Patent Document

BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention concerns a surgical retracting device and its method of manufacture. 
     It will be of use during surgical operations to retain or retract biological or synthetic tissue, in particular in mini-invasive operations. 
     2. Description of the Related Art 
     During surgical operations, in particular laparoscopies, the surgeon&#39;s range of movements is limited. They use various instruments including thread with a pea to lift various organs from the zone to be operated on. This instrument consists of a thread placed on a needle and equipped with a pea at its other end. The pea is created manually by the surgeon before or during the operation using cotton or gauze. This type of small ball of gauze or cotton is pricked by the needle so as to be held on the thread. This thread equipped with a pea is used by passing the needle through the biological and/or synthetic tissue until the pea comes into contact with the tissue. The surgeon then pulls on the thread in order to retract the tissue. 
     An instrument such as described above has the main disadvantage of having to be made manually by the surgeon. This is time wasting and does not guarantee the reliability of the finished assembly. Another disadvantage is that the surgeon could be pricked when preparing this assembly. 
     Therefore, there is a need for a thread-with-pea type instrument that can manufactured industrially and reproducibly. 
     SUMMARY OF THE INVENTION 
     To this end, the present invention concerns a surgical device comprising a linking element such as a thread and a support element with at least three holes in which the thread passes through so as to attach the button and the thread by a first knot on a first face of the support element and a second knot on the second face of the support element. For instance, a button may be used as the support element. 
     This device according to the invention may be manufactured industrially based on a simple process. The surgical fixing device could then be marketed in a form that would enable its immediate use by the surgeon. 
     The support element and the linking element are joined so as to ensure the strength of the linking element. Indeed, the support element and the knots on the first and the second face are connected so as not to weaken the linking element. 
     According to a preferred embodiment, at least three through holes on the support element are aligned so as to limit the strain on the interlinking element and therefore the risk of it breaking. 
     Other goals and advantages will appear in the following description of a preferred but not restrictive embodiment of the invention. 
     First of all it has to be remembered that the invention concerns a surgical retracting device comprising an linking element and a support element characterised in that the linking element is a thread and that the support element comprises a first face, a second face and at least three through holes in which the thread passes through, the support element and the thread being connected by means of a first knot on the first face and a second knot on the second face. 
     According to preferred but not restrictive variations of the invention, the device is such that:
         at least three through holes are aligned,   the support element is circular,   at least three holes are aligned on the diameter of the support element,   the support element has an elongated shape,   at least three holes are aligned on the diameter of the support element,   the support element has a central hole and two peripheral holes,   the central hole is positioned at the centre of the support element,   the two peripheral holes are equidistant from the central hole,   the arrangement of the first knot and the second knot ensures that the thread is held at the level of the first face and the second face respectively,   the first knot consists of a simple knot involving a length of the thread passing through the first peripheral hole and a length passing through the second peripheral hole, a length of thread passing around a free end of the thread on the side of the first face, a length of thread passing under the length of thread around the free end of the thread on the first face side,   the second knot consists of a length of the thread passing through the central hole towards the second face, a length of the thread passing around the length of the thread forming a bridge on the second face.       

     The present invention also concerns a process for the manufacture of a surgical retaining device characterised in that it includes the following stages:
         creation of a bridge on the first face between the two peripheral holes by successive passages of the thread through the first peripheral hole of the first face towards the second face then through the second peripheral hole of the second face towards the first face,   creation of a first knot on the first face,   passing the thread through the central hole of the first face towards the second face,   creation of the second knot on the second face by a complete turn around the bridge of the second face.       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
         FIG. 1  is a front view of the support element according to the invention. 
         FIG. 2  is a view of the surgical retaining device according to the invention. 
         FIGS. 3 to 8  show the different stages in the process for fabrication of the surgical device according to  FIG. 2 . 
         FIGS. 3 to 5 and 9 to 11  show the formation of the first knot. 
         FIGS. 6 to 8 and 12 to 14  show the formation of the second knot. 
         FIGS. 3 to 6 and 9 to 12  show the support element with the first face upwards. Whereas  FIGS. 7, 8 and 13, 14  show a reverse-side view of the support element with the first face downwards. 
         FIGS. 15 to 17  show a support element according to a second embodiment of the invention. 
         FIG. 15  is a perspective view. 
         FIG. 16  is a front view. 
         FIG. 17  is a view on section AA of  FIG. 16 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The remainder of the description employs the term “thread” and “button” but without this being restrictive. These terms may be more generally referred to as “linking element” and “support element”. 
