throbber
,
`
`United States Patent [191
`Chapman et a1.
`
`US005190544A
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,190,544
`Mar. 2, 1993
`
`[54] MODULAR FEMORAL FIXATION SYSTEM
`
`FOREIGN PATENT DOCUMENTS
`
`[75] Inventors: Michael W. Chapman, Sacramento,
`Calif.; Charles C. Edwards,
`32111111255: ’ 1:‘: d‘; Dan C’ Mm’
`’
`'
`P?ze H -tal Prod ts G ’ In _
`:
`73 A -
`[
`1
`sslgnee Newryog?iy. “c
`mup c ’
`
`[21] Appl. No.: 670,839
`
`[22] Filed;
`
`Mar, 18, 1991
`
`[62]
`
`_
`_
`Related U's' Apphcahon Data
`Division of Ser. No. 232,188, Aug. 15, 1988, Pat. No.
`5,041,114, which is a division of Ser. No. 877,626, Jun.
`23, 1936, Pat- NO- 4,776,330-
`
`[51] Int. Cl.5 ............................................ .. A61B 17/58
`[52] [1.5. Cl. . . . . . . . . . . . . . . . .
`. . . . . . . . . .. 606/69; 606/ 71
`[58] Field of Search ..................... ,. 606/53, 60, 62, 63,
`606/65’ 66’ 69’ 70’ 71’ 72’ 73’ 86’ 105
`
`[56]
`
`References Cited
`US. PATENT DOCUMENTS
`2,801,631 8/1957 Charnley ............................. .. 606/65
`3,463,143 3/1969 Tfeacg ___________ u
`3,996,931 12/1976 Callender, Jr. ..
`4,621,629 11/1986 Koeneman .......................... .. 606/65
`
`2405705 5/1979 France ................................ .. 606/69
`2406429 5/1979 France ................................ .. 606/69
`Primary Examiner-Robert A. Hafer
`Assistant Examiner-Sam Rimell
`Attorney, Agent, or Firm-Peter C. Richardson;
`Lawrence C. Akers; Elizabeth 0. Slade
`[57]
`ABSTRACT
`.
`.
`.
`A modular femoral internal implant system for use in
`the treatment of femoral disorders resulting from injury,
`disease or congenital defect includes at least three inter
`connectable components: 1) an elongated epiphyseaV
`metaphyseal implant, 2) an intramedullary rod and 3) an
`angled side plate having an elongated plate portion
`adapted to be secured to the outer cortical wall and a
`hollow sleeve adapted to extend into the femur. The
`epiphyseal/metaphyseal implant can be connected to
`either the angled side plate or the pimmmedullary rod_
`The System may also include an elongated bone plate
`connectable to the angled side plate, one or more addi
`tional epiphyseal/metaphyseal implants of variable
`length, an additional angled side plate, a distal buttress
`plate connectable to the elongated bone plate, and a
`plurality of bone screws of a universal design. Prefera
`my’ many "I an °f the °°mPonems °f ‘he Sysmm are
`made of an inert, resilient titanium-base alloy.
`
`6 Claims, 6 Drawing Sheets
`
`ZIMMER 1008
`Page 1
`
`

`
`US. Patent
`
`Mar. 2, 1993
`
`Sheet 1 of 6
`
`5,190,544
`
`5
`
`20 H 5 2
`
`a
`
`i
`
`20
`
`5,
`
`Q
`
`5
`
`ZIMMER 1008
`Page 2
`
`

`
`US. Patent
`
`Mar. 2, 1993
`
`Sheet 2 of 6
`
`5,190,544
`
`ZIMMER 1008
`Page 3
`
`

`
`US. Patent
`
`Mar. 2, 1993'
`
`Sheet 3 of 6
`
`5,190,544
`
`
`
`. l{\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
`
`l\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
`
`ZIMMER 1008
`Page 4
`
`

`
`US. Patent
`
`Mar. 2, 1993
`
`Sheet 4 of 6
`
`5,190,544
`
`1.9.1
`_F'
`
`.20.
`120
`
`120/5
`111
`111
`I.
