CONTINUOUS COMPRESSION FIXATION DEVICE FOR THE FUSION OF AN INTERCALARY STRUCTURAL AUGMENT

Abstract

A continuous compression fixation device for coupling a first bony structure to a second bony structure, including: a body structure; and a plurality of arm structures extending from the body structure, wherein at least one of the plurality of arm structures is configured to be coupled to the first bony structure and at least one opposed one of the plurality of arm structures is configured to be coupled to the second bony structure; wherein the body structure and the plurality of arm structures are manufactured from a shape memory material; and wherein tips of the at least one of the plurality of arm structures and the at least one opposed one of the plurality of arm structures are biased towards one another such that a desired compressive force is applied to an intercalary structural augment disposed between the first bony structure and the second bony structure.

Claims

1. A continuous compression fixation system adapted to couple a first bony structure to a second bony structure, comprising: an intercalary structural augment for insertion between the first bony structure and the second bony structure; a body structure manufactured from a shape memory alloy and comprising four outer edges and four corners; and four arm structures adapted to couple the body structure to the first bony structure and the second bony structure, wherein: each arm structure is coupled to and extends from the body structure from one of the four corners; and the shape memory material is adapted to provide a compressive force and resist a torsional force between the first bony structure and the second bony structure when the body structure and the four arm structures are deflected from a first configuration to a second configuration and subsequently released.

2. The continuous compression fixation system of claim 1, wherein the compressive force is applied to the intercalary structural augment disposed between the first bony structure and the second bony structure.

3. The continuous compression fixation system of claim 2, wherein the body structure is coupled to the intercalary structural augment disposed between the first bony structure and the second bony structure.

4. The continuous compression fixation system of claim 1, wherein the body structure comprises eight arcs.

5. The continuous compression fixation system of claim 3, wherein each of the eight arcs is formed by one of the four outer edges and one arm structure of the four arm structures.

6. The continuous compression fixation system of claim 1, wherein the body structure and the four arm structures are manufactured from a nitinol shape memory alloy.

7. The continuous compression fixation system of claim 1, wherein each of the four arm structures comprise one or more friction structures for securely retaining a respective arm structure in a hole drilled into a bony structure.

8. The continuous compression fixation system of claim 1, wherein the body structure comprises at least one exterior side surface forming a concave transition between an arm structure of the four arm structures and at least one opposed arm structure.

9. The continuous compression fixation system of claim 8, wherein each of the four arm structures comprises a tip.

10. The continuous compression fixation system of claim 9, wherein: a first arm structure of the four arm structures comprises a first tip; a second arm structure of the four arm structures comprises a second tip; and the first tip and the second tip are biased towards one another relative to a perpendicular orientation with respect to the body structure by a compressive force generated in a proximity of where each of the first arm structure and second arm structure are coupled.

11. The continuous compression fixation system of claim 10, wherein the first tip is tapered for insertion into a hole drilled into a bony structure.

12. The continuous compression fixation system of claim 11, wherein each of the four arm structures comprises one or more friction structures for securely retaining each arm structure in the hole drilled in the associated bony structure.

13. A continuous compression fixation system adapted to couple a first bony structure to a second bony structure, comprising: an intercalary structural augment for insertion between the first bony structure and the second bony structure; a body structure manufactured from a shape memory alloy; and two or more arm structures adapted to couple the body structure to the first bony structure and the second bony structure, wherein: each arm structure is coupled to and extends from the body structure; and the shape memory material is adapted to provide a compressive force and resist a torsional force between the first bony structure and the second bony structure when the body structure and the two or more arm structures are deflected from a first configuration to a second configuration and subsequently released.

14. The continuous compression fixation system of claim 13, wherein the compressive force is applied to the intercalary structural augment disposed between the first bony structure and the second bony structure.

15. The continuous compression fixation system of claim 14, wherein the body structure is coupled to the intercalary structural augment disposed between the first bony structure and the second bony structure.

16. The continuous compression fixation system of claim 15, wherein the body structure comprises an arc is formed by one outer edge and one arm structure of the two or more arm structures.

17. The continuous compression fixation system of claim 13, wherein the body structure and the two or more arm structures are manufactured from a nitinol shape memory alloy.

18. The continuous compression fixation system of claim 13, wherein each of the two or more arm structures comprise one or more friction structures for securely retaining a respective arm structure in a hole drilled into a bony structure.

19. The continuous compression fixation system of claim 13, wherein the body structure comprises at least one exterior side surface forming a concave transition between an arm structure of the two or more arm structures and at least one opposed arm structure.

