Abstract:
The invention relates to a needle stick guard for an anti-needle-stick puncturing kit for positioning a catheter according to the Seldinger technique, including a rocker having a journal so as to enable same to rotate about an axis, and an outer tip for locking the needle stick guard together with a base of another element of the puncturing kit. The rocker comprises three positions: a position in which it is locked together with another element of the puncturing kit; a position in which it is unlocked from the other element of the puncturing kit; and a protection position for trapping a sharp end of a needle in the guard.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a national phase entry under 35 U.S.C. §371 of International Application No. PCT/EP2010/066119 filed Oct. 26, 2010, published in French, which claims priority from FR 0957507 filed Oct. 26, 2009, all of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The invention relates to a needle stick guard for an anti-needle-stick puncturing kit for installing a catheter by the Seldinger method. 
         [0003]    The invention also relates to an anti-needle-stick puncturing kit for installing a catheter by the Seldinger method. 
       STATE OF THE ART 
       [0004]    The Seldinger method is a method for installing a central catheter intravenously with its distal end at the aorta. This method also allows an artery to be catheterized. 
         [0005]    The installation of a catheter by the Seldinger method comprises the following steps: insertion of the needle into a vein up to the desired location; insertion of a guide within the needle up to the desired location; withdrawal of the needle from the vein, the guide remaining in place; insertion of a catheter by sliding along the guide up to the desired location; and withdrawal of the guide. 
         [0006]    It is possible, between the needle withdrawal step and that of inserting the catheter, to widen the incision made by the needle in the skin by inserting, by sliding along the guide, a dilator known to those skilled in the art. Once the incision is enlarged, the dilator is withdrawn, the guide remaining in place. 
         [0007]    Handling a needle during the installation of a catheter by the Seldinger method carries a risk of injury to the operator. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    One object of the invention is to correct at least one disadvantage of the state of the art. 
         [0009]    To this end, the invention proposes a needle stick guard for an anti-needle-stick puncturing kit for installing a catheter by the Seldinger method, comprising: 
         [0000]    a rocker having a bearing allowing its rotation about an axis, and an external tip for locking the needle stick guard together with a base of another element of the puncturing kit; a body comprising: a proximal hole and a distal hole for inserting a tube of a needle and inserting a spiral guide between the proximal and distal holes; a slot for accommodating the rocker; and a housing on the periphery of the slot for receiving the bearing of the rocker; Characterized in that the rocker has three positions: a locking position wherein the external tip locks the needle stick guard together with the base of the other element of the puncturing kit; an unlocking position wherein the external tip releases the needle stick guard from the other element of the puncturing kit; and a protection position wherein the sharp end of the needle is trapped by the body of the rocker; and in that the rocker has a spur within the body for controlling the position of the rocker with respect to an outside diameter of the needle tube and/or of the spiral guide; the locking position being obtained when the spur rests on the needle tube; the unlocking position being obtained when the spur rests on the spiral guide; and the protection position being obtained when the spur rests neither on the needle tube nor on the spiral guide. 
         [0010]    Other optional and non-limiting features are: the guard also includes a resilient element to force the rocker toward the interior of the guard body; the proximal hole has a diameter fitted to the diameter of the needle tube; the proximal hole is made in a metal strip, the metal strip and the resilient element constituting a single part; the guard also includes an indentation extending outward with respect to the body and surrounding the proximal hole for receiving a local distortion of the needle tube; and the guard also has an intermediate hole between the proximal hole and the distal hole for stabilizing the needles with respect to the needle stick guard. 
         [0011]    The invention also proposes an anti-needle-stick puncturing kit for installing a catheter by the Seldinger method at a catheterization point on the skin of a living being comprising: a needle stick guard according to one of the embodiments of the invention; an immobilizing element for temporarily immobilizing the needle stick guard in proximity to the catheterization point; the immobilization element comprising a base for receiving the distal portion of the needle stick guard and a ridge arranged on the base and designed to be seized by the outer tip of the needle stick guard. 
         [0012]    Other optional and non-limiting features are: the immobilization element also includes a longitudinal element connected to the base by a hinge for moving the longitudinal element between a proximal position and a distal position; the longitudinal element being in contact with the skin in its distal position and allowing the temporary immobilization of the anti-needle stick guard by its attachment to the skin; the puncturing kit also includes a connector comprising: a guard housing for receiving a proximal portion of the needle stick guard; and a needle housing for receiving a base of the needle; the needle housing including means of connecting with the base of the needle; the guard housing of the connector is a slot fitted to the needle stick guard so as to block rocker in the locking position when the needle stick guard is lodged in the guard. 
