(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY(PCT)
`(19) World Intellectual Property
`=
`
`Organization
`
`International Bureau
`
`=z
`Soe=\
`
`AMCTATA AAAA
`
`(10) International Publication Number
`WO 2012/121726 Al
`
`(43) International Publication Date
`13 September 2012 (13.09.2012) WIiPO|PCT
`
`(51) International Patent Classification:
`AG6IF 2/44 (2006.01)
`A61B 17/86 (2006.01)
`A61B 17/80 (2006.01)
`A61B 17/17 (2006.01)
`
`et al; WOODCOCK
`(74) Agents: BAILEY, David, R.
`WASHBURNLLP, Cira Centre, 12th Floor, 2929 Arch
`Street, Philadelphia, PA 19104-2891 (US).
`
`(21) International Application Number:
`
`PCT/US201 1/027849
`
`aye
`.
`(22) International Filing Date:
`
`(25) Filing Language:
`
`10 March 2011 (10.03.2011)
`English
`.
`English
`(26) Publication Language:
`(71) Applicant
`(Gor CA only): SYNTHES USA, LLC.
`[US/US]; 1302 Wrights Lane East, West Chester, PA
`19380 (US).
`(71) Applicant (for all designated States except CA, US): SYN-
`THES GMBH [CH/CH]; Eimattstrasse 3, CH-4436 Ober-
`dorf (CH).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM,GT, HN,
`HR, HU, ID,IL,IN, IS, JP, KE, KG, KM, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
`MG, MK, MN, MW,MX, MY, MZ, NA, NG, NI, NO, NZ,
`OM,PE, PG,PH,PL, PT, RO, RS, RU, SC, SD, SE, SG,
`SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ,
`UA,UG,US, UZ, VC, VN, ZA, ZM, ZW.
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG,
`ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU,TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`Inventors; and
`EE, ES, FI, FR, GB, GR, HR, HU,IE, IS, IT, LT, LU, LV,
`Inventors/Applicants (for US only): SCHOENLY,Jared
`MC, MK,MT, NL,NO, PL, PT, RO, RS, SE, SL SK, SM,
`[US/US]; 1302 Wrights Lane East, West Chester, PA
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`19380 (US). EVANS, David [US/US]; 1302 Wrights Lane
`ML, MR,NE, SN, TD, TG).
`East, West Chester, PA 19380 (US). FENN, Matthew
`[US/US]; 1302 Wrights Lane East, West Chester, PA Published:
`19380 (US).
`
`(72)
`(75)
`
`with international search report (Art. 21(3))
`
`(54) Title: AWL SCREW FIXATION MEMBERS AND RELATED SYSTEMS
`
` £
`
`106
`rs180
`¢
`een
`mn
`ee
`/- ee ‘
`a
`a,
`ee a
`i
`
`Cros
`Fig.6B
`
`“104
`
`FOE
`
`a
`“sf
`
`eee
`a
`bagel
`S100
`
`(57) Abstract: Provided are fixation members (99f) useful in fixing an implant to a bone. The fixation members (99f) include an awl
`tip (104) so as to enable their secure installation by use of an awling motion, which in turn speeds the installation of the fixation
`members.
`
`000001
`
`Exhibit 1020
`LIFE SPINE,INC.
`IPR2022-01602
`
`Wo2012/121726A1IMTNINNTTTAUTOATANTA
`
`Exhibit 1020
`LIFE SPINE, INC.
`IPR2022-01602
`
`000001
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`AWL SCREW FIXATION MEMBERSAND RELATED SYSTEMS
`
`BACKGROUND
`
`[0001] Bone screws are commonly usedto fix adjacent bones or bone fragments with
`
`respect to each other, or to attach structure to bone. For example, bone screws are commonly
`
`used to help repair fractures in bone, to attach bone plates to bone,to fix adjacent vertebral
`
`bodies, and the like.