20. The continuous compression fixation system of claim 13, wherein each of the two or more arm structures comprises a tip.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The present invention is illustrated and described herein with reference to the various drawings, in which like reference numbers are used to denote like device components/method steps, as appropriate, and in which:

[0011] FIG. 1 is a perspective view of one exemplary embodiment of the continuous compression fixation device of the present invention in a deployed configuration,

[0012] FIG. 2 is a perspective view of one exemplary embodiment of the continuous compression fixation device of the present invention in an expanded configuration,

[0013] FIG. 3 is a front planar view of one exemplary embodiment of the continuous compression fixation device of the present invention in an implanted and deployed configuration,

[0014] FIG. 4 is a side planar view of one exemplary embodiment of the continuous compression fixation device of the present invention in an implanted and deployed configuration;

[0015] FIG. 5 is a perspective view of one exemplary embodiment of the continuous compression fixation device of the present invention in an expanded configuration;

[0016] FIG. 6 is a perspective view of one exemplary embodiment of the continuous compression fixation device of the present invention in an expanded configuration being implanted with an intervertebral cage;

[0017] FIG. 7 is a perspective view of one exemplary embodiment of the continuous compression fixation device of the present invention in a deployed configuration implanted with an intervertebral cage;

[0018] FIG. 8 is a front planar view of one exemplary embodiment of the continuous compression fixation device of the present invention in a deployed configuration implanted with an intervertebral cage;

[0019] FIG. 9 is a side planar view of one exemplary embodiment of the continuous compression fixation device of the present invention in a deployed configuration implanted with an intervertebral cage; and

[0020] FIG. 10 is a side planar view of another exemplary embodiment of the continuous compression fixation device of the present invention.

DETAILED DESCRIPTION

[0021] Referring now specifically to FIGS. 1-4, in one exemplary embodiment, the present invention provides a continuous compression fixation device 10 for coupling a first bony structure 12 to a second bony structure 14. The continuous compression fixation device 10 includes a body structure 16 and a plurality of arm structures 18 coupled to and extending from the body structure 16 towards the first bony structure 12 and the second bony structure 14. Accordingly, one or more of the plurality of arm structures 18 are configured to be coupled to the first bony structure 12 and one or more of the plurality of arm structures 18 are configured to be coupled to the second bony structure 14. In the exemplary embodiment illustrated, two of the arm structures 18 are associated with each of the bony structures 12 and 14, although other desired numbers of the arms structures 18 could be associated with each of the bony structures 12 and 14 equally.

[0022] The body structure 16 and the plurality of arm structures 18 are manufactured from a shape memory material, such as a shape memory polymer or a shape memory alloy like nitinol. It will be readily apparent to those of ordinary skill in the art that any suitable shape memory material may be utilized provided that it continuously biases the structure(s) at issue to an original intended shape after deflection, thereby resisting such deflection with a reactionary force. By design, the tips 20 of the plurality of arm structures 18 are biased towards one another relative to a perpendicular orientation with respect to the body structure 16, thereby providing a compressive force between the first bony structure 12 and the second bony structure 14 when the plurality of arm structures 18 are deflected and coupled to their respective bony structures 12 and 14. In other words, each of the plurality of arm structures 18 is intentionally angled inwards in at least one plane as illustrated and persistently seeks to return to such configuration despite its state of deflection and what it is coupled to. Preferably, by design, the tips 20 of the plurality of arm structures 18 are biased towards one another relative to the perpendicular orientation with respect to the body structure 16 such that a desired compressive force is applied to an intercalary structural augment 22 (FIGS. 6, 7, and 9) disposed between the first bony structure 12 and the second bony structure 14. Again, the tips 20 of the plurality of arm structures 18 are configured to be deflected away from one another prior to being coupled to the first bony structure 12 and the second bony structure 14, respectively. Thus, the plurality of arm structures 18 are opened up prior to implantation into appropriate holes drilled into the first bony structure 12 and the second bony structure 14, for example, and then released subsequent to implantation. This provides a desired compressive force between the first bony structure 12 and the second bony structure 14. This compressive force is applied (and in fact tailored) to the intercalary augment structure 22 disposed between the first bony structure 12 and the second bony structure 14, promoting both fixation and fusion, when appropriate.

[0023] The tips 20 (and other portions) of the plurality of arm structures 18 are preferably biased towards one another relative to the perpendicular orientation with respect to the body structure 16 by a compressive force generated primarily in the proximity of where each of the arm structures 18 and the body structure 16 are coupled, at the shoulders 24 of the continuous compression fixation device 10. In general, it is desirable that the body structure 16 and the plurality of arm structures 18 are integrally formed to minimize areas in which failure and corrosion can be initiated and propagate.

