ORTHOPAEDIC SCREWAPPARATUS
The present invention relates to an apparatus and method employed in the stabilization of bones and, more particularly, to an apparatus and method for placing screws in a long bone of a patient.
In a procedure to stabilize bones or stay a bone fracture, a bone fracture reduction rod or intramedullary nail is inserted into an intramedullary canal of the bone. With the development of imaging technology, surgeons have been able to place bone screws through holes in the intramedullary nails. Further, with the aid of a fluoroscope, a surgeon can visualize the hole and precisely place a screw through the bone and nail and into the opposite cortex of the long bone. The use of bone screws came about because previous methods of locking the nails in place, including elastic jamming and the use of Brooker Wills internal deploying fins, did not provide adequate rotational stability to the implanted nail. The use of bone screws not only increases the rotational stability of the implanted nail, but also enhances the union rate of the bone and promotes limb rehabilitation.
The use of such bone screws, however, presents certain challenges. For example, a surgeon has to have several drivers available because of a single nailing system typically employs a large number of different screws of various sizes. As a result, the surgeon may be required to exchange drivers (e.g. a small hex driver with a larger hex driver) in the middle of the procedure. Additionally, certain screw-driver assemblies require that the surgeon perform the drilling operation in at least two stages. In a first stage, a hole is drilled into the bone with a twist drill and then the surgeon employs a power drill to drive the screw partially into the bone and, in a second stage, the surgeon tightens the semi- implanted screw by hand. In between the stages, the surgeon must detach the drill and attach a manual river to the semi-implanted screw. Moreover, bone screws which are not secured to a driver during the procedure can slip off and become lost within surrounding muscle tissue. Retrieval of these screws is difficult
when the bone area is surrounded by a large amount of soft tissue, such as in the areas adjacent the forearm and the proximal thigh. This type of delay is not only unnecessary, but can compromise the success of the procedure.
The preparation of a bone screw implantation presents another set of challenges. In a typical procedure, the bone is pre-drilled and then measured with a direct measurement gauge. Then, the drill is withdrawn and the screw is placed into the pre-drilled hole. However, the soft tissue surrounding the bone tends to occlude the hole as soon as the drill is withdrawn making it difficult to place the screw in the pre-drilled hole. Thus, the surgeon must often relocate the hole twice, once to place the measuring device and again before inserting the screw.
According to the present invention there is provided an orthopaedic screw assembly for placing screws in a procedure for the stabilization of bones, the screw assembly comprising:
an elongated driver having a first end and a second end, wherein the first end includes a first geometrically shaped connection configuration adapted to engage a driving mechanism and the second end includes a second geometrically shaped connection configuration adapted to engage a corresponding geometrically shaped screw head;
a self-drilling screw having a first end, a second end, and a continuous step thread extending therebetween,
the first end of the screw including a geometrically shaped screw head adapted to drivingly engage with the second connection configuration of the second end of the driver and a locking connection configuration formed on the screw head,
the second end of the screw including a tip that is configured for driving entry into bone, and
wherein the step thread of the screw has a first section adjacent the first end and a second section adjacent the second end, the first section of the step thread being characterized by a thread that is of a different height or width or pitch than a thread of the second section of the step thread, and
a screw locking member insertable within the driver, the locking member having a connector portion adapted to engage the locking connection configuration formed on the screw head when the rod is inserted within the driver to lock the screw adjacent the driver.
The first section of the step thread may have a thread height, width or pitch that is greater than or smaller than the height, width or pitch of the thread of the second section of the step thread.
It is therefore, an object of the present invention to provide an orthopaedic screw assembly that includes a self-drilling (preferably self-tapping) screw and which is easier, faster and more practical to use than prior art orthopaedic screw assemblies. It is a further object of the invention to provide such a screw assembly having a retaining or locking means with a universal interface so that different size screws can be used with one driver.
