MXPA98003097A - Hu adjustment device - Google Patents

Abstract

A method for performing angular distraction osteogenesis by drilling holes of bone nail into the first and second sides of a segmented bone, inserting bone nails into the bone nail holes, fixing the bone pins on each side of the segmented bones until a distraction device, and adjusting the distraction device, so that the bone portion of the first side of the segmented bone is angularly adjusted, rotates or pivotally moves its position relative to the portion of bone on the second side of the bone segmented in Increasing exact, gradual and predetermined amounts over a period, so that the bone tissue remains healthy and the blood vessels and nerve terminals remain intact during the bending distraction procedure, a device is provided to achieve angular distraction osteogenesis that has a support member extending along a segmented piece of h Bone, means for securing the first side of the bone segmented to the support member and the second side of the bone segmented to the support member, and means for angularly adjusting the first section of bone segmented relative to the second segment of segmented bone; of angular adjustment includes a gear and a cooperating adjusting screw that rotates the gear when the screw is adjusted to easily angularly adjust or rotate the support member to the members to secure the bone pieces segmented with the support member in small Exactly increasing predetermined amounts over a period, the means for securing the bone pieces segmented to the support member include bone nail pliers that can be linearly adjusted or moved at increasing incremental distances along the support member; device has two arms, a central union to angularly adjust the two arms and two pinz bone nail to fix at least one bone nail on each side of the segmented bone with a respective arm, the arms are attached to the central joint and adjusted or rotated angularly in planes that are oriented one different from the other, and perhaps perpendicularly, and the bone nail forceps move linearly along each bra

Description

BONE ADJUSTMENT DEVICE BACKGROUND The present invention relates generally to a bone-adjusting device that can be used to obtain bone distraction osteogenesis, particularly when used in humans. The procedure of distraction osteogenesis has been employed by orthopedic surgeons to reconstruct and lengthen the long bones in the lower extremities. This procedure involves placing a piece of tilted bone under tension "so as to induce the formation of natural bone through the creation of a bone repair callus" which is then placed under tension and generates new bone. ("Distraction Osteogenesis for the Reconstruction of Mandibular Sinfisello Defects" by Annino and coauthors). In order to perform distraction osteogenesis, a surgeon generally performs an osteotomy by sectioning or segmenting the bone to be disrupted into one or more pieces, and when the bone heals, it is slowly and gradually dilated over a period of time. time so that the blood vessels and nerve terminals remain intact during the distraction procedure. For example, the bone can be extended one millimeter per day "frequently by making two half-millimeter extensions" for three or four weeks.

Frequently these distractions are effected by adjustments made by the patient's parents or another close relative or friend. A device that has been overcome by Nor is known that can be used to effect linear distraction. This device consists of two arms, a central assembly that holds the bone nails and two bone nail clamps that can be adjusted linearly along the entire length of the two arms and also retain the bone nails. The housing assembly allows the angular relationship between the arms to be restored or reconfigured in a single plane for the particular patient "before the device is fixed to the bone pins. Once the angular configuration of the patient device arms is fixed and fixed to the bone pins, the angular relationship between the arms is fixed and the bone nail clamps are adjusted along the length of the device to effect the linear distraction. This device »although it allows for linear distractions» does not allow infinite »continuous» angular adjustments in order to obtain angular distraction osteogenesis. A device such as that described in US Pat. No. 5,160,335 is known and can be used to effect distraction osteogenesis. This device is a nail fastener support comprising a clamp for grasping the bone nails »a jaw which locates the device along a clamping bar» a deflection member for adjusting the angular position of the clamp with respect to the clamp fixing bar and a blocking means to keep the device in a desired position. This device only contemplates distraction along a single axis and does not provide angular distraction. A device is known as described in US Pat. No. 3,961,854 which can be used to orient and maintain a rod or rod in any direction. It is composed of a U-shaped element in whose arms a flange which closes the U »at least two overlapping» cylindrical »plates, one of which is rotatably engaged in the flange and the other in the element in which it is detached, is releasably secured. U-shape »the adjacent surfaces of the plates each have indentations cooperatively defining a hole for receiving the rod or rod to be oriented. This device contemplates distraction along a single axis and does not provide angular distraction. An articulation injector is known as described in French patent application No. 2 »697.994» which may be used to effect distraction or compression. This device comprises two arms mounted on a central joint "where each arm is integral with a gearwheel of a pair of gears" and the rotation movement of each arm is controlled by a second engagement component »which meshes with the gearwheel . The second gear components »illustrated as screws» are located adjacent to each other in the central joint »and in orthogonal relation» so that the arms move in two orthogonal planes. The arms can be moved at an angle of 0 to 75 ° with respect to the hollow section of the central joint. Each arm has screw clamp units that have grooves that facilitate grip on nails implanted in the bone. The device of the gear components in the central joint makes the device bulky, limiting the amount of angular rotation to the arms and limiting the manner in which the screw clamping units can be placed together. There are obvious problems with these devices known from the prior art. Such devices provide linear adjustment only and do not provide a gradual, precise and controlled angular adjustment in order to form curved bones "bent or in other intricate ways" by means of angular distraction osteogenesis. The importance of being able to form curved sections or curved portions of bones "is demonstrated by the angular distraction of the jaw that rounds the patient's bite and appropriately contours the face. In addition »these previous devices do not allow three-dimensional distraction osteogenesis» where both linear adjustment and angular adjustment can be performed, both independently or simultaneously »along each of two independent axes that define two different planes.

