Source: http://www.google.com/patents/US20050154390?dq=4200770
Timestamp: 2016-07-23 13:16:39
Document Index: 733044711

Matched Legal Cases: ['art 25', 'art 25', 'art 25', 'art 46', 'art 46', 'art 46', 'art 46', 'art 25', 'art 46', 'art 46', 'art 46', 'arts 90', 'art 93', 'arts 90', 'art 225', 'art 225', 'art 231', 'arts 225', 'arts 222', 'arts 122', 'arts 122', 'arts 222', 'arts 241', 'art 241', 'art 241', 'arts 241', 'arts 241']

Patent US20050154390 - Stabilization device for bones comprising a spring element and manufacturing ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsAn elastic or flexible element for use in a stabilization device for bones or vertebrae is provided. The elastic or flexible element is provided in the form of an essentially cylindrical body with a first end and a second end opposite thereto, wherein at least one of the opposite ends of the cylindrical...http://www.google.com/patents/US20050154390?utm_source=gb-gplus-sharePatent US20050154390 - Stabilization device for bones comprising a spring element and manufacturing method for said spring elementAdvanced Patent SearchPublication numberUS20050154390 A1Publication typeApplicationApplication numberUS 10/982,188Publication dateJul 14, 2005Filing dateNov 5, 2004Priority dateNov 7, 2003Also published asUS8632570, US9345520, US20140222080, WO2005044123A1Publication number10982188, 982188, US 2005/0154390 A1, US 2005/154390 A1, US 20050154390 A1, US 20050154390A1, US 2005154390 A1, US 2005154390A1, US-A1-20050154390, US-A1-2005154390, US2005/0154390A1, US2005/154390A1, US20050154390 A1, US20050154390A1, US2005154390 A1, US2005154390A1InventorsLutz Biedermann, Wilfried Matthis, Jurgen HarmsOriginal AssigneeLutz Biedermann, Wilfried Matthis, Jurgen HarmsExport CitationBiBTeX, EndNote, RefManPatent Citations (30), Referenced by (453), Classifications (36), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetStabilization device for bones comprising a spring element and manufacturing method for said spring element
DETAILED DESCRIPTION OF THE INVENTION [0090] The invention and various embodiments thereof are presented in FIGS. 1 through 22 and the accompanying descriptions wherein like numbered items are identical. As used herein, the terms flexible element, flexible section, spring like element, elastic element or elastic section refer to an element or section of an element that can have spring-like elastic or flexible properties. [0091] Bone stabilization devices in accord with the present invention can be designed and implemented in a wide variety of ways. Typically, they will comprise two or more bone anchoring elements and a connecting element connecting at least two bone anchoring elements. At least one of the bone anchoring elements comprises an essentially cylindrical body segment having at one end a threaded portion for anchoring into bone tissue and further comprising a length of a flexible section having a helical slotted opening (or recess) in the outer surface of the cylindrical body, the slot extending radially inward. In certain preferred embodiments, a plurality of flexible sections can be used to provide the desired limited movement of the stabilized bones or vertebrae. In addition to locating the flexible section in a bone anchoring element, a flexible section also can be located in a connecting element, particularly in a rod-shaped connecting element. [0092] Bone anchoring elements useful in the practice of the present invention can have a variety of structures. As is illustrated in FIGS. 1 and 2, the one embodiment of a bone anchoring element 1 is implemented in the form of a single-piece bone screw comprising shaft 2 with a first threaded section 3, which is to be anchored in the bone, having a bone screw thread. The bone anchoring element 1 also has a second section 4, which is adjacent to first section 3 and bears no bone screw thread, as well as head 5 adjacent to the second section. From the free end of head 5, a pocket bore 6 with a pre-determined diameter extends throughout head 5 and the second section 4 in a direction coaxial to screw axis A. In the second section 4, shaft 2 comprises recess 7 in the surface, which extends along the surface in the form of a helix in the direction of axis A) having a pre-determined slope and a pre-determined length. In this embodiment, the recess 7 extends from the surface in the radial direction to the bore 6. Thus, second section 4 is implemented to be flexible in the form of a helical spring-like structure. The length L of the flexible section in the direction of the screw axis, the height H of recess 7 in the direction of the screw axis, the slope of the spiral, and the diameter of coaxial bore 6 are selected such that the helical spring is provided with the desired stiffness in response to the action of axial forces, flexural forces, and torsional forces on the bone screw. Alternatively, as another variable, the depth of the recess radially inward can be varied such that is does not extend fully to the bore to vary flexibility or stiffness. Spiral and helical as used herein is intended to cover a helix-type shape. [0093] In the embodiment shown, head 5 is implemented to have a lenticular shape and further comprises hexagonal recess 8 for a hexagon socket screw key at its free end. However, different head shapes and/or a different recess, such as a recessed head, for engagement of a