     As shown in  FIG. 2 , the surgical retraction device comprises two main components, a linking element consisting preferably of a thread  2  and a support element consisting preferably of a button  1 . 
     Thread  2  is preferably TEFLON® (polytetrafluoroethylene)-treated polyester braid that will limit the 5 frictional forces. 
     Button  1  is manufactured preferably from silicone. Button  1  comprises a first face A and the second face B. 
     Characteristically, button  1  has at least three through holes  6 ,  7 ,  8  allowing the passage of thread  2 . According to another embodiment, button  1  has more than three holes. Thread  2  passes advantageously through the different holes  6 ,  7 ,  8  of button  1  so as to form a first knot  18  on first face A of the button and a second knot  19  on the second face B of button  1 . This ensures that thread  2  is joined to button  1 . 
     In a preferred arrangement, thread  2  is equipped with a needle  3  at one of its ends. This needle pierces the abdominal wall; the thread is then secured outside the body of the patient and the biological and/or synthetic tissues can be retracted using the surgical device according to the invention. On the other end, equipped with needle  3  (needled end  4 ), thread  2  has a free end  5 . 
     Other embodiments may be envisaged. In particular, instead of using a thread  2  equipped with a needle  3 , electromagnetic means placed on both button  1  and on a complementary element may be proposed. Button  1  and the additional element are arranged on either side of the biological and/or synthetic tissue to be retracted. Button  1  is preferably placed on the inner face of the tissue to be retracted so that a practitioner may retract the tissue by applying tension to the thread. Therefore, fastening means may also be provided, such as miniature forceps. 
     In an advantageous arrangement, the three holes  6 ,  7 ,  8  are aligned. 
     Button  1  may be circular as shown on all the figures. In this case, the three holes  6 ,  7 ,  8  are aligned preferably across a diameter of button  1 . 
     According to another possibility not shown, button  1  is elongated in an ovoid shape to allow better use during operations involving small diameter trocars. According to this arrangement, the three holes  6 ,  7 ,  8  are aligned preferably on the longitudinal axis of button  1 . 
     This alignment of the three holes  6 ,  7 ,  8  allows advantageous execution of first knot  18  and second knot  19  roughly in the centre of button  1 , thereby centring thread  2 , and in particular its needled end  4  to enable correct application of button  1  on the biological and/or synthetic tissue to be retracted. 
     The three aligned holes  6 ,  7 ,  8  consist preferably of central hole  8  and two peripheral holes  6 ,  7 . In an advantageous arrangement, central hole  8  is situated in the centre of button  1 . By “centre” is meant the centre of a circular button  1  or, if its shape is different, the centre of gravity of button  1 . 
     According to a preferred embodiment, the three holes  6 ,  7 ,  8  are arranged symmetrically across the diameter of button  1  or on its longitudinal axis. 
     The applicant has observed that the embodiment in which the two peripheral holes  6 ,  7  are equidistant from central hole  8  allows satisfactory equilibrium of button  1  when used as the support element. Indeed, this arrangement enables balanced positioning of first knot  18  and second knot  19 . 
     First knot  18  is situated on first face A of button  1  and can be made first during the process of fabricating the surgical device according to the invention. First knot  18  is preferably a simple knot. It is made so that it is centred relative to button  1 ; that is to say, according to certain embodiments, it is positioned roughly at the level of central hole  8 . 
       FIGS. 9, 10 and 11  show stages in making first knot  18 . First of all, thread  2  passes through peripheral holes  6 ,  7  to form a bridge  9  on the second face of button  1 . To do this, needled end  4  of thread  2  is preferably inserted through first peripheral hole  6  on first face A in the direction of second face B. Then, threaded end  4  of thread  2  is passed through second peripheral hole  7  of second face B towards first face A. 
     Two ends  4  and  5  of thread  2  are found at first face A of button  1 . These two ends are brought together so as to execute a simple knot. Preferably, needled end  4  is wrapped around free end  5  of thread  2  so as to form a loop  20  through which needled end  4  is inserted and exits loop  20 . First knot  18  is tightened by pulling equally on the two ends  4 ,  5  of thread  2 . In a preferred arrangement, knot  18  is positioned at central hole  8 . The role of this first knot is to join thread  2  to button  1 . It also makes it possible to centre thread  2  at central hole  8  so that a second knot can be created at second face B of button  1  The arrangement of first knot  18  through two peripheral holes  6 ,  7  also distributes the strain over the entire surface of button  1 . 
