The present invention relates to a spinal implant and a manner of using the same, and more particularly, but not exclusively, relates an orthopedic device for treatment of spinal deformities.
The use of spinal implants to address orthopedic injuries and ailments has become commonplace in spinal surgery. In this arena, it is often desired to decrease the invasiveness of the procedures, improve implant integrity, reduce the potential for revision surgery, and provide more positive patient outcomes. Some of these implants utilize bone anchors that depend on interconnection between various components of the bone anchor to assemble the implant and implant systems associate therewith. In certain situations, it may be desirable for the bone anchor to include multi-axial capabilities so that a proximal portion of the bone anchor can pivot relative to the bone engaging portion of the bone anchor to facilitate assembly of the implant and alignment of the vertebrae to which the implant is attached. However, certain types of bone anchors lack a locking capability to prevent pivoting of the bone anchor after the construct is finally assembled and positioned in the patient. Thus, there is a need for additional contributions in this area of technology
According to one aspect, a unique bone anchor is provided to engage an elongate connecting element that extends along the spinal column to aid in the assembly of a spinal fixation system. The bone anchor includes multi-axial capabilities during implantation of the connecting element, and is lockable to a fixed orientation during assembly of the fixation system. Other aspects include unique methods, systems, devices, instrumentation, and apparatus involving a bone anchor with multi-axial capabilities that is lockable to a fixed or substantially fixed orientation.
The bone anchors include a distal shaft for engaging bony structure of a vertebral body and a proximal post pivotably mounted at or near the proximal end of the shaft. The bone anchors include a locking member that is engageable to the post and to the shaft to lock the post in a selected angular orientation relative to the shaft.
According to one embodiment, the shaft includes a head about which the distal end of the post is pivotably mounted. The locking member includes a stem portion positioned in a central lumen of the post and a securing portion engageable to the proximal end of the post to contact the proximal end of the stem in the lumen and force the distal end of the stem into contact with the proximal end of the head of the shaft to lock the post in position relative to the shaft. In another embodiment, the post includes a distal end received in and pivotally mounted to a proximal end of the shaft. The locking member includes an elongated stem received in a lumen of the post that opens at a distal end of the post in the shaft and at an opposite proximal end of the post. A proximal securing portion of the locking member engages the post to force the distal end of the stem in contact with a proximally facing surface of the shaft. In yet another embodiment, the proximal end of the shaft forms a receptacle that pivotably houses a ball-shaped member at a distal end of the post. The locking member includes an elongated stem received in a lumen of the post. The lumen opens at a distal end of the ball-shaped member in the receptacle and at an opposite proximal end of the post. A proximal securing portion of the locking member engages the post to force the distal end of the stem in contact with an inner surface of the receptacle. In a further refinement of this embodiment, the ball-shaped member is slotted so that the stem of the locking member expands the ball-shaped member to frictionally engage the inner surface of the receptacle. In a further refinement of any embodiment, an insert is provided in the lumen of the post that is deformed by the stem of the locking member into contact with the shaft to lock the post in position relative to the shaft.
Related features, aspects, embodiments, objects and advantages of the present invention will be apparent from the following description.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Posterior stabilization system 20 may be used for, but is not limited to, treatment of degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or a failed previous fusion associated with spinal column segment SC. Furthermore, spinal column segment SC may comprise any one or combination of the cervical, thoracic, lumbar and sacral regions of the spinal column. In certain procedures, spinal stabilization system 20 is secured to a spinal column segment SC with bone attachment devices 22 that include a distal bone engaging portion and a shaft portion that extends proximally from the bone engaging portion. The connecting elements 23 are offset to a side of respective ones of the bone attachment devices 22 and mounted to the proximal shaft portion with a coupling assembly. In one specific embodiment, the coupling assembly is like that found in Medtronic Sofamor Danek's TSRH® 3D spinal system. Of course, any suitable coupling assembly may be used to secure connecting elements 23 to one or more of the bone attachment devices. Furthermore, the bone attachment devices may be employed in surgical procedures and fixation systems like those described in the 2009 Medtronic Sofamor Danek USA, Inc. publication entitled “TSRH-3D PLUS MPA™ SPINAL INSTRUMENTATION DEFORMITY AND DEGENERATIVE SURGICAL TECHNIQUE”, which is incorporated herein by reference.
Connecting elements 23 can be in the form of an elongated spinal rod. The spinal rod may be solid or hollow along some or all of its length and/or may be of homogenous or heterogeneous composition. The spinal rod may also be of uniform cross-section along its entire length, or have a variable cross-section along its length. The spinal rod may include one or more interconnected spinal rod portions that lengthen or adjust in length to accommodate growth of spinal column segment SC over time in the cephalad-caudal directions. The spinal rod can be rigid, flexible, or include one or more flexible portions to permit at least limited spinal motion. Other embodiments of connecting element 23 contemplate any suitable spinal stabilization element positionable along the spinal column, including plates, bars, tethers, wires, cables, cords, inflatable devices, expandable devices, and formed in place devices, for example.
Referring to
Referring further to
Post 40 includes a central lumen 66 that extends on central longitudinal axis 42 and opens at distal end 44 and at proximal end 46. Central lumen 66 extends between recesses 62, 64 but is isolated from recesses 62, 64 by the body of post 40 in the illustrated embodiment to avoid interference with pins 58, 60. When it is desired to secure post 40 in a desired angular orientation relative to shaft 32, a locking member 70 is positionable through lumen 66 and engaged to post 40 and shaft 32. As further shown in
As shown further below with respect to
Another embodiment bone attachment device is shown in
Head 138 extends outwardly from shaft 132 and defines a receptacle 152 that receives ball-shaped member 144 of post 140. Head 138 defines a proximal end opening 148 and a retaining member 150 projecting into opening 148 to capture ball-shaped member 144 in receptacle 152 while allowing post 140 to pivot in any plane to an angular orientation relative to shaft 132. In order to lock post 140 in a selected angular orientation relative to shaft 132, locking member 70 can be positioned with stem 72 in longitudinal lumen 166 of post 140 and securing member 78 is threadingly engaged to internal threads 154 at the proximal end opening of lumen 166. Locking member 70 is advanced until distal end 74 contacts an internal concave surface 156 of receptacle 152 to provide a point force sufficient to lock post 140 in position relative to shaft 132.
