Spinal alignment and securement
20170238971 · 2017-08-24
Inventors
Cpc classification
A61B17/7032
HUMAN NECESSITIES
A61B2017/681
HUMAN NECESSITIES
A61B17/7037
HUMAN NECESSITIES
A61B17/7049
HUMAN NECESSITIES
International classification
Abstract
A surgical connection device for a spine is disclosed including a stabilization member, compression arms and traction arms, the device being used in conjunction with first anchor points fixed to vertebrae at a first lateral side of the spine and second anchor points fixed to vertebrae at a second lateral side of the spine. A first spinal rod may be attached to the first anchor points and a second spinal rod may be attached to the second anchor points. The compression arms connect the stabilization member to the first and second anchor points or rods and bear compressive forces. The traction arms connect the stabilization member to the first and second anchor points or rods and bear tensile forces. Application of both tensile and compressive forces via the device may serve to straighten, change a direction of bending or increase a degree of bending of the rods and/or spine. The use of the traction arms may also provide for a more flexible construct.
Claims
1. A surgical connection device for a spine, a plurality of first anchor points being fixed to vertebrae at a first lateral side of the spine, a plurality of second anchor points being fixed to vertebrae at a second lateral side of the spine, a first spinal rod being attached to the plurality of first anchor points and a second spinal rod being attached to the plurality of second anchor points, the device comprising: a stabilization member; a plurality of compression arms to connect the stabilization member to the first and second rods and bear compressive forces between the stabilization member and the first and second rods; and a plurality of traction arms to connect the stabilization member to the first and second rods and bear tensile forces between the stabilization member and the first and second rods.
2. The surgical connection device of claim 1, wherein the stabilization member is elongate.
3. The surgical connection device of claim 2, wherein the stabilization provides a third spinal rod that is configured to extend substantially parallel to the first and second rods.
4. The surgical connection device of any one of the preceding claims, wherein the plurality of compression arms comprise at least a first compression arm to connect between the stabilization member and the first rod and at least a second compression arm to connect between the stabilization member and the second rod.
5. The surgical connection device of claim 4, wherein the plurality of traction arms comprise at least two first traction arms to connect between the stabilization member and the first rod.
6. The surgical connection device of claim 5, wherein the two first traction arms connect to the first rod at positions on either side of the position at which the first compression arm connects to the first rod.
7. The surgical connection device of claim 5 or 6, wherein the plurality of traction arms comprise at least two second traction arms to connect between the stabilization member and the second rod.
8. The surgical connection device of claim 8, wherein the two second traction arms connect to the second rod at positions on either side of the position at which the second compression arm connects to the second rod.
9. The surgical connection device of any one of the preceding claims, wherein the connection positions of the compression arms to the stabilization member and/or the connection positions of the compression arms to the rods are variable along an axis of elongation of the stabilization member and rods.
10. The surgical connection device of any one of the preceding claims, wherein the connection positions of the traction arms to the stabilization member and/or the connection positions of the traction arms to the rods are variable along an axis of elongation of the stabilization member and rods.
11. The surgical connection device of any one of the preceding claims, wherein the compression arms are able to withstand substantially higher compressive forces than the traction arms.
12. The surgical connection device of any one of the preceding claims, wherein the traction arms are more flexible than the compression arms.
13. The surgical connection device of any one of the preceding claims, wherein the compression arms extend from the stabilization member in an anterior-lateral direction.
14. The surgical connection device of any one of the preceding claims, wherein a first one of the compression arms extends from the stabilization member in an anterior-lateral direction towards the first rod; a second one of the compression arms extends from the stabilization member in an anterior-lateral direction towards the second rod; one of the traction arms extends from the stabilization member in an anterior-lateral-superior direction from the stabilization member towards the first rod; another of the traction arms extends from the stabilization member in an anterior-lateral-inferior direction from the stabilization member towards the first rod; another of the traction arms extends from the stabilization member in an anterior-lateral-superior direction from the stabilization member towards the second rod; and another of the traction arms extends from the stabilization member in an anterior-lateral-inferior direction from the stabilization member towards the second rod.
15. The connection device of any one of the preceding claims, wherein the stabilization member is configured to locate medially and posteriorly of the first and second rods.
