Intrabody osteotomy implant and methods of use
10492917 ยท 2019-12-03
Assignee
Inventors
Cpc classification
A61B17/7083
HUMAN NECESSITIES
A61B17/7001
HUMAN NECESSITIES
A61F2/30767
HUMAN NECESSITIES
A61F2310/00029
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
A61B17/7032
HUMAN NECESSITIES
A61B17/708
HUMAN NECESSITIES
A61F2310/00017
HUMAN NECESSITIES
A61F2310/00293
HUMAN NECESSITIES
A61F2002/30032
HUMAN NECESSITIES
A61F2220/0016
HUMAN NECESSITIES
A61F2/4465
HUMAN NECESSITIES
A61F2002/4629
HUMAN NECESSITIES
A61F2210/0014
HUMAN NECESSITIES
A61B17/7085
HUMAN NECESSITIES
International classification
A61B17/80
HUMAN NECESSITIES
Abstract
Methods for surgically adjusting a curvature of a spine are disclosed. The methods provide for controlling the alignment of bony structures, such as vertebral bodies or portions thereof, as they are moved relative to one another during a surgical procedure. An intrabody implant disclosed and methods of use are also disclosed. The implant has an inclined surface, forming a wedge or other shape having, for example, an acute angle adapted to be placed between at least two separated portions of a single bony structure (such as a vertebral body). In some embodiments, the implant may be used to support portions of a vertebral body that have been separated surgically as part of a pedicle subtraction osteotomy and to orient the portions at a more predictable lordotic angle.
Claims
1. A method for surgically adjusting a curvature of a spine comprising vertebrae, the method comprising: removing a portion of a single vertebral body of the spine to form two at least partially separated portions of the single vertebral body; providing a wedge-shaped intrabody implant comprising a first surface and a second surface, the second surface disposed at an acute angle to the first surface, and wherein the first and second surfaces define an aperture extending through the implant; placing the wedge-shaped intrabody implant between the two at least partially separated portions of the single vertebral body; inserting a first pedicle screw into a second vertebral body superior to the single vertebral body and a second pedicle screw into a third vertebral body inferior to the single vertebral body; inserting a third pedicle screw in a vertebrae superior to the first pedicle screw and a fourth pedicle screw in a vertebrae inferior to the second pedicle screw; connecting the first pedicle screw and the second pedicle screw with a first rod; connecting the first, second, third, and fourth pedicle screws with a second rod; bringing into closer proximity the two at least partially separated portions of the single vertebral body such that the first and second pedicle screw advance towards one another along the first rod.
2. The method as recited in claim 1, wherein after the step of bringing into closer proximity the at least partially separated portions of the single vertebral body are oriented at a correction angle relative to one another.
3. The method as recited in claim 2, wherein the correction angle provides a lordotic correction to a spinal column at the level of the single vertebral body.
4. The method as recited in claim 2, wherein the correction angle provides a kyphotic correction to a spinal column at the level of the single vertebral body.
5. The method as recited in claim 1, wherein the removing step comprises a pedicle subtraction osteotomy (PSO) procedure.
6. The method as recited in claim 1, wherein the step of bringing into closer proximity further comprises securing the two at least partially separated portions of the single vertebral body relative to one another using an extradiscal stabilization system.
7. The method as recited in claim 1, further comprising repeating the removing, inserting, connecting, and step of bringing into closer proximity across one, two or more levels of the human spine to achieve an overall spinal correction across the one, two or more levels.
8. The method as recited in claim 1, further comprising, packing the aperture with a bone-growth promotion material prior to the placing step.
9. The method as recited in claim 1, wherein the acute angle is between 10 degrees and 30 degrees.
10. The method as recited in claim 9, wherein the acute angle is between 15 degrees and 25 degrees.
11. The method as recited in claim 1, wherein the first pedicle screw is positioned on a lateral side of spinous processes of the second vertebral body, and wherein the second pedicle screw is positioned on the same lateral side of spinous processes of the third vertebral body.
12. The method as recited in claim 1, wherein the first and second pedicle screws are dual headed screws and the first rod connects a first head of the first pedicle screw with a first head of the second pedicle screw.
13. The method as recited in claim 12, wherein the second rod connects a second head of the first pedicle screw with a second head of the second pedicle screw.
