Stable device for intervertebral distraction and fusion

• US 9,867,717 B2
• Filed: 01/13/2014
• Issued: 01/16/2018
• Est. Priority Date: 03/19/2009
• Status: Active Grant

• Current Assignee: EX Technology, LLC
• Original Assignee: EX Technology, LLC
• Inventors: Jimenez, Omar F.
• Primary Examiner(s): Nelson, Christine
• Application Number:
  US14/153,281
• Publication Number:
  US 20140194991A1
• Time in Patent Office: 1,464 Days
• Field of Search: 623 1715, 623 1716, 623 1717
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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 2002/30087 piezoelectric
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30364 Rotation about the common longitudinal axis
• CPC Class Codes: A61F 2002/30367 with additional means for preventing said rotation
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30522 releasable, e.g. using a releasable ratchet
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2002/30525 Worm gears
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30827 : Plurality of grooves
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30843 : Pyramidally-shaped
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

Improved methods and apparatuses for vertebral body distraction and fusion in accordance with various embodiments employ mechanisms for stabilizing a device so that the device can stay in the body and stably support the disc space during vertebral fusion following distraction of the adjacent vertebra by operation of the device. The device is inserted into the disc space and distracted from a compressed configuration to an expanded configuration to distract the disc space. Mechanisms for stabilizing the device in the expanded configuration constrain the device to zero degrees of freedom of movement to allow the device to stably support the disc space. A bone growth stimulant for promoting vertebral fusion can be inserted into an open space defined by the device, which continues to stably support the disc space during vertebral fusion.

Claims

1. A distractible intervertebral body fusion device adapted to be implanted into an intervertebral disc space in a patient'"'"'s body, comprising:

a first base plate having an outer bearing surface configured to interface with a first vertebra of the intervertebral disc space;

a second base plate having an outer bearing surface configured to interface with a second vertebra of the intervertebral disc space;

a plurality of blocks disposed between the first base plate and the second base plate, each block having an aperture therethrough;

an arm assembly extending between the first base plate and the second base plate on each of a first side and a second side of the base plates, each arm assembly comprising;

a first arm comprising first and second structural members, the first structural member hingedly attached at one end to one of the first base plate and the second base plate and at an opposing end to one of the blocks, and the second structural member hingedly attached at one end to the other of the first base plate and the second base plate and at an opposing end to the one of the blocks to which the first structural member is attached;

a second arm directly adjacent to the first arm and comprising third and fourth structural members, the third structural member hingedly attached at one end to one of the first base plate and the second base plate and at an opposing end to one of the blocks, and the fourth structural member hingedly attached at one end to the other of the first base plate and the second base plate and at an opposing end to the one of the blocks to which the third structural member is attached; and

a third arm linearly displaced from the first arm and the second arm and comprising fifth and sixth structural members, the fifth structural member hingedly attached at one end to one of the first base plate and the second base plate and at an opposing end to one of the blocks, and the sixth structural member hingedly attached at one end to the other of the first base plate and the second base plate and at an opposing end to the one of the blocks to which the fifth structural member is attached; and

first and second actuation members, the first actuation member adapted to extend through the apertures of a plurality of the blocks attached to the first, second and third arms of the arm assembly on the first side of the base plates and the second actuation member adapted to extend through the apertures of a plurality of the blocks attached to the first, second and third arms of the arm assembly on the second side of the base plates, each actuation member independently operable to drive the respective blocks closer together to expand the respective arms to cause the first base plate and the second base plate to move away from each other into a distracted position, and

wherein one or more blocks adjacent a common side of the first side and the second side of the base plates are separately driveable with the respective actuation member with respect to the other blocks on the common side such that the corresponding arms on the common side can be expanded by different amounts to position at least one of the first and second base plates in a lorditically angled configuration adapted to match a unique lordosis of a specific patient.

2. The device of claim 1, wherein each actuation member is a threaded member such that rotation of each actuation member in a first direction within the respective blocks causes the respective arms to expand and rotation of each actuation member in a second direction within the respective blocks opposite of the first direction causes the respective arms to collapse.

3. The device of claim 1, wherein the first arm and the second arm abut each other.

4. The device of claim 3, wherein the one end of the first structural member hingedly attached to the one of the first base plate and the second base plate abuts the one end of the third structural member hingedly attached to the one of the first base plate and the second base plate and the one end of the second structural member hingedly attached to the other of the first base plate and the second base plate abuts the one end of the fourth structural member hingedly attached to the other of the first base plate and the second base plate.

