Fully-Adjustable Bone Fixation Device
An orthopedic stabilization system of implants that includes a bone attachment means that provides poly-axial fixation of the system to the vertebrae, and a connector means that connects the bone attachment means to the spinal rod in a fashion that allows variable height adjustment of the spinal rod (dorsal in the case of posterior spinal pedicle fixation). The orthopedic stabilization system includes a locking means with a tightenable ball-joint arrangement that locks a post means to the bone attachment means in a desired relative spatial orientation. Several embodiments are disclosed, some using traditional mechanical locking means such as screw fasteners, taper-locking interfaces and collets. Embodiments are described that use the austenitic transformation of shape memory alloy (SMA) material to effect a locking of both the ball-joint arrangement and the connector means.
The present application is a divisional of U.S. application Ser. No. 12/931,371, now issued as U.S. Pat. No. 8,617,216, which claims the benefit of U.S. Provisional Application No. 61/341,762, filed Apr. 5, 2010, each of which is hereby incorporated by reference herein.
TECHNICAL FIELDThe field to which the disclosure generally relates includes orthopedic stabilization and spinal fixation of vertebrae, and in particular, a bone stabilization system that allows between the bone attachment means, e.g. screw, and longitudinal member, e.g. rod, all of the features of poly-axial positioning, variable height (dorsal) positioning, and a bulbous bone-metal interface for low-profile, stronger fixation to bone without restricting positioning.
BACKGROUNDSpinal implant systems can be engaged to or along one or more vertebrae of the spinal column for the treatment of various spinal conditions. Fasteners can be provided to secure the implant to a particular location along the spinal column. The implants can be provided to stabilize the spinal column for treatment, either by fixing the spinal column or by permitting at least some motion of the stabilized motion segments.
Multi-axial and uni-axial screws have been employed for securing elongated implants, such as rods, along one or more motion segments of the spinal column. Bolts, screws, and hooks are typically secured to the vertebrae for connection to the supporting rod. These vertebral anchors must frequently be positioned at various angles due to the anatomical structure of the patient, the physiological problem being treated, and the preference of the physician. It is difficult to secure connections between the spinal support rod and the vertebral anchors at all the various angles and elevations that are required, especially where there are different distances between the rod and bolts and where these components are located at different heights on the patient.
In the field of orthopedic stabilization and specifically, spinal fixation of vertebrae, there exist numerous devices designed to allow the surgeon to place screws, helical spikes, pegs, or other bone attachment means within bone tissue, and are adapted to allow the attachment of rods, plates, or other longitudinal support members in order to stabilize one vertebrae to adjacent vertebrae, and thereby, assist in the fusion or healing process of adjacent vertebrae. As mentioned earlier, these devices may be mono-axial which require a 90-degree connection between the axis of the screw and the axis of the rod, or can be poly-axial or variable-angle, thus allowing a rod/screw connection of an angle other than perpendicular. Examples of the aforementioned can be found in U.S. Pat. Nos. 6,280,442 and 5,474,555. Further, there exist some devices that allow both poly-axial positioning as well as variable dorsal height positioning (see U.S. Pat. Nos. 6,626,906 and 5,885,285). There have existed bone screws that contain a bulbous or cylindrical body portion that engage the bone opening and help secure the attachment of the bone screw to the bone (see U.S. Pat. No. 4,854,311).
However, there is a need for a connection assembly between a spinal rod and a vertebral anchor that allows the surgeon to fix the desired elevation between the rod and the bone anchor as well as fix the desired angle between the anchor and the spinal rod. This need also encompasses the need for minimizing the profile and bulk of any of the components used to engage the bone screw to the spinal rod in a variety of angular orientations.
SUMMARY OF EXEMPLARY EMBODIMENTS OF THE INVENTIONThe present invention is an orthopedic stabilization system of implants that includes a bulbous screw/bone interface, poly-axial fixation to the spinal rod, and variable height (dorsal in the case of posterior spinal pedicle fixation) positioning of the screw relative to the spinal rod.
