Adjustable bone plates

The present invention relates to a bone plate. More specifically, the present invention relates to bone plates having adjustable joints and / or reference marks.

The human skeleton consists of 206 individual bones that perform a variety of important functions, including support, movement, protection, mineral storage and blood cell formation. Damaged bone should be repaired quickly and accurately to ensure that the skeleton maintains its ability to perform these functions, and to reduce pain and ugliness. Bone that is broken or cut is usually treated with a fixation device that reinforces the bone and holds it in position during healing. Fixing devices may specifically include external fixing devices (such as casts and fixtures) and / or internal fixing devices (such as bone plates, nails, and bone screws).

A bone plate is a rugged, usually metallic internal device that attaches directly to the bone adjacent to the fracture (or cut). To use bone plates to repair bone discontinuities, surgeons usually (1) select the appropriate plate, (2) reduce the discontinuities (eg, fix the fracture), and (3) Fix the plate to the bone part located opposite the discontinuity using suitable fixtures such as screws and / or wires so that the bone part is fixed in place.<u style="single">。</u>

<p> Despite direct access to the bone portion when adding the bone plate, it is difficult for the surgeon to fix the bone portion in a precise alignment. For example, one or more of the bone portions may be relatively small and / or displaced from the bone plate. As a particular example, in the fixation of the distal radius, the distal bone portion is difficult to accurately position. More generally, during attachment of the bone plate, when the fixture is tightened, the fixture may be misplaced or misoriented so that the bone portion moves away from the desired position. is there. Therefore, in order to achieve accurate reduction of the fractured part, it is necessary to adjust the relative position of the bone part after the bone plate is fixed to the bone.</p>

<p> The present invention<u style="single">A bone plate having the adjustable joint according to claim 1 is provided. Embodiments are described in the dependent claims. Another aspect is the kit according to claim 27.</u></p>

The present invention provides a bone plate with adjustable joints and / or reference marks, and a method of using the bone plate to secure the bone.

Each bone plate may include multiple plate members connected by adjustable (rotatable and / or translational) joints. The adjustable joint may be configured such that the shape and / or length of the bone plate is modified by adjusting the angular arrangement of the plate members. The angular arrangement may be adjusted by the pivotal motion of the plate members around one axis or around multiple axes, and then the angular arrangement may be locked. Each plate member may define one or more openings. The plate member may be configured to be anchored to different regions of one bone or to different bones using fixtures placed within the opening.

The shape and / or length of the bone plate may be adjusted before, during and / or after the bone plate is fixed to the bone. When fixed after attachment, the movement of the plate member changes the relative placement of the attached bone portion, allowing the surgeon to improve the arrangement and / or spacing of the broken or cut bone in particular. You may. As a result, reduction, fixation and / or treatment is facilitated.

Bone plates with adjustable joints may be attached to the bone using any suitable method or procedure, as described herein, or may be otherwise attached. For example, the surgeon can (1) select the appropriate plate, (2) reduce (set) fractures or other discontinuities in the bone (at least partially), and (3) screw and / or wire. The plate can be fixed on the opposite side of the fracture using a suitable fixture such as (4) the plate can be deformed to control bone loss in the fracture. These steps<u style="single">、</u>Performed manually and / or mechanically.

FIG. 1 shows a series of views of a broken bone 20 in which the fractured portion 21 has been reduced and the bone is fixed by a pivotable bone plate 22.

FIG. 1A shows a bone plate 22 anchored to bone 20 without complete reduction of fracture 21. The bone plate 22 may include a first plate member 24 and a second plate member 26. Each of the plate members has one bone screw 30 (or other fixture) placed through it (or otherwise attached) into the bone 20 to secure the plate member to the bone. Alternatively, a plurality of openings 28 may be defined. Plate members are fixed (intraosseous fixation) or different, in particular, to different parts or pieces 32,34 of bone 20 located opposite a bone discontinuity such as a fracture 21 or section within one bone. It may be fixed to the joint between the bones (interbone fixation). The plate members 24, 26 may be connected by mechanical joints 38. In the joint 38, the plate members 24 and 26 are arranged in an angular arrangement (arrangement) of the plate members.<u style="single">Optional</u>Pivot and so that the intervals can be adjusted respectively<u style="single">Optional</u>It may be configured to allow translational movements. In this drawing, the joint 38 allows both pivotal and translational movements of the plate member.

FIG. 1B shows the improved arrangement of bone portions 32,34 after pivotal movement of the first plate member 24 and the second plate member 26 relative to each other, shown as step 40. The pivotal movement may be around one axis, or around two or more axes, such as around an axis that is approximately perpendicular to the plate member. For example, the joint 38 may be configured such that the first and second plate members bend or twist with respect to each other around three orthogonal axes.

FIG. 1C shows the result of any translational motion of the first plate member 24 and the second plate member 26 towards each other, shown as step 42. The translational movement may adjust the spacing of the bone portions, eg, compress (or stretch) the bone portions toward (or away from) each other, or move the plate members laterally. Further relative movement of the plate member at the joint 38 is restricted by the adjustment of the detent mechanism 44, such as a screw, in order to position the joint 38 in a fixed shape after the pivotal and / or translational movement of the plate member. You may.

Pivot of plate members relative to each other and<u style="single">Optional</u>Translational movement may be performed via any suitable mechanism of manipulating the bone and / or the bone portion connected to the bone and / or manipulating the bone plate and / or the handle or other device associated with the bone plate. .. Such operations may be performed by hand and / or using tools. For example, in Figure 1, the pivot and<u style="single">Optional</u>The translational motion may be directed by a handle (or handle) 46 connected to one or more of the plate members (see FIGS. 1A and 1B). The handle may be gripped by hand or by a tool to apply a directional force such as torque to one of the plate members. To increase torque by increasing the lever arm, the handle may be located relatively far from the joint and / or relatively long. The handle may be removed after the plate adjustment is complete, as shown in Figure 1C. In some embodiments, removing the handle may include removing the handle, for example, by rotating the handle to release the screw of the handle from the threaded opening of the bone plate.

Further aspects of the invention are described in the following sections, including (I) an overview of the bone plate, (II) plate members, (III) bone plate joints, (IV) reference marks and (V) examples.