BRIEF DESCRIPTION OF THE INVENTION It is an object of the present invention to provide a bone disrupting device that allows angular distraction and, in particular »precise angular distraction» gradually and easily controlled, in order to achieve angular distraction osteogenesis to form a curved or bent segment of bone . It is yet another objective to provide a device that can distract both linearly and angularly both independently and / or simultaneously. It is an additional objective to provide a device that can distract both linearly and angularly "where both linear and angular distractions can be effected around two independent arms" independently or simultaneously. It is a further objective to provide a device for performing three-dimensional distraction osteogenesis. A further object of the present invention is to provide a bone-altering device that allows for gradual and accurate »controlled adjustments» for example »by the patient himself» by a relative or other person without medical training or with relatively little medical training. It is also an object of the present invention to provide a small device. Lightweight, that is easily manufactured. A further object of the invention is to provide modular bone nail clamps that accept variable numbers of bone nails of the same size or of different sizes "for example" two of 2 mm or one of 3. It is a further objective that the bone nail clamps allow the placement of the bone nails as closely as possible "for example" to a spacing of less than 10 mm »and that they hold the bone nails in line with» and close of the distraction axis. It is a further objective to provide a device that allows gradual incremental and linear adjustments independently along two different axes, advancing the linear movement and calibrating, which allows an approximate expansion of 20 mm along each axis. It is another objective to provide a device that allows incremental and angular changes »easily operated» »of the arm or arms» that lock themselves to allow undesirable angular movement or rotation. It is a further objective to provide a device with angularly adjustable or rotating »independently activated» arms that have the center of rotation of each arm close to the axis of the arm or arms »and that close to each other. It is another objective to provide an external device that can be used both for the left side and for the right side of the patient. A method to perform angular distraction osteogenesis by drilling bone nail holes in the first and second sides of a segmented bone »inserting bone pins into the bone nail holes» connecting the bone pins on each side of the segmented bone to a distraction device »and adjusting the distraction device so that the first side of the segmented bone angularly" rotates or pivots its position with respect to the second side of the segmented bone "in precise quantities. gradual and of predetermined increments "over a period of time so that the bone tissue remains healthy and the blood vessels and nerve terminals remain intact during the process of distraction with flexion. The device according to the present invention alleviates the drawbacks of the prior art devices and achieves the aforementioned objectives and is used to obtain angular distraction osteogenesis. The device includes a support member extending along a segmented piece of bone and a means for securing the first side of the bone segmented to the support member "and a second side of the bone segmented to the support member" and means for angularly adjusting » rotating or pivoting the first side of the segmented bone with respect to the second side of the segmented bone. The device of the present invention allows incremental and controlled angular »incremental» adjustments to be made easily »rotation or pivoting of the bone segments, for a period of time »by a person without medical training or with relatively little medical training. The segmented pieces of bone are secured to the device by bone pins extending out from each side of the segmented bone and are attached to the support member by bone nail clamps. The means for angularly adjusting the first and second sides of the segmented bone with respect to one another can be obtained by angular adjustment of the claw of the bone nail or of the supporting member, and include having a gear driven by an adjusting screw. The screw cooperates with the gear to angularly or rotate the support member or the bone nail clamp or a portion thereof when the screw is adjusted. The angular adjustment mechanisms are self-drilling to avoid any undesirable angular movement. The device according to the present invention may also include bone nail clamps that fit linearly along the entire length of the adjuster member (arm). This linear adjustment can be advanced in steps "for example" by means of a sphere or a protuberance that is coupled with a depression or indentation and / or can be calibrated with a measuring scale. The bone nail clamps may additionally include a locking mechanism to prevent translation or undesirable linear movement along the supporting members (or arms) and may be configured to place the bone pins in line with and close to the axis of the bone. distraction of the bone. The device of the present invention may additionally be provided with means for retaining the clamp or bone nail clamps on the support member (arm). The device according to the present invention in a different embodiment has two elongated supporting members, that is to say arms, a means for angularly adjusting these two arms, that is to say, a central joint and a means for joining at least one nail of bone to each of those two arms, that is, clamps of bone nail. Each arm can be adjusted angularly so that the free end of each arm rotates in a plane around the fixed axis of that arm. These respective planes of angular adjustment are different from each other and can be perpendicular to each other. The device according to the present invention may additionally include two separate mechanisms for adjusting angular changes or rotation of the arms, one for each respective arm; and additionally it may be provided with arm adjusting mechanisms that lock themselves in order to prevent the desired angular movement. Precise three-dimensional distraction osteogenesis can be effected by means of independent adjustments in the length and distraction angle with the device of the present invention. The distraction osteogenesis of the human jaw is an example where the ability of three-dimensional adjustment would be useful. Specifically, this invention allows linear distraction to occur concurrently along two dependent i axes. For example, when used to obtain distraction osteogenesis of the jaw, this invention can effect linear expansion independently along the body of the jaw and the branches. This invention also allows angular distraction to occur concurrently along two dependent axes. The angular distraction of the jaw allows the doctor to round off the patient's bite and properly contour the jaw line.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side elevational view of a bone extension device of the present invention; Figure 2 is a perspective view of the left arm of Figure 1; Figure 2A is an end elevational view of the left arm of the figure 2; Figure 3 is a perspective view of the right arm of Figure l Figure 3A is an end elevation view of the right arm of Figure 3 »Figure 4 is a perspective view of the center joint of Figure 1, with several parts removed, in order to show the detail »Fig. 5 is a sectional view of an assembled central joint of Fig. 1» Fig. 6 is an end elevational view of the gear of Fig. 5 »Fig. 7 is a perspective view of the left bone nail clamp of figure 1 »with portions cut out to show the detail» figure 8 is a side elevational view of the left bone nail clamp of figure 1 »when assembled on the left arm »Figure 9 is a perspective view of the right bone nail clamp of Figure 1» a portion removed to show the detail »Figure 10 is an alternative embodiment of the device according to the present invention nvention, Figure 11 is a perspective view of the arm of the device of Figure 10, with portions cut away to show the detail; Figure 12 is a perspective view of the bone nail clamp of Figure 10; Figure 13 is a side elevational view of an alternative of the device of the present invention »providing two distractions» Figure 14 is a perspective view of the angular adjustment supporting part of Figure 13 »Figure 15 is a in side elevation of an alternative embodiment of the present invention; Figure 16 is an alternative modality of the device showing an alternative configuration of the central joint shown in cross section; Figures 17 and 18 are side elevational views of alternative modalities of the device of the present invention; Figure 19 is an alternative embodiment of the device of the present invention »showing an elongated central joint; and Figure 20 is a perspective view of the arms of Figure 19. Figure 21 is a perspective view of the device of the present invention and of a prior art device »as would be used in a human jaw.

DETAILED DESCRIPTION Referring more particularly to the drawings, "Figure 1 shows the device 10 which is a preferred mode of the present invention" and which can be used for three-dimensional distraction osteogenesis, having a left arm 20. a right arm 30 »a joint 80 central. a clamp 40 of left bone nail and a clamp 60 of right bone nail. Figures 2 »2A and Figures 3» 3A. show the left arm 20 and the right arm 30 »respectively. The arms 20, 30, are L-shaped with each arm having a head segment 22, 32, which is perpendicular to the arrow 28, 38. Each arrow 28, 38, is D-shaped in cross section and has threaded segments 24, 34, along its partially cylindrical surface, and a flat key segment 26"36, both extending along the arrow 28, 38. The arms 20, 30, are substantially identical, except for the orientation of the segments 26, 36 of flat key "with respect to the head segments 22, 32. On the other hand, the flat key-shaped segment 26 faces the same direction as the head section 22 of the left arm 20» as shown in FIG. 2A, and the flat key segment 36 looks 90 ° dextrologically with respect to the head segment 32 on the right arm 30 »as shown in Figure 3A. The central joint 80 shown in Figure 4 has a housing 81, two gears 84 »94 and two screws 88, 98 angular adjustment. The central joint SO adjusts the angular reaction between the arms 20, 30. The housing 81 has two U-shaped supports 83, 93, which have respective sets of holes in pairs 82 »92» that receive and support segments 22 »32 of the respective head of the arms 20 »30. The U-shaped supports define axes of rotation for the arms 20» 30 and are oriented in such a way that the axes of rotation define differently oriented planes and »preferably, they are in perpendicular relation one with another.

The angular adjustment screws 88, 98 have threads 89, 99 and are housed within the housing member 81 adjacent to the respective gears 84, 94 »as shown in the sectional view of the center joint 80 in Figure 5. The screw 98 fits within the hole 72 of the housing member 81. The head 96 of the screw 98 is of the same size as the minimum diameter of the screw, such that the peaks of the threads 99 are larger in diameter than the head 96 of the screw 98. The axial movement of the screw 98 is restricted by the threads 99 which are retained by the lip 73 of the housing 81 and by the other screw 88 which also fits within the larger hole 72 of the housing member 81. The screw 88 has a cunferential cylindrical notch 74 which is fitted with pin 75 to restrict axial movement of screw 88 but which allows rotational movement without restrictions. Each gear 84, 98 has an arm hole 86, 96 and a serrated segment 87, 97 along at least part of its circumference. Figure 5 shows the central joint with the gear 84 fitted between the U-shaped supports 83, so that the arm bore 86 of the gear 84 is aligned with the holes in pairs 82 of the U-shaped supports 83. similarly »the gear 84 is fitted between the U-shaped supports 93, in such a way that the arm hole 96 of the gear 94 is aligned with the pairwise holes 92 of the U-shaped support 93.