16. The connection device of any one of the preceding claims, wherein when the stabilization member is connected to the first and second rods by the arms, the direction of elongation of the stabilization member lies substantially parallel to the axis, or desired axis, of the spine and the stabilization member locates: (a) posteriorly of the rods at a position that is not substantially more posterior than the posterior extents of the tips of spinous processes of the vertebrae to which the anchor points are fixed; or (b) when one or more spinous processes of the vertebrae to which the anchor points are fixed have been removed, posteriorly of the rods at a position that is not substantially more posterior than the positions at which the posterior extents of the tips of the spinous processes of the vertebrae to which the anchor points are fixed were located prior to removal.
17. A surgical connection device for a spine, a plurality of first anchor points being fixed to vertebrae at a first lateral side of the spine and a plurality of second anchor points being fixed to vertebrae at a second lateral side of the spine, the device comprising: a stabilization member; a plurality of compression arms to connect the stabilization member to at least one first anchor point and at least one second anchor point and bear compressive forces between the stabilization member and the first and second anchor points; and a plurality of traction arms to connect the stabilization member to at least one first anchor point and at least one second anchor point and bear tensile forces between the stabilization member and the first and second anchor points.
18. A surgical method for a spine, a plurality of first anchor points being fixed to vertebrae at a first lateral side of the spine, a plurality of second anchor points being fixed to vertebrae at a second lateral side of the spine, a first spinal rod being attached to the plurality of first anchor points and a second spinal rod being attached to the plurality of second anchor points, the method comprising: connecting a stabilization member of a surgical connection device to the first and second rods using a plurality of compression arms that are configured to bear compressive forces between the stabilization member and the rods; and connecting a plurality of traction arms of the surgical connection device between the stabilization member and the first and second rods, the traction arms being configured to bear tensile forces between the stabilization member and the rods.
19. A surgical method for a spine, a plurality of first anchor points being fixed to vertebrae at a first lateral side of the spine and a plurality of second anchor points being fixed to vertebrae at a second lateral side of the spine, the method comprising: connecting a stabilization member of a surgical connection device to at least one first anchor point and at least one second anchor point using a plurality of compression arms that are configured to bear compressive forces between the stabilization member and the first and second anchor points; and connecting a plurality of traction arms of the surgical connection device between the stabilization member and at least one first anchor point and at least one second anchor point, the traction arms being configured to bear tensile forces between the stabilization member and the first and second anchor points.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0121] Embodiments of the present disclosure are now described by way of example only with reference to the accompanying drawings, in which:
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DESCRIPTION OF EMBODIMENTS
[0150] Embodiments of the present disclosure relate to posterior spinal surgery, including spinal fixation surgery, used in the treatment of spinal conditions such as spondylolisthesis, scoliosis, spinal trauma, spinal tumor and other spinal deformities or degenerative conditions. The surgery can involve inserting pedicle screws into vertebrae to establish anchor points. A stabilizing rod can then be secured between several of the anchor points to restrict or limit relative movement between vertebrae. This process can be carried out on opposite sides of the spine such that first and second rods are in place. When the posterior spinal surgery is completed, spinal fusion may be carried out through bone grafting and other means.
[0151] Embodiments of the present disclosure also relate to motion preservation devices, e.g. for use in conjunction with a mobile disc replacement or otherwise. In general, where bone fusion is carried out, articulation of the spine is substantially eliminated. Surgical connection devices according to embodiments of the present disclosure may be used as an adjunct to fusion, e.g., to provide motion preserving support to vertebrae located to one or both sides of a section of fused vertebrae, or to be used in place of a spinal fusion. In either case, the surgical connection device may provide for a stabilisation region of the spine while enabling motion preservation at or adjacent the stabilised region.
[0152] Perspective views of a surgical connection device 100 according to an embodiment of the present disclosure are provided in
[0153] The connection device 100 has a cruciform structure, with the axis of elongation of the stabilization member 110 configured to lie substantially parallel to the spinal axis and to the axes of elongation of the first and second rods 210, 220 when implanted.
[0154] Referring to
[0155] The first and second compression arms 120, 130 each extend both anteriorly and laterally from the stabilization member 110. Thus, when connected to the first and second rods 210, 220, the stabilization member 110 locates posteriorly and medially of each of the first and second rods 210, 220. A cross-sectional view of the device 100 along line A-A of
[0156] Referring to
[0157] The pair of first traction arms 141a, 141b are connected to the first rod 210 at positions on either side of the position at which the first compression arm 120 is connected to the first rod 210. In particular, one of the first traction arms 141a is connected to the first rod 210 at a position that is superior to the position at which the first compression arm 120 connects to the first rod 210 and the other first traction arm 141b is connected to the first rod 210 at a position that is inferior to the position at which the first compression arm 120 connects to the first rod 210. Similarly, the pair of second traction arms 142a, 142b are connected to the second rod 220 at positions on either side of the position at which the second compression arm 130 connects to the second rod 220. In particular, one of the second traction arms 142a is connected to the second rod 220 at a position that is superior to the position at which the second compression arm 130 is connected to the second rod 220 and the other second traction arm 142b is connected to the second rod 220 at a position that is inferior to the position at which the second compression arm 130 connects to the second rod 220.