screw-in tool also can be used, as is well known to those skilled in the art. [0094] As shown in FIG. 2, one embodiment of a stabilization device according to the present invention consists of a first bone anchoring element 1 in the form of the bone screw of FIG. 1 and a second bone anchoring element 11, which can be used as a conventional bone screw with no flexible section, as well as a plate 12 with recesses 12, 13 through which the shaft of the bone screws can be guided and the bone screw head received. [0095] In the embodiment shown in FIG. 2, the stabilization device is designed to stabilize two vertebrae 15, 16 which are connected rigidly to each other by means of a fusion element 17, e.g., a titanium cylindrical element, following the removal of the intervertebral disc or after removal of an intervening vertebra. [0096] In operation, the shafts of bone screws 1, 11 are first guided through recesses 12, 13 of the plate and then screwed into the respective vertebra 15, 16 until plate 12 rests against the vertebra. In this arrangement, the flexible section 4 of bone screw 1 can reside inside the vertebra. In this case, the vertebra can perform a limited motion only along the direction of the screw axis. When the in-growth of the fusion element results in said element being lowered into the bone the bone screw yields to some extent because of its flexible section. This prevents the generation of undesirable tension. [0097] The stabilization device as described can also utilize two bone screws, each with a flexible section 4. Further, to accommodate more than two screws the plate can be modified to provide the corresponding number of recesses for receiving the bone screws. The stabilization device is not only suitable for use at the spinal column but can also be applied in other cases in which osteosynthesis using plates is performed. [0098] Another embodiment of a bone anchoring element 21 useful in the practice of the present invention, as shown in FIGS. 3 a to 3 c, is implemented in the form of a monoaxial bone screw for connecting to a rod 100. The monoaxial bone screw comprises a shaft 22 with a first section 23 which is to be anchored in the bone and bears a bone screw thread and a section 24, which is adjacent to first section 23 and bears no bone screw thread, as well as a receiving part 25 for the reception of rod 100, whereby said receiving part 25 and shaft 21 are connected as a single (integral) part. The receiving part 25 can be essentially cylindrical in shape and includes a recess 26 which initiates at its free end and has a cross-section of a size just large enough for rod 100 to be inserted and fit in the base of recess 26. Any cross section can be used provided that the rod can be placed into the receiving part. Preferably a U-shaped cross section is used. U-shaped recess 26 forms two free legs 27, 28, which bear an internal screw thread 29 adjacent to their free end, whereby said internal screw thread 29 engages a corresponding external screw thread 30 of internal screw 31 that is to be screwed in between the legs for fixing rod 100. [0099] As is particularly apparent from FIG. 3 b, a coaxial bore 32 with a pre-determined depth extends from the base of U-shaped recess 26 towards bone screw thread section 23 through section 24 which bears no bone screw thread. The second section 24 of the shaft comprises a recess 33 which extends spirally along the surface of the shaft like a helix in the direction of the screw axis and extends in radial direction into bore 32. This provides for the flexibility of second section 24 and acts as a helical spring-like structure. In the example shown, the helix extends along the axis having a rotation counter to the bone thread, particularly when the recess extends radially into the bore. [0100] Another embodiment of a stabilization device according to the present invention consists of at least one bone anchoring element implemented in the form of a monoaxial screw with an flexible section 24, a second bone anchoring element implemented as a conventional monoaxial or polyaxial bone screw with no elastic section and a connecting rod. Instead of using a conventional monoaxial or polyaxial bone screw as a second anchoring element, the stabilization device may comprise a monoaxial bone screw according to FIGS. 3 a-3 c as the second anchoring element. [0101] In operation, the bone anchoring elements are screwed into their respective bone or, in applications on the spinal column into the respective vertebrae, followed by the insertion of rod 100 in the receiving parts, and fixation of the rod by means of the internal screw. In the process, monoaxial bone screw 21 is screwed into bone tissue so that the flexible section 24 protrudes preferably at least partially beyond the surface of the bone or vertebra. If the bone or vertebra is moved from its resting position, which is to be stabilized, flexible section 24 exerts a retroactive force on the bone or vertebra, which returns it to the resting position and thus limits its motion. [0102] Alternatively, the bone screw can be screwed far enough for elastic section 24 to protrude not at all or only very little beyond the surface of the bone. In this case the spring action of the flexible section can provide for some yield after adjustment. [0103] An alternative embodiment of a bone anchoring element useful in the present invention is