Methods and Surgical Kits for Minimally-Invasive Facet Joint Fusion

• US 20090234397A1
• Filed: 03/13/2009
• Published: 09/17/2009
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: minSURG International Incorporated
• Original Assignee: minSURG International Incorporated
• Inventors: Petersen, David A.
• Granted Patent: US 7,837,713 B2
• Time in Patent Office: Days
• US Class Current: 606/86.R
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 2017/0042 with special provisions for gripping
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30822 Circumferential grooves
• 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 2002/30859 having threaded portions of different pitches
• CPC Class Codes: A61F 2002/30881 Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue

Abstract

Disclosed herein are methods and surgical kits that can be used to fuse facet joints via a minimally invasive procedure (including an arthroscopic or percutaneous procedure). An exemplary method includes creating an incision; locating a facet joint with a distal end of a pin; sliding a substantially hollow drill guide over said pin wherein said drill guide comprises a proximal end, a distal end; removing said pin from within said drill guide; inserting a drill bit into said drill guide; drilling a hole into a bone of said facet joint; removing said drill bit; inserting a facet joint bone plug into said hole using a bone plug inserter having a raised portion at or near is proximal end, wherein said raised portion prevents over-insertion of said bone plug; and removing said drill guide.

Claims

1. A method comprising:

creating an incision;

locating a facet joint with a distal end of a pin wherein said facet joint is formed between two opposing bones and said pin comprises said distal end and a proximal end;

sliding a substantially hollow drill guide over said pin wherein said drill guide comprises a proximal end, a distal end, and a handle wherein said handle is nearer to the proximal end of the drill guide than to the distal end, said distal end comprises opposed teeth with a length longer than about 3 mm that can be inserted into said facet joint;

removing said pin from within said drill guide;

inserting a drill bit into said drill guide;

drilling a hole into a bone of said facet joint;

removing said drill bit;

inserting a facet joint bone plug into said hole using a bone plug inserter having a raised portion at or near is proximal end, wherein said raised portion prevents over-insertion of said bone plug; and

removing said drill guide.

2. A method according to claim 1 wherein said opposed teeth are about 3 mm to about 20 mm in length.

3. A method according to claim 2 wherein said opposed teeth are about 10 mm in length.

4. A method according to claim 1 wherein said opposed teeth comprise one or more selected from the group consisting of a straight portion and a tapered portion.

5. A method according to claim 4 wherein said straight portion is about 2 mm to about 10 mm in width.

6. A method according to claim 5 wherein said straight portion is about 3 mm in width.

7. A method according to claim 4 wherein said tapered portion tapers at an angle between about 1 degree to just under about 90 degrees.

8. A method according to claim 4 wherein said tapered portion tapers from a starting width of about 3 mm to a range from just below a width of 3 mm to a width of about 0.1 mm.

9. A method according to claim 7 wherein said taper is about an angle of 45 degrees.

10. A method according to claim 4, wherein said tapered portion comprises more than one taper.

11. A method according to claim 1 wherein said opposed teeth comprise at the distal end of said teeth, one or more selected from the group consisting of a flat edge, a sharp point and a rounded off edge.

12. A method according to claim 4 wherein said teeth comprise a straight portion and a tapered portion wherein said straight portion is about 3 mm in length and at the proximal end of said teeth, and said tapered portion is about 7 mm in length and at the distal end of said teeth.

13. A method according to claim 1 wherein said distal end of said drill guide comprises a plurality of teeth, wherein the plurality of teeth comprises two opposed teeth and one or more smaller teeth disposed between said two opposed teeth.

14. A method according to claim 1, wherein one of said opposed teeth comprises a straight portion with a first end and a second end, a tapered portion with a first end and a second end, said first end of said tapered portion being disposed at said second end of said straight portion, and an angled portion with a first end and a flat second end, said first end of said angled portion being disposed at said second end of said tapered portion, wherein said straight portion is about 3 mm in length and about 3 mm in width, said tapered portion and said angled portion, together, is about 7 mm in length, said tapered portion comprises a slight taper from said first end of said tapered portion to said second end of said tapered portion until said tapered portion is about 2.25 mm in width, said angled portion comprises a second taper at an angle of about 45 degrees, thereby providing a more extreme narrowing at said flat end of said angled portion.

