Expandable interbody implant and method

• US 9,211,195 B2
• Filed: 10/22/2014
• Issued: 12/15/2015
• Est. Priority Date: 10/13/2009
• Status: Active Grant

• Current Assignee: Nicholas Poulos
• Original Assignee: Nicholas Poulos
• Inventors: Poulos, Nicholas
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US14/520,892
• Publication Number:
  US 20150045891A1
• Time in Patent Office: 419 Days
• Field of Search: 623 1711- 1716
• US Class Current: 1/1
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: G06F 1/3206 Monitoring of events, devices or parameters that trigger a change in power modality
• CPC Class Codes: G06F 1/3209 Monitoring remote activity, e.g. over telephone lines or network connections
• CPC Class Codes: H04M 1/72454 according to context-related or environment-related conditions
• CPC Class Codes: H04W 4/02 Services making use of location information
• CPC Class Codes: H04W 4/029 Location-based management or tracking services
• CPC Class Codes: H04W 4/50 Service provisioning or reconfiguring
• CPC Class Codes: H04W 48/04 based on user or terminal location or mobility data, e.g. moving direction, speed
• CPC Class Codes: H04W 52/0254 detecting a user operation or a tactile contact or a motion of the device
• CPC Class Codes: H04W 64/00 Locating users or terminals or network equipment for network management purposes, e.g. mobility management
• CPC Class Codes: Y02D 30/70 in wireless communication networks

Abstract

An intervertebral implant that can be surgically introduced between adjacent vertebrae and expanded in situ to occupy an optimal space between the vertebrae. The implant is inserted into the evacuated disc space obliquely and then oriented so as to extend laterally across the anterior adjacent vertebrae with its outer ends of the implant supported by the cortical rims on the opposite sides of the vertebrae. The implant has two body members with a space therebetween so the implant may be then distracted and a spacer of predetermined thickness that may be inserted within the space between the body members so as to maintain a desired amount of distraction. The upper and lower surfaces of the implant may have a desired lordotic angle. A method of using an implant is disclosed which permits endoscopic visualization of the disc space.

Claims

1. A method of distracting and fusing two adjacent vertebrae bodies, each of said adjacent vertebrae bodies having a cortical rim and an endplate with an annulus and a disc space between said adjacent vertebrae bodies, said disc space having an interior within said annulus and further having disc material within the interior of the disc space, said method comprising the following steps:

a. make an incision in said annulus at a desired level to access the disc space between the adjacent vertebrae bodies, said incision being in a posterior lateral quadrant of said annulus and extending generally from an approximate location of a pedicle in said posterior lateral quadrant to a position in or proximate to an ipsilateral anterior lateral quadrant of said annulus, said incision being of sufficient length so as to simultaneously accommodate the insertion of surgical instrumentation and endoscopic instrumentation into said disc space thereby enabling endoscopic viewing of the interior of the disc space while performing discectomy and while preparing said endplates;

b. through said incision, perform a discectomy of the disc material within the disc space;

c. through said incision, prepare the endplates of said adjacent vertebrae bodies;

d. through said incision, distract said disc space;

e. through said incision, insert an implant into said disc space via said incision such that one end of said implant is at least partially received in an anterior portion of said incision such that said implant extends across said vertebrae bodies and is at least in part supported by said cortical rim so as to maintain distraction of said disc space; and

f. through said incision, insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

2. A method of distracting and fusing a disc space between two adjacent vertebrae bodies, said vertebrae bodies each having an annulus and a disc space therebetween, said disc space having an interior within said annulus and further having disc material within the interior of the disc space, said vertebrae bodies further having a cortical rim and an endplate within said annulus, an implant configured to be inserted into said disc space through a posterolateral incision in the annulus and having an elongate body having a height ranging between about 8 mm.-10 mm. and a width ranging between about 11 mm.-13 mm., said implant elongate body being of a length sufficient such that when the implant is positioned in the disc space said implant extends generally laterally of said vertebrae bodies so as to maintain distraction of said adjacent vertebrae bodies, said method comprising the following steps:

a. make an incision in said annulus at the desired level to access the disc space between the adjacent vertebrae bodies to be fused, said incision being in a posterior lateral quadrant of said annulus and extending generally from an approximate location of a pedicle in said posterior lateral quadrant toward an ipsilateral anterior quadrant of said annulus, said incision being of sufficient length so as to simultaneously accommodate the insertion of surgical instrumentation into the disc space and so as to accommodate the use of endoscopic instrumentation to enable visualization of the disc space while surgical procedures are carried out within the disc space;

b. perform a discectomy of the disc material within the disc space via said incision;

c. prepare the endplates of said adjacent vertebrae bodies;

d. insert said implant into said disc space via said incision so as to extend substantially across said vertebrae bodies in an anterior region of said disc space and so as to be at least in part supported on at least one of said cortical rims of said vertebrae bodies;

e. distract said disc space; and

f. insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

3. The method of claim 2 wherein the method further comprises inserting bone growth material into said disc space.

4. The method of claim 2 wherein said implant is an expandable implant having an upper and a lower body member with a space therebetween, and wherein said method further comprises using a distractor while said implant is installed within the disc space and to distract said upper and lower body members and installing a spacer between said upper and lower body members while said implant is distracted within the disc space so as to maintain a desired amount of distraction of said disc space.

5. A method of distracting and fusing two adjacent vertebrae bodies, each of said adjacent vertebrae bodies having a cortical rim and an endplate with an annulus and a disc space therebetween, said disc space having disc material therewithin, said method comprising the following steps:

a. make an incision in said annulus at a desired level to access the disc space between the adjacent vertebrae bodies, said incision being in a posterior lateral quadrant of said annulus and extending generally from an approximate location of a pedicle in said posterior lateral quadrant to a position in or proximate to an ipsilateral anterior lateral quadrant of said annulus, said incision being of sufficient length so as to accommodate the insertion of surgical instrumentation into the disc space and to enable endoscopic instrumentation to view the interior of said disc space so that discectomy of the disc space and preparation of the endplates of said vertebrae bodies may be performed while the surgeon endoscopically views the disc space;

b. utilize said endoscopic instrumentation so as to enable viewing of said disc space while performing steps “

c” and

“

d”

, below;

c. through said incision, perform a discectomy of the disc material within the disc space;

d. through said incision, prepare the endplates of said adjacent vertebrae bodies;

e. insert an expandable implant into said disc space via said incision;

f. through said incision, distract said implant and said adjacent vertebrae bodies;

g. fix said expandable implant in a desired distracted position within said disc space so as to maintain distraction of said adjacent vertebrae bodies; and

h. through said incision, insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

6. A method of distracting and fusing a disc space between two adjacent vertebrae bodies, said vertebrae bodies each having an annulus and a disc space therebetween, each said vertebrae bodies further having a cortical rim and an endplate within said annulus, an expandable implant having an elongate body configured to have a height ranging between about 8 mm.-10 mm. and a width ranging between about 11 mm.-13 mm. so that said implant may be inserted into the disc space through a posterolateral incision in the annulus, said implant being further configured to have a length so that when the implant is positioned in the disc space the implant extends generally laterally with respect to said vertebrae bodies, said expandable implant being capable of being distracted within said disc space so as to distract said adjacent vertebrae bodies and being capable of being fixed in a desired distracted condition so as to maintain a desired amount of distraction between said adjacent vertebrae bodies, said method comprising the following steps:

a. make an incision in said annulus at the desired level to access the disc space between the adjacent vertebrae bodies to be fused, said incision being substantially in a posterior lateral quadrant of said annulus and extending generally from an approximate location of a pedicle in said posterior lateral quadrant to a position in or proximate to an ipsilateral anterior lateral quadrant of said annulus, said incision being of sufficient length so as to accommodate surgical instrumentation for performing surgical procedures within said disc space and so as to permit the use of endoscopic instrumentation so as to enable the surgeon to visualize the interior of the disc space while performing said surgical procedures;