shown in FIG. 4. The bone anchoring element 41 is implemented in the form of a polyaxial bone screw. This screw comprises a single-piece screw element with a shaft 42 with a first section 43 which is to be anchored in the bone and a second section 44 which is adjacent to first section 43 and bears no bone screw thread, as well as a shead 45 which can have a spherically shaped segment, that is adjacent to second section 44. Head 45 is held by a receiving part 46. As in the preceding embodiments, second section 44, a flexible section, is implemented in the form of a helical recess in the surface of shaft 42, which comprises a coaxial bore 47, which extends from the free end of the head through the second section, and recess 48 extends radially in the wall to the bore. [0104] The receiving part 46 can have any shape. In the embodiment shown, the receiving part 46 is implemented in a conventional manner to be essentially cylindrical in shape and comprises at one of its ends a bore 49 in an axially symmetrical alignment with a diameter that is larger than that of shaft 42 and smaller than that of head 45. Moreover, receiving part 46 comprises a coaxial second bore 50 which is open at the end opposite to first bore 49 and whose diameter is sufficiently large for the screw element to be guided through the open end with the shaft through the first bore 49 until head 45 rests on the edge of first bore 49. Like receiving part 25 of the previous embodiment, receiving part 46 comprises a U-shaped recess which initiates at its free end, extends in the direction of first bore 49 and forms two free legs 52, 53. In an area adjacent to their free ends, legs 52, 53 comprise an internal screw thread which engages a corresponding external screw thread of an internal screw 54 for fixing rod 100 in the receiving part and also thereby fixing the bone screw head and the angle of the shaft of the bone screw. [0105] Moreover, a pressure element 55 is provided for the fixation of the screw head in the receiving part, said pressure element being implemented such that it comprises at it side facing head 45 a spherical recess 56 whose radius is essentially identical to the radius of the spherical segment-shaped section of head 45. The outer diameter of pressure element 55 is selected such that the pressure element is displaceable within receiving part 46 in the direction towards head 45. Moreover, the pressure element comprises a coaxial bore 57 allowing a screw-in tool to engage a recess in screw head 45 (not shown herein) for driving the screw into bone tissue. Any other shaped pressure element can be used provided that the pressure element fixes the screw head in the receiving part. [0106] Another embodiment of a stabilization device according to the present invention comprises at least two bone anchoring elements and a rod, whereby at least one of the bone anchoring elements is implemented as a polyaxial bone screw with a shaft with an flexible section 44, as illustrated in FIG. 4. The second bone anchoring element can be implemented as a conventional monoaxial or polyaxial bone screw without a flexible section or it can be implemented as a monoaxial bone screw or as a polyaxial bone screw with a flexible section as described herein. [0107] In operation, the screw element is first inserted into the receiving part until head 45 rests next to the edge of first bore 49. Then, the screw element is screwed into the bone or vertebra such that flexible section 44 protrudes preferably at least partially beyond the surface of the bone. Subsequently, the rod is inserted, the angular arrangement of the receiving part in relation to the screw element is adjusted and then fixed by tightening the internal screw. Similar to the preceding embodiment, the flexible section permits some limited motion around the resting position. [0108] Alternatively, the shaft may be screwed in sufficiently for the flexible section to protrude not at all or only very little beyond the surface of the bone. [0109] FIG. 5 shows an example of an application of the stabilization device for the stabilization of two vertebrae 58, 59 connected to each other by means of a fusion element 60, which replaces an intervertebral disc that has been removed. The operation corresponds to the description above. [0110] The limited mobility of vertebrae 58, 59 relative to each other can lead to an increase in the cyclic partial load which can stimulate the growth of bone and accelerate ossification. [0111] A further embodiment of a bone anchoring element useful in the present invention is shown in FIG. 6 a. Bone anchoring element 61 differs from the bone anchoring element shown in FIG. 4 by the structure of the screw element which includes detachable components, whereas all of the other parts are identical to those in FIG. 4. [0112] In the bone anchoring element 61, the bone screw thread section 63, the flexible section 64 and the head 65 are implemented as separate parts. Flexible section 64 consists of a cylindrical tube with a continuous coaxial bore 66 and recess 67 in its wall, which extends axially in the form of a helix in the cylinder wall and extends radially into bore 66. This arrangement forms a helical spring-like structure similar to the preceding embodiments. Adjacent to its corresponding free ends, flexible section 64 comprises, on both ends, an internal thread 68 of pre-determined