US2005267481A1PendingUtilityA1

Systems, devices and apparatuses for bony fixation and disk repair and replacement and methods related thereto

46
Assignee: CARL ALLENPriority: Oct 17, 2003Filed: Oct 18, 2004Published: Dec 1, 2005
Est. expiryOct 17, 2023(expired)· nominal 20-yr term from priority
A61B 17/32002A61B 17/1631A61B 17/1757A61B 17/1671A61F 2/4455A61B 17/8875A61B 17/1642
46
PatentIndex Score
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Claims

Abstract

The present invention features new methods, apparatuses and devices for fixing adjacent bone segments, segments of a bony structure and adjacent vertebrate of a spine. The methods, apparatuses and devices utilize a new apparatus for forming a channel in a surface of the bone or bony structure segments or adjacent vertebra or a channel submerged within the bone or bony structure segments or adjacent vertebra. In more particular embodiments such apparatuses and methods including forming an arcuate channel and which channel can receive therein a curved rod or implant member, which also preferably is arcuate, and avoids the associated problems with prior cage or straight rod and screw systems. Also featured are systems, apparatuses and methods for repairing, replacing or augmenting the nucleus and/or annulus of a disc.

Claims

exact text as granted — not AI-modified
1 . A method for forming a channel in one or more segments of a bony structure or adjacent vertebra of a spine, said method comprising the steps of. 
 positioning a frame assembly proximal the treatment or surgical site,    securing the frame assembly to adjacent segments of the one or more segments of the bone or bony structure or adjacent vertebra; and    rotating a drill bit in fixed relation to the frame assembly to form the channel in the surface or sub-surface of the bone, bony structure or vertebra.    
     
     
         2 . The method of  claim 1 , wherein said securing further includes, mechanically engaging a securing mechanism to the frame assembly and to the adjacent segments of the bone or bony structure or adjacent vertebra, wherein the frame assembly is maintained in fixed relation by such mechanical engagement  
     
     
         3 . The method of  claim 2 , wherein the frame assembly is maintained in fixed relation by such mechanical engagement and lateral stiffness of the securing mechanism.  
     
     
         4 . The method of  claim 2 , wherein the frame assembly being provided further includes a frame having a plurality of through apertures, each through aperture including a constricted portion and a plurality of securing members and wherein said securing further includes: 
 driving each of the plurality of securing members through the through apertures and the constricted portion and into the bone, bony structure or vertebra at the site, whereby the frame is secured in fixed relation to the bone, bony segments or vertebra by the engagement of the constricted portion with the securing member.    
     
     
         5 . The method of  claim 4 , wherein the frame is secured in fixed relation by the lateral stiffness of the securing members.  
     
     
         6 . The method of  claim 1 , further comprising: 
 providing a drill assembly including a drill bit;    attaching the drill assembly to the frame assembly so the drill bit follows a predetermined path in fixed relation with respect to the frame assembly; and    moving the drill bit through the predetermined path while the drill bit is rotating thereby cutting the channel with the drill bit.    
     
     
         7 . The method of  claim 1 , further comprising the steps of: 
 providing a pivot arm that rotates in fixed relation to the frame assembly;    operable coupling a drill bit to the pivot arm so the drill bit follows a predetermined path in fixed relation with respect to the frame assembly as the pivot arm is rotated.    
     
     
         8 . The method of  claim 7 , further comprising the step of rotating the drill bit while rotating the pivot arm thereby cutting the channel with the drill bit.  
     
     
         9 . The method of  claim 7 , further comprising the step of determining if the movement of the drill bit in a first direction formed one of a complete channel or a partial channel and in the case where it is determined that a partial channel was formed, detaching and re-attaching the drill assembly so as to be moveable in a second direction that is different from the first direction and moving the drill bit in the second direction.  
     
     
         10 . The method of  claim 8 , further comprising the step of determining if the rotation of the pivot arm in a first direction formed one of a complete channel or a partial channel and in the case where it is determined that a partial channel was formed, detaching and re-attaching the pivot arm so as to be rotatable in a second direction that is different from the first direction and rotating the pivot arm in the second direction.  
     