In one aspect of the invention, an orthopaedic screw assembly is provided for placing screws in the fracture reduction of bones. The screw assembly includes an elongated driver having a first end and a second end. The first end includes a geometrically-shaped connection configuration (e.g. external hexagon head) adapted to engage a driving mechanism and the second end includes a geometrically-shaped connection configuration (e.g. an internal hexagonal head) adapted to engage a corresponding geometrically- shaped screw head. Further, the assembly includes a self-drilling screw having a first end, a second end, and a continuous step thread extending therebetween. The first end of the screw includes a geometrically-shaped head (e.g. having an external hexagonal configuration) adapted to drivingly engage with the connection
configuration of the second end of the driver and a locking connection configuration formed on the screw head (e.g. an internally threaded opening). The second end of the screw preferably features a tip that is configured for driving entry into bone as well as a longitudinally extending flute for the removal of bone chips when the screw is drivingly advanced into bone material.
In one unique aspect of the invention, the step thread has a first section adjacent the first end of the screw and a second section adjacent the second end of the screw. The first section of the step thread is characterized by a thread height that is larger than a thread height of the second section of the step thread. The thread height associated with the first section is preferably at least about twenty five percent (and more preferably between about seventy five to about one hundred and fifty percent) larger than the thread height associated with the second section.
The assembly also includes a screw locking or retaining member (e.g. an elongated rod) insertable within the driver. The locking member has a connector portion adapted to engage the locking connection configuration formed on the screw head when the rod is inserted within the driver to lock the screw adjacent the driver. In one embodiment of the invention, the screw head has an internally threaded opening and the locking member has an externally threaded portion adapted to engage the internally threaded opening. In a further embodiment, the locking member has an opposite end with a recess or slot preferably adapted to drivingly engage with a driving mechanism such as a flathead or Phillips screwdriver. When the rod is inserted through the driver to engage the screw in this way, the screw is retained within the assembly and/or locked to the driver.
It is another object of the invention to provide an orthopaedic screw assembly that is usable or drivable with a variety of driving mechanisms including both power and hand driving mechanisms.
It is a further object of the present invention to provide a bone screw that can be safely drilled into hard cortical bone without causing irritation to adjacent soft tissue.
It is yet another object of the invention to provide an orthopaedic screw assembly that can be used to manipulate a screw in bone material without a significant risk of loss within the soft tissue or muscle.
A better understanding of the invention can be obtained when the detailed description of exemplary embodiments set forth below is reviewed in conjunction with the accompanying drawings, in which:
Fig. 1 is a schematic view of an orthopaedic screw assembly according to the present invention being employed to implant a bone screw through an implanted intramedullary nail;
Fig. 2 is a top plan view of an elongated driver of the screw assembly;
Fig. 3 is a side plan view of the drive of Fig. 2;
Fig. 4 is an exploded cross-sectional view of a retaining rod and elongated driver of the screw assembly illustrating insertion of the rod into the driver;
Fig. 5 is a top perspective view of one embodiment of a bone screw according to the present invention;
Fig. 6 is partial cut-a-way view of the head of the bone screw in Fig. 5;
Fig. 7 is a side plan view of the screw in Fig. 5;
Fig. 8 is a top plan view of the screw in Fig. 5;
Fig. 9 is a side plan view of a second embodiment of a bone screw according to the present invention;
Fig. 10 is a cross-sectional view of the bone screw assembly of the present invention;
Fig. 11 is an enlarged partial side view of the head portion of the retaining rod of the screw assembly;
Fig. 12 is an enlarged top view of a first end of the driver of the screw assembly;
Fig. 13 is an exploded view of a partially assembled screw assembly of the present invention;
Fig. 14 is an exploded perspective view of an assembled screw assembly of the present invention;
Fig. 15 is a top perspective view of third embodiment of a bone screw according to the invention;
Fig. 16 is a partial cut-away view of a head section of the bone screw of Fig. 15; and
Fig. 17 is a fourth embodiment of a bone screw according to the invention.