`116 "119\
`
`116
`,119
`
`F
`
`21,
`M
`
`133
`“4/” 125
`
`ZIMMER 1008
`Page 5
`
`

`
`US. Patent
`
`Mar. 2, 1993
`
`Sheet 5 of 6
`
`5,190,544
`
`ZIMMER 1008
`Page 6
`
`

`
`US. Patent
`
`Mar. 2, 1993
`
`Sheet 6 of 6
`
`5,190,544
`
`ZIMMER 1008
`Page 7
`
`

`
`MODULAR FEMORAL FIXATION SYSTEM
`
`This is a division of application Ser. No. 232,188, ?led
`on Aug. 15, 1988, now U.S. Pat. No. 5,041,114, which in
`turn is a division of application Ser. No. 877,626, ?led
`on Jun. 23, 1986, now US Pat. No. 4,776,330.
`
`BACKGROUND OF THE INVENTION
`'Internal ?xation of femoral fractures is one of the
`most common orthopedic surgical procedures. Many
`different types of femoral fractures are encountered in
`practice, including fractures in the femoral neck, inter
`trochanteric, mid-shaft and distal condylar regions. The
`femoral bone will sometimes fracture cleanly into two
`large fragments along a well-de?ned fracture line, and
`on other occasions fracture into many smaller frag
`ments. Often, more than one type of fracture will exist
`concurrently in different regions of the femur of an
`injured patient.
`20
`A wide variety of implants have been developed over
`the years for use in the internal ?xation of femoral frac
`tures. Although numerous excellent design achieve
`ments have been realized, several general problem areas
`remain. First, almost all of the currently available im
`plants have a highly specialized application limited to
`only one speci?c anatomical location in the femur.
`Thus, a hospital must maintain at great expense a very
`large and variegated inventory of different implants to
`handle all expected contingencies. These implants are
`generally not compatible, i.e. they cannot be intercon
`nected together in case of a complicated fracture pat
`tern extending into different anatomical regions of the
`femur. Second, each implant has its own peculiar attri
`butes and de?ciencies, and the use of many of the
`known implants involves the use of a surgical technique
`that is unique to that implant and sometimes compli
`cated and difficult as well. Consequently, the opportu
`nities for improper implant selection and surgeon error
`during, implantation are inevitably increased. Finally,
`tissue reactions with implants made of stainless steel and
`certain other surgical implant alloys tend to reduce the
`useful lifetime of the implants and require premature
`removal from the patient’s body.
`One very commonly utilized femoral internal ?xation
`device is an elongated implant (nail, screw, pin, etc.)
`adapted to be positioned along the longitudinal axis of
`the femoral neck with its leading end portion in the
`femoral head so as to stabilize a fracture of the femoral
`neck. The elongated implant may be implanted by itself
`or connected to another implant such as a side plate or
`intramedullary rod. The leading end portion of the
`implant typically includes means to positively grip the
`femoral head bone (external threads, expanding arms,
`etc.), but the inclusion of such gripping means can intro
`duce several signi?cant problems. First, implants with
`sharp edges on the leading end portion, such as the
`externally threaded implants, exhibit a tendency to mi
`grate proximally towards the hip joint bearing surface
`after implantation. Such proximal migration under
`60
`physiological loading, which is also referred to as femo
`ral head cut-out, can lead to signi?cant damage to the
`adjacent hip joint. Also, the externally threaded im
`plants can generate large stress concentrations in the
`vicinal bone during implantation which can lead to
`stripping of the threads formed in the bone and thus
`obviously a weakened grip. The movable arms of
`known expanding arm devices are usually free at one
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`65
`
`1
`
`5,190,544
`
`2
`end and attached at the other end to the main body of
`the leading end portion of the implant. As a result, all
`fatigue loading is concentrated at the attached ends of
`the arms and undesirably large bending moments are
`realized at the points of attachment.
`As stated above, known elongated implants used to
`stabilize fractures of the femoral neck are often con
`nected in use to a side plate which in turn is secured to
`the outer cortical wall of the adjacent femoral shaft, for
`example with bone screws. This type of assembly is
`often selected when a femoral neck fracture is a part of
`a more complicated fracture pattern including also one
`or more fractures in the metaphyseal and/or diaphyseal
`regions of the femur. Clearly, the surgeon desires to be
`able to select the appropriate length of the side plate
`depending upon the particular traumatic condition of
`the patient’s femur. However, the surgeon’s flexibility
`in this regard typically requires the hospital to maintain
`a costly inventory of implants.
