US20090069813A1 - Method and apparatus for bone fixation with secondary compression - Google Patents

Abstract

Disclosed is a fracture fixation device, for reducing and compressing fractures in a bone. The fixation device includes an elongate body comprising a first portion and a second portion that are detachably coupled to each other. The first portion defines a helical cancellous bone anchor and the second portion defines a distal end. An axially moveable proximal anchor is carried by the proximal end of the fixation device and is rotationally locked to the first portion. The device is rotated into position across the femoral neck and into the femoral head, and the proximal anchor is distally advanced to lock the device into place. The second portion is then detached from the first portion.

Description

PRIORITY INFORMATION
• This application is a continuation of U.S. patent application Ser. No. 10/830,631, filed Apr. 23, 2004, which is a divisional of U.S. patent application Ser. No. 09/991,367, filed Nov. 13, 2001, now U.S. Pat. No. 6,890,333, which is a continuation-in-part of U.S. patent application Ser. No. 10/012,687, filed Nov. 13, 2001, now U.S. Pat. No. 6,908,465, which is a continuation-in-part of U.S. application Ser. No. 09/822,803, filed Mar. 30, 2001, now U.S. Pat. No. 6,511,481, and the entire contents of each of these applications are hereby expressly incorporated herein by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to internal bone fracture fixation devices. In one application, the present invention relates to bone fracture fixation devices and methods adapted for fixation, among other fractures, of femoral neck and other proximal femoral fractures.
• 2. Description of the Related Art
• The femur, otherwise known as the thigh bone, generally comprises an elongate shaft extending from the hip to the knee. The proximal end of the shaft includes a head, a neck, a greater trochanter and a lesser trochanter. The head of the femur fits into the acetabular cup of the hip bone to form a ball and socket joint at the hip. The distal end of the femur includes a medial condyle and a lateral condyle. The condyles engage an upper end of the tibia to form the knee joint. Overall, the femur is the longest and strongest bone in the skeleton. However, portions of the femur are extremely susceptible to fracturing.
• Pertrochanteric fractures among geriatric patients are the most frequent in connection with those of the region of the neck of the bone. The advanced age and the pathologies which are encountered in these patients make a timely stabilization of skeletal injuries necessary in order to reduce to a minimum the bed confinement and the rehabilitation times. Preferably, devices and procedures are utilized which minimize complications brought about by the so-called immobilization syndrome, which may be lethal for patients in delicate metabolical circumstances. It is also preferable to reduce to a minimum blood losses related to surgical intervention. At the same time, the syntheses means utilized must be stable in order to allow the patient to very timely assume a seated position and, two or three days following the intervention, to reassume an erect posture with progressive bearing of weight.
• Internal fixation of femoral fractures in general is one of the most common orthopedic surgical procedures. Fractures of the femur occur in both the proximal portion of the femur and the distal portion of the femur. Fractures of the proximal portion of the femur (hip fractures) are generally classified as femoral neck fractures, intertrochanteric fractures and subtrochanteric fractures. Fractures of the distal portion of the femur (knee fractures) are referred to as supracondylar fractures. Supracondylar fractures generally extend vertically between the condyles at the lower end of the femur to separate the distal portion of the femur into two main bone fragments. A fracture line may be further comminuted to create a plurality of smaller bone fragments. Fractures of the femur which extend into the neck of the bone are generally more difficult to treat than fractures restricted to the shaft of the femur.
• Operative treatment of the fractures requires that the fractures be internally fixed and possibly compressed. Fractures of the neck, head or trochanters of the femur have been treated with a variety of compression screw assemblies which include generally a compression plate having a barrel member, a lag screw and a compressing screw. The compression plate is secured to the exterior of the femur and the barrel member is inserted into a predrilled hole in the direction of the femoral head. The lag screw which has a threaded end and a smooth portion is inserted through the barrel member so that it extends across the break and into the femoral head. The threaded portion engages the femoral head. The compressing screw connects the lag screw to the plate. By adjusting the tension of the compressing screw the compression (reduction) of the fracture can be adjusted.
• A variety of elongated implants (nail, screw, pin, etc.) have been developed, which are adapted to be positioned along the longitudinal axis of the femoral neck with a leading (distal) 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 introduce several significant problems. First, implants with sharp edges on the leading end portion, such as the externally threaded implants, exhibit a tendency to migrate proximally towards the hip joint weight bearing surface after implantation. This can occur when the proximal cortical bone has insufficient integrity to resist distal movement of the screw head. Such proximal migration under physiological loading, which is also referred to as femoral head cut-out, can lead to significant damage to the adjacent hip joint. Also, the externally threaded implants can generate large stress concentrations in the bone during implantation which can lead to stripping of the threads formed in the bone and thus a weakened grip. The movable arms of known expanding arm devices are usually free at one 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. In addition, conventional threaded implants generally exhibit insufficient holding power under tension, such that the threads can be stripped out of the femoral head either by overtightening during the implantation procedure or during post operative loading by the patient's weight.
• Thus, notwithstanding the variety of efforts in the prior art, there remains a need for an orthopedic fixation device with improved locking force such as within the femoral head in a femoral neck application, which resists migration and rotation, and which can be easily and rapidly deployed within the bone.
SUMMARY OF THE INVENTION
• There is provided in accordance with one aspect of the present invention, a method of securing a first bone fragment to a second bone fragment. The method comprises the steps of drilling a bore through the first bone fragment in the direction of the second bone fragment, and advancing through the bore a fixation device comprising a first portion and a second portion that are coupled to each other. A distal anchor of the fixation device is rotated to secure the fixation device to the second fragment, and the proximal anchor is axially advanced to engage the first fragment.
