Orthopaedic trauma bone plate kit

A kit for the construction of a bone plate assembly for fixation of a fractured bone is provided. The kit includes a plurality of plate members, a connecting member for retaining the plurality of plate members in a desired configuration and a plurality of locking members for securing the plate members to the connecting member.

FIELD

This application relates generally to the field of orthopedics, and more specifically to bone plates and systems for stabilization and compression of fractured or otherwise damaged bones. This application is related to U.S. patent application Ser. No. 11/527,951, filed Sep. 27, 2006 and titled “Flexible Bone Fixation Device”, and which is hereby incorporated herein by reference in its entirety.

BACKGROUND

Bone plates for internal fixation of fractured bones should generally conform to the contours of the fractured bone surface. This is especially true for compression plates that are screwed tightly against the bone. Matching the plate shape to the bone contours is important with compression plates in order to allow proper distribution of loads between the bone and the plate during healing of the fracture. It is also desirable for the plate to have a low profile and to blend with the bone surface as much as possible so as not to irritate or interfere with surrounding soft tissues, nerves, tendons, vessels, etc.

One type of bone plate for acetabular and other pelvic fractures is called a reconstruction bar. Conventional reconstruction bars are generally formed from a biocompatible metal that may be bent by the surgeon using special tools in order to configure the bar to conform to the bone. Typically the surgeon first forms a thin metal template by hand to conform to the bone surface at the fracture site. Working through an open incision, the surgeon bends the template to approximate the desired shape, places the template against the bone surface, removes the template, adjusts the shape of the template and repeats these steps until the template closely matches the shape of the bone surface. Then the surgeon, sometimes with the help of an assistant, uses a number of special forming tools to bend the reconstruction bar to be implanted into approximately the same configuration as the template, visually holding the bar and template side-by-side to assess when the bar is adequately similar to the template. This procedure may take several minutes of time and a significant amount of skill. The bar may then be attached to the bone using conventional cortical screws. It is not likely that the bar shape exactly matches the bone surface shape, so tightening of the bone screws may draw the bar against the bone surface, thereby inducing bending preloads at various locations along the bar due to the spring-back characteristic of the bar material. Alternatively, the bar may be implanted with significant gaps between various locations of the bar and the bone surface, resulting in the uneven transfer of loads between the bone and bar construct. Therefore, it would be advantageous to provide a reconstruction bar that may be implanted more quickly by the surgeon, requires fewer ancillary tools, is more conformable and contoured to the bone surface and is at least as effective as a fixation device compared to conventional reconstruction bars.

Another issue currently faced by orthopedic device manufacturers is the need to provide a full line of bone plates for a large variety of bone fractures and patient anatomies. The manufacturing costs associated with forming each rigid, one-piece bone plate is significant due largely to the need to configure the plate to approximately match the bone surface shape. Furthermore, a large product inventory must be provided to the user (hospitals) to be prepared for the many types of fractures and patient anatomies to be treated. Accordingly, it would be advantageous to provide bone plates that have broader indications, where each plate may be suitable for a larger variety of fractures and patient anatomies than currently available plates. Potentially, such bone plates may be produced at lower costs than current plates and inventories reduced without compromising surgical outcomes.

What is also needed is a bone fixation device and method such as described above (may be implanted quickly, requires fewer ancillary tools, is at least as effective as a fixation device compared to conventional fixation devices) that may be configured to conform to a broad, contoured bone surface. The fixation device may, for example, reduce the need to use multiple bone plates for particular types of fractures, including comminuted acetabular fractures (see Chapter 20 of Orthopaedic Surgery Essentials: TRAUMA, published by Lippincott Williams and Wilkins, 2006).

There is also a need to provide surgeons with devices and methods to create custom, bone fixation devices intraoperatively for less common types of bone fractures, and generally to provide recourse in cases in which conventional bone plates are unavailable.

SUMMARY

According to an embodiment of the present invention, a kit for the construction of a bone plate assembly for fixation of a fractured bone is provided. The kit includes a plurality of plate members, a connecting member for retaining the plurality of plate members in a desired configuration, and a plurality of locking members for securing the plate members to the connecting member.

According to one aspect of the kit, the plurality of plate members include at least two plate members.

According to another aspect of the kit, the locking members are bone screws. Each plate member includes at least one opening for retaining one of the bone screws such that the bone screws may securely attach the bone plate assembly to the fractured bone.

According to another aspect of the kit, the connecting member is flexible.

According to yet another aspect of the kit, the connecting member securely retains the plurality of plate members in a first arrangement wherein each of the plurality of plate members is moveably orientable with respect to each other such that the bone plate assembly may generally conform to the surface of the fractured bone, and wherein the locking member may fixedly secure the plate members to the connecting member in a second arrangement such that the bone plate assembly is sufficiently rigid to provide fixation of the fractured bone.

According to yet another aspect of the kit, the connecting member includes a plurality of flexible members. In the first arrangement the plurality of plate members are loosely retained on the connectors such that the flexible members may move longitudinally relative to each other, and in the second arrangement plate members are clamped tightly onto the connectors such that the flexible members are not permitted to move substantially relative to each other.