[0024] Each of the plurality of arm structures 18 includes a tapered and/or sharpened tip 20 such that it may be more easily disposed in the hole drilled into the associated bony structure 12 or 14. Each of the plurality of arm structures 18 further includes one or more friction structures 26 (e.g. protrusions, barbs, or threads) such that it is securely retained in the hole drilled into the associated bony structure 12 or 14.

[0025] Referring now specifically to FIG. 5, one exemplary embodiment of the continuous compression fixation device 10 of the present invention is illustrated. In this exemplary embodiment, the body structure 16 is a substantially planar structure 28 with a generally rectangular shape that terminates in a raised central ridge 30 to minimize its anatomical protrusion when the continuous compression fixation device 10 is implanted in a spinal column or the like. The body structure 16 may define any number of recesses, holes, or other openings as desired in a given application. In general, the plurality of arms structures extend away from the body structure 16 at an angle of between greater than about 0 degrees and less than about 45 degrees from perpendicular in a natural or resting state, with a few degrees past zero degrees preferred. This natural or resting angular displacement of the plurality of arm structures 18 is illustrated in one plane along each side of the continuous compression fixation device 10 and not in the perpendicular planes along the ends of the continuous compression fixation device, although such multidimensional angular displacement of the plurality of arm structures 18 is possible. In this exemplary embodiment, each of the plurality of arm structures 18 includes a generally tapered tip 20 for insertion purposes and a plurality of raised barbs 26 for retention purposes. The plurality of arm structures 18 meet the body structure 16 to form a plurality of arcs 32 that are designed to enhance conformal anatomical fit in a given application. As described above, the body structure 16 and the plurality of arm structures 18 are manufactured from a shape memory material, such as a shape memory polymer or a shape memory alloy like nitinol. It will be readily apparent to those of ordinary skill in the art that any suitable shape memory material may be utilized provided that it continuously biases the structure(s) at issue to an original intended shape after deflection, thereby resisting such deflection with a reactionary force. Again, in general, it is desirable that the body structure 16 and the plurality of arm structures 18 are integrally formed to minimize areas in which failure and corrosion can be initiated and propagate.

[0026] FIGS. 6-9 illustrate the continuous compression fixation device 10 of the present invention being implanted in a spine 34 of a patient after an intercalary structural augment 22, such as an intervertebral cage and/or bone graft, has been implanted into the prepared intervertebral space 36. FIG. 9 illustrates the low-profile nature of this installation. Although not specifically illustrated, the continuous compression fixation device 10 can be coupled directly to the intercalary structural augment 22, if desired.

[0027] Thus, the present invention provides continuous compression across a single-level, or multi-level, osseous segment, with or without the use of an intercalary cage/graft, with fixation using staple arms incorporating, in whole or in part, a shape memory material. The staple is manufactured in a deployed configuration with acute angles between the staple arms. These are heated/expanded and placed into a carrying mechanism, and subsequently deployed into bony structures across the intercalary structural augment. Once deployed, the staple will reconfigure to its original shape, providing continuous compression across the anterior and middle columns of the spine, for example, with most of the compressive force being directed through the middle column through the tips of the staple arms. Compression across the middle column, rather than through an anterior plate, minimizes the concern for iatrogenic kyphosis in the cervical and lumbar spine, for example, and focuses the compression more linearly across the intercalary structural augment.

[0028] It is additionally important to consider rotational strain across a fusion mass, just as one would consider resistance to flexion and extension. In that regard, the present invention incorporates a variety of angular connections to resist torsional stresses and provide a lower-strain, higher-stability construct than would typically be seen in existing routine spinal instrumentation after cyclic loading, for example.

[0029] Because of the conceptual similarity among all iatrogenic bony fusions, the continuous compression provided by the osseous staple design of the present invention would work for all bony fusions with intercalary structural augments. Other exemplary applications include opening wedge osteotomies with tri-cortical auto/allograft or other material/device osteotomy filling and deformity correction with structural augmentation.

[0030] Referring now specifically to FIG. 10, in another exemplary embodiment, the present invention provides a continuous compression fixation device 110 in which some or all of the plurality of arm structures 18 are replaced with conventional locking or nonlocking fixed or variable angle bone screws 112. The remaining arm structures 18, if any, operate as before. In the case where all of the arm structures 18 are replaced by bone screws 1 12, compressive force is provided solely by the shape memory material body structure 16 itself, which acts on the coupled bony structures through the bone screws 112.

[0031] Although the present invention is illustrated and described herein with reference to preferred embodiments and specific examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments and examples may perform similar functions and/or achieve like results. All such equivalent embodiments and examples are within the spirit and scope of the present invention, are contemplated thereby for all purposes, and are intended to be covered by the following non-limiting claims.