14. A method for surgically adjusting a curvature of a spine comprising vertebrae, the method comprising: removing a portion of a single vertebral body of the spine to form two at least partially separated portions of the single vertebral body; providing a wedge-shaped intrabody implant comprising a first surface and a second surface, the second surface disposed at an acute angle to the first surface, and wherein the first and second surfaces define an aperture extending through the implant; placing the wedge-shaped intrabody implant between the two at least partially separated portions of the single vertebral body; inserting a first pedicle screw into a second vertebral body superior to the single vertebral body and a second pedicle screw into a third vertebral body inferior to the single vertebral body; connecting the first pedicle screw and the second pedicle screw with a rod; and bringing into closer proximity the two at least partially separated portions of the single vertebral body such that the first and second pedicle screw advance towards one another along the rod.
15. The method as recited in claim 14, wherein after the step of bringing into closer proximity the at least partially separated portions of the single vertebral body are oriented at a correction angle relative to one another.
16. The method as recited in claim 14, further comprising, packing the aperture with a bone-growth promotion material prior to the placing step.
17. The method as recited in claim 14, wherein the acute angle is between 10 degrees and 30 degrees.
18. The method as recited in claim 17, wherein the acute angle is between 15 degrees and 25 degrees.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
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DETAILED DESCRIPTION
(18) The exemplary embodiments of an intrabody implant and related methods of use disclosed herein are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of an intrabody implant for placement after osteotomy and related methods for treating a vertebral column. It is envisioned that the disclosed intrabody implant and methods may provide, for example, a means for more accurately introducing a correction angle to a portion of the spinal column by virtue of the intrabody implant, which may enable a surgeon to more precisely predict the closure and/or correction angle despite variations in wedge angle that may be introduced in the bone-on-bone closure of known osteotomy procedures. In one embodiment, the wedge design of the intrabody implant may aid in the maintenance of anterior vertebral body height while allowing for closure (height collapse) on a posterior portion of the same vertebral body in order to introduce a corrective angulation.
(19) The various embodiments described herein may also be especially useful in maintaining the shape and position of the vertebral body during and after an osteotomy. For example, in known osteotomy procedures as a wedge-cut vertebral body (see
(20) Referring to
(21) As shown in
(22) The method may further comprise providing a wedge-shaped intrabody implant 100 (as described further herein with respect to
(23) As shown in
(24) According to various method embodiments, the correction angle of the spinal column defined at least in part by the acute angle of the intrabody implant may provide a lordotic correction to a spinal column at the level of the single vertebral body V. In other embodiments, the implant direction may be reversed such that the correction angle of the spinal column defined at least in part by the acute angle of the intrabody implant may provide a kyphotic correction to a spinal column at the level of the single vertebral body V. In some embodiments, the various embodiments of the present invention may provide a correction angle across multiple levels (such that the acute angles of several intrabody implants 100 may provide a lordotic correction to a spinal column across two or more levels). In such embodiments, the removing, providing, placing and closing or bringing into closer proximity steps disclosed herein may be repeated across two or more levels of the human spine to achieve an overall spinal correction across the two or more levels.
(25) In some method embodiments, the closing or bringing into closer proximity step described herein may further comprise securing the two at least partially separated portions V1, V2 of the vertebral body V about the implant 100 using an extradiscal stabilization system (which may include, for example, a rod 300 and pedicle screw 201, 202 construct as shown generally in
(26) Referring now to
(27) The method may further comprise the step of inserting pedicle screws 801 and 802 into vertebrae V2 and V3 adjacent to the vertebral body selected for the osteotomy procedure, or superior and inferior to the gap in the spine formed by removal of a vertebral body, intervertebral disc, or portions, or a combination thereof. As shown in
(28) The method further comprises the step of closing or bringing into closer proximity the at least partially separated portions of the single vertebral body such that the first and second pedicle screw advance towards one another along the rod. In this manner, the alignment of the spine is ensured and subluxation of the vertebrae is reduced or prevented. Set screws 811 and 812 or other closure mechanisms securing rod 900 into pedicle screws 801 and 802 may be selectively tightened and loosened during this step to control the advancement towards, or distance between, the pedicle screws as the bony structures V1 and V2 are brought towards one another. Bony structures V1 and V2 may be brought towards one another using any standard means or devices as known by one of ordinary skill in the art. For example, a pedicle subtraction osteotomy may be performed on a hinged operating table with the ends of the table slightly below the hinge at the start of the procedure. During closure of the spine, the hinged table may be flattened, thereby bringing bony structures V1 and V2 towards one another.