In one aspect of the invention, the stabilization system attaches a spinal rod to vertebrae utilizing a bone attachment means, a post means, a locking means and a connector means. The bone attachment means includes a spherical cup member that forms one end, and an integral bone interface member at the other end that attaches directly to the vertebrae. The post means includes a spherical ball member at one end that interfaces to the spherical cup member forming a ball-joint arrangement, and a post member integral to the spherical ball member and forming the other end of the post means. This allows multi-angle positioning of the stabilization system. The locking means locks the bone attachment means to the post means in a determined spatial orientation as formed in the ball-joint arrangement, thus assisting with poly-axial fixation. The connector means attaches the spinal rod to the post member at a determined height, thus providing variable height adjustment.
In another aspect of the invention, the aforementioned stabilization system includes the use of shape memory alloy (SMA). The austenitic transformation of SMA alloy material due to temperature variants can effect the locking of either the ball-joint arrangement, the post means to the spinal rod, or both.
In yet another aspect of the invention, the aforementioned stabilization system includes embodiments wherein the ball-joint arrangement components are made of either metal or polymer and locked by the use of ultrasonic welding or using adhesives between the structural surfaces.
In still yet another aspect of the invention, the aforementioned stabilization system utilizes mechanical locking means such as screw fasteners, taper-locking interfaces and collets.
Other exemplary embodiments of the invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while disclosing exemplary embodiments of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
Exemplary embodiments of the present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
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. The following description of the embodiment(s) is merely exemplary (illustrative) in nature and is in no way intended to limit the invention, its application, or uses.
For purpose of clarity, some of the referenced figures describe a spherical cup member. In practice, any number of geometric configurations suitable to receive a ball, such as a conical V-shaped (not shown) or stair-stepped recess (not shown) could constitute a ball-joint arrangement as described. Also, the surface of any of the ball, cup, post, or internal surface of any connector may be textured, grooved, coated, or otherwise modified with mechanical interdigitation to enhance the locking strength of the connection.
Hence, the above description of embodiments of the invention is merely exemplary in nature and, thus, variations thereof are not to be regarded as a departure from the spirit and scope of the invention.
Claims
1. An orthopedic stabilization system to attach a spinal rod to vertebrae, comprising: and a bone interface member that is integral to said spherical cup member and forms the other end of said bone attachment means, and interfaces to the vertebrae;
- a bone attachment means, including:
- a spherical cup member forming one end of said bone attachment means;
- a post means, including:
- a spherical ball member forming one end of said post means and interfaces with said spherical cup member to form a ball-joint arrangement; and
- a post member integral to said spherical ball member and forming the other end of said post means, the post member having a post height; a locking means to lock said bone attachment means to said post means in a determined spatial orientation; and a connector means to attach the spinal rod to said post member, the connector means having a connector height less than the post height such that the connector means can be positioned in a plurality of positions along the post height to provide a variable height adjustment between the spinal rod and bone attachment means.
2. The system of claim 1, wherein said locking means includes a thin-walled portion to close and lock the ball-joint arrangement.
3. The system of claim 2, wherein said locking means comprises a shape memory alloy (SMA) ring positioned circumferentially around said spherical cup member.
4. The system of claim 1, wherein said spherical cup member includes a plurality of fingers that define a plurality of slots.
5. The system of claim 3, wherein said locking means comprises a SMA ring circumferentially around said spherical cup member.
6. The system of claim 1, wherein said bone attachment means comprises a threaded bone screw.
7. The system of claim 1, wherein said bone attachment means, said locking means, said connector means and said post means comprise metals and polymers.
8. The system of claim 1, wherein said locking means includes the use of ultrasonic welding and adhesives.
9. An orthopedic stabilization system to attach a spinal rod to vertebrae, comprising: wherein, said spherical cup member includes a plurality of fingers that define a plurality of slots;
- a bone attachment means, including:
- a spherical cup member forming one end of said bone attachment means; and
- a bone interface member that is integral to said spherical cup member and forms the other end of said bone attachment means, and attaches to the vertebrae;
- a post means, including:
- a spherical ball member forming one end of said post means and interfaces with said spherical cup member to form a ball-joint arrangement; and
- a post member forming the other end of said post means; a locking means comprised of a SMA ring positioned circumferentially around said spherical cup member and locks said ball-joint arrangement in a determined spatial orientation; and a connector means.
