巴西专利BR112015003734B1 BONE FIXATION SYSTEM AND BONE FIXATION ELEMENT

专利PDF首页>>巴西专利

专利附录

专利说明

权利要求

类似技术

同族专利

引用文献

法律状态

优先权

专利摘要:
bone fixation system. The present invention relates to a bone fixation system having a bone implant with an implant body. the implant body defines an upper surface, a bone-facing surface spaced from the upper surface along a transverse direction, and at least one opening defined by the inner wall. a bone fixation element is configured for insertion at least partially through the opening. the bone fixation element has a head and a rod that extends relative to the head in a distal direction. the head defines a ridge and at least one thread that is spaced apart from the ridge in the distal direction. the ridge is configured to compress a bone implant against the at least one thread so as to fixedly retain the bone implant relative to the head.
公开号:BR112015003734B1
申请号:R112015003734-8
申请日:2013-08-23
公开日:2021-08-03
发明作者:Andreas Appenzeller；Daniel Fluri
申请人:Synthes Gmbh；
IPC主号:

专利说明:

REFERENCE TO RELATED REQUESTS
[001] This invention claims priority to US Patent Application Serial No. 13/832,518 filed March 15, 2013, US Patent Application Serial No. 61/786,937 Filed March 15, 2013, Application US Patent Serial No. 13/832,364 filed March 15, 2013, US Patent Application Serial No. 61/787,082 filed March 15, 2013, and US Patent Application Serial No. 61/692,673 filed 23 of August 2012, the disclosure of each of which is hereby incorporated by reference as if set forth in its entirety in the present invention. TECHNICAL FIELD
[002] The present disclosure relates to a bone fixation system, and particularly a bone implant, and a bone fixation element, methods for coupling a bone implant to a bone fixation element, and methods for bone fixation. BACKGROUND
[003] Bone implants are designed to help heal bone fractures and/or replace damaged tissue. Principles that outline the design of bone implants include anatomical reduction of fracture fragments, stable fixation to improve tissue healing, minimal invasion during the procedure to preserve the local blood supply, and early, pain-free mobilization for the patient can return to normal activities as soon as possible. These principles have guided the development of many examples of bone implants, such as bone plates, intramedullary pins, vertebral implants, etc., as well as screws and/or anchors configured to hold the bone implant in the desired position in the desired location. SUMMARY
[004] According to an embodiment of the present description, a bone fixation system includes a bone implant and at least one bone fixation element. The bone implant includes an implant body that defines an upper surface and a bone facing surface opposite the upper surface, and at least one bone fixation opening that extends through the implant body from the upper surface to the facing surface. to the bone. The opening of the bone fixation is at least partially defined by the threaded inner wall. The bone fixation element includes a head and a rod that extends relative to the head in a distal direction and is configured to be directed into an fixation location. The bone fixation element further defines a retaining surface and the head defines a threaded region that is spaced apart from the retaining surface along the distal direction. The threaded region is configured to threadedly engage the threaded inner wall as the bone fixation member rotates to advance the head distally into the opening until at least a portion of the threaded inner wall is trapped between the retaining surface and the threaded region. BRIEF DESCRIPTION OF THE DRAWINGS
[005] The aforementioned summary, as well as the detailed description, below, of the illustrative modalities of the bone fixation system of the present description, is best understood when read in conjunction with the attached drawings. It should be understood, however, that the present description is not limited to the precise schematic representations and arrangements shown. In the drawings:
[006] Figure 1A is a perspective view of a bone fixation system constructed according to a modality, which includes a bone implant and at least one bone fixation element fixed to the bone implant and to an underlying bone in order to secure the bone implant to the underlying bone;
[007] Figure 1B is an exploded perspective view of the bone fixation system illustrated in Figure 1A;
[008] Figure 1C is a perspective view of a bone fixation system illustrated in Figure 1A, which illustrates a first bone fixation element and a second bone fixation element securing a bone implant to a bone;
[009] Figure 2A is a perspective view of the bone implant illustrated in Figure 1A;
[0010] Figure 2B is a top plan view of the bone implant illustrated in Figure 2A;
[0011] Figure 2C is a cross-sectional elevation view of the bone implant illustrated in Figure 2B taken along line 2C2C;
[0012] Figure 3A is a side elevation view of the bone fixation element illustrated in Figure 1A;
[0013] Figure 3B is a cross-sectional elevation view of the bone fixation element illustrated in Figure 3A;
[0014] Figure 4A is a cross-sectional elevation view of the bone fixation system illustrated in Figure 1A, showing insertion of the bone fixation element into an opening of the bone fixation of the bone implant;
[0015] Figure 4B is a cross-sectional elevation view of the bone fixation system illustrated in Figure 4A, but showing the bone fixation element inserted further into the opening of the bone fixation so that a retention surface is adjacent to the bone implant;
[0016] Figure 4C is an enlarged cross-sectional elevation view of the bone fixation system illustrated in Figure 4B, taken on line 4C;
[0017] Figure 4D is a cross-sectional elevation view of the bone fixation system illustrated in Figure 4B, but showing the bone fixation element inserted further into the opening of the bone fixation so that a retention surface is pressed against the bone implant, thus fixing the bone implant in relation to the bone fixation element;
