Abstract:
A clamp guard ( 10,110,210 , . . . ) for securing to flexible tubing ( 50 ) such as catheters and their extension tubes and about a clamp ( 60 ) therealong for housing the clamp at least when the clamp is in a tubing-clamping state, to prevent inadvertent contact of the clamp by a foreign body and undesirable unclamping of the clamp. The clamp guard is removable from around the clamp when desired.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority from U.S. Provisional Patent Application Ser. No. 60/931,917 filed May 25, 2007. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This relates to flexible tubing and more particularly to medical tubing such as catheters and their extension tubes and to clamp devices therefor. 
       BACKGROUND OF THE INVENTION 
       [0003]    Catheters for the introduction or removal of fluids may be located in various venous locations and cavities throughout the body for the introduction or removal of such fluids. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter in which a first lumen introduces fluids and a second lumen removes fluids. These catheters are very useful for procedures such as hemodialysis, wherein blood is removed from a patient through the first lumen for processing in a hemodialysis machine, and the processed blood is returned to the patient through the second lumen. Alternatively, multiple catheters, each having a single lumen, may be inserted in multiple locations in the patient, such as in each femoral vein. 
         [0004]    Many such catheter assemblies are presently utilized that include extension tube assemblies at proximal ends of the lumens of multi-lumen catheters, and clamps are commonly used that allow manual actuation to clamp and unclamp the extension tubes to occlude fluid flow therethrough at selected times, such as during connection to and disconnection from tubing of hemodialysis machines. One particularly popular clamp is an in-line pinch clamp known as a Halkey-style or Roberts clamp, which has: a skeletal-like framework defining an axially extending body portion having transverse distal and proximal end portions; tube openings through its transverse distal and proximal end portions through which the tubing extends; a flexible latching arm extending proximally from the distal end portion thereof to a free end, and the transverse proximal end portion of the clamp comprising a catch arm extending to a free end upon which is defined a catch, for the latch arm free end to become latched thereto; and cooperating clamping sections that impinge on the tubing to occlude it when the clamp is in its clamping state, one clamping section being on the flexible arm and the other being defined on the axially extending body portion, both intermediate the distal and proximal ends. The latching arm is adapted to be easily manipulated by hand between latching and unlatching conditions that correspond with clamping and unclamping states of the clamp. Such a clamp would be maintained in the clamped state most of the time, that corresponds to all times other than when a practitioner is performing hemodialysis or infusion, or is withdrawing a blood sample. 
         [0005]    Such a clamp in its latched and clamped state has a drawback in that the free end of the catch arm can snag on clothing, linens, tubing, wiring and other articles and snag and strain the tubing and the catheter, potentially harming the patient or damaging the catheter assembly. Even more problematic is that the catch arm free end can snag sufficiently to unlatch the latching arm resulting in unclamping of the clamp permitting blood to flow freely from the patient, causing great harm, especially when the patient is unattended in order for remedial action to be performed. 
         [0006]    It is desired to provide a way of minimizing the possibility of the tubing clamp snagging or becoming inadvertently unclamped. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The present invention is directed to an article for placement about a flexible tubing clamp to guard against accidental opening thereof when in its clamped state occluding fluid flow through the flexible tubing. Preferably, the article envelopes most of the clamp to minimize any snagging by any portion of the clamp and also itself possesses a snagging-free external surface, such as by having minimal if any protrusions, and also, preferably, having rounded exposed edges and corners, which also presents an additional advantage of patient comfort. 
         [0008]    In one embodiment, the article is a housing that is adapted to be placed along the tubing adjacent to the clamp and that has distal and proximal openings in its distal and proximal ends, with the distal opening of the housing defining a large clamp-receiving opening and being adjacent the proximal end of the clamp, while the proximal opening is sufficiently large for the tubing to pass therethrough. The housing would preferably be movable along the tubing to envelop the clamp at least when the clamp is in its clamping state at which time the flexible latch arm of the clamp is in its latched state and such that the end of the clamp at which the free end of the latching arm is disposed, is totally within the housing. 
         [0009]    In another embodiment, the guard is a housing similar to that described above, wherein the interior of the housing is so dimensioned as to define a friction fit with the clamp wherein the housing is maintained about the clamp. 
         [0010]    In a third embodiment, similar to those described hereinabove, the guard housing includes an opening at its relatively closed end so shaped and dimensioned for receipt thereinto of the free end of the catch of the clamp in a snap-fit, for holding the guard housing in position about the clamp. 
         [0011]    In a fourth embodiment, the guard is a housing similar to those described hereinabove, wherein the housing is a two-part housing, the housing parts disposed about and along the flexible conduit in respective positions distally and proximally from the distal and proximal ends of the clamp, wherein the two housing parts are adapted to be secured together about the clamp. 
