Bone staple, instrument and method of use and manufacturing

Abstract

A new shape changing staple and instrument for the fixation of structures to include bone tissue and industrial materials. This new staple stores elastic mechanical energy to exert force on fixated structures to enhance their security and in bone affect its healing response. This staple once placed changes shape in response to geometric changes in the materials structure, including healing bone tissue. The staple is advanced over prior staples due to its: 1) method of operation, 2) high strength, 3) method of insertion, 4) compressive force temperature independence, 5) energy storing staple retention and delivery system, 6) compatibility with reusable or single use product configuration, 7) efficient and cost effective manufacturing methods, and 8) reduction in the steps required to place the device. In addition to the staple's industrial application an embodiment for use in the fixation of the musculoskeletal system is shown with staple, cartridge, and extrusion handle.

1 - 27 . (canceled) 
     
     
         28 . A pre-sterilized kit for performing a method of fixating a first bone and a second bone, wherein the pre-sterilized kit comprises:
 (a) a staple device, wherein
 (i) the staple device comprises a cartridge and only one bone staple, 
 (ii) the bone staple has a staple bridge and a plurality of staple legs connected to the staple bridge, 
 (iii) the staple bridge and the plurality of staple legs comprise a shape memory metal, 
 (iv) the cartridge comprises a channel in which the staple bridge and the plurality of staple legs are restrained in a first shape and in which the shape memory metal of the bone staple comprises stress induced martensite crystalline form of the shape memory metal, 
 (v) the first shape comprises the staple bridge in an elongated shape and the plurality of the staple legs are parallel to one another, and 
 (vi) each of the plurality of staple legs has a tip extended outside the cartridge, such that the tips of the plurality of staple legs are parallel to one another and separated by a pre-determined distance from one another; 
   (b) a drill bit operable for drilling holes in bone;   (c) a drill guide operable to guide drilling of at least one hole in the first bone and at least one hole in the second bone that correspond to the pre-determined distance of the tips of the plurality of staple legs; and   (d) an extrusion instrument that is configured to be movably coupled to the cartridge, wherein
 (i) after the tips of the plurality of staple legs are inserted into the plurality of drilling holes, the extrusion instrument is operable to move the staple relative to the cartridge to extrude and release the staple from the cartridge, 
 (ii) upon release of the bone staple from the cartridge,
 (A) the staple bridge and plurality of staple legs are no longer restrained in the first shape and are operable to move toward a second shape as the stress induced martensite crystalline form of the shape memory metal transitions to an austenite crystalline form of the shape memory metal, 
 (B) the second shape comprises the staple bridge in a contracted shape, as compared to the staple bridge in the first shape, and the plurality of staple legs are a non-parallel, convergent shape, and 
 (C) the bone staple is operable to pull the first bone and the second bone together and maintain the first bone and second bone under compression. 
 
   
     
     
         29 . The pre-sterilized kit of  claim 28 , wherein the staple bridge has an S-shaped staple bridge shape. 
     
     
         30 . pre-sterilized kit of  claim 28 , wherein the staple bridge has an O-shaped staple bridge shape. 
     
     
         31 . The pre-sterilized kit of  claim 28 , wherein
 (a) when the bone staple is in the first shape, the bone staple has one or more areas in which the shape memory metal is predominately in the stress-induced martensite crystalline form, and   (b) the one or more areas is selected from a group consisting of (i) portions of the plurality of the staple legs that adjoin the staple bridge, (ii) portions of curvature of the staple bridge, and (iii) combinations thereof.   
     
     
         32 . The pre-sterilized kit of  claim 28 , wherein the extrusion instrument is a mandrel. 
     
     
         33 . The pre-sterilized kit of  claim 28 , wherein the shape memory metal comprises nitinol. 
     
     
         34 . The pre-sterilized kit of  claim 28 , wherein the staple device and the extrusion instrument are integral. 
     
     
         35 . The pre-sterilized kit of  claim 28 , wherein the staple device and the extrusion instrument are separate. 
     
