Post-Operatively Adjustable Spinal Fixation Devices
20170231661 · 2017-08-17
Inventors
Cpc classification
A61B17/7022
HUMAN NECESSITIES
A61B17/7053
HUMAN NECESSITIES
A61B17/7004
HUMAN NECESSITIES
A61B17/7065
HUMAN NECESSITIES
A61B17/7056
HUMAN NECESSITIES
A61B17/7067
HUMAN NECESSITIES
B29C70/44
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A system for spinal fixation with a non-rigid portion at least one of the caudal or cephalad terminus. Various devices and techniques are described for transition from a rigid fixation construct to a less rigid support structure applied to a “soft zone” that will help share the stress created on the spinal levels caused by the fixed levels below. In specific embodiments the soft zone is provided by terminating the construct with one of a flexible tether or a dampening rod.
Claims
1. A system for spinal fixation, the system comprising: a first bone anchor, anchored to a first vertebra in a subject, the first bone anchor comprising a first bone fastener attached to a first rod housing; a rigid spinal rod seated in the first rod housing to restrict translation of the rigid spinal rod relative to the first bone anchor; a second bone anchor, anchored to a second vertebra in the subject, the second bone anchor comprising a second bone fastener attached to a second rod housing, wherein the rigid spinal rod is seated in the second rod housing to restrict translation of the rigid spinal rod relative to the second bone anchor; and a compressible spinal connector, connected to the second bone anchor, and anchored to a third vertebra in the subject, the compressible spinal connector comprising a modulation mechanism for modulating at least one of: the tension on the compressible spinal connector or the resistance to compression of the compressible spinal connector, wherein said modulation occurs in response to a remote signal.
2. The system of claim 1, wherein the remote signal is a spinning magnetic field.
3. The system of claim 1, wherein at least one of the following is at least partially composed of a non-absorbable biocompatible material: the first bone anchor, the second bone anchor, the rigid spinal rod, and the compressible spinal connector.
4. The system of claim 1, wherein the remote signal is a spinning magnetic field, and wherein at least one of the following is at least partially composed of a non-absorbable biocompatible material that is either non-magnetic or weakly magnetic: the first bone anchor, the second bone anchor, the rigid spinal rod, and the compressible spinal connector.
5. The system of claim 1, wherein the compressible spinal connector is a tether assembly.
6. The system of claim 5, wherein the modulation mechanism is an adjustable tensioner configured to vary the tension on a flexible tether between the second bone anchor and the third vertebra.
7. The system of claim 6, wherein the adjustable tensioner is a turnbuckle comprising a threaded first end coupler, a second end coupler, and a rotatable magnet that rotates in response to a spinning magnetic field and that is connected to the threaded first end coupler to cause the threaded first end coupler to rotate about its longitudinal axis when the rotatable magnet rotates.
8. The system of claim 6, wherein the adjustable tensioner comprises a spool about which the flexible tether is wound, and wherein rotation of a spool magnet drives rotation of the spool.
9. The system of claim 6, wherein the adjustable tensioner comprises a locking mechanism configured to maintain tension on the flexible tether when engaged.
10. The system of claim 5, wherein the flexible tether is constructed of a non-absorbable biocompatible material.
11. The system of claim 1, wherein the compressible spinal connector is a dampening spinal rod that is compressible and expandable.
12. The system of claim 11, the dampening spinal rod comprising: an elongate rigid portion for insertion into a bone anchor; a flared portion for receiving a terminal end of a second spinal rod, the flared portion comprising a rod cavity of sufficient diameter to accept the second spinal rod.
13. The system of claim 11, wherein the modulation mechanism is a friction brake configured to vary the resistance of the dampening rod to compression and tension.
14. The system of claim 13, wherein the friction brake comprises a set screw in a threaded channel positioned to exert compressive force on a spring, said spring positioned to exert compressive force against both the compression and expansion of the dampening rod.
15. The system of claim 14, wherein the set screw is magnetic and rotates in the threaded, channel in response to a spinning magnetic field.
16. The system of claim 1, wherein the compressible spinal connector is a telescoping spinal rod positioned within the second rod housing.
17. The system of claim 16, wherein the telescoping spinal rod comprises: a rod magnet configured to rotate when exposed to a spinning magnetic field and cause the telescoping spinal rod to either extend or collapse depending on the direction of the spinning magnetic field; a first elongate element containing a cavity; and a second elongate element dimensioned to at least partially fit within the cavity, and having an internally threaded region; wherein the modulation mechanism comprises a lead screw coupled to rotate when the rod magnet rotates, and comprising an externally threaded region engaged to the internally threaded region of the second elongate element, such that rotation of the lead screw causes the second elongate element to translate relative to the first elongate element.
