The present invention relates to a spinal rod connector assembly for axially aligning a first broken rod portion and a second broken rod portion of a broken in situ spinal posterior rod system, and for connecting the rod portions to each other. The connector assembly may be placed between two bone fasteners, most commonly pedicle screws, but may also span over one bone fastener. The invention also relates to a method for connecting broken spinal rod portions by means of a top-loading approach and a side-loading approach. The invention further relates to a kit containing a plurality of rod connectors enabling spinal rod portions which are straight, curved or angled relative to each other to be connected. The invention equally relates to a kit of rod connectors, which are mirror-imaged, and allow the rod portions that are shifted relative to each other to be realigned, in a minimally invasive manner, by using the rod connector itself.
In orthopaedic surgery around the spine, posterior spinal stabilisation systems are often placed to a target site to realign, re-correct or stabilise the spinal column to compensate for malalignment caused by for example degeneration of the spine, born malalignments, such as excessive lordosis, kyphosis and scoliosis, and for example trauma, such as fractures. During the fusion phase of the spine, during which the realigned vertebral bodies grow together, primary stability to the spine is provided by the posterior spinal stabilisation system in combination with an interbody fusion device. During this phase, the posterior spinal stabilisation system needs to withstand high loads and stresses. These loads may exceed the strength of the posterior spinal stabilisation system and cause its fracture. Most often the system fails due to fracture of the posterior rod, that is connecting at least two bone fasteners. Two fracture scenarios are most common, namely a fracture directly next to a bone fastener, at the interface of the bone fastener and the rod, and a fracture in the middle between two bone fasteners. The first scenario is characterised by a very short fractured rod portion and a long fractured rod portion between the bone fasteners. The second scenario is characterised by having two substantially equally long rod ends between the bone fasteners.
A construct, such as a posterior spinal stabilisation system, is best repaired in the original orientation, re-establishing the original correction. To be able to extend the system, according to common techniques, the full in situ rod is removed from the bone fasteners, and replaced by a new rod. Removal is executed by unscrewing so-called setscrews that rigidly fix the rod into the tulip head of the bone fastener. The rod is then pulled out after removal of all the setscrews. Now, a new rod is attached to the bone fasteners that are in place. The removal of the broken rod destabilises the spine during surgery, and requires a new, often large skin and soft tissue access to the implants. Especially in the cases of longer constructs, this can be a very invasive surgery.
It is an object of the present invention to overcome at least some of the problems associated with replacing or repairing a broken pedicle screw and rod construct. A solution is needed that may obviate the need of removal and replacement of the broken rod, and that also provides the ability to re-stabilise the broken spinal posterior rod system in a minimally invasive manner. Furthermore, a solution is also needed for different rod breakage scenarios, where the first scenario is characterised by a very short fractured rod end and a long fractured rod end between the bone fasteners, and the second scenario is characterised by having two substantially equally long rod ends between the bone fasteners. Moreover, there is a need for a solution which forms a spinal rod connector, and which allows different systems of different suppliers, and/or bent rods, straight rods, and/or curved rods to be rigidly repaired.
According to a first aspect of the invention, there is provided a spinal rod connector assembly as recited in claim 1.
The proposed spinal rod connector assembly has for instance the advantage that it helps a surgeon to substantially repair an existing and broken in situ spinal rod without the necessity of removing the rod portions and thus without destabilizing the spine and without requiring a large incision to replace the broken rod by a new rod.
According to a second aspect of the invention there is provided a kit of rod connectors as recited in claim 17.
The proposed kit has for instance the advantage that it helps the surgeon to repair an existing in situ spinal rod, where the original rod per repair situation may have e.g. any of the following shapes: a bent, curved or straight shape. The kit contains at least a first rod connector and a second rod connector, where the first rod connector allows straight rod portions to be connected, and the second rod connector allows rod portions of a curved shape to be connected.
According to a third aspect of the invention there is provided a method of repairing an in situ construct as recited in claim 20.
The proposed method allows a first rod portion to be connected to a second rod portion, in a top-loading manner, and allows the rod portions that are shifted with respect to each other to be realigned in a minimally invasive manner, by using the rod connector itself.
Other aspects of the invention are recited in the dependent claims attached hereto.
Other features and advantages of the invention will become apparent from the following description of non-limiting example embodiments, with reference to the appended drawings, in which:
The embodiments of the present invention will now be described in detail with reference to the attached figures. The embodiments are described in the context of repairing an in situ posterior spinal construct having a broken rod. Although the invention is specifically described in the context of extending the posterior spinal construct, the teachings of the invention are not limited to this environment. The teachings of the present invention are equally applicable to repairing rod-based stabilisation constructs for other bones as well. Identical or corresponding functional and structural elements which appear in the different drawings are assigned the same reference numerals. When the words first and second are used to refer to different elements, it is to be understood that this does not necessarily imply or mean that the first and second elements are somehow structurally substantially different elements or that their dimensions are substantially different unless specifically stated.