• In one application of the method, the second bone fragment comprises the head of a femur. Alternatively, the second bone fragment comprises a tibia, a fibula, a femur, a humurus, a radius, or an ulna. The first bone fragment may comprise a condyle.
• The method may additionally comprise the step of uncoupling the first portion from the second portion.
• In accordance with another aspect of the present invention, there is provided a femoral neck fracture fixation device. The device comprises an elongated body, having a proximal end and a distal end and comprising a first portion and a second portion detachably coupled to each other at a junction. The first portion includes an anti-rotational structure. A helical distal anchor is provided on the distal end. A first retention structure is provided on the body, proximal to the distal anchor, and a proximal anchor surface is moveably carried by the body. The proximal anchor includes a tubular sleeve that in a first position extends distally past the junction between the first portion and the second portion. The proximal anchor surface is moveable in the distal direction with respect to the body. The retention structure resists proximal movement of the proximal anchor surface with respect to the body, and the anti-rotational structure prevents rotational movement of the first portion with respect to the proximal anchor.
• In one embodiment, the first retention structure comprises a series of ridges or grooves. A second retention structure is preferably provided on the interior of the tubular sleeve for cooperating with the first retention structure on the body.
• In accordance with a further aspect of the present invention, there is provided a bone fracture fixation device. The fixation device comprises an elongate body having a proximal end and a distal end and comprising a first portion and a second portion that are detachably coupled to each other at a junction. A cancellous bone anchor and/or a cortical bone anchor is carried by the distal end. A proximal anchor is axially moveably carried on the body and includes a tubular portion that extends distally past the junction. Complementary surface structures are provided in between the first portion of the body and the proximal anchor to permit advancing the proximal anchor in the distal direction to tighten the fixation device but resist axial proximal movement of the proximal anchor and to prevent rotational movement between the first portion and the proximal anchor.
• In accordance with another aspect of the present invention, there is provided a method of treating a femoral fracture. The method comprises the steps of drilling at least one and preferably two or three bores distally into the femur in the direction of a fracture, and advancing into each bore a fixation device that comprises a body having a first portion that forms a distal bone anchor and a second portion that forms a proximal end. A proximal component is rotated to engage the distal anchor with the bone distal to the fracture, and a proximal anchor is advanced distally along the fixation device to compress the fracture.
• Preferably, the drilling step comprises drilling the bore along an axis which extends through the femoral neck and in the direction of the head of the femur. In one embodiment, the advancing a proximal anchor step comprises axially advancing the proximal anchor without rotating the proximal anchor with respect to the fixation device. The femoral fracture may be a femoral neck fracture (e.g., capital or subcapital), an intertrochanteric fracture or a subtrochanteric fracture.
• Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a posterior elevational posterior cross section through the proximal portion of the femur, illustrating two femoral neck fracture fixation devices positioned therein.
• FIG. 2 is a side perspective view of a fixation device similar to that ofFIG. 1.
• FIG. 2A is a posterior elevational cross-sectional view through the proximal portion of the femur, having a modified embodiment of a fixation device position therein.
• FIG. 3 is a side elevational view of the fixation device ofFIG. 2.
• FIG. 4 is a cross-sectional view taken through line4-4 ofFIG. 3.
• FIG. 4A is an enlarged view of portion4A ofFIG. 4.
• FIG. 4B is an enlarged view ofportion4B ofFIG. 4 with the fixation device in a first position.
• FIG. 4C is an enlarged view of portion4C ofFIG. 4 with the fixation device in a second position.
• FIG. 5 is a cross-sectional view taken through line5-5 ofFIG. 3.
• FIGS. 6A-C illustrate a procedure for using of the fixation device ofFIG. 1 to secure a femoral neck fracture.
• FIG. 7 is an anterior view of the distal tibia and fibula, with fixation devices similar to that ofFIG. 1 arranged across lateral and medial malleolar fractures.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• Although the fixation devices of the present invention will be disclosed primarily in the context of fractures of the proximal femur, the methods and structures disclosed herein are intended for application in any of a wide variety of bones and fractures, as will be apparent to those of skill in the art in view of the disclosure herein. For example, the bone fixation device of the present invention is applicable in a wide variety of fractures and osteotomies in the hand, such as interphalangeal and metacarpophalangeal arthrodesis, transverse phalangeal and metacarpal fracture fixation, spiral phalangeal and metacarpal fracture fixation, oblique phalangeal and metacarpal fracture fixation, intercondylar phalangeal and metacarpal fracture fixation, phalangeal and metacarpal osteotomy fixation as well as others known in the art. A wide variety of phalangeal and metatarsal osteotomies and fractures of the foot may also be stabilized using the bone fixation device of the present invention. These include, among others, distal metaphyseal osteotomies such as those described by Austin and Reverdin-Laird, base wedge osteotomies, oblique diaphyseal, digital arthrodesis as well as a wide variety of others that will be known to those of skill in the art. The bone fixation device may be used with or without plate(s) or washer(s), all of which can be either permanent, absorbable, or combinations.
• Fractures of the fibular and tibial malleoli, pilon fractures and other fractures of the bones of the leg may be fixated and stabilized with the present invention with or without the use of plates, both absorbable or non-absorbing types, and with alternate embodiments of the current invention. Fractures and osteotomies of the mid and hind foot, tarsal arthrodesis and osteotomy, or others as are known to those with skill in the art. One example is the fixation of the medial malleolar avulsion fragment.
• The fixation device of the present invention may also be used to attach tissue or structure to the bone, such as in ligament reattachment and other soft tissue attachment procedures. Plates and washers, with or without tissue spikes for soft tissue attachment, and other implants may also be attached to bone, using either resorbable or nonresorbable fixation devices depending upon the implant and procedure. The fixation device may also be used to attach sutures to the bone, such as in any of a variety of tissue suspension procedures.