b. utilize endoscopic instrumentation for viewing of said disc space;

c. perform a discectomy of the disc space via said incision in said annulus under endoscopic viewing of the disc space;

d. prepare the endplates of said adjacent vertebrae bodies under endoscopic viewing of the disc space;

e. insert said expandable implant into said disc space via said incision so as to extend generally laterally of said vertebrae bodies in an anterior region thereof;

f. distract said expandable implant and said adjacent vertebrae bodies;

g. fix said expandable implant and said adjacent vertebrae bodies in a desired distracted condition; and

h. insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

7. The method of claim 6 wherein said expandable implant is supported by at least a portion on said cortical rim.

8. The method of claim 7 wherein said expandable implant is supported on at least a portion on said cortical rim.

9. A method of distracting and fusing two adjacent vertebrae bodies, each of said adjacent vertebrae bodies having a cortical rim and an endplate with an annulus and a disc space therebetween, said method comprising the following steps:

a. make an incision in said annulus at a desired level to access the disc space between the adjacent vertebrae bodies, said incision being in a posterior lateral quadrant of said annulus and extending generally from an approximate location of a pedicle in said posterior lateral quadrant to a position in or proximate to an ipsilateral anterior lateral quadrant of said annulus, said incision being of sufficient length so as to accommodate surgical instrumentation for performing surgical procedures within said disc space and so as to permit the use of endoscopic instrumentation so as to enable the surgeon to visualize the interior of the disc space while performing at least some of said surgical procedures;

b. through said incision, perform a discectomy of the disc material within the disc space while under endoscopic viewing by said surgeon;

c. through said incision, prepare the endplates of said adjacent vertebrae bodies while under endoscopic viewing by said surgeon;

d. insert an implant into said disc space via said incision;

e. through said incision, distract said adjacent vertebrae bodies with said implant maintaining a desired distraction of said adjacent vertebrae bodies; and

f. through said incision, insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

10. A method of fusing two adjacent vertebrae bodies, each of said adjacent vertebrae bodies having a cortical rim and an endplate with an annulus and a disc space between said adjacent vertebrae bodies, said disc space having an interior within said annulus and further having disc material within the interior of the disc space, said method comprising the following steps:

a. make an incision in said annulus at a desired level to access the disc space between the adjacent vertebrae bodies, where at least a portion of said incision is in a posterior lateral quadrant of said annulus and where said incision is of a sufficient length so as to accommodate the insertion of endoscopic instrumentation into said disc space so as to enable viewing of the interior of the disc space and so as to permit the insertion of surgical instrumentation into said disc space for performing discectomy of the disc space and for preparing the endplates of said vertebrae bodies;

b. perform a discectomy of the disc material within the disc space;

c. prepare the endplates of said adjacent vertebrae bodies;

d. form an opening in an anterior contralateral side of said annulus;

e. distract said disc space;

f. insert an implant into said disc space via said incision such that said implant extends across said vertebrae bodies with said implant being at least in part supported by said cortical rim and maintaining distraction of said disc space; and

g. insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

11. The method of claim 10 wherein said implant comprises an expandable implant having an upper and a lower body member, and wherein said method further comprises:

h. using a distractor having operating members, inserting the operating members of said distractor between said upper and lower body members and distracting said body members and said adjacent vertebrae bodies.

12. The method of claim 11 further comprising:

i. wherein after said distractor has been operated to distract said adjacent vertebrae bodies a first distance, inserting a first paddle blade distractor between said operating members of said distractor, said paddle blade distractor having a predetermined width at least as great as the distance between said operating members of said distractor when said vertebrae bodies have been distracted a distance generally corresponding to said first distance;

j. rotating said first paddle distractor blade about its longitudinal axis so as to insure that said distractor operating members are distracted at least the width of said first paddle blade distractor and so as to insure that the operating members of said distractor are substantially parallel; and

k. inserting a spacer between said upper and lower body members of said expandable implant so as to maintain a desired amount of distraction of said adjacent vertebrae bodies.

