Embodiments of the present invention relate to bone fixation plates, and more particularly, to bone (e.g., spinal) fixation plates that resist back out of associated bone anchors (e.g., screws).
The spine is a flexible, multi-segmented column that supports upright posture in a human while providing mobility to the axial skeleton. The spine encases and protects vital neural elements while providing structural support for the body by transmitting the weight of the body through the pelvis to the lower extremities. The cervical spine exhibits a wide range of motion due to the orientation of its facets and the lack of supporting structures. The thoracic and lumbar regions of the spine also have a significant range of motion.
The spine is made up primarily of bone and intervertebral discs, which are surrounded by supporting ligaments, muscle, fascia, blood vessels, nerves, and skin. These elements are subject to a variety of pathological disturbances: inflammation, trauma, neoplasm, congenital anomalies, disease, etc. Trauma to the spine can play a large role in the etiology of neck and low back pain. For example, trauma frequently results in damage at the upper end of the lumbar spine, where the mobile lumbar segments join the less mobile dorsal spine. Excessive forces on the spine not only produce life-threatening traumatic injuries, but may contribute to an increased rate of degenerative change.
The cervical region of the spine comprises the seven most superior vertebrae of the spine, which begin at the base of the skull and end at the upper torso. Because the neck has a wide range of motion and is the main support for the head, the neck is extremely vulnerable to injury and degeneration.
Spinal fixation is a common method of treating spinal disorders, fractures, and degeneration. One common device used for spinal fixation is the bone fixation plate, which is typically used in conjunction with a graft device placed between the vertebral bodies. Generally, there are two types of spinal plates: (i) constrained plates and (ii) semiconstrained plates. Generally, a constrained plate completely immobilizes the vertebrae and does not allow for graft settling. In this instance, the plate itself carries a significant portion of the loading. Constrained plates are useful, for example, in patients with highly unstable anatomy, such as with a vertebrectomy, or in patients with little chance of bone growth, such as cancer patients. In contrast, a semiconstrained plate is dynamic and allows for a limited degree of graft settling through micro-adjustments made between the plate and bone screws attaching the plate to the spine. The operation of the semiconstrained plate stimulates bone growth because the loading is transferred through the graft. Each type of plate has its own advantages depending upon the anatomy and age of the patient, and the results desired by the surgeon.
A typical bone fixation plate includes a relatively flat, rectangular plate having a plurality of apertures formed therein. A corresponding plurality of bone screws may be provided to secure the bone fixation plate to the vertebrae of the spine. A common problem associated with such a bone fixation plate is the tendency for bone screws to become dislodged from the bone and “back out” from the plate, thereby causing the plate to loosen and the screws to protrude from the plate. For example, in a typical anterior cervical fusion surgery, the carotid sheath and sternocleidomastoid muscles are moved laterally and the trachea and esophagus are moved laterally in order to expose the cervical spine. The cervical plate is designed to lie on the anterior face of the spine, dorsal to the esophagus. Due to its relative location to the esophagus and other connective tissue, if the bone screw securing the plate to the cervical spine backs out, the bone screw could pierce the esophagus, causing not only pain and infection, but also posing a serious risk of death to the patient. Bone fixation plates with large anterior-posterior profiles (e.g., thickness) can also make it difficult for the patient to swallow post-surgery.
In view of the foregoing, it would be desirable to provide bone fixation assemblies that resist back out of associated bone anchors.
Embodiments of the present invention relate to bone plating systems that resist back out of associated bone anchors.
In an aspect, a bone fixation apparatus is provided that includes a bone fixation plate, a bone anchor (e.g., bone screw), and a bone anchor retaining member. The bone fixation plate includes a top surface, a bottom surface, and at least one aperture between the top surface and the bottom surface for permitting partial passage of a bone anchor through the plate. The bone fixation plate additionally includes a cavity formed between the top surface and the bottom surface, where the cavity at least partially intersects (e.g., is coaxial with) the aperture. The bone anchor retaining member is housed at least partially within the cavity, and is configured to transition from a first position to a second position in response to interaction with the bone anchor. In the first (e.g., open) position, the bone anchor retaining member permits partial passage of the bone anchor through the member. In the second (e.g., closed) position, the member resists back out of the bone anchor.
In some embodiments, the bone anchor retaining member may be formed generally in the shape of a ring. In one embodiment, in the first position the bone anchor retaining member may have a generally convex shape (e.g., conical). In the second position, the bone anchor retaining member may have a generally concave shape (e.g., inverse conical). In another embodiment, the bone anchor retaining member may have a generally convex shape in both the first and second positions.