         [0013]    An advantage of the needle stick guard and of the anti-needle-stick puncturing kit according to the invention is to allow operation of the puncturing kit without needle stick risk to the operator, without adding supplementary and constraining operations. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Other features, goals and advantages will appear upon reading the following detailed description, with reference to the drawings provided by way of illustration and without limitation, among which: 
           [0015]      FIG. 1  is a longitudinal section view of an needle stick guard according to the invention, and showing the guard in a first configuration; 
           [0016]      FIG. 2  is a longitudinal section view of the needle stick guard of  FIG. 1 , and showing the guard in a second configuration; 
           [0017]      FIG. 3  is a longitudinal section view of the needle stick guard of  FIG. 1 , and showing the guard in a third configuration; 
           [0018]      FIG. 4  is a three-quarters view of the needle stick guard of  FIG. 1 ; 
           [0019]      FIG. 5  is a three-quarters view of an immobilization element used with the needle stick guard of  FIG. 1 ; 
           [0020]      FIG. 6  is a longitudinal section view of an anti-needle-stick puncturing kit according to the invention with an immobilization element in its proximal position; 
           [0021]      FIG. 7  is a profile view of the anti-needle-stick puncturing kit of  FIG. 6  with the immobilization element in its distal position, in contact with the skin of a living being. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    An anti-needle-stick puncturing kit and a needle stick guard for the anti-needle-stick puncturing kit for installing a catheter by the Seldinger method are described hereafter with reference to  FIGS. 1 through 7 . 
         [0023]    The anti-needle-stick puncturing kit  1  according to the invention includes a needle stick guard  2 . 
         [0024]    In the rest of the detailed description, the adjectives “proximal” and “distal” designate positions relative to one another. The proximal position is that which is closer to the body of the operator holding the needle stick guard  2 . The distal position is that which is farther from the body of the operator holding the needle stick guard  2 . 
         [0025]    The needle stick guard  2  includes a body  22  including a proximal hole  221  and a distal hole  222  for the insertion of a tube  41  of a needle  4  and the insertion of a spiral guide  5  between the proximal  221  and distal  222  holes. 
         [0026]    The body  22  also includes a slot  223  for receiving a rocker  21 , and a housing  224  at the periphery of the slot  223  for receiving a bearing  211  of the rocker  21 . 
         [0027]    The needle stick guard  2  therefore includes a rocker  21  having a bearing  211  for its rotation about an axis  21  A, and an external tip  212  for locking the needle stick guard  2  together with a base  31  of another element of the puncturing kit  1 . 
         [0028]    The other element can for example be an immobilization element  3  of the needle stick guard  2  described later in greater detail. 
         [0029]    The other element can be any other element which needs to be locked together with the needle stick guard  2 . 
         [0030]    The rocker  21  exhibits three distinct positions, P 1 , P 2 , P 3  about its axis of rotation  21  A. 
         [0031]    A locking position P 1  is shown in  FIG. 1 . 
         [0032]    In this locking position P 1 , the external tip  212  locks needle stick guard  2  together with the base  31  of the other element  3  of the puncturing kit  1 . 
         [0033]    An unlocking position P 2  is shown in  FIG. 2 . 
         [0034]    In this unlocking position P 2 , the external tip  212  releases the needle stick guard  2  from the other element  3  of the puncturing kit  1 . 
         [0035]    A protection position P 3  is shown in  FIG. 3 . 
         [0036]    In this protection position P 3 , the sharp end  42  of the needle  4  is trapped by the body  22  and the rocker  21 . 
         [0037]    In order to control the position of the rocker  21  about its axis of rotation  21  A, the rocker  21  has a spur  213  within the body  22 . The spur  213  therefore extends into the slot  223 . 
         [0038]    Control of the position of the rocker  21  about its axis of rotation  21 A is carried out with respect to an outside diameter of the tube  41  of the needle  4  and/or of the spiral guide  5 . In greater detail, the spur  213 , the outside diameter of the tube  41  of the needle  4  and the diameter of the spiral guide  5  cooperate in such a way that: the locking position P 1  is obtained when the spur  213  is resting on the outer diameter of the tube  41  of the needle  4 ; the unlocking position P 2  is obtained when the spur  213  is resting on the outer diameter of the spiral guide  5 ; and the protection position P 3  is obtained when the spur  213  is resting neither on the outer diameter of the tube  41  of the needle  4  nor on that of the spiral guide  5 . 