     
         36 . The pre-sterilized kit of  claim 28 , wherein the bone staple is being restrained by the channel of the cartridge in a strain amount of the bone staple that is at least 6%. 
     
     
         37 . The pre-sterilized kit of  claim 36 , wherein the strain amount of the bone staple is between 6% and 13%. 
     
     
         38 . The pre-sterilized kit of  claim 36 , wherein the bone staple is being restrained by the channel of the cartridge with no substantial plastic deformation of the bone staple. 
     
     
         39 . The pre-sterilized kit of  claim 29 , wherein the bone staple is being restrained by the channel of the cartridge in a strain amount of the staple bridge that is at least 30%. 
     
     
         40 . A method of fixating a first bone and a second bone comprising the steps of:
 (a) selecting a pre-sterilized kit comprising a staple device, an extrusion instrument, a drill bit, and a drill guide, wherein
 (i) the staple device comprises a cartridge and only one bone staple, 
 (ii) the bone staple has a staple bridge and a plurality of staple legs connected to the staple bridge, 
 (iii) the staple bridge and the plurality of staple legs comprise a shape memory metal, 
 (iv) the cartridge comprises a channel in which the staple bridge and the plurality of staple legs are restrained in a first shape and in which the shape memory metal of the bone staple comprises stress induced martensite crystalline form of the shape memory metal, 
 (v) the first shape comprises the staple bridge in an elongated shape and the plurality of the staple legs are parallel to one another, and 
 (vi) each of the plurality of staple legs has a tip extended outside the cartridge, such that the tips of the plurality of staple legs are parallel to one another and separated by a pre-determined distance from one another; 
   (b) utilizing the drill bit and the drill guide to drill at least one hole in the first bone and at least one hole in the second bone that correspond to the pre-determined distance of the tips of the plurality of staple legs;   (c) inserting the tips of the plurality of staple legs into the plurality of drill holes;   (d) utilizing the extension instrument to move the staple relative to the cartridge to extrude and release the staple from the cartridge, wherein, upon release of the bone staple from the cartridge,
 (i) the staple bridge and plurality of staple legs are no longer restrained in the first shape and move toward a second shape as the stress induced martensite crystalline form of the shape memory metal transitions to an austenite crystalline form of the shape memory metal, 
 (ii) the second shape comprises the staple bridge in a contracted shape, as compared to the staple bridge in the first shape, and the plurality of staple legs are in a non-parallel, convergent shape, and 
 (iii) the bone staple pulls the first bone and the second bone together and maintains the first bone and second bone under compression. 
   
     
     
         41 . The method of  claim 40 , wherein the staple bridge has an S-shaped staple bridge shape. 
     
     
         42 . The method of  claim 40 , wherein the staple bridge has an O-shaped staple bridge shape. 
     
     
         43 . The method of  claim 40 , wherein
 (a) when the bone staple is in the first shape, the bone staple has one or more areas in which the shape memory metal is predominately in the stress-induced martensite crystalline form, and   (b) the one or more areas is selected from a group consisting of (i) portions of the plurality of the staple legs that adjoin the staple bridge, (ii) portions of curvature of the staple bridge, and (iii) combinations thereof.   
     
     
         44 . The method of  claim 40 , wherein the extrusion instrument is a mandrel. 
     
     
         45 . The method of  claim 40 , wherein the shape memory metal comprises nitinol. 
     
     
         46 . The method of  claim 40 , wherein the staple device and the extrusion instrument are integral. 
     
     
         47 . The method of  claim 40 , wherein the staple device and the extrusion instrument are separate. 
     
     
         48 . The method of  claim 40 , wherein the bone staple is being restrained by the channel of the cartridge in a strain amount of the bone staple that is at least 6%. 
     
     
         49 . The method of  claim 48 , wherein the strain amount of the bone staple is between 6% and 13%. 
     
     
         50 . The method of  claim 48 , wherein the bone staple is being restrained by the channel of the cartridge with no substantial plastic deformation of the bone staple. 
     
     
         51 . The method of  claim 40 , wherein the bone staple is being restrained by the channel of the cartridge in a strain amount of the staple bridge that is at least 30%.