     
         11 . The method of  claim 1 , further comprising the steps of: 
 locating an implant in the channel; and    attaching the implant within the channel to the bone, bony structure or vertebras.    
     
     
         12 . The method of  claim 11 , wherein said attaching includes securing the implant to the bone, bony structure or vertebra using a plurality or more of securing devices.  
     
     
         13 . An apparatus for forming a channel or opening in one of adjacent segments of a bone or bony structure or adjacent vertebrae of a spine, comprising: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit;    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage one of the bone, bony structure or vertebra.    
     
     
         14 . The apparatus of  claim 13 , wherein the base is configured and arranged so portions thereof proximal an exit of each of the plurality of first through apertures contact at least a portion of a surface of the one of the bone, bony structure or vertebra so as to form an enclosed pathway from a top surface of the base to the surface of the one of the bone, bony structure or vertebra.  
     
     
         15 . The apparatus of  claim 13 , wherein the securing mechanism comprises a plurality of members one end of which is configured for mechanical engagement with the one of the bone, bony structure or vertebra.  
     
     
         16 . The apparatus of  claim 15 , wherein the base further includes a plurality of second apertures extending between a top surface and a bottom surface thereof and wherein one of the plurality of securing mechanisms is received in a respective one of the plurality of second through apertures.  
     
     
         17 . The apparatus of  claim 16 , wherein each of the plurality of second through apertures is configured and arranged so a portion thereof mechanically engages a portion of the one of the securing mechanism received therein.  
     
     
         18 . The apparatus of  claim 16 , wherein each of the plurality of second through apertures is configured and arranged so the one end of the securing mechanism configured for mechanical engagement with the one of the bone, bony structure or vertebra is disposed within confines of the second through aperture before causing the one end to mechanically engage.  
     
     
         19 . The apparatus of  claim 13 , wherein the drill assembly includes: 
 an outer housing being operably coupled to the moving mechanism for rotating the drill bit about the point of rotation and through that at least one of the first through apertures; and    a drive cable wherein an end of the drive cable is operably coupled to the drill bit and a portion of the drive cable is disposed within the outer housing.    
     
     
         20 . The apparatus of  claim 19 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 4 ×Ldci    
     
     
         21 . The apparatus of  claim 19 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 3 ×Ldci    
     
     
         22 . The apparatus of  claim 19 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 2 ×Ldci    
     
     
         23 . The apparatus of  claim 19 , wherein the drive assembly further includes a flexible inner housing a portion of which is disposed with the outer housing and in which is received the drive cable.  
     
     
         24 . The apparatus of  claim 19 , wherein the drive assembly further includes a double radius inner member having two radii of curvatures, wherein one of the radii of curvatures is set so as to align the drive cable with respect to an axis of the outer housing proximal an end thereof proximal to the drill bit.  
     
     
         25 . The apparatus of  claim 13 , wherein the moving mechanism includes: 
 an arm member;    wherein a first end of the arm member is rotatably secured to the base so the arm member rotates about a fixed point;    wherein a portion of the arm member distal from the first end mechanically engages a portion of the drill assembly such that rotation of the arm member about the fixed point cause the drill bit to rotate about the point of rotation.    
     
     
         26 . The apparatus of  claim 25 , where the arm member includes a manipulating portion proximal a second end of the arm member being configured and arranged so a user can manipulate the arm member causing rotation.  
     
     
         27 . The apparatus of  claim 25 , wherein the arm member is configured and arranged so be removably rotatably secured to the base when the drill assembly is in a retracted position and configured and arranged so as not to be removable from the base when the drill assembly is in other operable positions.  
     
