# Patent

## Title
Orthopedic anchor assembly

## Abstract

In an exemplary embodiment, the present invention provides an anchor assembly that can be used for the fixation or fastening of orthopedic devices or instruments to bone tissue. In particular, the present invention preferably provides a variable angle or fixed angle anchor assembly that is able to securely connect the orthopedic device to bone tissue even when there is a variance in the angle and position of the assembly with respect to the device. Furthermore, in an exemplary embodiment, the present invention provides an anchor assembly having a locking mechanism that will quickly and easily lock the anchor assembly with respect to the orthopedic device.

## Background
FIELD OF THE INVENTION
The present invention is directed to a bone fixation assembly and, in particular, to an anchor assembly for securing an orthopedic device to bone tissue.
BACKGROUND OF THE INVENTION
As is known in the field of orthopedic surgery, and more specifically spinal surgery, bone anchors may be used for fixation or for the fastening of orthopedic devices or instruments to bone tissue. An exemplary use of bone anchors may include using the bone anchors to fasten an orthopedic device, such as a bone plate, a spinal rod, or a spinal spacer, to a vertebral body for the treatment of a deformity or defect in a patient's spine. Focusing on the bone plate example, bone anchors can be secured to a number of vertebral bodies and a bone plate can then be connected to the vertebral bodies via the bone anchors to fuse a segment of the spine. In another example, bone anchors can be used to fix the location of a spinal spacer once the spacer is implanted between adjacent vertebral bodies. In yet another example, bone anchors can be fastened to a number of vertebral bodies to anchor a spinal rod in place along a spinal column to treat a spinal deformity.
In each of these exemplary uses, a plurality of bone anchors are needed to fasten the orthopedic device to the area of treatment. In addition, depending on the extent of the disease or size of the defect to be treated, it is possible that several orthopedic devices each requiring a plurality of bone anchors may be required. Accordingly, the fastening of the orthopedic implants to the area of treatment can become a time consuming and even difficult task.
As such, there exists a need for bone anchors that can quickly and securely fasten an orthopedic device to the area of treatment.
SUMMARY OF THE INVENTION
In a preferred embodiment, the present invention provides an anchor assembly that can be used for the fixation or fastening of orthopedic devices or instruments to bone tissue. In particular, the present invention preferably provides a variable angle or fixed angle anchor assembly that is able to securely connect the orthopedic device to bone tissue even when there is a variance in the angle and position of the assembly with respect to the device. Furthermore, in a preferred embodiment, the present invention provides an anchor assembly having a locking mechanism that will quickly and easily lock the anchor assembly with respect to the orthopedic device.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred or exemplary embodiments of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
FIG. 1 is an exploded partial perspective view of one embodiment of an anchor assembly;
FIG. 2 is a partial perspective view of the anchor assembly shown in FIG. 1;
FIG. 3 is partial perspective view of the anchor assembly shown in FIG. 1;
FIG. 4 is a partial cross-sectional view of the anchor assembly shown in FIG. 1; and
FIG. 5 is a schematic view of another embodiment of an anchor assembly being seated and locked in an orthopedic device.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.
With reference to FIGS. 1-4, a preferred embodiment of an anchor assembly 10 is illustrated. The anchor assembly 10 preferably includes an anchor 11 and a locking mechanism 30. Although the anchor 11 will be discussed in the context of an orthopedic screw, it is contemplated that the anchor 11 can be any type of anchoring element including, but not limited to, a hook, a pin, or a nail. In a preferred embodiment, the anchor 11 includes, concentric to a longitudinal axis 12, a head portion 14, a neck portion 18 and a shank portion 16. The head portion 14 connects to the shank portion 16 through the neck portion 18. The anchor assembly 10 is preferably constructed from any biocompatible material including, but not limited to, stainless steel alloys, titanium, titanium based alloys, or polymeric materials.