According to another aspect of the kit, each of the plurality of plate members includes a groove for receiving the connecting member.

According to yet another aspect of the kit, the plate members define a bone contacting surface and the connecting member defines a longitudinal axis of the member. The plate members also define a first dimension perpendicular to the bone contact surface and the longitudinal axis, and a second dimension parallel to the bone contact surface and the normal to the longitudinal axis, the first dimension is greater that the second dimension.

According to another aspect of the kit, the first dimension is at least twice as large as the second dimension.

According to yet another aspect of the kit, the connecting member includes a first portion, a second portion spaced from the first portion and a retainer to retain the first portion and the second portion in a spaced apart relationship.

According to another aspect of the kit, a first of the plurality of plate members defines a surface thereof, a second of the plurality of plate members defines a surface for contact with the surface of the first plate member, and the surface of the first plate member and the surface of the second plate member provide planar contact with each other.

According to yet another aspect of the kit, the plurality of plate members include a first plate member having a first shape and a second plate member having a second shape, the second shape is different than the first shape.

According to yet another aspect of the kit, the plurality of plate members include a first plate member and a second plate member, the first plate member defines a first bone contacting surface and the second plate member defines a second bone contacting surface. The first bone contacting surface and the second bone contacting surface lie in different planes.

According to another aspect of the kit, the kit further includes a second connecting member for securing the plurality of plate members to each other. The second connecting member is spaced from the first mentioned connecting member.

According to yet another aspect of the kit, the kit further includes a tray for containing the plurality of plate members, the locking members and the connecting member prior to use.

According to another aspect of the kit, the plurality of plate members include a first plate member and a second plate member, positionable adjacent the first plate member. The first plate member and the second plate member define a longitudinal axis of the plate members. The plurality of plate members also include a third plate member adjacent the first plate member and extending from the first plate member in a direction skewed with respect to the longitudinal axis of the first plate member and the second plate member.

According to yet another aspect of the kit, the kit further includes a fourth plate member adjacent the first plate member and extending from the first plate member in a direction skewed with respect to the longitudinal axis of the first plate member and the second plate member.

According to another embodiment of the present invention, a kit for use in trauma surgery for cooperation with a bone is provided. The kit includes a first plate member having a first shape and a second plate member having a second shape. The kit also includes a connecting member for securing the plurality of plate members to each other. The second shape is different than the first shape.

According to an aspect of the kit, the first plate member defines a first bone contacting surface and the second plate member defines a second bone contacting surface. The first bone contacting surface and the second bone contacting surface lie in different planes.

According to yet another aspect of the kit, the connecting member may be fixedly secured to the plurality of plate members in a first arrangement wherein each of the plurality of plate members is moveably orientable with respect to each other and in a second arrangement in which each of the plurality of plate members is rigidly secured to each other.

According to yet another embodiment of the present invention, a method of stabilizing a damaged bone is provided. The method includes the steps of providing a kit of including a tray for storing a plurality of plate members and at least one connection, at least two of the plate members having different shapes and selecting at least one plate member from the plurality of plate members and at least one connection member from the plurality of connection members. The method also includes the steps of assembling the selected at lease one plate member to the selected one connection member, placing the assembled plate and connection member against the damaged bone, and locking the plate to the connection member.

According to another embodiment of the present invention, a kit for the construction of a bone plate assembly for fixation of a fractured bone is provided. The kit includes a plurality of plate members and a flexible track for retaining the plurality of plate members in a desired configuration. The kit also includes a plurality of locking members for securing the plate members to the connecting member.

According to an aspect of the kit, the track includes a flexible retainer containing a grouping of a plurality of flexible members. The track has at least one free end.

According to another aspect of the kit, the flexible members are formed from a malleable material, such that a surgeon may shape the track into an implant configuration to conform to the fractured bone surface. Each of the plurality of plate members may be assembled to the flexible track while the flexible track is in the implant configuration.

The technical advantages of the present invention include the ability to easily shape plates without bending tools to match contours of broad bone surfaces such as on the pelvis, thereby improving fixation and reducing surgical procedure time

The technical advantages of the present invention further include potential reduction of bone plate manufacturing costs and required inventory

The technical advantages of the present invention further include the ability to create a wide variety of custom plates intraoperatively for less common fractures or for when conventional bone plates are not available.

The technical advantages of the present invention further include a reduction in the need to use multiple bone plates for certain types of comminuted fractures.

Other technical advantages of the present invention will be readily apparent to one skilled in the art from the following figures, descriptions and claims.

Corresponding reference characters indicate corresponding parts throughout the several views. Like reference characters tend to indicate like parts throughout the several views.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the present invention and the advantages thereof are best understood by referring to the following descriptions and drawings, wherein like numerals are used for like and corresponding parts of the drawings.

Referring now toFIG. 1a bone plate assembly100according to the present invention is shown. The bone plate assembly100is utilized in trauma surgery for cooperation with a bone. For example, the bone plate assembly100may be utilized to form bone plate assembly102.

