  40  and  42  generally preserves the cross-sectional profile of the inner lumen  14  of the needle  10 . Additionally, the process of crimping the needle  10  pinches and outwardly extends a portion of the needle&#39;s outer surface  12  to provide a feature or crimp  30 , again while preserving the cross-sectional profile of the inner lumen  14 . 
         [0018]    In some embodiments, the depth  60  of the recess  50  and/or  52  is selected to be less than one-half of the outer diameter of the needle  10 . Additionally, in some embodiments the width  62  of the recess  50  and/or  52  is selected to be less than the outer diameter of the needle  10 . As such, when the needle  10  is compressed, or pinched between the upper and lower anvils  40  and  42 , the recessed portions  50  and  52  of the anvils  40  and  42  contact the outer surface  12  of the needle  10  to slightly compress the cross-sectional profile of the inner lumen  14 . Although the inner lumen  14  is slightly compressed, the recessed surfaces  50  and  52  of the upper and lower anvils  40  and  42  prevent occlusion of the lumen  14  thereby preserving the flow efficiency of the needle  10 . Additionally, the process of crimping the needle  10  pinches and outwardly extends a portion of the needle&#39;s outer surface  12  to provide a feature or crimp  30 , as shown in  FIGS. 2A and 2B . 
         [0019]    Referring now to  FIG. 2B , a perspective view of a crimped needle  10  is shown. The crimped portion  16  of the needle  10  may be configured to extend any length along the outer surface  12  of the needle  10 . The length  32  of the feature  30  along the needle  10  is generally determined by the length of the upper and lower anvils  40  and  42 . In some embodiments, the planar surfaces  44  and  46  of each anvil  40  and  42  is configured to provide a needle feature  30  that is compatible with a needle tip shield (not shown) or another needle safety device (not shown). For example, in some embodiments a needle feature is provided having a spiraled configuration. In other embodiments, a needle feature is provided having various configurations of height and width. Still further, in other embodiments an upper and lower anvil are used to provide a first needle feature occupying a first space on the outer surface of the needle, and a second needle feature occupying a second space. Other embodiments include providing a first needle feature having a first thickness, and providing a second needle feature having a second thickness. Finally, in some embodiments a plurality of alternating needle features is provided on the outer surface of the needle. In some embodiments, each alternating feature is oriented at approximately 90° to an adjacent alternating feature. In other embodiments, each alternating feature comprises a different profile or property to meet a specific need or provide a specific function. 
         [0020]    In  FIG. 2B , a single needle feature  30  is provided wherein a first portion  34  of the feature  30  occupies a first side of the needle  10  and a second portion  36  of the feature  30  occupies a second side of the needle  10 . Each portion  34  and  36  of the feature  30  flanks the inner lumen  14  of the needle such that the feature  30  does not interfere with the flow efficiency of the needle  10 . 
         [0021]    Referring now to  FIG. 3A , a needle  10  is shown prior to being compressed between an upper anvil  40  and a lower anvil  42 . In some embodiments of the present invention, a stylet or mandrel  70  is inserted into the inner lumen  14  of the needle  10  prior to compressing the needle  10 . The mandrel  70  generally comprises a hardened or semi-hardened material that is capable of maintaining its cross-sectional shape under compression. The presence of the mandrel  70  within the inner lumen  14  of the needle  10  preserves the cross-sectional shape of the inner lumen  14  during compression of the needle  10 . In some embodiments, the cross-sectional shape of the mandrel  70  is selected to be generally identical to the cross-sectional shape of the inner lumen  14 . 
         [0022]    In other embodiments, the cross-sectional shape of the mandrel  70  is selected to permit control reconfiguration of the cross-sectional shape of the inner lumen  14  during compression of the needle. For example, in some embodiments the cross-sectional shape of the mandrel  70  is elliptical. In other embodiments, the cross-sectional shape of the mandrel  70  is generally round yet comprises an outward extension or protrusion (not shown). As such, when the needle  10  is compressed between the upper and lower anvils  40  and  42 , the outward protrusion prevents compression of a portion of the needle  10  thereby forming a feature on the outer surface  12  of the needle  10 . 