`
`[0002] Existing bone screws and conventional methods of bone screw insertion can,
`
`however, introduce undesirable complications in such procedures. For example, conventional
`
`methods of bone screw insertion can lead to, inter alia, small and/or mobile bone fragments
`
`dislocating from the bone or bone segment dueto axial pressure and insertion torque
`
`transmission during screw insertion; screw loss during operation (including transporting the
`
`screw from its storage place to final fixation location in the patient); shear off and cam outof the
`
`screw head during screw insertion and/or removal; slipping between the screw driver interface
`
`and the screw driver; stripping of the screw driver interface; bone milling during rotational
`
`insertion of self drilling and/or self tapping screws; misalignmentofthe pre-drilled holes in
`
`adjacent bone fragments and/or bone plates which can lead to secondary dislocation and
`
`inaccurate positioning of the bone fragments and/or bone plate; suboptimal screw fixation due to
`
`angular misalignmentofa pre-drilled pilot hole’s axis and the desirable screw insertion axis; and
`
`post operative back-out of screws.
`
`[0003]
`
`In some cases, when conventional bone screwsare used to attach small bone
`
`segments that havelittle structural support, the axial and rotational force requiredto start a screw
`
`into such small fragments can be such that the fragment becomesdislocated. Additionally, when
`
`it is desirable to use a long bonescrew,driving the screw into bone can be laborious and time
`
`consuming.
`
`[0004] Existing bone screw fixation systemsalso, in somecases, require the user to
`
`form a pilot hole in the bone so as to provide a hole with which the screw threads can engage.
`
`Formingthis pilot hole, however, is labor-intensive and time-consuming, and can complicate the
`
`fixation procedure.
`
`000002
`
`000002
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`SUMMARY
`
`[0005]
`
`In accordance with one embodiment, the present disclosure provides bone
`
`implant assemblies, the assemblies including an implant that includes opposed bone-engaging
`
`surfaces and further defines at least one aperture extending therethrough; and a bone anchor
`
`configured to extend throughthe at least one aperture an into a bonesoasto fix the implant to
`
`the bone, the bone anchor including: a proximal end, a distal end opposite the proximal end, and
`
`an intermediate portion extending between the proximal and distal ends, wherein the distal end
`
`defines a tip configured to cut into the bone,at least a portion of the intermediate portion being
`
`unthreaded, and the proximal end of the bone anchordefines an exterior thread configured to
`
`engage a complementary thread of implant in the aperture.
`
`[0006] The present disclosure also provides bone anchors, the anchors including a body
`
`comprising a tip, a shaft that extends proximally from the tip, and an externally threaded head
`
`extending proximally from the shaft, the tip configured to penetrate into a bone, wherein at least
`
`a portion of the shaft is unthreaded and extends proximally from the tip; and an engagement
`
`feature configured to engage a complementary feature of a driving instrumentthat is configured
`
`to apply a torsional force to the bone anchorso as to drive the tip into the bone.
`
`DESCRIPTION OF THE DRAWINGS
`
`[0007] The foregoing summary, as well as the following detailed description of the
`
`preferred embodiments of the application, will be better understood whenread in conjunction
`
`with the appended drawings. For the purposesofillustrating the present disclosure, there are
`
`shownin the drawings preferred embodiments. It should be understood, however, that the
`
`instant application is not limited to the precise arrangements and/or instrumentalities illustrated
`
`in the drawings, in which:
`
`[0008]
`
`Fig. 1A is a perspective view of a bone anchor constructed in accordance with
`
`one embodiment;
`
`[0009]
`
`Fig. 1B isa side elevation view of the bone anchorillustrated in Fig. 1A;
`
`[0010]
`
`Fig. 1C is a front elevation view of the bone anchorillustrated in Fig. 1A;
`
`[0011]
`