As shown inFIG. 1, the bone plate assembly100includes a first plate member104. The first plate member104may have been a suitable shape and may as shown inFIG. 1, have a shape suitable for contact with a condylar portion of a bone2. For example, the first plate member104may have a generally truncated triangular shape such that the contact surface106of the plate member104may conform to a condylar portion of a bone.

The bone plate assembly100may further include a connecting member108for securing the plate members to each other. For example, as shown inFIG. 1, a first connecting member108may extend from end110of the first plate member104. The first connecting member108may be secured to the first plate member104in any suitable fashion. For example, the first connecting member108may be interferencely fitted into opening112formed in first plate member104. Alternatively, the first connecting member108may be welded or threadably attached to the first plate member104.

Plate member, for example the first plate member104may be made of any suitable durable material. For example, the first plate member104may be made of a durable plastic, a composite material or a metal. The material of which the first plate member104is made is preferably compatible with the human anatomy and if made of a metal, the material may be, for example made of a stainless steel alloy, a titanium alloy, or a cobalt chromium alloy.

For simplicity and as shown inFIG. 1, the bone contacting surface101may be a planar surface. To better conform to bone, the bone contact surface106may be arcuate and may be generally concave to mate with a generally convex periphery of, for example, a long bone.

The first connecting member108may include, for example, a plurality of flexible elements that are formed, for example, from a biocompatible material such as 316L stainless steel, titanium, titanium alloy or any one of numerous polymers known in the art. The material of the flexible element may be malleable or spring-like. The flexible elements may be held together in a grouping such that the flexible elements may slide longitudinally relative to each other unless clamped tightly together by second plate member116, whereby the clamped portion of connector108becomes relatively stiff. As described in the referenced patent application, the flexible elements may be clamped together to exhibit a beam stiffness that withstands a predetermined threshold force, thereby forming a suitably rigid construct for fixation of a fractured bone.

While the present invention may be practiced with a solitary connecting member108, as shown inFIG. 1, the bone plate assembly100may further include the second connecting member114. The second connecting member114is secured to first plate member104. The second connecting member114may be made of a similar material and may be of a similar size to that of the first connecting member. The second connecting member114may be connected to end110of the first member104by, for example, a connection112in the form of an interference fit, a threaded connection or by a weldment.

As shown inFIG. 1, the bone plate assembly100further includes a second plate member116. The second plate member116may be made of any suitable durable material and may for example be made of a metal. If made of a metal, the second plate member116may be made of, for example, cobalt chromium alloy steel, a stainless steel alloy or titanium alloy steel.

The first connecting member108and the second connecting member114may be, as shown inFIG. 1, formed from a flexible material. By making the first connecting member108and the second member114from a flexible material, the connecting members108and114may be positioned along the contour of the bone for which the bone plate assembly100is to be used. If the first connecting member108and second connecting member114are formed from a malleable material, they may be shaped like a template to generally match the contour of the bone surface. If the connecting members108and114are formed from a spring-like material, bone plate assembly100may tend to lift away from the bone surface until all the bone screws are inserted and tightened.

It should be appreciated that the connecting members108and114may include any of a possible number of arrangements of flexible elements. For example, the connecting members may be in the form of a circular bundle arrangement and a vertical stack arrangement. The flexible connecting members108and114may be provided with a length to build a plate assembly that is more than sufficient for the majority of surgical trauma needs. While the bone plate assembly100may include merely the connecting members108and114, the first plate member104and the second plate member116, it should be appreciated that additional plate members may be assembled onto the connecting members108and116to provide a bone plate assembly102of any of numerous lengths and configurations.

The second plate member114may be assembled onto the first connecting members108and the second connecting members114by advancing the second plate member in the direction of arrow118. For example, the first connecting member108may be slidably fitted through first channel120formed in the second plate member while similarly, the second connecting member114may be slidably fitted through second channel122formed in the second plate member116. The second plate member116is advanced in the direction of arrow118until the second plate member116is advanced to second position or assembled position124shown in phantom with the second plate member116in position against end110of the first plate member104.

Referring now toFIGS. 2 through 6, the second plate member116is shown in greater detail. The second plate member116is configured to permit the second plate member116to slidably move along the first connecting member108and the second connecting member114. It should be appreciated that the second plate member116may have a construction that is typical for all plate members that are to be fitted onto the first connecting member108and the second connecting member114of the bone plate assembly102ofFIG. 1.

Referring now toFIG. 2the second bone plate116includes the first channel120and the second channel122to permit the sliding movement of the connecting of the second plate member116along the connecting members120and122

The second plate member116as shown inFIGS. 2 through 6is adapted to have two configurations. In a first configuration the plate member116may slide along the connecting members. In a second configuration the plate member116is fixedly secured to the connecting members. To provide the two arrangements, the second plate member116may be constructed of two components.

For example, as shown inFIG. 2, the second plate member116includes a lower plate portion126and an upper plate portion128. In the first configuration, the upper plate portion128is permitted to move slightly with respect to the lower plate portion126such that the connecting members108and114may slide along the channels120and122. The upper plate portion128is secured to the lower plate portion126by, for example, a first plate rivet130and a spaced apart second plate rivet132. The first plate rivet130is fitted into first rivet opening134while the second plate rivet132is fitted into second rivet opening136. The openings134and136are formed in the lower plate portion126and in the upper plate portion128of the second plate member116.