         [0012]    Additional embodiments of the guard of the present invention are disclosed wherein the guard housing is positioned along the flexible conduit distally of the clamp and are translatable along the conduit to envelop the clamp from the distal end thereof, that is, the end from which the latching arm of the clamp extends. In a fifth embodiment, the guard housing defines an interior that is large enough just to receive the distal end portion of the clamp thereinto when the latching arm is in its latched state, and would define a friction fit with the clamp. While the free end of the proximal end portion of the clamp (i.e., the catch arm) would protrude from the housing and thus be exposed, the latching arm would be secured in its latched state by abutment with the guard housing even if the catch arm became inadvertently snagged. 
         [0013]    In a sixth embodiment, similar to the fifth, the guard housing defines an interior that, at the housing end remote from the clamp-receiving opening, includes a diverging top wall of the clamp-receiving opening that creates an enlarged interior clearance area that can receive thereinto the free end of the catch arm of the clamp that would obviate any snagging of the catch arm. 
         [0014]    A seventh embodiment of guard housing is similar to the immediately preceding embodiment, except that the end portion of the top wall does not diverge but instead protrudes beyond the proximal end of the housing and includes an overhang that defines a snap-fit with the free end of the catch arm to assure securing of the guard housing about the clamp when the clamp is fully received into the housing. 
         [0015]    Further, the embodiments could be adapted for retrofit application by including a clip structure for being applied laterally to the length of tubing, and could also have internal latch projections to latch to the clamp&#39;s skeletal-like framework. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    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: 
           [0017]      FIG. 1  is an isometric view of a first embodiment of clamp guard of the present invention; 
           [0018]      FIGS. 2 to 4  are isometric views of the clamp guard of  FIG. 1  disposed along an extension tube between a fitting and a clamp, respectively, spaced apart with the clamp in an opened state and the fitting being applied ( FIG. 2 ); spaced apart with the clamp in a closed clamping state ( FIG. 3 ); and the guard enveloping the clamp in its closed clamping state ( FIG. 4 ); 
           [0019]      FIG. 5  is a longitudinal cross-section view of the clamp guard assembled to the clamp as in  FIG. 4 ; 
           [0020]      FIGS. 6 and 7  are an isometric and distal end view a second embodiment of clamp guard; 
           [0021]      FIGS. 8 and 9  are an isometric and distal end view a third embodiment of clamp guard; 
           [0022]      FIGS. 10 to 12  are elevation views and a cross-section view similar to  FIGS. 3 to 5  of the clamp guard of  FIGS. 8 and 9 ; 
           [0023]      FIGS. 13 and 14  are an isometric views of a fourth embodiment of clamp guard having two parts that are assembled together about a clamp; 
           [0024]      FIGS. 15 and 16  are elevation and cross-section views of the clamp guard of  FIGS. 13 and 14  assembled to an extension tube spaced apart from and assembled about the clamp, respectively; 
           [0025]      FIGS. 17 to 20  are elevation views and a cross-section view of a fifth embodiment of clamp guard assembled along an extension tube similar to  FIGS. 2 to 5 , with the clamp guard similar to that of  FIG. 1 ; 
           [0026]      FIG. 21  is an isometric view of a sixth embodiment of clamp guard of the present invention adapted to be assembled to an extension tube from laterally thereof, and having internal latches to latch to the clamp; 
           [0027]      FIGS. 22 to 24  are cross-sectional, proximal and distal views of the clamp guard of  FIG. 21 , with  FIG. 24  shown assembled to an extension tube and enveloping the clamp; 
           [0028]      FIGS. 25 to 29  are elevation and cross-section views of an extension tube with a fitting and a clamp, and the clamp guard of  FIGS. 21 to 24 , showing, respectively, the clamp guard being assembled to the tubing, on the tubing with the clamp open, with the clamp closed, and with  FIGS. 28 and 29  enveloping the clamp in elevation and cross-section views, respectively; 
           [0029]      FIGS. 30 to 34  are views of a seventh embodiment of clamp guard of the present invention; 
           [0030]      FIGS. 35 to 38  are views of an eighth embodiment of clamp guard of the present invention; and 
           [0031]      FIG. 39  is an isometric view of a ninth embodiment of clamp guard having a hinge. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    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. Flexible tubing or conduit includes catheters and extension tubes therefore, without limitation. The terms “distal” and “proximal” refer, respectively, to directions away from and closer to the latching arrangement of the clamp. “Tubing” refers to flexible tubing of the type used in medical devices and includes catheters, intravenous tubing and extension tubes of catheters assemblies. 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. 