10. The system of claim 9, wherein said connector means includes a rod clamp means comprising a set screw locking mechanism to rigidly connect the spinal rod to said post means.
11. The system of claim 9, wherein said set screw locking mechanism promotes mechanical interdigitation when rigidly connected to the spinal rod.
12. The system of claim 9, wherein said bone attachment means, said rod clamp means and said post means comprise metals and polymers.
13. An orthopedic stabilization system to attach a spinal rod to vertebrae, comprising: wherein, said spherical cup member includes a plurality of fingers that define a plurality of slots;
- a bone attachment means, including:
- a spherical cup member forming one end of said bone attachment means; and
- a bone interface member that is integral to said spherical cup member and forms the other end of said bone attachment means, and attaches to the vertebrae;
- a post means, including:
- a spherical ball member forming one end of said post means and interfaces with said spherical cup member to form a ball-joint arrangement; and
- a post member forming the other end of said post means;
- a locking means comprised of a SMA ring positioned circumferentially around said spherical cup member and locks said ball-joint arrangement in a determined spatial orientation; and
- a rod clamp means, including:
- a collet locking mechanism to rigidly connect the spinal rod to said post means; and
- a post nut to tighten said collet locking mechanism, hereby locking the spinal rod and said post member in a desired relative position.
14. The system of claim 13, wherein said collet locking mechanism includes a screw thread section to position said post nut on said post member.
15. The system of claim 13, wherein said spherical cup member includes a thin-walled portion.
16. An orthopedic stabilization system to attach a spinal rod to vertebrae, comprising:
- a bone attachment means, including:
- a spherical cup member forming one end of said bone attachment means; and
- a bone interface member that is integral to said spherical cup member and forms the other end of said bone attachment means, and attaches to the vertebrae; wherein, said spherical cup member includes a plurality of fingers that define a plurality of slots;
- a post means, including:
- a spherical ball member forming one end of said post means and interfaces with said spherical cup member to form a ball-joint arrangement; and
- a post member forming the other end of said post means;
- a locking means comprised of a SMA ring positioned circumferentially around said spherical cup member and locks said ball-joint arrangement in a determined spatial orientation; and
- a rod clamp means including a SMA connector to rigidly connect the spinal rod to said post means in a desired relative position.
17. An orthopedic stabilization system to attach a spine rod to vertebrae, comprising:
- a bone screw having a screw thread on a bone attachment portion and a partially spherical cup on an opposing end portion;
- a post member having a ball member on one end and a post extending from the ball member, the post having a post height and the ball member positioned in the partially spherical cup;
- a locking member connected to said partially spherical cup, the locking member moveable from an unlocked position allowing movement between the ball member and the partially spherical cup, and a locked position maintaining the ball member in a fixed position within the partially spherical cup; and
- a rod connector for attaching the spine rod to the post, the rod connector having a post engaging portion defining an aperture sized to receive the post, the post engaging portion having a height less than the post height such that the post engaging portion can be positioned in a plurality of locations along the post height to vary the distance between the rod and the bone screw.
18. The system of claim 17, wherein the locking member comprises a shape memory alloy and the locking member moves between the unlocked position and the locked position by austenitic transformation due to a change in temperature.
19. The system of claim 17, wherein the locking member is formed of at least one of a metal or a polymer and the locking occurs by use of ultrasonic welding or adhesives to bond the locking member to the ball member.
20. The system of claim 17, wherein the locking member is formed of a deformable material and the transition from the unlocked position to the locked position occurs by material deformation.
Type: Application
Filed: Dec 30, 2013
Publication Date: Apr 24, 2014
Inventor: David L. Brumfield (Collierville, TN)
Application Number: 14/143,563
International Classification: A61B 17/70 (20060101);