• For example, peripheral applications for the fixation devices include utilization of the device for fastening soft tissue such as capsule, tendon or ligament to bone. It may also be used to attach a synthetic material such as marlex mesh, to bone or allograft material such as tensor fascia lata, to bone. In the process of doing so, retention of the material to bone may be accomplished with the collar as shown, or the pin and or collar may be modified to accept a suture or other material for facilitation of this attachment.
• Specific examples include attachment of the posterior tibial tendon to the navicular bone in the Kidner operation. This application may be accomplished using an appropriately sized implant of the present invention along with a washer with distally extending soft tissue spikes. Navicular-cuneiform arthrodesis may be performed utilizing the device and concurrent attachment of the tendon may be accomplished. Attachment of the tendon may be accomplished in the absence of arthrodesis by altering the placement of the implant in the adjacent bone.
• Ligament or capsule reattachment after rupture, avulsion or detachment, such as in the ankle, shoulder or knee can also be accomplished using the devices disclosed herein.
• The fixation devices may be used in combination with semi tubular, one-third tubular and dynamic compression plates, both of metallic and absorbable composition, if the collar is modified to match the opening on the plate.
• The canulated design disclosed below can be fashioned to accept an antibiotic impregnated rod for the slow adsorption of medication locally. This may be beneficial for prophylaxis, especially in open wounds, or when osteomyelitis is present and stabilization of fracture fragments is indicated.
• A kit may be assembled for field use by military or sport medical or paramedical personnel. This kit contains an implanting tool, and a variety of implant device size and types. The kit may include additional components such as sterilization or disinfectant materials, a skin stapler, bandages, gloves, and basic tools for emergent wound and fracture treatment. Antibiotic rods may be included for wound prophylaxis during transport.
• Referring toFIG. 1, there is illustrated a posterior side elevational view of the proximal portion of afemur10, having afixation device12 positioned therein. The proximal end of thefemur10 comprises ahead14 connected by way of aneck16 to the long body orshaft17 of thefemur10. As illustrated inFIG. 1, theneck16 is smaller in diameter than thehead14. Theneck16 andhead14 also lie on an axis which, on average in humans, crosses the longitudinal axis of thebody17 of thefemur10 at an angle of about 126°. The risk of fracture at theneck16 is thus elevated, among other things, by the angular departure of theneck16 from the longitudinal axis of thebody17 offemur10 and also the reduced diameter of theneck16 with respect to thehead14.
• Thegreater trochanter18 extends outwardly above the junction of theneck16 and thebody17 of thefemur10. On the medial side of thegreater trochanter18 is thetrochanteric fossa20. This depression accommodates the insertion of the obturator externus muscle. Thelesser trochanter21 is located posteromedially at the junction of theneck16 and thebody17 of thefemur10. Both thegreater trochanter18 and thelesser trochanter21 serve for the attachment of muscles. On the posterior surface of thefemur10 at about the same axial level as thelesser trochanter21 is thegluteal tuberosity22, for the insertion of the gluteus maximus muscle. Additional details of the femur are well understood in the art and not discussed in further detail herein.
• FIG. 1 illustrates afracture24 which crosses the femur approximately in the area of thegreater trochanter18. Fractures of the proximal portion of thefemur10 are generally classified as capital or subcapital femoral neck fractures, intertrochanteric fractures and subtrochanteric fractures. All of these fractures will be deemed femoral neck fractures for the purpose of describing the present invention.
• Referring toFIGS. 1-4, thefixation device12 comprises abody28 extending between aproximal end30 and adistal end32. The length, diameter and construction materials of thebody28 can be varied, depending upon the intended clinical application. In embodiments optimized for various fractures in an adult human population, thebody28 will generally be within the range of from about 10 mm to about 150 mm in length after sizing, and within the range of from about 2 mm to about 8 mm in maximum diameter. The major diameter of the helical anchor, discussed below, may be within the range of from about 2.7 mm to about 12 mm. In general, the appropriate dimensions of thebody28 will vary, depending upon the specific fracture. In rough terms, for a malleolar fracture, shaft diameters in the range of from about 3 mm to about 4.5 mm may be used, and lengths within the range of from about 25 mm to about 70 mm. For condylar fractures, shaft diameters within the range of from about 3.5 mm to about 6.5 mm may be used with lengths within the range of from about 25 mm to about 70 mm. For colles fractures (distal radius and ulna), diameters within the range of from about 2.0 mm to about 4.5 mm may be used with any of a variety of lengths within the range of from about 6 mm to about 70 mm.
• In one embodiment, thebody28 comprises titanium. However, as will be described in more detail below, other metals or bioabsorbable or nonabsorbable polymeric materials may be utilized, depending upon the dimensions and desired structural integrity of the finishedfixation device12.
• Thedistal end32 of thebody28 is provided with a cancellous bone anchor or distalcortical bone anchor34. Additional details of the distal bone anchor are described below. In general, in a femoral neck application,distal bone anchor34 is adapted to be rotationally inserted into the cancellous bone within thehead14 of thefemur10, to retain thefixation device12 within the femoral head.
• Referring toFIGS. 3,4, and4A, thebody28 comprises afirst portion36 and asecond portion38 that are coupled together at ajunction40. In the illustrated embodiment, thefirst portion36 carries thedistal anchor34 while thesecond portion38 forms theproximal end30 of thebody28. The first andsecond portions36,38 are preferably detachably coupled to each other at thejunction40. In the illustrated embodiment, the first andsecond portions36,38 are detachably coupled to each other via interlocking threads. Specifically, as best seen inFIG. 4A, thebody28 includes aninner surface41, which defines acentral lumen42 that preferably extends from theproximal end30 to thedistal end32 throughout thebody28. At the proximal end of thefirst portion36, theinner surface41 includes a first threadedportion44. The first threadedportion44 is configured to mate with a second threadedportion46, which is located on theouter surface45 of thesecond portion38. The interlocking annular threads of the first and second threadedportions44,46 allow the first andsecond portions36,38 to be detachably coupled to each other. In one modified embodiment, the orientation of the first and second threadedportions44,46 can be reversed. That is, the first threadedportion44 can be located on the outer surface of thefirst portion36 and the second threadedportion46 can be located on theinner surface41 at the distal end of thesecond portion38. Any of a variety of other releasable complementary engagement structures may also be used, to allow removal ofsecond portion38 following implantation, as is discussed below.