         [0033]    Generally, clamp members illustrated herein are of the Roberts type, but the present invention is not restricted to only this type of clamp; modifications may be made to the indicia-bearing article of the present invention to adapt to different styles of clamps, within the skill of the artisan. 
         [0034]    In the first embodiment shown in  FIGS. 1 to 5 , a first embodiment of clamp guard device  10  includes a body  12  having a pair of side walls  14 , 16 , a top wall  18 , bottom wall  20 , an interior  22  and a proximal end  24  with a tube aperture  26 , and distal end  28 . Optionally, one or more walls of the clamp guard  10  may have indicia thereon, as indicated at  30 . Also seen in  FIGS. 2 to 5  is an assembly of a length of flexible tubing  50 , a fitting  52  affixed to a proximal end of the tubing, and a clamp member  60  secured along the tubing  50 , the clamp being manipulatable between an unclamping state and a clamping state in which fluid flow through the tubing  50  is occluded. Clamp  60  is an in-line clamp having a skeletal-like framework body  62  having a distal end  64 , proximal end  66 , openings  68  through the distal and proximal ends through which the tubing extends, a latch arm  70  extending from the distal end  64  proximally to a free end  72 , and a catch arm  74  at the proximal end  66  extending transversely to a free end having a catch  76  that cooperates with the latch arm free end  72  when the clamp is in the latched and closed state.  FIGS. 3 and 5  show the cooperating clamping sections  78 , 80  that impinge on the flexible tubing  50 , as seen in  FIG. 5 , for its occlusion when the free end of the arm  70  is latched to catch  76  to hold it in the clamping state; such a clamp is conventionally known as a Roberts clamp. 
         [0035]    Generally, with respect to all of the disclosed embodiments, the clamp guard devices may be made of soft pliable polyurethane like 80A PELLETHANE® polymer (a product of Dow Chemical Co.), or silicone elastomer, or may be made of ABS, polyvinyl chloride, polypropylene or other suitable plastic materials that may alternatively produce semi-rigid or rigid properties. The clamp members may be made of similar suitable plastic materials but have substantial rigidity to maintain clamping of the flexible tubing; in-line pinching clamps are commonly made of polypropylene or acetal. The flexible tubing may be biocompatible elastomers such as silicone rubber, usually for catheters, or polyurethane, usually for extension tubing or some catheters. 
         [0036]    Further, with respect to all embodiments, it is preferred that the exposed edges of the guard be gently rounded to minimize skin irritation of the patient, problematic especially in certain patient populations with compromised skin such as patients with diabetes. Generally speaking, the guard of the present invention would fit snuggly about the clamp, or remain in position therearound such as by latches or snap fit, protect against inadvertent and undesirably unclamping of the clamp from the tubing, and be removable therefrom when it is desired to unclamp the clamp from the tubing. 
         [0037]      FIGS. 6 and 7  show a second embodiment of clamp guard  110  with a pair of side walls  114 ,  116 , top and bottom walls  118 ,  120 , a proximal end  124  with tube aperture  126 , and a distal end  128 . In this embodiment, guard body  112  is narrower between side walls  114 ,  116 , enabling proximal end  124  to establish a friction fit at internal corners  132  or along interior side surfaces with upper and lower side edges of a tubing clamp such as clamp  60  of  FIGS. 2 to 5 , upon receipt thereof into guard interior  122  when the clamp is in its closed state as in  FIG. 5 . Clamp guard  110  is removable from about clamp  60  permitting access thereto for unclamping the tubing, when desired. 
         [0038]    Clamp guard  210  of  FIGS. 8 to 12  provides for a latching arrangement to secure the clamp guard about the clamp  60  in its clamping state along the flexible tubing  50 . Clamp guard  210  has a distal end  228  open for receipt into its interior  222  of the clamp. A transverse opening  234  is defined at the junction of top wall  218  and proximal end  224 , associated with catch arm  74  of clamp  60 . As seen in  FIGS. 11 and 12 , when clamp  60  is in its clamping state and latch arm  70  is latched to catch arm  74 , clamp guard  210  is moved along tubing  50  until clamp  60  is received into interior  222 ; catch arm  74  snaps into transverse opening  234  and latches behind, or proximally of, overhang  236  of top wall  218  of the clamp guard, holding the clamp guard in position about the clamped clamp in a manner permitting removal therefrom for unclamping from the tubing, when desired. 
