throbber
12 Unlted States Patent
`
`10 Patent N0.:
`
`9
`9
`US 9 283 080 B1
`
`
`Lyren
`(45) Date of Patent:
`Mar. 15, 2016
`
`USOO9283080B1
`
`(54) HIP IMPLANT WITH POROUS BODY
`
`(71) Applicant: Four Mile Bay, LLC, Wadsworth, OH
`(Us)
`
`(72)
`
`Inventor: Philip Scott Lyren, Bangkok (TH)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U~S~C~ 154(b)by0days~
`
`(21) Appl.No.: 14/461,482
`
`(22)
`
`Filed;
`
`Aug. 18,2014
`
`Related U-S-APPIication Data
`
`(63) Continuation of application No. 13/592,349, filed on
`Aug. 23, 2012, now Pat. No. 8,821,582, which is a
`continuation-in-part of application No. 11/409,611,
`filed on Apr. 24, 2006, now Pat. No. 8,506,642, which
`is a continuation of application No. 10/446,069, filed
`on May 273 2003, now abandoned.
`Int Cl
`A6IF 2'/32
`A 6IF 2/36
`A61F 2/30
`(52) US. Cl.
`CPC ........... A61F 2/3609 (2013.01); A61F 2/30767
`(2013.01); A6IF 2002/3093 (2013.01)
`(58) Field of Classification Search
`CPC ............................ A61F 2/360972/3676; A61F
`2002/361142002/2698; A61B17/72717/7291
`See application file for complete search history.
`_
`References Clted
`U.S. PATENT DOCUMENTS
`
`
`(51)
`
`(56)
`
`(2006 01)
`~
`(2006.01)
`(2006.01)
`
`3,906,550 A *
`4,406,023 A *
`
`623/23.55
`..
`9/1975 Rostoker et a1.
`9/1983 Harris ........................ 623/23.29
`
`4,608,055 A *
`5,013,324 A
`£813,332 2 *
`5:219:363 A *
`5,314,494 A *
`5,496,375 A
`5,514,184 A *
`
`............. 623/22.46
`
`8/1986 Morrey et a1.
`5/1991 Zolman et a1.
`gfiggi
`3331621321151"""""""""" 128/898
`6/1993 Crowninshield etal.
`.. 623/23.34
`5/1994 Huiskes et a1.
`............ 623/23.35
`3/1996 Sisk et a1.
`5/1996 D01 et a1.
`
`..................... 623/23.3
`
`6,296,667 Bl :
`62303.61
`10/2001 Johnson et 31
`2543137332 3%,,
`gig/£2112
`1343883 $513er
`6:716:250 B2*
`623/2242
`4/2004 Ganjianpour
`7,981,161 B2*
`623/22.42
`7/2011 Choiet a1.
`......
`8,814,567 B2*
`...... 433/173
`8/2014 Zhang etal.
`
`2002/0151984 A1* 10/2002 White .............
`623/23.22
`
`623/22.42
`4/2003 McTighe et a1.
`2003/0074079 A1*
`623/22.42
`.....
`6/2004 Cheal et a1.
`2004/0107001 A1*
`
`623/23.46
`2006/0229734 A1* 10/2006 Yoon ...........
`
`5/2011 Lomicka ....................... 433/174
`2011/0123951 A1*
`
`OTHER PUBLICATIONS
`
`Zimmer, “Versys Collared Fiber Metal Midcoat Hip Prosthesis”
`2901.
`_
`_
`_
`_
`Amen :Versys Flber Metal Tapér HIP PTOSflleSlS” 199?
`IOS
`eSlS
`.
`glmnfliler, 37335315 F1ber Metal M1dcoat and Beaded M1dc0at H1p
`Zimmer, “Versys Collared Extra Extended Fiber Metal Midcoat Hip
`Prosthesis” 2002.
`2002.
`Zimmer, “Versys Collarless Fiber Metal Midcoat Hip Prosthesis”
`
`* cited by examiner
`
`Primary Examiner 7 Jan Christopher Merene
`Assistant Examiner 7 Steven Cotroneo
`
`(57)
`ABSTRACT
`Ahip implant has a neck body that connects to a bone fixation
`body. The bone fixation body has a porous structure with an
`elongated shape. An internal caVity is formed in the bone
`fixation body and includes a substance to stimulate bone
`growth.
`
`13 Claims, 8 Drawing Sheets
`
`
`
`
`Page 1 of18
`
`ZIMMER EXHIBIT 1001
`
`ZIMMER EXHIBIT 1001
`
`Page 1 of 18
`
`