I. Bone Plate Overview Bone plates, as described herein, are relatively thin (or plate-like) fixation devices configured to stabilize at least one bone upon attachment to the bone. To be equipped with. The fixation device is such that the fixation device hangs over a bone discontinuity (fracture, section, bone joint, etc.) so that the fixation device fixes the relative position of the bone portion located opposite the bone discontinuity. It may be configured. The fixation device is generally configured to be placed in contact with the outer surface of the bone and is therefore placed at least approximately outside the bone. The bone plate may be permanently in place or removed after the associated bone has partially or completely healed.

The bone plate may have a sturdy but malleable structure. In general, the bone plate must be stiffer and stronger than the section of bone on which the plate is laid, but must be sufficiently flexible (eg elastic) so that the bone is not significantly distorted. Suitable materials are biocompatible materials (titanium or titanium alloys, cobalt chromium, stainless steel, plastics, ceramics, etc.) and / or bioabsorbable materials (polyglucolic acid (PGA), polylactic acid (PLA). ), Their copolymers, etc.).

Bone plates may be configured to reduce irritation to bone and surrounding tissues. For example, the bone plate may be made of biocompatible material, as described above. Also, the bone plate has a thin and / or pinnate contour shape to reduce protrusion into adjacent tissue, and rounded, burr to reduce the effects of such protrusions. May have no surface.

The bone plate may have at least one, generally two or more different anchor (or bone attachment) portions configured to be anchored to the bone. Each anchor portion may be configured for a particular portion of the bone to fit a surface portion of the bone that is generally adjacent to the bone discontinuity. For example, a bone plate comprises a proximal anchor portion for attachment to a more proximal region of bone and a distal anchor portion for attachment of the same bone to a more distal region. May be good. In some embodiments, the bone plate may include a support (buttress) portion connected to an anchor portion. The support portion may be in a non-connecting form, allowing direct connection of the support portion to the bone by one or more fixtures. Such a support may use contact between the support and the fracture to limit movement of the fracture, or may include protrusions or claws to more effectively engage the fracture. Good.

The bone plates described herein may be sized and shaped to fit a particular portion of bone (or bone). The plate is generally elongated and has a length L, a width W and a thickness T. Here, the length L width W thickness T. During use, the long axis of the bone plate is aligned with the corresponding long axis of the bone or extends diagonally or laterally with respect to the long axis of the bone. The length and / or width of the bone plate may vary, for example, depending on the intended use, in order to adapt the plate to a preselected area of bone and / or a particular wound to the bone. For example, the plate may be approximately linear for use on the axis of long bones, or may have a non-linear shape for use near the ends of the bone, etc. Good. In some embodiments, the plate has an axial portion for attachment to the axial portion of the bone and an axial portion to provide a wider platform for attachment near the end of the bone. It is almost T-shaped with a connected lateral section. In some embodiments, the bone plate may be configured for use on both sides of the bone, such as when the bone is symmetrical. In some embodiments, the bone plate is asymmetric and may be configured to be used on either the left or right side of the bone.

The bone plates described herein may be configured for use with the appropriate bones of the human body and / or another vertebrate. Illustrative bones include, in particular, arms (cone, ulna, humerus), legs (femur, tibia, fibula, patella), hands, feet, vertebral bones, scapula, pelvis, skull, ribs and / or clavicle. Good. Specific examples for which a pivotal bone plate is suitable include the distal radius (such as the volar aspect of the distal radius) and the distal tibia.

The bone plate may have medial (facing the bone) and lateral (opposite the bone) surfaces. One or both of these surfaces so that the bone plate closely follows the surface of the target bone (or multiple bones) intended for it so that the bone plate remains thin and fits over the bone. It may be contoured. For example, the inner surface of the plate is nearly complementary in contour to the bone surface. The outer surface corresponds to the bone surface and is complementary to the inner surface of the plate.

The thickness of the bone plate is defined by the distance between the inner and outer surfaces of the plate. Plate thickness varies between and / or within plates depending on the intended use. For example, thinner plates may be configured for use in smaller bones and / or bones or areas of bone where soft tissue stimulation is more important. The thickness may vary within the plate. For example, as they extend over protrusions (protrusions, condyles, rough surfaces and / or similar ones), the plates become thinner, especially their profile and / or stiffness. The thickness of the plate may also vary to make it thinner, for ease of use, for example, where it needs to be deformed by bending and / or twisting. Thus, the plate is thicker and therefore stronger in areas that normally do not need to be contoured, such as along the axis of the bone.

Bone plates generally have multiple openings. The opening may be configured to receive a fixture to secure the plate to the bone. Alternatively, or in addition, the opening is blood flow to the fracture or surgical site, in particular to allow the plate to be operated with a tool (such as an attachable handle) and / or to facilitate treatment. It may be configured to change the local stiffness of the plate to facilitate flow.

The openings may have the appropriate position, size and / or density within each portion of the bone plate. The openings may be approximately aligned with a line along a portion of the plate and may be centered across the width of the plate, for example. Alternatively, the openings may be arranged in a non-linear manner, for example in a staggered arrangement. In some embodiments, the opening is configured so that the pair of bone screws can be oriented along a non-parallel path, for example, to increase the scaffolding of the pair of bone screws on the bone. May be<u style="single">。</u>

The opening may have any suitable shape and structure. The exemplary shape may be circular, elliptical, rectangular, rectangular or the like. The opening may be provided with a countersunk hole configured to receive, for example, the head of a bone screw. The openings may or may not be threaded, and each bone plate comprises one or more threaded and / or unthreaded openings. In some embodiments, the plate may comprise one or more elongated openings (slots) extending axially and / or laterally along each bone plate. The slot may be provided with a countersunk hole that provides compressive force as the bone screw advances in contact with the countersunk hole. Alternatively, or in addition, slots may be used to adjust the position of the bone plate and / or plate portion with respect to the bone before the plate is fully fixed to the bone.<u style="single">。</u>

Fixtures generally include any mechanism for fixing the bone plate to the bone, including screws, pins and wires in particular. A preferred fixture is a bone screw, including a single skin layer, a biskin layer and / or a spongy bone screw. Single-skin and bi-skin layers bone threads usually have relatively small threads for use in hard bone, such as those commonly found in the axial portion of bone, whereas spongy bone threads usually have long bone ends. It usually has relatively large screws for use with soft bone, such as those commonly found nearby (periarticular area). The bone screw of a single cortical layer penetrates the cortical layer of the bone once and is adjacent to the bone plate. The bone screw of the bicutaneous layer penetrates the skin layer of the bone twice, is adjacent to the bone plate, and faces the bone plate. In general, single-skin layer screws provide weaker support than double-skin layer screws because they penetrate fewer skin layers. The size and shape of the fixture may be selected based on the size, shape and arrangement of the openings, or vice versa. For example, a single skin layer bone screw may be suitable for a particular arrangement of openings.

