Removeable Set Screw for Medical Implant

The present application is directed to a set screw for use in applications where it is important for the head of the set screw to break away to leave a clean profile, but for the set screw to be removable, especially set screws for use in conjunction with medical implants.

Over recent years, medical implants for support of and correction of defects in various portions of the body, especially the spine, have improved dramatically. It is desirable to continue to improve these implants, so that the implants provide greater strength and durability and so that the implants are effective for the life of the patient. Furthermore, it is very desirable to provide such an implant which is low profile and interferes as little as possible with tissues surrounding the implant. Because the set screw which holds together various parts of the implant, especially spinal implants, has often been a limiting factor with respect to such implants, current attention has been directed to improving the set screw.

Set screws of the type used in medical implants have among other problems two somewhat conflicting requirements. It is important to be able to grasp the set screw and apply rotational force to it until it is set against an element of the implant and then torqued to a particular preselected amount. Because the torque applied to such set screws is comparatively high, this normally requires a protruding head with an external surface which can be grasped by a driving tool to set the screw at the preselected torque.

On the other hand, if the head sticks outwardly from the set screw after installation, then this presents a problem, since the head will interfere with surrounding tissue, such as muscle, ligament and the like. Consequently, set screws have been developed recently that have a break off head that is designed to break away from a base of the set screw upon the application of the preselected torque.

While the break away head satisfies the two above and noted requirements, it presents a problem of its own. That is, once the head breaks away, it is then quite difficult to grasp the remaining set screw base to remove it, should the implant need to be adjusted during installation or should later work on the implant require removal of the set screw.

Therefore, there needs to be some mechanism provided to allow the set screw to be removed. While the force or torque required to remove the base of the set screw after it has been installed is less than the installation torque, it is normally only approximately 70% of that required to install the set screw. Thus, a relatively large torque must be applied to the set screw base to remove it. Because it is imbedded in the implant and because it is low profile, there is little surface to grasp to allow the surgeon to remove the set screw, once installed.

Applicant, in a manner described in prior patent applications of applicant, and others have tried to develop different ways to effectively remove the set screw base once it has been broken away from the driving head. One of applicant's prior concepts was to provide an internal bore in the base of the set screw which may be a smooth wall bore or which may include some structure for assisting in the gripping of the wall by a tool and then utilizing a easy out tool or the like to try to grasp the interior of the bore for removal. Such structure was designed to try to provide sufficient torque to remove the base and in some cases functioned satisfactorily for this purpose, but in other cases did not. Because of the high torque applied to the base, it is not an easy process to remove the screw base in this manner mainly because of the inability to grasp the base or the likelihood of stripping any grip due to the torque required. In addition, the leverage radius that can be used on the interior wall is substantially less than can be applied to the exterior wall of the set screw.

Consequently, applicant foresaw a need for a set screw that would have a break away head to allow a preselected torque to be applied to the set screw and then have the head break away leaving a lower section and further that provided the surgeon with structure near the radial exterior of the screw base that could be accessed by a tool that would allow the surgeon to apply removal torque to remove the set screw with substantially greater grip and with substantially greater mechanical advantage as compared to use of a tool in a central bore.

Further, new methods of triggering breakage of the head from the base have been desired. Applicant found that a mechanism for providing side relief to the slots could also assure access to the slots after breakage and trigger the breakage in a preselected and desired location without requiring a groove or notch. Such breakage can be triggered by a radial bore that is relatively easy and inexpensive to construct.

A set screw is provided that is especially suited for use in medical implants and the like wherein it is desired to have a low profile set screw preferably that is installed at a preselected torque and is then removable should removal be required. The set screw includes a threaded lower section or base and a breakoff head.

In particular, the base and the head are originally joined at a breakaway location or region that is triggered by the location of the smallest cross-section of the screw in a plane perpendicular to an axis of rotation of the screw, such that as torque is increasingly applied to the head, the torque on the head reaches a preselected amount and the head breaks from the base at the preselected breakaway region.