`

`US. Patent
`
`Mar. 15, 2016
`
`Sheet 1 0f8
`
`US 9,283,080 B1
`
`
`
`
`
`
`
`
`
`
`
`
`Page 2 of 18
`
`Page 2 of 18
`
`

`

`U.S. Patent
`
`Mar. 15, 2016
`
`Sheet 2 of 8
`
`US 9,283,080 B1
`
`
`
`
`
`
`
`
`
`
`
`
`Page 3 of 18
`
`Page 3 of 18
`
`

`

`US. Patent
`
`Mar. 15, 2016
`
`Sheet 3 0f8
`
`US 9,283,080 B1
`
`
`
`
`
`Page 4 of 18
`
`Page 4 of 18
`
`

`

`US. Patent
`
`Mar. 15, 2016
`
`Sheet 4 0f8
`
`US 9,283,080 B1
`
`
`
`{—— 142
`
`e— 142
`
`FIG. 10A
`
`FIG. 103
`
`Page 5 of 18
`
`Page 5 of 18
`
`

`

`US. Patent
`
`Mar. 15, 2016
`
`Sheet 5 of8
`
`US 9,283,080 B1
`
`
`
`FIG. 11A
`
`FIG. 113
`
`Page 6 of 18
`
`Page 6 of 18
`
`

`

`U.S. Patent
`
`Diar.15,2016
`
`Sheet60f8
`
`US 9,283,080 B1
`
`
`
`FIG. 12
`
`FIG. 13
`
`Page 7 of 18
`
`Page 7 of 18
`
`

`

`US. Patent
`
`Mar. 15, 2016
`
`Sheet 7 of8
`
`US 9,283,080 31
`
`540A
`550A
`
`. w.
`.. “ca
`
`kf/SOOA
`510A
`520A
`
`540B
`
`530A
`
`
`
`500B
`
`£{/,
`5103
`
`5203
`
`5303
`
`FVG.14A
`
`fVG.14B
`
`550C 540C
`
`500C
`5100
`
`45/
`
`540D
`5503
`
`.c:;“¢.
`
`500D
`£52;//5103
`
` 520C
`
`530C
`
`FIG. 140
`
`FIG. 14D
`
`540E
`
`500E
`510E
`
`530E
`
`520E
`
`fVG.14E
`
`Page 8 of 18
`
`Page 8 of 18
`
`

`

`U.S. Patent
`
`Mar. 15, 2016
`
`Sheet 8 0f 8
`
`US 9,283,080 B1
`
`K 610 /
`
`6 0 0
`
`
`
`FIG. 15A
`
`FIG. 15B
`
`7 0 0
`720 \
`
`7 l 0
`
`740
`
`7 3 0
`750
`
`720
`
`\Bone from core
`\ growing to
`natural bone
`\ \\
`\Natural bone
`\ growrng into
`\ surface of
`\ Implant to core
`
`
`
`Bone from core
`\growlng to \
`natural bone
`\\\\
`Naturalbone \
`I. growing into
`surface ot\\
`
`melant to core \
`
`FIG. 16
`
`Page 9 of 18
`
`Page 9 of 18
`
`