`
`SUMMARY OF THE INVENTION
`It is an object of the present invention to provide a
`modular system of femoral internal implants, and instru
`mentation therefor, that can be employed to treat a
`number of different fracture patterns and other disor
`ders with a minimal number of interconnectable system
`components involving simple uncomplicated opera
`tional procedures in which surgical invasiveness and
`operation times are minimized.
`This and other objects of the invention are achieved
`with a novel kit for use in the amelioration of a number
`of different types of femoral disorders resulting from
`injury, disease or congenital defect with a minimal num
`ber of interconnectable components. The kit comprises
`at least the following components: 1) an elongated epi
`physeal/metaphyseal implant having a leading end por
`tion and a trailing end portion and adapted to grip bone
`at its leading end portion; 2) an intramedullary rod
`having a distal end and a proximal end; 3) an angled side
`plate comprising an elongated plate portion adapted to
`be secured to the outer cortical wall of the femoral shaft
`and an integral hollow sleeve extending at an angle
`from one end of the plate portion so that said hollow
`sleeve extends into the femur when the plate portion is
`secured to said cortical wall; and 4) means for connect
`ing the epiphyseal/metaphyseal implant to the intra
`medullary rod adjacent to one of the ends of the rod
`with the epiphyseal/metaphyseal implant at an angle
`with respect to the intramedullary rod.
`According to the invention, the components of the
`novel kit are dimensioned such that the elongated epi
`physeal/metaphyseal implant is capable of being con
`nected to the angled side plate by the insertion of the
`trailing end portion of the epiphyseal/metaphyseal im
`plant into the hollow sleeve of the angled side plate and
`the elongated epiphyseal/metaphyseal implant is also
`capable of being connected to the intramedullary rod
`with the use of said connecting means. Thus the same
`epiphyseal/metaphyseal implant can be either con
`nected to the intramedullary rod, to form for example a
`Y-nail type of assembly to treat an unstable subtrochan
`teric fracture pattern, or connected to the angled side
`plate, to form for example a side plate-pin assembly to
`treat a different fracture pattern. The intramedullary
`rod may be either connected to the elongated epi
`physeal/metaphyseal implant or implanted indepen
`dently of said implant and the angled side plate.
`
`ZIMMER 1008
`Page 8
`
`

`
`3
`The novel kit can be used to treat a variety of trauma
`conditions as well as to ameliorate other types of femo
`ral disorders including non-unions, congenital deformi
`ties and pathological deformities (e.g. Paget’s disease),
`and can also be utilized in the prophylactic ?xation of
`weakened bone, bone defects, etc., and in the perfor
`mance of osteotomies. Simple and uncomplicated surgi
`cal techniques can be employed and operating times and
`' implant inventories kept at a low level.
`As used herein the term “elongated epiphyseal/meta
`physeal implant” refers to an elongated implant adapted
`to be usedvin such a manner that it extends after implan
`tation from the epiphyseal region of the proximal femur
`into the adjacent metaphyseal region, or from the lateral
`to the medial epiphyseal region of the distal femur. In
`general, the elongated epiphyseal/metaphyseal implant
`can be a pin, nail, screw, etc. Preferably, the intramedul
`lary rod is axially cannulated and is provided with at
`least one through bore adjacent its distal end for recep
`tion of a locking screw.
`The modular femoral implant system advantageously
`includes components additional to the essential epi
`physeal/metaphyseal implant, intramedullary rod, an
`gled side plate and epiphyseal/metaphyseal implant
`intramedullary rod connection means. Thus, the kit
`preferably includes an elongated bone plate adapted to
`be secured to the outer cortical wall of the femoral
`shaft. The elongated bone plate and angled side plate
`are dimensioned such that the elongated bone plate can
`be connected to the plate portion of the angled side
`30
`plate to provide an extension of the effective length of
`said plate portion without having to inventory two
`complete angled side plates. The elongated bone plate
`can of course be utilized by itself in a conventional
`manner, if desired. Most preferably, several elongated
`bone plates of variable length are included in the kit.
`In a further preferred embodiment of the invention
`the kit includes a_ distal buttress plate including a rela
`tively?at elongated proximal portion adapted to be
`secured to the lateral distal femoral shaft and a rela
`- tively curved distal portion adapted to be secured to the
`lateral distal femoral condyle. In this embodiment the
`kit includes at least one elongated bone plate that is
`capable of being connected to each of the plate portion
`of the angled side plate and the proximal portion of the
`distal buttress plate for effective length extension pur
`poses, as desired.
