Methods and apparatus for forming shaped axial bores through spinal vertebrae

• US 7,569,056 B2
• Filed: 05/25/2004
• Issued: 08/04/2009
• Est. Priority Date: 02/16/2000
• Status: Expired due to Fees

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Cragg, Andrew H., Kagan, Jonathan
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/853,476
• Publication Number:
  US 20040220577A1
• Time in Patent Office: 1,897 Days
• Field of Search: 606/61, 606/79, 606/80, 606/96, 606/113, 606/159, 606/170, 606/180, 408/127, 407 36- 38
• US Class Current: 606/79
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/2821 : Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30566 : Helical springs
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/3097 : using laser
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61N 5/1027 : Interstitial radiation therapy
• CPC Class Codes: Y10S 606/914 : Toolkit for installing or removing spinal positioner or stabilizer

Abstract

One or more shaped axial bore extending from an accessed posterior or anterior target point are formed in the cephalad direction through vertebral bodies and intervening discs, if present, in general alignment with a visualized, trans-sacral axial instrumentation/fusion (TASIF) line in a minimally invasive, low trauma, manner. An anterior axial instrumentation/fusion line (AAIFL) or a posterior axial instrumentation/fusion line (PAIFL) that extends from the anterior or posterior target point, respectively, in the cephalad direction following the spinal curvature through one or more vertebral body is visualized by radiographic or fluoroscopic equipment. Preferably, curved anterior or posterior TASIF axial bores are formed in axial or parallel or diverging alignment with the visualized AAIFL or PAIFL, respectively, employing bore forming tools that can be manipulated from proximal portions thereof that are located outside the patient'"'"'s body to adjust the curvature of the anterior or posterior TASIF axial bores as they are formed in the cephalad direction. Further bore enlarging tools are employed to enlarge one or more selected section of the anterior or posterior TASIF axial bore(s), e.g., the cephalad bore end or a disc space, so as to provide a recess therein that can be employed for various purposes, e.g., to provide anchoring surfaces for spinal implants inserted into the anterior or posterior TASIF axial bore(s).

Claims

1. Apparatus for providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect from an anterior or posterior sacral target point of a sacral vertebra in alignment with a visualized, axial instrumentation/fusion line extending in the axial aspect through the series of adjacent vertebral bodies, wherein the axial aspect is curved in the posterior-anterior plane due to curvature of the spinal column, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising:

a controllable boring device configured for boring a curved trans-sacral axial bore from the accessed sacral target point in alignment with the axial instrumentation/fusion line cephalad and axially through the vertebral bodies of the series of adjacent vertebrae and any intervertebral spinal discs; and

a bore enlarging tool sized to fit within the curved axial bore, the tool adapted to be inserted from the accessed sacral target point to a selected location along the curved axial bore, the tool operable to enlarge a section of the curved axial bore to form at least one recess therein;

wherein the controllable boring device comprises an elongated drill shaft assembly comprising;

a drill bit attached to a flexible drive shaft;

a sheath with an inner lumen for receiving the flexible drive shaft, the sheath comprising a distal segment and one or more radially offset tip deflection wire lumens; and

one or more tip deflection wires disposed in the one or more radially offset tip deflection wire lumens for imparting a desired curvature in the distal segment of the sheath;

wherein the bore enlarging tool comprises a counterboring tool assembly comprising;

an elongate drive shaft extending between a shaft proximal end and a shaft distal end, the shaft having a shaft lumen;

a cutting head mounted to the shaft distal end, the cutting head comprising deployment/retraction means for deploying the cutting head from a retracted locked position to a deployed locked position and for retracting the cutting head from the deployed locked position to the retracted locked position, the cuffing head capable of cuffing away bone or intervertebral disc material while in the deployed locked position; and

rotating means for rotating the cutting head from the shaft distal end to cut away vertebral bone or disc material.

2. The apparatus of claim 1, wherein the retracted locked position comprises a radially retracted locked position.

3. The apparatus of claim 1, wherein the retracted locked position comprises an axially retracted locked position.

4. The apparatus of claim 1, wherein the deployed locked position comprises a radially deployed locked position.

5. The apparatus of claim 1, wherein the deployed locked position comprises an axially deployed locked position.

6. The apparatus of claim 1, wherein the rotating means comprises a cutting head motor attached to the shaft proximal end.

7. The apparatus of claim 1, wherein the cutting head further comprises:

a thin, flexible, tubular member extending distally from a cutting head proximal end located at the shaft distal end to a cutting head distal end; and

an elongated cutting wire extending between a cutting wire proximal end and a cutting wire distal end, the cutting wire proximal and distal ends extending into the flexible tubular member.

8. The apparatus of claim 1, wherein the cutting head further comprises at least one abrading cable attached to the shaft distal end.

9. The apparatus of claim 8, wherein the at least one cable is formed of a length of woven or braided metal or fabric tending to spring outward when unrestrained.

10. The apparatus of claim 8, wherein the bore counterboring tool assembly further comprises an elongated, flexible, restraining sheath having a sheath lumen extending from a sheath proximal end to a sheath distal end through which the drive shaft extends and within which the at least one abrading cable is enclosed in a restrained configuration during passage through the curved axial bore.