`

`US 9,283,080 B1
`
`1
`HIP IMPLANT WITH POROUS BODY
`
`BACKGROUND OF THE INVENTION
`
`Much effort has been directed to integrating hip implants
`into surrounding bone. Ideally, a hip implant would be placed
`into the femur, and thereafter bone would readily grow into
`the surface of the implant. To achieve this objective, many
`different surface technologies have been applied to hip
`implants. In some instances, the surface of the implant is
`roughened, grit-blasted, plasma-sprayed, or microtextured.
`In other instances, the surface is coated with a biological
`agent, such as hydroxylapatite (known as HA). In all of these
`instances, the goal is the same: Produce a surface on the hip
`implant into which surrounding bone will grow or bond.
`Porous coatings have also been applied to surfaces of hip
`implants. Porous surfaces are often thin coatings applied to
`the metallic substrate of the implant. Bone surrounding the
`implant can only grow into the thin coating itself. Bone can-
`not grow through the coating and into the metallic substrate.
`The depth of bone growth into the implant is limited to the
`depth of the porous coating. Bone simply cannot grow com-
`pletely through the implant or deeply into the body of the
`implant.
`
`SUMMARY OF THE INVENTION
`
`One example embodiment is a hip implant that includes a
`bone fixation body that connects to a neck body. The bone
`fixation body is formed of a porous structure that extends
`through a center ofthe bone fixation body in a cross-sectional
`view ofthe bone fixation body. An internal cavity is located in
`the porous structure of the bone fixation body. This internal
`cavity includes a substance to stimulate bone growth.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side view of an example embodiment of a hip
`implant.
`FIG. 2 is a cross-sectional view of the implant of FIG. 1
`embedded in the intramedullary canal of a femur.
`FIG. 3 is a side view of another example embodiment of a
`hip implant.
`FIG. 4 is a cross-sectional view of FIG. 3 showing the hip
`implant embedded in the intramedullary canal of a femur.
`FIG. 5 is a side cross-sectional view ofyet another example
`embodiment of a hip implant.
`FIG. 6 is a side view ofyet another example embodiment a
`hip implant.
`FIG. 7 is a top view of a horizontal cross section of an
`example embodiment.
`FIG. 8 is a top view of a horizontal cross section of another
`example embodiment.
`FIG. 9 is a top view of a horizontal cross section of yet
`another example embodiment.
`FIG. 10A is another example of a hip implant.
`FIG. 10B is a cross-section taken along lines 10B-10B of
`the hip implant in FIG. 10A.
`FIG. 11A is another example of a hip implant.
`FIG. 11B is a cross-section taken along lines 11B-11B of
`the hip implant in FIG. 11A.
`FIG. 12 is a cross-section of another example of a hip
`implant.
`FIG. 13 is a cross-section of another example of a hip
`implant.
`FIG. 14A is an example ofa cross-section ofa bone fixation
`body ofa hip implant.
`
`2
`
`FIG. 14B is another example of a cross-section of a bone
`fixation body of a hip implant.
`FIG. 14C is another example of a cross-section of a bone
`fixation body of a hip implant.
`FIG. 14D is another example of a cross-section of a bone
`fixation body of a hip implant.
`FIG. 14E is another example of a cross-section ofa bone
`fixation body of a hip implant.
`FIG. 15A is an example cross-section ofa neck body ofa
`hip implant.
`FIG. 15B is an example cross-section of a bone fixation
`body of a hip implant.
`FIG. 16 is a partial cross-sectional view of a hip implant
`embedded in a femur of a patient.
`
`DETAILED DESCRIPTION
`
`In one example embodiment, a hip implant includes two
`separate and distinct bodies, a neck body and a bone fixation
`body. Together, these bodies connect together to form a femo-
`ral hip implant.
`The bone fixation body is formed of a porous structure,
`such as titanium, tantalum, or other metals, polymers, or
`alloys suitable for a hip prosthesis. The bone fixation body has
`at least one cross-section in which the porous structure is
`completely porous. This completely porous structure can
`extend through a portion of the bone fixation body (e. g.,
`throughout a cross-section) or through the entire body of the
`bone fixation body. For example in one embodiment, the bone
`fixation body is completely porous from its proximal to distal
`ends and does not include a metal substrate. In another
`
`example embodiment, a portion of the bone fixation body is
`completely porous and does not include a metal substrate. In
`at least one cross-sectional view then, the bone fixation body
`has a porous structure with no solid metal substrate.
`In one example embodiment, the porous structure extends
`entirely through a cross-section of the bone fixation body of
`the hip implant along the region where the hip implant
`engages femoral bone. As such, the depth ofbone growth into
`the hip implant is not restricted to a thin porous coating.
`Instead, bone can grow deeply into the bone fixation body of
`the hip implant or completely into and even through the bone
`fixation body of the hip implant (i.e., bone can grow from one
`side of the hip implant through its center and to another
`oppositely disposed side). The hip implant can become fully
`integrated into surrounding bone with the structure of bone
`dispersed throughout
`the bone fixation body of the hip
`implant.
`In one example embodiment, the geometric structure ofthe
`porous structure ofthe bone fixation body is shaped and sized
`to emulate the shape and size of natural bone surrounding the
`hip implant. The porous structure of the bone fixation body
`thus replicates the porous structure ofnatural bone itself. The
`porous structure readily accepts and encourages surrounding
`bone to grow into and even through the bone fixation body of
`the hip implant.
`the bone fixation body
`In one example embodiment,
`includes an internal cavity with a substance that causes and/or
`stimulates bone growth. This internal cavity can be enclosed
`within the bone fixation body without an egress or ingress.
`Alternatively, one or more openings in the bone fixation body
`or hip implant can lead to the internal cavity.
`In one example embodiment, the bone fixation body and/or
`internal cavity include one or more substances to cause and/or
`stimulate bone growth. This substance can be placed through-
`out the bone fixation body and/or internal cavity so bone
`grows deeply into the hip implant or completely through the
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Page 10 of 18
`
`Page 10 of 18
`
`