[0158] The traction arms 141a, 141b, 142a, 142b are connected to the stabilization member 110 via slots 115 provided in the stabilization member 110. In this embodiment, the traction arms 141a, 141b, 142a, 142b generally have a fixed angle to the rods 210, 220 and can be slid along a respective one of the slots 115 to be connected to the stabilization member 110 at an appropriate location.
[0159] When the device 100 is implanted, the first compression arm 141a extends from the stabilization member 110 in an anterior-lateral(right) direction towards the first rod 210, the second compression arm extends from the stabilization member 110 in an anterior-lateral(left) direction towards the second rod 220; one of the pair of first traction arms 141a extends from the stabilization member 110 in an anterior-lateral(right)-superior direction towards the first rod 210, the other one of the pair of first traction arms 141b extends from the stabilization member 110 in an anterior-lateral(right)-inferior direction towards the first rod 210, one of the pair of second traction arms 142a extends from the stabilization member 110 in an anterior-lateral(left)-superior direction towards the second rod 220, and the other one of the pair of second traction arms 142b extends from the stabilization member 110 in an anterior-lateral(left)-inferior direction towards the second rod 220.
[0160] The two pairs of traction arms 141a, 141b, 142a, 142b are placed under tension between the stabilization member 110 and the first and second rods 210, 220, resulting in superior and inferior portions of each of the first and second rods 210, 220 being pulled towards the stabilization member 110 while the first and second compression members 120, 130 maintain an intermediate portion of each of the first and second rods 210, 220, located between the superior and inferior portions, at a substantially fixed distance away from the stabilization member 110. The controlled application of tensile forces and compressive forces to different portions of the first and second rods 210, 220 can straighten the first and second rods 201, 220, change a direction of bending of the first and second rods 210, 220 or increase a degree of bending of the first and second rods 210, 220. Bending of the first rod 210, following connection of the traction arms 141a, 141b, 142a, 142b, is illustrated in
[0161] A flow chart 1000 indicating steps carried out to connect the connection device 100 to the first and second rods is provided in
[0162] The device 100 can be manufactured in a variety of different shapes and sizes, e.g., for use with spines of differing sizes or for use at spinal portions that have or have not been subjected to a laminectomy. Referring to
[0163] The stabilization member may therefore provide a third elongate stiffening element, e.g. a form of third rod, which is posteriorly located relative to the first and second rods. By positioning the stabilization member posteriorly of the first and second rods, and through the provision of both traction and compression arms, a surgeon may be provided with a significantly increased ability to control the application of forces applied to vertebrae via the first and second rods for the purpose of re-alignment and/or stabilization of the vertebrae. Substantial forces may be applied to the rods via the arms in any direction in three-dimensional space. The forces may be transmitted to vertebrae by pedicle screws attached to the rods, without pulling out the screws or breaking the pedicle. There may be provided reinforcing of the rod/screw construct in all planes to resist or modulate deforming loads applied to the construct during weight bearing, e.g., prior to the fusion of the spine. The devices and apparatus may assist in the application of forces to adjacent segments of the rod/screw construct, e.g. sections defined between immediately adjacent pedicle screws or between a plurality of pedicle screws. The devices and apparatus may buffer against undesirable distortion at an end of the construct for example, while maintaining e.g., a lordotic or kyphotic bias, for example. These forces may be applied off-spinal-axis where a slight enduring scoliosis is encountered. The devices and apparatus may provide for a triangular-cross section of reinforcement and may provide means of shaping rods in situ.