11. Apparatus for providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect from an anterior or posterior sacral target point of a sacral vertebra in alignment with a visualized, axial instrumentation/fusion line extending in the axial aspect through the series of adjacent vertebral bodies, wherein the axial aspect is curved in the posterior-anterior plane due to curvature of the spinal column, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising:

a controllable boring device configured for boring a curved, trans-sacral axial bore from the accessed sacral target point in alignment with the axial instrumentation/fusion line cephalad and axially through the vertebral bodies of the series of adjacent vertebrae and any intervertebral spinal discs; and

a bore enlarging tool sized to fit within the curved axial bore, the tool adapted to be inserted from the accessed sacral target point to a selected location along the curved axial bore, the tool operable to enlarge a section of the curved axial bore to form at least one recess therein;

wherein the controllable boring device comprises an elongated drill shaft assembly comprising;

a flexible drive shaft;

an exposed drill bit attached to a distal end of the flexible drive shaft; and

a pre-curved inner sheath, and an outer sheath configured to move over the pre-curved inner sheath;

wherein the bore enlarging tool comprises a counterboring tool assembly comprising;

an elongate drive shaft extending between a shaft proximal end and a shaft distal end, the shaft having a shaft lumen;

a cutting head mounted to the shaft distal end, the cutting head comprising deployment/retraction means for deploying the cutting head from a retracted locked position to a deployed locked position and for retracting the cutting head from the deployed locked position to the retracted locked position, the cutting head capable of cuffing away bone or intervertebral disc material while in the deployed locked position; and

rotating means for rotating the cutting head from the shaft distal end to cut away vertebral bone or disc material.

12. The apparatus of claim 11, wherein the retracted locked position comprises a radially retracted locked position.

13. The apparatus of claim 11, wherein the retracted locked position comprises an axially retracted locked position.

14. The apparatus of claim 11, wherein the deployed locked position comprises a radially deployed locked position.

15. The apparatus of claim 11, wherein the deployed locked position comprises an axially deployed locked position.

16. The apparatus of claim 11, wherein the rotating means comprises a cutting head motor attached to the shaft proximal end.

17. Apparatus for providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect from an anterior or posterior sacral target point of a sacral vertebra in alignment with a visualized, axial instrumentation/fusion line extending in the axial aspect through the series of adjacent vertebral bodies, wherein the axial aspect is curved in the posterior-anterior plane due to curvature of the spinal column, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising:

a controllable boring device configured for boring a curved, trans-sacral axial bore from the accessed sacral target point in alignment with the axial instrumentation/fusion line cephalad and axially though the vertebral bodies of the series of adjacent vertebrae and any intervertebral spinal discs; and

a bore enlarging tool sized to fit within the curved axial bore, the tool adapted to be inserted from the accessed sacral target point to a selected location along the curved axial bore, the tool operable to enlarge a section of the curved axial bore to form at least one recess therein;

wherein the controllable boring device comprises;

a flexible drive shaft;

a drill bit attached to a distal end of the flexible drive shaft;

a sheath with an inner lumen for receiving the flexible drive shaft, the sheath comprising a distal segment and one or more radially offset tip deflection wire lumens; and

one or more tip deflection wires disposed in the one or more radially offset tip deflection wire lumens for imparting a desired curvature in the distal segment of the sheath.

18. Apparatus for providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect from an anterior or posterior sacral target point of a sacral vertebra in alignment with a visualized, axial instrumentation/fusion line extending in the axial aspect though the series of adjacent vertebral bodies, wherein the axial aspect is curved in the posterior-anterior plane due to curvature of the spinal column, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising:

a controllable boring device configured for boring a curved, trans-sacral axial bore from the accessed sacral target point in alignment with the axial instrumentation/fusion line cephalad and axially though the vertebral bodies of the series of adjacent vertebrae and any intervertebral spinal discs; and

a bore enlarging tool sized to fit within the curved axial bore, the tool adapted to be inserted from the accessed sacral target point to a selected location along the curved axial bore, the tool operable to enlarge a section of the curved axial bore to form at least one recess therein;

wherein the controllable boring device comprises;

a flexible drive shaft;

a drill bit attached to a distal end of the flexible drive shaft;

a pre-curved sheath with an inner lumen for receiving the flexible drive shaft and an outer sheath configured to move over the pre-curved sheath.

19. Apparatus for providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect from an anterior or posterior sacral target point of a sacral vertebra in alignment with a visualized, axial instrumentation/fusion line extending in the axial aspect through the series of adjacent vertebral bodies, wherein the axial aspect is curved in the posterior-anterior plane due to curvature of the spinal column, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising:

a controllable boring device configured for boring a curved, trans-sacral axial bore from the accessed sacral target point in alignment with the axial instrumentation/fusion line cephalad and axially through the vertebral bodies of the series of adjacent vertebrae and any intervertebral spinal discs; and

a bore enlarging tool sized to fit within the curved axial bore, the tool adapted to be inserted from the accessed sacral target point to a selected location along the curved axial bore, the tool operable to enlarge a section of the curved axial bore to form at least one recess therein;

wherein the controllable boring device comprises;

a flexible drive shaft;

a drill bit attached to a distal end of the flexible drive shaft; and

a sheath with an inner lumen for receiving the flexible drive shaft, wherein the sheath comprises a sheath longitudinal axis, the inner lumen being radially offset from the sheath longitudinal axis to locate the drill bit offset from the sheath longitudinal axis.