`

`US 9,283,080 B1
`
`3
`hip implant from one side to an oppositely disposed side.
`Bone growth, as such, is not restricted to the surface ofthe hip
`implant.
`In one example embodiment, the substance in the internal
`cavity includes a porous structure that causes and/or stimu-
`lates bone growth from within the internal cavity. Bone grows
`from the internal cavity toward an exterior surface ofthe bone
`fixation body. After the hip implant is implanted, bone can
`thus simultaneously grow from the internal cavity toward an
`exterior surface of the bone fixation body and from the exte-
`rior surface of the bone fixation body toward the internal
`cavity. New bone growth thus concurrently occurs and origi-
`nates from two separate and distinct locations (i.e., from
`locations within the hip implant and from locations exterior to
`the hip implant).
`As noted, the porous structure of the hip implant enables
`bone to grow deeply into or completely through the hip
`implant or portions ofthe hip implant. Bone growth deep into
`the body of the hip implant provides a strong interface
`between the hip implant and surrounding natural bone. As
`such,
`the likelihood that
`the hip implant will
`loosen is
`reduced. Further, the overall long-term acceptance of the hip
`implant in the bone is increased. Further yet, the porous
`structure of the bone fixation body and internal cavity reduce
`the overall weight ofthe hip implant. The size and shape ofthe
`internal cavity also enables the physical properties ofthe bone
`fixation body to more closely emulate the physical properties
`of natural bone.
`
`Referring to FIGS. 1 and 2, a hip implant 10 is shown
`according to an exemplary embodiment of the invention.
`Implant 1 0 is preferably constructed ofa biocompatible mate-
`rial such as titanium, titanium alloy, or other metals or alloys
`suitable for a hip prosthesis. Implant 10 comprises two pri-
`mary components or bodies, a neck body 14 and a bone
`fixation body 16.
`The neck body 14 is located at the proximal end 18 of the
`hip implant 10 and functions to connect the hip implant 10 to
`a spherically shaped femoral ball 19 and acetabular compo-
`nent (not shown). The neck body extends from a flat or planar
`distal end surface 21 to a proximal end surface 23. Further, the
`neck body has a base portion 20 that includes a collar 22
`adapted to seat against a resected or end portion ofa femur. An
`interface is adapted to connect the neck body to the femoral
`ball. A neck portion 24 extends outwardly from the base
`portion 20. This neck portion has a short cylindrical configu-
`ration and has an end 26 with a slight taper. This end 26 is
`adapted to be received in a correspondingly shaped and sized
`cylindrical recess 30 in the femoral ball 19. Together, end 26
`and recess 30 form a Morse taper connection.
`Preferably, the neck body 14 is formed of a biocompatible
`metal, such as a solid metal piece of titanium, titanium alloy
`or other metals or alloys suitable for a hip prosthesis. The
`body can be machined to have a size and shape shown in the
`figures or other sizes and shapes adapted for use as a hip
`implant.
`The bone fixation body 16 has an elongated tapering shape
`that extends from a flat or planar proximal end surface 40 to a
`rounded distal end surface 42. The distal end surface 21 of
`
`neck body 14 connects or fuses to the proximal end surface 40
`of the bone fixation body 16 at a junction 44.
`In the exemplary embodiments of FIGS. 1 and 2, bone
`fixation body 16 is formed from a porous metal, such as
`titanium. The body has a completely porous structure that
`extends throughout the entire body from the proximal end
`surface 40 to distal end surface 42. Specifically, as shown in
`FIG. 2, body 16 does not include a solid metal substrate.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`
