Method, system, and apparatus for boney structure tap

Embodiments of a bony structure tap with a plurality of landmarks. Other embodiments may be described and claimed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. Provisional Application No. 61/599,931, filed Feb. 16, 2012, entitled “METHOD, SYSTEM, AND APPARATUS FOR BONEY STRUCTURE TAP”, and assigned Attorney Docket No. TS002US, which is incorporated by reference herein.

TECHNICAL FIELD

Various embodiments described herein relate generally to tapping or creating an opening for a threaded implant in a bony structure, including systems and methods for creating an opening for a threaded implant in a bony structure.

BACKGROUND INFORMATION

It may be desirable to creating an opening for a threaded implant in a bony structure in a closed, semi-closed, or occluded field and monitor the depth of the opening or tapping.

DETAILED DESCRIPTION

FIG. 1Ais an isometric diagram of a mammalian bony segment tap system10according to various embodiments. The bony segment tap system (BSTS)10may include a distal tapping section30and handle20. The handle20may include a proximal tool coupling interface24, extension26, and grip22therebetween. In an embodiment a tool such as a fixed or ratcheting tool may be removably coupled to the tool coupling interface24. In another embodiment a fixed or ratcheting tool may be fixably coupled to the tool coupling interface24or directly to the handle section20.

The distal tapping section30may include a distal tap section32and one or more depth markers36A to36B. In an embodiment a depth marker36A may be separated from the distal tap section32by a smooth, smaller diameter section34A. In addition a second smaller diameter may separate the first depth marker section36A from the second depth marker36B. A further smaller diameter section34C may separate the second depth marker36B from a larger diameter extension26of the handle20. In an embodiment the first and the second depth markers or depth marking sections36A,36B may be small tap sections that are spirally aligned with the tap section32(as shown inFIG. 1Gif the tap section32spiral threads were extended to depth marking section36A, the spirals would coincide or link radially about the longitudinal axis of the tap system10(the longitudinal axis extending from the tool interface24to the distal, slanted end38.)

In an embodiment the entire BSTS10may be cannulated28along the longitudinal axis so the BSTS10may be inserted over a K-wire or guide-wire60(FIG. 2A) in an embodiment. In an embodiment the cannulation28may have a radius of 1 to 2 mm or about 1.5 mm. It is noted the BSTS10may have an overall length of about 140 mm to 300 mm or about 220 mm in an embodiment. The maximum radius of the tap section32threads39E (FIG. 1F) may vary as a function of the radius the respective threaded implant (50A to50D,FIGS. 4A to 4D). In an embodiment a threaded implant maximum thread radius39E of the tap section32may be smaller than the respective threaded implant50A50D outer radius (of its threads54A to54D) to provide a secure coupling between the tapped bony section222B (FIG. 2E) and the threaded implant50. In an embodiment the BSTS10maximum thread diameter39E may be about 4.0 mm, 5.0 mm, 6.0 mm, and 7.0 mm where the corresponding threaded implant50thread54A to54D outer diameter is about 4.5 mm, 5.5 mm, 6.5 mm, and 7.5 mm, respectively.

The BSTS10distal tap section32length may vary as a function of the tap depth needed in a bony structure. Similarly the one or more partial thread depth markers36A,36B distance from the BSTS10tip38may vary of a function of possible tap depths for a bony structure and the possible lengths of the threaded implant50A to50D threaded sections54A to54D. In an embodiment a threaded implant50A to50D threaded sections54A to54D may have a length from about 30 mm to 70 mm. In an embodiment the threaded sections54A to54D may have predetermined different lengths to accommodate different bony structure and patient structures such as 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, and 60 mm.

The distance between spirals39A,39B,39C,39D, and39E may be fixed and may be a function of the corresponding threaded implant50A to50D,50to be implanted into the tap or opening formed by the use or operation of the BSTS10. Similarly the height or peak, leading edge angle, and trailing edge angle of the threads39A to39E,36A,36B may be a function of the corresponding threaded implant50A to50D,50to be implanted into the tap or opening formed by the use or operation of the BSTS10. In an embodiment the width between adjacent threads, spirals, peaks39A to39E,36A,36B may be about 1.5 to 3.0 mm and about 1.9 mm or 2.5 mm in an embodiment. The leading edge angle of threads, spirals, peaks39A to39E,36A,36B may be about 20 to 30 degrees or about 24 degrees in an embodiment. The trailing edge angle threads, spirals, peaks39A to39E,36A,36B may be about 7 to 20 degrees or about 12 degrees in an embodiment.

FIG. 1Bis a diagram of a mammalian bony segment tap system distal tapping section30according to various embodiments. As shown inFIG. 1Bthe distal section32may include a plurality of threads or spirals that increase in diameter from the tip38. In an embodiment the tip38also be beveled and include a cut out47to ease introduction and rotation into a bony structure. In an embodiment the bevel may have about a 60 degree relative to the longitudinal axis. As also shown inFIG. 1B, each partial spiral depth marker section36A,36B may be separated from adjacent spirals and extension26by a section34A,34B, and34C. In an embodiment the sections34A,34B,34C may have a uniform length. Further the distance from last spiral in section32to peak spiral36A from peak spiral36A to peak spiral36B may also have a uniform or known distance. In an embodiment the spiral32length is also known. Accordingly, the distance from the tip38to the last spiral of section32, the spiral36A, and the spiral36B may be known.