The second plate member116may include a plate fastener opening138for receiving bone screw140for securing the second plate member116to bone2. The opening138is formed in the lower plate portion126and in the upper plate portion128of the second plate member116. The bone screw140may be in the form of a cancellous screw or a cortical screw.

Referring now toFIGS. 3 through 6, second plate member116is shown in greater detail. Referring now toFIG. 3, the channel, for example first channel120, defines a channel height CH. The upper plate portion128and the lower plate portion126define a space or gap having a gap width GW. The first connecting member108defines a connecting member diameter CD. It should be appreciated that if the connecting member diameter CD of the connecting member108has a dimension larger than the channel height CH when the lower plate portion126and the upper plate portion128are urged into contact in second configuration, the upper plate portion128and lower plate portion126will squeeze or hold the connecting member108in the channel120.

Alternatively, when the lower plate portion126and the upper plate portion128are spaced apart, the gap width GW and the channel height CH are greater than the connecting member diameter CD of the connecting member108. In this first configuration, the second plate member116is able to move in the direction118along the connecting members108and114.

Referring now toFIGS. 5 and 6, the second plate member116includes the fastener opening138. The fastener opening138cooperates with the fastener140to cause the upper plate portion128to move toward lower plate portion126to fixedly secure the second plate member116to the connecting members108and114. The fastener opener138includes a counter bore142that matingly fits and holds head144of the bone fastener140. The fastener opener138further defines internal threads146formed in lower plate portion126. The internal threads146mate with external threads148formed on bone fastener140. As the bone fastener140is advanced through the fastener opening138, the external threads148on the bone fastener140cooperate with internal threads146on the lower plate portion128of the second plate member116to draw the upper plate portion128against the lower plate portion126to secure the second plate member116to the connecting members108and114.

It is also possible to provide bone screw140with two threaded portions (not shown), wherein a first threaded portion engages the bone and a second threaded portion engages internal threads146of second plate member116. With this arrangement, the type of thread of each threaded portion may be individually adapted to the desired application.

Referring now toFIGS. 7 through 13, additional plate members for use with the bone plate assembly100are shown. For example and referring now toFIG. 7, a third plate member150is shown. The third plate member150includes channels and a bone screw opening similar to that of the second plate member116. The third plate member150includes parallel opposed first sides152as well as a second side set of opposed sides154which are not parallel with each other. By providing the third plate member150, the bone plate assembly102may be configured to have a longitudinal axis that is not linear.

Referring now toFIG. 8, yet another plate member for use in bone plate assembly102is shown as fourth plate member156. The fourth plate member156has a pair of channels and a bone screw opening similar to that of the second plate member114and includes a first set of parallel sides158as well as a third and fourth opposed set of sides160which are not parallel.

Referring now toFIG. 9, yet another plate member is shown as fifth plate member162. The fifth plate member162includes a side164which is curved or arcuate. The arcuate surface164may be utilized at the end of distal portion of the bone plate assembly102.

Referring now toFIG. 10a plate member with yet another shape is shown as sixth plate member166. The sixth plate member166has a shape generally that of a parallelogram.

Referring now toFIG. 11yet another plate member is shown as seventh plate member168. The seventh plate member168is generally L-shaped and includes an opening170in a bone portion172that extends outwardly or beyond the channels174of the seventh plate member168.

Referring now toFIG. 12yet another plate member is shown as eighth plate member176. The eighth plate member176includes two spaced apart bone screw openings and is rectangular.

Referring now toFIG. 13yet another plate member is shown as ninth plate member178which includes opposed wings180.

FIG. 14shows the completed bone plate assembly102, in which the second plate member116abuts against first plate member104such that a minimal length of connectors108and114are exposed, thereby maximizing the rigidity of the assembly. Another plate member, for example fourth plate member156ofFIG. 8, is positioned tightly against second plate member116. An additional plate member, for example another second plate member116, is positioned against fourth plate member156. A tenth plate member182having a configuration which is a mirror image of that of a fourth plate member156may be positioned against second plate member116. For example third plate member150may be positioned against the tenth plate member180. Finally, fifth plate member162having the arcuate portion164may be positioned against third plate member150. The seven plate members shown inFIG. 14are urged against each other and the excess portions183of the first connector108and second connector114are preferably removed by, for example, a conventional surgical wire cutting tool (not shown) such that a unitary bone plate or a rigid bone plate assembly102is provided.

Referring now toFIG. 14Aa poly-axial screw assembly140A is shown. The poly-axial screw assembly140A may be used as a substitute to bone screw140or may be used in addition to bone screw140. A single assembly140A may be used or a plurality of assemblies140A may be positioned as desired on the plate assembly102. The assembly140A includes a bushing137A with a spherical periphery138A that swivels in a spherical pocket139A formed in plate member104A. The bushing137A is split and expands to lock screw142A into any one chosen of a multitude of angles by a tapered threaded head141A on screw142A with engages tapered threads143A formed in hole145A in bushing137A. A more thorough description of a poly-axial bushing may be found in U.S. Pat. No. 5,954,722 to Bono and in US Patent Application Publication No. 2005/0049594 to Wack et al., both hereby incorporated by reference in their entireties.