• In a modified arrangement, thesecond portion38 can comprise any of a variety of tensioning elements for permitting proximal tension to be placed on thedistal anchor34 while the proximal anchor is advanced distally to compress the fracture. For example, any of a variety of tubes or wires can be removably attached to thefirst portion36 and extend proximally to the proximal handpiece. In one such arrangement, thefirst portion36 can include a releasable connector in the form of a latching element, such as an eye or hook. Thesecond portion38 can include a complementary releasable connector (e.g., a complementary hook) for engaging thefirst portion36. In this manner, thesecond portion38 can be detachably coupled to thefirst portion36 such proximal traction can be applied to thefirst portion36 through the second portion as will be explained below. Alternatively, the second portion48 may be provided with an eye or hook, or transverse bar, around which or through which a suture or wire may be advanced, both ends of which are retained at the proximal end of the device. Following proximal tension on the tensioning element during the compression step, one end of the suture or wire is released, and the other end may be pulled free of the device. Alternate releasable proximal tensioning structures may be devised by those of skill in the art in view of the disclosure herein.
• Theproximal end30 of the fixation device is provided with aproximal anchor50.Proximal anchor50 is axially distally moveable along thebody28, to permit compression of thefracture24 as will be apparent fromFIG. 1 and the description below. As will be explained below, complimentary locking structures such as threads or ratchet like structures between theproximal anchor50 and thebody28 resist proximal movement of theanchor50 with respect to thebody28 under normal use conditions. Theproximal anchor50 preferably can be axially advanced along thebody28 without rotation as will be apparent from the disclosure herein.
• In the illustrated embodiment,proximal anchor50 comprises ahousing52 such as a tubular body, for coaxial movement along thebody28. As best seen inFIGS. 1 and 4, in a final position, thehousing52 extends distally past thejunction40 between thefirst portion36 and thesecond portion38. Thehousing52 is provided with one ormore surface structures54 such as a radially inwardly projecting flange56 (seeFIGS. 4B and 4C), for cooperating withcomplementary surface structures58 on thefirst portion36 of thebody28. In the illustrated embodiment, thecomplimentary surface structures58 comprise a series of annular ridges orgrooves60. Thesurface structures54 andcomplementary surface structures58 permit distal axial travel of theproximal anchor50 with respect to thebody28, but resist proximal travel of theproximal anchor50 with respect to thebody28.
• For example, as best seen inFIG. 4B, the proximal end of theflange56 is biased towards the longitudinal axis of thebody28. As such, when theproximal anchor50 is urged proximally with respect to thebody28, theflange56 engages the grooves orridges60 of thecomplementary surface structures58. This prevents proximal movement of theproximal anchor50 with respect to thebody28. In contrast, as best seen inFIG. 4C, when theproximal anchor50 is moved distally with respect to thebody28, theflange56 can bend outwardly away from thebody28 and theridges60 so as to allow theproximal anchor50 to move distally. Of course, those of skill in the art will recognize that there are a variety of other complementary surface structures, which permit one way ratchet like movement. For example, a plurality of annular rings or helical threads, ramped ratchet structures and the like for cooperating with an opposing ramped structure or pawl can also be used. In one embodiment, opposing screw threads are dimensioned to function as a ratchet.
• Retention structures58 are spaced axially apart along thebody28, between aproximal limit62 and adistal limit64. The axial distance betweenproximal limit62 anddistal limit64 is related to the desired axial working range of theproximal anchor50, and thus the range of functional sizes of thefixation device12. Thus, the present invention provides a bone fixation device which can provide compression across a fracture throughout a range of motion following the placement of the distal anchor. The distal anchor may be positioned within the cancellous and/or distal cortical bone, and the proximal anchor may be distally advanced throughout a range to provide compression across the fracture without needing to relocate the distal anchor and without needing to initially locate the distal anchor in a precise position with respect to the proximal side of the bone. Providing a working range throughout which tensioning of the proximal anchor is independent from setting the distal anchor allows a single device to be useful for a wide variety of fractures, as well as eliminates the need for accurate device measurement and accurate placement of the distal anchor. In many applications, the working range is at least about 10% of the overall length of the device, and may be as much as 20% or 30% or more of the overall device length. In the context of a femoral application, working ranges of up to about 10 mm or more may be provided, since estimates within that range can normally be readily accomplished within the clinical setting. In other applications, such as a metatarsal fracture, a working range in the area of from about 1 mm to about 2 mm may be all that is necessary. The embodiments disclosed herein can be scaled to have a greater or a lesser working range, as will be apparent to those of skill in the art in view of the disclosure herein.
• Theproximal anchor50 includes aflange66 that seats against the outer surface of the femur or tissue adjacent the femur. Theflange66 is preferably an annular flange, to optimize the footprint or contact surface area between theflange66 and the femur. Circular or polygonal shaped flanges for use in femoral head fixation will generally have a diameter of at least about 4 mm greater than theadjacent body28 and often within the range of from about 4 mm to about 20 mm or more greater than theadjacent body28.