`FIG. 2 shows the implant 10 embedded in a femur 50 of a
`patient. In this embodiment, the implant is embedded into the
`intramedullary canal 52 of the femur. The length of the bone
`fixation body 16 extends along the region where the implant
`contacts surrounding bone. As shown, the collar 22 seats
`against a resected end 56 ofthe femur above an entrance 57 to
`the intramedullary canal 59. In this embodiment, the bone
`fixation body 16 extends into the intramedullary canal, and
`the neck body 14 extends outwardly from the resected end of
`the intramedullary canal and femur. Further, the proximal end
`surfaced 40 is adjacent the entrance 57 to the intramedullary
`canal.
`
`As noted, the bone fixation body 16 has a porous structure
`that extends throughout the body from the proximal end sur-
`face to the distal end surface. By “porous,” it is meant that the
`material at and under the surface is permeated with intercon-
`nected interstitial pores that communicate with the surface.
`The porous structure can be formed by sintering titanium,
`titanium alloy powder, metal beads, metal wire mesh, or other
`suitable materials, metals, or alloys known in the art.
`The porous structure ofbody 1 6 is adapted for the ingrowth
`of cancellous and cortical bone spicules. In the exemplary
`embodiment, the size and shape of the porous structure emu-
`lates the size and shape of the porous structure of natural
`bone.
`
`Preferably, the average pore diameter of body 16 is about
`40 pm to about 800 um with a porosity from about 45% to
`65%. Further, the interconnections between pores can have a
`diameter larger than 50-60 microns. In short, the geometric
`configuration of the porous structure should encourage natu-
`ral bone to migrate and grow into and throughout the entire
`body 16. Although specific ranges are given for pore diam-
`eters, porosity, and interconnection diameters, these ranges
`are exemplary and are applicable to one exemplary embodi-
`ment. In other embodiments, these ranges could be modified,
`and the resulting hip implant still within the scope of the
`invention.
`
`Preferably, body 16 is created with a sintering process. One
`skilled in the art will appreciate that many variations exist for
`sintering, and some of these variations may be used to fabri-
`cate the present invention. In the exemplary embodiment, the
`neck body is formed from a solid piece of metal and prepared
`using conventional and known machining techniques. Next, a
`ceramic mold is provided. The mold has a first cavity that is
`sized and shaped to match the size and shape of the bone
`fixation body. In this first cavity, the sintering material can be
`placed. The mold also has a second cavity that is adjacent and
`connected to the first cavity. This second cavity is sized and
`shaped to receive the neck body. The neck body is positioned
`in the second cavity such that the distal end surface is adjacent
`and continuous with the first cavity.
`The sintering material is then placed into the first cavity.
`This material may be a titanium alloy powder, such as Ti-6Al-
`4V. Some of this powder will contact the distal end surface of
`the neck body. The mold is then heated to perform the sinter-
`ing process. During this process, as the material in the first
`cavity heats and sinters, the bone fixation body forms and
`simultaneously bonds or fuses to the distal end surface of the
`neck body.
`The size and shape of the pores and porous structure pro-
`duced in the first cavity depend on many factors. These factors
`include, for example, the temperature obtained in the fumace,
`the sintering time, the size and shape of sintering material, the
`composition ofthe sintering material, and the type of ceramic
`mold used. These factors (and others) can be varied to pro-
`duce a bone fixation body in accordance with the present
`
`Page 11 0f18
`
`Page 11 of 18
`
`