`Fig. 2A is a perspective view of a bone anchor constructed in accordance with
`
`another embodiment;
`
`[0012]
`
`Fig. 2B is a side elevation view of the bone anchorillustrated in Fig. 2A;
`
`[0013]
`
`Fig. 2C is a front elevation view of the bone anchorillustrated in Fig. 2A;
`
`[0014]
`
`Fig. 3A is a perspective view of a bone anchor constructed in accordance with
`
`another embodiment;
`
`000003
`
`000003
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`[0015]
`
`Fig. 3B is a side elevation view of the bone anchorillustrated in Fig. 3A;
`
`[0016]
`
`Fig. 3C is a front elevation view of the bone anchorillustrated in Fig. 3A;
`
`[0017]
`
`Fig. 4A is a perspective view of a bone anchor constructed in accordance with
`
`another embodiment;
`
`[0018]
`
`Fig. 4B is a side elevation view of the bone anchorillustrated in Fig. 4A;
`
`[0019]
`
`Fig. 4C is a front elevation view of the bone anchorillustrated in Fig. 4A;
`
`[0020]
`
`Fig. 5A is a perspective view of a bone anchor constructed in accordance with
`
`another embodiment;
`
`[0021]
`
`Fig. 5B is a side elevation view of the bone anchorillustrated in Fig. 5A;
`
`[0022]
`
`Fig. 5C is a front elevation view of the bone anchorillustrated in Fig. 5A;
`
`[0023]
`
`Fig. 6A is a perspective view of a bone anchor constructed in accordance with
`
`another embodiment;
`
`[0024]
`
`Fig. 6B is a side elevation view of the bone anchorillustrated in Fig. 6A;
`
`[0025]
`
`Fig. 6C is a front elevation view of the bone anchorillustrated in Fig. 6A;
`
`[0026]
`
`Fig. 6D is a side elevation view of the bone anchorsimilar to Fig. 6B, but
`
`including threads constructed in accordance with another embodiment;
`
`[0027]
`
`Fig. 7 is a perspective view of a bone implant assembly in accordance with one
`
`embodiment, including an implant and a plurality of bone anchors;
`
`[0028]
`
`Fig. 8 is an exploded perspective view of the bone implant assemblyillustrated
`
`in Fig. 7;
`
`[0029]
`
`Fig. 9 is a side elevation of the bone implant assembly illustrated in of Fig.7;
`
`[0030]
`
`Fig. 10 is an exploded view of a bone implant assembly constructed in
`
`accordance with another embodiment;
`
`[0031]
`
`Fig. 11 is an exploded view of the bone implant assemblyillustrated in Fig. 10;
`
`[0032]
`
`Fig. 12 is an exploded view ofa portion of the bone implant assembly illustrated
`
`in Fig. 10;
`
`[0033]
`
`Fig. 13A is a top plan view ofa fixation plate of the implantillustrated in Fig.
`
`10;
`
`[0034]
`
`Fig. 13B is a front elevation view ofthe fixation plate illustrated in Fig. 10A;
`
`[0035]
`
`Fig. 13C is a top elevation view offixation plate similar to the fixation plate
`
`illustrated in Fig. 13A, but constructed in accordance with another embodiment;
`
`[0036]
`
`Fig. 13D is a front elevation view ofthe fixation plate illustrated in Fig. 10C;
`
`[0037]
`
`Fig. 14A is a side elevation view of a bone anchorconstructed in accordance
`
`with another embodiment;
`
`-3-
`
`000004
`
`000004
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`[0038]
`
`Fig. 14B is a side elevation view of a bone implant assembly including an
`
`implant and a bone anchor, showing the bone anchorinserted through an implantand partially
`
`inserted into a pilot hole of an underlying bone;
`
`[0039]
`
`Fig. 14C is a side elevation view of the bone implant assemblyillustrated in Fig.
`
`14B, showingthe bone anchorfurther driven into the pilot hole such that threads of the bone
`
`anchor engage the underlying bone;
`
`[0040]
`
`Fig. 14D is a side elevation view of the bone implant assembly illustrated in Fig.
`
`14C, showing the bone anchorfurther driven into the bone and seated against the implant;
`
`[0041]
`
`Fig. 15A is an exploded view of an exemplary bone implant assembly;
`
`[0042]
`
`Fig. 15B is a side elevation view of the bone implant assembly of Fig. 15A, with
`
`the fixation plate and spacer assembled together;
`
`[0043]
`
`Fig. 15C is a perspective view of the bone implant assembly of Fig. 15A, with
`
`the fixation plate and spacer assembled together;
`
`[0044]
`
`Fig. 15D is a top elevation view of the bone implant assembly of Fig. 15C; and
`
`[0045]
`
`Fig. 15E is a rear elevation view of the bone implant assembly of Fig. 15D.