The base includes a threaded surface that is radially spaced from the axis of rotation and that is received in a cooperatively and matingly threaded bore in a first medical implant or the like. The bottom of the base includes an axially projecting tip that may be a point, a ring, both or another similar structure for frictionally engaging a second implant during rotation so as to secure the second implant relative to the first.

The head includes an outer grippable surface for gripping and applying torque and an internal bore to receive tools for guiding during installation.

The screw base has a top that includes a non-planar removal structure sized and shaped to receive a removal tool and provide purchase to the removal tool so that that tool may be utilized to reverse torque of the base and remove the base from a receiving bore. The removal structure is preferably not accessible when the head is attached to the base and the base is in a receiving bore but becomes accessible when the head breaks from the base. In a preferred embodiment the removal structure is a pair of slots. In particular, located along the outer wall of the screw and extending partially along the base and partially along the head are a pair of non-intersecting or spaced slots. The slots extend radially part way into the screw and are preferably positioned opposite or diagonally with respect to each other and are positively spaced by a wall supporting central core. The slots extend through the threaded surface on the base. The slots provide for removal of the base after the set screw is installed and the head broken away.

A removal tool is provided to remove the base utilizing the slots. The tool includes a manipulative handle operably connected to a pair of ears adapted to be received in the base slots after the head is removed. The ears are spaced, sized and positioned to be received in the slots radially inward of the threads on the threaded surface so that the tool can be inserted into the slots without engaging or interfering with the threads of the first implant bore to allow counterclockwise rotational force or torque to be applied to the base through the ears by rotation of the tool by a user and in this way remove the base from the implants. The radially outward position of the slots provides a mechanical advantage to the user.

Also associated with the slots is a circular bore that is positioned such that the center axis of the bore, which is also the location of the largest cross-section of the bore, is located in the breakaway region of the screw, so as to reduce the cross-section of the screw in this region and to trigger breakage when preselected torque is applied to the head. The bore also preferably provides relief at the location of breakage. That is, normally when breakage between the head and base occur, some of the metal adjacent to the slots may be twisted into the slot opening, thereby preventing easy access of the tool to the slot. The bore is positioned to at least partially overlap the slot on the leading edge of the slot as it rotates counterclockwise. The bore assures that the tool will have sufficient space to be easily received in the slot and to provide a receptive area for deformation of metal, next to the slot during torquing.

Therefore, the objects of the present invention are: to provide a set screw for use in conjunction with medical implants and the like wherein the set screw has a low profile after installation, provides for installation to a preselected torque and is removable from the implant after installation; to provide such a set screw having a breakoff head and a region of reduced cross-section produced by a bore that is centered in a plane perpendicular to the axis of installation so as to trigger breakage at a preselected location across the plane; to provide such a set screw having a removal structure located on the base that is accessible to receive and provide purchase 7 to a removal from the base and, preferably wherein the removal structure comprises a pair of axially extending and radially penetrating slots that extend along an outer threaded surface of the base and head of the screw such that the slots intersect with the location whereat the head breaks from the base and such that the slots are positioned and shaped to receive a tool to apply counterclockwise rotation to the base to remove the set screw from the implant after breakage; to provide such a set screw including a relief region adjacent to the slots to insure that a removal tool has full access of the slots; to provide such a screw that has such slots positioned to provide a mechanical advantage to removal of the base over that provided by mechanisms and systems that remove the base through internal structure; to provide such a screw wherein the relief bore next to each slot is also centered on the plane where breakage is preferred and the relief bore creates a smaller cross-section at that plane so as to trigger breakage at a preselected torque; to provide a tool having ears adapted to be received in the slots for applying a removal torque; to provide such a tool wherein the ears include gripping cleats; to provide such a set screw in combination with medical implants to secure a first implant to a second implant; and to provide such a set screw, tool and overall implant system that is comparatively easy to use, easy to produce, and especially well adapted for the intended usage thereof.

Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention.

The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.

FIG. 1 is a perspective view of a removable set screw with a break off head and a base in accordance with the present invention.