     
         28 . An apparatus for forming a channel or opening in one or more segments of a bone or bony structure or adjacent vertebrae of a spine, comprising: 
 a base including a plurality of first through apertures and a plurality of second through apertures, wherein the base is configured and arranged so portions thereof proximal an exit of each of the plurality of first through apertures is configured so the portions contact at least a portion of a surface of the one of the bone, bony structure or vertebra so to form an enclosed pathway from a top surface of the base to the surface of the one of the bone, bony structure or vertebra    a securing mechanism operably coupled to the base for securing the base to one of the bone, bony structure or vertebra, wherein the securing mechanism includes a plurality of members one end of which is configured for mechanical engagement with the one of the bone, bony structure or vertebra, and wherein one of the plurality of securing mechanisms is received in a respective one of the plurality of second through apertures;    a drill assembly including a drive cable and a drill bit operably coupled to an end of the drive cable;    an arm member being rotatably secured to the base and being mechanically coupled to a portion of the drill assembly so as to allow rotation of the drill bit about a point of rotation and through at least one of the first through apertures.    
     
     
         29 . The apparatus of  claim 28 , wherein each of the plurality of second through apertures is configured and arranged so a portion thereof mechanically engages a portion of the one of the securing mechanism received therein and wherein each of the plurality of second through apertures is configured and arranged so the one end of the securing mechanism configured for mechanical engagement with the one of the bone, bony structure or vertebra is disposed within confines of the second through aperture before causing the one end to mechanically engage.  
     
     
         30 . The apparatus of  claim 28 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within an outer housing (Ldci) of the drill assembly satisfies the relation:  
           Ldc≦ 4 ×Ldci    
     
     
         31 . The apparatus of  claim 28 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within an outer housing (Ldci) of the drill assembly satisfies the relation:  
           Ldc≦ 3 ×Ldci    
     
     
         32 . The apparatus of  claim 28 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within an outer housing (Ldci) of the drill assembly satisfies the relation:  
           Ldc≦ 2 ×Ldci    
     
     
         33 . A system for forming a channel in one of adjacent segments of a bone, a bony structure or adjacent vertebra of a spine, comprising a drilling apparatus and a motor, wherein said drilling apparatus includes: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit, the drill bit being operably coupled to the motor    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage one of the bone, bony structure or vertebra.    
     
     
         34 . The system of  claim 33 , wherein the drill assembly includes: 
 an outer housing being operably coupled to the moving mechanism for rotating the drill bit about the point of rotation and through that at least one of the first through apertures; and    a drive cable wherein one end of the drive cable is operably coupled to the drill bit, another end of the drive cable is operably coupled to the motor and a portion of the drive cable is disposed within the outer housing.    
     
     
         35 . The system of  claim 34 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 4 ×Ldci    
     
     
         36 . The system of  claim 34 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 3 ×Ldci    
     
     
         37 . The system of  claim 34 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 2 ×Ldci    
     
     
         38 . The system of  claim 33 , wherein the moving mechanism includes: 
 an arm member;    wherein a first end of the arm member is rotatably secured to the base so the arm member rotates about a fixed point;    wherein a portion of the arm member distal from the first end mechanically engages a portion of the drill assembly such that rotation of the arm member about the fixed point cause the drill bit to rotate about the point of rotation.    
     
     
         39 . The system of  claim 34 , wherein the arm member is configured and arranged so be removably rotatably secured to the base when the drill assembly is in a retracted position and configured and arranged so as not to be removable from the base when the drill assembly is in other operable positions.  
     
     
         40 . A system for forming a channel in one or more segments of a bone, a bony structure or adjacent vertebra of a spine, comprising a drilling apparatus and a motor, wherein said drilling apparatus includes: 
 a base including a plurality of first through apertures and a plurality of second through apertures, wherein the base is configured and arranged so portions thereof proximal an exit of each of the plurality of first through apertures is configured so the portions contact at least a portion of a surface of the one of the bone, bony structure or vertebra so to form an enclosed pathway from a top surface of the base to the surface of the one of the bone, bony structure or vertebra    a securing mechanism operably coupled to the base for securing the base to one of the bone, bony structure or vertebra, wherein the securing mechanism includes a plurality of members one end of which is configured for mechanical engagement with the one of the bone, bony structure or vertebra, and wherein one of the plurality of securing mechanisms is received in a respective one of the plurality of second through apertures;    a drill assembly including a drive cable and a drill bit, where one end of the drive cable is operably coupled to the drill bit and another end of the drive cable is operably coupled to the motor;    an arm member being rotatably secured to the base and mechanically coupled a portion of the drill assembly so as to allow rotation of the drill bit about a point of rotation and through at least one of the first through apertures.    
     