18. The system of claim 1, wherein a second rigid spinal rod is seated in an additional rod housing of an additional bone anchor that is anchored in at least one of the first and second vertebrae.
19. The system of claim 18, wherein a transverse connector is fastened to the first rigid spinal rod and the second rigid spinal rod.
20. The system of claim 1, comprising: a third bone anchor comprising a third bone fastener and a third rod housing, anchored to the first vertebra; a fourth bone anchor, comprising a fourth bone fastener and a fourth rod housing, anchored to the second vertebra; a second rigid spinal rod seated in the third rod housing and the fourth rod housing; and a first flexible tether at least partially wrapped around a structure of the third vertebra and connected to both of the first and second rigid spinal rods to exert tension between the third vertebra and the first and second rigid spinal rods; wherein the compressible spinal connector is an adjustable tether assembly, the adjustable tether assembly comprising: a second flexible tether encircling the structure of the third vertebra and a spinous process of a fourth vertebra; and a tensioner connected to the first and second rigid spinal rods, the tensioner comprising a first magnet mounted to rotate in response to a spinning magnetic field, and a tether connection configured to increase or decrease then tension on the second flexible tether depending on the direction of rotation of the first magnet.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
DETAILED DESCRIPTION
[0027] Illustrative embodiments of a system for spinal fixation, parts, and methods for use thereof, are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The system for spinal fixation, parts, and methods for use thereof disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
[0028] This disclosure describes a variety of transitional or terminal components that may be implanted as part of a spinal fixation construct 5 to decrease the potential for subsequent development of junctional disease or failure. In the examples shown only the cephalad most level (for terminal hardware) or levels (for multilevel transitional hardware) of the fixation construct 5 (e.g. those utilizing the exemplary components described herein) are illustrated. It should be appreciated, however, that the entire fixation construct 5 may extend any number of levels from a single level construct to a long construct spanning multiple spinal levels and multiple spinal regions from the lumbosacral to cervical regions (such as the example construct illustrated in
[0029] A general embodiment of the system comprises a first bone anchor 10, anchored to a first vertebra in a subject, the first bone anchor 10 comprising a first bone fastener 15 attached to a first rod housing 20. A rigid spinal rod 25 is seated in the first rod housing 20 to restrict translation of the rigid spinal rod 25 relative to the first bone anchor 10. The rigid spinal rod 25 is seated in the rod housing 35 of a second bone anchor 30, anchored to a second vertebra in the subject, so as to restrict translation of the rigid spinal rod 25 relative to the second bone anchor 30. A compressible spinal connector 40 is connected to the second bone anchor 30 and anchored to a third vertebra in the subject. The compressible spinal connector 40 has a modulation mechanism 45 for modulating either the tension on the compressible spinal connector 40 or its resistance to compression (or both). The modulation occurs in response to a remote signal. Consequently modulation of the tension and/or resistance to compression does not require access to the device 5 through the patient's tissues, and may be performed post-operatively. The remote signal may be, for example, an electromagnetic signal. A specific example of the remote signal is a spinning magnetic field.
[0030]
[0031] The components in the system 5 are constructed from one or more non-absorbable biocompatible materials. Specific examples of such suitable materials include titanium, alloys of titanium, steel, and stainless steel. Parts of the system 5 could conceivably be made from non-metallic biocompatible materials, which include aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polymers such as polypropylene. Interference with the spinning magnetic field can be reduced by constructing one or more portions of the system 5 from a nonmagnetic or weakly magnetic material. Specific examples of such nonmagnetic non-absorbable biocompatible material include titanium, alloys of titanium, aluminum oxide, calcium oxide, calcium phosphate, hydroxyapatite, zirconium oxide, and polymers such as polypropylene. Examples of weakly magnetic materials include paramagnetic materials and diamagnetic materials. In a specific embodiment, the weakly magnetic material is austenitic stainless steel.
[0032] The first, second, and third vertebrae may be adjacent or non-adjacent to one another, in any combination. Thus it is contemplated that the first vertebra will be adjacent to the second, which will be adjacent to the third; the first vertebra will be nonadjacent to the second, which will be adjacent to the third; the first vertebra will be nonadjacent to the second, which will be nonadjacent to the third; and that the first vertebra will be adjacent to the second, which will be nonadjacent to the third.
[0033] According to one example the non-rigid support structure 5 is created through the application of a compressible spinal connector 40 in the form of one or more tether assemblies 95, such as those shown in the exemplary embodiment in
[0034] The tethers 97 may be attached between the fixation hardware 5 and the soft-zone (e.g. one or more non-fixed levels above), and/or directly between the bone elements of one or more fixed levels and the soft-zone, and/or between two or more of the non-fixed levels in the soft-zone. The tether 97 may be formed of any material suitable for medical use. For example, the tether 97 may be made from allograft tendon, autograft tendon, braided, woven, or embroidered polyethylene, braided, woven, or embroidered polyester, polyether ether ketone (PEEK), or polyetherketoneketone (PEKK). In some instances the tether 97 may be formed of elastic material.