15. A method comprising:

creating an incision;

locating a facet joint with a distal end of a pin wherein said facet joint is formed between two opposing bones and said pin comprises said distal end and a proximal end;

sliding a substantially hollow spatula over said pin wherein said spatula comprises a proximal end, a distal end and a body wherein said distal end comprises a planar wedge, and said body comprises a longitudinal marking that can indicate the orientation of said planar wedge and one or more transverse guide markings near the proximal end of said spatula;

adjusting the rotation of said planar wedge until said planar wedge enters said facet joint;

sliding a substantially hollow drill guide over said spatula wherein said drill guide comprises a proximal end, a distal end, and a handle wherein said handle is nearer to the proximal end of the drill guide than to the distal end, said distal end comprises two opposed teeth that can be inserted into said facet joint and a marking on said proximal end that can be aligned with said longitudinal marking on said spatula thereby allowing the orientation of said opposed teeth to be in approximately the same plane defined by said planar wedge;

inserting said drill guide into said incision until said proximal end of the drill guide aligns with said first transverse guide mark on said spatula;

aligning said longitudinal marking on said spatula with said marking on said drill guide thereby aligning said opposed teeth in approximately the same plane defined by said planar wedge;

further inserting said drill guide into said incision and using said one or more transverse guide markings to indicate the depth of the insertion of said teeth of said drill guide into said facet joint;

removing said spatula from within said drill guide;

inserting a drill bit into said drill guide;

drilling a hole into a bone of said facet joint;

removing said drill bit;

inserting a facet joint bone plug into said hole using a bone plug inserter having a raised portion at or near its proximal end, wherein said raised portion prevents over-insertion of said bone plug; and

removing said drill guide.

16. A method according to claim 15 wherein said spatula comprises between one transverse guide mark to five transverse guide marks.

17. A method according to claim 16 wherein said spatula comprises three transverse guide marks.

18. A method according to claim 16 wherein said transverse guide marks are equidistant from each other.

19. A method according to claim 16 wherein said transverse guide marks are about 1 mm to about 20 mm apart from each other.

20. A method according to claim 19 wherein said transverse guide marks are about 10 mm apart from each other.

21. A method according to claim 17 wherein a first transverse guide mark is near the proximal end of said spatula, a second transverse guide mark that is further from the proximal end of said spatula than said first transverse guide mark, and a third transverse guide mark that is further from the proximal end of said spatula than said second transverse guide mark.

22. A method according to claim 21 wherein the step of inserting said drill guide into said incision further comprises inserting said drill guide into said incision until said proximal end of the drill guide aligns with said first transverse guide mark on said spatula;

aligning said longitudinal marking on said spatula with said marking on said drill guide thereby aligning said opposed teeth in approximately the same plane defined by said planar wedge;

further inserting said drill guide into said incision until said proximal end of the drill guide aligns with said second transverse guide mark on said spatula, thereby indicating that said distal end of said drill guide is at the entry level of said facet joint or closely approaching it;

further aligning said longitudinal marking on said spatula with said marking on said drill guide thereby assuring said opposed teeth are in approximately the same plane defined by said planar wedge; and

further inserting said drill guide into said incision until said proximal end of the drill guide aligns with said third transverse guide mark on said spatula, thereby indicating that said opposed teeth are fully inserted or approximately fully inserted into said facet joint.

23. A method comprising:

creating an incision;

locating a facet joint with a distal end of a pin wherein said facet joint is formed between two opposing bones and said pin comprises said distal end and a proximal end;

sliding a substantially hollow spatula over said pin wherein said spatula comprises a proximal end, a distal end and a body wherein said distal end comprises a planar wedge, and said body comprises a longitudinal marking that can indicate the orientation of said planar wedge, and one or more transverse guide markings near the proximal end of said spatula;

adjusting the rotation of said planar wedge until said planar wedge enters said facet joint;

sliding a substantially hollow drill guide over said spatula wherein said drill guide comprises a proximal end, a distal end wherein said distal end comprises opposed teeth with a length longer than about 3 mm that can be inserted into said facet joint, a handle wherein said handle is nearer to the proximal end of the drill guide than to the distal end, and a marking on said proximal end that can be aligned with said longitudinal marking on said spatula thereby allowing the orientation of said opposed teeth to be in approximately the same plane defined by said planar wedge, and;

inserting said drill guide into said incision until said proximal end of the drill guide aligns with said first transverse guide mark on said spatula;

aligning said longitudinal marking on said spatula with said marking on said drill guide thereby aligning said opposed teeth in approximately the same plane defined by said planar wedge;

further inserting said drill guide into said incision until said proximal end of the drill guide aligns with said second transverse guide mark on said spatula, thereby indicating that said distal end of said drill guide is at the entry level of said facet joint or closely approaching it;

further aligning said longitudinal marking on said spatula with said marking on said drill guide thereby assuring said opposed teeth are in approximately the same plane defined by said planar wedge;

further inserting said drill guide into said incision and using said one or more transverse guide markings to indicate the depth of the insertion of said teeth of said drill guide into said facet joint;

removing said spatula from within said drill guide;

inserting a drill bit into said drill guide;

drilling a hole into a bone of said facet joint;

removing said drill bit;

inserting a facet joint bone plug into said hole using a bone plug inserter having a raised portion at or near its proximal end, wherein said raised portion prevents over-insertion of said bone plug;

removing said drill guide; and

closing said incision wherein said pin has also been removed prior to said closing of said incision.

