Abstract:
A sternum closure device for securing parts of severed sternum, such as a human sternum following surgery. The device includes an anvil, capable of forming staples, a bracket positioned, opposite the anvil, an instrument for creating openings in the sternum a clamping mechanism and a mechanism for feeding, mounting and applying the staples. The bracket is joined with the anvil through a displacement mechanism. The instrument for forming opening is designed as a bit brace having a reducing gear and two chucks, to enable concurrent drilling of openings in both severed parts of the severed sternum. The mechanism for feeding and mounting the staples comprises a ribbed bed, a cartridge containing staples and an instrument for mounting the staples. The clamping means enables drilling of openings in both severed parts of sternum, and feeding and mounting the staples. Specially designed pincers are also provided for mounting the staples and other special staples. A plurality of approximator brackets are provided for holding two halves of a severed sternum for stapling.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This Application is a Continuation-In-Part of co-pending application Ser. No. 09/799,475 filed Mar. 5, 2001, which is a Continuation-In-Part of co-pending application Ser. No. 09/626,802 filed Jul. 27, 2000, both of which are hereby incorporated by reference specifically for disclosure on the sternum closure device and in general, in its entirety. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to medical devices for closure of a severed sternum and pincers for mounting staples and special staples. In particular, the invention is directed to a sternum closure assemblies and methods for re-approximating split portions of tissue to retain the split portions in adjacent contacting relation to promote healing thereof. Additionally, the invention is directed to specially designed pincers which are used to bring the two halves of the sternum and holds them firmly together without movement so that the stapler can be used accurately.  
         BACKGROUND OF THE INVENTION  
         [0003]    During surgery that involves a median sternotomy, for example, open-heart surgery, the sternum is cut longitudinally to allow access to the organs within the thoracic cavity. A partial or median sternotomy is a procedure by which a saw or other approximate cutting instrument is used to make a midline, longitudinal incision along a portion or the entire axial length of the patient&#39;s sternum, allowing two opposing sternal valves to be separated laterally. Upon completion of the surgery, the sternum is rejoined and closed securely.  
           [0004]    Traditionally, the sternal halves have been closed with stainless steel wires which are wrapped around or through the sternal halves to engage in face-to-face relationship and compressed together while the sternum heals. For example, in one version, a surgical needle with the metal wire is led via both split portions of a severed sternum and the free metal wire is cut-off. In another version, the wire tips are further led via openings in special staples, to project outside and the tips are twisted together by tightening the suture, U.S. Pat. No. 4,512,346 and U.S. Pat. No. 5,849,012. However, these devices have certain shortcomings, in that they require significant force, are difficult to maneuver and the sharp wire edges sometimes cause injury and eventually, infection to soft tissues.  
           [0005]    Other prior art sternum closure assemblies include one or two metal plates, these plates being provided with rows of openings, through which extend the screws, pins, or metal wire, to bring together the severed portions of the sternum. U.S. Pat. No. 4,585,341. These devices have drawbacks in that they are ineffective in fixing the split portions of the severed sternum. Moreover, they are foreign bodies in the thoracic cavity, and they can cause disturbance in blood supply to the osseous tissue, thereby prolonging healing and increasing chances of infection.  
           [0006]    The strap assemblies known heretofore incorporate clamps, clasps, bands, strips with or without openings and complex locking mechanisms. U.S. Pat. No. 5,356,417; U.S. Pat. No. 5,462,542; and U.S Pat. No. 6,007,538. The use of compression presents problems for blood circulation and soft tissues. Other versions of sternum closure devices use tongs, plugs or guns with anvils, to apply staples through the osseous tissue of the sternum. U.S. Pat. No. 4,122,989; and U.S. Pat. No. 4,481,960. However, these devices suffer from several drawbacks, for example, significant force is required to puncture the osseous tissue and insert a staple. In addition, these prior art devices are imprecise in positioning the staples, and do not permit the anvil to bend the staple through 180° angle. Finally, the devices are cumbersome and cause shaking of the organs in the thoraxic cavity.  
           [0007]    A certain amount of emphasis has also been directed towards the use appropriate staples which minimize healing time, minimize distortion of the material stapled, minimize damage of material stapled, minimize scar tissue formation and achieve uniform compression of stapled material. U.S. Pat. No. 5,342,396 and U.S. Pat. No. 5,667,527. However, these devices suffer from several of the same drawbacks discussed above for earlier models of the sternum closure devices and systems.  
           [0008]    It would accordingly be desirable to provide a sternum closure device which is stable in construction and effectively secures the severed portions of sternum or other tissue together, i.e., secures the staples in well defined locations, at a predetermined angle, and at a desirable tension to promote uniform healing of the tissue portions while avoiding complications associated with tissue injury, infection and compression. It would also be desirable to provide an instrument which can bring the two halves of the sternum and holds them firmly together without movement so that the stapler can be used accurately.  
           [0009]    The two halves of the severed sternum have to be held firmly in place while the stapling process is being performed. Therefore the present sternal approximating bracket has been invented to perform this process quickly and more strongly than previous inventions. It is suggested that 3 of these sternal approximating brackets are placed so as to hold the two halves of the sternum firmly.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention provides improved devices and methods of joining with staples, the opposite portions of a severed sternum following a median or partial sternotomy that overcomes the above cited problems inherent in previous sternum closure devices. Generally, the present invention is embodied in an anvil for bending the staples, a bracket positioned opposite the anvil, a means for making openings in the tissue, and a means for feeding and mounting the staples.  
           [0011]    According to a first aspect of the invention, a sternum closure device comprises an anvil having an element comprising two slots, said element being used for bending the staples with precision in a specific angular range up to 180°. A bracket is provided with an additional slot to guide the drilling means and to mount the staples in the sternum. Other improvements to the anvil and bracket include bending elements which facilitate their mounting on the sternum portions. The bracket is provided with a post and a lock, the post having two mutually perpendicular openings and a pin mounted on it, and the lock comprising a housing with a slot, and a spring-actuated locking element with a handle situated in the slot.  