In some embodiments, the bone anchor retaining member may include multiple surfaces (e.g., tabs) extending towards a center of the aperture formed within the bone fixation plate. In the second position, a distance between the plurality of surfaces may be less than a distance between the plurality of surfaces in the first position.
In still other embodiments, the member may transition from the first position to the second position via a third position, wherein in the third position a distance between the plurality of surfaces is less than both the distance between the plurality of surfaces in the first position and the distance between the plurality of surfaces in the second position.
In some embodiments, the bone anchor retaining member may be flat (e.g., a flat ring-shaped member) both before and after partial passage of the bone anchor through the member. In response to interaction of the retaining member with the bone anchor, the retaining member may deform in the direction of advancement of the anchor, thus increasing the size of an internal diameter of the member such that it allows partial passage of the anchor. The retaining member may then return to its original, flat configuration in order to resist back out of the anchor.
In some embodiments, the bone fixation plate includes a generally part-spherical surface adjacent to the at least one aperture and the top surface, for example, for multi-angular articulation with a complimentary part-spherical surface of the bone anchor.
In some embodiments, the bone fixation plate comprises a generally part-cylindrical surface adjacent to the at least one aperture and the bottom surface.
In some embodiments, when the bone anchor is advanced fully into the plate, the width of the aperture in the bone fixation plate may be substantially equal to a width of an adjacent portion of the bone anchor. This may constrain movement of the fixation plate subsequent to the procedure (e.g., rigid fixation). In other embodiments, the width of the aperture may be greater than the width of the adjacent portion of the bone anchor, which may allow for dynamic movement of the fixation plate at an implantation site.
In some embodiments, the width of the cavity in the bone fixation plate may be substantially equal to a width of the bone anchor retaining member, which may constrain movement of the fixation plate. In other embodiments, the width of the cavity may be greater than the width of the bone anchor retaining member, which may allow for dynamic movement of the fixation plate at an implantation site.
In still other embodiments, the bone fixation plate may include multiple aperture and/or cavity sizes, which may allow the same plate to be used for both rigid and dynamic fixation, at the option of the surgeon. For example, the same bone fixation plate may include a set of apertures and/or cavities configured for rigid fixation, and an independent set of apertures and/or cavities configured for dynamic fixation.
In some embodiments, the bone anchor may be a bone screw that includes a head, a shoulder in communication with the head, a groove in communication with the shoulder, and a threaded shank in communication with the groove. The head may be configured for articulation with the bone fixation plate. The shoulder may be configured to contact the bone anchor retaining member when the member is in the first position. The groove may be configured to receive the bone anchor retaining member when the member is in the second position. A width of the shoulder may be greater than a width of the threaded shank.
In some embodiments, the bone anchor retaining member may be formed from an elastic material.
In still other embodiments, the bone anchor retaining member may form a plurality of peaks and valleys in top and bottom surfaces of the member. The retaining member may be configured to transition from a first, convex position to a second, convex position in response to interaction of the member with the bone anchor. In the first position, the bone anchor retaining member may permit partial passage of the bone anchor through the member. In the second position, the retaining member may resist back out of the bone anchor.
In some embodiments, the bone fixation plate may include an attachable cover member (e.g., ring-shaped cover member) that is substantially co-axial with the cavity and the ring-shaped member and that is configured to prevent the ring-shaped member from ejecting from the cavity. In some embodiments, the cover member forms the bottom surface of the bone fixation plate.
In another aspect, a method for bone fixation is provided. The method includes advancing a bone anchor (e.g., screwing a bone screw) through a bone fixation assembly and into bone, and encountering resistance to the advancing before the bone anchor is advanced fully into the bone, where the resistance is attributable to the bone fixation assembly. The method additionally includes advancing the bone anchor into the bone to overcome the resistance, and subsequent to the further advancing, resisting back out of the bone anchor from the bone fixation assembly. In some embodiments, encountering resistance to the advancing includes contacting a portion of the bone fixation assembly with a shoulder of the bone anchor.
In still another aspect, a bone fixation apparatus is provided that includes means housed within a bone fixation plate for resisting advancement of a bone anchor before the bone anchor is advanced fully into the bone. Upon further advancement of the bone anchor through the bone fixation plate, the means housed within the bone fixation plate further comprises means for resisting back out of the bone anchor from the bone fixation plate.