length. On its end opposite to the tip to be screwed in, the bone screw thread section 63 comprises a cylindrical protrusion 69 having an outer thread that engages the inner thread 68 of flexible section 64. On its side opposite to the flattened end, head 65 also comprises a cylindrical protrusion 70 with an outer thread which engages the inner thread 68 of the flexible section 64. [0113] In operation, the screw element of bone anchoring element 61 is assembled first by screwing together the bone anchoring section 63, the flexible section 64 and the head 65 followed by insertion of this assembly into the receiving part 46. The further operation is identical to that of the preceding embodiment. [0114] The bone anchoring element according to this embodiment is advantageous in that it is simpler to manufacture. It has the added advantage that flexible sections 64 of varying length and stiffness can be provided and selected prior to use to suit the application at hand, and assembled with heads of a pre-determined size and thread shafts of a pre-determined length to form a screw element. [0115] FIG. 6 b shows a further development of the flexible element 64 of FIG. 6 a. The flexible section 640 shown in FIG. 6 b comprises a core 641 inside. The core 641 has cylindrically shaped ends 642 with a diameter such that the core can be pushed into the bore hole of the flexible section 640. The cylindrically shaped sections 642 and the flexible section 640 comprise transverse bores into which pins 643 for fixation of the core are inserted. Between the cylindrical sections 642 the core comprises a section 644 having a substantially rectangular cross section, as can be seen from FIG. 6 c. The cross section of section 644 is not limited to a rectangular shape but can have another shape, for example an oval or an asymmetric shape. The core allows for adjustment of the flexural and/or torsional stiffness of the flexible section. In addition, the flexural stiffness in a particular direction depends on the orientation of the core in the bore. Preferably, the core is made from a material having a lower stiffness that the flexible element. [0116] The polyaxial screw is not limited to the embodiment described above, but rather can be any other polyaxial screw with a three-piece screw element according to the description above. Accordingly, the first bore hole of the embodiment shown in FIG. 6 a can have a smaller diameter than the screw shaft, if, in operation, the screw head, with its cylindrical projection leading, is introduced through second bore hole into receiving part first, before the flexible element and screw shaft are screwed onto screw head. In this case, it is sufficient for the first bore hole to have a diameter large enough to accommodate the cylindrical projection of the screw head to provide engagement with the flexible section. [0117] The receiving part also can be provided such that the screw element can be inserted from below and is clamped in the receiving part by means of a pressure element, for example a snap ring. In this case, the bore hole is larger than the diameter of screw head. [0118] Also, the rod fixation is not limited to the internal screw shown in FIG. 6 a, but an additional external nut can be provided or any known type of rod fixation can be used. Alternative methods for fixation are well known to those skilled in the art and can be used in place of the fixation methods shown herein. [0119] If the flexible element projects beyond the surface of the bone at least in part, the flexible element is capable of absorbing bending forces as well as tension and pressure forces. When the flexible element is positioned such that it does not project beyond the surface of the bone, the screw element, due to the recess of the flexible section, still is capable of giving way in response to a movement of the bone or vertebra. This prevents the development of unfavorable tension. [0120] In a further embodiment shown in FIGS. 7 a and 7 b the bone anchoring element is implemented in the form of a Schanz screw 81. Schanz screw 81 comprises a first threaded section 82 and an adjacent cylindrical thread-free shaft section 83 with no head. A coaxial pocket bore 84 extends from the free end through to the threaded section. A recess 86 extends in the form of a helix along cylindrical wall in the direction of the screw axis over a pre-determined length and extends radially into the bore 84. Thus, the wall in a pre-determined section 85 of cylindrical section 83 is provided with said recess forming an flexible section in the form of a helical structure as in the embodiments described above. In addition, cylindrical shaft section 83 comprises notches 87 on its circumference which are arranged at a pre-determined distance from each other. In the embodiment shown, the notches are circular. Adjacent to its free end, the cylindrical shaft section comprises a hexagonal recess 88, or any other recess shape, for engaging a screw-in tool. [0121] In operation, especially in an external stabilization device (fixator), Schanz screw 81 can be used jointly with conventional Schanz screws and conventional connecting elements and fixation rods. Schanz screw 81 is screwed into the bone fragment to be fixed such that flexible section 85 protrudes beyond the bone surface and optionally also beyond the surface of the skin. This arrangement provides for limited