           [0012]    According to a second aspect of the invention, the bracket is joined with the anvil through a spring-actuated screw having a handle, said screw being positioned in a threaded opening located in the bracket. Two guides are situated between the anvil and the bracket and parallel to the screw, said guides being installed in the openings of the bracket to facilitate displacement of the bracket with respect to the anvil.  
           [0013]    The sternum closure device of the present invention comprises a bit brace with a gear and two chucks having interchangeable drills for simultaneously drilling openings in both portions of a severed sternum. The gear includes a housing, said housing including a basis with a lug, and a cover. The lug is provided with an opening and a slot. A drive gear wheel is installed on a driving shaft, said driving shaft being joined with a pneumatic drive. Two drive gear wheels are in engagement with the drive wheel gear. The drive wheel is fastened on the drive shafts and the chucks with interchangeable drills are installed on these drive shafts.  
           [0014]    According to another aspect of the invention, the sternum closure device comprises a means for feeding and mounting the staples, including a carrying element constructed of a bed, said bed having a first and second surface. Two ribs provided with a positive stopper are situated perpendicularly to the bed surface. The bed surface and each rib are provided with slots. The first bed surface is also provided with a lug having a threaded opening and a locking screw. The second and opposite bed surface is designed as a wall having a handle. A sub-assembly used for mounting the staples, is installed on the bed surface, said sub-assembly comprising an L-shaped lever and two spring-actuated posts. Said L-shaped lever has a shaft side and a long side. The two spring-actuated posts are locked on the bed surface and passed through the openings in the shaft side of the L-shape lever. The long side of the L-shaped lever is placed in the slot of the bed surface.  
           [0015]    A cartridge is placed between the bed ribs, said ribs having an internal side and an external side. The cartridge comprises slots for the staples and a spring-wise element situated between the cartridge and the face wall of the bed. The spring-wise element presses the cartridge with staples against a plurality of stoppers installed on the internal side of the bed ribs.  
           [0016]    According to a preferred embodiment of the invention, an instrument for drilling openings is installed on the bracket post along with precise and well-controlled means for feeding and mounting staples. A compression spring is situated between the instrument for drilling openings and the means for feeding and mounting staples. The instrument for drilling opening may be displaced from the bracket post when necessary.  
           [0017]    According to yet another preferred embodiment of the invention, especially designed pincers for mounting staples into the severed sternum are provided. These pincers bring the two halves of the sternum and holds them firmly together without movement so that the stapler can be used accurately. These pincers are not bulky nor do they interfere with the use of the stapler and application of the staples.  
           [0018]    The sternum closure device of the present invention comprises a clamping mechanism installed on the bracket providing reciprocating displacement along the bracket, and consisting of a carrying element, an assembly for mounting the staples, a cartridge containing the staples, and a lock fixing the clamping mechanism on the bracket. The assembly, the cartridge, and the lock are fastened on the carrying element. The carrying element is provided with two guide-openings for drilling openings in the parts of the severed sternum by one of any drilling instrument which is used in sternal surgery.  
           [0019]    According to another aspect of the invention, the sternum closure device comprises a carrying element constructed of a bed, having a rib provided with a cut and situated perpendicularly to the bed. The assembly for mounting the staples, constructing as a pressure mechanism comprises a pusher with a transmitting element and spring-wise element. The transmitting element being fastened to the pusher. The cartridge is fastened on the bed and comprises a holder of the staples and means for feeding of the staples. The means contains a pressure element is placed inside the holder. The pressure element comprises a handle and spring-wise element. The lock is fastened on the bed and is constructed as a housing comprising a locking element with a handle and spring-wise element. The locking element and the spring-wise element are placed inside the housing.  
           [0020]    In the present invention, the two halves of the severed sternum have to be held firmly in place while the stapling process is being performed. Therefore the present sternal approximating bracket has been invented to perform this process quickly and more strongly than previous inventions. It is suggested that 3 of these sternal approximating brackets are placed so as to hold the two halves of the sternum firmly.  
           [0021]    The advantages of these sternal approximating brackets is that: a) they have a low profile and so do not interfere with the smooth performance of the stapling process, b) if compression fixation of the sternum is anticipated (this is an accepted method of external fixation in the treatment of various orthopedic fractures), this sternal approximating bracket can be inserted through the intact skin so as to compress the two halves of the severed sternum and left in place until union has been achieved. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]    A more complete understanding of the present invention and the attendant advantages and features thereof will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:  
         [0023]    [0023]FIG. 1 is a side view of a sternum closure device positioned in the state of drilling openings in the sternum.  
         [0024]    [0024]FIG. 2 is a top view of the sternum closure device, taken in the plane of FIG. 1.  
         [0025]    [0025]FIG. 3 is a side view of the sternum closure device when it is in the state of mounting staples.  
         [0026]    [0026]FIG. 4 is a top view of the sternum closure device, taken in the plane of arrow E. of FIG. 3 FIG. 5 is a front view of the sternum closure device, taken in the plane of arrow B of FIG. 1.  
         [0027]    [0027]FIG. 6 is a front view of the sternum closure device, taken in the plane of arrow F. of FIG. 3.  
         [0028]    [0028]FIG. 7 is a sectional view of the sternum closure device, which is shown in Fig. 2, in the plane of line C-C; this device is in the state preceding drilling the openings in the sternum.  
         [0029]    [0029]FIG. 8 is a sectional view of the sternum closure device, which is shown in FIG. 2, in the plane of line C-C; this device is in the process of drilling the openings in the sternum.  
         [0030]    [0030]FIG. 9 is a sectional view of the sternum closure device, which is shown in Fig. 4, in the plane of line G-G; this device is in the state preceding mounting the staples in the sternum.  
