A MODIFIED COMPRESSION APPLIANCE AND ASSOCIATED HARDWARE FOR USE IN SPINAL SURGERY
20230404627 ยท 2023-12-21
Inventors
Cpc classification
A61B17/7077
HUMAN NECESSITIES
A61B17/7032
HUMAN NECESSITIES
International classification
Abstract
A compression assembly for positioning spinal vertebra to which are attached anchors on which is mounted a lockable primary rod movable relative to the anchors. The assembly comprises a compression tool capable of inducing a compressive force to said anchors to enable said positioning of said vertebra. The compression tool having first and second arms each having a distal working end which in use, a first of said arms engages the rod. Each said first and second distal working ends of the tool, each have a formation which co-operates with the rod; the formation on the second arm by co-operation with an anchorage associated with or on the primary rod enabling a concurrent rotation of the rod and translation of a vertebra to which the rod is connected via the vertebral anchors during compression applied to said anchors by the compression tool prior to locking of the rod by the vertebral anchors when vertebrae are in a selected position.
Claims
1. A compression assembly for positioning spinal vertebra to which are attached anchors on which is mounted a lockable primary rod movable relative to the anchors; the assembly comprising a compression tool capable of inducing a compressive force to said anchors to enable said positioning of said vertebra; the compression tool having first and second arms each having a distal working end which in use, a first of said arms engages the rod; characterised in that each said first and second distal working ends of the tool, each have a formation which co-operates with the rod; the formation on the second arm by co-operation with an anchorage associated with or on the primary rod enabling a concurrent rotation of the rod and translation of a vertebra to which the rod is connected via the vertebral anchors during compression applied to said anchors by the compression tool prior to locking of the rod by the vertebral anchors when vertebrae are in a selected position.
2. A compression assembly according to claim 1 wherein, the formation on the second of said arms which enables the vertebral translation is configured to maintain the engagement with the anchorage on the primary rod during said concurrent compression and translation of the vertebrae.
3. A compression assembly according to claim 2 wherein, the formation on the first arm of the compressor comprises a two pronged fork defining a recess which locates over and receives the primary rod.
4. A compression assembly according to claim 3 wherein, the formation on the first arm is configured to co operate with the rod by accommodating downward pressure on the rod transmitted to the rod via the first arm.
5. A compression assembly according to claim 4 wherein, the formation on the first arm permits relative movement between the formation and the rod.
6. A compression assembly according to claim 5 wherein the first and second arms are detachable from the compression tool.
7. A compression assembly according to claim 6 wherein said rotation of the rod induced by the compressor is along a sagittal plane
8. A compression assembly according to claim 7 wherein, the formation on the second arm of the compressor comprises a two pronged fork with a bridge spanning from one fork to another
9. A compression assembly according to claim 8 wherein, the bridge engages an inclined recess formed in the primary rod.
10. A compression assembly according to claim 7 wherein, the formation on the second arm comprises a circular opening.
11. A compression assembly according to claim 10 wherein, the circular opening on the second arm receives and end of the primary rod thereby retaining the second arm against the rod.
12. A compression assembly according to claim 7 wherein, the formation on the second arm comprises a cantilevered post.
13. A compression assembly according to claim 12 wherein, the cantilevered post is configured to engage an opening in the rod.
14. A compression assembly according to claim 7 wherein, the formation on the second arm comprises a hook.
15. A compression assembly according to claim 14 wherein, the hook engages underneath the rod.
16. A compression assembly according to claim 7 wherein the vertebral anchors are pedicle screws each including a recess which receives and retains the primary rod, the pedicle screws capable of locking the rod once a compression and translation of vertebrae required for lordosis is achieved by the compressor.
17. A compression assembly according to claim 16 wherein, the compression tool has a scissor action enabled by a pivot.
18. A compression assembly according to claim 17 wherein, the rod has a preformed opening.
19. A compression assembly according to claim 18 wherein, the preformed opening is a circular recess at one end of the primary rod.
20. A compression assembly according to claim 19 wherein, the preformed opening is a slot.
21. A compression assembly according to claim 20 wherein, the preformed slot accommodates a bridge in a fork formation in the second arm.
22. A compression assembly according to claim 21 wherein, the preformed slot is configured to prevent separation and withdrawal of the bridge when the rod is under sagittal plane rotation.
23. A compression assembly according to claim 22 wherein, the formation in the primary rod which receives the second arm of the compressor is selected from the following formations: an opening, a groove, a slot, an abbreviation, a recess, a through hole, indent.