In a preferred embodiment, the head portion 14 of the anchor 11 has a generally spherical shape and includes at least one resilient finger element 20. In another preferred embodiment, the head portion 14 includes four resilient finger elements 20. Preferably, located on either side of the resilient finger element 20 is an elongated groove 22. The grooves 22 may be configured and dimensioned to correspond with the end of a driving instrument (not shown) designed to engage the anchor 11, and consequently the anchor assembly 10.
As best shown in FIG. 4, the generally spherical shape of the head portion 14 is configured and dimensioned to be received within a correspondingly shaped cavity 52 in an orthopedic device 50 which may be part of a spinal fixation system. In an exemplary embodiment, the orthopedic device 50 is a bone plate, but the orthopedic device can be any device, such as a spinal rod “tulip” style holder or a spinal spacer. The shape of the head portion 14 and the correspondingly shaped cavity 52 allows the anchor assembly 10 to pivot, rotate and/or move with respect to the orthopedic device 50. In another embodiment, instead of allowing the anchor assembly 10 to pivot, rotate and/or move with respect to the orthopedic device 50, the head portion 14 and the correspondingly shaped cavity 52 may be configured and dimensioned to keep the anchor assembly 10 in a fixed position. In an exemplary use, the head portion 14 of the anchor 11 is received in the cavity 52 of the orthopedic device 50 and the anchor assembly 10 is pivoted, rotated or moved until the desired orientation with respect to the orthopedic device 50 is met. The anchor assembly 10 is then locked in place, which is discussed in detail below, in the cavity 52 of the orthopedic device 50. In a preferred embodiment, the head portion 14 also includes texturing 24 that extends along at least a portion of the head portion 14. The texturing 24 on the head portion 14 provides additional frictional surfaces which aid in locking the anchor assembly 10 in place with respect to the orthopedic device 50.
Turning back to FIGS. 1-3, in a preferred embodiment, the neck portion 18 of the anchor 11 integrally connects the head portion 14 with the shank portion 16. The diameter of the neck portion 18 is preferably dimensioned to match the minor diameter of the anchor 11. By having the diameter of the neck portion 18 dimensioned at least as large as the minor diameter of the anchor 11, the overall rigidity and strength of the anchor 11 is increased.
In a preferred embodiment, the shank portion 16 of the anchor 11 includes a shaft 26 surrounded at least in part by a thread portion 28. The diameter of the shaft 26 is the minor diameter of the anchor assembly 10. In a preferred embodiment, the diameter of the shaft 26 remains generally constant from a proximal end of the shaft 26 toward a distal end of the shaft 26. The constant diameter of a majority portion of the shaft 26 allows for optimal anchor positioning when the anchor assembly 10 is inserted into a predetermined area in the bone tissue. The constant diameter also allows for varying the depth positioning of the anchor assembly 10 in the bone. For example, if a surgeon places the anchor assembly 10 into bone tissue at a first depth and decides the placement is more optimal at a second, shallower depth, the anchor assembly 10 can be backed out to the second depth and still remain fixed in the bone. In another embodiment, the diameter of the shaft 26 may vary along its length, including increasing in diameter from the proximal end to the distal end or decreasing in diameter from the proximal end to the distal end.
With continued reference to FIGS. 1-3, the thread portion 28 surrounding the shaft 26 extends, in a preferred embodiment, from the distal end of the shaft 26 to the neck portion 18. In another preferred embodiment, the thread portion 28 may extend along only a portion of shaft 26. The thread portion 28 is preferably a Modified Buttress thread but the thread can be any other type of threading that is anatomically conforming, including, but not limited to Buttress, Acme, Unified, Whitworth and B&S Worm threads.
In a preferred embodiment, the diameter of the thread portion 28 decreases towards the distal end of the anchor 11. By having a decreased diameter thread portion 28 near the distal end of the anchor 11, the anchor 11 can be self-starting. In another preferred embodiment, anchor 11 may also include at least one flute to clear any chips, dust, or debris generated when the anchor assembly 10 is implanted into bone tissue.
Looking again at FIGS. 1-4, the anchor assembly 10 preferably includes the locking mechanism 30. In a preferred embodiment, the locking mechanism 30 will lock the anchor assembly 10 with respect to the orthopedic device 50 thereby preventing the anchor assembly 10 from disengaging from the orthopedic device 50. The locking mechanism 30 preferably includes a locking member 32 which is configured and dimensioned to be received in an opening 34 in the anchor 11.