5. The device of claim 1, wherein each of structural members is hingedly attached to the respective first base plate or second base plate with a pin and further hingedly attached to the respective block with a pin.

6. The device of claim 5, wherein the first structural member and third structural member are attached to the one of the first base plate and the second base plate with separate pins and the second structural member and fourth structural member are attached to the other of the first base plate and the second base plate with separate pins.

7. A distractible intervertebral body fusion device adapted to be implanted into an intervertebral disc space in a patient'"'"'s body, comprising:

a first base plate;

a second base plate;

a first arm on each of a first side and a second side of the base plates extending between the first base plate and the second base plate, each first arm hingedly attached at one end to the first base plate and at an opposing end to the second base plate;

a second arm directly adjacent to the first arm on each of the first side and the second side of the base plates extending between the first base plate and the second base plate, each second arm hingedly attached at one end to the first base plate and at an opposing end to the second base plate; and

a third arm linearly displaced from the first arm and the second arm on each of the first side and the second side of the base plates extending between the first base plate and the second base plate, each third arm hingedly attached at one end to the first base plate and at an opposing end to the second base plate; and

first and second actuation members extending axially between the first base plate and the second base plate, each actuation member independently rotatable between the first base plate and the second base plate to expand the first, second and third arms on a respective side of the base plates to cause the first base plate and the second base plate to move away from each other into a distracted position, and

wherein at least two of the first arm, second arm and third arm on each of the sides of the base plates are separately expandable with respect to each other with the respective actuation member such that the arms can be expanded by different amounts to position at least one of the first and second base plates in a lordotically angled configuration adapted to match a unique lordosis of a specific patient.

8. The device of claim 7, wherein each actuation member is a threaded member such that rotation of each actuation member in a first direction causes the respective arms to expand and rotation of each actuation member in a second direction opposite of the first direction causes the respective arms to collapse.

9. The device of claim 7, wherein the first arm and the second arm abut each other.

10. The device of claim 9, wherein the one end of the first arm hingedly attached to the first base plate abuts the one end of the second arm hingedly attached to the first base plate and the opposing end of the first arm hingedly attached to the second base plate abuts the opposing end of the second arm hingedly attached to the second base plate.

11. The device of claim 7, wherein each of the arms is hingedly attached to the first base plate with a pin and to the second base plate with a pin.

12. The device of claim 11, wherein the first arm and the second arm are hingedly attached to the first base plate with separate pins and to the second base plate with separate pins.

13. The device of claim 7, wherein each arm comprises two structural members.

14. A distractible intervertebral body fusion device adapted to be implanted into an intervertebral disc space in a patient'"'"'s body, comprising:

a first base plate having an outer bearing surface configured to interface with a first vertebra of the intervertebral disc space and first and second sides;

a second base plate having an outer bearing surface configured to interface with a second vertebra of the intervertebral disc space and first and second sides;

a pair of first arms extending between and hingedly attached to the first base plate and the second base plate, one of the first arms on each of the first and second sides of the base plates;

a pair of second arms extending between and hingedly attached to the first base plate and the second base plate, one of the second arms on each of the first and second sides of the base plates, wherein the first pair of arms and second pair of arms are expandable between a collapsed configuration and an expanded configuration in which the first base plate and the second base plate are distracted with respect to each other;

a pair of stabilizing arms extending between and hingedly attached to the first base plate and the second base plate, one of the stabilizing arms on each of the first and second sides of the base plates;

a pair of actuation members, each actuation member extending adjacent one of the first and second sides of the base plates and independently rotatable to expand the first, second and stabilizing arms along the respective side of the base plates to distract the base plates with respect to each other; and

wherein the stabilizing arms are adapted to stably maintain the base plates in the distracted position under in-vivo loads with zero degrees of freedom, and

wherein at least two of the first arm, second arm and stabilizing arm on each of the sides of the base plates are separately expandable with respect to each other with the respective actuation member such that the arms can be expanded by different amounts to position at least one of the first and second base plates in a lordotically angled configuration adapted to match a unique lordosis of a specific patient.

15. The device of claim 14, further comprising a plurality of blocks positioned between the first base plate and the second base plate, each block operably connected with at least one of the arms, and wherein the actuation members each extend through at least some of the blocks.

16. The device of claim 14, wherein each actuation member is a threaded member such that rotation of each actuation member in a first direction causes the respective arms to expand and rotation of each actuation member in a second direction opposite of the first direction causes the respective arms to collapse.

17. The device of claim 14, wherein each arm comprises two structural members.