Access kits for enabling axial access and procedures in the spine

• US 7,799,033 B2
• Filed: 11/19/2007
• Issued: 09/21/2010
• Est. Priority Date: 10/23/2003
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Assell, Robert L., Cragg, Andrew H., Ainsworth, Stephen D., Dickhudt, Eugene A.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): WOODALL, NICHOLAS W
• Application Number:
  US11/942,488
• Publication Number:
  US 20080071282A1
• Time in Patent Office: 1,037 Days
• Field of Search: 606/86.R, 606/96, 606/101, 606/104
• US Class Current: 606/86.00R
• 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. An access kit for enabling access to a site in a bone, comprising:

a guide pin introducer comprising an introducer handle and a rigid elongate introducer tube extending from the introducer handle, the introducer tube having a introducer tube length extending between an introducer tube proximal end and an introducer tube distal end, the introducer tube length configured to extend from a skin incision near the paracoccygeal region through the pre-sacral space to an anterior target point on a sacral vertebral body, the guide pin introducer defining a lumen having a lumen diameter;

a stylet;

a guide pin slideably positionable within the lumen of the guide pin introducer, comprising a solid elongate rod having a rod outer diameter less than the guide pin introducer lumen diameter, a rod length extending between a rod proximal end and a rod distal end, the rod length being greater than the introducer tube length; and

removable a guide pin handle releasably attached to the rod proximal end and configured to allow the guide pin introducer to be proximally withdrawn over the rod proximal end when the guide pin handle is removed from the rod proximal end.

2. The access kit as in claim 1, further comprising a guide pin extension comprising:

a guide pin extension diameter no larger than the rod outer diameter, configured to be slideably positionable within the lumen of the guide pin introducer for removal of the guide pin introducer tube over the guide pin extension; and

a releasable coupling on the proximal end of the solid elongate rod of the guide pin releasably connected to the guide pin extension.

3. The access kit as in claim 1, further comprising at least one bone dilator comprising a first cannulated rod, having an outer diameter configured for insertion into a bore through bone, a proximal end and a distal end.

4. The access kit as in claim 3, further comprising a second cannulated rod, having an elongate body and a radially-extending handle on a proximal end of the elongate body, the elongate body comprising an outer diameter greater than the outer diameter of the first cannulated rod, the elongate body configured for enlarging the bore.

5. The access kit as in claim 4, further comprising at least one bone dilator with a removable sheath wherein at least one cannulated rod is removably positionable within the tubular sheath.

6. The access kit as in claim 3, further comprising at least one cannulated slap hammer, for reciprocal movement over a guide pin extending through the first cannulated rod and slap hammer.

7. The access kit as in claim 1, further comprising at least one twist drill.

8. The access kit as in claim 4, the second cannulated rod having a greater lumen diameter than the outer diameter of the first cannulated rod, the second cannulated rod configured to be insertable over the first cannulated rod into the bore.

9. The access kit as in claim 4, further comprising at least a third cannulated rod, having a greater diameter than the second cannulated rod.

10. The access kit as in claim 5, further comprising a first retention structure on the sheath and a second, complementary retention structure on the at least one cannulated rod, to releasably attach the sheath to the at least one cannulated rod.

11. The access kit as in claim 5, further comprising a comprising a lock for releasably retaining the sheath on the at least one cannulated rod.

12. The access kit as in claim 1, further comprising a spinal implant comprising:

a distal portion configured for distal rotational engagement with a superior vertebral body cephalad to a disc space;

a proximal portion configured for proximal rotational engagement with an inferior vertebral body caudal to the disc space, wherein the distal rotational engagement and proximal rotational engagement to increase a distance between the superior and inferior vertebral bodies; and

an intermediate portion between the distal and proximal portion.