Method and apparatus for manipulating material in the spine

• US 7,914,535 B2
• Filed: 02/06/2009
• Issued: 03/29/2011
• Est. Priority Date: 10/23/2003
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Cragg, Andrew H, Ainsworth, Stephen D, Dickhudt, Eugene A, Assell, Robert L
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Yang; Andrew
• Application Number:
  US12/367,397
• Publication Number:
  US 20090143809A1
• Time in Patent Office: 781 Days
• Field of Search: 606/279, 606/80, 606/83, 606/914, 606/86.A, 606/246, 606/79, 606/81, 606/93, 606/86, 83875-877
• US Class Current: 606/79
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7074 Tools specially adapted for spinal fixation operations other than for bone removal or filler handling A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39
• CPC Class Codes: A61B 17/8615 at the central region of the screw head
• CPC Class Codes: A61B 17/888 the driver bit acting on the central region of the screw head
• CPC Class Codes: A61B 17/8888 at its central region
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element

Abstract

Disclosed are surgical tools, tool sets and methods for percutaneously accessing and preparing treatment sites within the spine for subsequent treatment procedures. The treatment site may be an inter-vertebral motion segments in the lumbar and sacral regions of the spine. The tool set may comprise introducer tools and bone dilators for accessing and tapping into a targeted site, such as, for example, the anterior surface of the S1 vertebral body. The tool set may also comprise cutters and extractors for preparing the treatment site for subsequent treatment procedures. The tool set may additionally comprise a bone graft inserter, an exchange system, and/or a temporary distraction tool for further preparing the treatment site for subsequent treatment procedures.

Claims

1. A method of preparing the spine for a subsequent procedure, comprising the steps of:

identifying an access site on the anterior surface of the spine;

forming a lumen from the access site into the sacrum, through at least one vertebral body and into at least one intervertebral disc, wherein the intervertebral disc comprises a disc nucleus surrounded by a disc annulus;

introducing a cutter apparatus through the lumen and into the intervertebral disc, the cutter comprising an axially elongated rotatable shaft having at least one radially outwardly extendable cutter blade; and

rotating the cutter blade to disrupt nucleus material,

wherein the cutter further comprises a cutter sheath having a sheath lumen extending between a sheath proximal end and a sheath distal end,

wherein the cutter blade is coupled to the shaft, the cutter blade having an extended configuration and a retracted configuration, the extended configuration comprising the cutter blade extending generally transverse to the longitudinal axis away from the rotatable sheath, the retracted configuration comprising the cutter blade extending substantially parallel the longitudinal axis inside the sheath,

wherein the cutter blade further comprises an elongate ribbon with a first end and a second end coupled to the shaft wherein the ribbon doubles back on itself to form a closed loop such that a bend is positioned between the first and second end.

2. The method as in claim 1, additionally comprising the step of removing the nucleus cutter tool and introducing a nucleus removal tool.

3. The method as in claim 2, further comprising the step of rotating the nucleus removal tool to engage disrupted nucleus material, and removing the disrupted nucleus material.

4. The method as in claim 1, wherein the cutter blade extends radially outwardly from an axis of rotation, and is inclined in a distal direction.

5. The method as in claim 1, wherein the cutter blade inclines radially outwardly from an axis of rotation in a proximal direction.

6. The method as in claim 1, the cutter further adapted to extend through a trans-sacral axial bore along an axis extending cephalad from a sacral vertebral body through at least one vertebral body end plate cephalad of the S-1 vertebral body.

7. The method as in claim 6, the axially elongated rotatable shaft extending along a longitudinal axis between a shaft proximal end and a shaft distal end, at least a portion of the shaft moveably positioned within the sheath lumen.

8. The method as in claim 6, wherein the cutter blade is coupled to the shaft proximate the shaft distal end, and the ribbon further comprises a distal segment and a proximal segment, the first end and second end extending generally parallel to the longitudinal axis of the shaft, the distal segment and the proximal segment extending generally parallel to each other and being connected at the bend, the bend being located on the ribbon proximate a maximum transverse distance away from the longitudinal axis of the rotatable shaft in the extended configuration.

9. The method as in claim 8, further comprising moving the sheath axially along the longitudinal axis of the shaft to actuate the cutter blade between the extended configuration and the retracted configuration.

10. The method as in claim 8, the cutter blade further comprising:

a first side surface on the cutter blade for positioning adjacent a vertebral end plate when the cutter blade is oriented generally transverse to the longitudinal axis in the extended configuration;

a second side surface on the cutter blade, separated from the first side surface by a blade thickness;

a first edge on the cutter blade;

a second edge on the cutter blade; and

at least one cutting edge on at least one of the first and second edges.