`The novel kit of the present invention preferably
`includes a plurality of threaded self-tapping cortical
`bone screws for use in securing the elongated plate
`portion of the one or more angled side plates to the
`outer cortical wall of the femoral shaft and, when the
`kit includes an intramedullary rod with a distal through
`bore and one or more elongated bone plates, securing
`the distal end of the intramedullary rod to the distal
`femur, securing said bone plate(s) to the outer cortical
`wall of the femoral shaft, and connecting said plate
`portion(s) and bone plate(s) together in axial alignment.
`The kit preferably includes a plurality of such screws
`each having a head and a threaded shank, with said
`screws being identical except for variations in the
`length of the threaded shanks. Although not every one
`of these screws can be used in all of the capacities set
`forth above (for example short cortical screws cannot
`be used to secure the distal end of the intramedullary
`rod), the provision of a plurality of threaded self-tap
`ping cortical bone screws of universal screw head and
`screw shank design (except for variations in screw
`
`5,190,544
`4
`shank length) provides substantial opportunities for
`interchangeability in use and reduced inventory levels,
`and requires the surgeon to be familiar with only one set
`of cortical screw characteristics, attributes and tech
`niques of use. Furthermore, said bone screws can be
`used independently as bone fixation screws to hold
`fragments of bone together during healing of a fracture.
`Most preferably, the heads of the cortical screws and
`the apertures in the plate portion(s) and bone plate(s)
`intended to receive them are con?gured in such a man
`ner that the screws are capable of a universal rotation
`with respect to the plate portion or bone plate within a
`cone having an apex angle of at least about 20° when the
`screw head is fully advanced into the aperture receiving
`it. Thus, for example, the underside of the universal
`screw head may be spherically rounded (convex
`towards the bone) and the abutting surfaces of the
`screw-receiving apertures complimentary thereto (and
`of course concave away from the bone).
`Preferably, the components of the novel kit of the
`invention are made of a resilient, physiologically inert
`titanium-base alloy such as Ti-ll.5Mo-6Zr-4.5Sn, Ti
`6Al-4V or Ti-3Al-2.5V. The physiological inertness of
`such alloys reduces the potential for adverse tissue reac
`tions (as compared to e.g. stainless steel) and thus will
`serve to increase product lifetime in vivo after implanta
`tion. Also, most of the currently available implants for
`the internal fixation or amelioration of femoral fractures
`or other disorders are made of highly rigid materials,
`thus leading in many circumstances to excessive “stress
`shielding” in which too much of the stresses applied to
`the femur are borne by the implant rather than the heal
`ing bone in the fracture region. Stress shielding may
`delay fracture healing and weaken the surrounding
`bone. This problem of stress shielding is greatly allevi
`ated by making the components of the kit out of a resil
`ient titanium-base alloy.
`In a preferred distribution of components, the kit
`comprises: 1) two epiphyseal/metaphyseal implants of
`different length, 2) an angled side plate in which the
`hollow sleeve and plate portion are mutually oriented at
`an oblique angle so that the hollow sleeve is adapted to
`extend into the intertrochanteric region when the plate
`portion is secured to the outer cortical wall of the adja
`cent femoral shaft, 3) an angled side plate in which the
`hollow sleeve and plate portion are substantially per
`pendicular so that the hollow sleeve is adapted to ex
`tend into the distal condylar region of the femur when
`the plate portion is secured to the outer cortical wall of
`the adjacent distal femoral shaft, 4) an intramedullary
`rod (preferably having a through bore adjacent its distal
`end), 5) means for connecting the shorter of the two
`epiphyseal/metaphyseal implants to the intramedullary
`rod adjacent to the proximal end of the rod to form a
`Y-nail type of assembly, 6) a plurality of cancellous and
`cortical bone screws, and 7) at least one elongated bone
`plate capable of being connected in axial alignment to
`the plate portion of each of the angled side plates for
`effective length extension purposes. The shorter epi
`physeal/metaphyseal implant is also capable of being
`connected to the substantially perpendicularly-angled
`side plate, while the longer epiphyseal/metaphyseal
`implant is capable of being connected to the obliquely
`angled side plate. With this highly preferred distribu
`tion of components, the components of the kit can be
`assembled together in different ways or used indepen
`dently to treat or ameliorate most of the femoral frac
`
`50
`
`55
`
`60
`
`65
`
`20
`
`25
`
`40
`
`45
`
`ZIMMER 1008
`Page 9
`
`

`
`5,190,544
`5
`6
`more evenly distributed along the strip. The actuation
`ture conditions and other femoral disorders commonly
`encountered by orthopedic surgeons.