`

`US 9,283,080 B1
`
`5
`invention. Further, these factors (and others) can be varied to
`produce a strong bond between the bone fixation body and
`neck body.
`Once the sintering process is finished, the neck body is
`directly fused to the bone fixation body. These two bodies are
`now permanently connected together to form the hip implant.
`In the aforementioned sintering process, the bone fixation
`body simultaneously forms and attaches to the neck body.
`One skilled in the art though will appreciate that each ofthese
`bodies can be fabricated independently and subsequently
`connected together. If the bodies are made separately, then
`they may be attached or fused together using known welding
`or brazing techniques, for example.
`In FIG. 1, for example, the bone fixation body has an
`elongated tapering body with a slight bow. The bone fixation
`body, though, may have other configurations and still be
`within the scope of the invention. The size and shape of the
`body depend on the size and shape of the cavity of the mold
`during the sintering process. This cavity can be shaped, for
`example, to emulate the natural size, shape, and contour of a
`human intramedullary canal. As such, the bone fixation body
`will more naturally fit into the intramedullary canal and con-
`form to the natural anatomical contours of a human patient.
`FIGS. 3 and 4 show another hip implant 50 according to an
`exemplary embodiment of the invention. With some differ-
`ences, implant 50 is similarly configured to the implant 10. As
`one difference, the neck body 60 of implant 50 has two
`different and distinct regions on its outer surface. A first
`region 62 has a smooth outer surface. A second region 64 has
`a bone-engaging surface that is contiguous and adjacent to the
`first region 62 on one side and contiguous and adjacent the
`porous bone fixation body 66 on the other side. The second
`region is non-porous and is shaped as a band that extends
`completely around the neck body. This second region can be
`formed on the outer surface of the neck body with various
`techniques. These techniques include, for example, coating
`with HA, grit-blasting, etching, micro-texturing, other non-
`porous surface treatments, or combinations of these tech-
`niques. This surface 64 is provided as an intermediate zone
`between the porous body and the smooth first region 62.
`As shown in FIG. 4, the second region 64 is below collar 68
`and is positioned into the intramedullary canal to contact
`bone. Region 64, then, contacts bone, and region 62 does not
`contact bone and extends above it.
`
`FIG. 5 shows another implant 70 according to another
`exemplary embodiment of the invention. With some differ-
`ences, implant 70 is similarly configured to the implant 10. As
`one difference, neck body 72 includes a male protrusion 74
`that extends outward from base portion 76. This protrusion 74
`is adapted to extend partially into the bone fixation body 78 of
`implant 70. The protrusion 74 forms a core for the bone
`fixationbody. As shown in FIG. 5, this protrusion extends past
`the proximal end surface 80 and into the bone fixation body.
`The depth of the protrusion into the bone fixation body can be
`increased or decreased in various embodiments and still
`
`remain within the scope of the invention. For example, the
`protrusion can partially extend into the bone fixation body
`and remain substantially near the proximal end surface. Alter-
`natively, the protrusion can extend farther into the bone fixa-
`tion body toward the distal end surface 82. In this latter
`embodiment, the protrusion gradually tapers as it extends
`toward the distal end surface.
`
`The size and shape of the protrusion can also have various
`embodiments and still remain within the scope of the inven-
`tion. For example,
`the protrusion can be cylindrical or
`polygonal, such as rectangular or square. Other configura-