mobility at a predefined site depending on the stiffness of the flexible section. The Shanz screw having a flexible section also can be made in component parts similar to the bone screw as described above. [0122] FIG. 8 shows the application of the Schanz screw according to FIGS. 7 a and 7 b in an external fixator for the stabilization of bone parts 90, 91 of a fractured bone. Similar to polyaxial screw 41 above (FIG. 4), Schanz screw 92 having a flexible section also comprises for this purpose a spherical segment-shaped head (not shown herein) that is held in a receiving part 93. Bone parts 90, 91 are stabilized by means of Schanz screw 92 and conventional polyaxial bone screws 94, which are connected to rods 100, 101 and further the rods are connected together by means of a conventional connecting element 95. [0123] Modifications of the embodiments described above are possible. In particular, elements of one embodiment may be combined with elements of another embodiment. The implementation of the screw element in the form of several parts according to the embodiment of FIG. 6 a can also be used in the monoaxial bone screw according to FIGS. 3 a to 3 c, whereby in this case the receiving part can be screwed into the flexible section. In addition the Schanz screw according to FIGS. 7 a and 7 b can also be implemented in the form of several component parts. In yet another modification, the bone screw thread section and the flexible section can be connected into one part and only the head and/or the receiving part can be screwed in. [0124] The shaft of the bone anchoring element can also have a hook shaped section instead of a bone thread for anchoring in the bone. [0125] In yet another embodiment a separate cylindrical core is provided which is to be inserted into the bore that extends through the flexible section. This allows for additional adjustment of the stiffness of the flexible section. In another embodiment, the diameter of the flexible section differs from that of the bone screw thread section. A larger diameter can thus be used to attain increased stiffness. [0126] FIGS. 9 a and 9 b further illustrate an embodiment of a flexible section or flexible element 101 as a separate component, as discussed above. The flexible element 101 consists of a cylindrical tube with a continuous coaxial bore hole 102 and a recess 103 extending in the wall for a predefined length in the form of a helix with a predefined pitch along the direction of the cylinder axis, and which extends radially from the outer cylindrical surface into coaxial bore 102. Thereby, a helical spring-like structure is formed. The length of the helix-shaped recess in the direction of the cylinder axis, the axial height of the recess, the pitch of the helix, and the diameter of the coaxial bore hole are selected to provide a desired stiffness of the flexible element with respect to axial forces, bending forces, and torsional forces acting on the element. Adjacent to each of its free ends, flexible element 101 comprises an internal thread 104, 104′ that extends axial for a predetermined length. The external diameter of the flexible element is selected according to the particular application. The selection of the afore mentioned parameters are well known to those ordinary skilled in the art. [0127] As shown in FIG. 10 a, flexible element 101 can be inserted as a part of a flexible rod-shaped element 130. The flexible rod-shaped element 130 consists of flexible element 101 and two cylindrical rod sections 131, 131′ each comprising at their end a cylindrical projection 132, 132′ with an external thread 133, 133′ that cooperates with internal thread 104, 104′ of flexible element 101. In this application, the rod sections and the flexible element have essentially identical external diameters. The length of rod sections 131, 131′ and of flexible element 101 can be selected independently of each other with respect to a desired application. For example, the rod-shaped element can be used to connect pedicle screws at the spinal column. Owing to the properties of flexible element 101, the rod-shaped element 130 thus formed absorbs compression, extension, bending and torsional forces to a predetermined degree. [0128] FIG. 10 b shows an flexible rod-shaped element 180 that differs from flexible rod-shaped element 130 in that a first rigid rod section 181 has a larger external diameter than flexible element 101, and the second rigid rod section 181′ has a smaller external diameter than flexible element 101. Alternatively, both rod sections can have a larger or smaller diameter than the flexible element. [0129] FIG. 11 shows a stabilization device 190 for the spinal column, wherein two bone anchoring elements 191, 191′ with screw elements 193, each provided with a flexible element 101 according to the invention, and a flexible rod-shaped element 192 (with a flexible element 101) for connecting the two bone anchoring elements are used. The multiple-piece design of the flexible rod-shaped element and the screw element permits stabilization devices 190 to exhibit a wide variety of features by combining only a few basic elements. The stabilization device does not necessarily have to comprise bone anchoring elements with a flexible element and a flexible rod-shaped element. Depending on the field of application, it also is possible to provide only a flexible rod-shaped element