         [0039]    In  FIGS. 13 to 16 , clamp guard embodiment  310  is seen to comprise two housing parts,  312 A and  312 B, that self-secure to each other about the clamped clamp  60  in a manner permitting disassembly to access the clamp for unclamping when desired. Housing parts  312 A and  312 B each have a transverse end section  324 , 328  respectively each having an opening  336 , 326  through which the tubing extends, and each has an open opposite end  338 , 340  enabling receipt thereinto of ends of the clamp. Preferably, housing part  312 A is disposed distally of the clamp along the tubing  50 , and housing part  312 B is disposed proximally of the clamp, as seen in  FIGS. 15 and 16 , and both housing parts are translatable along the tubing and about the clamp after which the housing parts latch to each other. As shown, the distal end  338  of housing part  312 A is received into proximal end  340  of housing part  312 B, and latch projections  342  at the distal end of housing part  312 A latch into ends  344  of latch slots  346  along side walls of housing part  312 B for latching the housing parts to each other about the clamp  60 . 
         [0040]    Another embodiment of clamp guard  410  is seen in  FIGS. 17 to 20 , comprising a unitary housing  412 . Clamp guard  410  is disposed along the tubing distally of the clamp and is translatable proximally to receive all but the proximal end of the clamp  60  into interior  422  thereof. Clamp guard  410  is dimensioned to establish a friction fit with and about clamp  60  when in its clamping state, in a manner permitting removal therefrom for accessing the clamp for unclamping the tubing. 
         [0041]    Clamp guard embodiment  510  of  FIGS. 21 to 29  also comprises a unitary housing  512 . Clamp guard  510  is similar to clamp guard  410  of  FIGS. 17 to 20  except that it is adapted to latch directly onto the clamp. Clamp guard  510  is seen to provide a wide slot  548  along bottom wall  520  and continuing along distal end section  528  and opening onto distal opening  526 ; this permits clamp guard  510  to be secured onto the flexible tubing from laterally thereof, as seen in  FIGS. 24 and 25 . Within interior  522  of clamp guard  510 , adjacent to distal end section  528  thereof, are a pair of opposed latch projections  542  that are shaped and dimensioned to latch proximally of the proximal inside surface of clamp distal end  64 , as seen best in  FIG. 28 . (In  FIG. 24 , latch projections  542  are seen because of apertures through distal end section  528  remaining as relics from the molding process.) At the proximal end  524  of clamp guard  510 , the top wall  518  includes an outwardly angled wall portion  550  that will be disposed outwardly of and over catch arm  74  of clamp  60  to inhibit snagging thereof by any foreign objects such as tubing, wires, clothing and so on that could otherwise tend to inadvertently and undesirably unclamp the clamp from the tubing. 
         [0042]    An additional clamp guard embodiment  610  is illustrated in  FIGS. 30 to 34 , comprising a unitary housing  612 . This embodiment is similar to clamp guard  210  of  FIGS. 8 to 12 , but is disposed on tubing  50  distally of clamp  60 . Top wall  618  of housing  612  includes an overhang  636  at otherwise open proximal end  624  that will snap over catch arm  74  of clamp  60 . 
         [0043]    A further, eighth embodiment of clamp guard  710  is shown in  FIGS. 35 to 38 , wherein the clamp guard distal end includes a tubing opening  726  through the proximal wall  728 , similar to the clamp guards of  FIGS. 2 and 7 ; optionally, a slotted entrance could be provided similar to that in the clamp guard configuration of  FIG. 22 . Further, the embodiment lacks a bottom wall, so that it may be clipped onto the tubing and moved adjacent the distal end of the clamp and then rotated or pivoted about the clamp in its closed position. A pair of catches  742  facing each other at the bottom edges of the opposing clamp guard sidewalls, will latch onto and about the bottom edges  82  of the clamp to secure the clamp guard in position about the clamp. 
         [0044]    In  FIG. 39 , a ninth embodiment of clamp guard  810  is illustrated. Clamp guard  810  has two half portions  852 , 854  joined to each other by a living hinge  856 . A first half portion  852  includes a latch member  858  along the opposite side from the hinge, and the second half portion  854  includes a catch  860  along the opposite side from the hinge. The first and second half portions can be pivoted about living hinge  856  until latch member  858  and catch  860  latchingly engage, for clamp guard  810  to be secured about a clamp. A transverse body section  862  may be included at one end of clamp guard  810 , having a tubing aperture  826  therethrough by which the clamp guard can be secured to the tubing during assembly. 
         [0045]    Further variants of the invention include a guard of two parts latchable to each other directly around the clamp in similar fashion to the clamp guard of  FIGS. 35 to 38 , without self-retaining to the flexible tubing directly (not shown). It is also foreseeable that the clamp guard of the present invention may be free of one of the two side walls, or be free of a bottom wall or a distal end wall. 
         [0046]    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.