An orthopaedic screw assembly 10 embodying the present invention is depicted in Figs. 1 and 10. As will be discussed in more detail below, the orthopaedic screw assembly 10 of the invention is particularly adapted for use in the stabilization of bones such as the fracture reduction of bones and, more particularly, for placing a screw through the holes of an intramedullary nail and for securing the nail within the intramedullary canal of a long bone. The present can also be used to insert isolated lag screws within a plate or to insert external fixation pins.
Referring to Figs. 1 and 10, the orthopaedic screw assembly 10 includes an elongated driver 12, an elongated screw locking or retaining rod 14, and a self-drilling screw 16. As best shown in Figs. 2 through 4, the elongated driver 12 has a first end 18, a second end 20 and a longitudinal passage 26 therebetween. In a preferred embodiment, driver 12 is cylindrical in shape. A portion of the first end 18 preferably has a generally graduated, hexagonally-shaped, exterior connection configuration 22 that is sized and shaped to engage a conventional driving mechanism (e.g. a manual handle or power driving mechanism). Further, a portion of the second end 20 has a preferably hexagonally-shaped interior connection configuration 24 that is sized and shaped to engage a hexagonally- shaped screw head. In alternative embodiments, the first end 18 and the second end 24 may be equipped respectively with exterior and interior connection configurations of various geometric shapes and sizes. Among a number of suitable connection means alternatives are internal and external hex, threaded, slotted, cruciate and torx configurations. The modification required to incorporate any of such types of connection means structure to the exemplary driver 12 will be apparent to those skilled in the art upon reading the description and/or viewing the drawings provided herein.
The connection configuration 22 includes a series of flats 28 which are configured to engage a power or hand driving mechanism of a type known to those skilled in the art. One type of driving mechanism suitable for use with the elongated driver 12 is one having a ZIMMER® style fitting. The elongated driver 12 and retaining rod 14 are preferably made of stainless steel; however other metals or alloys may be used.
The retaining rod 14 has a first end 30 and a second end 32. Referring to Fig. 11 , the first end 30 includes a connector portion in the form of a generally cylindrical head portion 34 and a rectangular slot 36 located thereon. The slot 36 is preferably configured to connectingly engage the blade of a screwdriver or other driver means known to those skilled in the art. Now referring to Figs. 4 and 13, the second end 32 of the retaining rod 14 features an
externally threaded connection portion 38 for connecting the screw 16 of the present invention.
It should be understood, however, that the retaining rod 14 of the invention is equally adapted to employ connection means generally known in the art and other than those embodied by connector portions 34, 38. For example, a blade connection means (i.e. for engaging a slot) may be used instead of the threaded connection portion 34 an slot 36 combination.
Fig. 5 through 8 depict one embodiment of the self-drilling screw 16 according to the invention. The self-drilling screw 16 includes a shaft portion 51 having a first end 40 and a second end 42, and a continuously advancing spiral ridge or threading 52 threaded evenly about the outer surface of the shaft portion 51. Further, the screw 16 preferably includes a generally known hexagonally shaped head 44 that is positioned adjacent the first end 40 of the shaft portion 51. The hexagonally shaped head 44 is separated from the first end 40 of the screw 16 by a circular collar 45. The screw head 44 also includes a generally conical shaped recess or opening 46. The inside walls of the recess or opening 46 is formed with internal threading 48 that is configured to mate and engage with the threading 38 on the second end 32 of the retaining rod 14 (Fig. 6). In this way, the retaining rod 14 may be used to manipulate the screw 16 and to maintain or lock the screw 16 in a desired position.