13. The method of claim 12 further comprising:

l. wherein prior to performing step k, removing said first paddle blade distractor from between said operating members of said distractor, and operating said distractor so as to distract said adjacent vertebrae bodies a second distance greater than said first distance; and

m. inserting a second paddle blade distractor between said operating members of said distractor where said second paddle blade distractor is wider than said first paddle blade distractor and then rotate said second paddle blade distractor about its longitudinal axis so as to insure that said distractor operating members are distracted at least the width of said second paddle blade distractor and are substantially parallel.

14. The method of claim 11 wherein said expandable implant further comprises a spacer, and wherein said method comprises inserting said spacer between said upper and lower body members so as to maintain distraction of said vertebrae members.

15. The method of claim 10 further comprising:

h. installing one end of said implant in said opening and installing another end of said implant in the anterior portion of said incision such that said implant is oriented to extend across said adjacent vertebrae bodies and is at least in part supported on at least one of the cortical rims of said vertebrae bodies.

16. The method of claim 10 wherein said expandable implant includes a spacer, and wherein said method further comprises inserting said spacer between said upper and lower body members of said expandable implant after said upper and lower body members have been distracted.

17. The method of claim 10 wherein said implant comprises an expandable implant having an upper and a lower body member, each of said body members having an outer surface and an inner surface with a space between said inner surfaces and wherein said implant upper and lower body members are movable toward and away from one another, and wherein said method further comprises:

h. with said implant installed across said vertebrae bodies, using a distractor having operating members, inserting the operating members of said distractor between said upper and lower body members and distracting said body members; and

i. after distracting said upper and lower body members, inserting a spacer between said upper and lower body members.

18. The method of claim 10 further comprising extending said opening in said anterior contralateral side of said annulus toward the posterior for relaxation of the annulus.

19. The method of claim 10 wherein said incision extends at least in part into an adjacent anterior lateral quadrant of said annulus.

20. The method of claim 19 wherein said opening extends posteriorly into an adjacent lateral posterior quadrant of said annulus.

21. The method of claim 10 wherein said opening constitutes a first opening, and wherein said method further comprises forming a second opening in an opposite anterior quadrant of said annulus generally opposite said first opening and inserting a first end of said implant into said first opening and inserting a second end of said implant into said second opening.

22. A method of distracting and fusing a disc space between two adjacent vertebrae bodies, said vertebrae bodies each having an annulus and a disc space therebetween, said disc space having disc material therein, each said vertebrae bodies further having a cortical rim and an endplate within said annulus, an expandable implant having an elongate body of a length sufficient such that when the implant is positioned in the disc space said implant extends across said vertebrae bodies and is at least in part supported by at least one of said cortical rims of said adjacent vertebrae bodies, said expandable implant having a lower body member and an upper body member movable toward and away from one another and having a spacer configured to be inserted between said upper and lower body members so as to maintain distraction of said adjacent vertebrae bodies, said method comprising the following steps:

a. make an incision in said annulus at the desired level to access the disc space between the adjacent vertebrae bodies to be fused, said incision being substantially in a posterior lateral quadrant of said annulus and being of sufficient length so as to accommodate surgical instrumentation for performing surgical procedures within said disc space and so as to accommodate endoscopic instrumentation in said disc space so as to enable visualization of the disc space for the surgeon performing said surgical procedures;

b. perform a discectomy of the disc space via said incision in said annulus under endoscopic viewing of the disc space;

c. prepare the endplates of said adjacent vertebrae bodies under endoscopic viewing of the disc space;

d. form an opening in an anterior contralateral side of said annulus;

e. insert said expandable implant into said disc space via said incision so as to extend substantially across said vertebrae bodies in an anterior region of said disc space and so as to be at least in part supported by at least one of said cortical rims;

f. distract said expandable implant and said disc space;

g. insert said spacer between said upper and lower body members of said expandable implant so as to substantially maintain distraction of said adjacent vertebrae bodies; and

h. insert bone graft material in said disc space so as to promote fusing of said adjacent vertebrae bodies.