`
`DETAILED DESCRIPTION
`
`[0046] The present disclosure may be understood more readily by reference to the
`
`following detailed description taken in connection with the accompanying Figs. and examples,
`
`which form a part of this disclosure. It is to be understoodthat this disclosure is not limited to
`
`the specific devices, methods, applications, conditions or parameters described and/or shown
`
`herein, and that the terminology usedherein is for the purpose of describing particular
`
`embodiments by way of example only andis not intended to be limiting of the present
`
`disclosure.
`
`ee
`
`forms
`
`a
`
`[0047] Also, as used in the specification including the appended claims, the singular
`99 66
`
`an,” and “the” include the plural, and reference to a particular numerical value
`
`includesat least that particular value, unless the context clearly dictates otherwise. The term
`
`“plurality”, as used herein, means more than one. When a range ofvalues is expressed, another
`
`embodimentincludes from the one particular value and/orto the other particular value.
`
`Similarly, when values are expressed as approximations, by use of the antecedent“about,” it will
`
`be understoodthat the particular value forms another embodiment. All ranges are inclusive and
`
`combinable.
`
`[0048]
`
`It is to be appreciated that certain features of various embodiments set forth in
`
`the present disclosure whichare, for clarity, described herein in the context of separate
`
`-4-
`
`000005
`
`000005
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`embodiments, may also be provided in combination in a single embodiment. Conversely,
`
`various features of the present disclosure that are, for brevity, described in the context of a single
`
`embodiment, mayalso be provided separately or in any subcombination. Further, reference to
`
`values stated in ranges includes each and every value within that range.
`
`[0049] Certain terminology is used in the following description for convenience only
`
`and is not limiting. The words “right”, “left”, “top” and “bottom” designate directions in the
`
`drawings to which reference is made. The words “inwardly” and “outwardly” refer to directions
`
`toward and away from,respectively, the geometric center of the device and designated parts
`
`thereof. The words, “anterior”, “posterior”, “superior”, “inferior”, “lateral”, “medial”, “sagittal”,
`
`“axial”, “coronal,” “cranial,” “caudal” and related words and/or phrases designate preferred
`
`positions and orientations in the human body to which reference is made andare not meant to be
`
`limiting. The terms “anchor” and“fixation member” maybe used interchangeably.
`
`[0050] The disclosed components will now be described by way ofreference to the
`
`appendedfigures.
`
`[0051] Referring now to Figs. 1A-1C, a bone fixation member, such as bone anchor
`
`99a, includes a body 101 that is elongate along a central longitudinal axis L, and defines a
`
`proximal end 100, a distal end 104 spaced from the proximal end 100 along the longitudinal axis
`
`L, and disposed opposite the proximal end 100, and an intermediate portion 108 disposed
`
`between the proximal end 100 andthe distal end 104.
`
`[0052] The bone anchor 99a defines a tip 116 at the distal end 104 that is capable of
`
`penetrating or cutting a vertebral body (e.g., bone) or other structure. The proximal end 100 of
`
`the bone anchor 99a defines a head 103 that is suitably configured so as to engage at least one
`
`complementary engagement feature 111 of a driving instrument, such as a screwdriveror other
`
`driver device, that applies a force that biases the tip of bone anchor 99a into an underlying bone,
`
`such as a vertebral body.
`
`[0053] The bone anchor99a can further include a shaft 113 that can have a
`
`substantially constant diameter and extends between the head 103 and the tip 116. The shaft can
`
`also increase in diameter along a direction from the tip 116 toward the head 103, however the
`
`slope of the outer surface of the shaft 113 can be different from that of the tip 116.
`
`[0054] The shaft 113 may have a diameter that remainsessentially constant overits
`
`length. Alternatively, for instance as shown in Fig. 5A, the diameter of the shaft 113 mayvary,
`
`for instance, along a direction from the distal end to the proximal end by any amountas desired.