[0035] A specific example of the adjustable tensioner 100 is a turnbuckle 105 comprising a threaded first end coupler 110, a second end coupler 115, and a rotatable magnet 120 that rotates in response to a spinning magnetic field and that is connected to the threaded first end coupler 110 to cause the threaded first end coupler 110 to rotate about its longitudinal axis when the rotatable magnet 120 rotates. An embodiment of such a turnbuckle 105 is shown in
[0036] As pictured in
[0037] Another embodiment of the adjustable tensioner 100 is a spool 165 about which the flexible tether 97 is wound, and wherein rotation of a spool magnet 170 drives rotation of the spool 165. An example of such an embodiment is shown in
[0038] Another embodiment of the compressible spinal connector 40 is a dampening rod 235. The dampening rod 235 is a rod that is both expandable and compressible, and the resistance to expansion and compression is controlled by means of the modulation mechanism 45. The modulation mechanism 45 in this embodiment may take the form of a friction brake 240. The dampening rod 235 accommodates dynamic travel or length adjustment of the rod 235 between the fixed connectors 390. The friction brake 240 can include a set screw 205 that is itself magnetic, or connected to a magnet (“brake magnet”) 245 that may be controllable via an external adjustment device 155. The degree of tension and support provided by the dampening rod 235 can be controlled by increasing or decreasing friction with the set screw 205. Some embodiments of the friction brake 240 can also lock down the rod 235 entirely, to prevent any expansion or compression, should it later become necessary to fix one or more levels in the soft-zone. An embodiment of the dampening rod 235 is shown in
[0039] A telescoping rod 255 may also be employed in the system. The telescoping rod 255 may be implanted at levels above a fixation construct 5 in patients that are at high risk of developing PJK or other adjacent segment diseases. The rods 255 may be implanted as a prophylactic and used if needed to extend the length for pain relief. An example of the telescoping rod 255 is shown in
[0040] Whenever the adjustment mechanism is actuated by the rotation of a magnet 120, as a safety precaution, a magnetic immobilization plate 295 may be positioned sufficiently close to the rotatable magnet 120 to cause the rotatable magnet 120 to adhere to the immobilization plate 295 in the absence of a strong external magnetic field. The magnetic immobilization plate 295 will hold the rotating magnet 120 in position, preventing it from rotating, until a stronger magnetic field is applied, such as the rotating magnetic field that is used to adjust the modulation mechanism 45. Like the rotating magnet 120, the immobilization plate 295 may be constructed from a suitable magnetic material, such as a ferromagnetic material. The immobilization plate 295 may be used on its own, or in combination with a locking mechanism 195 as described above.
[0041] A specific embodiment of the system is shown in
[0042] The system may be bilateral, in which the network of bone anchors and rods is present on either side of the spine. Such a bilateral system may comprise a second rigid spinal rod 25b seated in an additional rod housing 365 of an additional bone anchor 370 that is anchored in at least one of the first and second vertebrae. As shown in
[0043] Methods of using the system 5 to fix the relative positions of a first vertebra and a second vertebra in a subject are provided. In a general embodiment the method comprises anchoring a first bone anchor 10 to the first vertebra, the first bone anchor 10 comprising a first bone fastener 15 attached to a first rod housing 20; seating a rigid spinal rod 25a in the first rod housing 20 to restrict translation of the rigid spinal rod 25a relative to the first bone anchor 10; anchoring a second bone anchor 30 to the second vertebra, the second bone anchor 30 comprising a second bone fastener 33 attached to a second rod housing 35; seating the second rigid spinal rod 25b in the second rod housing 35 to restrict translation of the rigid spinal rod 25b relative to the second bone anchor 30; connecting a compressible spinal connector 40 to the second bone anchor 30, the compressible spinal connector 40 comprising a modulation mechanism 45 for modulating at least one of the tension on the compressible spinal connector 40 or the resistance to compression of the compressible spinal connector 40, wherein said modulation 45 occurs in response to a remote signal; anchoring the compressible spinal connector 40 to a third vertebra in the subject; and transmitting the remote signal to the modulation mechanism 45 post-operatively, to cause said modulation to occur. The system 5 may have any of the components and arrangements described above. The compressible spinal connector 40 can be any described as suitable for the system above, including any of the described embodiments of the tether assembly 95, dampening rod 235, and telescoping rod 255.
[0044] An example of an external adjustment device 155 used to non-invasively drive the adjustment mechanisms on the various implants described herein is represented in