• In the illustrated embodiment, thebone contacting surface68 of theflange44 is tapered and generally faces theshaft17 of thefemur10. In other embodiments, the bone contacting surface69 can resides in or approximately on a plane, which is perpendicular with respect to the longitudinal axis of thebody28. In other embodiments, other angular relationships between thebone contacting surface68 of theflange66 and the longitudinal axis of thebody28 andhousing52 may be utilized, depending upon the anticipated entrance angle of thebody28 and associated entrance point surface of thefemur10. In general, the longitudinal axis extending through thehead14 andneck16 of the human femur is inclined at an angle of approximately 126° from the longitudinal axis of thelong body17 of thefemur10. Angles between the longitudinal axis ofbody28 andtissue contacting surface68 within the range of from about 90° to about 140° will generally be utilized.
• As shown inFIG. 2A, in a modified embodiment, thehousing52 of theproximal anchor50 can include one or more one ormore barbs41 that extend radially outwardly from thetubular housing52.Such barbs41 provide for self tightening after the device has been implanted in the patient as described in a co-pending U.S. patent application Ser. No. 10/012,687, entitled DISTAL BONE FOR BONE FIXATION WITH SECONDARY COMPRESSION”, filed Nov. 13, 2001, which is hereby expressly incorporated by reference herein. Thebarbs41 may be radially symmetrically distributed about the longitudinal axis of thehousing52. Eachbarb41 is provided with atransverse engagement surface43, for anchoring theproximal anchor50 in the bone. Thetransverse engagement surface43 may lie on a plane which is transverse to the longitudinal axis of thetubular housing52 or may be inclined with respect to the longitudinal axis of thetubular housing52. In either arrangement, thetransverse engagement surface43 generally faces thebone contacting surface68 of theflange44. As such, thetransverse engagement surface43 inhibits proximal movement of the proximal anchor with respect to the bone.
• The clinician can be provided an array ofproximal anchors50 of varying angular relationships between thebone contacting surface68 and the longitudinal axis of thebody28 and housing52 (e.g., 90°, 100°, 110°, 120°, and 130°). Asingle body28 can be associated with the array such as in a single sterile package. The clinician upon identifying the entrance angle of thebody28 and the associated entrance point surface orientation of thefemur10 can choose theanchor50 from the array with the best fit angular relationship, for use with thebody28.
• With particular reference toFIGS. 3, theproximal end30 of thebody28 may be provided with arotational coupling70, for allowing thesecond portion38 of thebody28 to be rotationally coupled to a rotation device. Theproximal end30 of thebody28 may be desirably rotated to accomplish one or two discrete functions. In one application of the invention, theproximal end30 is rotated to remove thesecond portion38 of thebody28 following tensioning of the device across a fracture or to anchor an attachment to the bone. Rotation of therotational coupling70 may also be utilized to rotationally drive the distal anchor into the bone. Any of a variety of rotation devices may be utilized, such as electric drills or hand tools, which allow the clinician to manually rotate theproximal end30 of the body. Thus, therotational coupling70 may have any of a variety of cross sectional configurations, such as one or more flats or splines.
• In one embodiment, therotational coupling70 comprises a proximal projection of thebody28 having an axial recess with a polygonal cross section, such as a hexagonal cross section. Therotational coupling70 is illustrated as a female component, machined or milled or attached to theproximal end30 of thebody28. However, the rotational coupling may also be in the form of a male element, such as a hexagonal or other noncircular cross sectioned projection.
• As illustrated, thebody28 is cannulated to accommodate installation over a placement wire as is understood in the art. The cross section of the illustrated central cannulation is circular but in other embodiments may be non circular, e.g., hexagonal, to accommodate a corresponding male tool for installation or removal of thesecond portion38 of thebody28 as will be explained below. In other embodiments, thebody28 may partially or wholly solid.
• In all of the embodiments illustrated herein, thedistal anchor34 comprises ahelical locking structure72 for engaging cancellous and/or distal cortical bone. In the illustrated embodiment, the lockingstructure72 comprises a flange that is wrapped around the axial lumen. The flange extends through at least one and generally from about two to about 50 or more full revolutions depending upon the axial length of the distal anchor and intended application. For most femoral neck fixation devices, the flange will generally complete from about 2 to about 20 revolutions. Thehelical flange72 is preferably provided with a pitch and an axial spacing to optimize the retention force within cancellous bone, to optimize compression of the fracture.
• Thehelical flange72 of the illustrated embodiment has a generally triangular cross-sectional shape (seeFIG. 4). However, it should be appreciated that thehelical flange72 can have any of a variety of cross sectional shapes, such as rectangular, oval or other as deemed desirable for a particular application through routine experimentation in view of the disclosure herein. The outer edge of thehelical flange72 defines an outer boundary. The ratio of the diameter of the outer boundary to the diameter of the central lumen can be optimized with respect to the desired retention force within the cancellous bone and giving due consideration to the structural integrity and strength of thedistal anchor34. Another aspect of thedistal anchor34 that can be optimized is the shape of the outer boundary and the central core, which in the illustrated embodiment are generally cylindrical.
• Thedistal end32 and/or the outer edges of thehelical flange72 may be atraumatic (e.g., blunt or soft). This inhibits the tendency of thefixation device12 to migrate anatomically proximally towards the hip joint bearing surface after implantation (i.e., femoral head cut-out). Distal migration is also inhibited by the dimensions and presence of theproximal anchor50, which has a larger footprint than conventional screws.
• A variety of other arrangements for thedistal anchor32 can also be used. For example, the various distal anchors described in U.S. patent application Ser. No. 09/822,803, filed Mar. 30, 2001, and co-pending U.S. patent application entitled “DISTAL BONE FOR BONE FIXATION WITH SECONDARY COMPRESSION”, filed Nov. 13, 2001 can be incorporated into thefixation device12 described herein. The entire contents these applications are hereby expressly incorporated by reference. In particular, the distal anchor may comprise a single helical thread surrounding a central core, much as in a conventional screw, which has been cannulated to facilitate placement over a wire. Alternatively, a double helical thread may be utilized, with the distal end of the first thread rotationally offset from the distal end of the second thread. The use of a double helical thread can enable a greater axial travel for a given degree of rotation and greater retention force than a corresponding single helical thread. Specific distal anchor designs can be optimized for the intended use, taking into account desired performance characteristics, the integrity of the distal bone, and whether the distal anchor is intended to engage exclusively cancellous bone or will also engage cortical bone.
