APPARATUS AND METHOD FOR USE IN THE TREATMENT OF HAMMERTOE

Abstract

An orthopedic drill bit includes a cutting head formed to include diametrically opposed cutting lips leading to a central point and away to a radiused periphery to center said bit. The drill includes flutes extending from a cutting end, said flutes having a dulled periphery to prevent out of round holes. The flute design increases in width progressively from the tip up the shank, to maintain an adequate and unrestricted space for chips to easily move upward, preventing the chips from being compressed into a smaller opening while maintaining the tapered depth of the flutes for strength.

Claims

1-15. (canceled)

16. An apparatus for coupling at least two pieces of bone material together comprising: a hollow proximal half with an internal surface and an external surface for implantation into a first of two pieces of a host material; a hollow distal half with an internal surface and an external surface for implantation into a second of the two pieces of the host material; each of said proximal and distal halves having a longitudinal axis, said distal half having a thread pattern helically disposed on the external surface and wound in a first direction, said proximal half having a thread pattern helically disposed on the external surface wound in a second direction opposite to said first direction; means to removably attach said distal and proximal halves together such that, when united together, rotation of either said proximal or distal half causes said halves to move relative to one another until they are either dissociated or bound together; wherein said thread pattern on said external surfaces each have a portion defining self-tapping threads, said self-tapping threads having tooth flanks on each half facing each other and defining an included angle relative to said respective axes of said proximal and distal halves of less than 90 degrees, and each of said self-tapping threads has an opposite flank on each tooth with an included angle relative to said longitudinal axes of said proximal and distal halves greater than or equal to 90 degrees; and an articulating joint interposed between said proximal half and said distal half; wherein the articulating joint comprises a proximal joint part coupled to the proximal half and a distal joint part coupled to the distal half, wherein said proximal part is pivotably coupled to said distal part; and wherein a locating pin is formed on one of the proximal joint part and the distal joint part, and a groove is formed in another of the proximal joint part and the distal joint part, and the locating pin is engaged with the groove to limit articulation of the articulating joint to a substantially planar movement within a limited range of articulation.

17. The apparatus of claim 16 where the proximal half and the distal half each comprise at least two opposing self-tapping bores defined through the internal and external surfaces and the external threads of each respective half to act as a repository for the removed debris of the bone material.

18. The apparatus of claim 16, further comprising a pivot pin extending through a pivoting axis of the proximal joint part and the distal joint part.

19. The apparatus of claim 16, wherein one end of the proximal joint part is threadably coupled to the proximal half, and one end of the distal joint part is threadably coupled to the distal half.

20. The apparatus of claim 16, further comprising a locking means for preventing relative rotation between the proximal joint part and the proximal half.

21. The apparatus of claim 16, further comprising a locking means for preventing relative rotation between the distal joint part and the distal half.

22. The apparatus of claim 16, wherein said limited range of articulation is a range of approximately 90 degrees.

23. An apparatus for coupling at least two pieces of bone material together comprising: a hollow proximal half with an internal surface and an external surface for implantation into a first of two pieces of a host material; a hollow distal half with an internal surface and an external surface for implantation into a second of the two pieces of the host material; each of said proximal and distal halves having a longitudinal axis, said distal half having a thread pattern helically disposed on the external surface and wound in a first direction, said proximal half having a thread pattern helically disposed on the external surface wound in a second direction opposite to said first direction; means to removably attach said distal and proximal halves together such that, when united together, rotation of either said proximal or distal half causes said halves to move relative to one another until they are either dissociated or bound together; wherein said thread pattern on said external surfaces each have a portion defining self-tapping threads; and an articulating joint interposed between said proximal half and said distal half; wherein the articulating joint comprises a proximal joint part coupled to the proximal half and a distal joint part coupled to the distal half, wherein said proximal part is pivotably coupled to said distal part; and wherein a locating pin is formed on one of the proximal joint part and the distal joint part, and a groove is formed in another of the proximal joint part and the distal joint part, and the locating pin resides within the groove to limit articulation of the articulating joint to a bending movement as would correspond to a bending movement of a joint of human digit.

24. The apparatus of claim 23, wherein said self-tapping threads have tooth flanks on each half facing each other and define an included angle relative to said respective axes of said proximal and distal halves of less than 90 degrees.

25. The apparatus of claim 24, wherein each of said self-tapping threads has an opposite flank on each tooth with an included angle relative to said longitudinal axes of said proximal and distal halves greater than or equal to 90 degrees.

26. The apparatus of claim 23, further comprising a pivot pin extending through a pivoting axis of the proximal joint part and the distal joint part.

27. The apparatus of claim 23, wherein one end of the proximal joint part is threadably coupled to the proximal half, and one end of the distal joint part is threadably coupled to the distal half.

28. The apparatus of claim 23, further comprising a locking means for preventing relative rotation between the proximal joint part and the proximal half.