II. Plate Member The anchor and / or support portion of the bone plate may be defined by a separate component of the bone plate called the plate member. Each plate member may define a different anchor and / or support portion of the bone plate. The pivotal bone plates described herein may include two or more plate members. In some embodiments, the bone plate may comprise at least three plate members, with each adjacent pair of plate members connected by a mechanical joint.

The plate member may have any suitable size and shape. In general, the plate members may be sized and shaped according to the intended target bone portion of each plate member. Therefore, the plate member of the bone plate may be configured to correspond to the anchor and / or support portion of the bone plate (ie, a single bone plate) without mechanical joints. In some embodiments, one or more of the plate members may be substantially linear and / or approximately T-shaped.

The plate member may be configured to be anchored (and / or engaged) to one bone or different parts of two or more bones. Therefore, each plate member may include one or more connecting mechanisms. The connecting mechanism may be any structure of the plate member that allows the plate member to be attached to the fixture or to the bone. An exemplary connection mechanism is a threaded opening for engaging with a threaded fixture and a screw for engaging with a screw and / or wire, hook, pin, protrusion and / or similar. It may be provided with a non-mountain opening. Each plate member may have no openings (eg, plate members configured to support bone), one opening, or two or more openings. For two or more openings, the plate member may be, in particular, a combination of all threaded openings, all unthreaded openings, and / or threaded and unthreaded openings. In some embodiments, the plate member is threaded or threaded, especially to facilitate operation of the plate member and / or its corresponding bone plate after it has been attached to the bone. It may have an opening configured to be engaged by a tool such as a non-handle.

III. Bone Plate Joints The bone plates described herein include one or more joints.<u style="single">Ru</u>.. Each joint may be any connection between the plate members that allows the plate members to move relative to each other.<u style="single">In the bone plate of the present invention, the distance between the plate members of the bone plate is adjusted by the angular arrangement of the plate members and optionally by the pivotal movement of the first plate member about two or more non-parallel axes. Has joints arranged to allow rotatable (bending and / twisting) and optionally translational movement with respect to each other.</u>.. Each joint has (1) an adjustable shape that allows the plate members to move independently, and (2) a fixed shape in which the angular arrangement and / or spacing of the plate members is fixed.<u style="single">To do</u>。

Joints may be formed in the bridge region between the plate members. The bridge area may be defined by orienting the plate member contacts and / or may include one or more additional components such as bridge members over the gaps between the plate members. In some embodiments, the joint slides (and therefore plate members) relative to each other on the surface (and thus plate members).<u style="single">Pivot direction and optional translation direction</u>) May be provided with nearly complementary surfaces of the plate members in contact with each other. The nearly complementary surface may have any suitable shape, such as hemispherical (or spherical), planar, curved (semi-cylindrical).

<u style="single">The joints that characterize the bone plates of the invention are pivotable around two or more non-parallel (or parallel) axes.</u>.. The axis may be the semimajor axis of a flat surface (or plate member) in order to obtain the twist of the plate. Alternatively, or in addition, the axis may be a normal or "vertical" axis located approximately perpendicular to the plane defined by the plane (ie, one of the plate members). .. The axis or axes may also be one or more lateral or "horizontal" axes that extend diagonally and / or perpendicular to the long axis of the plate or plate member. Normal and / or lateral axes provide bending of the plate.

Any suitable type of pivotal joint may be provided within the bone plate. In some embodiments, the joint allows pivotal movement around three orthogonal axes. An exemplary pivotable joint that allows a plate member to pivot around three orthogonal axes is a ball joint (ball-in socket). A ball joint comprises at least one joint surface formed as a complete sphere or as part of a sphere (hemispherical). In some embodiments, a ball joint comprising a portion of the sphere is preferred over the entire spherical joint to minimize the contour shape of the joint. Ball joints allow plate members to bend and twist with respect to each other. Alternatively, the joint may be a hinge joint (pin in the hole) that allows pivotal movement around a single axis. In some embodiments, the joint may be two or more joints that allow pivotal movement around an isolated axis, such as an isolated orthogonal axis (see Example 4 below). In some embodiments, the joint (or joints) may allow a change in angular arrangement coupled with translational motion (see Example 5 below).

The pivotal joint may be locked by a detent mechanism to secure the angular arrangement of the plate members. An exemplary detent mechanism includes a fixture such as a screw or bolt. Fixtures are threaded to engage, compress, and / or extend plate members and / or associated components such as bridge members to provide frictional engagement and restrict movement, for example. You may receive it. In some embodiments, the detent mechanism may compress the plate members together. In some embodiments, the detent mechanism may include a conical screw that extends the joint component as the conical screw advances.

Appropriate structures may be provided on the joints to guide and / or limit the movement of the plate members. Such guide and / or restriction structures, in particular, ridges and / or other protrusions that slide in the groove, or pins or fixtures that are guided by slots, and / or corresponding sets of indentations or complementary teeth. It may have teeth / sawtooth received by the sawtooth. The guide / restriction structure allows continuous adjustment (eg, a ridge that slides in a groove or a ball that rotates in a socket), or discrete adjustment positions (eg, serrations received by a depression). The guide / restriction structure may limit the separation of the plate members (eg, dovetail ridges received within the corresponding dovetail grooves).

Sliding is allowed by a guide / restriction structure along one or more axes. For example, in order to adjust the length of the plate, the sliding may be along the long axis of the plate. Alternatively, or in addition, there is lateral sliding to shift the plate, such as within a T-shaped bone plate, or to adjust the lateral position of the laterally extending plate member. May be good.