         [0031]    [0031]FIG. 10 is a sectional view of the sternum closure device, which is shown in FIG. 4, I the plane of line G-G; this device is in the process of mounting the staples.  
         [0032]    [0032]FIG. 11 is a sectional view in the plane of line D-D of a displacement mechanism, which is shown in FIG. 1.  
         [0033]    [0033]FIG. 12 is a view following detail I, which is shown in FIG. 7.  
         [0034]    [0034]FIG. 13 is a sectional view of the sternum closure device, which is shown in FIG. 8, in the plane of line H-H.  
         [0035]    [0035]FIG. 14 is a sectional view of the sternum closure device, which is shown in FIG. 9, in the plane of line K-K.  
         [0036]    [0036]FIG. 15 demonstrates the closed sternum with the set of mounted staples.  
         [0037]    [0037]FIG. 16 is a side view of a sternum closure device positioned in the state of drilling openings in the sternum.  
         [0038]    [0038]FIG. 17 is a side view of the sternum closure device when it is in the state of mounting staples.  
         [0039]    [0039]FIG. 18 is a top view of the sternum closure device, taken in the plane of arrow A of FIG. 1.  
         [0040]    [0040]FIG. 19 is a top view of the sternum closure device, taken in the plane of arrow L of FIG. 2.  
         [0041]    [0041]FIG. 20 is a sectional view of the sternum closure device, which is shown in FIG. 18, in the plane of line N-N; this device is in the state preceding drilling the openings in the sternum.  
         [0042]    [0042]FIG. 21 is a sectional view of the sternum closure device, which is shown in FIG. 19 in the plane of line P-P; this device is in the state preceding mounting the staples in the sternum.  
         [0043]    [0043]FIG. 22 is a sectional view of the sternum closure device, which is shown in FIG. 19, in the plane of line P-P; this device is in the process of mounting the staples.  
         [0044]    [0044]FIG. 23 is a sectional view of the sternum closure device, which is shown in FIG. 20, in the plane of line R-R.  
         [0045]    [0045]FIG. 24 is a sectional view of the sternum closure device, which is shown in FIG. 22, in the plane of line S-S.  
         [0046]    [0046]FIG. 25 demonstrates the closed sternum with the set of mounted staples.  
         [0047]    [0047]FIG. 26 is a side view of the pincers for mounting staples.  
         [0048]    [0048]FIG. 27 is a butt view of the pincers for mounting staples, taken in the plane of arrow A of FIG. 16.  
         [0049]    [0049]FIG. 28 is a butt view of the pincers for mounting staples, taken in the plane of arrow B of FIG. 16.  
         [0050]    [0050]FIG. 29 is a side view of the pincers with special staple, taken in the plane of arrow C of FIG. 17.  
         [0051]    [0051]FIG. 30 is a side view of the special staple, which is shown in FIG. 19.  
         [0052]    [0052]FIG. 31 is a sectional view of the special staple, which is shown in FIG. 20 in the plane of line D-D.  
         [0053]    [0053]FIG. 32 is a side view of the pincers with special staple before setting of the special staple on the severed sternum.  
         [0054]    [0054]FIG. 33 is a side view of the pincers with special staple after setting of the special staple on the severed sternum.  
         [0055]    [0055]FIG. 34 is a side view of the sternal approximator bracket.  
         [0056]    [0056]FIG. 35 is a sectional view of the sternal approximator bracket, which is shown in FIG. 34 in the plane of line X-X.  
         [0057]    [0057]FIG. 36 is a side view of the sternal approximator bracket before setting of the sternal approximator bracket on the severed sternum FIG. 37 is a side view of the sternal approximator bracket after setting of the sternal approximator bracket on the severed sternum. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0058]    According to yet another preferred embodiment of the invention, especially designed pincers for mounting staples into the severed sternum are provided. These pincers bring the two halves of the sternum and holds them firmly together without movement so that the stapler can be used accurately. These pincers are not bulky nor do they interfere with the use of the stapler and application of the staples.  
         [0059]    The sternum closure device of the present invention comprises a clamping mechanism installed on the bracket providing reciprocating displacement its along of the bracket, and consisting of a carrying element, an assembly for mounting the staples, a cartridge containing the staples, and a lock fixing the clamping mechanism on the bracket. The assembly, the cartridge, and the lock are fastened on the carrying element. The carrying element is provided with two guide-openings for drilling openings in the parts of the severed sternum by one of any drilling instrument are in use in sternal surgery.  
         [0060]    According to another aspect of the invention, the sternum closure device comprises a carrying element constructed of a bed, having a rib provided with a cut and situated perpendicularly to the bed. The assembly for mounting the staples, constructing as a pressure mechanism comprises a pusher with a transmitting element and spring-wise element. The transmitting element being fastened to the pusher. The cartridge is fastened on the bed and comprises a holder of the staples and means for feeding of the staples. The means contains a pressure element is placed inside the holder. The pressure element comprises a handle and spring-wise element. The lock is fastened on the bed and is constructed as a housing comprising a locking element with a handle and spring-wise element. The locking element and the spring-wise element are placed inside the housing.  
         [0061]    Referring to FIGS.  1  to  13 , a sternum disclosure device  1  is shown to provide a system and method for joining two portions  2  and  3 , of a severed sternum  4 , by means of staples  5 , having legs  6  and  7 , which are inserted through openings  8  and  9  of the severed sternum  4 .  
         [0062]    A preferred embodiment of the sternum closure device includes an anvil for bending staples. This anvil is positioned on the internal side of the severed sternum. A bracket is situated on the outer side of the severed sternum, opposite the anvil. The anvil comprises an element for bending the staples. It is designed to have two slots. In addition, the bracket has a third slot which is intended to be guide for the drills and for mounting the staples on the sternum. The unique feature about the present invention is that the anvil and the bracket are designed with bends such that these bends facilitate their proper mounting on the sternum.  