`
`For instance, the outer surface of the shaft 113 can define an angle of from about 3 degrees to
`
`about 15 degrees. Accordingly, the diameter of the distal end of the shaft can be reduced, in
`-5-
`
`000006
`
`000006
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`some embodiments, relative to the diameter of the proximal end of the shaft 113 by from about
`
`99.65% to about 99.8%. The shaft 113 may be of essentially constant diameter along a portion
`
`of its length, and include a region of varying diameter.
`
`[0055] The distal end 104 can have a longitudinal length relative to that of the shaft 113
`
`as desired. For instance, the length of the taper on distal end 104 to the total length of shaft
`
`below the screw head (108+104)) can be from about 1:2 to about 1:5.
`
`[0056] The length of the unthreaded portion of the shaft 113 may be from about 10 mm
`
`to about 25 mm,or from about 12 mm to about 20 mm. Theratio of the length of the threaded
`
`portion of the shaft 113 to the length of the anchor below the head(i.e., 104 + 108) is suitably in
`
`the range of from about 1:1 to 1:10, or from 1:2 to about 1:5. The radial height of the threads
`
`126 on the threaded portion of the shaft can be from about 0.1 mm to about 0.5 mm,or even
`
`from about 0.2 mm to about 0.3 mm. Adjacent threads 126 may be spaced from one another by
`
`from about 0.8 mm to about 2 mm,or even by from about 0.9 mm to about 1.8 mm.
`
`[0057]
`
`In this regard, it should be appreciated that when the shaft 113 defines a
`
`substantially constant diameter, the outer surface of shaft 113 also defines a slope different from
`
`that of the tip 116. It should be further appreciated that the slope of the outer surface of the shaft
`
`113 can be substantially equal to that of the tip 116 (see Figs. 5A-C). The engagement member
`
`111 of the head 103 can be provided as a recess 112 that is star-shaped as illustrated, but can be
`
`cross-shaped, pyramidal, hexagonal, helical, or other configurations knownin the art that
`
`facilitate robust engagement between the anchorand the driving instrument. The StarDrive™
`
`system from Synthes (www.synthes.com) is considered a suitable system for driving the anchors
`
`described herein. In some embodiments (not shown), the bone anchor 99a maydefine a tip 116
`
`and shaft 113 that extends proximally from the tip 116. The shaft may have a proximal end (at a
`
`distance from the tip 116), which end is adapted to engage with a driving instrument. For
`
`example, the proximal end may include a recess as described above. In some variations, such
`
`anchors maybe characterized as being free of a head 103. In such embodiments, the shaft is
`
`directly driven.
`
`[0058] The engagement member 111 can alternatively be configured as a protrusion as
`
`desired that is configured so as to engage with a driver device that applies a distal biasing force
`
`to the bone anchor 99a so as to implant the bone anchor 99a into the underlying bone. Such a
`
`protrusion may havea cross-section that is triangular, square, pentagonal, hexagonal, or
`
`otherwise shaped as desired. The protrusion can, for instance, be received by a socket or other
`
`grip ofthe installation device.
`
`000007
`
`000007
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`[0059] The bone anchor 99a can be configured as a bone screw, wherebythe
`
`intermediate section 108 of the bone anchor body 101 defines an exterior feature, such as a
`
`thread 110 that extends about the shaft 113. The exterior feature can be configured as a bone
`
`thread that is adapted to securably engage with the underlying bone into which the bone anchor
`
`is implanted. The thread 110 may be helical in configuration (e.g., helical thread 126 in Fig.
`
`6B), or may be a stepped,helical thread in configuration, as illustrated in Figs. 1A-B. The thread
`
`110 may be pyramidal in cross-section and have a sharp distal end.
`
`[0060] The thread 110 mayalternatively define a flat distal end, a roundeddistal end, or
`
`any alternatively sized or shaped distal end as desired. The thread 110 may span the entire
`
`length of the intermediate region 108, or can alternatively span only a portion of the intermediate
`
`region 108, as shownby the thread 126 in Fig. 6B. The user can drive the bone anchor 99a into
`
`the underlying bone until the thread 110 contacts the bone, at which point the user may then
`
`apply a torsional force to the bone anchor 99aso as to screw the bone anchor 99a into the bone
`
`for final seating.