The toothed segments 87, 97 of the gears 84, 94 mesh with the threads 89, 99 of the angular adjustment screws 88, 98, both for retaining the angular adjustment screws 88, 98 within the housing 81, as well as for the Angular adjustment screws 88 »98 rotate the gears 84, 94. In the preferred embodiment of FIGS. 4 and 5, the housing 81 is configured in such a way that the angular adjustment screws 88, 98 extend along the same. axis, so that both can be easily adjusted while the device is in use. In this embodiment, with the screws aligned back to back, the ends of the angular adjustment screws 88, 98 have spokes 90, 91 at their ends, so that the rotation movement is not transferable between them. In the preferred embodiment, the angular adjustment screws 88, 98 have normal machine threads 89, 99 and the gear segments 87, 97 of the gears 84, 94 have V-shaped notches or V-shaped teeth which have the same helix angle and the same pitch as the respective angular adjustment screws 88, 98. In particular, the helix angle T is the angle at which the teeth are formed in the gear with respect to their axis, parallel to the axis. axis of rotation shown in figure 6 and step p would be equal to the helix angle and the pitch of the machine screws 89, 99, of the angular adjustment screws 88, 98. In addition, the profile of the V-shaped teeth would match the machine thread profile to ensure proper alignment when the angular adjustment screws 88, 98 are rotated and the respective gears 84, 94 rotated. Alternatively »Gears 84» 94 can be common gears with teeth in the form of involution which are well known in the art, in which case the angular adjustment screws 88 »98 would be common and ordinary worm screws» configured in such a way that they couple with the teeth of the common gears. V-shaped teeth are preferred because they require less intricate machining to form co-operating gears and worm screws, and "besides" normal gears would have to be larger than V-shaped tooth gears "but then there is no they would be able to make the same precise angular adjustments »gradual and controlled» to the arms of the device. The head segments 22, 32 of the arms 20 » 30 adjust by means of holes by respective pairs 82"92 of the central joint 80 and the arm holes 86" 96 of the gears 84"94. Each respective arm 20" 30 is properly oriented and then secured to the gears 84"94 by any of many ways. In this mode »holes 85» 95 are drilled inside the gears 84 »94 and the head segments 22» 32 of the arms 20 »30» and the nails 7 are inserted therein. 17. During operation »the SB screw of angular adjustment rotates the gear 84 which finally pivots or rotates the arm 20 in a plane. Similarly, the angular adjustment screw 98 rotates the gear 94 which finally pivots or rotates the arm 30 in a plane. The plane on which the arm 20 rotates is oriented differently with respect to »and in this mode it is perpendicular to» the plane on which the arm 30 rotates. The configuration of the central joint 80 »as shown in the figure 4 »allows the two independent centers of rotation of the arms 20» 30 to be located very close to each other and within the central portion of the device. Figure 7 shows the clamp 40 of left bone nail »having a cursor 42» a head 50, a screw 56 and a wheel 46. The clamp 40 of left bone nail fits around and moves along the left arm 20. The cursor 42 has two cylindrical extensions 45 »a hole 41 (shown in Figure 9)» an extended portion 44 having a recessed surface 41 extending across the width of the slider 42 »a screw hole 49 piercing the recessed surface 41 and two diametrical notches 43» of semicircular form »spaced apart in parallel and They extend across the width of the sunken surface 41. The two cylindrical extensions 45 have D-shaped holes 47 which are configured to fit around the left arm 20. The D-shaped holes 47 are oriented in the cylindrical extensions 45 of so that the bone nails held by the left bone nail clamp 40 will remain perpendicular to the flat key segment face 26 of the left arm 20, when the nail clamp 40 The left bone moves along the left arm 20. In addition, the D-shaped holes 47 are oriented in the cylindrical extensions 45 in such a way that the extended portion 44 of the slider 42 is directed towards the central joint 80 when the clamp 40 of left bone nail is assembled on the left arm 20. The cap or head 50 has a screw hole 58 through its entire thickness and a lower surface 52 having two diametrical grooves 54 parallel »along the entire length of the width of the lower surface 52 of a partial indic acid shape. The cover 50 is screwed to the slider 42 with the screw 56 which fits in the threaded hole 58 of the cover 50 »and the threaded hole 49 of the slider 42» in such a way that the diametrical notches 43 of the slider 42 oppose the diametrical notches 54 of the lid 50 »thereby forming holes adapted to receive and retain the bone nails (not shown). The bone nails are secured to the bone nail clamp 40 by tightening the screw 56. As shown in Fig. 8, the cover 50 is preferably connected to the slider 42 by means of an ear 53. As seen in the figures 7-8, the wheel 46 fits between the two cylindrical extensions 45 of the slider 42, so that the left arm 20 can fit through the cylindrical extensions 45 and the wheel 46. The wheel 46 is threaded along the its internal circumference to be coupled with the threaded segments 24 »34 of the arms 20» 30. The left bone nail clamp 40 moves along the left arm 20 »as the wheel 46 is rotated. the rotation of the wheel 46 »can be provided notches or threads along its external surface. When the wheel 46 is rotated in one direction, the left bone nail clamp 40 moves away from the center joint 80 (see Figure 1) and inversely when the wheel 46 is rotated in the opposite direction the clamp 40 of the left bone nail moves towards the center joint 80. Due to the coupling of the left arm 20 with the D-shaped holes 47 of the cylindrical extensions 45 »the clamp 40 of left bone nail can not rotate around the left arm 20. Figure 9 shows the right bone nail clamp 60 which is substantially identical to the left bone nail clamp 40 except that the D-shaped holes 47 of the cylindrical extensions 45 are oriented differently (as shown in FIG. sample), so that the extended portion 44 of the cursor 42 of the right bone nail clamp 60 is directed toward the center joint 80 when the bone nail clamp 60 is assembled. right »on the right arm 30. The device of the present invention of ZO Preferably it has a stepwise advancing aspect so that the bone nail clamps can be moved along the arms in predetermined increments. One way to provide this stepwise advancement aspect is to provide a small hole 41, as shown in Figure 9 »between the two cylindrical extensions 45 of the slider 42» which is equipped with a spring 55 and a small sphere 58. The wheel 46 is provided with several indentations or depressions 51 'in this embodiment 4, which are spaced equidistantly along its outer circumferential surface' which engage the sphere 58 to provide a remarkable sensation and / or a remarkable sound 'in a manner that when the wheel 46 turns from one indentation 51 to the next, a known linear adjustment occurs along the length of the arms 20 »30. In addition» the flat key segments 26 of each arm 20 »30» can be marked in the manner shown so that the linear distance traveling clamps 40 »60 of bone nail along the arms 20» 30 »can be measured. The device of the present invention is also preferably provided with means for retaining the bone nail clamps on the arms. It is understood that many ways can be used to obtain this aspect "for example" altering the threaded segment at a point on the free end of the arms 20 »30, so that the threads on the wheels do not mesh properly with the threads on the threads. the arms 20 »30. Another means would be to provide a cap or other similar securing mechanism, as is well known in the art, which engages with the threads on the arms and acts as a limiter. The preferred means for retaining the clamps in the device of the present invention is to flare the ends of the arms 20, 30 »in order to stop and damage the threads in the arms. The central joint 80 may also be configured as shown in Figure 1, to retain the bone nails, for example, by making the holes 71 for receiving the bone nails and the fixing screws 76 retain the bone nails. in the holes 71, fixing them in this way to the central joint 80. It is understood that other ways of retaining the housing in the bone nail can be used such as, for example, using two plates with opposite diametrical notches and holding them together. as described with reference to clamps 40, 60 of bone nail. By configuring the center joint 80 to retain the bone nails »more than one distraction can occur, such as a distraction between the center joint 80 and the arm 20, as well as the center joint 80 and the arm 30. In addition, the arms 20 , 30 may be equipped with more than one bone nail clamp each, so that multiple linear distractions may occur such as a bone transport. Without intending to establish limitations "and only for illustrative purposes", the central joint can be configured in such a way that the center of rotation for each arm is within 5 mm of the other. The bone nail clamps can be configured to retain two 2 mm nails or a 3 mm nail "and the diametrical grips of the bone nail clamps can be at a distance of IO mm. The device can allow linear expansion up to ZO mm along each arm »and an angular movement up to 120 °. It is contemplated »that the device is made of stainless steel» with the angular adjustment screws formed of 455 HT »the housing» the arms »the cursor and the cover formed of 17-4 and the gears and the wheels formed of stainless steel» Gal l-Tough ™, made by Carpenter Technology Corporation for its characteristics of wear resistance and self-lubrication. Although the device »in its preferred form, has been described with two arms, it should be understood that the use of a single arm or of several arms is also contemplated, ie, more than two. For example, the alternative embodiment of Figure 10 illustrates an angular distraction device having a single arm. Figure 10 shows the device 110 that can be used to perform angular and linear distraction osteogenesis, having an arm 120, a left bone nail clamp 140 and a right bone nail clamp 160, having an assembly 180 of angular adjustment. The arm 120 has a core member 122, a cylindrical shaped telescoping member 124 which slides along the core member 122 and a length adjustment screw 126. The core member 122 has a threaded hole 161, having internal thread, into which fits and engages a length adjusting screw 126. A collar 125 in the telescoping member holds the length adjustment screw 126 on the member. telescopic, so that it can not move axially, but allows the screw 126 to rotate freely. The length adjustment screw is rotated so as to adjust the length of the arm 120. As shown in Figure 11, the external shape of the core member 122 is of non-circular cross-sectional shape and can be axysymmetric, and is coupled with the internal shape of the telescopic member 124, to prevent rotation of the telescopic member 124 around the core member 122. The left bone nail clamp 140 has two plates 145, 155"each of which has a central hole 146, 156 and two diametrical notches 143, 153 »spaced in parallel and extending the full width of the plates 145, 155. The plates 145, 155 are configured on the arm in such a way that the diametrical notches 143 oppose the notches diameters 153 to form holes adapted to receive and retain the bone nails (not shown). The left bone nail clamp 140 is fixed to the arm 120, so that it does not rotate or translate linearly along the arm 120. The manner of attaching the left bone nail clamp 140 to the arm 120 of Figure 10 is by providing threads 127 along the end portion of the left end on the arm 120 »and by having a nut 142 hold the plates 145» 155 in place. In particular »the nut 142 is fitted on the threaded portion 128 of the arm 120 and the plates 145» 155 are placed on the arm 120 by fitting the threaded portion 128 through the central holes 146, 156. The threaded portion 128 of the arm 120 It has a non-circular cross section and has a smooth portion that has no threads, which prevents the plates from rotating. After the nut 142 and the plates 145 »155 are placed on the arm 120» a limiter 129 is provided at the distal end. left arm 120 to allow plates 145 »155 to detach from arm 120. During e. func tioning »the bone nails are placed in the holes formed by the diametrical notches 143» 153 and the nut 142 is rotated to clamp and fix the bone nails in the plates 145 »155 and the plates 145» 155 to the arm 120 The right bone nail clamp 160 of FIGS. 10 and 12 has two supporting members 165 and a cylindrically shaped hole 167 formed between the supporting members 165 which the telescopic member 124 receives from the arm 120, so that it can sliding along the telescopic member 124. A threaded hole 127 extends through both of the supporting members 165 and receives a screw 1Z8 that can be tightened to fix the bone nail clamp 160 on the telescopic member 124.