29. The apparatus of claim 23, further comprising a locking means for preventing relative rotation between the distal joint part and the distal half.

30. The apparatus of claim 23, wherein said limited range of articulation is a range of approximately 90 degrees.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] FIG. 1 is an exploded view of the threaded device depicting both the distal and proximal portions of the threaded device.

[0039] FIG. 2 is a partially cutaway cross-sectional view of the distal portion of the threaded device shown in FIG. 1.

[0040] FIG. 3 is a partially cutaway cross-sectional view of the proximal portion of the threaded device shown in FIG. 1.

[0041] FIG. 4 is a side cross-sectional view of a hammer toe in which the illustrated embodiment of the invention is employed.

[0042] FIG. 5 is a side cross-sectional view of a hammer toe after the joint has been opened and guide pins inserted in preparation for drilling of a receiving bore into each of the opposing phlanges into which bores the halves of the bone pin of the illustrated embodiment will be implanted.

[0043] FIG. 6 is a side cross-sectional view of a hammer toe after the bone pin halves of the illustrated embodiment have been implanted, but before they have been joined together.

[0044] FIG. 7 is a side cross-sectional view of a hammer toe after the bone pin halves of the illustrated embodiment have joined together.

[0045] FIGS. 8 and 9 are exploded perspective views of embodiments incorporating an articulating joint between distal and proximal portions of the threaded device.

[0046] The invention and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the invention defined in the claims. It is expressly understood that the invention as defined by the claims may be broader than the illustrated embodiments described below.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Turning now to FIG. 1, a distal half 1 and a proximal half 5 of the bone pin 34 are shown. As described below distal half 1 is implanted in the distal phlange and proximal half 5 is implanted into the proximal phlange of a hammer toe joint. Both halves 1, 5 are generally cylindrical with a longitudinal bore define therethrough on the longitudinal axis of each half. The distal half 1 includes an external helical thread 3 defined into the exterior surface of the distal half 1. The tooth 32 of the external helical thread 3 is defined between a minor diameter 8 and a major diameter 7. Similarly, an external helical thread 4 is also defined into the exterior surface of the proximal half 5, however the external thread 3 of the distal half 1 has a greater pitch than that of the threads 4 of the proximal half 5. The proximal half 5 further comprises a male peg 29 on its distal end. An external helical thread 6 is defined into the exterior surface of the male peg 29. A mating internal female thread 10 is defined into a bore 11 of the proximal end of the distal half 1.

[0048] Both the distal and proximal halves 1, 5 include at least a pair of diametrically opposed tapping bores 30 perpendicularly defined through the cylindrical surface and perpendicular to the longitudinal axis of each half. The tapping bores 30 are preferably oval shaped and are defined on opposing sides through the threads 3, 4 of each of the halves 1, 5 respectively, however other shapes or other configurations may be used without departing from the original spirit and scope of the invention. The tapping bores 30 are defined with very sharp cutting edges through the thread 3, 4 to enable the threads 3, 4 to become self-tapping. The perpendicular bores 30 also serve as a repository for the bone chips created during the thread cutting process. This allows the chips to be moved into and contained within the perpendicular bore 30 in each half 1, 5 thereby preventing galling, interference and radial forces during the thread cutting process. This produces clean cut threads within the friable bone or other host material similar to those cut with a tap, but unlike the imperfect threads cut by the crude and dull edges of prior art self-tapping devices.

[0049] The internal components of the distal half 1 of the current device can been seen in the partially cutaway cross-sectional view of FIG. 2. The distal half 1 has an internal bore 11 with a smooth portion for receiving peg 29 and followed by a threaded portion carrying mating threads 10, which bore 11 extends from the proximal end 24 of the distal half 1 to an internal hexagonally shaped bore 12. Internal female quick lock thread 10 is defined within a portion of the smooth internal surface 11. The internal hexagonally shaped bore 12 is disposed along the longitudinal axis of the distal half 1 and extends to distal end 23 of the distal half 1.

[0050] Also seen in FIG. 2 is the orientation of the external threads 3 in relation to the longitudinal axis of the distal half 1. Those external threads 3 located proximally of the tapping bores 30 are leading tooth flanks 13, and those external threads 3 through which tapping bores 30 are defined are trailing tooth flanks 14. The leading tooth flanks 13 are orientated at less than a 90 degree angle from the longitudinal axis of the distal half 1. The trailing tooth flanks 14 are orientated at an angle between 90 and 95 degrees relative to the longitudinal axis of the distal half 1. The recited angles of the leading and trailing tooth flanks 13, 14, when engaged in a host material or bone, help produce an interlocking mechanical grip on the host material or bone. The trailing tooth flanks 14, unlike the leading tooth flanks 13, are open faced due to the oval shaped tapping bores 30 being defined through them. This configuration results in the trailing tooth flanks 14 having a sharp, angled edge, which when rotated about the longitudinal axis will cut into the surrounding bone or host material and thus render bone pin 34 self-tapping.