For a better understanding of the present invention, including the various objects and advantages thereof, reference is made to the following detailed description, taken in conjunction with the accompanying illustrative drawings, in which like reference characters refer to like parts throughout, and in which:
Bone fixation plate 102 may form a plurality of apertures 108 (e.g., six circular or part-circular apertures in the embodiment of
Bone anchors 104 may be configured at their distal ends 112 for self-tapping or self-drilling. Proximal ends 114 (heads) of bone anchors 104 may include a recess (e.g., having a non-circular cross-sectional shape) and/or other features for receiving a complimentary tip of a surgical tool. For example, in the embodiment of
Bone fixation plate 102 may also form apertures 116 and slots 118 in communication with cavities 110, and indentations 120. Apertures 116 and indentations 120 may be configured for attachment to a delivery tool that positions plate 102 at an appropriate implantation site. In some embodiments, apertures 116 and/or slots 118 may permit access to anchor retaining members 106 to permit passage of a tool that re-opens/re-inverts members 106 from the closed position to the open position. In some embodiments, to re-open (unlock) member 106 after bone anchor 104 is screwed into place, bone anchor 104 may be unscrewed or otherwise backed out (e.g., about 1 thread turn), followed by introduction of a tool through a slot 118 to invert/open member 106. In other embodiments, member 106 may be re-opened by a tool that is secured to plate 102 and bone anchor 104. The tool may incorporate a member (e.g., trigger actuated member) that pushes against the top side of plate 102 while the tool is secured to and exerting an upward force on anchor 104, thus forcing anchor 104 upwardly and causing retaining member 106 to invert and open.
Bone fixation assembly 100 and its various components may be made from any suitable material or combination of materials. For example, in some embodiments, all of components 102, 104, and 106 may be made from titanium, stainless steel, and/or other biocompatible metal(s). In other embodiments, one or more (e.g., all) of components 102, 104, and 106 may be made from a polymer or one or more biocompatible ceramic(s), such as the doped silicon nitride ceramic described in commonly-owned U.S. Pat. No. 6,881,229, which is hereby incorporated by reference herein in its entirety. The one or more materials used for anchor retaining member 106 preferably have an elastic property.
In some embodiments, bone fixation plate 102 may have a lordotic curvature that corresponds to a lordotic curvature of the human cervical spine. For example, an anterior face of plate 102 may be contoured and rounded so as to reduce or eliminate irritation of the esophagus and the surrounding tissues.
In some embodiments, bone fixation plate 102 may be configured to promote bone ingrowth to the plate. For example, in some embodiments, at least a portion of bone fixation plate 102 may be made from a porous material, such as the porous silicon nitride ceramic described in commonly-owned U.S. Pub. Appln. No. 20050049706, which is hereby incorporated by reference herein in its entirety. Alternatively or additionally, one or more bone contacting surfaces of bone fixation plate 102 may be roughened, for example, by mechanical blasting and/or plasma spraying with metal particles of one or more sizes.
In some embodiments, bone fixation plate 102 may be coated with a bio-active material having an osteoconductive property, such as hydroxyapatite or a calcium phosphate material. Alternatively or additionally, bone fixation plate 102 may carry one or more therapeutic agents, for example, for enhancing bone fusion and ingrowth. Examples of such therapeutic agents include natural or synthetic therapeutic agents such as bone morphogenic proteins (BMPs), growth factors, bone marrow aspirate, stem cells, progenitor cells, antibiotics, and other osteoconductive, osteoinductive, osteogenic, bio-active, or any other fusion enhancing material or beneficial therapeutic agent. In some embodiments, bone anchor 104 and/or anchor retaining member 106 may be porous, roughened, and/or coated with one or more bio-active and/or therapeutic materials.
In the open position, anchor retaining member 106 may form an opening having a width greater than width 218 of threaded shank 212, where width 218 is equal to the major diameter of the threads. In other embodiments, the width of the opening within anchor retaining member 106 in the open position may be greater than (e.g., only slightly greater than) the width of the minor diameter of the threads, such that the screw is threaded through the anchor retaining member 106. The width of aperture 108 formed by surfaces 206 and 208 may also be greater than width 218. This may allow threaded shank 212 to pass through bone fixation plate 102 and anchor retaining member 106 and into bone. Shoulder 214 of bone anchor 104 may be wider than the opening in member 106, which may cause shoulder 214 to contact member 106 as anchor 104 is screwed into the bone. For example, shoulder 214 may contact anchor retaining member 106 just prior (e.g., less than about 1 screw turn prior) to bone anchor 104 being fully screwed into the bone. Additional screwing of bone anchor 104 into the bone after the occurrence of such contact may cause anchor retaining member 106 to transition from the open position to the closed position. In some embodiments, providing anchor retaining member 106 within plate 102 causes member 106 to interact with shoulder 214 and not the top of screw head 114 (
Thus it is seen that bone fixation plates with anchor retaining members are provided. Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the invention as defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the following claims. The claims presented are representative of the inventions disclosed herein. Other, unclaimed inventions are also contemplated. The applicant reserves the right to pursue such inventions in later claims.