24. A compression assembly according to claim 7 wherein the second arm formation cooperates with the rod via a detachable attachment to the rod.
25. A compression assembly according to claim 24 wherein the detachable attachment comprises an attachment body having jaws defining an internal space which receives the primary rod.
26. A compression assembly according to claim 25 wherein, the internal space is generally C shaped
27. A compression assembly according to claim 26 wherein, the jaws are lockable about the primary rod by a locking screw.
28. A compression assembly according to claim 27 wherein, the attachment body further comprises an outstanding formation which receives and retains the formation on the second arm.
29. A compression assembly according to claim 28 wherein, the formation on the second arm comprises a cantilevered post.
30. A detachable arm for detachable attachment to a compression tool used for positioning spinal vertebra to which are attached anchors on which is mounted a lockable primary rod movable relative to the anchors; the compression tool capable of inducing a compressive force to said anchors to enable said positioning of said vertebra; the compression tool having first and second detachable arms, one said detachable arm having a distal working end formation which in use, engages with and cooperates with the primary rod; he formation on the arm by co-operation with an anchorage associated with or on the primary rod enabling a concurrent rotation of the rod and translation of a vertebra to which the rod is connected via the vertebral anchors during compression applied to said anchors by the compression tool prior to locking of the rod by the vertebral anchors when vertebrae are in a selected position.
31. A detachable attachment for detachable attachment to a primary rod to which are attached vertebral anchors on which is mounted the primary rod; a compression tool used for positioning spinal vertebrae capable of inducing a compressive force to said vertebral anchors to enable said positioning of said vertebrae; the compression tool having first and second detachable arms, one said detachable arm having a distal working end formation which in use, engages with and cooperates with the detachable attachment to the primary rod; the formation on the arm by co-operation with the detachable attachment to the primary rod enabling a concurrent rotation of the rod and translation of a vertebra to which the vertebral anchors are during compression applied to said anchors by the compression tool prior to locking of the rod by the vertebral anchors when vertebrae are in a selected position.
32. A compression tool for enabling positioning spinal vertebra by acting on anchors attached to said vertebra and which have mounted thereon a lockable primary rod; the compression tool capable of inducing a compressive force to said anchors to enable said positioning of said vertebra; the compression tool having first and second arms each having a distal working end which in use, engages the rod; characterised in that each said first and second distal working ends of the tool, have a formation which co-operates with the rod; at least one said formations by engagement with the rod resisting separation between the at least one formation and the rod during compression of the screws and rotation of the rod to effect translation of a vertebra during compression applied to said anchors prior to locking of the rod by the anchors.
33. A compression tool according to claim 32 wherein, the formation on the first of said arms comprises a two pronged fork which receives the rod between the forks.
34. A compression tool according to claim 33 wherein, the formation on the second of said arms comprises a cantilevered post which engages an opening in the rod.
35. A compression tool according to claim 33 wherein, the formation on the second of said arms comprises a hole which enables engagement with the rod via and end of the rod.
36. A compression tool according to claim 33 wherein the formation on the second of said arms comprises a hook which engages an underside of the rod.
37. A compression tool according to claim 33 wherein the formation on the second of said arms comprises a two pronged fork having a bridge spanning between the prongs, the bridge engaging a recess in the rod.
38. A compression tool according to claim 37 wherein the recess in the rod is configured to retain the bridge by rotation of the arm relative to the recess.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:
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DETAILED DESCRIPTION
[0066] The present invention will now be described in more detail according to a preferred embodiment but non limiting embodiment and with reference to the accompanying illustrations. The examples referred to herein are illustrative and are not to be regarded as limiting the scope of the invention. While various embodiments of the invention have been described herein, it will be appreciated that these are capable of modification, and therefore the disclosures herein are not to be construed as limiting of the precise details set forth, but to avail such changes and alterations as fall within the purview of the description. Although the invention in one form will be described with reference to transverse rods extending from the compressor it will be appreciated by persons skilled in the art that alternative formations which achieve the inventive objects are contemplated, including the shape, angle, size orientation and material of construction of the compressor formations. A reference to a primary rod will be a reference to a rod used in co-operation with a pedicle screw or the like in a spinal rod and screw assembly.