[0164] While the device 100, e.g., as illustrated in
[0165] In an alternative embodiment, to enable the connection device to be used in conjunction with vertebrae that have not been subjected to a laminectomy, while positioning the stabilization member on the mid-sagittal plane, the stabilization member may comprise a central opening to receive one or more spinous processes. For example, with reference to
[0166] Referring again to
[0167] The second ends 122, 132 of the compression arms 120, 130 may be connected to the respective rods 210, 220 via a connection element such as an integral or separately formed sleeve or foot-piece, which is clamped to the rod 210, 220. If the rods 210, 220 are not parallel, as is often the case, the compression arms 120, 130 may be bent manually to accommodate this non-parallel rod alignment without weakening their resistance to compression. Example foot-pieces 123, 133, which mount to the rods 210, 220, are illustrated in
[0168] To provide for increasingly secure engagement between the compression arms 120, 130 and the rods 210, 220, a connection arrangement may be provided as illustrated in
[0169] The second ends of the traction arms 141a, 141b, 142a, 142b may be connected to the respective rods 210, 220 via hook elements 1411, as indicated very generally in
[0170] To provide for increasingly secure engagement between the traction arms 141a, 141b, 142a, 142b and the rods 210, 220, a locking piece 143 can be provided as illustrated in
[0171] The screw 144 also provides a pivot for the locking piece 143, around which the locking piece 143 can rotate relative to the traction arm 141a. When the screw 144 is in a loosened stated, the locking piece 143 can pivot away from the hook element 1411 to a storage position as illustrated in
[0172] In connection devices according to embodiments of the present disclosure, the stabilization member can have the added benefit of providing a guiding or reattachment surface for spinal musculature and fascia after surgery, allowing better wound closure and care. It may allow the musculature to lie in a more anatomic post-operative plane and hence may decrease post-operative pain/stiffness. It may improve post-operative muscular power and function and provide for more efficient energy utilization of these muscles to residual un-instrumented levels. Additionally, the stabilization member and/or other parts of the device, may be used as a support for further dynamic connectors between instrumented vertebrae allowing controlled yet flexible deformity correction superior to and/or inferior to the fused section. Furthermore, the device may act as a scaffold for increased bone graft attachment points and hence greater fusion mass.
[0173] In a further embodiment of the present disclosure, as illustrated in
[0174] In a further variation, a combination of traction and compression arms may be employed with or without further stiffening additions, to retain a kyphotic, lordotic and rotational stiffness, yet allow longitudinal displacement of the pedicle screws (or other vertebral securing means) with respect to each other, as is desirable to occur with growing, younger scoliotic patients. By this expedient approach, repeated surgeries or stunting of growth may be obviated while still correcting the deformity of scoliosis in younger patients. The longitudinal “play” in the arms can be achieved by uniaxial pliability in their formed shape, such as can be generated by a single plane of spring forming within the material and stiffening cross members for rotational stability.
[0175] With reference to
[0176] The cross-bar 31 and buttress 32 can be integrally formed or can be separate pieces that are assembled during surgery, e.g. by being snap-fit to each other and/or to the stabilization member 110 and first and second rods 210, 220. The cross-bar 31 and buttress 32 are each elongate, with their directions of elongation extending substantially perpendicularly to each other. The cross-bar 31 extends in a medial-lateral direction and the buttress 32 extends in an anterior-posterior direction, providing in combination a generally T-shaped support 30.
[0177] A support configured in a similar manner to the support 30 described above can be used in conjunction with other types of surgical connection devices according to embodiments of the present disclosure. In one embodiment, with reference to
[0178] With reference to
[0179] With reference to
[0180] Diagonally extending arched rods 41, 42, 43, connected to substantially straight first and second rods 210, 220, are described above with reference to
[0181] In any of the embodiments disclosed herein, the surgical connection device may modify the stiffness of the spine at different positions of the spine, e.g. at different vertebral levels, to different degrees. The stiffness may be may be modified through the provision of a stabilizing member with varying stiffness over its length, and/or through the provision of arms connecting the stabilizing member to rods or anchor points that have differing stiffness properties. The stiffness may be selected depending on the degree of motion preservation required and the location of the required motion preservation. The stabilization member and/or arms may vary in stiffness through material selection, diameters and/or shape including sinuosity, e.g. flexible s-bends.
[0182] The stabilization member and/or arms may have varying flexibility across different planes. For example, they may have omni-directional flexibility, bi-directional flexibility, or uni-directional flexibility. The stabilization member and/or arms with omni-direction flexibility may have uniform flexibility in every plane or different flexibility in different planes. Directional variation in flexibility may be achieved through shaping of the stabilization member and/or arms. For example, any one of the arms may be have a plate-like configuration similar to the arm 146 illustrated in
[0183] In any of the embodiments, one or more of the arms may include resorbable elements such as resorbable collars that serve to stiffen the arms, but which are gradually resorbed within the body such that their stiffening effect gradually reduces over time. Thus, any one or more arms may have a flexibility that changes over time. This can be advantageous where increased stiffening and stabilization is required immediately post-implantation, to ensure appropriate patient recovery, but where increased flexibility and motion preservation is desirable thereafter.