         [0023]    A feature  30  is formed as the upper and lower anvils  40  and  42  are drawn towards one another, thereby compressing the needle  10  within opposing recessed surfaces  50  and  52 . In some embodiments, the width  62  of the recess  50  and/or  52  is configured to be less than the width or outer diameter  18  of the needle  10 . As such, when the upper and lower anvils  40  and  42  are pressed together, opposing planar surfaces  44  and  46  contact and plastically deform the outer surface  12  of the needle  10  to provide a needle feature  30 , as shown in  FIG. 3B . Additionally, in some embodiments the width  62  of the recess  50  and/or  52  is configured to be less than the width of the outer diameter  18  of the needle, yet greater than the diameter of the inner lumen  14 . Thus, when the upper and lower anvils  40  and  42  compress the needle  10 , the outer surface  12  of the needle  10  is plastically deformed to provide a needle feature  30  while leaving sufficient material between the needle feature  30  and the inner lumen  14 . In some embodiments, the combination of the recessed surfaces  50  and  52 , and the inserted mandrel  70  preserve the cross-sectional shape of the inner lumen  14  of the needle  10  during the compression process. 
         [0024]    Referring now to  FIG. 3B , a needle  10  is shown following compression between the upper and lower anvils  40  and  42 . Following formation of the needle feature  30  via plastic deformation of the outer surface  12  of the needle  10 , the stylet or mandrel  70  is removed from the inner lumen  14  to reveal the preserved cross-sectional shape of the needle  10 . In some embodiments, an outer surface of the mandrel  70  is coated with a lubricant prior to being inserted into the inner lumen  14  of the needle  10 . As such, the lubricant assists in removal of the mandrel  70  following the compression process. 
         [0025]    Referring now to  FIG. 4 , a needle  10  is shown following compression of a needle  10  between an upper anvil  80  and a lower anvil  82 . In some embodiments of the present invention, a needle feature  90  is provided by pinching a portion of a needle  10  between opposing anvils  80  and  82 , each anvil having a positively protruded contact surface  100 . The protruded contact surface  100  generally comprises a rounded profile that is configured to strike the outer surface  12  of the needle  10  to provide a divot  92  in the outer surface  12  of the needle  10 . One of skill in the art will appreciate that the protruded surface  100  may include any profile shape, including, but not limited to, spherical, square, rectangular, elliptical, triangular, polyhedral, concave, convex, parabolic, and combinations thereof. 
         [0026]    In some embodiments, the divot  92  provides a negative or relief surface that comprises a needle feature  90 . In other embodiments, the process of making the divot  92  displaces other portions of the outer surface  12  of the needle  10  to provide positive or outwardly protruding surfaces (not shown) that comprise a needle feature. Still further, in other embodiments the divot  92  provides an edge surface  94  that comprises a needle feature. For some methods, it is desirable to insert a mandrel  70  into the inner lumen  14  of the needle  10  prior to striking the needle  10  with the opposing anvils  80  and  82 . In some embodiments, the mandrel  70  is positioned such that the mandrel  70  overlaps the portion of the needle  10  proximal to the upper and lower anvils  80  and  82 . As such, upon striking the outer surface  12  of the needle  10  with the opposing anvils  80  and  82 , the cross-sectional profile of the inner lumen  14  is preserved. 
         [0027]    The methods of the present invention provide a variety of needle features on an outer surface of a needle, while generally preserving a cross-sectional profile on the needle&#39;s inner lumen. The methods of the present invention further permit the formation of multiple needle features having multiple shapes and dimensions as required by a user for a specific or general application. Accordingly, the methods of the present invention are adapted to provide useful, functional, and highly modifiable needle features on the outer surface of a needle. 
         [0028]    The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.