In a preferred embodiment, the locking member 32 has a head member 36 and a shaft member 38. The head member 36 preferably includes an opening 40 for receiving a driving instrument (not shown). The opening 40 may also include threading 42 that is capable of threadingly engaging a driving instrument for reasons explained below. In a preferred embodiment, the shaft member 38 includes at least one protrusion 44 extending along at least a portion of the circumference of the shaft member 38. Focusing on FIG. 4, at least a portion of the shaft member 38, in a preferred embodiment, also includes a hollow portion 46 which allows at least a portion of the shaft member 38 surrounding the hollow portion 46 to flex inwardly.
Turning back to FIGS. 1 and 4, the opening 34, preferably, is generally annular and extends coaxially with the longitudinal axis 12 from the head portion 14 through the neck portion 18 into the shank portion 16. The opening 34 preferably also includes at least two recesses 47, 48, each recess 47, 48 extending along at least a portion of the circumference of the opening 34. Each recess 47, 48 is configured and dimensioned to accommodate the protrusion 44.
In an exemplary use of the anchor assembly 10 with the orthopedic device 50, the orthopedic device 50 is first oriented and placed in the area of treatment. The orthopedic device 50 is then fastened to the bone tissue via at least one anchor assembly 10 which is received in at least one cavity 52 of the orthopedic device 50. Looking at FIG. 4, in a preferred embodiment, the cavity 52 has a generally spherical shape with a first diameter y at an upper portion 54. When viewed from the upper portion 54 to a lower portion 56, the diameter of the cavity 52 generally increases until approximately the middle portion of the cavity 52. The diameter of the approximately middle portion of the cavity 52 is a second diameter x. The diameter of the cavity 52 then decreases from the approximately middle portion of the cavity 52 to the lower portion 56, where the diameter of the cavity near the lower portion 56 is the same as or smaller than the first diameter y.
In a preferred embodiment, the anchor assembly 10 passes through the cavity 52 until the head portion 14 of the anchor 11 abuts the top portion 54 of the cavity 52. As can be seen in FIG. 4, in a preferred embodiment, the diameter of the head portion 14 of the anchor 11 is generally the same width as diameter x. Since the top portion 54 of the cavity 52 has a diameter y, which is smaller than the diameter x, as the head portion 14 is brought into the cavity 52, the finger elements 20 of the head portion 14 resiliently bias inwardly reducing the diameter of the head portion 14 until the head portion 14 fits through top portion 54 of the cavity 52. Once the head portion 14 passes through the top portion 54, the resilient finger elements 20 return back to their original position as the head portion 14 is seated in the cavity 52.
As best seen in FIGS. 3 and 4, in a preferred embodiment, once the anchor assembly 10 is seated in the cavity 52, the anchor assembly 10 can be locked in the cavity 52 by actuating the locking mechanism 30. In a preferred embodiment, a user actuates locking mechanism 30 by pushing on the head member 36 of the locking member 32. The downward force moves the locking member 32 further into the opening 34. As the locking member 32 moves into the opening 34, the protrusion 44 will disengage from the recess 47. Since, in a preferred embodiment, the diameter of the shaft member 38 of the locking member 32 is generally equivalent to the diameter of the opening 34 near the neck portion 18 and the shaft portion 16, the shaft member 38 will flex inwardly, aided by the hollow portion 46, to accommodate the protrusion 44 once it disengages from the recess 47. The locking member 32 will continue to move further into opening 34 until the protrusion 44 engages the recess 48 at which point the head member 36 will be seated between the resilient finger elements 20 of the head portion 14. The anchor assembly 10 is now locked in the cavity 52 since the head member 36, once seated between the resilient finger elements 20, prevents the resilient finger elements 20 from flexing inwardly. It is important to note that the disengagement of protrusion 44 from recess 47 and the engagement of the protrusion 44 with the recess 48 (and vice versa) provides the user with audible and/or tactile feedback allowing the user to quickly and easily confirm the locked or unlocked status of the anchor assembly 10.