[0051] The corresponding internal components of the proximal half 5 of the current device can be seen in FIG. 3. The proximal half 5 includes a smooth, hexagonally shaped internal bore 19 which extends from the proximal end 26 of the proximal half 5, to the distal end 25 of the proximal half 5. The external threads 4 helically disposed around the proximal half 5 have a major diameter 22 and a minor diameter 21. Those external threads 4 located distally with respect to the tapping bores 30 are leading tooth flanks 17, and those external threads 4 through which the tapping bores 30 are defined are trailing tooth flanks 18. The leading tooth flanks 17 are orientated at an angle 90 to 95 degrees relative to the longitudinal axis of the proximal half 5. The trailing tooth flanks 18 are orientated at an angle less than 90 degrees relative to the longitudinal axis of the proximal half 5. The recited angles of the leading and trailing tooth flanks 17, 18, when engaged in a host material or bone, help produce an interlocking mechanical grip on the host material or bone. The cutting faces of the thread teeth are open faced due to the oval shaped tapping bores 30 defined through them. This configuration results in the teeth faces having sharp, angled edges which when rotated about the longitudinal axis will cut into the surrounding bone or host material and thus enable the bone pin 34 to be self-tapping.

[0052] Currently, well established medical procedures teach that solid fixation of the toe joint to eliminate articulation is the most satisfactory solution for treating the common malady of hammer toe. The current device helps accomplish this procedure in a novel and improved way by being inserted between the proximal and distal phalanges of a patient.

[0053] First, a surgeon or other medical professional opens the soft tissues of the patient’s hammer toe as shown in FIG. 4 and then surgically partially separates the joint. The joint is then opened furthered by bending the partially disconnected distal phalanges downward to expose the proximal end of the bone as shown in cross-sectional view of FIG. 5. A guide pin hole is then drilled through the end of the proximal portion of the bone and then a guide pin 36 is then installed to help facilitate the use of a cannulated drill bit to further open the inside of the bone into a large enough cavity to accommodate the proximal half 5 of the bone pin 34.

[0054] The proximal end 26 of the proximal half 5 is inserted into the drilled hole in the proximal phlange. A hex shaped driving tool, commonly known in the art, is then inserted into the distal end 25 of the proximal half 5 and extended into the hexagonally shaped internal bore 19. The proximal half 5 is then screwed into the surrounding bone in the proximal phlange by rotating the hex shaped driving tool. As the proximal half 5 is being rotated, the open faced trailing tooth flanks 18 cut into the surface of the surrounding bone of the proximal phlange and allow the external threads 4 to dig deeper into the bone. Bone chips or any other refuse from the host material is removed by the external threads 4 and pushed into the oval shaped tapping bores 30 and out of the way of the self-tapping external threads 4, thus preventing galling and any unnecessary radial forces from being produced. As the proximal half 5 is rotated into the bone, the external threads 4 self-tap the proximal half 5 more deeply into the proximal phlange and more securely implant half 5 into the host material, until just the male peg 29 is left protruding beyond the end of the proximal phlange.

[0055] With the distal phalanges bent downward a second pilot hole is drilled into the proximal end of the bone of the distal phalanges entirely through to the distal end of the toe. An alignment pin is inserted into the pilot hole in the proximal end of the distal bone at the opened joint. The cannulated drill is inserted over the pin and used to increase the size of the pilot hole to a depth to allow insertion of the distal half 3 of the bone pin 34.

[0056] The distal end 23 of the distal half 1 is first inserted into the proximal end of the distal phlange and a hex shaped driving tool, commonly known in the art, is inserted into the proximal end 24 of the distal half 1. In order to be inserted correctly, the hex shaped driving tool extends past the internal female quick lock thread 10 and into the internal hexagonally shaped bore 12. Once the hex driving tool is in place, the distal half 3 is then rotated into the pilot hole in the same fashion as the proximal half 5. As the distal half 1 is being rotated, the open faced trailing tooth flanks 14 cut into the surface of the surrounding bone and allow the external threads 3 to dig deeper into the bone of the distal phlange. Bone chips or any other refuse from the host material is removed by the external threads 3 and pushed into the oval shaped tapping bores 30 and out of the way of the self-tapping external threads 3, thus preventing galling and any unnecessary radial forces from being produced. As the distal half 1 is rotated into the bone, the external threads 3 self-tap the distal half 1 more deeply into the bone and half 1 is more securely implanted into the bone, until just a fillet 27 defined on the proximal end 24 of the distal half 1 is left protruding beyond the proximal end of the bone of the distal phlange.