[0067] Restoration of the correct shape of the spine is one of the modern metrics of a successful lumbar spinal fusion operation. However despite this knowledge, numerous studies show that fusing the spine in a suitably lordotic shape is often not achieved. Failure to fuse the lumbar spine with adequate lordosis can result in increased pain, worse quality of life and more surgery for adjacent segment disease. Currently, achievement of optimal lordosis is to a significant extent influenced by limitations on the compressor instrument characteristics and features and vertebral motion in fusion. The present invention to be described in detail below, provides a compressor tool having working ends which optimise vertebral motion in fusion to thereby optimise lordosis. This is enabled by formations on the working end or ends of the compressor which engage the rod so that the tool can apply a rotational force to the rod at the same time as application of a compression force.
[0068] The engaging formation enables an engagement with the rod which in turn enables optimisation of motion segment behaviour during the compression phase of spinal fusion. This enables an increase in the extent of lordosis. According to one embodiment, the rods may be adjusted to accommodate the formations on the distal working ends of the arms of the compressor. According to a preferred embodiment the modified compressor works in conjunction with existing or modified rodsi.e. all tulip based pedicle screw systems with appropriate sized rods. One advantage of the present invention is that it enables additional rod movement control without having to lock one of the pedicle screws against the rod to prohibit the tendency for unwanted axial rotation of the rod during the compression step. More specifically it allows the new compressor to control the rod position without locking either tulip.
[0069] The modification to the compression tool described herein provides a mechanical advantage when compression is applied to pedicle screws prior to locking of a rod by the screws when a required optimal degree of vertebral lordosis has been achieved. The formation on the distal end of an arm of the compression tool resists separation between the arm and rod. The tool allows the surgeon to apply the required compression and at the same time sagittal rotation of the rod inducing a translation of one vertebra. The sagittal rotation of the rod during compression of the pedicle screws prevents unwanted axial rotation of the rod and unwanted displacement of the rod relative to the screws during positioning of the vertebra for the required lordosis.
[0070] According to the conventional technique, when compression of the screws is induced by a compression tool for setting the required lordosis (spinal curvature) the rod must be locked against one screw to avoid unwanted axial rotation/displacement and/or relative movement between the rod and screws. Using the modified tool according to the present invention there is no need to pre lock the rod to one of the screws as the sagittal rotation of the rod which induces translation of a disc and enabled by the formation on the distal end of one arm of the compression tool avoids relative movement between the rod and screws during setting of the required lordosis. A frictional resistance between rod and screw is achieved when the rod is rotated in the sagittal plane. This means that one surgeon can at the same time, apply the required compression and attend to locking of the screws without concern that unwanted displacement of the rod will occur during that process.
[0071] The present invention enables achievement of more lordosis that can otherwise be achieved using conventional compressors. The surgeon can achieve this using one hand which at the same time compresses and rotates (induced by pulling up on the rod) leaving the other hand free to tighten/lock the pedicle screws against the rod. Alternatively, the surgeon can simultaneously perform the aforesaid function of compression and rotation on two compressors at the same time which may require an assistant to tighten the pedicle screws to effect rod locking.
[0072] Although the invention is described herein with reference to various embodiments, a preferred embodiment provides an assembly which employs an implantable longitudinal rod which has an opening such as a recess, hole, slot, abbreviation, indent, at or near one end of the rod and a compressor having two arms one having a distal formation for pressing the rod down and the other arm having a formation which maintains engagement between the rod and arm formation when pulling up or pushing down on the rod.
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[0074] In an alternative embodiment, posts 14 and 15 are fixed to distal arms 10 and 11 respectively but do not undergo rotation relative to arms 10 and 11. In that case their movement is in unison with respective distal arms 10 and 11.
[0075] According to one embodiment arms 10 and 11 may detachably receive and retain respective transverse posts 14 and 15. In this regard, the device can be fitted with the transverse rods as attachments allowing interchangeability of working ends. Alternatively arms 10 and 11 are detachable and include rods or other analogous formation as a working end to be used as described. The geometry of posts 14 and 15 allows their use in effecting distraction, compression and rotation about an axis parallel to the axes through the rods.
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[0078] The present invention teaches an improved compressor and distractor device which includes formations to accommodate an opening in either a rod or pedicle screw to thereby enable more versatile manipulation of the spinal vertebra. Specifically, the transverse posts 14 and 15 are capable of engagement with opening 30 to allow both compression and rotation of vertebra at the same time. This enables a surgeon to more accurately position the screw and rod system 20 to achieve the correct lordosis. This arrangement allows the compressor distractor device 1 to connect with bony anchors such as screws 24, 25, or 26 as selected by a surgeon and with opening 30 in rod 27 to effect movement of spinal vertebra in multiple directions. For example, with one of posts 14 or inserted into a pedicle screw and the remaining other post (14 or 15 inserted into opening 30 a surgeon can compress compression of the pedicle screw and at the same time by virtue of the engagement of one of posts 14 or 15 with opening 30 to effect rotation of the spinal vertebra as device 1 moves through a plane transverse to the axis of posts 14 and Rod 27 after correct setting of the vertebra may be left in situ or removed. As the screws which are anchored in bone this causes the bone to move relative to the rod 27. A contemporaneous rotation of the rod 27 allows a close simulation of the anatomical translational behaviour and more accurate setting of the vertebra in their desired position. behaviour and practice device 1 can induce compression.