As mentioned earlier, the head portion 36 includes the opening 40 which may include threading 42. The threading 42 in opening 40 engages a driving instrument (not shown) allowing a user to pull on the locking mechanism 30 thereby unlocking the anchor assembly 10 in the event a user wants to disengage the anchor assembly 10 from the orthopedic device 50.
In another exemplary use of the anchor assembly 10 with the orthopedic device 50, the orthopedic device 50 is first oriented and placed in the area of treatment. The orthopedic device 50 is then fastened to the bone tissue via at least one anchor assembly 10 which is received in at least one cavity 52 of the orthopedic device 50. In this exemplary use, after the anchor assembly 10 is seated in the cavity 52, but before the anchor assembly 10 is locked in the cavity 52, the anchor assembly 10 is pivoted, rotated or otherwise moved until the desired orientation with respect to the orthopedic device 50 is met. The anchor assembly 10 is then locked in place at that desired orientation by actuating the locking mechanism 30 as discussed above.
In this exemplary use, to lock the anchor assembly 10 at the desired orientation another preferred embodiment of the anchor assembly 10, and more specifically, another preferred embodiment of the locking mechanism 30 is necessary. In this preferred embodiment, the locking mechanism 30 is configured and dimensioned to resiliently bias the resilient finger elements 20 of head portion 14 outwardly when the locking mechanism 30 is pushed from the first, unlocked position, to the second, locked position. By resiliently biasing the finger elements 20 outwardly, the finger elements 20 will push against the walls of the cavity 52 thereby locking the anchor assembly 10 in place in the desired orientation. To resiliently bias the finger elements 20 outwardly, the head member 36 of the locking mechanism 30, preferably, is configured and dimensioned to include tapering surfaces and a diameter larger than the diameter of the opening 34 near the head portion 14.
Turning to FIG. 5, a preferred embodiment of the anchor assembly 100 is shown. The anchor assembly 100 is similar to anchor assembly 10, as such, only the differences between the two embodiments are addressed herein. The anchor assembly 100 preferably includes an anchor 110 and a locking mechanism 130. In a preferred embodiment, the anchor 110 includes, concentric to a longitudinal axis 112, a head portion 114, a neck portion 118 and a shank portion 116. The head portion 114 connects to the shank portion 116 through the neck portion 118. In a preferred embodiment, the head portion 114 of the anchor 110 has a generally spherical shape and includes a resilient ring element 120 captured between an upper and lower end of the head portion 114.
With continued reference to FIG. 5, in a preferred embodiment, the locking mechanism 130 will lock the anchor assembly 100 with respect to the orthopedic device 150 thereby preventing the anchor assembly 100 from disengaging from the orthopedic device 150. The locking mechanism 130 preferably includes a locking member 132 which is configured and dimensioned to be received in an opening 134 in the anchor 110.
In an exemplary use of the anchor assembly 100 with the orthopedic device 150, the orthopedic device 150 is first oriented and placed in the area of treatment. The orthopedic device 150 is then fastened to the bone tissue via at least one anchor assembly 100 which is received in at least one cavity 152 of the orthopedic device 150. In a preferred embodiment, the anchor assembly 100 passes through the cavity 152 until the head portion 114 of the anchor 110 abuts a top portion of the cavity 152. Since the top portion of the cavity 152 has a diameter that is smaller than the diameter of the head portion 114, to fit the head portion 114 into the cavity 152, the resilient ring 120 is resiliently bias inwardly, reducing the diameter of the head portion 114, until the head portion 14 fits through top portion of the cavity 152. Once the head portion 114 passes through the top portion of the cavity 152, the ring 120 returns back to its original position as the head portion 114 is seated in the cavity 152.
With continued reference to FIG. 5, in a preferred embodiment, once the anchor assembly 100 is seated in the cavity 152, the anchor assembly 100 can be locked in the cavity 152 by actuating the locking mechanism 130. In a preferred embodiment, a user actuates locking mechanism 130 by pushing on the locking member 132. The downward force moves at least a portion of the locking member 132 into opening 134. The anchor assembly 100 is now locked in the cavity 152 since the locking member 132, once seated in the opening 134, prevents the ring 120 from flexing inwardly.
The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