     
         41 . The system of  claim 40 , wherein each of the plurality of second through apertures is configured and arranged so a portion thereof mechanically engages a portion of the one of the securing mechanism received therein and wherein each of the plurality of second through apertures is configured and arranged so the one end of the securing mechanism configured for mechanical engagement with the one of the bone, bony structure or vertebra is disposed within confines of the second through aperture before causing the one end to mechanically engage.  
     
     
         42 . The system of  claim 40 , wherein the drill assembly includes: 
 an outer housing being operably coupled to the moving mechanism for rotating the drill bit about the point of rotation and through that at least one of the first through apertures, wherein a portion of the drive cable is disposed within the outer housing.    
     
     
         43 . The system of  claim 42 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 4 ×Ldci    
     
     
         44 . The system of  claim 42 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 3 ×Ldci    
     
     
         45 . The system of  claim 42 , wherein a length of the drive cable (Ldc) and a length of the drive cable portion within the outer housing (Ldci) satisfies the relation:  
           Ldc≦ 2 ×Ldci    
     
     
         46 . A method for gaining access to the intreverebral disc space, said method comprising the steps of. 
 positioning a frame assembly proximal the treatment or surgical site,    securing the frame assembly to adjacent segments of a bone or bony structure or adjacent vertebra; and    rotating a drill bit in fixed relation to the frame assembly to form a channel in the surface or sub-surface of the bone, bony structure or vertebra that communicates with the intreverebral disc space.    
     
     
         47 . A method for augmenting the nucleus of a disk between vertebral endplates of adjacent vertebral bodies of a spine, said method comprising the steps of: 
 creating an arcuate preformed aperture in one of the adjacent vertebral bodies that extends through the vertebral endplate of the spine and into the nucleus of the disk;    inserting nucleus augmentation material though the preformed aperture and into the nucleus of the disk; and    filling at least a portion of the preformed aperture with a non-compressible material.    
     
     
         48 . The nucleus augmentation method of  claim 47 , wherein said inserting nuclear augmentation material includes inserting a nucleus prosthetic through the preformed aperture and into the nucleus.  
     
     
         49 . The nucleus augmentation method of  claim 47 , further comprising the steps of: 
 inserting a annular closure mechanism through the preformed aperture; and    positioning the closure mechanism proximal the annulus defect, thereby closing the defect.    
     
     
         50 . The nucleus augmentation method of  claim 47 , wherein said creating an arcuate preformed aperture includes; 
 positioning a frame assembly proximal the adjacent vertebral bodies,    securing the frame assembly to the adjacent segments of the adjacent vertebral bodies; and    rotating a drill bit in fixed relation to the frame assembly to form the sub-surface channel in one of the adjacent vertebral bodies.    
     
     
         51 . The nucleus augmentation method of  claim 47 , wherein said creating an arcuate preformed aperture includes providing an apparatus for forming a channel or opening in adjacent segments of one of the vertebral bodies, wherein the provided apparatus includes: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit;    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage the adjacent vertebral bodies.    
     
     
         52 . A method for repairing the nucleus of a disk between vertebral endplates of adjacent vertebral bodies of a spine, said method comprising the steps of: 
 creating an arcuate preformed aperture in one of the adjacent vertebral bodies that extends through the vertebral endplate of the spine and into the nucleus of the disk;    removing at least some of the natural nucleus material;    inserting nucleus and/or annulus augmentation material though the preformed aperture and into the nucleus of the disk; and    filling at least a portion of the preformed aperture with a non-compressible material.    
     
     
         53 . The nucleus disc repair method of  claim 52 , wherein said inserting nuclear augmentation and/or annulus material includes inserting a nucleus prosthetic through the preformed aperture and into the nucleus.  
     