In the illustrated embodiment of
As shown in
In use, shaft 232 is engaged to the bony structure of the vertebra, and post 240 is manipulated to the desired angular orientation relative to shaft 232. Locking member 70 is inserted into lumen 266 of post 240 and securing portion 78 is threadingly engaged to threads 254. Stem 72 acts as a wedge to open ball member 244 by moving segments 247 radially outwardly to frictionally engage inner wall surface 256 of head 238 and provide an interference fit therewith. In addition, the distal end 74 of stem 72 can be advanced to penetrate or seat against the portion of inner wall surface 256 aligned with lumen 266.
Referring to
Referring to
Distal end 444 of post 440 includes a pair of arms 448, 450 extending along opposite sides of head 438 to form a U-shaped clevis or yoke. Head 438 of shaft 432 is positioned in a receptacle defined between arms 448, 450. Each of the arms 448, 450 includes a bore 454, 456, respectively, that receives mounting pin 458. Mounting pin 458 extends from bore 462 that extends laterally through opposite sides of head 438 and into bores 454, 456 of arms 448, 450. Pin 458 can be fixed in bore 462 so that pin 458 rotates in each bore 454, 456 of arms 448, 450. Post 440 is pivotable about a pivot axis 443 defined by pin 458 that is orthogonal to central longitudinal axes 434, 442 so that central longitudinal axis 442 is positionable at any angle in a plane that is defined by axes 442, 434. The selected angular orientation can range from +90 degrees from central longitudinal axis 434, as shown in
Post 440 includes a central lumen 466 that extends on central longitudinal axis 442 and opens at distal end 444 and at proximal end 446. When it is desired to secure post 440 in a desired orientation relative to shaft 432, a locking member 470 is positionable into the proximal end opening of lumen 466 and engaged to post 440. Locking member 470 includes a proximal head 476 and a distal securing portion that extends into lumen 466 to contact a proximal end 475 of an elongated stem 472 that is housed in lumen 466. Stem 472 extends from a distal end 474 to a proximal end 475. As locking member 470 is threadingly advanced into lumen 466, securing portion 478 contacts proximal end 475 of stem 472 to push distal end 474 of stem 472 against a proximal end of head 438 when it is desired to lock post 440 in a selected angular orientation relative to shaft 432. Distal end 474 creates a point force on head 438 that locks post 440 in the selected angular orientation and prevents pivoting movement of post 440 relative to shaft 432.
Head 476 includes an external driving configuration to receive a driving tool to facilitate application of the desired force to lock post 440 relative to shaft 432. In the illustrated embodiment, the driving configuration forms an external hex-shape. Other embodiments contemplate other configurations for driving locking member 470, including external box shapes and other shapes, and/or internal recesses that are hex-shaped, star-shaped, Allen-shaped, T-shaped, slot-shaped, or other suitable configuration. In yet a further embodiment, the material thickness joining head 476 to securing portion 478 can be sized so that head 476 is severed or removed from securing portion 478 upon application of a threshold torque. This provides a reduced profile or no profile configuration for locking member 470 extending from the proximal end of post 440 when post 440 is located in position relative to shaft 432.
The bone anchors discussed herein can be used in any suitable spinal stabilization system. Surgical instruments can also be mounted to the bone anchors for using in positioning components of the fixation system and in aligning vertebrae of the spinal column. For example, an elongated extension or other instrument can be removably engaged to the proximal end of the post of the bone anchors discussed herein during implantation. The extension can then be removed so that a locking member or portion of the locking member can be engaged to the post to lock the post in the selected angular orientation relative to the shaft.
The bone anchors discussed herein can be provided in a number of sizes and configurations, including varying lengths, diameters and bone screw thread arrangements. The post can include a smooth outer surface, and may also include a tool engaging configuration formed on its inner and/or outer surfaces. The bone anchors discuss herein can be formed of titanium, stainless steel, cobalt-chrome or any other suitable biocompatible metal or non-metal material. The bone anchors include a proximal post and a distal shaft that is threaded or otherwise configured for anchoring within vertebral bone. The proximal post is connected directly to the distal shaft portion, although embodiments where the post is indirectly connected to the shaft are also contemplated. In some embodiments, a housing or head is provided between the post and shaft to provide a location in which to pivotably mount the post to the shaft. In some embodiments, the head or housing is formed integrally with the shaft. Other embodiments contemplate that the head or housing is integrally formed with the post, or is a separate component that is separately attached the post and to the shaft. In any event, the head or housing provides a connection that allows the post to pivot relative to the shaft. Of course, it is understood that the relative size of the components can be modified for the particular vertebra(e) to be instrumented and for the particular location or structure of the vertebrae to which the bone anchor will be engaged.
Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof. Furthermore, the terms “proximal” and “distal” refer to the direction closer to and away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would insert the medical implant and/or instruments into the patient. For example, the portion of a medical instrument first inserted inside the patient's body would be the distal portion, while the opposite portion of the medical device (e.g., the portion of the medical device closest to the operator) would be the proximal portion.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that all changes and modifications that come within the spirit of the invention are desired to be protected.