During a tapping procedure the location of these landmarks relative to the bony structure may enable a user to determine the depth of the tap formed via the BSTS10(such as shown inFIGS. 2A to 2D). In particular in a closed procedure or occluded field radiographic images (such as simplified images shown inFIGS. 3A to 3D) may also show these landmarks (each of32,36A,36B) relative to the bony structure and may enable a user to determine the depth of the tap or threads formed via the BSTS10. In an embodiment the BSTS10or at least the distal section30may be formed of a radio-opaque material including a metal, alloy or treated ceramic. In an embodiment the BSTS10may be formed of a stainless steel material including SUS631 with a HRC of 45. In an embodiment the landmarks (end of section32, position of36A, and position of36B may be based on common lengths of threaded implants50A to50D threaded sections54A to54D to be inserted into a bony structure222B. As noted above threaded sections54A to54D may have predetermined different lengths of about 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, and 60 mm. In an embodiment the end of section32may be about 35 mm (from the tip38), location of36A may be about 45 mm from the tip38, and the location of36B may be about 55 mm from the tip38.

Based on these know landmark locations a user (such as a physician or physician assistant, or veterinarian may employ the BSTS10to tap a bony structure and simultaneously determine the implant size appropriate for the bony structure and formed opening. In an embodiment a practitioner may employ the process shown inFIG. 4in conjunction with the BSTS10to form a tapped opening in a bony structure. As shown inFIG. 2A, 220Aa practitioner may start the BSTS10into a bony structure222B activity302.FIG. 3Ashows a side image250A of the BSTS10starting a tapped or threaded opening in a bony structure where the image or diagram250A may be generated by a radiographic device such as a C-arm.

As shown inFIG. 2B, 220Ba practitioner may continue to form the tapped opening into a bony structure222B via the BSTS222B by rotating the BSTS10a predetermined number of complete rotations activity304. A practitioner may then take a radiographic image (activity308) and use the landmarks32,36A,36B to determine the depth of the tap and location of tap tip238relative to bony structure boundaries (activity310).FIG. 3Bshows a side image250B of the BSTS10with a tapped or threaded opening in a bony structure up to the end of the tap section32where the image or diagram250B may be generated by a radiographic device such as a C-arm.

If the desired depth is achieved (activity312) then a practitioner may use the landmarks32,36A,36B to select a proper length implant50A to50D threaded section54A to54D for implantation into the formed threaded opening (activity314). Otherwise a practitioner may repeat activities. For example a practitioner may advance the tap to the landmark36A (shown inFIG. 2C, 220C,FIG. 3C, 250C) or landmark36B (shown inFIG. 2D, 220D,FIG. 3D, 250D) if the bony structure boundaries support such depths.

Then a practitioner may insert an implant52with a threaded section54C having a desired or selected length based on the BSTS10noted landmarks32,36A,36B. As noted and shown inFIG. 1G, the landmarks36A,36B are partial spirals that would correspond with the spiral pattern formed by the distal section32if the distal section30spiral32was extended (45A,45B,45C,45D). This configuration helps guide the BSTS10sections36A,36B into the threads formed in the bony structure by the distal section30spirals or threads32. As noted above and shown inFIG. 1Cthe distance between two adjacent threads35A,35B (of a spiral32) and the forward pitch33and reverse or back pitch31may be selected as a function of the implant thread section54A to54D to be inserted into the formed, threaded, opening in a bony structure222B.FIG. 1Dshown that the landmarks36A,36B spirals have the same forward and reverse pitch33,31as the spiral32and have a section34B without spirals34B between the landmarks36A,36B and more proximal section34C after the landmark36B without spirals.FIG. 1Eshows that another section34A between the spiral32and landmark36A may also not include spirals. In an embodiment the sections34A and34B may be about the same length.

FIG. 1Fshows the distal spiral32threads39A,39B,39C,39E may increase from a minimal diameter to a maximum diameter where the difference between the minimal diameter39A and maximum diameter for a thread39E may be about 1 mm (or about 0.6 mm in an embodiment). In an embodiment the BSTS10may be employed to create a threaded opening in a spinal vertebra222A,222B,222C pedicle process232C,234C,232B,234B,232A,234A where a disc240A,240B,240C may separate adjacent vertebra222A,222B,222C and the vertebra222A,222B,222C may include dorsal processes236A,236B,236C. The implants50,50A to50D with threaded sections54A to54D may be poly-axial or mono-axial pedicle screws. The screws may also be cannulated so the screws50,50A,50D may be inserted over the guide wire or K-wire60after the BSTS10has been removed from the bony structure.

Further the bony regions222A,222B,222C may be vertebra separated by spinal discs240A,240B,240C in a cervical, thoracic, or lumbar region of a mammal including a human. In embodiment each bony segment222A-C may include a pedicle pair232A-C,234A-C, and a dorsal spinous process236A-C.