         [0063]    The bracket is also provided with a rotatable post and a lock. The post is provided with two mutually perpendicular openings and a pin. The lock comprises of a housing with a slot. A spring-actuated locking element having a handle is situated in the slot in the lock housing.  
         [0064]    Referring to FIG. 1, the sternum device  1  comprises of an anvil  10  and a bracket  20 , said anvil and said bracket being joined together by a displacement means  40 . The sternum device  1  further comprises of an instrument  60  which is provided to form openings in the sternum, and a staple feeding means  100 , which is used for feeding and mounting the staples.  
         [0065]    Referring to FIGS. 1 and 9, anvil  10  is provided with two slots  11  and  12  for the purpose of bending staples  5 , a bend  13  and a through opening  14  used for joining the displacement means  40 . The bracket  20  comprises of a through slot, a bend  22  and a threaded opening  23 , said opening  23  serving to attach the displacement means  40 . The bracket  20  further comprises of two through openings  24  and  25 , and a cylindrical post  26 . The cylindrical post  26  is installed on bracket  20  to provide a turning means, the cylindrical post being further provided with two openings  27  and  28 , and a pin  39 . A lock  31  is installed traversally to cylindrical post  26  and the lock  31  is fastened on bracket  20 .  
         [0066]    The bracket is joined to the anvil through a displacement mechanism. This mechanism provides reciprocating displacement of the bracket with respect to the anvil. The displacement mechanism comprises of a spring-actuated screw with a handle. This screw is positioned in the threaded opening in the bracket where it is attached to the anvil. Two guides are situated between the anvil and the bracket. These guides are parallel to the screw and are locked in the anvil. The guides are installed in the through openings of the bracket to enable its displacement in the direction of the guides.  
         [0067]    Referring to FIGS. 1 and 9, the anvil  10  and bracket  20  are joined via the displacement means  40  to enable reciprocating displacement of bracket  20  to and from the anvil  10 . The displacement means comprises of screw  41 , said screw extending into a handle  42 , a compression spring  43  and two guides  44  and  45 . The screw  41  is fastened through a threaded opening  23  in bracket  20 , and is locked rotatably in the opening  14  of anvil  10 . A spring  43  is installed between the anvil  10  and the bracket  20 , in line with the screw  41 . Guides  44  and  45  are locked onto the anvil  10  and are in a parallel position to screw  41 . Guides  44  and  45  are installed in such a way through openings  24  and  25  of bracket  20  to enable displacement of bracket  20  along guides  44  and  45 .  
         [0068]    Referring to FIG. 10, lock  31  comprises of housing  32 , a locking element  33 , a spring  34  and a handle  35 . The locking element  33  and the spring  34  are introduced partially into housing  32 , and the locking element  33  is presented from dropping out by the handle  35 , said handle  35  being installed in a slot  36  located in the housing  32 .  
         [0069]    In a preferred embodiment of the sternum closure device, the instrument for formation of openings in the sternum is constructed as a hand bit brace, a pneumatic bit brace, a laser perforator or an ultra-sound perforator. The bit brace comprises of a gear and two chucks. These chucks have interchangeable drills for simultaneously drilling openings in both portions of the severed sternum, which are to be attached.  
         [0070]    The gear consists of a housing. The housing includes a basis with a lug and a cover. The lug is provided with a through opening and a slot. A plurality drive of gear wheels each installed on a driving shaft. The driving shaft is then joined to a pneumatic drive. Chucks with interchangeable drills are also installed on the drive shafts.  
         [0071]    Referring to FIGS. 1, 2,  5 ,  7  and  8 , an instrument  60  is provided for formation of openings. The instrument is constructed as a bit brace  61  with a pneumatic drive  62  and two chucks  63  and  64 . The two chucks are provided for mounting interchangeable drills  65  and  66 . The instrument  60  further comprises a gear  71 . Gear  71  is installed over housing  72 , said housing comprising of a basis  73  and a cover  74 . Base  73  is provided with lug  75 , said lug  75  having an opening  76  and a slot  77 . A driving gearwheel is arranged in the internal space of housing  72 , and installed on a driving shaft  79 . The driving shaft  79  is mounted on base  73  of housing  72  by means of bearings  86 ,  87 ,  88  and  89 . The driving shaft  79  is further completed with the pneumatic drive  62 , said drive being designed as a pneumatic motor. Chucks  63  and  64  are installed on driving shafts  84  and  85  and these chucks are used for mounting the interchangeable drills  65  and  66 .  
         [0072]    Instrument  60  and pin  29  are installed on cylindrical post  26  to enable displacement along the cylindrical post  26 . The pin  29  is locked on cylindrical post  26  via slot  77  of lug  75  of gear  71 . Thus, pin  29  limits the magnitude of instrument  60  and prevents its turning around post  26 .  
         [0073]    A portable means of feeding and mounting the staples is constructed as a bed with two ribs situated perpendicularly to the bed surface. The ribs are provided with a positive stopper. The bed surface and each rib are provided with through slots. One bed surface is provided with a lug, the lug having a threaded through opening and a locking screw in it. The other bed surface is designed as a wall with a handle.  
         [0074]    Referring to FIGS. 3, 4,  6 ,  9 ,  10  and  14 , a feeding and staple mounting means  100  comprises of a carrying element constructed as bed  101  having two ribs  102  and  103 . These ribs are perpendicular to bed  101  and each rib is provided with longitudinal slots  104  and  105 . Stoppers  106  and  107  are installed on the internal side of each rib  102  and  103 , respectively. Bed  101  is provided with two lugs  108  and  109 , said lugs in turn are provided with openings  110  and  111  respectively. Bed  101  is further provided with slot  112 , said slot  112  being placed in parallel to sides  113  and  114  of bed  101 . Side  113  is provided with lug  115 , which in turn has an opening  116  and a locking screw  117  fastened to the opening  116 . Wall  118 , having an internal side and an external side, is situated in perpendicular to bed  101  on side  114 . Handle  119  is locked to wall  118 . A cylindrical support  120  is further installed on the internal side of wall  118 .  