## Claims

1. An anchor assembly for fastening an orthopedic device to bone tissue, comprising:
an anchor comprising a head portion having at least one resilient element at least partially defining an opening, a shank portion for engaging the bone tissue, and a neck portion for connecting the head portion and the shank portion, and
a locking mechanism having a head member and a shaft member, the locking mechanism received in the opening, and wherein the shaft member includes a hollow portion to allow at least a portion of the shaft member to flex,
wherein the locking mechanism is slideably movable in the opening from a first position to a second position, and
wherein in the first position, the shaft member is received in the opening and in the second position, the head member and the shaft member are received in the opening, preventing the at least one resilient element from flexing inwardly,
wherein at least a portion of the shaft member of the locking mechanism includes a diameter larger than a diameter of the opening of the anchor to cause the shaft member to flex radially inwards, in relation to a longitudinal axis of the locking mechanism, when the locking mechanism is moved from the first position to the second position.

2. The anchor assembly of claim 1, wherein the opening extends from the head portion through the neck portion into the shaft portion.

3. The anchor assembly of claim 2, wherein the opening includes at least one recess.

4. The anchor assembly of claim 3, wherein the shaft member includes a protrusion for engaging the at least one recess.

5. The anchor assembly of claim 4, wherein the protrusion engages a first of the at least one recess when the locking mechanism is in the first position and the protrusion engages a second of the at least one recess when the locking mechanism is in the second position.

6. The anchor assembly of claim 1, wherein the head portion has a spherical shape defined at least in part by the at least one resilient element.

7. The anchor assembly of claim 1, wherein the at least one resilient element comprises four resilient elements, each of the four resilient elements being separated by grooves configured and dimensioned to receive a driving instrument.

8. The anchor assembly of claim 1, wherein the head member has a head member opening for receiving a driving instrument.

9. The anchor assembly of claim 8, wherein at least a portion of the head member opening is threaded.

10. An anchor assembly system for fastening an orthopedic device to bone tissue, comprising:
an anchor comprising a head portion having at least one resilient element at least partially defining an opening, a shank portion for engaging the bone tissue, and a neck portion for connecting the head portion and the shank portion;
a locking mechanism having a head member and a shaft member, the locking mechanism received in the opening, and wherein the shaft member includes a hollow portion to allow at least a portion of the shaft member to flex; and
an orthopedic device having a cavity for receiving the head portion of the anchor,
wherein the locking mechanism is slideably movable in the opening from a first position where the head portion is unlocked and can be removed from the cavity to a second position where the head portion is locked and cannot be removed from the cavity,
wherein at least a portion of the shaft member of the locking mechanism includes a diameter larger than a diameter of the opening of the anchor to cause the shaft member to flex radially inwards, in relation to a longitudinal axis of the locking mechanism, when the locking mechanism is moved from the first position to the second position.

11. The anchor assembly system of claim 10, wherein in the first position, the shaft member is received in the opening, and in the second position, the head member and the shaft member are received in the opening.

12. The anchor assembly system of claim 10, wherein the opening extends from the head portion through the neck portion into the shaft portion.

13. The anchor assembly system of claim 12, wherein the opening includes at least one recess.

14. The anchor assembly system of claim 13, wherein the shaft member includes a protrusion for engaging the at least one recess.

15. The anchor assembly system of claim 14, wherein the protrusion engages a first of the at least one recess when the locking mechanism is in the first position and the protrusion engages a second of the at least one recess when the locking mechanism is in the second position.

16. The anchor assembly system of claim 10, wherein the head portion has a spherical shape defined at least in part by the at least one resilient element.

17. The anchor assembly system of claim 10, wherein the at least one resilient element comprises four resilient elements, each of the four resilient elements being separated by grooves configured and dimensioned to receive a driving instrument.

18. The anchor assembly system of claim 10, wherein the head member has a head member opening for receiving a driving instrument.

19. The anchor assembly system of claim 18, wherein at least a portion of the head member opening is threaded.

20. An anchor assembly system for fastening an orthopedic device to bone tissue, comprising:
an anchor comprising a spherical head portion having at least one resilient element at least partially defining an opening, a shank portion for engaging the bone tissue, and a neck portion for connecting the head portion and the shank portion;
a locking mechanism having a head member and a shaft member having a protrusion, the locking mechanism received in the opening, and wherein the shaft member includes a hollow portion to allow at least a portion of the shaft member to flex; and
an orthopedic device having a spherical cavity for receiving the head portion of the anchor,
wherein the opening has a plurality of recesses for engaging the protrusion,
wherein the locking mechanism is slideably movable in the opening from a first position where the head portion is unlocked and can be removed from the cavity to a second position where the head portion is locked and cannot be removed from the cavity,
wherein in the first position, the shaft member is received in the opening and in the second position, the head member and the shaft member are received in the opening, and
wherein the protrusion engages a first of the plurality of recesses in the first position and the protrusion engages a second of the plurality of recesses in the second position,
wherein at least a portion of the shaft member of the locking mechanism includes a diameter larger than a diameter of the opening of the anchor to cause the shaft member to flex radially inwards, in relation to a longitudinal axis of the locking mechanism, when the locking mechanism is moved from the first position to the second position.