• With particular reference toFIGS. 2 and 5, the fixation device may include an antirotation lock between thefirst portion36 of thebody28 and theproximal collar50. In the illustrated embodiment, thefirst portion36 includes a pair offlat sides80, which interact with correspondingflat structures82 in theproximal collar50. One or three or more axially extending flats may also be used. As such, rotation of theproximal collar50 is transmitted to thefirst portion36 anddistal anchor34 of thebody28. Of course, those of skill in the art will recognize various other types of splines or other interfit structures can be used to prevent relative rotation of the proximal anchor and thefirst portion36 of thebody28.
• To rotate the proximal collar, theflange66 is preferably provided with a gripping structure to permit an insertion tool to rotate theflange66. Any of a variety of gripping structures may be provided, such as one or more slots, flats, bores or the like. In one embodiment, theflange44 is provided with a polygonal, and, in particular, a pentagonal orhexagonal recess84. SeeFIG. 4.
• In use, the clinician first identifies a patient having a fracture to be treated, such as a femoral neck fracture, which is fixable by an internal fixation device. The clinician accesses the proximal femur, reduces the fracture if necessary and selects a bone drill and drills a hole90 (seeFIG. 6A) in accordance with conventional techniques. Frequently, thehole90 has a diameter within the range from about 3 mm to about 8 mm. This diameter may be slightly larger than the diameter of thedistal anchor34. Thehole90 preferably extends up to or slightly beyond thefracture24.
• Afixation device12 having an axial length and outside diameter suitable for thehole90 is selected. Thedistal end32 of thefixation device12 is advanced distally into thehole90 until thedistal anchor34 reaches the distal end of thehole90. Theproximal anchor50 may be carried by thefixation device12 prior to advancing thebody28 into thehole90, or may be attached following placement of thebody28 within thehole90. Once thebody28 andproximal anchor50 are in place, the clinician may use any of a variety of driving devices, such as electric drills or hand tools to rotate theproximal anchor50 and thuscancellous bone anchor34 into the head of the femur.
• Once theanchor34 is in the desired location, proximal traction is applied to theproximal end30 ofbody28, such as by conventional hemostats, pliers or a calibrated loading device, while distal force is applied to theproximal anchor50. In this manner, theproximal anchor50 is advanced distally until theanchor50 fits snugly against the outer surface of the femur or tissue adjacent the femur and thefracture24 is completely reduced as shown inFIG. 6B. Appropriate tensioning of thefixation device12 is accomplished by tactile feedback or through the use of a calibration device for applying a predetermined load on the implantation device. One advantage of the structure of the present invention is the ability to adjust compression independently of the setting of thedistal anchor34.
• Following appropriate tensioning of theproximal anchor50, thesecond portion38 of thebody28 is preferably detached from thefirst portion36 and removed. SeeFIG. 6C. In the illustrated embodiment, this involves rotating thesecond portion38 with respect to the first portion via thecoupling70. In connection with many of the fractures identified previously herein, asingle fixation device12 may be all that is clinically indicated. However, two or three ormore fixation devices12 may be utilized to reduce a single fracture, depending upon the location and physical requirements of the fractured portion of the bone. For example, in the case of proximal femoral fractures of the type illustrated herein, typically at least two and preferably threefixation devices12 will be implanted to span the femoral neck. The use of threefixation devices12 desirably provides sufficient compression across the fracture, as well as minimizes the risk of rotation of the head of the femur around the axis of asingle fixation device12. The proximal end of the fixation devices may be connected together such as through a three-holed plate or rod, or may be independent of each other.
• Following removal of thesecond portion38 of eachbody28, the access site may be closed and dressed in accordance with conventional wound closure techniques.
• In a modified arrangement, thesecond portion38 may form part of the driving device, which is used to rotate theproximal anchor50 and thuscancellous bone anchor34 into the head of the femur. Thesecond portion38 is used to apply proximal traction so as to compress the fracture. After appropriate tensioning, thesecond portion38 can be de-coupled from thefirst portion36 and removed with the driving device.
• In the foregoing variation, thesecond portion38 may be connected to a rotatable control such as a thumb wheel on the deployment device. A container may be opened at the clinical site exposing the proximal end of the implant, such that the distal end of thesecond portion38 may be removably coupled thereto. Proximal retraction of the hand tool will pull the implant out of its packaging. The implant may then be positioned within the aperture in the bone, rotated to set the distal anchor, and the hand piece may be manipulated to place proximal traction on thesecond portion38 while simultaneously distally advancing the proximal anchor. Following appropriate tensioning across the fracture, thesecond portion38 may be disengaged from the implant, and removed from the patient. In the example of a threaded engagement, thesecond portion38 may be disengaged from the implant by rotating a thumb wheel or other rotational control on the hand piece. In an alternate embodiment, such as where thesecond portion38 comprises a pull wire, following appropriate tensioning across the fracture, a first end of the pull wire is released such that the pull wire may be removed from the implant by proximal retraction of the second end which may be attached to the hand piece.
• Preferably, the clinician will have access to an array offixation devices12, having, for example, different diameters, axial lengths and, if applicable, angular relationships. These may be packaged one per package in sterile envelopes or peelable pouches, or in dispensing cartridges which may each hold a plurality ofdevices12. Upon encountering a fracture for which the use of a fixation device is deemed appropriate, the clinician will assess the dimensions and load requirements, and select a fixation device from the array, which meets the desired specifications.
• In some instances, a clinician may want to introduce two ormore fixation devices12 into thefemoral head14 to secure thefracture24. This may be desirable if the clinician determines that, based upon the nature of thefracture24, there is a possibility that thehead14 of thefemur10 could rotate about asingle fixation device12. Even minor rotation can inhibit the healing of the fracture. Significant rotation can result in failure of the fixation device or necrosis of the femoral head. Two ormore fixation devices12 may also be desirable where the direction of the fracture is generally parallel to the axis of implantation as is understood in the art.