The slippery branch may be locked in place by any suitable detent mechanism. The detent mechanism may provide only a continuous range of lock positions or discrete lock positions. For example, the detent mechanism may be a fixture such as a screw (or a plurality of screws). The screws may be adjustable within a slot defined by a single plate member to allow a continuous range of adjustments. Alternatively, the screw may be received in one of a limited set of aligned openings defined by plate members to provide discrete locking positions. In other embodiments, the detent mechanism for translational (and / or pivotal) movement may be a tab or button that is bent, pressed, or otherwise moved to a holding position.

Further embodiments of adjustable bone plates with pivotally and / or sliding joints (and / or deformable portions) are described in the Examples below.<u style="single">To</u>Has been described.

IV. Reference mark The bone plate may include a reference mark. Reference marks may be placed adjacent to pivotal joints, linearly sliding joints, and / or slots. The reference mark may indicate an angular arrangement and / or a linear arrangement with respect to another part of one part of the bone plate. Alternatively, the reference mark may indicate the position of the bone screw in the slot. The reference mark may be any visible indicator on the bone plate. These indicators are used during the first manufacturing, for example, by casting the plate using a mold configured to form the indicator (eg, in the mold for forming grooves or ridges in the plate, respectively). Ridge or groove), may be formed on or in the plate. Alternatively, or in addition, the indicator is added after manufacture, for example, by etching or cutting the indicator into an existing component of the plate, and / or by adding it as an additional component of the plate. May be added to. In some cases, the indicator may be provided as an alternative or in addition on a guide or template co-located with the plate before or during installation and may be removed prior to the end of installation. The exemplary reference mark may include, in particular, dots, dashed lines, symbols, letters, numbers, letters, words, shapes and / or colors.

In some embodiments, the first member of the bone plate has an arcuate (or linear) row of reference marks and the second member of the bone plate has a single reference mark or marker. You may. The arcuate row may have numbers or letters corresponding to various angular (or translational) positions. The numbers may include positive and negative numbers to indicate opposite directions of pivotal movement. A row of reference marks may be compared to the marks during relative rotation (or translational movement) of one of the plate members with respect to the other in order to measure the adjustment of the angle (or translational direction). Such angular (or translational) adjustments may be pre-determined, for example, by x-rays, analysis of the bone itself or the tissue supported by the bone. For this purpose, corresponding or complementary reference marks may be provided on the equipment or tools used to select and / or place bone plates such as x-ray templates, measurement guides, etc. Alternatively, or in addition, settings for standard or commonly used reference marks, for example, additional indicators (stars "^*"Etc.) may be used to identify these marks and record them on the plate. Numerical values such as angle and distance can be assigned to the adjustment. Reference marks may be configured to mark a range of angles or distances, as these marks mark when adjustment values are reached during the movement of the plate member. Pivotable bone plates with reference marks are suitable for fixing bone cuts or fractures, or for fixing different bones across bone joints.

A further embodiment of a pivotal bone plate with a reference mark is described in Example 7 below.<u style="single">To</u>Has been described.

V. Examples The following examples illustrate selected embodiments and embodiments of the invention with a pivotable bone plate and an exemplary use of a pivotal bone plate to secure bone. There is. These examples are provided for illustration purposes and are not intended to limit or define the full scope of the invention.

(Example 1) An exemplary fracture portion for fixation with a pivotal bone plate This example illustrates an exemplary fracture portion that can be fixed with a pivotal bone plate of the present teaching. (See Figure 2).

FIG. 2 shows the upper right limb 60 exhibiting a Cory's fracture 62, a very common fracture of the distal radius 64 that normally occurs when reaching for a fall. The location of the fracture is indicated with respect to the skin of the distal forearm 66 and hand 68, shown by virtual lines. In Cory's Fracture 62, a smaller, distal fracture 70 is located on the back of the larger proximal bone segment 72 of the radius. Cory's fracture 62 is reduced and fixed by the pivotable bone plate described herein by placement of the bone plate on the volar (anterior or inferior) 74 of the radius. This arrangement reduces or avoids tendon inflammation that accompanies flexion when the bone plate is attached to the volar (posterior or superior) 76 of the radius. Alternatively, the bone plates described herein are used on the volar surface of the distal radius or on other suitable bones or bone surfaces.

(Example 2) Bone plate with joints for pivotal movement around three axes This example is a broken distal part in which parts of the bone plate can bend and twist with respect to each other. Describes a bone plate for use on the radius (see Figures 3-6).

3 and 4 show a transverse intermediate cross-section and a volar side view of the broken rib 64 with a pivotally movable bone plate 80 fixed to the rib adjacent to the palm surface 74, respectively. The pivotable bone plate 80 comprises a proximal plate member 82 and a distal plate member 84 connected by a pivotal joint 86.

Proximal plate member 82 has a semimajor axis that is located approximately parallel to the semimajor axis of the radius. The plate member 82 is substantially linear. The plate member 82 is secured to the proximal segment 72 of the radius by a plurality of bone screws 88. The bone screw 88 is a bidermal bone screw or a single skin layer bone screw as shown herein. Bone screw 88 is oriented along a parallel or non-parallel path defined by openings 90-94 of the proximal plate member.

The path through which the bone screw travels is defined by the fit between the fixture (such as the bone screw or pin) and the opening. Fitting is a tight fitting that at least nearly defines the angle at which the fixture travels through the bone plate and into the bone due to the placement of the fixture at a pre-defined angle. Alternatively, fitting is a more unconstrained fitting that allows the placement of the fixture at a selected angle within a range of angles. The type of fit for each fixture is determined by the surgeon during the installation of the bone plate by the choice of each fixture.

Tight fit may be defined by screw or non-screw engagement with the wall of the fixture opening. Tight fit may be defined by the threaded engagement of the threaded fixture with its corresponding threaded opening. The screw engagement predefines the angle of the fixture with respect to the long axis and locks the angle position. Alternatively, or in addition, tight fitting is defined by a strict correspondence between the diameter of the handle of the fixture and the diameter of the opening, especially the cylindrical portion of the opening. The diameter of the fixture is defined by a threaded or unthreaded segment of the fixture handle (approximately adjacent to the fixture head). The diameter of the opening is defined by an unthreaded or threaded opening. Therefore, tight fitting at a given angle is achieved by unthreaded or threaded handle segments engaged by either threaded or unthreaded openings.