[0057] Holding the proximal phalange that contains the proximal half 5 in one hand, the surgeon pulls distal phalange containing the distal half 1 away slightly while rotating the distal phlange counterclockwise so that the proximal end 24 of the distal half 1 is installed over the distal end 25 of the proximal half 5, making sure that the male peg 29 is aligned with and inserted into the smooth inner bore 11 of the distal half 1. The distal half 1 may then be tightened and coupled to the proximal half 5 by either using a spanner wrench commonly known in the art interfaced with two opposing wrench flats 16 defined on the external surface of the distal half 1 as shown in FIG. 1, or by using a hex shaped wrench inserted through the drilled pilot hole at the distal end of the toe and into the distal end 23 of the distal half 1. In the latter instance the hex wrench is inserted into the internal hexagonally shaped bore 12 and then rotated. As the distal half 1 is being rotated, the external threads 6 on the male peg 29 of the proximal half 5 engage the internal female quick lock thread 10. The distal half 1 is rotated about the male peg 29 until the male peg 29 makes contact with the shoulder 36 at the proximal end of internal hexagonal bore 12 and further engagement with the internal female quick lock thread 10 is no longer possible. With the distal half 1 and proximal half 5 now firmly coupled together, the bone pin 34 comprised of halves 1 and 5 effectively becomes a single piece. The bone pin 34 is further rotated by the hex wrench in a clockwise direction, which due to the opposing left and right hand orientated threads of the distal half 1 and proximal half 5 as discussed above, cause the separated proximal and distal phalanges to be drawn together and further increase the stability and strength of the coupling of the bone pin 34. The distance between the phalanges can then be easily adjusted by rotation of the coupled proximal half 5 and distal half 1 in either a clockwise or counterclockwise direction as shown in FIG. 7.

[0058] Turning to FIGS. 8 and 9, an articulating joint 40 may be interposed between said proximal half and said distal half in certain embodiments, wherein flexion between the coupled proximal half 5 and distal half 1 is desired, such as flexion between coupled phalanges is desired as to replace a joint.

[0059] Referring in particular to FIG. 8, the articulating joint 40 comprises a proximal joint part 41 adapted to be coupled to the proximal half 5, and a distal joint part 51 adapted to be coupled to the distal half 1, wherein the proximal joint part 41 is pivotably coupled to the distal joint part 51. In the drawings, the articulating joint 40 is embodied as a ball-and-socket type of pivotable coupling, wherein a ball end 42 of the proximal joint part 41 is pivotably inserted into a socket end 52 of the distal joint part 51. The ball end 42 may be further retained within the socket end 52 of the distal joint part 51 by a pivot pin 58 extending through a pivoting axis of the socket end 52 and the ball end 42.

[0060] A mating end 43 of the proximal joint part 41 is adapted for coupling to the proximal half 5. In the shown embodiment, a mating internal female thread 44 defined in a bore of the mating end 43 is adapted for coupling to the male peg 29 of the proximal half 5. Similarly, a mating end 53 of the distal joint part 51 is adapted for coupling to the distal half. In the shown embodiment, a male peg comprising threads 54 is defined on the mating end 43, and is adapted for coupling to the internal female thread 11 of the distal half 1. It can be recognized that the coupling interfaces of the mating ends 43, 53 duplicate those of the proximal and distal halves 5, 1, such that the articulating joint 40 can be simply interposed between the proximal and distal halves 5, 1.

[0061] Turning to FIG. 9, locking elements are shown for preventing relative rotation between the articulating joint 40 and the proximal and distal halves 5, 1, to prevent decoupling or loosening of the threaded couplings between the articulating joint 40 and the proximal and distal halves 5, 1. On the proximal side, a through hole 45 is formed in the mating end 43, and is threaded to receive a locking screw 46. When tightened, the locking screw 46 impinges on the male peg 29. A receiving part 47 may be formed on the male peg as an indentation or aperture to receive an end of the locking screw 46, or as simply a flat surface as shown against which the end of the locking screw 46 may be tightened to prevent relative rotation of the parts. A similar arrangement is shown on the distal side, wherein a threaded through hole 55 is formed in the distal part for receiving locking screw 56, and a receiving part 57 is formed on the male peg of the distal joint part 51.

[0062] Turning to FIG. 8 again, locating pin 60 aligns with groove 61 as the ball 42 is located into the socket 52. As locating pin 60 resides within groove 61, the articulation is limited in both directions ranging from approximately aligned with the axis of the assembly to approximately 90 degrees from said axis limiting the bending movement as would be normal to digits such as fingers and toes. As the locating pin 60 and the mating groove 61 reside within the ball and socket, pinch points are avoided throughout the range of movement to protect various soft tissues.

[0063] Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following invention and its various embodiments.

[0064] Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the invention is explicitly contemplated as within the scope of the invention.

[0065] The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.

[0066] The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.

[0067] Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.

[0068] The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.