`
`[0061] The thread 110 may havethe cross-section of an obtuse or scalenetriangle,
`
`whichcross-section allowsthe installed fixation body to resist a pull-out force. Thread 110
`
`allow bone anchorto be installed by applying of a torsional force to the bone anchor 99a so as to
`
`advancethe thread 110 into the underlying bone. The thread 110 defines a height that extends
`
`out from the shaft 113 along a direction angularly offset from the longitudinal axis L of the bone
`
`anchor 99a, such as substantially perpendicular to the longitudinal axis L. The height can be
`
`substantially constant, or can vary along the length (e.g., along longitudinal axis L) of the shaft
`
`113. For example, the thread 110 may havea heightthat is larger(1.¢., is taller) closer to the
`
`proximal end 100 of the anchor 99a andthat is smaller (i.e., shorter) closer to the distal end 104
`
`of the anchor 99a. In one exemplary embodiment, the thread 110 at the distal end of the anchor
`
`99a may havea height of x, and the thread 110 at the proximal end of the anchor may have a
`
`height of 1.3x. Alternatively, the thread 110 may havea height that is constant along the length
`
`of the bone anchor. In one such embodiment, the thread 110 may havea heightofx atall thread
`
`locations. In yet another embodiment (not shown), the intermediate region 108 of the anchor 99a
`
`tapers from the proximalto the distal ends of the anchor 99a, but the thread 100 varies in height
`
`along the longitudinal axis L suchthat that the diameter of the anchor 99a is constant.
`
`[0062] The bone anchor99a can further define an external thread 102 located at the
`
`proximalend 100 of the body 101, for instance at the head 103. The external thread 102 is
`
`suitably configured to engage a complementary thread in another component, such as an implant,
`
`so as to provide locking fixation between the implant and the underlying bone. For example, the
`-7-
`
`000008
`
`000008
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`external thread 102 may engage an internal thread of an aperture in a fixation plate or other
`
`device into which the anchoris installed. The Synfix™ system from Synthes
`
`(www.synthes.com) is one example of such a locking system.
`
`[0063]
`
`In some embodiments, the aperture may be an enclosed channel extending
`
`through a portion of the implant. Such an embodiment is shown by figure 15a, in which aperture
`
`228 extends throughthe fixation plate 216. Channels that are circular in cross-section are
`
`considered suitable apertures. In some embodiments, the channelis fully enclosed within the
`
`implant. The channel, however, need not be fully enclosed within the implant; in some
`
`embodiments, the aperture may be a channelorslotthat is at least partially open to the
`
`environmentexterior to the implant.
`
`[0064] The exterior thread 102 of the bone anchor may be a dual lead thread; such dual
`
`leads enable the user to more quickly implant the bone anchor into a componentthat bears a
`
`complementary thread. The external thread 102 may be an external helical thread. In some
`
`embodiments, the proximal end of the bone anchor 99a includes one or more splines that engage
`
`with complementary structures in a fixation body or other component.
`
`[0065] The tip 116 of the bone anchor 99a can be configured so as to penetrate or cut
`
`vertebral bone so as to enable secure insertion of the bone anchorinto the vertebral body. As
`
`shown in Fig. 1, the distal end 104 is adapted to penetrate bone. The distal end 104 includes a
`
`sharp tip 116, and can further include cutting facets 114 that can extend helically about the tip
`
`116. By reference to Fig. 2, the distal end 104 can be configuredas a trocar tip. Suchtips allow
`
`the user to implant the bone anchor(at least partially) into the vertebral body by hammering or
`
`otherwise forcing the tip into the vertebral body; a pilot hole is not always needed. Trocartips
`
`may be pyramidal or multi-faceted; the distal end 104 shown in Figure 2B is pyramidalin
`
`configuration.
`
`[0066] An awling motion or other back-and-forth reciprocating motion may be used to
`
`effect penetration of the tip 116 into the underlying bone, which awling motion in turn biases the
`
`tip 116 against the bone and effects cutting or penetration. The awling may be a
`
`twisting/torquing back-and-forth motion while the anchor 99a is biased into the underlying bone.