         [0075]    Feeding means  100  further comprises of a cartridge  131  which is positioned between ribs  102  and  103  of bed  101 , and a spring  132 . Cartridge  131  is designed as a parallel component having slots  133  used for positioning the staples  5 . A bracket  135  having an opening  136  is positioned on face side  134  of cartridge  131 . Cartridge  131  is installed between ribs  102  and  103  and is held inside the bed  101  by two pins  137  and  138 . These two pins are positioned in slots  104  and  105  of ribs  102  and  103  respectively. Spring  132  is arranged in a cylindrical support  120  of wall  118 . It is further inserted partially in opening  136  of bracket  135 .  
         [0076]    Feeding means  100  further comprises subassembly  141 , used for mounting the staples. The subassembly  141  comprises a pressure L-shaped lever  142 , two posts  143  and  144 , and two springs  145  and  146 . The L-shaped lever  142  has a short side  147 , the short side  147  having two openings  148  and  149 . Posts  143  and  144  pass through openings  148  and  149  respectively. Springs  145  and  146  are installed singly on posts  143  and  144  respectively. The subassembly  141  is installed on bed  101 . The L-shaped lever has a long side  150 , which is introduced in slot  112 . Posts  143  and  144  and springs  145  and  146  are locked through openings  110  and  111  of lugs  108  and  109 , respectively.  
         [0077]    Staple feeding means  100  is mounted on post  26  and instrument  60  and locked in place by a screw  117 . In addition, spring  161  is installed on feeding means  100  and instrument  60 .  
       OPERATION OF THE STERNUM CLOSURE DEVICE  
       [0078]    The mode of operation of the sternum closure device is described herein below.  
         [0079]    The bracket  20  is moved progressively in direction away from anvil  10  by the displacement mechanism  40  (see FIG. 11). The screw  41  is rotated by handle  42 , for example, in an anti-clockwise direction. Bracket  20  moves progressively along guides  44  and  45  in direction away from anvil  10  with releasing spring  43 . This results in greater distance between anvil  10  and bracket  20 . Anvil  10  and bracket  20  are positioned correspondingly from the internal and external sides of portion  2  and  3  of the severed sternum  4 .  
         [0080]    Bend  13  of anvil  10  and bend  22  of bracket  20  facilitate mounting anvil  10  and bracket  20  on sternum  4 .  
         [0081]    With rotation of screw  41  by handle  42  in the opposite direction (in this case—in the clock-wise direction), bracket  20  moves progressively along guides  44  and  45  towards anvil  10 . This motion is accompanied with compression of spring  43  and decrease of the distance between anvil  10  and bracket  20  in reference to the internal and external portions  2  and  3  respectively, of the severed sternum  4 .  
         [0082]    The sternum closure device  1  is arranged in the position of drilling openings in portions  2  and  3  of the severed sternum  4  (FIGS. 1, 2,  5 ,  7 ) by lock  31  (FIG. 12).  
         [0083]    In the initial state spring  34  of lock  31  is released and the locking element  33  is placed in one of two mutually perpendicular through openings  27  or  28  of post  26  of bracket  20 . As displacement handle  35  moves along slot  36 , the locking element  33  is removed from the corresponding openings  27  or  28  of post  26  by compression of spring  34 . Then post  26  is released from locking and it turns in bracket  20  until the axis of the through opening  27  is aligned with the axis of the locking element  33  of lock  31 . With descending handle  35  the compressed spring  34  pushes out the locking element  33  from housing  32 . The locking element is introduced in such a way into the through opening  27  of the post  26 , that it fixes in a position of the drilling openings.  
         [0084]    Drilling openings  8  and  9  are performed in portions  2  and  3  of the severed sternum  4  (FIGS. 7, 8) by instrument  60  intended for drilling openings. This instrument is installed on post  26  of bracket  20  to allow its reciprocating motion along post  26 . Then the pneumatic motor  62  is switched on. The motor via the drive gear wheel  78  and two driven gear wheels  82  and  83  of gear  71  causes two chucks  63  and  64  to rotate with drills  65  and  66  respectively (FIG. 7). By pushing in direction of arrow PUSH onto cover  74  of gear  71  of instrument  60 , the bit brace  61  is displaced along post  26  of bracket  20  toward anvil  10 . This displacement is accompanied by compression of spring  161  and drills  65  and  66 , which pass via slot  21  of bracket  20 . Openings  8  and  9  are drilled simultaneously correspond to two portions  2  and  3  of the severed sternum  4  (FIGS. 8, 13). The magnitude of displacement of instrument  60  along post  26  is limited by the length of slot  77  and the limiting pin  29  (FIGS. 8, 13). With completion of drilling opening  8  and  9  (see FIG. 13), compression on instrument  60  is stopped. It returns to its initial position by release of spring  161  (see FIG. 8).  
         [0085]    Then the sternum closure device  1  is transferred in the state of mounting staples  5  in sternum  4  (FIGS. 3, 4,  6 ,  9 ) by lock  31  (FIG. 12). With displacement of handle  35  of lock  31  along slot  36 , the locking element  36  is removed from the through opening  27  of post  26 , and compresses spring  34 . Then post  26  is released and it is turned in bracket  20  until the axis of the through opening  28  is aligned with the axis of the locking element  33  of lock  31 . With descending handle  35  the compressed spring  34  pushes out the locking element  33  from housing  32 . Then this locking element is introduced into the through opening  28  of post  36  fixings in such a way that it facilitates mounting of the staples.  
