US2009259263A1PendingUtilityA1

Apparatus and methods of fixating bone

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Assignee: BIOMET MICROFIXATION INCPriority: Apr 11, 2008Filed: Apr 11, 2008Published: Oct 15, 2009
Est. expiryApr 11, 2028(~1.8 yrs left)· nominal 20-yr term from priority
A61F 2220/005A61F 2002/30448A61F 2/2875A61B 2017/00951A61B 2017/00004A61B 17/688A61F 2/2846
51
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Claims

Abstract

Apparatus and methods of fixating bone include repairing or remodeling a hard tissue defect with a composite bone structure. The composite bone structure includes at least two hard tissues or bones and a scaffold material fixed together by an adhesive component. The apparatus and methods include positioning the hard tissues/bones, conforming the scaffold material to at least a portion of a surface of the hard tissues/bones, contacting the adhesive component with the hard tissues/bones and the scaffold material, and changing the material state of the adhesive component to another material state at which the adhesive component fixes together the hard tissues/bones and the scaffold material, thereby forming a composite bone structure having a desired rigidity.

Claims

exact text as granted — not AI-modified
1 . A method of fixating bone, comprising:
 connecting at least two bones and a scaffold material with an adhesive component such that the adhesive component is in contact with at least a portion of a surface of each of the bones and the scaffold material; and   fixating the bones and the scaffold material to define a desired structure having a desired rigidity based on changing a material state of the adhesive component.   
     
     
         2 . The method of  claim 1 , wherein the fixating further comprises changing the material state of the adhesive component so that the desired rigidity substantially corresponds to a rigidity of the bones. 
     
     
         3 . The method of  claim 1 , wherein the adhesive component comprises a synthetic polymer, and wherein the fixating further comprises exposing the adhesive component to a radiation-based initiator or a chemical-based initiator operable to change the adhesive component to a cured state. 
     
     
         4 . The method of  claim 1 , wherein the adhesive component comprises a synthetic polymer, and wherein the fixating further comprises polymerizing the adhesive component to a partial polymerization state, repositioning at least one of the bones while connected to the adhesive component in the partial polymerization state, and allowing or actively promoting further polymerizing of the adhesive component from the partial polymerization state to a substantially full polymerization state to fixate the repositioned bones and the scaffold material. 
     
     
         5 . The method of  claim 4 , wherein changing the adhesive component to the substantially full polymerization state further comprises exposing the adhesive component to an ambient radiation source not directed primarily on the adhesive component or the scaffold material. 
     
     
         6 . The method of  claim 1 , wherein changing the material state of the adhesive component further comprises changing the adhesive component from a first perceived color to a second perceived color, wherein the second perceived color is perceptively different from the first perceived color. 
     
     
         7 . The method of  claim 1 , wherein the scaffold material comprises a first biocompatible material and the adhesive component comprises a second biocompatible material, wherein the first biocompatible material and the second biocompatible material have substantially similar rates of resorption. 
     
     
         8 . The method of  claim 1 , wherein the scaffold material and the adhesive component both comprise substantially the same biocompatible material. 
     
     
         9 . The method of  claim 1 , wherein the adhesive component comprises at least one material selected from the group comprising: urethane-based, resorbable synthetic polymer and isocyanate-based, resorbable synthetic polymer. 
     
     
         10 . The method of  claim 1 , in which the bones are obtained from at least one location selected from the group comprising: a cranial skeleton location and a maxillofacial skeleton location. 
     
     
         11 . The method of  claim 1 , further comprising adding an effective amount of the adhesive component to the scaffold material. 
     
     
         12 . The method of  claim 1 , further comprising holding the bones in a desired relative orientation, conforming the scaffold material to at least a portion of the surface of each of the bones while positioned in the desired relative orientation, and changing the material state of the adhesive component after the conforming and while the bones are positioned in the desired relative orientation. 
     
     
         13 . The method of  claim 12 , wherein the holding further comprises holding against a surface of a mold. 
     
     
         14 . The method of  claim 12 , wherein the conforming further comprises changing a material state of the scaffold material. 
     
     
         15 . The method of  claim 1 , further comprising:
 accessing the bones at a location within a body;   removing the bones from the body;   holding the bones in a desired relative orientation outside of the body;   conforming the scaffold material to at least a portion of a surface of each of the bones while positioned in the desired relative orientation outside of the body;   changing the material state of the adhesive component after the conforming and while the bones are positioned in the desired relative orientation outside of the body; and   securing the fixated bones and scaffold material to at least a portion of a skeletal bone at the location within the body.   
     