• Thefixation device12 of the present invention may also be used in combination with intramedullary nails or rods, as will be understood by those of skill in the art.
• Thefixation device12 of the present invention may be used in any of a wide variety of anatomical settings beside the proximal femur, as has been discussed. For example, lateral and medial malleolar fractures can be readily fixed using the device of the present invention. Referring toFIG. 7, there is illustrated an anterior view of thedistal fibula120 andtibia122. Thefibula120 terminates distally in thelateral malleolus124, and thetibia122 terminates distally in themedial malleolus126.
• Afixation device12 in accordance with the present invention is illustrated inFIG. 7 as extending through thelateral malleolus124 across the lateralmalleolar fracture128 and into thefibula120.Fixation device12 includes adistal anchor34 for fixation within thefibula120, anelongate body28 and aproximal anchor50 as has been discussed.
• FIG. 7 also illustrates afixation device12 extending through themedial malleolus126, across a medial malleolar fracture130, and into thetibia122. AlthoughFIG. 7 illustrates fixation of both a lateralmalleolar fracture128 and medial malleolar fracture130, either fracture can occur without the other as is well understood in the art. Installation of the fixation devices across malleolar fractures is accomplished utilizing the same basic steps discussed above in connection with the fixation of femoral neck fractures.
• The fixation devices of the present invention may be made from either conventional bioabsorbable materials or conventional non-absorbable materials, combinations thereof and equivalents thereof. In addition, natural materials such as allografts may be used. Examples of absorbable materials include homopolymers and copolymers of lactide, glycolide, trimethylene carbonate, caprolactone, and p-dioxanone and blends thereof. The following two blends may be useful: 1) the blend of poly(p-dioxanone) and a lactide/glycolide copolymer, as disclosed in U.S. Pat. No. 4,646,741 which is incorporated by reference and (2) the glycolide-rich blend of two or more polymers, one polymer being a high lactide content polymer, and the other being a high glycolide content disclosed in U.S. Pat. No. 4,889,119 which is incorporated by reference. Additional bioabsorbable materials are disclosed in copending application Ser. No. 09/558,057 filed Apr. 26, 2000, the disclosure of which is incorporated in its entirety herein by reference.
• The fixation devices may also be made from conventional non-absorbable, biocompatible materials including stainless steel, titanium, alloys thereof, polymers, composites and the like and equivalents thereof. In one embodiment, the distal anchor comprises a metal helix, while the body and the proximal anchor comprise a bioabsorbable material. Alternatively, the distal anchor comprises a bioabsorbable material, and the body and proximal anchor comprise either a bioabsorbable material or a non-absorbable material. As a further alternative, each of the distal anchor and the body comprise a non-absorbable material, connected by an absorbable link. This may be accomplished by providing a concentric fit between the distal anchor and the body, with a transverse absorbable pin extending therethrough. This embodiment will enable removal of the body following dissipation of the pin, while leaving the distal anchor within the bone.
• The components of the invention (or a bioabsorbable polymeric coating layer on part or all of the anchor surface), may contain one or more bioactive substances, such as antibiotics, chemotherapeutic substances, angiogenic growth factors, substances for accelerating the healing of the wound, growth hormones, antithrombogenic agents, bone growth accelerators or agents, and the like. Such bioactive implants may be desirable because they contribute to the healing of the injury in addition to providing mechanical support.
• In addition, the components may be provided with any of a variety of structural modifications to accomplish various objectives, such as osteoincorporation, or more rapid or uniform absorption into the body. For example, osteoincorporation may be enhanced by providing a micropitted or otherwise textured surface on the components. Alternatively, capillary pathways may be provided throughout the body and collar, such as by manufacturing the anchor and body from an open cell foam material, which produces tortuous pathways through the device. This construction increases the surface area of the device which is exposed to body fluids, thereby generally increasing the absorption rate. Capillary pathways may alternatively be provided by laser drilling or other technique, which will be understood by those of skill in the art in view of the disclosure herein. In general, the extent to which the anchor can be permeated by capillary pathways or open cell foam passageways may be determined by balancing the desired structural integrity of the device with the desired reabsorption time, taking into account the particular strength and absorption characteristics of the desired polymer.
• One open cell bioabsorbable material is described in U.S. Pat. No. 6,005,161 as a poly(hydroxy) acid in the form of an interconnecting, open-cell meshwork which duplicates the architecture of human cancellous bone from the iliac crest and possesses physical property (strength) values in excess of those demonstrated by human (mammalian) iliac crest cancellous bone. The gross structure is said to maintain physical property values at least equal to those of human, iliac crest, cancellous bone for a minimum of 90 days following implantation. The disclosure of U.S. Pat. No. 6,005,161 is incorporated by reference in its entirety herein.
• The components of the present invention may be sterilized by any of the well known sterilization techniques, depending on the type of material. Suitable sterilization techniques include heat sterilization, radiation sterilization, such ascobalt60 irradiation or electron beams, ethylene oxide sterilization, and the like.
• The specific dimensions of any of the bone fixation devices of the present invention can be readily varied depending upon the intended application, as will be apparent to those of skill in the art in view of the disclosure herein. Moreover, although the present invention has been described in terms of certain preferred embodiments, other embodiments of the invention including variations in dimensions, configuration and materials will be apparent to those of skill in the art in view of the disclosure herein. In addition, all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein. The use of different terms or reference numerals for similar features in different embodiments does not imply differences other than those which may be expressly set forth. Accordingly, the present invention is intended to be described solely by reference to the appended claims, and not limited to the preferred embodiments disclosed herein.