FIG. 2 is a front elevational view of the set screw with the rear side being identical.

FIG. 3 is a side elevational view of the set screw with the opposite side being identical.

FIG. 4 is a cross sectional view of the set screw, taken along line 4--4 of FIG. 3.

FIG. 5 is a fragmentary side elevational view of the set screw on a reduced scale positioned in an implant with a head of the set screw broken away from a lower base thereof and having portions removed to show detail thereof.

FIG. 6 is an enlarged fragmentary top plan view of the set screw and implant of FIG. 5, showing the bore after breakaway of the set screw head.

FIG. 7 is a side elevational view of a tool to remove the set screw base from the implant.

FIG. 8 is a fragmentary side elevational view of the implant of FIG. 5 with the set screw base being removed by the removal tool.

FIG. 9 is an enlarged and cross sectional view of the set screw base and tool, taken along line 9--9 of FIG. 8.

FIG. 10 is an enlarged fragmentary view of the removal tool, taken within circle 10 of FIG. 7.

FIG. 11 is an enlarged fragmentary front elevational view of the removal tool.

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.

The reference numeral 1 generally designates a set screw in accordance with the present invention used in conjunction with a medical implant system 3 (FIG. 5) and having an associated removal tool 4 (FIG. 7).

The set screw 1 has an upper section or head 10 and a lower section or base 11 originally joined together along a planar breakaway zone or region 12. The set screw 1 is rotatable about a central axis A that passes longitudinally through the center of the screw 1, and the plane of the breakaway region 12 is perpendicular to the axis A.

The head 10 has an outer grippable surface 15, which in the illustrated embodiment includes six planar faces 16 joined together in a hexagonal shape, such that the faces 16 lie in planes that are parallel to but are spaced from the axis A.

The surface 15 is sized and shaped to receive a driving or installation tool (not shown) of any conventional type for torquing or clockwise (as viewed from a top 19 of the head 10) rotating the set screw 1, preferably having a hex head for mating with the screw head 10. A bore 18 extends from the top 19 of the head 10 partially through the head 10 and is coaxial with axis A. The bore 18 preferentially receives a nipple from a driving tool during insertion. Near the top of the bore 18 is an internal chamber or relief 21. A pair of tool receivers 22 extend between the bore 18 and the surface 15 near the head top 19. The receivers 22 operably receive a portion of a driving tool during installation of the set screw 1. A suitable driving tool for use with the set screw 1 of the present invention is illustrated in my co-pending application Ser. No. 08/726,828 on TOOLS FOR USE IN INSTALLING OSTEOSYNTHESIS APPARATUS UTILIZING SET SCREW WITH BREAK-OFF HEAD, now U.S. Pat. No. 5,941,885, which is incorporated herein by reference.

The purpose of the head 10 is to allow a surgeon or other user to apply a driving tool to grip the surface 15 and apply rotational force or torque to the screw 1 to firmly set the base 10. The head surface 15 allows good leverage about the axis A and mechanical advantage to allow an installer to gain purchase and apply a high torque once the set screw 1 is set. As discussed in greater detail below, the head 10 breaks away from the base 11 at a preselected torque.

Although the illustrated surface 15 is hexagonal in cross section, surfaces of other shapes including non polyhedral shapes may be utilized for the grippable surface 15.

The base 11 has a radially outer surface 24 that is threaded and which is coaxial with but spaced from the axis A. A thread 25 (FIG. 2) winds helically about the surface 24 and has an associated peak and valley.

The thread 25 of the threaded surface 24 is sized and shaped to be received in an implant bore, as described below. A bottom 26 of the base 11 has an axially projecting tip 27 providing frictional engagement and preferably penetration into an object against which the screw 1 is operably set. The tip 27 and which is described further below extends outward parallel to the axis A. The tip 27 of the illustrated embodiment includes a point 29 and sharp edged ring 30 that is radially spaced from the point 29. Although the point 29 and ring 30 are shown in the illustrated embodiment, it is foreseen that just one may be used and that other types of projecting tips may also be used in accordance with the present invention.