     
         54 . The nucleus disk repair method of  claim 52 , further comprising the steps of: 
 inserting a annular closure mechanism through the preformed aperture; and    positioning the closure mechanism proximal the annulus defect, thereby closing the defect.    
     
     
         55 . The nucleus disk repair augmentation method of  claim 52 , wherein said creating an arcuate preformed aperture includes; 
 positioning a frame assembly proximal the adjacent vertebral bodies,    securing the frame assembly to the adjacent segments of the adjacent vertebral bodies; and    rotating a drill bit in fixed relation to the frame assembly to form the sub-surface channel in one of the adjacent vertebral bodies.    
     
     
         56 . The nucleus disk repair method of  claim 52 , wherein said creating an arcuate preformed aperture includes providing an apparatus for forming a channel or opening in adjacent segments of one of the vertebral bodies, wherein the provided apparatus includes: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit;    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage the adjacent vertebral bodies.    
     
     
         57 . A method for placement of a disk between vertebral endplates of adjacent vertebral bodies of a spine, said method comprising the steps of: 
 creating an arcuate preformed aperture in one of the adjacent vertebral bodies that extends through the vertebral endplate of the spine and into the nucleus of the disk;    removing at least some of the natural nucleus and annulus material;    inserting an artificial disk though the preformed aperture and into the intravertebral disk space; and    filling at least a portion of the preformed aperture with a non-compressible material.    
     
     
         58 . The nucleus disk repair augmentation method of  claim 57 , wherein said creating an arcuate preformed aperture includes; 
 positioning a frame assembly proximal the adjacent vertebral bodies,    securing the frame assembly to the adjacent segments of the adjacent vertebral bodies; and    rotating a drill bit in fixed relation to the frame assembly to form the sub-surface channel in one of the adjacent vertebral bodies.    
     
     
         59 . The nucleus disk repair method of  claim 57 , wherein said creating an arcuate preformed aperture includes providing an apparatus for forming a channel or opening in adjacent segments of one of the vertebral bodies, wherein the provided apparatus includes: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit;    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage the adjacent vertebral bodies.    
     
     
         60 . A method for repairing the annulus of a disk between vertebral endplates of adjacent vertebral bodies of a spine, said method comprising the steps of: 
 creating an arcuate preformed aperture in one of the adjacent vertebral bodies that extends through the vertebral endplate of the spine and into the nucleus of the disk;    removing at least some of the natural nucleus and annulus material;    inserting an annulus repair device though the preformed aperture and into the intravertebral disk space;    inserting nucleus and/or annulus augmentation material though the preformed aperture and into the nucleus of the disk; and    filling at least a portion of the preformed aperture with a non-compressible material.    
     
     
         61 . The nucleus disc repair method of  claim 60 , wherein said inserting nuclear augmentation and/or annulus material includes inserting a nucleus prosthetic through the preformed aperture and into the nucleus.  
     
     
         62 . The nucleus disk repair method of  claim 60 , further comprising the steps of: 
 positioning the annular repair device proximal the annulus defect, thereby closing the defect.    
     
     
         63 . The nucleus disk repair augmentation method of  claim 60 , wherein said creating an arcuate preformed aperture includes; 
 positioning a frame assembly proximal the adjacent vertebral bodies,    securing the frame assembly to the adjacent segments of the adjacent vertebral bodies; and    rotating a drill bit in fixed relation to the frame assembly to form the sub-surface channel in one of the adjacent vertebral bodies.    
     
     
         64 . The nucleus disk repair method of  claim 60 , wherein said creating an arcuate preformed aperture includes providing an apparatus for forming a channel or opening in adjacent segments of one of the vertebral bodies, wherein the provided apparatus includes: 
 a base including a plurality of first through apertures;    a drill assembly including a drill bit;    a moving mechanism operably coupled to each of the base and the drill assembly for rotating the drill bit about a point of rotation and through at least one of the first through apertures;    a securing mechanism operably coupled to the base for securing the base, the securing mechanism be configured and arranged so as to mechanical engage the adjacent vertebral bodies.

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