and bone anchoring elements with rigid screw elements. [0130] FIG. 12 shows another embodiment of a flexible element 140. Flexible element 140 differs from flexible element 101 only in that an internal thread 141 that extends along the entire length of the flexible element instead of the two internal threads 104, 104′. [0131] FIG. 13 shows an alternative embodiment of a flexible element 150. In contrast to the previously described embodiments, it comprises rigid end sections 151 and 151′ and a reduced number of helical recess turns. This permits one to design the flexibility of the element independent of the length of the element. [0132] FIGS. 14 a and 14 b show a flexible element 160 according to another alternative embodiment which, in contrast to the preceding embodiments, comprises two regions 161 on the outer surface of the element that are offset by 180 degrees relative to each other and are concave in shape towards the center axis. The length L′ of regions 161 in the axial direction is no more than equal to the length L of the helical recess, and the radius of curvature of the shaped regions 161 is such that the turns of the helical recess are not interrupted. Owing to this design, the flexible element has a “waisted shape” (i.e., a shape like a waist of a person) in a direction that is perpendicular to the center axis, thus possessing less stiffness in this direction. This permits the flexible element to have oriented stiffness which suits the purpose of certain applications. [0133] FIG. 15 shows a flexible element 172 according to a further alternative embodiment that comprises a rod-shaped core 171 that is slid into the hole in addition to the flexible element 101 described above. On the one hand, the core can serve as a limit stop in case flexible element 172 is subjected to pressure forces. On the other hand, core 171 can be used to increase the stiffness of flexible element 172 with respect to bending forces. The core can have a circular cross section or as shown in FIG. 6 c a cross section which produces an oriented flexibility in a specific direction. The material used for the core can be the same as or a different material from that used for the flexible element. In any case the materials used for the core must be biocompatible materials, as is well known to those skilled in the art. [0134] A flexible element 260 according to another embodiment is shown in FIG. 16. It comprises on its one end a cylindrical projection 261 with an external thread instead of a bore hole with an internal thread as described previously. Accordingly, the element to be connected to this end of the flexible element is provided with a bore hole with a corresponding internal thread. The other end of the flexible element 260 is provided with a pocket bore hole 262 in which an internal thread 263 is provided, like in the embodiments described above. [0135] Flexible element 270 according to further alternative embodiment is shown in FIG. 17. It comprises on each of its ends a cylindrical projection 271, 272 with an external thread. [0136] In a modification to embodiments of the flexible element described previously, another alternative embodiment comprises a flexible element that does not have a continuous bore hole from one end of the helical recess to the opposite end. Further, optionally, the recess does not extend from the outer surface of the cylinder to the bore hole throughout the axial length of the helical recess. [0137] As a further example of an application of flexible element 101, FIG. 18 a shows an exploded view of a connection element 200 that consists of a rod-shaped element 131, a flexible element 101 and a plate 201. Rod-shaped element 131 comprises a projection 132, shown as a cylindrical projection, with an external thread 133 for screwing into the internal thread 104 that is adjacent to the one end of flexible element 101. Plate 201 also comprises a cylindrical projection 202 with an external thread 203 for screwing into the internal thread 104′ that is adjacent to the other end of flexible element 101. The plate 201 consists of two sections 204, 204′ that are circular in the plan view and connected to each other by means of fin 205. The width B of fin 205 is smaller than the outer diameter D of circular sections 204, 204′. Two bore holes 206, 206′ coaxial to the circular sections are provided through the plate to accommodate countersunk screw heads. As shown in FIG. 18 b, a first side 207 of the plate preferably has a concave curvature, whereas a second side 208 of the plate preferably has a convex curvature for abutment of this side against a bone surface. The different radii of curvature of the two sides 207, 208 of plate 201 cause plate 201 to taper towards its lateral edges 209. This allows the plate to be both compact and stable As shown in FIG. 18 b, bore holes 206, 206′ comprise, adjacent to the second side 208 an orifice 206 a and, adjacent to the orifice, a first section 206 b, shown as a cone shaped section, and a second section 206 c that is adjacent to the first section and first side 207. Their shape makes these bore holes 206, 206′ suitable for receiving countersunk screw heads. The shape of bore holes 206, 206′ also can be different from the shape described above as long as they are suitable to receive a countersunk screw head. [0138] FIG. 19 shows an example of an application using the connection