Referring now toFIGS. 15 and 16, the bone plate assembly102is shown inFIG. 15in a first configuration184in which adjacent bone plate members are spaced from each other in this configuration the bone plate may be conformed to the shape of the bone. The first configuration184may have the necessary rigidity to form a stable, fixation construct on the fractured bone, although the rigidity of bone plate assembly102as shown inFIG. 15depends largely on the material and design of connectors108and114. Referring now toFIG. 16the bone plate assembly102is shown in a second configuration186. In second configuration186adjacent plate members are positioned in abutment or close proximity to each other such that the individual bone plates together with the connection members provide for a rigid construction to support the bone.

Referring now toFIG. 16A, alternate fasteners to bone screw140ofFIG. 6Aare shown. It should be appreciated that the bone screw140may be substituted by poly-axial cancellous bone screw assembly140B, by poly-axial bone pin assembly140C, by locked bone pin140D, by locked cortical bone screw140E, by locked cancellous bone screw140F, by un-locked cortical bone screw140G, by un-locked cancellous bone screw140H.

Continuing to refer toFIG. 16A, it should be appreciated that small holes may be placed in the bone plate104ofFIG. 1to receive, for example, guide pins, for example, guide pin140J.

Referring now toFIG. 16B, it should further be appreciated that the bone plate104ofFIG. 1may utilize bushing that may be placed in the opening of the plate104to receive drills and reamers to prepare the holes for receiving the bone screws and the bone pins. For example a bushing151A may be threadably engaged by threads153A to bone plate104B to guide a drill (not shown). A more thorough description of a guide bushing may be found in US Patent Application Publication No. 2006/0149250 to Castaneda et al., hereby incorporated by reference in its entirety.

FIG. 17shows a bone plate assembly kit101from which components may be selected for assembling the bone plate assembly100ofFIG. 1. Kit101includes a tray188similar to those known in the art for organizing orthopaedic devices to be used in a specific surgical procedure. Tray188and its components may be constructed of materials that can withstand many cycles of steam autoclave sterilization.

As shown inFIG. 17, the kit101may include the first plate member104. It should be appreciated that a plurality for example two first plate members104may be included in the kit101. It should also be appreciated that the additional plate members, for example second plate member116, may be included in the kit101and, for example, a plurality, for example, two second plate members116may be included in the kit101. Similarly the kit101may include one or more third plate members150, fourth plate members156, fifth plate members162, sixth plate members166, seventh plate members178, eighth plate members176, as well as, ninth plate members178. It should be appreciated that tenth plate member182may also be included in the kit, as well as additional plate members, for example plate members179and181. It should be appreciated as shown inFIG. 17, that first connector member108and second connecting member114may be of sufficient length to accommodate the longest possible bone plate assembly that reasonably may be needed by the surgeon to perform trauma surgery. The kit101may also include bone screws140for use with the plate members. It should be appreciated that the bone screws140may all be of the type ofFIG. 6Aand may be of varying lengths and sizes to accommodate different bones and different portions of bone. Further it should be appreciated that the bone screws may be of other types such as those shown inFIG. 16A

While the bone plate assembly100ofFIGS. 1 to 17is well suited for bone plates where the bone contact surface of bone2is generally planar, it should be appreciated that bone plates to accommodate bones that cover a plurality of planes is desired. Such bones may include the shaft and condylar portions of long bones and bones with irregular shapes, for example bones associated with the pelvis.

For example, and is shown inFIGS. 18 and 19yet another embodiment of the present invention is shown as bone plate assembly200. The bone plate assembly200is utilized to prepare a bone plate assembly202which provides for bone contact surfaces on a plurality of planes.

For example,FIG. 18shows a bone plate assembly200that uses components from the kit101. For example, the bone plate assembly200may include first plate member104from the kit101. The first plate member104includes the first connecting member108as well as the spaced apart second connecting member114. Additional bone plate members may be assembled in sequence onto the connecting members108and114by feeding the connecting members108and114through the channels formed in the plate members. If connecting members108and114are formed from a malleable material, they may pressed against the bone surface and hand-shaped to match the contours of the bone surface, then removed from the bone surface so that the plate members may easily be slid onto them in the proper sequence. The loose assembly may then be positioned on the bone surface and attached to the bone with the bone screws. As each bone screw is tightened, the respective plate member clamps tightly onto the connectors to stiffen that portion of the bone plate assembly.

As shown inFIG. 18, the second bone plate116may be positioned adjacent first plate member104. Similarly as to the plate102of the kit101ofFIGS. 1 through 17, the bone plate assembly200ofFIGS. 18 and 19is utilized by positioning the first connecting member108and the second connecting member114along the bone2. The malleable connecting members108and114are positioned adjacent to bone such that when the plate member114is assembled onto the connecting members108and114, the plate member closely conforms to the bone.