         [0086]    Mounting staples  5  in the through openings  8  and  9  in respective portions  2  and  3  of the severed sternum  4  (see FIGS. 9, 10) is performed by mechanism  100  of feeding and mounting staples. This is accomplished by locking mechanism  100  on post  26  of bracket  20 . Cartridge  131  is filled by staples  5  through slots  133 . When mounting the staples, the locking mechanism is set above the through slot  21  of bracket  20 . Cartridge  131  with staples  5  are forced from Cartridge  131  onto stoppers  106  and  107  by spring  132  (FIG. 10). While pushing in direction of arrow PUSH on the short side  137  of the L-shaped lever  142 , the cartridge is displaced along two posts  143  and  144  towards anvil  10 . This is accompanied by compression of springs  145  and  146 . The long side  150  of the L-shaped lever  142  passes via the through slot  112  and presses out the first staple  5  from the through slot  133  of cartridge  131 . This staple is introduced in turn via the through slot  21  of bracket  20  by its two legs  6  and  7  corresponding to openings  8  and  9  in portions  2  and  3  respectively, of the severed sternum  4 . With further pushing on the short side  147  of the L-shaped lever  142 , legs  6  and  7  of staple  5  pass via openings  8  and  9 . The form of legs  6  and  7  is changed with bending because of slots  11  and  12  of anvil  10 , while pulling together portions  2  and  3  of the severed sternum  4  (FIGS. 10, 14).  
         [0087]    The angle in which the two legs of the staple bend is circular and effectively secures the two divided portions of the sternum in a stable grip. The present invention is directed to a sternum closure device which securably retains a plurality of staples around sternum portions to maintain the portions in adjacent engaged relation during healing. The present invention minimizes damage of a tissue stapled and prevents formation of scar tissue.  
         [0088]    After mounting of staple  5  is completed the compression (FIG. 5), on lever  142  is terminated. It returns to its initial position owing to release of springs  145  and  146  (FIG. 9). After egress of the long side  150  of L-shaped lever from the through slot  133  of cartridge  131 , spring  131  is released. The cartridge  131  is displaced through one further step until the next staple  5  is arranged in through slot  133 , with stoppers  106  and  107  (FIGS. 9, 14). In order to mount additional staple  5 , bracket  20  is displaced progressively away from anvil  10  by the displacement mechanism  40  (FIG. 11). Rotation of screw  41  by handle  42  in an anti-clock wise direction allows displacement of bracket  20  progressively along guides  44  and  45  toward anvil  10 . This release spring  43  and enlarges the distance between anvil  10  and bracket  20 .  
         [0089]    Then the sternum closure device  1  is made ready for mounting the next staple  5 . This process of mounting displacing and compressing staple  5  is repeated as necessary.  
         [0090]    When mounting of all required staples  5  is completed (the closed sternum with all mounted staples is shown in FIG. 15), the sternum closure device  1  is removed.  
         [0091]    Referring to FIG. 16, the sternum closure device  1  comprises of an anvil  210  and a bracket  220 , the anvil and the bracket are joined together by a displacement mechanism  240 . The sternum closure device  1  further comprises of an clamping mechanism  260 , which is used for forming openings and mounting the staples  5  in the sternum  4 .  
         [0092]    Referring to FIGS.  16 ,  20 - 24 , anvil  210  is provided with two slots  211  and  212  for the purpose of forming staples  5 , a opening  213  used for joining the displacement mechanism  240 . The bracket  220  comprises of a through slot  221  and a threaded opening  222 , said opening  222  serving to join the displacement mechanism  40 .  
         [0093]    The bracket is joined to the anvil through a displacement mechanism. This mechanism provides turning of the bracket with respect to the anvil. The displacement mechanism comprises of a screw with a handle. This screw is positioned in the threaded opening in the bracket where it is joined to the anvil.  
         [0094]    Referring to FIGS.  16 - 24 , the anvil  210  and bracket  220  are joined via the displacement mechanism  240  and are fastened with an axle  241  to enable turning of bracket  220  to and from the anvil  210 . The displacement mechanism  240  comprises of screw  242 , said screw  242  extending into a handle  243 . The screw  242  is fastened through a threaded opening  222  in bracket  220 , and is locked rotatable by spherical element  244  in the opening  213  of anvil  210 .  
         [0095]    Referring to FIGS. 16, 17,  20  and  22 , the bracket  220  is provided with a handle  223 , said handle  223  is installed on the bracket  220 . The handle  223  provided a lever  224 , the lever  224  is fastened on handle  223  by an axle  225  with possibility of its turning. The lever  224  have two ends  226  and  227 , the end  226  is arranged inside the handle  223 , the end  227  is free and is arranged from outside the handle  223 . In initial position (FIGS. 16, 17,  20  and  21 ) the lever  224  is holding by spring  228 . The bracket  20  also is provided with two openings  229  and  230  for fixing the clamping mechanism  260  on the bracket  220 .  
         [0096]    In a preferred embodiment of the sternum closure device, the clamping mechanism comprises a carrying element, an assembly for mounting staples, a cartridge containing staples, and a lock fixing of the clamping mechanism on the bracket.  
         [0097]    The carrying element is constructed as a bed with one rib is situated perpendicularly to the bed surface. The rib is provided with one cut. The bed comprises also two guide-openings.  
         [0098]    The assembly for mounting staples is fastened on the bed and is constructed as pressure mechanism comprising the pusher with the transmitting element. The transmitting element being fastened to the pusher.  
         [0099]    The cartridge is fastened on the bed and comprises a holder of the staples and means for feeding of the staples.  
         [0100]    The lock fixing of the clamping mechanism on the bracket is fastened on the bed and is constructed as a housing comprising a locking element with a handle.  
         [0101]    The clamping mechanism  260  consists of the carrying element, which is constructed as the bed  261  with the rib  262  being arranged perpendicularly to the surface of the bed  261 , the assembly  270  for mounting staples  5  is fastened on the bed  261 , the cartridge  280  containing staples  5  is fastened on the bed  261 , and the lock  290  fixing of the clamping mechanism  260  on the bracket  220 . The rib  262  of the bed  261  is provided with the cut  263  and the bed  261  comprises two guide-openings  264  and  265 .  