         [0039]    The arrangement of a rocker  21  having these three positions is advantageous for an anti-needle-stick puncturing kit  1  having in addition, for example, an immobilization element  3  to temporarily immobilize the needle stick guard  2  in proximity to a catheterization point  71  made on the skin  7  of a living being. 
         [0040]    The immobilization element  3  allows the needle stick guard  2  to be temporarily held immobile. Thus, upon withdrawal of the needle  4  along the needle stick guard  2 , this makes it possible to prevent the needle stick guard  2  from being dragged along by the withdrawal motion of the needle  4 . 
         [0041]    This is important for bringing the sharp end  42  of the needle  4  into the needle stick guard  2 . 
         [0042]    The immobilization element  3  can include a base  31 , for receiving a distal portion of the needle stick guard  2 , and a ridge  32  arranged on the base  31 . This ridge  32  is designed to be seized by the external tip  212  of the needle stick guard  2 ; the seizing of the ridge  32  with the external tip  212  allowing the needle stick guard  2  to be locked together with the immobilization element  3 . 
         [0043]    During the installation of a catheter by the Seldinger method, the puncturing kit  1  is used as follows. 
         [0044]    First of all, the needle  4 , the tube whereof is already inserted between the proximal hole  221  and the distal hole  222  of the needle stick guard  2 , is inserted through the skin  7  at the catheterization point  71  using its sharp end  42 . Upon insertion of the needle  4 , the puncturing kit  1  is brought close to the skin  7  up to the catheterization point  71 . 
         [0045]    The external tip  212  is seizing the ridge  32 . For example, the external tip  212  constitutes a stop for the ridge  32 : the immobilization element  3  cannot be separated from the needle stick guard  2  as illustrated in  FIG. 1  (also showing the spiral guide  5  already inserted; see below). 
         [0046]    Once the needle  4  is in place, the spiral guide  5  is inserted inside the  4  needle (and therefore through the needle stick guard  2 ) up to the desired location within a vein or an artery. The needle  4  must then be withdrawn, while the needle stick guard  2  must remain in place: this is made possible thanks to the immobilization element  3 . 
         [0047]    For example, as illustrated in  FIG. 5 , the immobilization element  3  also includes a longitudinal element  33  connected to the base  31  by a hinge  34  for moving the longitudinal element  33  between a proximal position and a distal position. 
         [0048]    When the spiral guide  5  is inserted into the needle  4  (in the direction leading from the proximal hole  221  toward the distal hole  222 ) and set in place, the longitudinal element  33 , initially folded over toward the needle stick guard  4  (in its proximal position), is brought into contact with the skin  7  in its distal position. Its attachment to the skin  7  allows the immobilization of the needle stick guard  2  because it is locked together with the immobilization element  3 . 
         [0049]    The attachment of the longitudinal element  33  can be provided either by simple pressure of the longitudinal element  33  on the skin  7  (pressure applied by the operator&#39;s hand), or by the use of an adhesive (adhesive plaster or other), or by any other suitable means. 
         [0050]    During withdrawal of the needle  4  (in the direction leading from the distal hole  222  toward the proximal hole  221 ), the spur  213  of the rocker rests on the outer diameter of the tube  41  of the needle  4 . The needle stick guard  2  is therefore locked together with the immobilization element  3 . 
         [0051]    When the needle is withdrawn sufficiently, the spur  213  no longer rests on the outer diameter of the tube  41  of the needle  4 , but rather on the outer diameter of the spiral guide  5  (unlocking position P 2 , see  FIG. 2 ): the rocker has then undergone a rotation about its axis of rotation  21  A due to its weight. 
         [0052]    This rotation of the rocker  21  can also be provided for thanks to a resilient element  23  provided on the needle stick guard  2  to force the rocker  21  toward the inside of the body  22  of the guard  2 . 
         [0053]    For example, the rocker  21  has a contact surface  214  and the resilient element  23 , which can be a strip of metal, presses on the contact surface  214  so as to exert a force toward the inside of the slot  223 . 
         [0054]    The force exerted is weak enough that the needle  4  can easily be moved by sliding between the distal hole  222  and the proximal hole  221 , and that later, during withdrawal of the needle stick guard  2  when the spur  213  is resting on the spiral guide  5 , the spiral guide  5  is not dragged along. But the force exerted must be greater than the weight of the rocker  21  and greater than the friction forces between the bearing  211  and its housing  224 . 
         [0055]    The rotation of the rocker  21  causes the external tip  212  to lift, releasing the ridge  32 : the ridge  32  no longer abutting the external tip  212 , the needle stick guard  2  can be moved away from the immobilization element  3 . 