The bone plate assembly200as shown inFIG. 18further includes a first non-planar plate member290which includes first and second parallel faces292as well as non-parallel faces294. The first non-planar plate member290is positioned against second plate member116. A second non-planar plate member296is positioned adjacent the first non-planer plate member290. An additional second plate member116is positioned adjacent the second non-planar plate member296. An additional second non-planar plate member296is positioned adjacent the second place member116. Similarly a second first non-linear plate member290is positioned adjacent the second non-planar plate member296. A fifth planer member162is positioned adjacent the first non-planar plate member292for the plate assembly202ofFIG. 18.

After the fifth plate member162is positioned adjacent the first non-planar plate member290, the additional portions183of the first connecting member108and the second connecting member114are removed by for example a surgical wire cutting tool which trims off the excess of the flexible member that extends beyond the plate member162.

Referring now toFIG. 19the second non-planar locking plate member296is shown in greater detail. The plate member296includes a bone fastener opening238for receiving for example bone fastener140. The plate member296further includes first rivet opening234that receives first rivet230, as well as second rivet opening236that receives second rivet232. The plate member296further includes first channel220, as well as spaced apart second channel222. The plate member296further includes first and second parallel sides252, as well as non-parallel sides254. The non-parallel sides254include a side255which is not perpendicular with bone contact surface206of the plate member296.

While the plate assembly202of the bone plate assembly200ofFIGS. 18 and 19and the bone plate assembly100ofFIGS. 1 through 17may be suitable for many bone fractures, for those situations in which the area in both the X direction and Y direction for the fracture is large a bone plate may be necessary with greater width and yet, considerable length. Such a situation may occur in a fracture of the pelvis.

Referring now toFIGS. 20 through 25, another embodiment of the present invention is shown as a bone plate assembly300, which may provide three-dimensional fixation of a fracture on a broad, contoured surface of a bone such as the ilium.

For example, and as shown inFIG. 20, the bone plate assembly300may include a first bone plate301a second bone plate303, and a third bone plate305connected to the second bone plate303. The kit also includes a fourth bone plate307connected to the first bone plate301, a fifth bone plate309connected to the fourth bone plate307, a sixth bone plate311connected to the fifth bone plate309, and a seventh bone plate313connected to the sixth bone plate311.

The bone plate assembly300may further include an eighth bone plate315connected to the first bone plate301, a ninth bone plate317connected to the eighth bone plate315, a tenth bone plate319connected to the ninth bone plate317and an eleventh bone plate321connected to the tenth bone plate319. The bone plate assembly300may further include a twelfth bone plate323connected to the first bone plate301and a thirteenth bone plate325connected to the third bone plate305. The bone plate assembly300may further include a fourteenth bone plate327connected to the twelfth bone plate323, a fifteenth bone plate329connected to the fourteenth bone plate327and a sixteenth bone plate331connected both to the thirteenth bone plate325and the fifteenth bone plate329. The bone plate assembly300may further include a seventeenth bone plate333connected to the fourteenth bone plate327. While the bone plate assembly300may be made, as shown inFIG. 20, of planar plate members, it should be appreciated that non-planar members, such as the plate member296ofFIG. 19, may be used with the bone plate assembly300.

Referring now toFIG. 21, the plate assembly302is shown attached to an ilium8of a patient. It should be seen that the plate assembly302may follow a plurality of planes to conform to the contour of the ilium8or other broad bone surfaces.

The bone plate assembly300like the bone plate assembly200ofFIGS. 18 and 19and the bone plate assembly100ofFIGS. 1-17may include components of the bone plate assembly200and the bone plate assembly100. The bone plate assembly300may for example include bone screws140as well as rectangular bone plates116. The bone plate assembly300includes bone plates to provide for connection of bone plates both in a line and in a second line normal to the first line to form a grid of bone plates.

For example and as shown inFIGS. 22 and 23, the bone plate assembly300may include an X type bone plate341. The bone plate member341, as shown inFIGS. 22 and 23includes first channel320, as well as spaced apart second channel322. The plate member341may further include a first connector343which extends from plate member341.

The plate member341may further include a second connector345spaced from and parallel to the first connector343. The first connector343and second connector345are perpendicular to the first channel320and the second channel322to form a rectangular grid for the assembling of plate members. The plate member341may further include a third connector347extending from the plate member341in a direction opposed to first connector343. Similarly the plate member341may further include a fourth connector349extending from the plate member341in a direction opposed to the second connector345.

The plate member341, similarly to the plate member160ofFIG. 2, may include a first rivet330and a spaced apart second rivet332. The first rivet330fits into first rivet opening334while the second rivet332fits into second rivet opening336. The plate number342further includes a fastener opening338for use with plate fastener140.

Referring now toFIG. 24yet another plate member for use with the bone plate assembly300is shown as T shaped plate member351. The T shaped plate member351includes a first channel353and a spaced apart second channel355. The plate member351further includes a first connector357positioned perpendicular to first channel353and a second connector359extending from the plate member351in a direction parallel to first connector357. The T shaped plate member351further includes a bone fastener opening361for receiving the bone screw140.