11. The method as in claim 10, wherein the cutting edge is coplanar with the first side surface.

12. The method as in claim 10, wherein the cutting edge is coplanar with the second side surface.

13. The method as in claim 10, wherein the cutting edge is centered on a plane positioned in-between the first side surface and the second side surface.

14. The method as in claim 10, the cutter blade comprising a first cutting edge on the first edge and a second cutting edge on the second edge.

15. A method of preparing the spine for a subsequent procedure, comprising the steps of:

identifying an access site on the anterior surface of the spine;

forming a lumen from the access site into the sacrum, through at least one vertebral body and into at least one intervertebral disc, wherein the intervertebral disc comprises a disc nucleus surrounded by a disc annulus;

introducing a cutter apparatus through the lumen and into the intervertebral disc, the cutter comprising an axially elongated rotatable shaft having at least one radially outwardly extendable cutter blade; and

rotating the cutter blade to disrupt nucleus material,

wherein the cutter is further adapted to extend through a trans-sacral axial bore along an axis extending cephalad from a sacral vertebral body through at least one vertebral body end plate cephalad of the S-1 vertebral body, the cutter further comprising a cutter sheath having a sheath lumen extending between a sheath proximal end and a sheath distal end,

wherein the cutter blade is coupled to the shaft proximate the shaft distal end, the cutter blade having an extended configuration and a retracted configuration, the extended configuration comprising the cutter blade extending generally transverse to the longitudinal axis away from the sheath, the retracted configuration comprising the cutter blade extending substantially parallel the longitudinal axis inside the sheath,

wherein the cutter blade further comprises;

a first side surface on the cutter blade for positioning adjacent a vertebral end plate when the cutter blade is oriented generally transverse to the longitudinal axis in the extended configuration;

a second side surface on the cutter blade, separated from the first side surface by a blade thickness;

a first edge on the cutter blade;

a second edge on the cutter blade; and

at least one cutting edge on at least one of the first and second edges,

wherein the cutter blade further comprises an elongate ribbon that comprises a first end, a distal segment, a bend, a proximal segment and a second end, the first end and second end extending generally parallel to the longitudinal axis of the shaft, the distal segment and the proximal segment extending generally parallel to each other and being connected at the bend, at which the ribbon folds back upon itself such that the second side surface generally opposes itself, the bend being located on the ribbon proximate a maximum transverse distance away from the longitudinal axis of the shaft in the extended configuration.

16. The method as in claim 15, wherein the elongate ribbon inclines radially outwardly from an axis of rotation in the extended configuration.

17. The method as in claim 15, wherein the first end and second end include an attachment structure for attachment to a rotatable drive shaft.

18. The method as in claim 17, wherein the attachment structure comprises an aperture.

19. The method as in claim 17, wherein both the first end and the second end are adapted for connection to the rotatable drive shaft.

20. A method of preparing the spine for a subsequent procedure, comprising the steps of:

identifying an access site on the anterior surface of the spine;

forming a lumen from the access site into the sacrum, through at least one vertebral body and into at least one intervertebral disc, wherein the intervertebral disc comprises a disc nucleus surrounded by a disc annulus;

introducing a cutter apparatus through the lumen and into the intervertebral disc, the cutter comprising a cutter sheath and an axially elongated rotatable shaft having at least one radially outwardly extendable cutter blade; and

rotating the cutter blade to disrupt nucleus material;

wherein the cutter sheath comprises a sheath lumen extending between a sheath proximal end and a sheath distal end;

the shaft extends along a longitudinal axis between a shaft proximal end and a shaft distal end, at least a portion of the shaft moveably positioned within the sheath lumen;

the cutter blade comprising an elongate ribbon comprising;

a first end, a distal segment, a bend, a proximal segment and a second end, the distal segment and the proximal segment being connected at the bend, at which the ribbon folds back upon itself such that the second side surface generally opposes itself;

a first side surface for positioning adjacent a vertebral end plate when the blade is oriented generally transverse to the longitudinal axis;

a second side surface separated from the first side surface by a blade thickness;

at least one cutting edge;

wherein the distal segment comprises a first attachment structure secured proximate the shaft distal end and the proximal segment comprises a second attachment structure secured proximate the shaft distal end, wherein one of the first and the second attachment structures comprises a slot and the other of the first and the second attachment structures comprises a hole, the first attachment structure and the second attachment structure are secured to the shaft distal end with a pin.