Loosening the screw 128 allows the bone nail clamp 160 to be placed along the entire length of the telescoping member 124. The right bone nail clamp 160 also contains an angular adjustment assembly 180. The angular adjustment assembly 180 has an angular adjustment screw 198 and two nail securing plates 162, 172. The angular adjustment screw 198 is similar to, and may be identical to the angular adjustment screw 88 described in FIGS. 4 and 5. The two nail fastening plates 162, 172, have a circular shape along a portion. of its perimeter 163, 173 and are formed with V-shaped teeth 185, 195 similar to those described in figures 4-6. Angular adjustment screw 198 and V-shaped teeth 185, 195 are configured to cooperate and engage with each other as previously described when reference was made to angular adjustment screw 88 and gear 84 in Figures 4 to 6 , such that when rotating the screw 198 the plates 162, 172 are angularly adjusted. The nail securing plates 162 »172 are angularly adjusted in unison. The nail fastener plates 162, 172 are also formed with two diametrical notches 166, 176, each fixed spaced in parallel and extending the full width of the nail securing plates 162, 172. Each nail securing plate 162. 172 also it may be provided with a screw hole 167 extending therethrough throughout its thickness and which is adapted to receive a threaded pin 168. The nail securing plates 162, 172 are disposed on the threaded pin 168 such that the diametrical notches 166 oppose the diametrical notches 176 to form holes for clamping the bone nails. A nut 169 is screwed onto the threaded pin 168 to press the plates 162, 172 together to hold the bone pins. However, the threaded pin 168 allows the plates 162-172 to be angularly adjusted around the pin 168 when the plates are tightened together by means of the nut 196. The modality shown in Figure 13 can be used to effect two distractions and has two arms 220"a central joint 270 and clamps 240, 260 of bone nail. The arms 220 are identical and each has a core member, a telescoping member that slides along the core member and a length adjustment screw, as described with reference to Figures 10 and 11. Each clamp 240, 260, of bone nail is also equal to the bone nail clamp 160 described in Figures 10 and 12. Both arms 220 are connected to the center joint 270 by means of the angular adjustment supporting piece 275, which is shown in Figure 14. The central joint 270 has two bone nail holes 207 for receiving the bone nails and two set screws 208 for clamping the bone nails into the holes 207 and attaching them to the center joint 270. The angularly adjustable supporting part 275 has two U-shaped bearing extensions 276, with circular holes 277 configured to receive the shaft 280 and a U-shaped engaging section 271, which has a portion that is perimeter. circular river. The engagement section 271 has a hole 273 and U-shaped teeth 272, as previously described with respect to Figures 4-6, formed along its circular perimeter. The angular adjusting supporting part 275 has a hole 284 which receives the angular adjustment screw 285. A pin and a notch similar to those described with reference to FIGS. 4 to 6 are used to retain the screw 285 in the supporting part. angular adjustment, while allowing rotation. The arms 220 are provided with ends having a disc-shaped perimeter 283, with teeth 282 formed therein, similar to the engaging section 271 of the part angular support 275. The arm 220 is provided with a hole 284 (not shown) configured to receive the shaft 280. The circular perimeter 283 of the arm 220 is inserted between the U-shaped bearing extensions 276 and the angular adjustment part 275 » so that the hole 284 is aligned with the circular holes 277 and the axis 2SO is inserted there. The arm 220 can be fixed to the shaft 280 in many ways and in this fashion is fixed by drilling a hole through the circular perimeter 283 and the shaft 280 and using pin similar to that used in the preferred embodiment described in figures 1-6. The V-shaped teeth 282 on the arm 220 engage and cooperate with the threads of the angular adjustment screw 285 so that when the screw 285 is rotated the arm 220 is angularly adjusted or rotated with respect to the adjustment part 275 angular. The central joint 270 has two sets of supports 265 U-shaped, a set at each end which is used to connect the supporting part 275 of angular adjustment to the central joint 270, in the same way that the arm 220 is connected to the supporting part 275 of angular adjustment. In particular, the U-shaped supports 265 with circular holes 267 are provided, configured to receive the cylindrical shaft 290. The engagement section 271 of the angular adjustment supporting part 275 is received in the central joint 270 between the set supports in U-shape 265. The shaft 290 is inserted through the hole 267 in the center joint 270 and the hole 273 in the angular adjustment supporting piece 275. A pin, similar to pin 7 of FIG. 4, is used to secure the supporting part 275 of angular adjustment to the central joint 270. Furthermore, the central joint 270 has two holes 274 formed at its ends and in proximity to the supports 265. U-shaped to receive angular adjustment screws 295. Angular adjustment screws are received in holes 274 and retained there by means of a pin and a notch as described with reference to Figures 4-5. The threads on the angular adjustment screw 295 cooperate with and mesh with the V-shaped notches 272 in the angular adjustment supporting piece 275, so that the rotation of the screw 295 angularly adjusts the angular adjustment supporting piece 275. It should be understood that Figure 12 has been described with reference to a double angular adjustment mechanism, but that a single angular adjustment mechanism can be provided by connecting the arm with its disk-shaped circular perimeter and the V-shaped teeth in its end directly between the U-shaped extensions 265 and the central joint 270, with an axis. It should also be understood that only one arm 220 is used with the mechanism of a single angular adjustment or double angular adjustment and / or with or without the angular adjustment mechanism incorporated in the bone nail clamps 240, 260. In the alternative embodiment of Figure 15, device 210 is substantially equal to device 10 except for minor differences that are now to be described. In the embodiment of Figure 15 the arms 320 are fixed to supports 387. Each support 387 contains and retains angular adjustment screws 388 »389» in the manner described with reference to Figures 4 and 5. Gears 384 »385 are provided ( not shown) and they are both semicircular and fixed to each other. The brackets 387 are retained on the gears 384 »385 by cylindrical shafts 317» 327 (not shown) that allow the brackets 387 and the arms 320 to rotate about their respective gears 384, 385. The gears are oriented in different planes and in the embodiment of Figure 15 are perpendicular to each other, so that the arms 320 rotate in perpendicular planes. The gears 384, 385 are provided with V-shaped teeth which are shown and described with reference to FIGS. 4-5 »which cooperate with the common machine threads in the angular adjustment screws 388, 398, respectively» of so that rotation of the screws angularly adjusts the arms 320 around the respective gears 384 »385. The bone nail clamps 340, 360 are similar to the bone nail clamps 40, 60 of the preferred embodiment. However, the bone nail clamps 340, 360 in FIG. 15 have U-shaped staple clips 370 to prevent the wheel 346 from rotating and thereby holding the bone clamps 340, 360 in a position fixed with respect to the arms 320"330. As shown in Figure 15, each U-shaped stapler 370 is attached at one end to the cylindrical extension 345 and extends through and in contact with the wheel. 