24. A method according to claim 23 wherein said opposed teeth are a length of about 10 mm.

25. A method according to claim 23 wherein said opposed teeth comprise a straight portion and a tapered portion wherein said straight portion is about 3 mm in length and at the proximal end of said teeth, and said tapered portion is about 7 mm in length and at the distal end of said teeth.

26. A method according to claim 23, wherein one of said opposed teeth comprises a straight portion with a first end and a second end, a tapered portion with a first end and a second end, said first end of said tapered portion being disposed at said second end of said straight portion, and an angled portion with a first end and a flat second end, said first end of said angled portion being disposed at said second end of said tapered portion, wherein said straight portion is about 3 mm in length and about 3 mm in width, said tapered portion and said angled portion, together, is about 7 mm in length, said tapered portion comprises a slight taper from said first end of said tapered portion to said second end of said tapered portion until said tapered portion is about 2.25 mm in width, said angled portion comprises a second taper at an angle of about 45 degrees, thereby providing a more extreme narrowing at said flat end of said angled portion.

27. A method according to claim 23 wherein said spatula comprises three transverse guide marks.

28. A method according to claim 27 wherein said transverse guide marks are about 10 mm apart from each other.

29. A method according to claim 27 wherein a first transverse guide mark is near the proximal end of said spatula, a second transverse guide mark that is further from the proximal end of said spatula than said first transverse guide mark, and a third transverse guide mark that is further from the proximal end of said spatula than said second transverse guide mark.

30. A method according to claim 29 wherein the step of inserting said drill guide into said incision further comprises inserting said drill guide into said incision until said proximal end of the drill guide aligns with said first transverse guide mark on said spatula;

aligning said longitudinal marking on said spatula with said marking on said drill guide thereby aligning said opposed teeth in approximately the same plane defined by said planar wedge;

further inserting said drill guide into said incision until said proximal end of the drill guide aligns with said second transverse guide mark on said spatula, thereby indicating that said distal end of said drill guide is at the entry level of said facet joint or closely approaching it;

further aligning said longitudinal marking on said spatula with said marking on said drill guide thereby assuring said opposed teeth are in approximately the same plane defined by said planar wedge; and

further inserting said drill guide into said incision until said proximal end of the drill guide aligns with said third transverse guide mark on said spatula, thereby indicating that said opposed teeth are fully inserted or approximately fully inserted into said facet joint.

31. A method according to claim 23 wherein said distal end of said drill guide comprises a plurality of teeth, wherein the plurality of teeth comprises two opposed teeth and one or more smaller teeth disposed between said two opposed teeth.

32. A method according to claim 23 wherein said inserting of said facet joint bone plug into said hole comprises sliding an inserter instrument into said drill guide wherein said inserter instrument has a proximal end and a distal end and a facet joint bone plug associated with said distal end;

and

disengaging the facet joint bone plug from said distal end of said inserter instrument into said drilled hole.

33. A method according to claim 23 further comprising tapping said spatula further into said facet joint following the initial inserting of said planar wedge into said facet joint.

34. A method according to claim 23 further comprising tapping said drill guide following said aligning of said markings so that said opposed teeth of said drill guide engage facet joint bone to secure the orientation of said drill guide until said removing of said drill guide.

35. A method according to claim 23 further comprising tapping said facet joint bone plug into said facet joint following said inserting.

36. A surgical kit comprising:

a substantially hollow spatula comprising a proximal end, a distal end, and a body wherein said distal end comprises a planar wedge, said substantially hollow spatula comprising a guide mark; and

a

a drill guide comprising a proximal end, a distal end, and a handle wherein said handle is nearer to the proximal end of said drill guide than to said distal end and wherein said distal end comprises opposed teeth with a length longer than about 3 mm;

a spinal pin;

a drill bit;

a bone plug inserter comprising a proximal end and a distal end, wherein the distal end is configured to interact with a bone plug and wherein said proximal end comprises a raised portion that prevents over-insertion of said bone plug;

a bone plug holder; and

wherein all components of said kit can be stored and sterilized in a single autoclavable tool box.

37. The surgical kit of claim 36 wherein said spatula and said drill guide each further comprises a marking, wherein when said marking on said drill guide is matched or aligned with said marking on said spatula, the orientation of said opposed teeth is in approximately the same plane defined by said planar wedge.

38. The surgical kit of claim 37 wherein said marking on said spatula indicates the rotation of said planar wedge.

39. The surgical kit of claim 36 further comprising one or more tools selected from the group consisting of a spinal needle, an impacter, a hammer, a drill, a reamer, a dilator and a bone plug.

40. The surgical kit of claim 36 further comprising a bone plug.

41. The surgical kit of claim 39 wherein the drill bit is configured to grind the bone and compact some of the drilled bone within the hole.

42. The surgical kit of claim 37, wherein the spatula comprises one or more transverse guide markings.

43. The surgical kit of claim 42, wherein the spatula comprises three transverse guide markings.