element 200 of FIG. 18 a, in which plate 201 is fixed from the posterior side to two vertebrae 211 of the cervical spine by means of two bone screws 210 and in which the rod-shaped element 131 that is connected to the plate by means of a spring-like element 101 is anchored in vertebrae 212 of the thoracic spine by means of three bone anchoring elements 215. Optionally, one or more of the bone anchoring elements comprises a flexible section. [0139] A further example of an application of a stabilization device in accord with the present invention is illustrated in FIG. 20 a. There, flexible element 101 is used in a dynamic pelvis stabilization device 230. The dynamic pelvis stabilization device consists of bone anchoring elements 228, 228′, 228″ that are connected to each other by means of rod-shaped elements 131, 131′, 131″ and flexible elements 101, 101′. [0140] Like the two other bone anchoring elements 228′, 228″ the bone anchoring element 228 consists of two components 225, 231 that are screwed to each other by means of a screw 227 engaging a thread 234 in the first component 225 and a thread 235 in the second component 231 (see FIG. 20 b). The top view shown in FIG. 20 a shows only the top part 225. Rod-shaped element 131 is clamped between the two components 225, 231 in a recess 232 in the first part 225 and in a recess 233 in the second part 231 such that bone anchoring element 228 is firmly connected to rod-shaped element 131. Moreover, both parts 225, 231 are each provided with a bore holes 236, 237, which are in coaxial alignment in the assembled state. Adjacent to bore hole 236, a spherical recess 238 and adjacent to bore hole 237, a spherical recess 239 is provided which serve to receive the head 253 of a bone screw 226. Bone screw 226 comprises a shaft-shaped section 251 with an external bone thread 252 for screwing into the bone, and a spherical segment-shaped head section 253 with a radius that is essentially identical to the radius of spherical recesses 238, 239. Optionally, the bone screw comprises a flexible section as described and discussed above. [0141] Like the bone anchoring element, connection element 224 consists of two parts 222, of which only one is depicted in the top view shown in FIG. 20 a. Guided within a recess in the connection element, rod-shaped element 131 is clamped between these two parts 122 such that connection element 224 is firmly connected to rod-shaped element 131. [0142] Rod element 221 consists of a head section 221 b and a shaft section 221 a. Head section 221 b is clamped between the two parts 122 in a recess (not shown) and, thus, is connected to the two parts 222 such that it can be fixed in a certain pivot position. The head section can be ball-shaped or can have another shape which allows pivoting in the recess. At its end opposite to head section 221 b, shaft section 221 a comprises a cylindrical projection (not shown) with an external thread that is screwed into the internal thread (not shown) of flexible element 101′. [0143] A further example of an application of a stabilization device comprising a flexible element 101 according to the invention is shown in FIG. 21. In this embodiment, flexible element 101 is part of an external fixator for stabilizing a bone 241 that consists of two parts 241 a and 241 b. [0144] A first and a second Schanz screw 243, 243′ are screwed into first part 241 a of bone 241, and a third Schanz screw 243″ is screwed into the second part 241 b of bone 241. The first Schanz screw 243 and the second Schanz screw 243′ are connected to the third Schanz screw 243″ by means of a first rod 245 a second rod 245′ in a generally known fashion. In addition, the first and the second rod 245, 245′ are connected to each other by means of a coupling element 246 in a generally known fashion. As shown in this embodiment, the first and the second rod are firmly connected. [0145] The first rod 245 is provided in three pieces, two rod-shaped elements 131, 131′ and one flexible element 101, as described above with reference to FIG. 10 a. The first rod-shaped element is firmly connected to the one end of flexible element 101 by means of a screw connection, and the second rod-shaped element is firmly connected to the other end of flexible element 101 by means of a screw connection, as described above. [0146] The dynamic stabilization of bone 241 allows for minor motions of the two bone parts 241 a and 241 b relative to each other. These minor motions lead to a desirable stimulation for the fusion of the two bone parts 241 a, 241 b. [0147] Depending on the field of application, one or more of the Schanz screws of the external fixator can comprise a flexible element as part of its shaft, as described above. [0148] The manufacture of a flexible element 101 such as shown in the embodiment of FIGS. 9 a and 9 b by means of milling can start with a cylinder made of a biocompatible material, e.g. titanium, with a predetermined external diameter, in which a recess 103 (or slot) is milled with a thin disk milling cutter along a helix whose main axis is collinear to the main axis of the cylinder. Subsequently, preferably, a bore hole 102 can be formed along the main axis of the cylinder over the entire length of the cylinder such that helix-shaped recess 103 extends radially into bore hole 102. For the stability of flexible element 101, the runout of the helix at the transition