346. The shape and configuration of the U-shaped staple insurer is such that it is deviated or loaded towards the wheel 346. The wheel 346 is provided with notches 347 and the U-shaped staple belay has an extension 375 where makes contact with the wheel 346 in order to engage with a notch 347 and hold the wheel in place. The driving force between the free end of each of the U-shaped staple insurers 370 and wheel 346 is such that wheel 346 will be held firmly in place., but will be overcome if sufficient force is applied to the wheel 346. In addition, the portion of the bone pin clamps 340, 360, which holds the bone pins is light »and slightly different in the embodiment of Figure 15 with respect to to the modality of figures 7-9. The sunken surface 34.1 extends through the entire slider 342 and the lid 350 covers the entire upper part of the slider 342. The screw 356 is displaced from the bone nail slots 378 and secures the lid 350 to the slider 342 to secure the nail or bone nails. In the alternative embodiment of Figure 16, the device 410 is substantially the same as the preferred embodiment shown in Figure 1, except for minor differences in the left arm 420 and the center joint 480, which will be described. The central joint 480 in Figure 16 is shown in dissection to reveal its internal components. There is only a U-shaped support 493 in the central form 480 »which is configured in such a way that angular adjustments can be made to the right arm 430, by means of the adjusting screw 498 in correspondence with the gear 494, as shown in FIG. described substantially in the embodiment of Figure 1. However, instead of the second U-shaped support, the central joint 480 shown in Figure 16 has an extended, sandwich support 483 having a pivot corner 411, a corner 413 of adjustment and a distal corner 412. The sandwich bracket 483 has an inner layer 414 and an outer layer 415 and accommodates the angle adjustment screw 488 in the adjustment corner 413, and the V-fit 484 between the inner layer 414 and the outer layer 415. The inner layer 414 is the mirror image of the outer layer 415. The V-gear 484 has teeth or notches 487 and is retained within the sandwich support by an axle 417 at the pivot corner 411. The threads 489 of the screw 488 are engaged with the teeth 487 in the 484 V-gear. Angular adjustments can be made to the left arm 420 by rotating the angular adjustment screw 488, which rotates the V-gear 484, which is connected to the left arm 420. When the gear 484 in V »is rotated it moves in and out of the sandwich support 483. The configuration of the center joint 480 minimizes the distance between the pivot points of the two arms and places the points of rotation as close as possible. The alternative embodiment shown in Figure 17 is substantially the same as the device described in Figure 1. However, the center joint is structured in such a way that the angle adjustment screws 588, 598 are perpendicular to each other. The bone nail clamps 540, 560 are similar to 1 as shown in Figure 15. The alternative modality shown in Figure 18 is substantially the same as that shown in the embodiment of Figure 17. However, the joint 680 is configured in such a way that the angular adjustment screw 688 fits inside the central seal 680 on the other side of the gear 684. This configuration makes the central seal 680 more compact in FIG. 18, than the central joint 5BO of the Figure 17. In the alternative embodiment of Figure 19, the arms 720, 730 are identical to those shown in Figure 20, wherein each head segment is directly connected to the gear 784. The arms 720, 730 rotate about the axes of rotation »in such a way that the planes of rotation of each arm are perpendicular to each other. The central joint 780 is structured in such a way that the screws 788"798 are located in a different position to the gear and" in particular "are perpendicular to each other. The clamps 740, 760 of Figure 19 are essentially similar to the bone nail clamps 40, 60 of Figure 1, since the cylindrical extensions 745, the D-shaped holes 747 and the wheels 746 are equal. However, due to the extended linear nature of the 780 central joint, the extended portions 744 of the bone nail clamps 740, 760 must extend further away from the cylindrical extensions 745, than the extended portions 44 of the bone nail clamps 40, 60 »so that the nail clamps of bone 740, 760 can adjust over the bone nails that are placed close together, as at the beginning of the distraction. Additionally, the sunken surface 741 of the cursor 742 has a V-shaped notch 743 and the lid 750 has a semicircular notch 754. It should be understood that the cross-sectional shapes of the notches 743, 754 can be inverted. The V-shaped notch 743 of the slider 742 opposes the semicircular notch 754 to form an adjustable hole 758 in the bone nail clamps 740, 760 »to retain the nail or the bone nails of different size, either a 2 mm or 3 mm bone nail. The bone nail clamps 740 »760 are secured to a bone nail by aligning the bone nail in the adjustable hole 758 and tightening the screw 756. Figure 21 shows the device of the present invention 10 on the left» in comparison with a linear distraction device known to the right »as would be used to perform distraction osteogenesis of a human jaw. The device of the present invention has particular utility when angular distraction is necessary in order to bend the bone or form curved bone, such as in the jaw in order to round the face and provide an appropriate bite. The ability to adjust the arms one with respect to the other, which is provided by the device shown on the left side of Figure 21 »allows the bone to bend or bend to its proper shape. The advantage of the device of the present invention is that it can perform distraction osteogenesis both linearly and angularly »both independently and simultaneously» and depending on the modality »it can perform linear and angular distraction» around two independent axes »defining defined planes of different way »thus providing three-dimensional distraction. The device of the present invention is used by drilling at least one bone nail hole on both sides of the segmented bone or "where an osteotomy is intended to be performed" in a manner known in the art. The bone nails are grafted into the perforated bone nail holes so that a portion of each bone nail extends from the bone. In particular »the bone pins 5 are inserted and fixed on a first side of a segmented bone» and the bone pins 5 are inserted and fixed on a second side of a segmented bone »and the distraction device is connected . The bone nail clamps are fitted over the outer segments of bone nail, so that at least one bone nail fits through each of the bone nail clamps in the arm or arms of the device. A template can be used to adjust the device before mounting it on the bone nails. With reference to the distraction device of figure 10, the bone nail clamps 40 and 60 are then tightened so that the device is firmly connected to the bone nails. Linear distraction is performed by gradually moving the bone clamp clamps 40 »60 at some distance along the arms 20» 30 »by rotating the wheel 46. It is contemplated that the linear distraction of about 1 mm per day will occur when suffering distractions of half a millimeter twice a day. It is further contemplated that these adjustments will be made by the patient, by the parents or other persons, not necessarily with medical experience. The angular distraction is carried out by making small angular adjustments to the arms 20, 30 of the device by turning the screws 88 »98. It is further contemplated that the patient, parents or other individuals not necessarily with medical experience adjust the device angularly according to the with the doctor's instructions. It is understood that pure angular distraction can occur without suffering any linear distraction osteogenesis. The angular adjustment of the arm occurs gradually, incrementally, and precisely, in a controlled and predetermined manner, over a period of time, so that the bone remains healthy and the blood vessels and nerves remain intact. Additionally, it is understood that linear and angular adjustments may occur concurrently or separately.