A more unlimited fit is defined by the size and / or shape relative to the size and / or shape of the fixture. For example, the opening has a diameter sufficiently larger than the diameter of the fixture to allow the fixture to achieve various angular arrangements within the opening. Alternatively, or in addition, the openings have slanted or curved walls to allow the fixture to pivot in various angular arrangements.

One or more openings, such as openings 92,94, are elongated openings or slots. The slots are arranged axially and / or laterally on the plate member. The slot has a reference mark 98 placed adjacent to the slot (see Figure 5). The reference mark is configured to measure the movement of the bone plate in the direction in which each slot extends. In some embodiments, the slot places the bone screw in the bone of slot 92,94 and one of slots 92,94 before additional bone screw is placed in the bone through the opening 90. Or both are configured to allow axial or angular adjustment of the proximal plate member 82.<u style="single">。</u>

The distal plate member 84 has its semimajor axis located laterally along the semimajor axis of the radius. The plate member 84 is substantially T-shaped or fan-shaped. The plate member 84 is secured to the distal fracture of the radius 70 by a plurality of single or bidermal bone threads 102 placed within the bone thread through the distal plate member opening 104. The opening 104 may be threaded, unthreaded, or a combination thereof. Bone threads are selected for threaded or non-threaded engagement with the opening 104. Further, each bone screw, the angle of placement of the particular bone screws (or other fasteners) are defined in advance by the opening 104 so chosen so that, or, as described above for opening 90-94 In addition, it can be selected within a certain angle range.

The pivotable joint 86 bends and bends the distal plate member 84 relative to the proximal plate member 82 before, during and / or after the plate member is fixed to the distal radius. It is configured to allow twisting. FIG. 5 shows bending motions 106,108 and twisting motions 110 around two axes for the distal plate member.

3 and 4 show the position of the bone plate 80 before the final reduction of the plate member and therefore before the final reduction of the fracture portion 62. (1) By arranging the joint 86 in an adjustable shape by loosening the lock screw 112, (2) by the corresponding movement of the connected handle 114, one or more axes of the distal plate member 84. Tighten the lock screw 112 by rotating around (such as clockwise in both Figures 3 and 4) and (3) to secure the relative position of the plate members and the bones attached to them. By arranging the joint 86 in a fixed shape, pivot adjustment is achieved.

5 and 6 show an additional aspect of the pivotable bone plate, in particular the aspect of the pivotable joint 86. The joint 86 comprises upper and lower hemispherical surfaces 122,124 provided within the plate member. The hemispherical surfaces 122 and 124 are convex and concave, respectively, and have similar radii of curvature. Therefore, the upper surface 122 slides along the lower surface 124 to achieve pivotal motion around three orthogonal axes. The upper and lower surfaces are held apposition by a hemispherical retainer 126, approximately in the form of a washer, and a screw 112. The hemispherical retainer is configured to be received within the hemispherical cavity 128 defined by the distal plate member. The retainer and hemispherical cavity have similar radii of curvature.

The pivotal joint 86 includes a detent mechanism 129 to limit the pivotal movement. In particular, the detent mechanism comprises a lock screw 112 that is received and rotated within the retainer and distal plate member openings 130, 132, respectively, and screw-engaged with the threaded holes 134 of the proximal plate member. .. Therefore, the lock screw is advanced or advanced to define the amount of frictional engagement between the plate member surfaces 122,124 to determine whether the plate member surfaces are movable or fixed with respect to each other. Be drawn in. In some embodiments, the proximal plate member comprises a lower surface 124 and the distal plate member comprises an upper surface 126. Alternatively, or in addition, the pivotal joint is inverted from the shape shown here so that the retainer 126 is configured to act as a nut that is screwed and placed adjacent to the bone. May be done. In this case, the lock screw 112 is disposed from the outer surface of the plate member through the respective openings of the plate member and screw-engages with the retainer.

The bone plate 80 comprises an inner surface 140,142 and an outer surface 144,146 on the plate member (see FIG. 6). The inner surfaces 140,142 may or may not be configured to be substantially coplanar when the bone plate is in the intermediate adjustment position, as shown herein. An opening, such as opening 90, is defined between the inner and outer surfaces. The opening comprises a countersunk hole 148 and a hole 150. The holes 150 are particularly cylindrical or extend towards the inner surface.

(Example 3) Bone plate with joints for pivotal and translational movements This example is on a broken distal rib where the bone plates can bend, twist, and slide in translational directions with respect to each other. Describes a bone plate for use (see Figures 7 and 8).

The bone plate 170 includes a proximal plate member 172, a distal plate member 84, and a bridge member 174 that connects the two plate members. The bone plate comprises two joints that allow pivotal and translational movement of the plate members, a pivotable joint 86 and a translational joint 175. The pivotal joint 86 is configured as described above for Example 2 and is not further mentioned herein.

The translationally movable joint 175 is defined by the telescopic relationship of the bridge member 174 with the proximal plate member 172. In particular, the bridge member 174 comprises opposing elongated ridges or guides 176 configured to be received within a complementary recess or orbit 178 defined by a proximal plate member.

The axial position of the bridge member 174 is fixed by the detent mechanism 180. The detent mechanism includes a retainer 182 (such as a washer) and a fixture 184 (such as a screw or bolt). The fixture is disposed through the retainer and screw-engaged with the threaded hole 186 of the bridge member 174. Proceeding the fixture into the threaded hole presses the retainer 182 to engage the retaining surface 188 of the proximal plate member 172, thereby limiting translational motion. The retainer is loosened to allow further sliding at joint 175.

Before and / or after fixing the joint 175, a bone screw 190 is placed in the bone through the opening 192 of the proximal plate member 172. The bridge member 174 comprises an elongated passage 194 that allows the bone screw to be received over a continuous range of axial positions of the bridge member. The passage is configured to allow the head of the bone screw to travel through the passage, or the head of the bone screw is engaged by a bridge member.

(Example 4) Bone plate with isolated pivotal joints This example illustrates a bone plate with multiple isolated joints configured to pivot around orthogonal axes. (See Figure 9).