between the helical section and the end-side section of the flexible element can be of major significance. It is therefore preferred to finish the runout of the helix at both ends of the helix with a end-milling cutter such that the sharp edge on the inside of the bore hole is removed. For this purpose, the runout is milled with a end-milling cutter at an angle tangential to the contour of the helix. Subsequently, the component is deburred on its inside and outside. Finally, an internal thread 104, 104′ is formed in each of the two end sections of bore hole 102. Alternatively, the internal thread is formed continuously thoughout the entire length of the cylinder. [0149] As an alternative to milling, a flexible element 300 can be manufactured from the cylindrical body by wire-cut-EDM, laser treatment or water jet treatment. As is shown in FIG. 22, this method also starts with a cylinder with a predetermined external diameter D′, in which is formed a bore hole 301 along the main axis A over the entire length of the cylindrical body. Then, a cut is made in the wall of the hollow cylinder, thus formed, along a helix 302 using one of the procedures mentioned above depending on the thickness of the wall. The runout 303 of helix 302 is formed preferably to take the shape of a quarter circle such that the finishing of runout 303 in an additional work step as compared to the milling procedure can be dispensed with. The shape of the runout does not necessarily have to be a quarter circle but, rather, can be any other shape, such as the shape of another section of a circle by which the load peaks in the material can be kept low during operation. Moreover, it is not necessary to debur in this manufacturing procedure. Finally, an internal thread is formed at least in each of the two end sections of bore hole 301 like in the manufacturing procedure using milling. [0150] In a modification, the procedures described above are modified by replacing the internal thread with a cylindrical projection having an external thread by turning on a lathe at a suitable point in the procedure, preferably at the start. In this case, the diameter of the bore hole must be smaller than the diameter of the cylindrical projection. [0151] In a further modification of the manufacturing procedure, the flexible element is manufactured without a continuous bore hole. [0152] The present invention is by no means limited to the examples of the monoaxial and polyaxial bone screws and the Shanz screw actually described herein. Other implementations of these, in particular as it concerns the receiving parts and fixation devices, are also considered in the invention. However, the shaft should have an elastic or flexible section. Moreover, the present invention can also be applied to hooks. [0153] In another embodiment the elastic section is provided with a cover preventing the in-growth of tissue material or vessels. The cover can be hose-shaped. Also, a polymeric cover can be used. The cover can include drugs to prevent in-growth of tissue material or vessels. [0154] The materials which can be used for the stabilization device as a whole, for example for the screw or the rod, for the spring like element and/or for the core are biocompatible materials, for example biocompatible metals such as titanium, or biocompatible plastic materials. Also, shape memory alloys having known superelastic properties, such as nitinol, for example, can be used either for the whole screw or rod with the the flexible section or for the flexible section or the spring like element alone. If a core is provided, the core individually or in combination with the other components can also be made from a shape memory alloy. [0155] All embodiments described above agree in that they provide the advantage of the limited mobility of the bone parts and/or vertebrae leading to an increase in the cyclical partial load which stimulates the growth of bone. [0156] The bone stabilization device according to the invention has the further advantage that forces acting via the connecting element on the bone anchoring elements when the bone parts or vertebrae are in motion are decoupled totally or partially from the part of the bone anchoring element which is firmly anchored in the bone. Therefore, loosening of the bone anchoring element can be avoided. This is particularly relevant for the stabilization of vertebrae where a limited motion of the vertebrae with respect to each other could be desired. [0157] The embodiments described above and shown herein are illustrative and not restrictive. The scope of the invention is indicated by the claims rather than by the foregoing description and attached drawings. The invention may be embodied in other specific forms without departing from the spirit of the invention. Accordingly, these and other changes which come within the scope of the claims are intended to be embraced therein. 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KG, GERMANYFree format text: CHANGE OF LEGAL FORM;ASSIGNOR:BIEDERMANN MOTECH GMBH;REEL/FRAME:027603/0504Effective date: 20090720Mar 16, 2012ASAssignmentOwner name: BIEDERMANN TECHNOLOGIES GMBH & CO. KG, GERMANYFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BIEDERMANN MOTECH GMBH & CO. KG;REEL/FRAME:027873/0551Effective date: 20120308Dec 2, 2014CCCertificate of correctionRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services