Located between the head 10 and base 11 is the breakaway region 12. The location 12 is in a plane that is typically perpendicular to the axis A. When the head 10 breaks from the base 11, as shown in FIG. 5, a top or upper surface 31 is left on the base 11. The region 12 has a reduced cross sectional area perpendicular to the axis A, as compared to the surrounding regions of the screw 1. It is applicant's theory that this reduced cross-section and geometry thereof is what triggers the breakage at the selected location for the breakaway region 12. Preferably, the breaking of the head 10 from the bore 11 leaves the base upper surface 31 relatively smooth and free from burrs, although the metal may deform slightly sideways due to twisting.

The region 12 in the illustrated invention is produced by a combination of three elements. The first element is a pair of slots 35 and 36 (FIG. 4). The second element is a pair of bores 40 and 41 (FIG. 6), which will be discussed in greater detail below, and which are drilled radially inward from the side of the screw 1 such that the center axis of each bore 40 and 41 lies in the plane of the desired breakaway region 12 and so as not to extend to the set screw axis A. The third element is a cylindrically shaped surface 43 located between the head 10 and the base threaded surface 24. Because the surface 43 has no thread it has a slightly smaller cross-section than the threaded portion of the surface 24, even though the trough associated with the thread 25 is the same radial distance out from the axis A or the surface 43, because the thread 25 winds helically about the surface 24 and crosses any plane taken perpendicular to the axis A on one side thereof. Consequently the surface 43 is somewhat smaller in cross-section as compared to the planar cross-section through the surface 24 by the amount of the thread size 25.

While all uses of the elements surface 43, bores 40 and 41 and slots 35 and 36 function together to determine the breaking torque and location of break of the illustrated embodiment, it is foreseen that for some desired torques or that other externally applied structure, structural details or geometry modification to reduce the cross-section at the desired point of breakage may be used in accordance with the invention.

Extending radially inward from the head surface 15 and the base surface 24 is the pair of slots 35 and 36 which are spaced and non-intersecting. In this embodiment the slots 35 and 36 operably function as non-planar removal structure located in the base upper surface 31 that is adapted to receive and provide purchase to a removal tool 4, such that the removal tool 4 may apply torque to the base 11 to remove a set base 11. Each of the slots 35 and 36 is elongate with the greatest length being aligned parallel to the axis A. Each of the slots 35 and 36 is formed by milling or drilling and extends perpendicular to or radially inward toward the axis A, but does not intersect with the axis A. Each slot 35 and 36 is positioned in opposed relationship or diametrically relative to the other.

Each slot 35 and 36 extends substantially along the base outer surface 24 and in the illustrated embodiment each slot 35 and 36 extends parallel to the axis A along about two thirds of the surface 24. The slots 35 and 36 extend through the breakaway region 12 and in the illustrated embodiment extend partly along the head surface 15. The depth of each slot 35 and 36 may vary somewhat, but must accommodate the removal tool 4. In the illustrated embodiment the slots 35 and 36 each extend approximately 60% of the distance between the lowest part of the threaded surface 24 and the axis A. The width of each of the slots 35 and 36 in the illustrated embodiment is about one third of the diameter of the base 11, but it is foreseen that slots of other size may be used in accordance with the invention, especially considering the size and shape of the tool 4 and the overall diameter of the set screw 1.

Although a pair of slots 35 and 36 is shown in the illustrated embodiment, it is foreseen that three or more slots could be utilized in accordance with the invention and that in some instances even a single slot may be used. Furthermore, it is foreseen that the removal structure may be formed of slots have somewhat unusual shaped openings, such as pie shaped or that the removal structure could be simply a flattening of portions of opposite sides of the base 11 near the top surface 31 and extending downwardly to allow a tool to grip the base 11 when in a bore. A wide variety of removal structures may be utilized in the invention. However, the shape and configuration of such structures is limited when combined with a breakaway head that prevents access to the removal structures until the head is removed. Because of the location and position of the breakaway head an engineer is limited in making and placing the removal structure.