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[0081] Compressor 1 can act parallel or at an angle to the long axis. posts 14 and 15 of device 1 can be adapted with a variety of geometries including angulated hollow tube, allen key engagement, alternative male female interfitting. A variety of dimensions are contemplated for the posts and the nature of the male female engagement can be interchanged. For example the primary rods may include a formation which engages and is retained by the compression device 1. It is contemplated that the co-operation between the formation/s on the primary rod and the formation/s of the compression device 1 is a connection allowing shear force transmission for strength. Device 1 according to one embodiment includes a ratcheting lock which enables setting of the device once engaged. The transverse post member connection to the primary rod allows relative rotation to occur between the formation of the primary rod and the co-operating engaging compressor post formations. As a result of this engagement the compressor is able to tilt and apply anteropostero forces in addition to Cranio caudal forces. Combined left and right instruments connected to screws can impart axial rotation forces to the spine. According to one embodiment, posts 14 and 15 are fixed to the compressor 1 without any relative rotation between the compressor and engaging formation extending therefrom.
[0082] In practice the device and assembly of the present invention in all its forms can be used according to the following methodology which is described by reference to a non limiting first example. One rod is attached to two bone anchors (pedicles) on one side of an exposed spine. A second rod is attached on the opposite side; for example rods are attached to poly axial tulips of screws entering pedicles of L5 and Si. Pedicle tulips are rotated to 90 degrees from a permanent position. Openings for rods lie transversely. The poly axial nature of most tulips allow engagement of the tool rods even if screws are not perfectly aligned. Different length rods allow engagement with tulips even if not in the same sagittal plane. Formations on the distal ends of compressor Device 1 (described previously as posts 14 and 15), fit into the tulip. Posts 14 and 15 can be locked to tulip screws by caps. According to one embodiment, the rod may rotate relative to the compressor due to rotational engagement with compressor arms (10 and 11). Each rod can be locked to prevent unwanted withdrawal and to immobilise the tulip. Locking of tulips securely, prevents unwanted rod withdrawal and prevents unwanted head motion during compression. Alternatively, the rod can be left loose in the tulip and restrained from axial rotation by interaction with the compressor.
[0083] Another practical example of the operation of the assembly of the invention is described below. After attachment of one arm of the compressor device 1 to one selected anchor and the other arm to an adjacent anchor, a surgeon can pivot compressor 1 and pull up one anchor and at the same time push down an adjacent anchor. This can impart strong reduction forces in the sagittal plane. The surgeon can move and manipulate both sides of the spinal vertebra concurrently to achieve a variety of movements hereinbefore described. For example, if the left hand compressor is used to induce compression and a right hand side compressor is used to distract, this will correct coronal imbalance. On the other hand, if the left hand pushes superior vertebrae downwards while the right hand compressor pulls the superior vertebrae upwards, this will rotate superior vertebrae leading to correction of axial rotation. From the aforesaid, it can be seen that the improvements to the compressor device 1 described herein allow correction of complex deformity at one segment. Once the corrected position for the spinal vertebrae has been set, the spine can be held in position while temporary or permanent primary rods are inserted. This may be done one side of the sagittal plane at a time holding the spine in position with one of the compressor devices while adding a temporary or permanent rod to the contralateral side. The compressor is replaced with a permanent rod joining pedicle screws that is locked into position.
[0084] Various embodiments for the primary rods are contemplated to accommodate the formation on the distal end of a compressor device. For example, the primary rods may include multiple openings, alternative formations to the openings such as but not limited to, altering the male female interfitting, employment of alternative key in lock arrangements which may include rod widening, narrowing alternation of the cross section at the point of engagement with the compressor device, a hinged attachment or slide.