`tions are possible as well; the protrusion can taper or have
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`longitudinal ribs placed along its outer surface. The size and
`shape of the protrusion can have various embodiments to
`serve various functions. For example, the protrusion can be
`sized and shaped to provide a strong connection between the
`neck body and bone fixation body. The protrusion can be
`sized and shaped to provide an anti-rotational
`interface
`between the neck body and bone fixation body. Further, the
`protrusion can be sized and shaped to provide additional
`strength to the bone fixation body or more equally or effi-
`ciently distribute loads from the neck body to the bone fixa-
`tion body. Other factors as well may contribute to the design
`of the protrusion.
`FIG. 6 shows another implant 90 according to an exem-
`plary embodiment of the invention. Implant 90 has a bone
`fixation body 92 with an outer surface that has a plurality of
`undulations 94, such as hills and valleys. These undulations
`may be provided as tiny ripples or waves. Alternatively, the
`undulations may be larger and more rolling. Regardless, the
`undulations are adapted to firmly secure the implant into the
`intramedullary canal of the femur after the implant is placed
`therein.
`
`As shown in FIG. 6, the undulations extend along the entire
`length of the bone fixation body 92 from the proximal end
`surface 96 to the distal end surface 98. In alternative embodi-
`
`ments, the undulations do not extend along the entire length
`ofthe bone fixation body, but partially extend along this body.
`FIGS. 7-9 show various
`longitudinal cross-sectional
`shapes of the bone fixation body for different exemplary
`embodiments of the invention. The bone fixation body may
`have one single longitudinal cross-sectional shape, or the
`body may have numerous different longitudinal cross-sec-
`tional shapes. FIGS. 7-9 represent examples of some of these
`shapes.
`FIG. 7 shows a trapezoidal longitudinal cross-sectional
`shape. FIG. 8 shows a triangular longitudinal cross-sectional
`shape. FIG. 9 shows an elliptical or oval longitudinal cross-
`sectional shape.
`The bone fixation body can be adapted to induce bone
`growth partially into or entirely through the body. The body,
`for example, can be doped with biologically active sub-
`stances. These substances may contain pharmaceutical
`agents to stimulate bone growth all at once or in a timed-
`release manner. Such biological active substances are known
`in the art.
`
`FIGS. 10A and 10B show a hip implant 100 according to an
`example embodiment. The hip implant 100 comprises two
`primary components or bodies, a neck body 114 and a bone
`fixation body 116.
`The neckbody 114 is located at the proximal end 118 ofthe
`hip implant 100 and functions to connect the hip implant 100
`to a spherically shaped femoral ball and acetabular compo-
`nent. The neck body extends from one or more flat or planar
`distal end surfaces 121 to a proximal end surface 123. A neck
`portion 124 extends outwardly from a base portion 120. This
`neck portion has a short cylindrical configuration and has an
`end 126 with a slight taper. This end 126 is adapted to be
`received in a correspondingly shaped and sized cylindrical
`recess in the femoral ball (shown in FIGS. 1 and 2).
`Preferably, the neck body 114 is formed ofa biocompatible
`metal, such as one or more of a solid metal piece of titanium,
`titanium alloy, polymer, or other metals or alloys suitable for
`a hip prosthesis. The neck body can be machined, casted,
`molded, or otherwise configured to have a size and shape
`shown in the figures or other sizes and shapes adapted for use
`as a hip implant.
`The bone fixation body 116 has an elongated tapering
`shape that extends from a proximal end 140 to a rounded
`
`Page 12 0f18
`
`Page 12 of 18
`
`