The invention has been described herein in considerable detail "both as regards the preferred embodiment and various alternative embodiments" in order to allow those skilled in the art to manufacture and use the device according to the present invention. . However, it is understood that this invention can be carried out by means of different devices having various modifications with respect to the modalities described herein, without departing from the scope of the invention itself.

Claims (29)

NOVELTY OF THE INVENTION CLAIMS

1. - A device for obtaining angular distraction osteogenesis in a segmented piece of bone »characterized in that it comprises: a central joint» a first arm and a second arm having two axes of respective rotation and connected to the central joint; means for securing a first side of the bone segmented to the first arm; means for securing a second side of the segmented bone to the second arm; means for independently and angularly adjusting the first arm with respect to the second arm »comprising a first gear having a radius and means for rotating the first gear; and means for independently and angularly adjusting the second arm with respect to the first arm »comprising a second gear having a radius and means for rotating the second gear; wherein the shortest distance between the axes of rotation of the first and second arms is less than the sum of the first gear radius and the second gear radius.

2. The device according to the rei indication 1 »further characterized in that the means for rotating the first gear comprises a first angular adjustment screw and the means for rotating the second gear comprises a second angular adjustment screw.

3. - The device according to claim 2. further characterized in that at least one angular adjustment screw is self-locking to prevent undesirable angular movement.

4. The device according to claim 1 »further characterized in that it additionally comprises means for linearly translating the position of the at least one bone securing means along the length of the respective arm.

5. The device according to the re-indication 4 »further characterized in that it additionally comprises means for measuring the linear translation of the bone securing means along the length of its respective arm.

6. The device according to claim 5 »further characterized in that the translation measuring means comprise scale frames along the length of the arm.

7. The device according to claim 4 »further characterized in that it comprises means for locking the linear translation means to prevent undesirable linear movement of the bone securing means along the length of the arm.

8. The device according to claim 4 »further characterized in that it comprises means for retaining at least one bone securing means in its respective arm.

9. The device according to the rei indication 1 »further characterized because it is configured and adapted for use as an external bone distraction device.

10. The device according to claim 1 »further characterized in that the means for independently and angularly adjusting at least one arm are contained within the central joint.

11. The device according to claim 2, further characterized in that the first angular adjustment screw is in direct meshing engagement with the first engagement and the second angular adjustment screw is in direct meshing engagement with the second engagement.

12. The device according to claim 11, further characterized in that at least one angular adjustment screw has common machine threads and at least one gear has V-shaped teeth, configured to mesh with the threads of machine, so that the rotation of the screw rotates the screw.

13. The device according to claim 1, further characterized in that the first arm adjusts angularly in a plane oriented differently to the second arm.

14. The device according to claim 13 »further characterized in that the first arm adjusts angularly in a plane that is perpendicular to the plane formed by the angular adjustment of the second arm.

15. The device according to claim 2, further characterized in that the two angular adjustment screws are aligned along the same axis.

16. The device according to claim 1, further characterized in that the central joint, the first arm and the second arm each contain means for securing bone pins to a segment of bone.

17. The device according to claim 16, further characterized in that it additionally comprises a second means for securing bone nails to the first arm.

18. A method for performing angular distraction osteogenesis of a human jaw "characterized in that it comprises the steps of: (a) drilling a bone nail hole in the bone of the first and second sides of a segmented jaw; (b) inserting bone nails into the holes for bone nail drilled in the segmented jaw; (c) joining at least one bone nail on the first side of the segmented jaw to a first arm of a distraction device »(d) joining at least one bone nail on the second side of the segmented jaw to a second arm of the distraction device; and (e) angularly adjusting at least one of the two arms of the distraction device with respect to the other of the two arms "in a controlled and accurate" slow manner so that the bone portion on the first side of the Segmented jaw moves angularly relative to the portion of bone on the second side of the segmented jaw.

19.- The method according to the claim

18"further characterized in that the dialysis device comprises: a support member for extending through a segmented piece of bone; first means for securing at least one bone nail on the first side of the segmented bone to the support member; second means for securing at least one bone nail on the second side of the segmented bone "to the support member" and means for angularly adjusting the nail or the bone pins on the first side of the segmented bone "with respect to the nail or pins of the bone. bone on the second side of the segmented bone.

20. A device for obtaining distraction osteogenesis "characterized in that it comprises: a first elongate supporting member; a second elongate support member; means for securing at least one bone nail to the first elongate support member; means for securing at least one bone nail to the second elongate support member; and an adjusting means for independently and angularly adjusting the first elongate support member with respect to the second elongate support member "so as to bend the bone in a way that the bone tissue remains healthy and the blood vessels and nerve terminals remain intact during the process of bending; wherein the adjusting means comprises a first gear having V-shaped teeth and a first angle adjusting screw having common machine threads; the first angular adjusting screw is in contact with and meshes with the V-shaped teeth of the first gear »such that the rotation of the first angular adjusting screw angularly fits the first elongated bearing member.

21. A device according to claim 20 »further characterized in that the adjusting means further comprises a second gear having V-shaped teeth and a second angular adjusting screw having common machine threads; the second angular adjusting screw is in engaging engagement with the V-shaped teeth of the second engagement »so that the rotation of the second angular adjustment screw angularly fits the second elongate support member.

22. The device according to claim 21 »further characterized in that the first elongated support member angularly fits in a first pland the second elongated support member angularly adjusts in a second pl the first plbeing oriented differently with respect to the second pl

23. The device according to claim 22 further characterized in that the first angular adjustment plis perpendicular to the second angular adjustment pl

24. The device according to claim 23 »further characterized in that the two angular adjustment screws are arranged along the same axis.

25. The device according to claim 20, further characterized in that it further comprises means for linearly adjusting the position of at least one of the bone nail securing means along the length of its respective elongated supporting member.