The bone plate 210 comprises two pivotable joints 212,214 that are connected to the proximal plate member 216 and the distal plate member 218 using a bridge member 220. The pivotal joint 212 allows the pivotal movement indicated by 222 around the normal axis 224. The joint 212 is defined by juxtaposition of the distal plate member 218 with the bridge member 220 on the contact surfaces 226,228 of these members. The contact surfaces 226,228 are generally flat. The contact surface comprises serrations or other complementary structures to limit pivotal movement when the detent mechanism 230 is driven.

The detent mechanism 230 may be provided by a connector 232 such as a screw that passes through an opening 234 in the distal plate member 218 and screw-engages with the threaded hole 236 of the bridge member 220. Advancement of connector 232 compresses both the distal plate member and the bridge member to limit pivotal movement. The surface shape of the contact surfaces 226,228 facilitates limiting movement when the detent mechanism is driven.

The hinge joint 214 allows the pivotal movement indicated by 240 around the lateral axis 242. The hinge joint is formed between the bridge member 220 and the proximal plate member 216. The hinge joint detent mechanism 244 includes a lock screw 246 that acts axially on the hinge joint to compress the hinge joint in parallel with the shaft 242. In some embodiments, the detent mechanism acts radially, in particular, on the hinge joint.

(Example 5) Bone plate with integrated joints for sliding and pivoting This example is a bone plate for fixing a broken radius in which an integrated joint for sliding and pivoting is contained. Explained (see Figure 10)<u style="single">.. This example is outside the scope of the present invention and is described only for the purpose of providing information.</u>

The bone plate 270 comprises a proximal plate member 272 and a distal plate member 274 connected by a joint 276. Joint 276 allows axial movement, indicated by 278, and pivotal movement around axis 282, indicated by 280. The plate members have contact surfaces 284,286 that slide in the translational direction and pivot with respect to each other. The plate members are connected by connectors 288,290 (such as screws) that extend into threaded holes 296 and threaded slots 29, respectively, through elongated openings 292,294. The plate members are positioned by the pivotal and translational movements of the plate members, and then the connectors 288,290 are advanced by advancing the connectors 288,290 until their heads apply compressive force to the countersunk surface 302,304 of the distal plate member 274. Fixed in place.

(Example 6) Bone plate with combined translational and pivotal movements This example illustrates a bone plate for fixing a broken radius to which the bone plate binds translational and pivotal movements (Figure). 11 ~ See Fig. 14)<u style="single">.. This example is outside the scope of the present invention and is described only for the purpose of providing information.</u>

FIG. 11 shows a bone plate 320 with a proximal plate member 322 and a distal plate member 324 connected by two joints 326,328. The first joint 326 allows the pivotal movement indicated by 330 around the normal axis 332 and is therefore similar to the joint 212 in Example 4. The second joint 328 is specifically located below or above the first joint and is configured to allow the plate member to slide in the translational direction. However, the path through which the plate member slides is arcuate, as further described below, so that the second joint allows coupled translational and circular motions.

FIG. 12 shows an axial cross section of a selected portion of the bone plate 320. The plate members 322,324 are connected via a bridge member 340 that contacts the plate member on the opposing surfaces 342,344 of the bridge member. The upper surface 342 provides a contact surface for the pivotal movement of the proximal plate member 322 at the first joint 326. The lower surface 344 provides a contact surface that defines the curvilinear path indicated by 346, along which the distal plate member 324 slides. The curvilinear path follows a circular path, as indicated by the alternative position of the proximal plate member 322 achieved by sliding along the path 346 indicated by the virtual contour line 348.

13 and 14 show a cross-sectional view and an exploded view of the bone plate 320, respectively. Joints 326,328 include a detent mechanism 350 with connector 352. The connector is, in particular, a screw that extends through an opening in the proximal plate member 322 and the bridge member 340. The screw is received by a threaded nut 354 held in a slot 356 defined by a distal plate member 324. Slot 356 is narrow within slot 356 near the bridge member to define a wall 358 that engages the nut shelf 360 to hold the nut.

(Example 7) Bone plate with reference mark This example illustrates a bone plate with reference mark configured to measure angle and / or translational adjustment of the plate (FIGS. 15 and 16). reference).

FIG. 15 shows an exploded view of the bone plate 390. The bone plate 390 is configured to fix the position of the incisal portion after incision, for example. The bone plate 390 comprises an axial (ie proximal) plate member 392 connected by a pivotal joint 396 and a lateral (ie distal) plate member 394. The pivotable joint 396 allows the lateral plate member 394 to pivot around one axis, such as the normal axis 398, as indicated by 397.<u style="single">However, in the case of the bone plate of the present invention</u>, Pivotable joints are configured to allow pivotal movement around more than one axis, as described throughout this teaching.<u style="single">Be done</u>.. The pivotable joint 396 is adjustable and can then be secured by a lock screw 402 or other detent mechanism.

The bone plate 390 comprises an angle index mechanism 404 with an angle reference mark 406 and a mark 408. The angle reference mark 406 and the mark 408 may be placed on different plate members 392,394, respectively, or vice versa.

The bone plate comprises slot 410 and a linear indicator mechanism 412 that provides axial measurements of alignment. Slot 410 may extend alongside the major axis of the axial plate member 392. Slot 410 receives a bone screw that guides the linear sliding of the bone plate with respect to the bone screw (and thus the underlying bone). The linear gliding provides axial adjustment of the bone plate before the bone screw is fully tightened and / or after the other bone screw of the bone plate is placed in the bone through the additional opening 414. The linear gliding is performed before and / or after the bone screw is placed in the bone through the opening 416 of the opposing (eg lateral) plate member. The position within the linear slot 410 is marked by a reference mark 418 aligned parallel to the slot adjacent to the edge of the slot. Linear reference marks may have any suitable spacing and orientation, including alphanumeric characters (such as numbers and letters), symbols and / or other indicators that identify and / or distinguish individual marks. It may have a suitable form.