(29) A surgeon may also use any other means, tool, or apparatus to adjust the distance between the bony structures V1 and V2 and/or pedicle screws 801 and 802, including, but not limited to, distractors, compressors, extenders, or controllers. For example, it may be necessary to adjust the distance between bony structures V1 and V2 independently from pedicle screws 801 and 802 in order to adjust the angle of the adjacent faces of V1 and V2. By using a combination of tightening and loosening set screws 811 and 812, or other closure mechanisms securing rod 900 in pedicle screws 801 and 802, such as distractors, compressors, extenders, controllers, and/or other tools as may be known to those of ordinary skill in the art, a surgeon may adjust the distance between pedicle screws 801 and 802 along rod 900, either increasing, decreasing, or maintaining the distance, while moving adjacent faces V1 and V2. Distractors known in the artmay be used, e.g., to hold pedicle screws 801 and 802 apart as portions of the spine are manipulated, Compressors known in the artmay further be used, e.g., to bring pedicle screws 801 and 802 closer together as portions of the spine are manipulated. Exemplary tools, e.g., compressors and distractors, are disclosed in, e.g., U.S. Pat. No. 7,686,814, incorporated herein by reference in its entirety. Extenders may be attached to, e.g., pedicle screws 801 or 802 and may alter the distance and/or relative orientation therebetween in order to ease connection to rod 900 or other spinal rods, or to provide additional means for interaction. Exemplary extenders are disclosed in, e.g., U.S. Pat. Nos. 8,663,289, 8,727,972, and 8,828,059, all incorporated herein by reference in their entirety. A controller that may be, e.g., secured to pedicle screws 801 and 802 and may be used to selectively apply compression or distraction forces thereto is disclosed in, e.g., U.S. Pat. No. 9,402,660, incorporated herein by reference in its entirety.
(30) Referring now to
(31) In some method embodiments, the closing or bringing into closer proximity step described herein may further comprise securing a corrected spinal curvature using an extradiscal stabilization system (which may include, for example, a stabilization rod 1000 and pedicle screws 801, 802, 803, and 804 as shown generally in
(32) Referring now to
(33) The components of implant 100 can be fabricated from a variety of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of implant 100, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate, tricalcium phosphate, or fluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, biocompatible ceramics, mineralized collagen, bioactive glasses, porous metals, bone particles, bone fibers, morselized bone chips, bone morphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-), osteoblast cells, growth and differentiation factor (GDF), insulin-like growth factor 1, platelet-derived growth factor, fibroblast growth factor, or any combination thereof.
(34) According to the various embodiments provided herein, the implant 100 may comprise a first surface 110 configured for engaging a first V1 of the at least two separated portions of the bony structure. The implant 100 further comprises a second surface 120, disposed opposite the first surface 110, and configured for engaging a second V2 of the at least two separated portions of the bony structure. As shown in
(35) As shown in
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(37) Referring again to
(38) As shown in
(39) In other embodiments, the implant 100 may, for example, be expandable in a number of ways, including by, e.g., sliding wedge, turnbuckle, ratchet, hinge, expandable balloon, ratchets, stackable implants, vaneers slid inside the implant top and bottom like shims, via the use of springs, or via telescoping designs. Exemplary expandable implants and methods of their use are disclosed in, e.g., U.S. patent application Ser. Nos. 14/885,472, 15/008,805, and, 15/009,582, and U.S. Pat. Nos. 7,118,579, 7,655,027, 7,922,729, and 8,771,321, all incorporated herein by reference in their entirety. Once expanded, graft and/or other bone growth promoting material inserted into the implant by various cannula, tubing, syringes, tamps, or other mechanisms as known to those of ordinary skill in the art. An exemplary graft and/or bone growth material delivery device is disclosed in, e.g., U.S. Pat. No. 8,092,464, incorpored herein by reference in its entirety.
(40) It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.