         [0056]    The needle stick guard  2  is moved away from the immobilization element  3  by the operator by continuing to pull on the needle  4  in the manner known to those skilled in the art. 
         [0057]    For example the proximal hole  221  of the needle stick guard  2  has a diameter fitted to the diameter of the tube  41  of the needle  4  and the tube  41  of the needle  4  has a local distortion  43  so that the tube  41  has, in at least one direction, dimensions greater than the diameter of the proximal hole  221 . For example, the tube  41  is flattened at one spot. 
         [0058]    The distance between the sharp end  42  and the local distortion  43  is selected so that the sharp end  42  remains inside the needle stick guard  2  when the spur  213  of the rocker  21  is no longer in contact with the outer diameter of the tube  41  of the needle  4 , and so as to make possible the rotation of the rocker  21  about its axis of rotation  21  A toward its protection position P 3 . 
         [0059]    The operator then continues to withdraw the needle  4 , drawing the needle stick guard  2  away from the immobilization element  3  until the spiral guide  5  is completely disengaged from the needle stick guard  2 : the spur  213  no longer resting on the outer diameter of the spiral guide  5 . 
         [0060]    When the spur  213  no longer rests on the outer diameter of the spiral guide  5 , the rocker  21  undergoes a rotation about its axis of rotation  21  A toward the inside of the slot  223  due to its weight and/or possibly due to the resilient element  23  toward its protection position P 3  as illustrated in  FIG. 3 . 
         [0061]    In the protection position P 3  the rocker prevents the sharp end  42  from re-emerging from the needle stick guard  2  as a result of a movement of the needle  4  in the direction leading from the proximal hole  221  toward the distal hole  222 . The movements of the needle  4  can therefore be constrained thanks to the rocker  21 , on the one hand, and the local distortion  43  of the tube  41  of the needle  4 . 
         [0062]    When the needle stick guard  2  includes the resilient element  23 , the fact that it is selected so that the force that it exerts on the contact surface  214  of the rocker  21  is greater than the weight  21  makes it possible to prevent the rocker  21  from leaving the slot  223  if the needle stick guard  2  happens to be turned over. 
         [0063]    Operationally, the proximal hole  221  can be made in a metal strip  24 , the metal strip  24  and the resilient element  23  forming a single part. 
         [0064]    Thus when the operator withdraws the needle  4  in the direction leading from the distal hole  222  toward the proximal hole  221 , the local distortion  43  of the tube  41  of the needle  4  comes into abutment against the periphery of the proximal hole  221  and deforms the metal strip  24 . The deformation of the metal strip  24  brings about the application of an additional force by the resilient element  23  on the contact surface  214  of the rocker  21  that further favors the rotation of the rocker  21  about its axis of rotation  21  A. 
         [0065]    The needle stick guard  2  can also include, in the cases where the proximal hole  221  is fitted to outside diameter of the tube  41  of the needle  4 , an indentation  224  extending outward with respect to the body  22  and surrounding the proximal hole  221  for receiving the local distortion  43  of the tube  41  of the needle  4 . 
         [0066]    The needle stick guard  2  can also include an intermediate hole  225  between the proximal hole  221  and the distal hole  222  for stabilizing the needle  4  with respect to the needle stick guard  2 . 
         [0067]    The position of the intermediate hole  225  is selected so as to position it between the proximal hole  221  and the rocker  21  when it is in its protection position P 3 , the tube  41  of the needle  4  then passing through the proximal hole  221  and the intermediate hole  225 . 
         [0068]    The anti-needle-stick puncturing kit  1  can also include a connector  6  comprising: a guard housing  61  for receiving a proximal portion of the needle stick guard  2 ; and a needle housing  62  for receiving a base  44  of the needle  4 . 
         [0069]    Thus, thanks to this connector  6 , the mounting of the needle  4  in the needle stick guard  2  is easier. The handling of the needle is also facilitated, since the operator can handle the connector  6 , the dimensions whereof being selected to be larger than those of the base  44  of the needle  4 . Indeed, during withdrawal of the needle  4 , the operator handles the connector  6 . 
         [0070]    The needle housing  62  includes means for connecting with the base  44  of the needle  4 , for example a Luer type recess. 
         [0071]    The guard housing  61  of the connector  6  can be a recess fitted to the needle stick guard  2  so as to block the rocker  21  in the locking position P 1  when the needle stick guard  2  is housed in the guard housing  61 . 
         [0072]    The base  44  of the needle  4  can have a funnel (of the Luer type for example) that eases the insertion of the spiral guide  5 .