         [0102]    The assembly  270  for mounting staples  5  constructing as the pressure mechanism comprises the pusher  271  with the transmitting element  272  and spring-wise element  273 . The transmitting element  272  being fastened to the pusher  271 .  
         [0103]    The cartridge  280  is fastened on the bed  261  and comprises a holder  281  of the staples  5  and means  282  for feeding of the staples  5 . The means  282  contains a pressure element  283  is placed inside the holder  281 . The pressure element  283  comprises a handle  284  and spring-wise element  285 .  
         [0104]    The lock  290  fixing of the clamping mechanism  260  on the bracket  220  is fastened on the bed  261  and is constructed as a housing  291  comprising a locking element  292  with a handle  293  and spring-wise element  294 . The locking element  292  and spring-wise element  294  are placed inside the housing  291 .  
         [0105]    The bracket  220  comprises also two openings  229  and  230  for fixing the locking element  292  of the lock  290 .  
         [0106]    The mode of operation of the embodiment of the sternum closure device is described herein below.  
         [0107]    The bracket  220  is turned in direction away from anvil  210  by the displacement mechanism  240  (see FIG. 20). The screw  242  is rotated by handle  243  in threaded opening  222  of the bracket  220 , for example, in a counter clockwise direction. Bracket  220  turns around axle  241  in direction away from anvil  210 . This results in greater distance between anvil  210  and bracket  220 . Anvil  10  and bracket  220  are positioned correspondingly from the internal and external sides of parts  2  and  3  of the severed sternum  4 .  
         [0108]    With rotation of screw  242  by handle  243  in the opposite direction (in this case—in the clockwise direction), bracket  220  turns around axle  241  towards anvil  210 . This motion is accompanied with decrease of the distance between anvil  210  and bracket  220  to contact with the internal and external parts  2  and  3  respectively, of the severed sternum  4 .  
         [0109]    The sternum closure device  1  is arranged in the position of drilling openings in parts  2  and  3  of the severed sternum  4  (FIGS. 16, 18,  20  and  23 ) by lock  290  (FIG. 5). In the initial state spring  294  of lock  290  is released and the locking element  292  is placed in one of two openings  229  or  230  of bracket  220  (in this case—in the opening  230 ).  
         [0110]    Drilling openings  8  and  9  are performed in parts  2  and  3  of the severed sternum  4  (FIG. 23) by one of any drilling instrument, which are used in sternal surgery (for example, pneumating bit brace—not shown on the drawings). Openings  8  and  9  are drilled by turns correspond to two parts  2  and  3  of the severed sternum  4  through two guide-openings  264  and  265  of bed  261  of clamping mechanism  260  (FIG. 23).  
         [0111]    After drilling openings  8  and  9  the clamping mechanism  60  is transferred in the state of mounting staples  5  in sternum  4  (FIGS. 17, 19,  21 ,  22 ,  24 ) by lock  290  (FIGS. 20, 22). The locking element  292  is removed from the opening  230  of the bracket  220  by means of lifting the handle  293  compressing spring  294 . Then move the clamping mechanism  260  along the bracket  220  until the opening  230  of the bracket  220 . With descending handle  293  the compressed spring  294  releases and the locking element  292  sets in the opening  229  of the bracket  220 .  
         [0112]    Mounting staples  5  in the through openings  8  and  9  in respective parts  2  and  3  of the severed sternum  4  (FIGS. 22, 24) is performed by assembly  270 . Before mounting staples the cartridge  80  is filling in the staples  5 . The filling of the staples accomplishes with displacement to back of handle  284  of the means  282  compressing spring  285 . The staples  5  are setting on the holder  281 . With descending handle  284  the compressed spring  285  pushes out the pressure element  283 , which pressing of the staples  5  to rib  262  of the bed  261 . With raising of the lever  224  by the end  226  (FIG. 22) the spring  228  is stretching, and the lever  224  turns around the axle  225 . The free end  227  of the lever  224  presses to the pusher  271  of the assembly  270  compressing the spring  273 . The pressure passes by the transmitting element  272  to the staple  5 . The first staple  5  is introduced via the slot  221  of the bracket  220  by its two legs  6  and  7  corresponding to openings  8  and  9  in parts  2  and  3 , respectively, of the severed sternum  4 . With further pushing on the pusher  271  of the assembly  270 , legs  6  and  7  of the staple  5  (FIG. 24) pass via openings  8  and  9 . The form of legs  6  and  7  is changed with bending of slots  211  and  212  of the anvil  210 , while pulling together parts  2  and  3  of the severed sternum  4  (FIGS. 24, 29).  
         [0113]    The angle in which the two legs of the staple bend is circular and effectively secures the two severed parts of the sternum in a stable grip. The present invention is directed to a sternum closure device, which securably retains a plurality of staples around sternum parts to maintain the parts in adjacent engaged relation during healing. The present invention minimizes damage of a tissue stapled and prevents formation of scar tissue.  
         [0114]    After mounting of staple  5  is completed raising the end  226  of the lever  224  is terminated. It returns to its initial position owing to release of springs  228 . After return the lever  224  to the initial position, the pusher  271 , transmitting element  272  and spring  273  of the assembly  270  are released and returned to initial position. With return transmitting element  272  to the initial position, the pressure element  283  of the means  282 , which pressing the next staples  5  to rib  262  of the bed  261  and partially releases spring  285 .  
         [0115]    In order to mount next staples  5 , bracket  220  is displaced progressively away from anvil  210  by the displacement mechanism  240 . Rotation of screw  242  by handle  243  in the counter clockwise direction allows turning of the bracket  220  relative to the anvil  210  around of the axle  241 . It enlarges the distance between anvil  210  and bracket  220 .  