One example way of repairing an in situ spinal construct is characterised by substantially equally long rod ends between two adjacent bone fasteners, where the ends have a sufficient length for attachment of a connector thereto. A connector can be connected between the two adjacent bone fasteners. Another example way of repairing an in situ spinal construct is characterised by very short and long fractured rod ends between the bone fasteners, where the short end is too short for attachment of a connector thereto. The connector must be connected over the bone fastener at the opposite side of the bone fastener. A bone fastener in this context means an intermediate structural element, which can be brought into the target bone, and forms a stabile connection between the target bone and the remaining spinal construct. Most often a bone fastener is a fastening element, such as a screw.
Referring to
The rod connector body 11 further comprises a rod receiving passage 18 extending between the first body end 12 and the second body end 13, where the passage 18 comprises a first passage end section 19, a second passage end section 20 and a passage middle section 21 located between the first and second passage end sections. These different passage sections are thus located adjacently and longitudinally along the passage. The first passage end section is at least open or extending into the first body end 12 and into the first body side 14. In a similar manner, the second passage end section is at least open or extending into the second body end 13 and the second body side 15. In other words, in this specific design of the rod connector, the first passage end section and the second passage end section open up in opposite directions. Thus, these end sections are arranged and located opposite to each other.
The first passage end section comprises a first passage top wall 22a, a first and substantially opposite first passage bottom seat 23a, and a first passage side seat 24a extending between the top wall and the bottom seat. Opposite to the first passage side seat 24a, a first passage side entrance 25a is present. In a similar manner, the second passage end section comprises a second passage top wall 22b, a second and substantially opposite second passage bottom seat 23b, and a second passage side seat 24b extending between the top wall and the bottom seat. Opposite to the second passage side seat 24b, a second passage side entrance 25b is present. The passage sections are sized and shaped to capture or receive (for instance snugly or play-free manner) the rod portions as described later. In the present example, the passage middle section 21 is sized and shaped as a first pocket 31 extending at the body bottom side 17 over the full body width BW. Therefore, the passage middle section substantially only comprises a third passage top wall 22c. Furthermore, the first passage end section and the second passage end section define a first passage central axis A1, and a second passage central axis A2, respectively, which in this example are substantially parallel to the longitudinal axis of the rod connector. These axes are aligned and they coincide with each other, or they intersect each other. As explained in greater detail later, the first pocket 31 forms a cut-out, which can be engaged over at least one rod portion in a top-loading approach. Then, upon turning the rod connector around its axis A4, the rod portions are simultaneously captured within the passage end sections. In other words, the first passage side seat 24a engages with a first side of one of the rod portions, while the second passage side seat 24b engages with a second, and opposite side of the other rod portion. Simultaneously, the passage top walls and the bottom seats also engage with the rod portions so that the rod portions can be snugly captured within the passage 18. It is to be noted that in the examples explained in the present description, the top walls and the bottom seats have a flat or substantially flat surface. Furthermore, in the examples explained in the present description, the top wall surfaces and the bottom seat surfaces are parallel or substantially parallel to each other, although they could have given angle between them instead. Moreover, in the example shown, the bottom seats extend from their respective side wall until the respective body side wall.
Referring to the body top side 16 of the rod connector, the body top side 16 comprises at least one locking hole 26a, 26b, 26c, 26d, extending from the body top side into or over the passage. In this example, the rod connector comprises four locking holes. The locking holes are sized and shaped to engage with at least one of the rod fastener 50a, 50b, 50c, 50d (in this example first to fourth rod fasteners). According to one example, at least one of the locking holes comprises an internal thread feature (female thread), and at least one of the rod fasteners comprises an external thread feature (male thread), or vice versa. Furthermore, the body top side 16 may comprise at least one first instrument attachment means 28a, 28b, such as a hole or recess (threaded or non-threaded) for connecting to an implant inserter or insertion instrument 70, as explained in greater detail later. Alternatively (not depicted) at least one the first body end 12, second body end 13, first body side 14, second body side 15, and body bottom side 17 comprises at least one instrument attachment means 28a, 28b. In a preferred embodiment, for the rod connector as depicted, being designed for a top-loading surgical approach, the attachment means is located on the top side, thereby keeping the implant and instrument assembly as small as possible, and thereby providing ease of disengagement of both the inserter and implant when implanted and secured in its final position. According to another example, the first attachment means 28a is sized and shaped as a threaded bore 30, and the second attachment means 28b is sized and shaped as a (non-threaded) recess 29. The attachment means are sized and shaped to engage with instrument features that are shaped in a substantially complementary manner and rigidly fixate the rod connector assembly to the insertion instrument 70, and thereby allow forceful manipulation of the rod connector. It is to be noted that the attachment means may be compatible with various state-of-the-art connection methods.
When a posterior spinal construct is implanted, often in certain sections, the rods need to be adapted or contoured to the intended anatomical correction. This adaption is made by bending or reshaping the rod. Alternatively, pre-bent rods can be obtained. A bend can be a hard bend, comprising a relatively short bending area or region between for example two straight areas or regions. Alternatively, a soft bend can be made, wherein a relatively constant curvature is given to the rod.