The second end 42 of the screw 16 features a tip 50, preferably conical in shape, and a flute 54 that runs longitudinally from the tip 50 into a portion of the screw 16 intersecting a portion of the threading 52 (Figs. 5 and 8). Further, the flute 54 provides a means for the removal of bone chips as the screw 16 is advanced into bone material. The tip 50 is preferably foreshortened so as to improve bone contact at the tip 50 of the screw 16 as the screw 16 is implanted into the bone. The pitch of the threading 52 should be sufficiently small to advance the screw 16 at a rate which allows the top 50 to cut effectively into the bone, but sufficiently large to
provide adequate bone purchase and/or to minimize the number of turns required to seat the screw 16. A suitable pitch for the threading 52 may be one in the range of about 5 threads per inch to about 50 threads per inch. The length of the screw 16 is generally from about 10 to about 200 millimetres.
Fig. 9 depicts an alternate from of the bone screw 16 according to the invention. The bone screw 16 includes a shank portion 56 between the first and second ends 40, 42 or the screw 16.
Figs. 15 and 16 depict a self drilling screw 16' according to a preferred form of the self drilling screw according to the invention. The screw 16' features a captured step thread 52' having a first section 52a' and a second section 52b'. As will be described in greater detail below, the first section 52a' is structurally and functionally distinct from the second section 52b. In most other respects, however, the screw 16' is substantially similar in structure and function to the screw 16 depicted in Figs. 5 through 8 and described above.
The self drilling screw 16' includes a shaft portion 51 ' having a first end 40' that includes a preferably hexagonally shaped head 44', and a second end 42' that features a preferably foreshortened conical tip 50'. The hexagonally shaped head 44' has a generally conical shaped recess or opening 46', wherein an internal threading 48' is formed on the internal walls. Further, a circular collar 45' is positioned intermediate the head 44' and the step thread 52'. The second end 42' of the screw 16' also features a flute (not shown) that runs longitudinally from the conical tip 50' into a portion of the step thread 52'. As discussed previously with respect to the screw 16, the flute provides a means for removal of bone chips from the path of the screw 16' as the screw 16' as the screw 16' in advanced into bone material.
The step thread 52' is a spirally advancing ridge that is formed and threaded evenly about the outside surface of the shaft position
51 '. The step thread 52' extends between the first end 40' of the shaft portion 51 ' and the second end 42' of the shaft portion 51 '. The step thread 52' also defines a helical groove 62' that advances about the shaft portion 51 ' in parallel relation with the step thread 52'. As best shown in Fig. 16, the second section 52b' of the step thread 52' extends from the second end 42' to a transition section 52c' located intermediate the first end 40' and the second end 42'. From the transitional section 52' the first end 52a' of the step thread 52' then extends toward the first end 40' of the screw 16' and terminates adjacent the circular collar 45'.
Although the pitch of the first section 52a' is substantially identical to the pitch of the second section 52b', the first and second sections 52a', 52b' are structurally and functionally distinct. Referring to Fig. 16, the second section 52b' features a top portion 64b' that is preferably relatively broad and wide, whereas the first section 52a' features a ridge top 64a' that is preferably relatively narrow. Moreover, the first section 52a' of the step thread 52' is preferably significantly enlarged from the second section 52b'. In particular, the first section 52a' is advantageously characterized by a thread height or groove depth (i.e. the vertical height from the bottom of the helical groove 62' to the ridge top portion 64a' of the thread 52') that is dimensionally greater than the thread height or groove depth associated with the second section 52b'.
Preferably, the thread height associated with the second section 52b' is at least twenty five percent larger than the thread depth of the second section 52b' (i.e. 1-1/4 times larger). More preferably, the thread height of the first section 52a' is about fifty percent to one hundred and twenty five percent larger than the thread depth of the second section 52b'. Most preferably, the thread depth of the first section 52a' is about as twice as large as the thread depth of the second section 52b'.