`

`US 9,283,080 B1
`
`7
`distal end 142. The proximal end includes one or more flat or
`planar surfaces 144. One or more ofthese surfaces connect to
`the distal end surfaces 121 ofthe neckbody 114 at an interface
`or junction 146.
`As shown in FIG. 10B, the bone fixation body 116 forms a
`shell 148 with a completely porous structure that extends
`throughout the entire bone fixation body from the proximal
`end 140 to the distal end 142. This shell 148 has a hollow
`
`center that forms an internal chamber or cavity 150 located
`inside the bone fixation body 116. The internal cavity 150
`extends from a location adjacent the interface 146 to the distal
`end 142. A circular opening 152 leads into the internal cavity
`150 and forms at the distal end 142 of the bone fixation body
`116. The internal cavity 150 is thus enclosed inside of the
`porous structure of the bone fixation body 116.
`As shown in FIG. 10B, the internal cavity 150 includes a
`substance 154 to cause or stimulate bone growth. This sub-
`stance 154 fills the internal cavity 150 from a proximal end
`surface of the internal cavity to an oppositely disposed distal
`end surface of the internal cavity. Alternatively, the sub stance
`can partially fill the internal cavity or be absent from the
`internal cavity.
`A shape and/or size of the internal cavity 150 can vary
`along its longitudinal length. In an example embodiment, this
`shape matches or emulates the external shape of the bone
`fixation body 116. As the size and/or shape of the bone fixa-
`tion body 116 changes, the size and/or shape of the internal
`cavity 150 correspondingly changes. With regard to size for
`example, as the cross-sectional diameter of the bone fixation
`body increases or decreases, the cross-sectional diameter of
`the internal cavity proportionally increases or decreases to
`match the increases or decreases in the diameter of the bone
`
`fixation body. With regard to shape for example, the bone
`fixation body 116 has an elongated cylindrical or elliptical
`shape at a distal end portion 156 in cross-section. Likewise,
`the internal cavity 150 has an elongated cylindrical or ellip-
`tical shape at this distal end portion 156. At a proximal end
`portion 158, the bone fixation body has a rectangular or
`trapezoidal shape in cross-section. Likewise, the internal cav-
`ity 150 has a rectangular or trapezoidal shape at this proximal
`end portion 158. Thus, as the size and/or shape of the bone
`fixation body changes along its longitudinal length, the size
`and/or shape of the internal cavity can also change to match
`with or correspond to these changes.
`In an example embodiment, the internal cavity 150 is cen-
`trally located inside of the bone fixation body 116 such that
`the sides or walls 160 ofthe internal cavity are equally spaced
`from an external surface 162 of the bone fixation body. The
`walls 160 can include one or more grooves 164 formed in the
`porous structure of the bone fixation body. These grooves
`form one or more channels that extend from the circular
`
`opening 152 to an end surface 166 of the internal cavity 150.
`As shown in FIG. 10B, the internal cavity 150 has a larger
`diameter in cross-section adjacent the interface 146 at the
`proximal end 158 than at the distal end 156. The size of the
`internal cavity narrows and tapers as it transitions from the
`proximal end of the hip implant toward the distal end of the
`hip implant.
`While the hip implant 100 is being positioned into the
`femur ofthe patient, bone, tissue, and/orblood enters and fills
`the internal cavity 150. As the hip implant passes into the
`medullary canal of the femur, bone, tissue, and/or blood are
`forced into the internal cavity and travel upwardly along the
`grooves 164 toward the end surface 166. The grooves guide
`and facilitate the passage ofbone, tissue, and/orblood into the
`internal cavity. For example, bone travels in the grooves 164
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`8
`from the opening 152 to the end surface 166 in order to fill or
`collect within the internal cavity 150.
`The grooves 164 can be straight and extend parallel to each
`other from the opening 152 to the end surface 166. Altema-
`tively, the grooves can be nonlinear, such as being curved or
`spiraling. Grooves facilitate the transfer of bone, tissue, and/
`orblood into the internal cavity 150 while the hip implant 100
`is being forced, pressed, or inserted into the femur. Altema-
`tively, the internal cavity 150 can be formed without grooves.
`FIGS. 11A and 11B show a hip implant 200 with a neck
`body 202 that connects to a bone fixation body 206 according
`to an example embodiment. With some differences, the hip
`implant 200 is similarly configured to the hip implant 100 in
`FIGS. 10A and 10B. As one difference, the hip implant 200
`includes an internal cavity 210 that is enclosed and trapped
`within the bone fixation body 206. One of end this internal
`cavity 21 0 is located near or adj acent ajunction 218 where the
`neck body 202 connects to a proximal end 214 of the bone
`fixation body 206. Another end of this internal cavity 210
`extends toward a distal end 216 ofthe bone fixation body 206.
`In an example embodiment, the internal cavity 210 is com-
`pletely enclosed within the bone fixation body 206. The bone
`fixationbody 206 completely surrounds the sides, the top, and
`the bottom of the internal cavity 210 (i.e., the internal cavity
`is surrounded on all sides by the porous structure). As such,
`the internal cavity 210 lacks an ingress (such as a hole or a
`passageway) for entering the cavity or an egress for exiting
`the cavity (such as a hole or a passageway). Nonetheless, the
`open-celled configuration of the porous structure of the bone
`fixation body does allow bone to grow into and through the
`bone fixation body. Thus, the internal cavity can still commu-
`nicate with the porous structure ofthe bone fixation body and
`with bone external to the bone fixation body through the
`interconnected interstitial pores to enable bone growth since
`the internal cavity is surrounded by and formed within an
`open-celled porous structure. Alternatively, the bone fixation
`body 206 includes openings, holes, and/or passageways from
`an external surface 238 to the internal cavity 210.
`As shown in FIG. 11B, the internal cavity 210 includes a
`substance 220 to cause or stimulate bone growth. This sub-
`stance 220 fills the internal cavity 210 from a proximal end
`surface 230 of the internal cavity to an oppositely disposed
`distal end surface 232 of the internal cavity. Alternatively, the
`substance can partially fill the internal cavity or be absent
`from the internal cavity.
`In one example embodiment, the substance 220 is trapped
`within the enclosed internal cavity.

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket