Inter-Body Implantation System and Method

• US 20110009969A1
• Filed: 07/09/2010
• Published: 01/13/2011
• Est. Priority Date: 07/09/2009
• Status: Active Grant

• Current Assignee: R Tree Innovations, LLC
• Original Assignee: R Tree Innovations, LLC
• Inventors: Puno, Rolando M.
• Granted Patent: US 9,814,599 B2
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/708 with tubular extensions coaxially mounted on the bone anchors
• 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 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• 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 2002/30056 differing in radiographic density
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30365 with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30624 Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30632 : with rotation-limiting stops, e.g. projections or recesses
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2002/30808 : parallel
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• 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 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0032 : differing in radiographic density
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A system for implanting an inter-body device between adjacent vertebrae comprises an inter-body device having a plurality of cans secured to a flexible bridge and having a relief portion therebetween. An inserter tube and complementary bullnoses are advantageously secured to the vertebrae by an extension arm for securing the assembly precisely in place. A plurality of articulating trial implants are provided to test fit a disc space for the proper sized inter-body device.

Claims

1. A system for insertion of an inter-body device into a disc space between adjacent vertebrae, said disc space being accessible through an annulotomy, said disc having been removed from said disc space through a discectomy, and said vertebrae having a plurality of pedicle screws secured thereto, comprising:

a first bullnose having a distal end shaped to distract said disc space, a central shaft, and a proximal end for engaging a handle to which said bullnose may be secured;

an inserter tube having a distal end for placement in said annulotomy space, and a proximal end comprising a hollow handle, and a channel therebetween; and

a second bullnose having a distal end shaped to advance into said disc space, a longitudinal shaft, and a proximal end shaped to engage a handle, whereby said second bullnose is sized to be accepted through the channel of said inserter tube.

2. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

an inserter tube having a distal end comprising a curved lateral wall and a straight medial wall to facilitate delivery of said inter-body device into said disc space.

3. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

an inserter tube comprising a pair of opposed upper and lower walls and a pair of opposed medial and lateral walls and having a distal end comprising a curved lateral wall having a predetermined length and a straight interior wall having a length less than that of the curved lateral wall to facilitate delivery of said inter-body device into said disc space.

4. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

an inserter tube having a hollow handle at a proximal end thereof in communication with said tube, through which said bullnose and said inter-body device may be inserted.

5. A system for insertion of an inter-body device into a disc space as claimed in claim 4 comprising:

an inserter tube having a locking flange on a proximal end of said hollow handle for engaging a complementary locking flange.

6. A system for insertion of an inter-body device into a disc space as claimed in claim 2 comprising:

an inserter tube having a plurality of depth indicators on an exterior surface thereof proximate said distal end for determining the depth of said inserter tube in said disc space.

7. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a trial implant secured to an articulating arm for insertion through said inserter tube into said disc space to determine proper sizing for an inter-body device.

8. A system for insertion of an inter-body device into a disc space as claimed in claim 2 comprising:

a plurality of trial implants having a plurality of lengths, heights, and widths for insertion in said disc space to determine proper sizing for an inter-body device.

9. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a second bullnose having a longitudinal groove disposed in one side of said longitudinal shaft from the proximal end to the distal end thereof, for accepting a suture used to manipulate said inter-body device.

10. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a second bullnose having a distal end shaped to advance said inter-body device into said disc space.

11. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a second bullnose having a distal end shaped to advance into said disc space, a longitudinal shaft, a proximal end shaped to engage a handle, and a pair of opposed longitudinal grooves along two sides of said shaft for permitting clearance of a suture secured to said inter-body device.

12. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a plurality of bullnoses having distal ends comprising a plurality of different heights for distracting said disc space.

13. A system for insertion of an inter-body device into a disc space as claimed in claim 12 wherein the distal ends of said plurality of bullnoses comprise a plurality of insertion depth marks.

14. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a box cutter having a head with a distal end comprising a shaped tip for advancing into said disc space and a pair of opposed cutting edges spaced longitudinally from said tip for shaving a posterior endplate of said adjacent vertebrae as said box cutter head is advanced through said annulotomy.

15. A system for insertion of an inter-body device into a disc space as claimed in claim 5 comprising:

a trial handle for engaging a proximal end of said first and second bullnoses, said trial handle adapted to be secured to said inserter tube handle.

16. A system for insertion of an inter-body device into a disc space as claimed in claim 5 comprising:

a trial handle having a locking flange on a distal end thereof for engaging said inserter tube handle and securing said trial handle thereto, wherein a one of said bullnoses is secured to said trial handle, inserted in said inserter tube, and secured to said inserter tube handle.

17. A system for insertion of an inter-body device into a disc space as claimed in claim 7 comprising:

an articulating arm having a distal end and a proximal end having a longitudinal slot therein;

a trial implant having a distal end and a proximal end connected by a central hinge, said implant proximal end rotatably secured to the distal end of said articulating arm; and

a trial implant rod having a pair of spaced distal tips and a proximal end for securing to an insertion tool, said distal tips connected by a hinge pin at a proximal end thereof, wherein said slot of said articulating arm is engaged by said hinge pin, and whereby said trial implant pivots around said central hinge, said distal end of said articulating arm, and said proximal end of said articulating arm for effective placement into said disc space.

18. A system for insertion of an inter-body device into a disc space as claimed in claim 17 comprising:

a plurality of trial implants having a plurality of lengths, heights, and widths for insertion in said disc space to determine proper sizing for an inter-body device.

19. A system for insertion of an inter-body device into a disc space as claimed in claim 17 comprising:

an insertion tool shaft having a distal end secured to said trial implant rod, and a proximal end; and

a trial handle for engaging said proximal end of said first insertion tool shaft, said trial handle adapted to be secured to said inserter tube handle.

20. A system for insertion of an inter-body device into a disc space as claimed in claim 4 comprising:

a bone graft funnel having a central aperture therein, said funnel adapted to be secured to said inserter tube hollow handle for delivering a bone graft material to said disc space through said inserter tube.

21. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a bone graft plunger having a flexible angled tip at a distal portion thereof and a plunger shaft connected to said angled tip, said bone graft plunger capable of being inserted through said inserter tube to force a bone graft material into said disc space.

22. A system for insertion of an inter-body device into a disc space as claimed in claim 21 wherein said flexible angled tip is shaped to fit tightly in said inserter tube, thereby forcing any bone graft material therein into said disc space.

23. A system for insertion of an inter-body device into a disc space as claimed in claim 21 wherein said flexible angled tip is comprised of an elastomer.

24. A system for insertion of an inter-body device into a disc space as claimed in claim 21 wherein said plunger shaft is comprised of an elastomer.

25. A system for insertion of an inter-body device into a disc space as claimed in claim 21 wherein said flexible angled tip is elongated to advance into said disc space, and wherein said flexible angled tip is curved in a relaxed state.

26. A system for insertion of an inter-body device into a disc space as claimed in claim 21 wherein said bone graft plunger is comprised of a flexible metal alloy.

27. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

an extension arm having an elongated body having a distal end and a proximal end, said arm adapted to be secured to at least one of said pedicle screws at a distal end thereof, and having a clamp secured to the proximal end thereof for securing said inserter tube thereto.

28. A system for insertion of an inter-body device into a disc space as claimed in claim 4 comprising:

an extension arm having an elongated body having a distal end and a proximal end, said arm adapted to be secured to at least one of said pedicle screws at a distal end thereof, and having a clamp secured to the proximal end thereof for securing said inserter tube handle thereto.

29. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

an extension arm having an elongated channel having a distal end and a proximal end, said channel secured at a distal end thereof to at least one of said pedicle screws, and having a clamp secured to an adjustable clamp guide, said clamp guide movable along said channel to secure said clamp at a point thereon, wherein said clamp secures said inserter tube to said extension arm in a precise location.