It is understood that the structural differences between the first section 52a' and the second section 52b' may be expressed or described in alternative ways. For example, rather than referring to
a thread height or groove depth dimension, the first and second sections 52a', 52b' may be described as having different circular diameters. In such case, the dimension associated with the first section 52a' is significantly greater than the dimension associated the second section 52b'. Alternatively, the first section 52a' and second section 52b' can be the same diameter in which the diameter between the first and second sections 52a1 and 52b' is varied such that the diameter of the second end 52b' is greater than the diameter of the first end 52a'. The same results can be achieved by changing the pitch of the thread in which the pitch is varied between the first and second sections 52a', 52b' such that the pitch becomes smaller in the second section 52b' than it is in the first section 52a'. Also the width of each individual thread can change from a thinner thread width in the first section 52a' to a thicker thread width in the second section 52b'.
Applicants have discovered that the use of the self-drilling screw 16' (as depicted in Figs. 15 and 16) in lieu of the screw 16 depicted in Figs. 5 through 8 provides additional advantages. More specifically, the use of the screw 16' addresses a problem of bone strippage, which occurs during insertion of the screw in the near cortex of the bone. Such strippage of the bone can result in reduced or lost bone purchase and increase the potential fro screw back out. By providing enlarged threads adjacent the head 44' of the screw 16' (i.e. the first section 52a'), the screw purchase on the near cortex is very stable (when the screw 16' is inserted into the bone). During insertion, the first section 52a' engages the near cortex of the bone just before the screw 16' reaches its final position.
The length of the first section 52a' may be lengthened or shortened as necessary to obtain a desired bone purchase or to suit the particular bone area wherein the screw 16' is to be inserted. Thus, an orthopaedic screw assembly 10 according to the invention may include screws 16' having first sections 52a' and shaft positions 51' of various lengths. For example, Fig. 17 depicts an elongated version of the screw 16' depicted in Figs. 15 and 16, wherein like
elements are referred to using like reference numerals. The first section 52a' is provided adjacent the head 44' and covers less than twenty five percent of the total length of the shaft position 51 ' of a longer screw and up to thirty five percent of the total length of the shaft portion 51 ' of a shorter screw.
It should be noted that the screws 16 and 16' of the present invention may be formed of various constructions as is necessary or desirable for the intended application and, thus can take on a variety of lengths, diameters, thread configurations, and other designs. Any of several such adaptation of the present invention will be apparent to one of ordinary skill in the art upon reading the description and/or viewing the figures provided herein.
Referring now to Fig. 13, the orthopaedic screw assembly 10 is assembled by inserting the hexagonally shaped head 44 of screw 16 into the hexagonally shaped opening 24 of driver 12 and then inserting rod 14 into the passageway 26 of the driver 12. The rod 14 may be brought into threaded engagement with the screw 16 by using a screwdriver, for example, to rotatably operate the head portion 34 such that the threaded end 38 of rod 14 engages the threaded opening 46 of the screw head 44 (fig. 3). The head portion 34 of the retaining rod 14, which is diametrically larger than the passage 26, remains outward of the passage 26 for easy access. When threadedly engaged with the rod 14, the screw 16 is referred to as being locked to driver 12 or, more specifically, being locked within the hexagonally shaped opening 24 of driver 12. In this respect, the retaining rod 14 is also referred to as a locking member.
When a power drill or hand driving mechanism is connected to the hexagonally shaped portion 22 of the driver 12 and operated, the entire assembly 10 rotates as the screw 16 is drilled into bone material. Moreover, the driver 12 and or rod 14 may be employed, for example, to manipulate the screw 16 within large muscle areas without the undue risk of loss of the screw 16.
The orthopaedic screw assembly 10 also allows for a large variety of screws to be used during the implantation of a single nailing system in combination with a single driver. Further, the drive 12 of the screw assembly 10 is connectable with and drivable by a variety of power and hand driving mechanisms and handles in one compact unit.
Although the present invention has been described with reference to its preferred embodiments, those skilled in the art will recognize changes that may be made in form and structure that do not depart from the spirit of the invention already described in the specification and embodied in the claims that follow.