26. The device according to claim 25, further characterized in that the means for securing the nail or the bone nails to the first elongate supporting member comprises a bone nail clamp having two extensions provided with holes, a wheel provided. from a hole and means to secure the nail or the bone nails to the bone nail clamps; the wheel being adjusted between the two extensions and the arm being fitted in the holes provided in the two extensions and in the wheel.

27. The device according to claim 26, further characterized in that the means for linearly adjusting the bone nail securing means comprise threaded portions in the respective elongate supporting member and threads in the wheel.; the threaded portions in the elongate support member engage with the threads in the wheel to provide linear movement of the securing means of the bone nails along the respective elongate supporting member.

28. The device according to claim 27, further characterized in that the bone nail clamp has a spring with a sphere provided therein, in a hole located between the two extensions and the wheel has predetermined indentations, equi-spaced as along its outer circumference; the indentations being configured to fit lightly with the sphere as the wheel rotates.

29. The device according to the rei indication 2B, further characterized in that the bone nail clamp comprises means for holding bone nails of various sizes. 30.- An external device, bone lengthener »for performing three-dimensional distraction osteogenesis, characterized in that it comprises: a first arm having a head segment and an ar a second arm that has a head and arsegment; a central joint that has two angular adjustment screws, two supports and two gears; the first support forms an axis of rotation for the first arm and is configured to receive the first gear and the head segment of the first arm; and the second support forms an axis of rotation for the second arm and is configured to receive the second gear and the head segment of the second arm; the axis of rotation of the first arm is different from the axis of rotation of the second arm, and the screws are arranged to be adjacent to and in engaging engagement with the respective gears, in such a way that rotation of the first screw rotates the first gear and adjusts angularly the first arm; and the rotation of the second screw rotates the second gear and angularly adjusts the second arm; a first bone nail clamp set in and linearly adjustable along the length of the first arm; and a second bone nail clamp set in and linearly adjustable along the length of the second arm; wherein each bone nail clamp comprises two cylindrical extensions provided with holes; a wheel provided with a hole; and means for securing the bone nails to the bone nail clamps; where the wheel is fitted between the two cylindrical extensions and the arm is fitted in the holes provided between the two cylindrical extensions and the wheel. 31.- The device according to the rei indication 30 »further characterized in that the axis of rotation of the first arm is perpendicular to the axis of rotation of the second arm. 32. The device according to claim 30 »further characterized in that the first and second arms are integrally connected to their respective meshing. 33. The device according to claim 30, further characterized in that it further comprises means for retaining at least one of the bone nail clamps in at least one of the arms. 34. The device according to claim 33 »further characterized in that the bone nail clamp restoring means includes an immovable lifting cap» secured to the arof the arm to prevent the bone nail clamp from falling from the arms . 35.- The device according to claim 30 »further characterized in that the ar of the first and second arms have threads» and the internal surface of the wheels has threads, the threads of the arms are coupled with the threads of the wheels for provide linear translation of the bone nail clamps along the length of the arms. 36.- The device according to claim 35, further characterized in that the wheel of at least one of the bone nail clamps is provided with indentations along predetermined, equal, angular positions along its circumference. a »at least one of which cooperates with a protrusion in the cylindrical extension of the bone nail clamp» so that the predetermined linear adjustments of the bone nail clamp can be determined.

37. - The device according to the re-indication 30, further characterized in that it further comprises means for angularly orienting the bone nail clamps on the arms, so that both clamps are properly oriented with the bone pins extending from the bone . 38.- The device according to claim 37, further characterized in that the means for angularly orienting the bone nail clamps include the first and second arms of non-circular section, cooperating with the respective non-circular holes in the cylindrical extensions of the claws of bone nail. 39.- The device according to claim 30, further characterized in that the means for securing the nail or the bone nails to the bone nail clamps comprises: a bone nail clamp portion having at least one notch semicircular; a cover plate having a V-shaped notch; and a screw for connecting the cover plate to the bone nail clamp portion, the cover plate being adjustably secured so that the semicircular notch opposes the V-shaped notch to provide a hole that is adapted for secure the bone nail. 40.- A device capable of performing linear osteogenesis and angular osteogenesis in order to effect a bone shape correction in a three-dimensional curve "while the device is in place in a patient" characterized said device because it comprises: (1) a piece central "(2) a first arm having a first longitudinal axis and a first lever arm having a first lever arm axis» substantially perpendicular to the first longitudinal axis; (3) a first clamp connected to the first arm to hold first bone nails; the first clamp being linearly adjustable along the first longitudinal axis; (4) a second arm having a second longitudinal axis and a second lever arm having a second lever arm axis »substantially perpendicular to the second longitudinal axis; (5) a second clamp connected to the second arm to hold second bone nails; the second clamp being linearly adjustable along the second longitudinal axis; wherein the first arm and the second arm are positioned within the central part and are rotatable and lockable independently of each other at independently selected, spaced positions, so as to form an incremental angle modifier! to modify the angle α between the first bone nails of the first clamp and the second bone nails of the second clamp »and to modify the angle between the first and second longitudinal axes. 41. A device according to claim 40, further characterized in that the first lever arm axis is substantially perpendicular to the second lever arm axis. 42.- A device according to the rei indication 41 »characterized in that the first arm is rotatable within a plane P and at an angle ß between about 0 ° and about 180 °» when measured from the second arm, inside the plane P-,; and wherein the second arm is independently rotatable within a plane w and an independent gamma angle between about 0o and about 180 ° »when measured from the first arm within the plane P_., and wherein the plane 9 is substantially perpendicular to the JJ plane. 43.- A device according to claim 42, further characterized in that the second lever arm axis and the first lever arm axis are spaced only slightly at a distance of only about 0 mm to 10 mm »and where the gamma angle and the beta angle are independent and extend between about 0o and about 135o. 44.- A device characterized in that it comprises: (1) a central part that houses a first arm for holding a first clamp for holding first bone nails and a second arm for holding a second clamp for holding second bone nails; wherein the first arm has a first longitudinal axis and the second arm has a second longitudinal axis; and (2) an incremental angle modifier! operable in combination with the first arm and the second arm »and modifying and locking the operating angle between the first longitudinal axis of the first arm and the second longitudinal axis of the second arm, in any selected plane of a multiplicity of planes extending within a hemisphere a multiplicity of times while the device is in place in the patient "so that a bone correction is made in a curved bone. 45.- A device according to claim 44, further characterized in that the angle modifier increases! it comprises a first thread of ordinary and common bone and a first worm gear, which are operable together in combination and extend into a first plane, and a second common thread of bone and a second worm gear, which are operable together in combination and they spread in the background; wherein the first plane and the second plane are substantially perpendicular, and wherein the angle of operation between the first clamp arm and the second clamp arm is an angle or selected such that the angle 6 extends within a hemisphere . 46.- A device for obtaining distraction osteogenesis, characterized in that it comprises: a first elongated support member having a rotation axis; a second elongate support member having a rotation axis; means for securing at least one bone nail to the first elongate supporting member, the securing means comprising a bone nail clamp having two extensions provided with holes, a wheel provided with a hole and means for securing the nail or the nails from bone to the bone nail clamp; the wheel being adjusted between two extensions and the arm adjusted in the holes provided in the two extensions and the wheel; wherein the bone nail clamp has a spring with a sphere provided thereon in a hole located between the two extensions "and the wheel has two predetermined indentations" equispaced along its outer circumference; the indentations being configured to fit easily with the sphere as the wheel rotates; means for securing at least one bone nail to the second elongate support member; means for independently and annularly adjusting at least one of the first and second elongate supporting members to the other supporting member, in order to bend the bone in such a way that the bone tissue remains healthy and the blood vessels and the nerve terminals remain intact during the bending procedure; and means for linearly adjusting the position of at least one of the bone nail securing means along the entire length of its respective elongated supporting member which comprises threaded portions in the respective arm and threads in the wheel. the arm is engaged with the threads on the wheel to provide the linear movement of the bone nail securing means, along its respective elongate supporting member. 47.- The device according to claim AG, further characterized in that the bone nail clamp comprises means for holding various sizes of bone nail. 48. A device according to claim 1, further characterized in that the distance between the axes of rotation of the first and second arms is around 0 mm to 10 mm. 49.- A device according to claim 1, further characterized in that the first arm has a substantially L shape. 50.- A device according to re-indication 1, further characterized in that the first arm is angularly adjustable on a scale Approximately 0o to 135 °. 51.- The device according to claim 50, further characterized in that the first arm is angularly adjustable on a scale of approximately 0 to 120 °. 52. The device according to claim 2, further characterized in that the distance between the axis of rotation of the first arm and the second arm is approximately 0 mm to 10 mm, and the two angular adjustment screws are aligned along of the same axis. 53. A device according to claim 20, further characterized in that the first elongate supporting member is angularly adjustable on a scale of approximately 0 to 135 °. 54.- The device according to claim 53 »further characterized in that the first elongated support member is angularly adjustable on a scale of approximately 0 to 120 °. 55.- A device according to claim 21 »further characterized in that the first and second elongated supporting members have two respective rotation axes; each of the first and second gears has a respective radius "and wherein the shortest distance between the two respective axes of rotation is less than the sum of the first gear radius and the second gear radius. 56.- The device according to claim 54 »further characterized in that the first elongated support member is substantially L-shaped. 57.- The device according to claim 56» further characterized in that the angular adjustment screws are aligned to the length of it. 58.- A device according to claim 30 »characterized in that each of the first and second gears has a respective radius and the shortest distance between the axis of rotation of the first and second arms is less than the sum of the first gear radius and the second gear radius. 59.- The device according to claim 30 »further characterized in that the two gears have V-shaped teeth and the two angular adjustment screws have common machine threads» the two angular adjustment screws are in contact with and they mesh with the V-shaped teeth of the two gears respectively »so that the rotation of the first angular adjustment screw angularly adjusts the first arm» and the rotation of the second angular adjustment screw angularly adjusts the second arm. 60.- The device according to claim 30 »further characterized in that the first arm is adjustable angularly on a scale of approximately 0 ° to 135 °. 61.- A device according to claim 60 »further characterized in that the first arm is angularly adjustable on a scale of approximately 0 to 120 °. 62.- A device according to claim 30 »further characterized in that the two angular adjustment screws are disposed along the same axis. 63.- A device in accordance with the re vindication 40, further characterized in that the first arm is adjustable angularly on a scale of approximately 0 ° to 135 °. 64.- The device according to claim 63, further characterized in that the first and second arms are angularly adjustable each on a scale of approximately 0 to 120 °. 65.- The device according to the reference 40, further characterized in that the angle modifier increases! it comprises at least one gear with V-shaped teeth and at least one angular adjustment screw with common machine threads which are arranged to make contact and mesh with the V-shaped teeth in the gear, so that the Angular adjustment screw rotation adjust angularly at least one of the arms. GG.- A device for obtaining angular distraction osteogenesis in a segmented piece of bone, characterized in that it comprises: a first arm; a second arm connected to the second arm; means for securing the first side of the bone segmented to the first arm; means for securing the second side of the segmented bone to the second arm; a first gear and a first angle adjusting screw for angularly adjusting the first arm with respect to the second arm; and a second gear and a second angular adjustment screw for angularly adjusting the second arm with respect to the first arm; wherein the two angular adjustment screws are aligned along the same axis.