Claims (16)

1. A femoral neck fracture fixation device, comprising:

an elongate body, having a proximal end and a distal end and comprising a first portion and a second portion that are detachably coupled to each other at a junction;

a helical anchor on the distal end;

a retention structure on the body, proximal to the anchor; and

an anti-rotational structure on the first portion of the body,

a proximal anchor, moveably carried by the body and comprising a tubular sleeve that in a first position extends distally past the junction between the first portion and the second portion,

wherein the proximal anchor is movable in the distal direction with respect to the body, the retention structure resists proximal movement of the proximal anchor with respect to the body and the anti-rotational structure prevents rotational movement of the first portion of the body with respect to the proximal anchor.

2. A femoral neck fracture fixation device as inclaim 1, wherein the first retention structure comprises a series of ridges or grooves.

3. A femoral neck fracture fixation device as inclaim 2, further comprising a second retention structure on the interior of the tubular sleeve for cooperating with the first retention structure on the body.

4. A femoral neck fracture fixation device as inclaim 3, further comprising a transverse flange extending radially outwardly from the tubular sleeve.

5. A femoral neck fracture fixation device as inclaim 4, wherein the flange is angularly moveable with respect to a longitudinal axis of the tubular sleeve.

6. A femoral neck fracture fixation device as inclaim 1, further comprising a rotational coupling on the second portion of the body.

7. A femoral neck fracture fixation device as inclaim 1, further comprising a rotational coupling on the proximal anchor.

8. A femoral neck fracture fixation device as inclaim 1, further comprising a first threaded portion on a proximal portion of the first portion and a second threaded portion on a distal portion of the second portion, the first threaded portion and the second threaded portion configured to detachably couple the first and second portions to each other at a junction.

9. A bone fracture fixation device, comprising:

an elongate body, having a proximal end and a distal end and comprising a first portion and a second portion that are detachably coupled to each other at a junction;

a bone anchor on the distal end;

a proximal anchor, moveably carried by the body and comprising a tubular sleeve that in a first position extends distally past the junction between the first portion and the second portion,

complimentary surface structures in between the first portion of the body and the proximal anchor that permit advancing the proximal anchor in the distal direction to tighten the fixation device but that resist axial proximal movement of the proximal anchor and prevent rotational movement between the first portion and the proximal anchor.

10. A method of treating a femoral fracture, comprising the steps of:

drilling a bore distally into the femur in the direction of a fracture;

advancing into the bore a fixation device that comprises a body having a first portion that forms a cancellous bone anchor and a second portion that forms a proximal end;

rotating a proximal anchor of the fixation device so to engage the cancellous bone anchor with bone tissue distal of the femoral fracture; and

advancing the proximal anchor distally along the fixation device to compress the fracture.

11. A method of treating a femoral fracture as inclaim 10, wherein the drilling step comprises drilling the bore along an axis which extends through the femoral neck and into the head of the femur.

12. A method of treating a femoral fracture as inclaim 10, wherein the advancing step comprises advancing a fixation device wherein the cancellous bone anchor comprises a helical anchor and the first portion includes a plurality of retention structures proximal to the helical anchor for engaging the proximal anchor.

13. A method of treating a femoral fracture as inclaim 10, wherein the advancing a proximal anchor step comprises axially advancing the proximal anchor without rotating the proximal anchor with respect to the fixation device.

14. A method of treating a femoral fracture as inclaim 10, wherein the fracture is a femoral neck fracture, an intertrochanteric fracture or a subtrochanteric fracture.

15. A method of treating a femoral fracture as inclaim 10, further comprising separating and removing the second portion from the first portion.

16. A method of treating a femoral fracture as inclaim 15, wherein separating and removing the second portion from the first portion comprises rotating the second portion with respect to the first portion.

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