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The rod connector body 11 further comprises a rod receiving passage 18 extending between the first body end 12 and the second body end 13, where the passage 18 comprises a first passage end section 19, a second passage end section 20 and a passage middle section 21 located between the first and second passage end sections. These different passage sections are thus located longitudinally along the passage. The first passage end section is at least open or extending into the first body end 12 and into the first body side 14. In a similar manner, the second passage end section is at least open or extending into the second body end 13 and the first body side 14. Furthermore, the passage middle section 21 is also open towards the first body side 14. In other words, in this specific design of the rod connector, all the passage sections are open towards the first side. The first passage end section comprises a first passage top wall 22a, a first and substantially opposite first passage bottom seat 23a, and a first passage side seat 24a extending between the top wall and the bottom seat. Opposite to the first passage side seat 24a, a first passage side entrance 25a is present. The second passage end section comprises a second passage top wall 22b, a second and substantially opposite second passage bottom seat 23b, and a second passage side seat 24b, extending between the top wall and the bottom seat. Opposite to the second passage side seat 24b a second passage side entrance 25b is present. The passage middle section comprises a third passage top wall 22c, a third and substantially opposite third passage bottom seat 23c, and a middle passage side wall 47 extending between the top wall and the bottom seat. Opposite to the third passage side seat 24b, a third passage side entrance 25c is present. The passage sections are sized and shaped to capture the rod portions as described later. In this example, the side wall 47 forms the side seat 24c. Furthermore, the first passage end section and the second passage end section define a first passage central axis A1, and a second passage central axis A2, respectively. These axes are aligned and they coincide with each other, or they intersect each other. The passage side seats in this example (as also in the other example explained in the present description) have a rounded surface, which has a shape, which is a complementary to the shape of the surface of the rod portions.
The body top side 16 comprises at least one locking hole 26a, 26b, 26c, 26d extending from the body top side into or over the passage. The locking holes are sized and shaped for engaging with at least one rod fastener 50a to 50d. According to one example, at least one of the locking holes comprises an internal thread feature, while at least one of the rod fasteners comprises an external thread feature, or vice versa. Furthermore, the body top side 16 may comprise at least one first instrument attachment means 28a, 28b for connecting to an implant inserter 70. Alternatively (not depicted) at least one of the first body end 12, second body end 13, first body side 14, second body side 15, and body bottom side 17 comprises at least one instrument attachment means 28a, 28b.
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The rod connector as depicted in
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Another situation of rod breakage of an in situ spinal construct is characterised by very short and long fractured rod ends between the bone fasteners, where the short end is too short for attachment of a connector thereto. The connector must be connected over the bone fastener at the opposite side of the bone fastener. Referring to
The first passage end section comprises a first passage top wall 22a, a first and substantially opposite first passage bottom seat 23a, and a first passage side seat 24a extending between the top wall and the bottom seat. Opposite to the first passage side seat 24a, a first passage side entrance 25a is present. In a similar manner, the second passage end section comprises a second passage top wall 22b, a second and substantially opposite second passage bottom seat 23b, and a second passage side seat 24b extending between the top wall and the bottom seat. Opposite to the second passage side seat 24b, a second passage side entrance 25b is present. The passage sections are sized and shaped to capture the rod portions as described later. The middle section is sized and shaped as a second pocket 46 starting at the body first side 14 and the body bottom side 17 and has a pocket length PL measured along the direction of the body length BL. The second pocket may extend along the full body height, or it may instead extend from the body bottom side only along a portion of the body height towards the top side 16. The middle section may comprise a third passage side seat or wall 24c, and it may also comprise a passage top wall 22c. Furthermore, the first passage end section, second passage end section and middle section define at least two central axes A1, A2, which may be aligned and coincide with each other or they may intersect each other.
The body top side 16 comprises at least one locking hole 26a, 26b, 26c, 26d, extending from the body top side into or over the passage. The locking holes 26 are sized and shaped for engaging with at least one rod fastener 50a to 50d. According to one example, at least one of the locking holes is configured as an internal thread feature, while at least one of the rod fasteners comprises an external thread feature, or vice versa. Furthermore, the body top side 16 may comprise at least one first instrument attachment means 28a, 28b for coupling to an implant inserter 70. Alternatively, (not depicted) at least one of the first body end 12, second body end 13, first body side 14, second body side 15, and body bottom side 17 comprises at least one instrument attachment means 28a, 28b.
While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive, the invention being not limited to the disclosed embodiments. Other embodiments and variants are understood, and can be achieved by those skilled in the art when carrying out the claimed invention, based on a study of the drawings, the disclosure and the appended claims. New embodiments or variants may be obtained by combining any of the above teachings.
In the claims, the word “comprising” or “including” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that different features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be advantageously used. Any reference signs in the claims should not be construed as limiting the scope of the invention.
Number | Date | Country | Kind |
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00208/20 | Feb 2020 | CH | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/050527 | 1/24/2021 | WO |