[0184] An example of a surgical connection device 50 including arms with resorbable elements according to an embodiment of the present disclosure is illustrated in
[0185] In another embodiment, as shown in
[0186] With reference to
[0187] With reference to
[0188] The first control arm 83 is adapted to control a movement of the second portion of the spine, including the non-fused superior vertebrae 2306, relative to the stabilization member 81. At the second portion 812 of the stabilization member 81, the stabilization member 81 locates at a position that is medial to a first lateral edge 2307 of the vertebra 2306. The first control arm 83 projects outwardly from the second portion 812 of the stabilization member in a direction towards the first lateral edge 2307.
[0189] The first control arm 83 is rotatable relative to the second portion 812 of the stabilization member 81 and rotatable relative to the vertebra 2306. Rotation is achieved through the provision of articulated joints 831 between the first control arm 83 and stabilization member 81 and between the first control arm 83 and the vertebra 2306.
[0190] The first control arm 83 is substantially rigid such as to maintain a fixed length while permitting movement between the vertebra 2306 and the stabilization member 81.
[0191] A variation of the connection device 80 is illustrated in
[0192] The second control arm 84 is also rotatable relative to the second portion 812 of the stabilization member 81 and rotatable relative to the vertebra 2306. Rotation is again achieved through the provision of articulated joints 841 between the second control arm 84 and stabilization member 81 and between the second control arm 84 and the vertebra 2306.
[0193] By providing a first control arm 83, or first and second control arms 83, 84, which arm(s) control movement of the vertebra 2306 relative to the stabilization member 81, the surgical connection device 80 can provide for re-alignment of the scoliotic spine. Where a recipient of the surgical connection device is a child, for example, natural movement of the spine may occur as a result of growth of the spine post-implantation. The growth may be such as to move the vertebra 2306 in a direction away from the first portion of the spine including fused vertebrae 2301, 2302, 2303. However, by connecting the control arm(s) to the non-fused vertebra 2306, the direction of growth is controlled by the surgical connection device 80. Relative lengthening of the spine forces the control arm(s) 83, 84 to rotate through an arc in respective planes. The orientation of each plane is selected to drive a desired correction of the tilt and rotation of the scoliotic spine. Assisting in this process is the anchoring of the stabilization member to the fused portion of the spine.
[0194] When a single, first control arm 83 is employed, the rotation of the arm 83 forces lateral and posterior movement of the vertebra 2306, from a position as represented in
[0195] When both a first control arm 83 and a second control arm 84 are employed, the rotation of the arms 83, 84 forces lateral and posterior movement of the vertebra 2306 along with rotation of the vertebra about the spinal axis, from a position as represented in
[0196] The surgical connection device 80, while not restricting growth of the spine, may therefore force a straightening or other type of shape adjustment of the spine during growth of the spine. This can be particularly advantageous to treat scoliosis of the spine in children, although the connection device is not necessarily limited to such use. By taking the approach disclosed, growth of the spinal column may not be retarded, the need for re-operation to allow growth may be obviated or at least reduced, and correction of the spine can be achieved post-operatively and in a gradual fashion.
[0197] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure.
[0198] For example, while the device illustrated in some of the Figures is provided with compression arms projecting across a single transverse plane only, in other embodiments, compression arms may project over different transverse planes or in other directions. Two pairs of first and second compression arms may be provided, for example, located at different positions along the axis of elongation of the stabilization member.
[0199] As another example, in any one of the embodiments further arms of rods may be connected to the arms, e.g., the traction or compression arms, in a longitudinally arranged manner. This may further stabilise the construct and provide further stiffening or induction of tension. The further arms or rods may run substantially parallel to the first and second rods and to the stabilisation device, for a portion or whole of the construct. This may be particularly advantageous where the first and second rods (connected between the anchor points) are excluded, in order to increase rigidity of the construct.
[0200] As yet another example, the device may comprise additional arms that are connectable to the stabilisation member where longer constructs are desired. For example, first and second compression arms may be integral to the system, but for longer constructs further compression arms may be also be included or selectively introduced by the surgeon.
[0201] The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.