`mechanism of this novel expansion sleeve implant is
`simple and foolproof and includes no complicated mov
`In addition to the overall modular concept of the
`ing parts that might malfunction during implantation.
`femoral implant system, the present invention is also
`Preferably, the plunger includes a raised annular rib
`directed to the particular design of various of the com
`adjacent the trailing end of the plunger body portion,
`ponents of the system. Thus, included within the con
`cept of the present invention is a novel bone implant for
`which rib is adapted to ?t into a corresponding groove
`provided in the inner wall of the circular ring of the
`use in the stabilization of a bone fracture comprising an
`integral substantially cylindrical expansion sleeve hav
`expansion sleeve when the plunger is fully advanced
`ing a smoothly rounded circumferentially-closed dome
`within the sleeve. This rib and groove combination
`serves to lock the plunger and sleeve against undesired
`at one end, a circumferentially-closed circular ring at its
`relative axial displacement after implantation.
`other end, and a plurality of thin elongated strips ex
`It is highly preferred that the expansion sleeve be
`tending between, and connected at their opposed ends
`to, the circumferentially-closed dome and ring, said
`made of a resilient material such as a titanium-base al
`strips being of varying radial thickness along their
`loy. In this case, the resilient strips of the expansion
`sleeve will expand radially outwardly in elastic defor
`length and having textured outer surfaces; and an elon
`mation when the plunger is advanced into the sleeve
`gated plunger having at one end thereof a substantially
`cylindrical body portion having a diameter essentially
`and will revert to their original shape (to facilitate re
`equal to the inner diameter of the circumferentially
`moval of the sleeve, if desired) when the plunger is
`closed circular ring of the expansion sleeve. When the
`withdrawn. Also, whether or not the sleeve is made of
`expansion sleeve is held in a cavity in a bone fragment
`a resilient material, it is desirable to design it so that
`openings are provided in the sleeve in its rest position.
`on one side of a fracture and the plunger is advanced
`through said circular ring and into the interior of the
`An extrudable material such as a bone cement for en
`sleeve with its substantially cylindrical body portion in
`hancement of the bone implant ?xation can be placed‘
`the leading position, the plurality of thin elongated
`into the sleeve and then extruded through these open
`ings to the bone-implant interface as the plunger is ad
`strips in the sleeve are caused to expand radially out
`wardly and thereby securely grip the bone fragment.
`vanced. The desired openings in the sleeve can be dis
`tinct gaps between the strips in the rest position of the
`The novel bone implant of this aspect of the invention
`sleeve, or some other type of opening.
`can be, but is not necessarily, an epiphyseal/meta
`physeal implant.
`In a preferred surgical implantation technique, a
`guide wire is placed into the patient’s bone at the de
`As used herein the topographical term “circumferen
`sired location, a substantially cylindrical cavity to re
`tially-closed” means that a path can be traced entirely
`around the circumference of a hollow structure having
`ceive the implant is formed with a drill or reamer can
`nulated to fit over the guide wire, the expansion sleeve
`an axis while avoiding any break or gap or other inter
`is secured (preferably releasably) at its smoothly
`ruption in the solid material of the structure. Thus, for
`example, a split ring would not be circumferentially
`rounded dome to an elongated cannulated rod (carrying
`the plunger) which extends within the expansion sleeve
`closed, while a closed ring would be. The uninterrupted
`and through the circumferentially-closed circular ring
`path may be irregular in contour but must be continuous
`thereof, the expansion sleeve is inserted into and held in
`for a full 360° with respect to the axis of the structure in
`question.
`place within the prepared cavity in the bone by means
`Because the expansion sleeve of the bone implant of
`of the elongated rod (which ?ts over the guide wire),
`and the plunger is advanced along said insertion rod
`this aspect of the invention has a smoothly rounded
`into the interior of the expansion sleeve. More prefera
`circumferentially-closed dome at its leading end, the
`likelihood of signi?cant proximal implant migration or
`bly, the insertion rod is externally threaded at one end
`and the dome of the expansion sleeve is provided with
`“cut-out” in the femoral head is greatly reduced (as
`45
`a centrally-disposed threaded axial through bore for the
`compared, for example, to an externally-threaded bone
`releasable attachment of the externally threaded end of
`screw or tri-flanged nail). This is a very important fea
`ture giving rise to substantially improved product life
`the insertion rod.