`
`This may be contrasted with a screwing-type motion in which the anchor 99ais rotated in a
`
`single direction while being biased or otherwise driven into the underlying bone.
`
`[0067]
`
`In one non-limiting example, the user may engage a screwdriveror similar
`
`implement into recess 112 of the anchor 99a, and then apply an awling motion to the anchor 99a
`
`so as to install the anchor into underlying bone. In some embodiments, the user may formapilot
`
`hole in the underlying bone. Such pilot holes, however, are not necessary, and the anchor 99a
`-8-
`
`000009
`
`000009
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`maybe configured so as to permit installation into underlying bone withoutthe use ofa pilot
`
`hole. In other cases, the tip 116 is driven distally into the underlying bone and penetrates into
`
`the bone in a nail-like manner.
`
`[0068]
`
`In other embodiments, the tip 116 is driven into the underlying bone, and the
`
`anchor 99ais further inserted into the bone by way ofthe described awling motion. In other
`
`embodiments, the tip 116 is driven (e.g., via hammering) into the underlying bone, and the
`
`anchor 99ais itself then further driven into the bone by way of a hammeringor nailing force.
`
`Anchors 99a maythusbe installed by a nailing or hammering force, an awling, or some
`
`combination. The anchor 99a mayalso be configured — e.g., with a helical thread — so as to be
`
`installed by application of a screwing force. It is to be understood that the above-described
`
`techniques are applicable to any of the anchors 99a, 99b, 99c, 99d, 99e, 99f, and 99g disclosed in
`
`Figures 1-6, 14, and elsewhere herein, and that the various described anchors do notlimit the
`
`scope of this disclosure.
`
`[0069] The anchor maybe constructed such that the tip 116, the distal end 104, or both,
`
`maybeinstalled by a nailing, hammering, or awling motion, and the remainder of the anchor 99a
`
`is then installed by a screwing motion. Thetip 116 of the bone anchor 99a can be configured as
`
`a trocar tip that can include multiple facets 106, that are separated from one another by sharp
`
`edges 118, and thus configured to drive into the underlying bone. The tip 116 may havea helical
`
`or screw-like configuration, as shown bythe distal end 104 in Fig. 1B. The anchor 99a can thus
`
`increase the speed of implantation as comparedto existing bone screwsthat receive a continuous
`
`torsional driving force. The bone anchor 99a can be implanted into a pre-formed pilot hole that
`
`extends into the underlying bone(see, for instance Figs. 14B-D).
`
`[0070] With continuing reference to Figs. 1A-C, the bone anchor 99a can further
`
`include an external thread 102 at the proximal end 100, for instance at the head 103, the thread
`
`102 configured to engage with a complementary thread of a bone implant, such as a bone
`
`fixation plate. The head 103 can further be conical in shape, and is configured to be used in
`
`conjunction with a receiving aperture in another component, such as an implant, which receiving
`
`aperture is cylindrical or even conical in configuration. Accordingly, the depth of penetration of
`
`the bone anchor 99a can be controlled, as the head 103 cannot be advanced beyond the point at
`
`whichthe conical head has fully engaged with the conical receiving aperture (see e.g., Figs. 7-8).
`
`[0071] Referring now to Figs. 4A-C,the exterior feature of the intermediate section 108
`
`can include ridges 122. The ridges 122 mayall be of the same heightor of different heights.
`
`The ridges 122 may be of the same height along the entirety of the intermediate section 108, or
`
`of differing heights along the entirety of the intermediate section. In one embodiment, the ridges
`-9-
`
`000010
`
`000010
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`122 define a greater height at the proximal end of the anchorthan at the distal end of the anchor,
`
`as shown in, e.g., Figure 14A. In accordance with the illustrated embodiment, the ridges 122
`
`encircle at least a portion of the intermediate portion 108. The ridges 122 may be configured so
`
`as to resist proximally-directed pull-out forces when the bone anchor 99a hasbeeninstalled into
`
`a body, such as underlying bone.