Referring now toFIG. 24Athe bone plate assembly300may further include solitary connectors363for use with the bone plate assembly300.

Referring again toFIG. 20, the plate assembly302may be assembled in various orders. For example, the third plate member305, which may be in the form of T shaped plate member351as shown inFIG. 24, is utilized. The second plate member303which may be in the form of plate member116ofFIG. 2is assembled against third plate member305by inserting the first connector357and the second connector359of the first plate member305into the channels in the second plate member303.

Next, the first plate member301is connected to the second plate member303. The first plate member301may be in the form of an X plate member341, as shown inFIG. 22. The first plate member301is assembled to the second plate member303by inserting the first connector357and the second connector359into the channel320and322of the X plate member301. The fourth plate member307, which may be in the form of116ofFIG. 2, is assembled against first plate member301by positioning the first connector357and the second connector359into the channels of the fourth plate member347.

Next, the fifth plate member309, which may be in the form of plate member156ofFIG. 8, is positioned in fourth plate member307. The first connector357and the second connector359are inserted into channels formed in fifth plate member309. Next, the sixth plate member311is secured against fifth plate member309. The sixth plate member311may be in the form of plate member150ofFIG. 7. The sixth plate member311is secured to the fifth plate member309by positioning the first connector357and the second connector359into the channels formed in the sixth bone plate311.

Next the seventh bone plate313, which may be in the form of bone plate162ofFIG. 9, is secured against sixth bone plate311by inserting the first connector357and the second connector359into channels formed in the seventh bone plate313. Next, the eighth bone plate315is secured to the first bone plate301. The eighth bone plate315may be in the form of bone plate116ofFIG. 2. The bone plate315is secured to the first bone plate311by inserting the first connector343and the second connector345into channels formed in the bone plate315.

Next the ninth bone plate317is secured to the eighth bone plate315. The ninth bone plate317may be in the form of T plate member351as shown inFIG. 24. The ninth bone plate317is secured to the eighth bone plate315by inserting the first connector343and the second connector345into the channels formed in the bone plate300ninth bone plate317. Next the tenth bone plate319is secured to the ninth bone plate317. The tenth bone plate319may be in the form of bone plate316ofFIG. 2. The tenth bone plate319is secured to the ninth bone plate317by inserting the first connector357and the second connector359into the channels formed in the tenth bone plate319. Next, the 11th bone plate321which may be in the form of plate116ofFIG. 2is secured to the tenth bone plate319by inserting the first connector357and the second connector369into cavities into channels formed in 11th bone plate321.

Next the twelfth bone plate is secured to the first bone plate301. The twelfth bone plate323may be in the form of bone plate116ofFIG. 2. The twelfth bone plate323is secured to the first bone plate311by inserting the third connector347and the fourth connector349into channels formed in the twelfth bone plate323. Next, the fourteenth bone plate is connected to the fifteenth bone plate. The fourteenth bone plate327may be in the form of a T shaped bone plate351seeFIG. 24. The fifteenth bone plate329may be in the form of bone plate116ofFIG. 2. The fifteenth bone plate329is secured to the fourteenth bone plate327by inserting the first connector343and the second connector345into channels formed in fifteenth bone plate329. The sixteenth bone plate331may then be secured to the fifteenth bone plate329.

The sixteenth bone plate331may be in the form of a T shaped plate member351as shown inFIG. 24. The sixteenth bone plate331is connected to the fifteenth bone plate329by inserting first connector343and second connector345into channels formed in the sixteenth bone plate331. Next, the seventeenth bone plate333is connected to the fourteenth bone plate327. The seventeenth bone plate333may be in the form of bone plate116as shown inFIG. 2. The seventeenth bone plate333is connected to the fourteenth bone plate327by inserting third connector347and fourth connector349into channels formed in seventeenth bone plate333.

The thirteenth bone plate is next connected to the sixteenth bone plate331. The thirteenth bone plate325may be in the form of bone plate116ofFIG. 2. The thirteenth bone plate325is secured to the sixteenth bone plate116by inserting fifth first connector357and second connector359into channels formed in thirteenth bone plate325. Next, the assembly of the 13th, 14th, 15th, 16th, and 17thbone plates is inserted into the assembly of the remaining bone plates by inserting the first connector357and the second connector359into channels formed in third bone plate member305and inserting connectors347and349into channels formed in fourteenth bone plate327.

FIG. 25shows a kit301including a tray388containing all the components that may be used for bone assembly300. As for kits201and301, kit301may be customized to provide the necessary components for specific types or classes of bone fracture repairs, and may be constructed of materials suitable for steam autoclave sterilization. The kit301may also include bone screws140for use with the plate members. It should be appreciated that the bone screws140may all be of the type ofFIG. 6Aand may be of varying lengths and sizes to accommodate different bones and different portions of bone. Further it should be appreciated that the bone screws may be of other types such as those shown inFIG. 16A.