     As can be seen in  FIG. 6 , once first knot  18  has been executed on first face A of button  1 , needled end  4  of thread  2  is inserted through central hole  8  of first face A towards second face B. At second face B, needled end  4  will pass successively over bridge  9  then under bridge  9  in order to execute a 360° turn around bridge  9 . Second knot  19  enables thread  2  to be blocked on button  1 . In fact, during manufacture followed by use, tension is applied to thread  2  through its needled end  4  so as to retighten the first knot and bring bridge  9  closer to the surface of second face B of button  1  so as to press on and block length of thread  22  that is positioned under bridge  9 . 
     Second knot  19  also acts to centre thread  2 . In fact, thread  2  exits from central hole  8  of second face B in a central position, second knot  19  holding thread  2  in this central position. This central position of thread  2  relative to button  1  allows button  1  to be correctly positioned when used on biological and/or synthetic tissue. 
     From a structural standpoint, the first knot consists of a simple knot and includes: a length of thread  11  passing through first peripheral hole  6  of first face A towards second face B, a length of thread  12  forming a bridge  9  on second face B between first peripheral hole  6  and second peripheral hole  7 , a portion of thread  13  passing through second peripheral hole  7  of second face B towards first face A, a length of thread  14  passing around loose end  5  of thread  2 . This length of thread  14  can be distinguished from a length of thread  23  by passing over free end  5  of thread  2  forming a loop  20  through which passes needled end  4 : this is the length of thread  15  positioned under free end  5 . 
     Second knot  19  consists of a length of thread  16  passing through central hole  8  of first face A towards second face B and a length of thread  17  passing around the length of thread  12  forming bridge  9 . This length of thread  17  consists of a length of thread  21  situated on the length of thread  12  and a length of thread  22  situated under the length of thread  12 . 
     The surgical fixing device according to the invention may be used in particular for small invasive operations when the surgeon has to operate on a difficult-to-access zone and has to maintain organs retracted from the operation zone. According to a first application, the device enables a thread to be held against biological tissue so as to retract it. The surgeon passes the needle through synthetic tissue such as netting and then through the abdominal wall so as to retract the biological tissue. Button  1  enables the formation of a support zone at the level of the biological and/or synthetic tissue and thread  2  allows tension to be applied in order to maintain the tissue retracted. 
     According to a variant, the surgeon may use the device according to the invention without any additional element, and to do so will pass needle  3  through biological tissue on which button  1  presses, thereby applying traction to the biological tissue to be retracted by thread  2 . 
     The device according to the invention, especially first knot  18  and second knot  19 , enables joint use of thread  2  and button  1  even if thread  2  should break at one of its ends, since it allows the surgeon to recover button  1 -thread  2  assembly simultaneously, without any risk of losing the components of the device inside the patient. 
     The device according to the invention may be radiologically opaque or not, and may be in a material that can be reabsorbed or not. 
     As an example, a circular type button  1  may be around 9 mm across and 3 mm thick. When the button is elongated, button  1  is around 15 mm long. 
     In a preferred embodiment, the holes have a diameter of around 1.5 mm. According to an embodiment in which holes  6 ,  7 ,  8  are aligned and equidistant, the distance between each hole is around 1.13 mm. The distance will be preferably the same between holes  6  and  7  and the outer edge of button  1 . In a preferred arrangement, thread  2  between second knot  19  and its needled end is between 9 and 10 cm long. Needle  3  is preferably 50 mm long. 
     REFERENCES 
     
         
           1 . Support element/Button 
           2 . Thread 
           3 . Needle 
           4 . Needled end 
           5 . Free end 
           6 . 1 st  peripheral hole 
           7 . 2 nd  peripheral hole 
           8 . Central hole 
           9 . Bridge 
           10 . Turn 
           11 . Length of thread passing through 1 st  peripheral hole 
           12 . Length of thread forming a bridge on the second face between 1 st  and 2 nd  peripheral hole 
           13 . Length of thread passing through 2 nd  peripheral hole 
           14 . Length of thread around the free end of the thread 
           15 . Length of thread passing under length of thread  14   
           16 . Length of thread passing through the central hole towards the second face 
           17 . Length of thread commencing the length of thread  12   
           18 . First knot 
           19 . Second knot 
           20 . Loop formed by lengths of thread  11 - 13  and face A 
           21 . Length of thread situated on length  12   
           22 . Length of thread under length  12   
           23 . Length of thread on free end  5   
         A. First face 
         B. Second face

Technology Category: 1