     
         16 . The method of  claim 1 , further comprising performing a surface preparation on at least a portion of the surface of each of the bones, wherein the surface preparation improves an ability of the adhesive component to attach to the respective portion of the surface. 
     
     
         17 . The method of  claim 16 , wherein performing the surface preparation further comprises roughening the portion of the surface of each of the bones, and wherein connecting further comprises placing the scaffold material such that the adhesive component contacts the respective roughened surfaces. 
     
     
         18 . The method of  claim 16 , wherein performing the surface preparation further comprises removing at least a portion of periosteum from at least the portion of the surface of each of the bones prior to the connecting with the scaffold material. 
     
     
         19 . The method of  claim 18 , further comprising replacing the portion of the periosteum over the scaffold material at each portion of the surface of the bones after connecting the bones with the scaffold material. 
     
     
         20 . The method of  claim 1 , further comprising adding a bone void filler between at least a portion of the bones. 
     
     
         21 . The method of  claim 1 , further comprising adding a bone growth-promoting material in contact with the bones. 
     
     
         22 . A method of craniomaxillofacial surgery, comprising:
 accessing at least two bones at least partially defining a hard tissue defect at a location within a body, wherein the location comprises a cranial location or a maxillofacial location;   positioning the bones into a desired relative orientation;   conforming a scaffold material to at least a portion of a surface of each of the bones;   contacting an adhesive component between at least a portion of each of the bones and the scaffold material; and   fixating the bones and the scaffold material in the desired relative orientation to remodel the hard tissue defect, wherein the fixating is based on changing the adhesive component to a material state at which the adhesive component fastens together the bones and the scaffold material with a desired rigidity.   
     
     
         23 . A composite bone structure, comprising:
 a first bone having a first surface;   at least one other bone, wherein each other bone comprises a respective second surface;   a scaffold material positioned to connect the first bone and the at least one other bone, wherein the scaffold material is adaptable to conform to the first surface and each respective second surface; and   an adhesive component in contact with at least a portion of the first bone, each other bone and the scaffold material, wherein the adhesive component has a material state that is changeable to another material state at which the adhesive component affixes the first bone, each other bone and the scaffold material to define a composite bone structure having a desired rigidity.   
     
     
         24 . The composite bone structure of  claim 23 , wherein the desired rigidity substantially corresponds to a rigidity of the first bone and each other bone. 
     
     
         25 . The composite bone structure of  claim 23 , wherein the adhesive component comprises a synthetic polymer, wherein the another material state comprises a cured state, and wherein the synthetic polymer is operable to change to the cured state based on exposure to a radiation-based initiator or a chemical-based initiator. 
     
     
         26 . The composite bone structure of  claim 23 , wherein the adhesive component is further operable to change from a first perceived color prior to achieving the another material state to a second perceived color at the another material state, wherein the second perceived color is perceptively different from the first perceived color. 
     
     
         27 . The composite bone structure of  claim 23 , wherein the scaffold material comprises a first biocompatible material and the adhesive component comprises a second biocompatible material, wherein the first biocompatible material and the second biocompatible material have substantially similar rates of resorption. 
     
     
         28 . The composite bone structure of  claim 23 , wherein the scaffold material and the adhesive component each comprise substantially the same biocompatible material. 
     
     
         29 . The composite bone structure of  claim 23 , wherein the scaffold material is operable to carry the adhesive component. 
     
     
         30 . The composite bone structure of  claim 23 , wherein the adhesive component comprises a urethane-based, resorbable synthetic polymer. 
     
     
         31 . The composite bone structure of  claim 23 , wherein at least the first bone or the at least one other bone comprises a cranial bone or a maxillofacial bone or a mandible. 
     
     
         32 . The composite bone structure of  claim 23 , wherein the first bone and each other bone in the composite bone structure have a desired relative orientation. 
     
     
         33 . The composite bone structure of  claim 23 , further comprising periosteum positioned on the scaffold material. 
     
     
         34 . The composite bone structure of  claim 23 , further comprising a bone void filler positioned between at least two of the first bone and each other bone. 
     
     
         35 . The composite bone structure of  claim 23 , further comprising a bone growth-promoting material positioned between at least two of the first bone and the at least one other bone.

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