According to the present invention and referring now toFIG. 26yet another embodiment is shown as bone plate assembly400. The plate assembly402as shown inFIG. 26includes a first plate member404to which a flexible track405is secured. The flexible track405extends outwardly from end410of the first plate member404. The flexible track405includes a first connector408and a second spaced apart connector414. The first connector408and the second connector414are contained by a webbed retainer407. The webbed retainer407and the first connector408and second connector414form the flexible track405.

The webbed retainer407may be formed from an implantable polymer that can withstand repeated cycles of a steam autoclave.

The webbed retainer407encapsulates the first connecting first connector408and the second connector414. The retainer407may encapsulate the first connector408and the second connector414by, for example, an extruding process. Alternatively the first connector408and the second connector414may be heat-welded between layers of a polymeric film or between opposite sides of a flattened, thin wall, polymeric tube. Preferably, webbed retainer407loosely encapsulates connectors408,414to permit sliding movement of the flexible members comprising each of the connectors, as in the previous embodiments, until clamped between the plate members. Also, webbed retainer407may be sufficiently thin, for example in the range of 0.1 to 0.5 mm, to allow a desired flexibility of flexible track405and to allow easy penetration by self-tapping bone screws when attached to the fractured bone. In addition, webbed retainer407may have a lubricious surface to facilitate assembly and adjustment of the plate members.

In addition to first plate member404, the bone plate assembly400includes a second plate member416that is slidably fitted along the flexible track405. The second plate member406includes a first channel420and a spaced apart second channel422which receive the first connector408and second connector414respectively. The second plate member416includes a transverse opening438for receiving bone screw440.

Referring now toFIG. 27, the second plate member416is shown in greater detail. The second plate member416includes an upper plate portion426and a second lower plate portion428. The upper plate portion426and lower plate portion428define a gap427between each other. The gap between the upper plate portion427and the lower plate portion428may be accomplished by rivets, similar to those shown inFIGS. 2-6. Alternatively, as shown inFIG. 27, the upper plate portion426and lower plate portion428may be attached together by a bridge429. As a consequence, plate member416may be assembled to the webbed flexible retainer member assembly in a “clip-on” fashion.FIG. 32is an isometric view of plate member416with a bone screw fully inserted there through. It should be noted that the screw should not be inserted into plate member416while assembling to the flexible track405.

For example and referring again toFIG. 26, the second plate member416may be installed in a direction generally transverse to the longitudinal axis of track405, that is by advancing the plate member416from first position427as shown in phantom to second position429as shown in solid. By installing in this direction, the assembly of the plate members may be more readily performed particularly in less invasive procedures. In addition, it is not necessary to assemble the plate members in a proper sequence since each plate member can easily be positioned onto track405between other plate members already assembled to the track405. Similarly, each assembled plate member may be removed from track405without requiring removal of adjacent plate members. It is possible, therefore, for the surgeon to easily modify the bone plate assembly400during the fracture repair procedure.

Referring now toFIG. 28the flexible track405is shown in greater detail. As shown inFIG. 28the first connector408and the second connector414are encapsulated by the retainer407. As in previous embodiments, each of connectors408and414may include a grouping of a plurality of flexible members409,415respectively, in any one of a number of possible arrangements. The flexible members may be formed, for example, from metallic wire or polymeric filaments and arranged in a circular grouping as shown inFIG. 28. Relative longitudinal movement among the flexible members permits flexibility of connectors408,414. When the plate members are tightly clamped around connectors408,414to prohibit such relative longitudinal movement, the flexible track405becomes sufficiently rigid to provide fixation of the fractured bone.

Referring now toFIGS. 29 through 31, the second plate member416is shown in greater detail. The second member416includes the first channel as well as the spaced apart second channel. An opening438is formed in the upper plate portion426and the lower plate portion428to permit the locking screw bone screw440to pass there through.

As shown inFIG. 30, internal threads446are formed in the opening438. A counter bore442for receiving the head of the bone screw440is formed in upper plate portion426of the second plate member416.

It is also possible to provide each plate member416, as for all the previous embodiments of the plate member, without any threaded holes. It would then be necessary to tighten the bone screw until the plate member compresses tightly against the bone surface so that the plate member clamps onto the connectors with sufficient force to stiffen the bone plate assembly. This arrangement may be preferred in the repair of fractures in healthy bone but perhaps not in osteoporotic bone in which screw engagement in the weak bone tissue is not optimal.

A method for performing trauma surgery includes obtaining a 3D image of fractured bone, converting a 3D image into CAD model of fractured bone, inputting CAD model of the image into rapid prototype machine for example an SLA machine. The method1100further includes making a 3D physical model of the fractured bone, providing a bone fixation device, assembling the trial bone fixation device that conforms to a 3D physical model of the fractured bone and assembling the implantable bone fixation device having the same configuration as the trial device.

According to another aspect of the method of performing trauma surgery, the method includes providing a kit including a tray for storing a plurality of plate members and at least one connection member. At least two of the plate members have different shapes. The method further includes selecting at least one plate member from the plurality of plate members and at least one connection member from the plurality of connection members, assembling the selected at least one plate member to the selected one connecting member placing the assembled plate and connection member against the damaged bone and locking the plate to the connection member.