FIG. 16 is a plan view of the angle marking mechanism 404 of the bone plate 390. The mechanism 404 includes angle reference marks 406 arranged in an arcuate arrangement. The reference mark comprises, in particular, a line segment extending radially from Axis 398 and / or a dotted line and / or a dashed line. Adjacent pairs of reference marks 406 define any suitable angle with the Axis 398 of the pivotable joint 396. For example, adjacent reference marks define, in particular, 1, 2, 5 or 10 degrees. In some embodiments, the reference mark 406 is, in particular, a long mark indicated by 420, which is here 30 degree apart, and a short side mark, which is indicated by 422, which is here 10 degree apart. It has major or small marks that are visually distinguishable. The marking mechanism 404 also, or otherwise, comprises alphanumeric characters such as the number 424 that identifies and / or acts as such a reference mark. In some cases, standard (eg preferred and / or commonly used) settings for reference marks, for example by using alternative fonts, symbols or sizes, and / or additional "standards". "Settings" mark 426 (star "Star"^*It is indicated on the plate by identifying these marks using "etc.).

The mark 408 is configured to provide a site where the reference marks are compared in order to identify one of the reference marks 406 that are closest to the mark. For example, in this drawing, mark 408 is aligned with a reference mark labeled "-30" to indicate a 30 degree rotation of the lateral plate member from a zero degree neutral position. The angle reference mechanism 404 is used to adjust the angular position of the lateral plate member 392 by a predetermined angle. The angle may be pre-determined by any suitable analysis, such as an x-ray examination of the bone to which the plate is attached, measurement of the angle of misalignment of the bone or limbs with an external measuring device or the like.

Uses for reference marks in bone plates with reference marks extend to preoperative and / or postoperative analysis. For example, prior to placement of the bone plate, the surgeon can "dial in" or otherwise preset the approximate settings for the bone plate. Pre-set values are for preoperative analysis (eg x-ray templates and / or other measurement tools with corresponding or complementary reference marks), with the corresponding uninjured site on the opposite side of the patient's body. Comparison (eg, using uninjured left radius measurements to determine appropriate presets for the injured right radius), comparison with statistical data collected from various patients (eg) It is determined from (in the form of the reference table). Alternatively, or in addition, after placement of the bone plate, the surgeon records the final settings for possible postoperative use. In some cases, reference marks are used in the field using x-rays, magnetic resonance and / or similar techniques to allow continuous accurate position non-invasive monitoring, and post-operative plate adjustment. It is readable by. Suitable reference marks for such applications include, in particular, changes or changes in thickness, contour shape and / or plate composition.

(Example 8) Pivotable Bone Plate This example is another pivotable bone plate for use on a broken distal radius, where parts of the bone plate can bend and twist with respect to each other. The bone plate is described (see Figures 17-19). Some aspects of this bone plate are shared with the plates described above and described in more detail in the bone in Example 2.

FIG. 17 shows a bone plate 450 configured for use on the volar surface of the distal radius. The bone plate 450 is asymmetric and is configured for use on only one side of the human body and on the left radius in this drawing. The bone plate 450 comprises a proximal anchor portion 452, a distal anchor portion 454, and a pivotable joint 456 that joins the proximal and distal anchor portions.

Proximal anchor portion 452 is an axial portion configured to be substantially aligned with the semimajor axis of the radius. Proximal anchor portion 452 defines multiple openings 458-464 to receive fixtures such as bone screws. Proximal opening 464 is a slot arranged approximately along the long axis of proximal anchor portion 452. Each of the openings may or may not be threaded and may or may not be countersunk. In some embodiments, one or more of the openings, such as the opening 458, are configured as lateral slots. At least part of the opening<u style="single">、</u>They are arranged in a staggered arrangement, such as on both sides of the central axis 466 of the plate, to orient the bone screws along a staggered, non-parallel path. Thus, this partial opening defines different paths of bone screw movement based on the different orientation of the opening and / or the thread wall. The periphery of the proximal anchor portion 452 forms a wavy or wavy appearance in the proximal portion when viewed from a position perpendicular to the plane defined by the plate (having the length and width of the plate). In order to do so, it almost follows the arrangement of the openings shown by 468. Proximal anchor portion 452 also comprises one or more smaller openings 470 configured to receive smaller diameter fixtures such as wires.

The distal anchor portion 454 is configured to be anchored in the wide distal region of the radius. Therefore, the distal portion 454 is wider than the proximal portion 452 and extends distally in a fan-like shape so that the entire plate is approximately T-shaped. The distal anchor portion 454 is arranged in one or more rows approximately laterally to the central axis 466 of the proximal anchor portion 452 when the plate is adjusted to the neutral position as shown here. A plurality of openings 472 to 474 are defined. The openings 472,474 are arranged, in particular, in one or more linear or arcuate rows.

The distal opening may be threaded (shown in 472), unthreaded (shown in 474), or a combination thereof, as in this drawing (see also Figure 18). Each opening is configured to receive a bone screw or other fixture (such as a pin) at a fixed angle or at a selected angle within a range of angles. The choice between fixed or variable angles is how close the screw or other fixture fits into the opening and / or screw, as described in more detail above in Example 2. Engagement is defined by whether it is used to fix the angle of the screw / fixture.

The distal anchor portion 454 comprises one or more additional openings 476 located distal to the openings 472,474. The distal opening 476 is used, for example, to receive a fixture placed within the styloid process of the distal radius, especially when the styloid process is fractured or amputated.

The distal anchor portion 454 is contoured to fit onto the volar surface of the distal radius. Thus, the distal anchor portion 454 has a laterally protruding inner surface 478 and a laterally recessed outer surface 480, particularly within the proximal section 482 of the distal anchor portion 454. The distal section 484 of the distal anchor portion 454 is configured to be located distal to the volar distal margin of the radius. Thus, the distal anchor portion 454 comprises a lateral contour shape 486, such as a slight depression, at the bifurcation between the proximal and distal sections 482,484 of the distal anchor portion. The lateral contour shape 486 is configured to receive the volar distal edge 488 of the radius (see FIG. 19). The periphery of the distal anchor portion 454 is shaped to roughly correspond to the contour of the distal radius. For example, the distal lateral margin 490 of the distal anchor portion 454 extends farther in the more inclined and / or distal direction, and the distal intermediate margin 492 is more rounded.