`and substantially reduced bone damage. The feature
`The present invention also includes a preferred in
`that the expandable strips in the expansion sleeve extend
`strument for use in inserting a surgical implant (e.g. the
`novel expansion sleeve-containing bone implant of the
`between, and are connected at their opposed ends to,
`two circumferentially-closed structures (i.e. the
`invention discussed above) into a cavity in a patient’s
`bone. This novel insertion instrument comprises an
`smoothly rounded dome at the leading end of the ex
`elongated axially cannulated rod having an externally
`pansion sleeve and the circular ring at the trailing end)
`is also signi?cant since it means that these thin strips
`threaded portion adjacent one of its ends and an exter
`nally smooth portion extending from the externally
`have no free ends that can contribute to cut-out or catch
`threaded portion towards the other end of the rod; a
`on the wall of a prepared cavity in the patient’s bone
`structure during implantation. No signi?cant torque
`hollow sleeve receiving the elongated rod, which
`sleeve is capable of sliding movement upon the exter
`(which can cause rotation of the femoral head during
`nally smooth portion of the rod; and means for advanc
`insertion or stripping of the bone material) has to be
`60
`applied to the implant during its implantation, and the
`ing the hollow sleeve along the externally smooth por
`tion of the elongated rod towards the externally
`radial expansion of the textured strips provides a highly
`threaded portion of the rod. The sleeve advancing
`effective and secure bone gripping action distributed
`along the surface of the sleeve without generating ex
`means is preferably structured in such a way that it
`positively prevents movement of the hollow sleeve
`cessive stress concentrations in the bone adjacent the
`implant. Additionally, because the expandable strips are
`along the rod in a direction away from the externally
`threaded portion of the rod while it is engaged with the
`anchored at both ends fatigue loading is not concen
`sleeve. Suitable sleeve advancing means include a
`trated at one end of the strip and bending moments are
`
`30
`
`20
`
`65
`
`ZIMMER 1008
`Page 10
`
`

`
`20
`
`25
`
`30
`
`5,190,544
`8
`7
`be, for example, another bone plate, an angled side
`knurled knob threaded upon a second externally
`threaded portion of the elongated rod on the opposite
`plate, a distal buttress plate, or the like. Thus, a further
`advantage of the novel elongated bone plate of the
`side of the externally smooth portion than the afore
`mentioned ?rst externally threaded portion, or a
`invention is that it can be readily connected to a surgical
`implant having an elongated plate portion adapted to be
`spreader tool which interacts with ratchets provided on
`the elongated rod on said opposite side of its externally
`secured to a patient’s bone by means of bone fasteners
`smooth portion.
`received in apertures in the elongated plate portion,
`By using the preferred implantation technique and
`which plate portion has upper and lower surfaces, with
`a cavity being formed in the lower surface of the plate
`insertion instrument described above, with the hollow
`portion at a free end thereof, said cavity extending lon
`sleeve of the instrument positioned behind and forcing
`the plunger of the implant into the expansion sleeve, the
`gitudinally from said free end to a shoulder defming an
`novel expansion sleeve and plunger-containing bone
`end of the cavity and said cavity having a transverse
`cross-section complementary to that of the elongated
`. implant of the invention can be readily inserted into the
`bone plate of the invention. An important consequence
`‘ prepared cavity in the patient’s bone in a simple surgical
`procedure involving low consumption of time and mini
`of the complementary designs of the transverse cross
`sections, including downwardly-inwardly tapered side
`mal risk of surgical error or equipment malfunction and
`walls, of the surgical implant cavity and elongated bone
`having highly reproducible results from case to case.
`plate is that the bone plate “dovetails” with the surgical
`The same insertion instrument can be used withbone
`implants of different length. The feature that the sleeve
`implant so that it can enter and be removed from the
`cavity in the surgical implant only by relative axial
`advancing means positively prevents rearward move
`movement through the cavity opening at the free end of
`‘ment of the sleeve along the rod is signi?cant because it
`the elongated plate portion of the surgical implant.