The illustrated slots 35 and 36 generally differ from conventional screwdriver slots in two ways. In particular, the slots 35 and 36 do not pass through the center axis A of the set screw in such a manner that the upward projecting sidewall 48 and 49 on either sides of and positioned between the slots 35 and 36 generally are supported in the middle in the present invention whereas such sidewalls produced by a conventional flat screwdriver slot are not centrally supported by anything.

Secondly, the spacing of the slots 35 and 36 toward the radially outer portion of the screw base 11 allows application of force by a tool where the lever arm from the rotation axis A is greatest. In a conventional screw with a standard slot head, a substantial portion of the center of the screwdriver exerts little, if any, force against the screw because the lever arm is so short, most of the force being exerted by the radially outward portion of the screwdriver head.

Because the set screw 1 of the illustrated embodiment presents only radially outward slots, such as 35 and 36, a removal tool, such a tool 4 must engage the slots 35 and 36 in a manner to assure good mechanical advantage and leverage to allow removal of the base 11. In some instances it is also foreseen that the base 11 without the head 10 could be rotated clockwise in an installation direction and torqued in a set position using a tool such as the tool 4 in the slots 35 and 36 without a head 10 attached to the base 11.

The bores 40 and 41 are positioned to be centered over the breakaway region 12 and are each partially overlapping a respective slot 35 and 36, as shown in FIG. 3. That is, the center of each bore 40 and 41 lies in the plane of the breakaway region 12 so that the widest radial cross-section of each bore 40 and 41 also lies in the plane of the breakaway region 12. Each bore 40 and 41 is positioned to the side of a respective associated slot 35 and 36 so as to approximately halfway overlap the slot and form a relief area 45 next to the slot on the leading edge side as the screw 1 is rotated clockwise (as viewed in FIG. 6). The bores 40 and 41 are cylindrical and in the illustrated embodiment have the same depth as the slots 35 and 36.

The illustrated set screw removal tool 4 is T-shaped and includes an elongate shaft 50 with a handle 51 extending perpendicularly in opposite directions from one end thereof. At an end opposite the handle 51 is a set screw engaging tool head 52. As best seen in FIGS. 10 and 11, the tool head 52 includes a pair of axially projecting and slot receiving tabs, lugs or ears 54 and 55. The ears 54 and 55 are separated or spaced by a slot or channel 56. The ears 54 and 55 are sized and shaped to be received inward of the thread 25 within the slots 35 and 36 once the head 10 has been broken from the base 11 and the channel 56 spans a center core 57 of the set screw 11 between the slots 35 and 36. The ears 54 and 55 may also be utilized to insert a base 11 without a head. The ears 54 and 55 are adapted to be positioned or set in the slots 35 and 36 so as to be received therein, as is illustrated in FIGS. 8 and 9. The channel 56 is sufficiently large in size to receive a center core 57 of the set screw located between the slots 35 and 36. The ears 54 and 55 are also sized to not extend outwardly into the thread 25 of the base 11 or mating thread of the implant system 3. The center core 57 preferably extends to the upper surface 31 of the base 11 and joins opposite sidewalls 48 and 49 of the base 11 together in a comparatively strong construction that does not easily collapse radially inward.

Located near a lower end of each of the ears 54 and 55 is a cleat 58. The cleats 58 are positioned on the sides of the ears 54 and 55 that engage the slots 35 and 36 when the tool is rotated counterclockwise to remove the base 11. As a substantial amount of torque is applied to the tool 4 to remove set screw base 11, once the base 11 has been secured to the implant system 3, the cleats 58 serve to grip the sidewalls of the slots 35 and 36 and reduce the likelihood of slippage. If one of the ears 54 or 55 should break during removal of the base 11, the broken ear is simply removed and a new tool 4 is utilized for the purpose.