[0085] In a further embodiment, sliders may be attached to the primary rods connecting pedicle screws for manipulation. The slider location may be local or adjacent. A top opening in a slider receives and retains the device 1. A bottom opening receives and retains a longitudinal primary rod. A formation such as a but not limited to a transverse post on compressor 1 is inserted and the compressor is manipulated to move screws to a desired position at which point tulips are locked to a primary longitudinal rod to fix the spinal vertebrae in a desired position.
[0086] According to one embodiment, the sliders include locking fasteners which may for example be grub screws which allow relative locking between the primary rod and slider. With one compressor on each side of the spine, the compressor can be rotated, lifted up and pushed down. The use of the slider with the primary rods modified to accommodate the compressor allows the application of rotational, and compression forces alone or in combination.
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[0091] Each of anchor screws include respective locking nuts 120 121 and 122 which allow each of screws 111, 112 and 113 to be locked to primary rod 100 or to be free to rotate relative to rod 100. This provides wide versatility to manipulate compressor 80 rotationally and along a scissor plane. Since each anchor screws 111, 112 and 113 are fastened to separate bone elements 114, 115 and 116 (usually vertebra), each can be selectively locked to rod 100 to prevent axial and rotational movement relative to rod 100. Locking of the anchors against rod 100 may be effected by using an Allen key. In the arrangement of
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[0093] This is one example of the numerous vertebral movement combinations which can be achieved using the assembly including lordotic adjustment by rotation of compressor 80 and selective locking of one or more of anchors 111, 112 and 113 against rod 100.
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[0095] Each of anchor screws locking nuts 120 121 and 122 allow each of screws 111, 112 and 113 to be locked to primary rod 100 or to be free to rotate relative to rod 100. Arm 88 is able to effect a rotation of rod 100 via engagement with formation 98. Arm 89 is able to press down on rod 100 via formation 101. The arrangement in
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[0097] Lifting the cranial end translates superior vertebrae which unlocks facets. Rod 100 may in another embodiment be lifted by hook formation 97. This translation improves compression even when facets resected. Both Tulips/screw anchors remain unlocked during compression yet the position of rod 100 is still controlled. This is one major advantage of the modified compressor arms according the present invention. Another advantage is that the use of one hand to create the required lordosis allows two rod and screw assemblies to be adjusted simultaneously. Ideally rod 100 has a transverse hole at one end. Rods 50, 51, 52 and 53 have respective openings 54-57 as described in
[0098] According to a method aspect the lordosis is effected according to the following steps: Once rod 100 is engaged with the pedicle screws, one arm 89 with forked formation 101 pushes down on the rod 100 while arm 88 of the compressor engages rod 100 at the cranial end and due to formation 98 resists separation between arm 88 and rod 100. Formation 101 is loaded on rod 100 at a distal end of rod 100. Caps used to lock tulips/screws to rod 100 are added but left loose. Compressor 80 is squeezed and at the same time is lifted at the cranial end and pushed down at the caudal end. This translates superior vertebrae (and top of spine) backwards, unlocking facet joints. This action is enhanced by rod formation 98. Two pedicle screws are compressed iorst and when they have been set and locked, they are then in unison compressed against the third vertebra. Post formation 98 controls the position of rod 100. It presents rollover of rod 100 and applies the compression. Once the screws are locked the compressor is removed and final tightening of the screws takes place. As only one hand is required to rotate and compress and one to lock caps, one person can set the lordosis. A second assistant can set lordosis on the second rod and screw assembly in a similar manner.
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[0103] The arrangements described herein allow a surgeon to generate compression, distraction, rotation or a combination of those forces, depending upon a selection from the working arms and selective locking of one or more of the anchors 111, 112 and 113 to rod 100, to manipulate the vertebra into a desired setting.
[0104] The system described above with interchangeable working arms allows a surgeon to apply a compressive force between adjacent screws to increase lordosis to improve sagittal balance. The surgeon may distract bone to gain access to the inter vertebral disc spaces for removal of disc, and insertion of spacers and bone graft materials both for support and to aid fusion. The instrumentation described allows one (instead of two) surgeon to apply compression forces and also to tighten the screws in the position determined by the surgeon. The instrumentation according to the present invention (unlike the apparatus of the prior art), also allows the application of a rotational force required to obtain optimal lordosis. Contemplated is a modular rod holder as one of the interchangeable working arms for the compressor. After a rod is inserted a handle is removed and a compressor is attached to a rod holding portion. The holder has the same mechanism to allow the rod to hang loosely via its through hole as if it was connected to a lateral rod.
[0105] It will be appreciated by those skilled in the art that numerous variations and modifications may be made to the invention without departing from the overall spirit and scope of the invention broadly described herein.