         [0116]    Then the sternum closure device  1  is made ready for mounting the next staple  5 . This process of mounting displacing and compressing staple  5  is repeated as necessary.  
         [0117]    When mountings of all required staples  5  is completed (the closed sternum  4  with all mounted staples is shown in FIG. 25) the sternum closure device  1  is removed.  
         [0118]    Referring to FIGS.  26  to  33 , the pincers  300  are shown to provide a system and method for temporarily joining two parts  2  and  3 , of a severed sternum  4 , by means of special staples  301 , having legs  302  and  303 .  
         [0119]    Referring to FIGS.  26 - 28 , the pincers  300  comprise of a handle  311  with a jaw  312  is intended for setting of the special staple  301 , and a lever  321  with a jaw  322  which is intended for extension of the special staple  301 . The handle  311  and the lever  321  are jointed together by an axle  331  which permits turning of the levers, and a spring  332  which facilitates the return in the initial position.  
         [0120]    Referring to FIGS.  26 - 29 , the handle  311  is provided with a slot  313  for the purpose of passing the jaw  322  of the lever  321  at the time of its turning. The jaw  312  of the handle  311  is provided a cut section  314  for setting of the special staple  301 . The jaw  322  of the lever  321  comprises of a opening  323  for holding of the special staple  301 .  
         [0121]    Referring to FIGS.  30 - 31 , the special staple  301  is provided with the legs  302  and  303 . The leg  302  is changeable, any leg  302  may have a different length, the length of the leg  302  being selecting in accordance with the width of the severed sternum  4 . The length of the leg  303  is constant. The legs  302  and  303  are provided with threaded parts  304  and  305  respectively. The legs  302  and  303  are installed in a holder  306 , which comprises two openings  307  and  308 . The special staple  301  also comprises a spring  309  and a nut  310 . The leg  302  by its threaded part  304  is screwed into threaded opening  307 , and the leg  303  is inserted into the holder through the opening  308 . The spring  309  is installed inside the holder through the opening  308  from one side to the opposite side of the leg  308 . The spring  309  is fastened by means the nut  310 .  
         [0122]    The mode of the operation of the pincers for mounting staples is described herein below.  
         [0123]    In initial position the special staple  301  is installed in the pincers  300  so that the threaded part  305  of the leg  303  is put into opening  323  of the jaw  322 , and the other side of the leg  303  is put into cut  314  of the jaw  312  (see FIG. 29).  
         [0124]    By pushing in the direction of the arrow PUSH onto the lever  321 , it turns around the axle  331 . The spring  332  compresses, and the jaw  322  presses on the threaded part  305  of the leg  303 . The spring  309  compresses and the leg  303  pulls out from the opposite side of the opening  308 , while a distance between free ends of the legs  302  and  303  is extending. In this position the pincers  300  with the special staple  301  are set on the severed sternum  4  (see FIG. 32). After setting of the special staple  301  on the severed sternum  4 , the lever  321  is released in direction of arrow RELEASE. The spring  332  is released, the lever  321  is turned around the axle  331  backwards, the spring  309  of the special staple  301  is released also, and the legs  302  and  303  are pressed to the parts  2  and  3  the severed sternum  4  (see FIG. 33). The pincers  300  are removed from the special staple  301 .  
         [0125]    For the mounting of the next special staples  301 , the operation is repeated.  
         [0126]    Referring to FIGS.  24  to  32 , a sternum closure device  1  is shown to provide a system and method for joining two parts  2  and  3 , of a severed sternum  4 , by means of staples  5 , having legs  6  and  7 , which are inserted through openings  8  and  9  of the severed sternum  4 .  
         [0127]    A preferred embodiment of the sternum closure device includes an anvil for forming staples. This anvil is positioned on the internal side of the severed sternum. A bracket is situated on the outer side of the severed sternum, opposite the anvil. The anvil comprises an element for forming the staples. It is designed to have one slot. In addition, the bracket has a second slot which is intended to guide the drills and for mounting the staples on the sternum.  
         [0128]    The unique feature about the present invention is that the anvil and the bracket are fastened with the axle and are jointed by means of the displacement mechanism that provides reliable holding of the device on the severed sternum.  
         [0129]    The second unique feature about the present invention is that the lever is fastened in the handle of the bracket such that facilitates mounting of the staples on the severed sternum.  
         [0130]    Referring to FIGS.  34  to  37 , the sternal approximator bracket  401  is shown to provide a system and method for temporary or permanent joining two parts  2  and  3 , of a severed sternum  4 , by means of sternal approximator brackets  401 , having legs  402  and  403 .  
         [0131]    Referring to FIGS. 34, 35 said leg  403  comprises the threaded stud  404  and nut  405 . Said leg  402  consists non-through rectangular opening  406  and through opening  407 . Said leg  403  inserted into said opening  406 , said stud  404  inserted into said opening  407  and prominent part of said stud  404  and screwed with said nut  405 .  
         [0132]    The mode of operation of the sternal approximator bracket is described herein below.  
         [0133]    In initial position said leg  403  of the sternal approximator bracket  401  is positioned into said leg  402  so that said stud  404  projects from said leg  402  and screwed with said nut  405  (see FIG. 34).  
         [0134]    With setting said sternal approximator bracket  401  on said severed sternum  4  said legs  402  and  403  slide apart by unscrew said nut  405  (see FIG. 36). Then said sternal approximator bracket  401  is installing on said severed sternum  4  and said nut  405  is screwing along said stud  404  by any spanner or ratchet, which gives the best fit. Said parts  2  and  3  said severed sternum  4  are pressing tightly and fixing (see FIG. 37).  
         [0135]    Removing said sternal approximator bracket  401  from said severed sternum  4  executes in the back order.  
         [0136]    The present invention provides a relatively simple and less traumatic means to effect sternum closure which can be performed rapidly and effectively by the surgeon. While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the invention, but merely as exemplification of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the invention as defined by the claims appended hereto.