`
`[0072] The ridges 122 also allow the bone anchor to be implanted by application of a
`
`distal driving force, such as a hammering applied to the head 103. This force may be applied by
`
`way of a mallet or by mechanical means, such as a sonic hammeror other driver. A pinion drive
`
`may also be used to drive the anchorinto the vertebral body. The ridges may, as described
`
`elsewhere herein, be characterized as being a right triangle in cross-section. The ridges may also
`
`be scalene, equilateral, or obtuse triangles in cross-section. The ridges mayall be of the same
`
`height; some of the ridges may be of different heights from one another. Furthermore, the tip
`
`116 can be pointed, and thus devoid of cutting facets 114 illustrated in Figs. 1A-1C.
`
`[0073] Ridges 122 are suitably triangular in cross-section so as to resist pull-out when
`
`the anchor has been inserted into vertebral bone or other material. While the exemplary
`
`embodiment shownin Fig. 4 includes a plurality of ridges 122 that can be concentric, and can be
`
`arranged along essentially the entire length of the intermediate region 108, the ridges 122 of any
`
`of the bone anchors described above can extend alongall or a portion of the length of the
`
`intermediate region 108, such as the shaft 113. For example, the ridges may be present only at
`
`the part of the intermediate region that is immediate adjacent to the proximal end 100.
`
`Alternatively, the ridges maybe present at the part of the intermediate region that is adjacent to
`
`the distal end 104 of the anchor. The anchor may bear one, two, three, or more ridges. The
`
`ridges may configured such that the intermediate region includes one or more “ridge-less”
`
`regions that are smooth and free of ridges. One such region is shown by unthreaded region 180
`
`in Figure 2A.
`
`[0074] The distal end 104 of the bone anchor embodiment 99d of Figs. 4A-C features a
`
`pyramidal tip 116 that defines a plurality of facets 106 separated from one another by
`
`longitudinally extending edges 118. In this particular embodiment, the ridges 122 are present on
`
`portions of the distal end 104 that are not facets of the tip.
`
`[0075] An alternative variant is shown in Figs. 2A-C, showingthat the intermediate
`
`region 108 of the bone anchor 99b maybe substantially smooth and thusfree of ridges, screw
`
`threads, and the like. The intermediate region 108 maybe ofessentially constant cross-section
`
`(as shown), but can also taper inwardly toward the longitudinal axis L along a direction from the
`
`proximal end 100 toward the distal end 104 of the bone anchor. The bone anchor 99b may
`-10-
`
`000011
`
`000011
`
`

`

`WO 2012/121726
`
`PCT/US2011/027849
`
`include a neck 120 or othertransition region disposed between the head 103 andthe shaft 113 of
`
`the bone anchor 99b.
`
`[0076] The neck 120 mayact to prevent over-insertion of the anchor into an implant
`
`device, so as to control the depth to which the anchoris inserted. As one example, when the
`
`anchor shownin Figs. 2A-C is inserted into a bone implant(e.g., a bone fixation plate), the
`
`thread 102 of the proximal end 100 engages with a complementary thread of the implant. Once
`
`the exterior thread 102 of the anchoris fully engaged with the complementary thread ofthe
`
`implant, the collar 120 of the anchor can contact a flange of the implant. The flange can be sized
`
`so as to prevent passage ofthe collar 120. In this way, the inventive anchors and systems may be
`
`configured to control the depth of anchor penetration.
`
`[0077]
`
`In the case of the variant bone anchor 99b shown in Fig. 2A-C, the anchor may
`
`be installed by biasing (e.g., by hammering)thetip of the anchorinto the bone material of
`
`interest. The user may then further insert the anchor into the bone by application of additional
`
`force (by hammeringor by applying a constant pushing force, such as force applied by a pinion
`
`or screw drive). Once the anchor has been sufficiently inserted into the subject that the locking
`
`means(e.g., the external thread 102 of the proximal end 100) engages with a complementary
`
`thread on another component of an implant, such asafixation plate.
`
`[0078] The user may then apply a twisting force via the recess 112 in the anchorso as
`
`to fully engage the thread 102 of the anchor andto lock the anchor into place