Shown in FIGS. 5, 6 and 8 is the set screw 1 in combination with the medical implant system 3. The medical implant system 3 that is illustrated includes a bone screw 60 and a rod 61. In the illustrated embodiment the bone screw 60 is implanted in a vertebral bone 62. In conventional medical implant systems of the type illustrated herein, there are a wide range of parts that are utilized including hooks, connectors, bars, plates and numerous other elements that are all interconnected together by means of set screws. The set screw 1 of the present invention may be used for interconnecting together any of the various elements.

In the illustrated embodiment, the bone screw 60 includes a first bore 64 that is sized and shaped to slideably receive the rod 61 and is often perpendicular to the central elongate axis of the bone screw 60. The rod 61 is positioned in the first bore 64 in the illustration. The bone screw 60 includes a second threaded bore 65 which intersects with the first bore 64 and which is generally aligned to be coaxial with the bone screw 60. The thread of the thread bore 65 is sized and shaped to receive the thread 25 on the base outer surface 24 of the set screw 1.

The set screw 1 is, thus, first threaded into the threaded bore 65 until the projecting tip 19 engages the rod 61. Thereafter, clockwise rotation producing an increasing torque is applied to the set screw 1 to set the set screw 1 both within the threaded bore 65 and against the rod 61. As the set screw 1 is rotated, the set screw point 29 and ring 30 frictionally engage and partially penetrate into the rod 61. As increasing torque is applied to the set screw 1, the torque finally reaches a preselected torque where the head 10 breaks from the base 11, as is illustrated in FIG. 5.

The torque can be substantially varied according to the system and set screw, but it has been found that a torque of 90 inch pounds is highly effective when setting the set screw 1 so as to prevent relative motion between the various elements of the system 3, including the bone screw 60 and rod 61. The torque with which the head 10 breaks from the base 11 is generally determined by the material of construction of the set screw, the overall diameter of the breakaway region 12, the size and depth of the bores 40 and 41, the size and shape of the slots 35 and 36 and the radius of the surface 43, although other factors may be used to set the break point, as noted before, that generally are based on the cross-sectional area of the screw 1 in the selected breakaway region 12.

Subsequent to the head 10 breaking from the base 11, the upper surface 31 of the base 11 is preferably beneath or substantially even with a top 67 of the bone screw 63. In this manner the set screw 1 does not have a projecting head 10 and is comparatively low profile.

Consequently, in operative use, the set screw base 11 secures a first implant, such as the bone screw 60, to a second implant, such as the rod 61, by means of the set screw 1 being threadably held in the first implant bore 65 and set against the second implant or rod 61 by rotation and application of torque thereto.

Subsequent to the set screw base 11 being set, it is sometimes necessary to remove the base 11. This occurs when the implant system 3 must be adjusted during installation or at a later time when original parts of the system must be removed for some reason. When this occurs, the removal tool 4 is utilized. In particular, the removal tool ears 54 and 55 are placed in the slots 35 and 36. Thereafter, the user applies counterclockwise rotation to the handle 51 to urge the ears 54 and 55 against respective sides of the slots 35 and 36. Sufficient torque is applied in this manner to unseat the base 11. The ears 54 and 55 are sufficiently radially inward so as not to interfere with the threads on the interior of the bone screw threaded bore 65. This allows a subsequent set screw 1 to be utilized in the bore 65 to reset the bone screw 60 relative to the rod 61. The tool 4 may also be used to reset or initially set the base by clockwise rotation if the head 10 is removed so as to allow access to the slots 35 and 36.

While the torque required to unseat the set screw base 11 varies from system to system and with the type of metal used, it has been found that the torque required to unseat the base 11 is often approximately 70% of the torque required to seat the screw 1.

It is foreseen that the set screw 1 of the present invention can be constructed of many different types of materials. When the set screw 1 is to be utilized for medical implants, the material of construction should be as compatible as possible with implantation and it has been found that stainless steel and titanium are typically preferred as materials of construction for such uses.

Although the set screw of the present invention is described and illustrated in conjunction with mainly medical implants, as it advantageously provides for many of the requirements peculiar to such implants as opposed to other types of set screws, it is foreseen that the set screw of the present invention may also be used with other types of systems.

It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.