23. The method of claim 22 further comprising the following steps:

i. wherein said step of distracting said expandable implant includes inserting the operating members of a distractor between said upper and lower body members of said implant and operating said distractor to distract said body members such that a gap is present between said operating members; and

wherein said step of inserting said spacer between said upper and lower body members of said expandable implant comprises placing said spacer within said gap between said operating blades and moving said spacer to its desired position between said upper and lower spacer body members.

24. The method of claim 23 further comprising:

j. after said distractor has been operated to distract said vertebrae bodies a first distance and prior to inserting said spacer between said upper and lower body members of said expandable implant, inserting a first paddle blade distractor having a predetermined width at least as great as the distance between said operating members of said distractor when said vertebrae bodies have been distracted a distance generally corresponding to said first distance, and

k. rotating said paddle distractor blade about its longitudinal axis so as to insure that said distractor blades are distracted at least the width of said first paddle blade distractor thereby to insure that the operating members and tips of said distractor are substantially parallel.

25. The method of claim 24 further comprising:

l. removing said first paddle blade distractor and operating said distractor so as to distract said vertebrae a second distance greater than said first distance; and

m. inserting a second paddle blade distractor between said operating members of said distractor where said second paddle blade distractor is wider than said first paddle blade distractor and then rotating said second paddle blade distractor.

26. The method of claim 22 further comprising:

i. wherein said step of inserting said implant further involves inserting one end of said implant in said opening and to orient said implant to extend across said vertebrae bodies with another end of said implant received in an anterior portion of said incision.

27. The method of claim 22 further comprising:

i. after inserting said spacer between said body members, installing bone growth material in said disc space.

28. A method of distracting a disc space between two adjacent vertebrae bodies to be fused together, said adjacent vertebrae bodies having an annulus and a disc space therebetween with disc material within the disc space, each of said adjacent vertebrae bodies further having a cortical rim and an endplate within said annulus, said method comprising the following steps:

a. make an incision in said annulus at the desired level to access a disc space between the adjacent vertebrae to be fused, a portion of said incision being in a posterior lateral quadrant of said annulus and extending anteriorly at least partially into a proximate anterior quadrant of said annulus, said incision being of sufficient length so as to accommodate surgical instrumentation for performing surgical procedures within said disc space and so as to accommodate endoscopic instrumentation in said disc space;

b. perform a discectomy of the disc space via said incision in said annulus under endoscopic viewing of the disc space;

c. prepare the endplates of said adjacent vertebrae bodies under endoscopic viewing of the disc space;

d. form an opening in an anterior contralateral side of said annulus;

e. provide an implant having an elongate body of a length sufficient such that when the implant is positioned in an anterior portion of said disc space said implant extends across said vertebrae bodies; and

f. insert said implant into said disc space via said incision and positioning the implant so as to extend substantially across said adjacent vertebrae bodies in the anterior region of said vertebrae bodies with one end of said implant being at least partially received in said opening and with another end of said implant being at least partially received in an anterior portion of said incision so that said implant is at least in part supported by at least one of said cortical rims upon retraction of said disc space.

29. A method of distracting a disc space between two adjacent vertebrae bodies to be fused together, said vertebrae bodies having an annulus and a disc space therebetween with disc material within the disc space, each of said vertebrae bodies further having a cortical rim and an endplate within said annulus, said method comprising the following steps:

a. make an incision in said annulus at the desired level to access a disc space between the adjacent vertebrae to be fused, said incision being substantially in a posterior lateral quadrant of said annulus;

b. perform a discectomy of the disc material within the annulus via said incision;

c. prepare the endplates of said adjacent vertebrae bodies;

d. form a first opening in an anterior contralateral side of said annulus;

e. form a second opening in said annulus substantially opposite said first opening;

f. insert an expandable implant into said disc space via said incision, said implant having ends that are received in said first and second openings such that the implant extends substantially across said vertebrae bodies in an anterior region of said vertebrae bodies and is at least in part supported by at least one of said cortical rims;

g. distract said expandable implant; and

h. install a spacer between said upper and lower bodies of said implant so as to maintain distraction.