67. - A device for obtaining angular distraction osteogenesis in a segmented piece of bone, characterized in that it comprises: a central joint a first arm and a second arm connected to the central joint; at least two bone nails; a first bone nail clamp located on the first arm, to secure at least one bone nail to a first side of the segmented bone; a second bone nail clamp located in the second arm, for securing at least one bone nail to a second side of the segmented bone; means for independently and angularly adjusting the first arm with respect to the second arm, comprising a first gear and a means for securing the first gear; and means for independently and angularly adjusting the second arm with respect to the first arm, comprising a second gear and a means for rotating the second gear »wherein at least one bone nail clamp comprises an angular adjustment assembly for angularly adjusting the at least one bone nail with respect to the bone nail clamp. 68.- The device according to claim 67, further characterized in that the angular adjustment assembly comprises two nail clamp plates, adapted to hold bone nails between them and an angular adjustment screw with machine threads, wherein the two nail clamp plates have V-shaped teeth formed in at least a portion of their parameter that mesh with the machine threads of the angular adjustment screw, such that the rotation of the angular adjustment screw angularly adjusts the nail clamp plates. 69.- The device according to claim 6B »further characterized in that the first nail clamp plate has a semicircular notch formed therein, adapted and configured to receive a bone nail; and the second nail clamp plate has a V-shaped notch formed therein, adapted and configured to receive a bone nail; The nail clamp plates are located in such a manner that the semicircular notches and the V-shaped notches oppose each other in order to retain at least one of the bone nails. The device according to claim 67, further characterized in that the first arm is angularly adjustable on a scale of approximately 0 ° to 120 °. 71.- The device according to claim 70, further characterized in that the second arm is angularly adjustable on a scale of approximately 0 to 120 °. 72. The device according to claim 46, further characterized in that the distance between the axes of rotation of the first and second support members is approximately 0 mm to 10 mm.

73. - The device according to claim 66, further characterized in that the first gear has V-shaped teeth and the first angular adjustment screw has common machine threads that are arranged to mesh with the V-shaped teeth in the second gear and rotate the first arm on an approximate scale of 0o to 135 °. 74.- The device according to claim 73, further characterized in that e! second gear has V-shaped teeth and the second angular adjustment screw has common machine threads which are arranged to mesh with the V-shaped teeth in the second gear, and rotate the second arm on an approximate scale of 0o to 135 °.

SUMMARY OF THE INVENTION

A method to perform angular distraction osteogenesis by drilling bone nail holes in the first and second sides of a segmented bone, inserting bone nails into the bone nail holes, fixing the bone pins on each side of the segmented bones to a distraction device, and adjusting the distraction device, so that the bone portion of the first side of the segmented bone angularly rotates or pivots its position in relation to the bone portion on the second side of the bone segmented in amounts Accurate, gradual and predetermined growths over a period, so that the bone tissue remains healthy and the blood vessels and nerve terminals remain intact during the bending distraction procedure; a device is provided for achieving angular distraction osteogenesis having a support member extending through a segmented piece of bone means for securing the first side of the bone segmented to the support member and the second side of the bone segmented to the member of support, and means for angularly adjusting the first segment of segmented bone relative to the second section of segmented bone; the angular adjustment means includes a gear and a cooperating adjusting screw that rotates the gear when the screw is adjusted to easily angularly adjust or rotate the support member or means for securing the bone pieces segmented with the support member in small predetermined quantities increasing »exact» during a period; the means for securing the bone pieces 5 segmented to the support member include bone nail clamps that can be adjusted only or moved at a distance, gradual and growing along the support member; in one modality »the device has two arms» a central union to angularly adjust the two arms and two

ÍO bone nail forceps to fix at least one bone nail on each side of the segmented bone with a respective arm; the arms are attached to the central union and adjust or rotate angularly in planes that are oriented one different from the other "and perhaps perpendicularly" and the clamps of

£ 5 bone nail moves linearly along each arm f.

twenty

25 CR / cgt * P9S / 4Z3F