30. A system for insertion of an inter-body device into a disc space as claimed in claim 4 comprising:

an extension arm having an elongated channel having a distal end and a proximal end, said channel secured at a distal end thereof to at least one of said pedicle screws, and having a clamp secured to an adjustable clamp guide, said clamp guide movable along said channel to secure said clamp at a point thereon, wherein said clamp secures said inserter tube handle to said extension arm in a precise location.

31. A system for insertion of an inter-body device into a disc space as claimed in claim 1 comprising:

a flexible sleeve capable of being inserted into said inserter tube and advanced into said disc space.

33. A method for replacement of a disc between adjacent vertebrae, as claimed in claim 1 comprising the further steps of:

a.) placing a bone graft funnel on a proximal end of said inserter tube;

b.) depositing morselized bone graft material into said bone graft funnel;

c.) advancing said bone graft material into said inserter tube utilizing a bone plunger tip until said bone graft material is as far into said disc space as possible;

d.) detaching said extension arm from said pedicle screws; and

e.) removing said inserter tube from said disc space.

34. A method for replacement of a disc between adjacent vertebrae, as claimed in claim 1 comprising the further steps of:

a.) providing a plurality of handles for engaging said trial implants, said first and second bullnoses, said distractors, said box cutters, said implants and said bone plunger tips.

35. A method for replacement of a disc between adjacent vertebrae, as claimed in claim 3 comprising the further steps of:

a.) providing a slap hammer attachment for said plurality of handles for applying a longitudinal force along a longitudinal axis of said inserter tube.

32. A method for replacement of a disc between adjacent vertebrae, said disc having been removed from a disc space between said adjacent vertebrae, said vertebrae having a plurality of pedicle screws secured thereto, and said disc space being accessible by an annulotomy procedure comprising the steps of:

a.) distracting the disc space with a distractor of a predetermined height;

b.) noting the depth of insertion of said distractor and the height thereof;

c.) applying a contralateral distractor to vertebrae adjacent to said disc space to maintain disc height;

d.) removing said distractor;

e.) inserting a box cutter instrument into the disc space, said box cutter having the same height as said distractor, thereby shaving a posterior endplate of said adjacent vertebrae;

f.) securing an extension arm capable of holding an instrument loosely to an inferior pedicle screw;

g.) inserting a first bullnose having first bullnose tip and a height the same as said distractor into an inserter tube having a distal end for entering said disc space;

h.) inserting said inserter tube and first bullnose into said disc space through said annulotomy in an orientation of approximately zero degrees in the saggittal plane until said first bullnose reaches the depth of said distractor;

i.) removing said first bullnose from said inserter tube;

j.) inserting a second bullnose having a blunt bullnose tip and a height the same as said distractor into said inserter tube and advancing said second bullnose and said inserter tube deeper into said disc space until said second bullnose tip touches the anterior annulus of said disc space;

k.) securing said inserter tube to said extension arm to fix its position in said disc space;

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l.) tightening said universal extension arm to said inferior pedicle screw to secure said inserter tube and said extension arm securely in their respective positions;

m.) removing said second bullnose;

n.) assembling a trial implant having a height the same as said distractor height and a predetermined first length to a handle, and deploying said implant into said disc space through said inserter tube;

o.) repeating step n with a plurality of trial implants having differing lengths and identical heights to determine the longest trial implant that can be deployed in said disc space;

p.) confirming acceptable position of the longest trial implant in said disc space using a conventional imaging technique and removing said trial implant from said disc space;

q.) selecting an inter-body device having the same height and length as said trial implant from step p.) and threading a suture through a hitch on said implant;

r.) inserting said implant through said inserter tube with the curvature thereof directed medially and inserting said second bullnose into said inserter tube behind said implant;

s.) advancing said implant through said inserter tube and into said anterior disc space;

t.) confirming acceptable implant position in said disc space using a conventional imaging technique;

u.) removing said suture by pulling said suture through said inserter tube; and

v.) removing said bullnose from said inserter tube.