`permits the surgeon to readily stop advancement of the
`plunger during its insertion into the expansion sleeve
`Also, no relative rotation is permitted between the sur
`without releasing the compressive force being placed
`gical implant and bone plate. When the end of the bone
`plate abuts the shoulder at the other end of the cavity,
`upon the plunger by the hollow sleeve of the insertion
`instrument.
`no relative translational movement is possible between
`the surgical implant and bone plate except for axial
`Another aspect of the present invention is a novel
`elongated bone plate having an upper surface intended
`separation. By insuring that at least one bone fastener
`receiving aperture in the elongated plate portion of the
`to face away from the patient’s bone that is wider than
`surgical implant overlies a bone fastener-receiving aper
`a lower surface intended to face towards the patient’s
`ture in the bone plate when the plate is inserted into said
`bone, and two side surfaces connecting the upper and
`cavity in the surgical implant and abuts the shoulder at
`lower surfaces which are tapered inwardly toward one
`the end of the cavity, a stable and secure assembly of
`another in the direction from the upper surface to the
`surgical implant and bone plate, in which the length of
`lower surface. The bone plate has a substantially con
`the elongated plate portion of the surgical implant is
`stant thickness between the two side surfaces and is
`35
`effectively extended by the elongated bone plate, can be
`adapted to be secured to a patient’s bone by means of
`realized when the assembled surgical implant and bone
`bone fasteners received in apertures in the bone plate.
`plate are secured together. to the patient’s bone.
`Because the lower surface adjacent the bone is thinner
`The present invention comprises additionally a novel
`(preferably 70% to 90% in width) than the upper sur
`distal buttress plate adapted to be secured to the outer
`face at which stresses from physiological bending mo
`cortical wall of the lateral distal femur by means of bone
`ments applied to the plate tend to be at a maximum, the
`necessary periosteal tissue stripping adjacent the bone
`fasteners received in apertures in the plate. The plate
`includes a relatively ?at elongated proximal portion
`for implantation purposes can be reduced without ex
`cessively sacri?cing the strength of the bone plate under
`adapted to be secured to the lateral distal femoral shaft
`and a relatively curved distal portion, curved out of the
`bending. In one preferred embodiment said upper and
`plane of the proximal portion, adapted to be secured to
`lower surfaces are de?ned in transverse bone plate
`the lateral distal femoral condyle.
`cross-sections by arcs of two concentric circles, while
`For injuries including a sagital fracture through the
`the two side surfaces are de?ned therein by two straight
`radial lines passing through the common center of said
`distal epiphyseal bone, it is highly desirable to use a
`distal buttress plate in conjunction with at least two lag
`concentric circles.
`It is also preferred that an elongated bone plate of this
`screws used for fracture reduction in the distal condylar
`aspect of the invention comprise two parallel integral
`region, with these lag screws being positioned in close
`proximity to, but not passing through, the distal portion
`downwardly-extending rails located at opposite sides of
`the lower surface and extending along substantially the
`of the buttress plate. Thus, in accordance with this
`entire length of the bone plate. These two rails serve to
`aspect of the invention, two spaces for the accommoda
`tion of a pair of lag screws are left adjacent the sides of
`lift the lower surface of the bone plate away from the
`a thin neck connecting a wider, generally rounded head
`‘ surface of the patient’s bone so as to permit enhanced
`vascularization of the bone directly beneath the lower
`at the distal end of said distal portion and a still wider
`distal portion body having a greater maximum width
`surface and thus avoid any excessive weakening of that
`than the elongated proximal portion of the buttress
`bone tissue.
`_
`plate. Preferably, at least one elongated aperture capa
`As has been discussed above in connection with the
`ble of receiving two bone fasteners is provided in the
`modular femoral implant kit or system of the invention,
`distal portion head and a pair of such elongated aper
`it is highly advantageous to provide an elongated bone '
`plate that can be readily connected to the elongated
`tures, one on each side of the body, are provided in the
`plate portion of another surgical implant in a simple,
`distal portion body. It is also preferred that the rela
`tively ?at proximal portion of the buttress plate be pro
`foolproof, non-time consuming surgical method so as to
`effectively provide an extension of the length of said
`vided with an appropriately dimensioned cavity for a
`elongated plate portion. The other surgical implant may
`"dovetailed” connection to the novel bone plate of the
`
`40
`
`

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