FIG. 18 shows an exploded view of the bone plate 450 and especially the pivotal joint 456. The pivotal joint comprises a hemispherical surface 502,504 of proximal and distal anchor portions 452,454, respectively. These hemispherical surfaces are complementary so that they can slide with each other around three axes. The retainer 506 comprises a hemispherical cavity 508 so that the retainer can be received by the second hemispherical surface 510 of the proximal anchor portion 452. Fixtures 512, such as screws, are screw engaged through the retainer and the proximal anchor portion 452 into the threaded hole 514 of the distal anchor portion 454. The fixture is rotated in both directions to provide an adjustable and fixed shape of the bone plate.<u style="single">Included in the present invention</u>In embodiments, the joint 456 is as described throughout this teaching.<u style="single">Two</u>Pivot movement around the axis of<u style="single">Optional</u>Translational movement<u style="single">Tolerate</u>.. The relative placement of the anchor portions 452,454 is adjusted by a tool that engages one or both of the portions, such as one or more of the plate openings.

FIG. 19 shows a bone plate 450 placed on the volar surface of the distal radius 530. The proximal anchor portion 452 is anchored to the proximal bone region 532 and the far anchor portion 454 is anchored to the distal bone region 534. A pivotal joint 456 is placed adjacent to the fracture site 536 distal to the bone. The distal anchor portion 454 is above the volar distal edge 488 of the radius so that the styloid process 538 is secured to the distal anchor portion 454 using a fixture placed within the opening 476. Extends to. Therefore, the pedicle discontinuity 540 (such as the fracture) is bridged by the distal anchor portion 454. The outer surface of the bone plate may be longitudinally concave and the inner surface may be longitudinally convex to follow the contour shape of the volar surface of the distal radius.

<figref num="1">FIG. 5 is a series of views of a fractured bone showing the fractured portion being reduced and the bone anchored by a pivotal bone plate according to this teaching.</figref><figref num="2">It is a side view of the bone of the right hand and the distal forearm in which the fractured portion of the distal bone is placed on the volar side and tilted, and the fractured bone is collised.</figref><figref num="3">According to this teaching, a first example of a bone plate is anchored to the volar surface of a broken radius and is configured to bend and twist within the bone plate, lateral center of the broken radius in FIG. It is a cross-sectional view.</figref><figref num="4">It is a volar view of the broken radius and the bone plate of FIG.</figref><figref num="5">It is a partial decomposition view of the bone plate of FIGS. 3 and 4 as viewed from a position approximately above the outer surface of the bone plate when there is no distal radius and there is a bone screw.</figref><figref num="6">It is a partial cross-sectional view of the bone plate of FIG. 5 as seen substantially along line 6-6 of FIG.</figref><figref num="7">FIG. 2 is an exploded view of a second example of a bone plate for fixing a broken distal radius in which the axial and lateral portions of the bone plate according to this teaching can pivot and slide with respect to each other. ..</figref><figref num="8">It is a cross-sectional view of the bone plate of FIG. 7 when assembled, as seen substantially along line 8-8 of FIG.</figref><figref num="9">According to this teaching, the axial and lateral portions of the bone plate of the bone plate for fixing a broken distal radius, which can pivot and slide relative to each other around isolated orthogonal axes. It is an exploded view of the third example.</figref><figref num="10">According to this teaching, the axial and lateral portions of the bone plate can slide pivotally and laterally around one axis with respect to each other, in the bone plate for fixing a broken distal radius. It is an exploded view of the 4th example.</figref><figref num="11">According to this teaching, the axial and lateral parts of the bone plate are fixed to a broken distal radius that can slide along a pivotal and curvilinear path around the normal axis with respect to each other. It is an exploded view of the fifth example of the bone plate for.</figref><figref num="12">It is a partial cross-sectional view of the bone plate of FIG. 11 as seen substantially along line 12-12 of FIG.</figref><figref num="13">It is sectional drawing of the bone plate of FIG. 11 as seen substantially along line 13-13 of FIG.</figref><figref num="14">It is an exploded view of the bone plate of FIG.</figref><figref num="15">Exploded view of a sixth example of a bone plate for fixing a broken distal radius, where the portion of the bone plate according to this teaching is pivotal and has a reference mark for marking the angular portion of the plate portion. Is.</figref><figref num="16">FIG. 5 is a partial plan view of the bone plate of FIG. 15 in assembled form, showing a further aspect of the reference mark and showing the use of the reference mark to measure the angular arrangement of the plate portion.</figref><figref num="17">FIG. 5 is a plan view of a seventh example of a bone plate for fixing a broken distal radius in which portions of the bone plate can pivot with respect to each other around multiple axes according to this teaching. ..</figref><figref num="18">It is an exploded view of the bone plate of FIG.</figref><figref num="19">It is a side elevation view of the bone plate of FIG. 17 placed on the volar surface of the distal radius for fixing the distal radius fracture according to this teaching.</figref>

Code description

20 Bone 21 Fracture 22 Bone plate 24 1st plate member 26 2nd plate member 30 Bone screw 32,34 Part 38 Joint 40,42 Step 44 Non-return 46 Handle 60 Upper right limb 62 Cory's fracture 66 Forearm 68 Hand 70 Distal Fracture 72 Proximal Bone Segment 74 Volar Side 80,170,270,320,390,450 Bone Plate 82,172,216,272,322,392 Proximal Plate Member 84,218,274,324,394 Distal Plate Member 86,175,212,214,326,328,396,456 Joint 88,102,190 Bone 88,102,190 Exercise 112,246,402 Lock screw 114 Handle 122,124,502,504 Hemispherical surface 126,182,506 Retainer 128,508 Cavity 129,180,244,350 Detent mechanism 140,142 Internal surface 144,146 External surface 148 Countersunk hole 150,514 Hole 174,220,340 Bridge member 176 Raised or guide 178 Indentation or orbit 184 Fixture 186,236,296 Threaded hole 186,236,296 Threaded hole 188 Normal Axis 226,228,284,286 Contact Surface 232,288,290,352 Connector 242 Lateral Axis 278 Axial Movement 282 Axis 29 Threaded Slot 302 Countersunk Surface 342,344 Surface 346 Path 354 Threaded Nut 356,410 Slot 358 Wall 360 Shelf 398 Axis 404 Angle Index Mechanism 406 Angle reference mark 408 Mark 412 Indicator mechanism 418 Reference mark 426 Standard setting mark 452 Proximal anchor part 454 Distal anchor part 466 Central axis 486 Lateral contour shape 488 Volar distal edge 490 Distal lateral peripheral edge 492 Distal intermediate peripheral edge 532,534 Bone area 538 Stemous protrusion 540 Stem-like discontinuity