[0018] Figure 4E is an enlarged cross-sectional elevation view of the bone fixation system illustrated in Figure 4D, taken on line 4E;
[0019] Figure 5 is a perspective view of the bone fixation system as illustrated in Figure 1A, but showing the bone implant constructed according to an alternative modality;
[0020] Figure 6A is an exploded perspective view of the bone fixation system as illustrated in Figure 1B, but showing the bone fixation element constructed according to another modality; and
[0021] Figure 6B is a cross-sectional elevation view of the bone fixation system illustrated in Figure 6A, but showing the bone fixation element attached to the bone implant. DETAILED DESCRIPTION OF ILLUSTRATIVE MODALITIES
[0022] Referring to Figures 1A to 1C, a bone fixation system 20, according to a modality, is configured to stabilize a bone that has been fractured at one or more fracture sites in a plurality of bone fragments. The bone fixation system 20 includes a bone implant 24 and a bone fixation member 26 configured to be inserted at least partially through the bone implant 24 to secure the bone implant 24 to an underlying fixation site 28. The fixation site 28 may be a bone fixation site defined by a bone 27 as illustrated, an implant, or a device configured to receive a bone fixation member. For example, bone 27 can define a pair of attachment sites, such as a first attachment site 28a of a first bone fragment 27a of bone 27, and a second attachment site 28b of a second bone fragment 27b of bone 27. Bone 27 can define a bone gap 27c, which can be defined by an LF fracture site, which separates the first bone fragment 27a from the second bone fragment 27b. Attachment sites 28a-b can be located at any anatomical site in a skeletal system. For example, attachment sites 28a-b may be located in the skull, spine, any long bone such as the humerus, femur, tibia, fibula, or any other location in the skeletal system where attachment is desired. The fixation site 28 can also be an additional implant, device or prosthesis configured to receive the bone fixation member therethrough by fixation to the bone.
[0023] The bone fixation element 26 is configured to be coupled to the bone implant 24 when the bone fixation element 26 is fully inserted into the bone implant 24 as illustrated in Figure 1A. For example, bone implant 24 includes an implant body 30 that is substantially elongated along a central implant axis 32 (see Figures 2A and 2B). Bone implant 24 can be elongated along the central implant axis 32, which can be linear or non-linear as desired. The implant body 30 includes sides 38 and 40 which are spaced from one another along a lateral implant axis 33 or a second direction which may be angularly offset, e.g. perpendicular, relative to the central implant axis 32 .
[0024] According to an embodiment, the central implant axis 32 may extend along a longitudinal direction L, and the sides 38 and 40 are spaced apart along the lateral direction A which is substantially perpendicular to the longitudinal direction L Thus, reference to the longitudinal direction L in the present invention may also refer to the central implant axis 32, except where otherwise indicated. Furthermore, reference to the lateral direction A in the present invention may equally refer to the lateral implant axis 33 or the second direction, except where otherwise indicated. The implant body 30 may further define a bone facing surface 52 that is configured to face the attachment site 28 when the bone implant 24 is attached to the attachment site 28, and an opposing or upper surface 54 that faces the attachment site. in the opposite direction from the fixation site 28 when the bone implant 24 is fixed at the fixation site 28. The bone facing surface 52 and the opposite upper surface 54 may be spaced apart from each other along a transverse direction T which is substantially perpendicular to the longitudinal direction L and the lateral direction A. The bone-facing surface 52 is spaced from the upper surface 54 in a distal direction, and the upper surface 54 is spaced from the bone-facing surface in a proximal direction.
[0025] The bone implant 24 defines a plurality of bone fixation openings 56 extending through the implant body 30 along the transverse direction T from the upper surface 54 to the bone facing surface 52, and at least one inner wall 53 which extends between the upper surface 54 and bone facing surface 52 and defines each opening of the bone attachment 56. At least a portion of each inner wall 53 may be curved as it extends along the transverse direction T. As will be described in detail below, at least a portion of the inner walls 53 may be threaded so as to threadably mate with complementary threads of the bone fixation element 26 when the bone fixation element 26 is directed into the respective opening of the bone fixation 56.
[0026] Bone implants 24 are described in the present invention as extending horizontally along a longitudinal direction "L" and a lateral direction "A", and vertically along a transverse direction "T". Unless otherwise specified in the present invention, the terms "longitudinal", "transverse" and "lateral" are used to describe the orthogonal directional components of various components of bone fixation systems and component axes. It should be noted that although the longitudinal and lateral directions are illustrated as extending along a horizontal plane and the transverse direction is illustrated as extending along a vertical plane, the planes covering the various directions may be different during the use. Furthermore, the description refers to components and/or portions of such bone fixation system components which include a "proximal end" and a "distal end". Thus, a "proximal direction" or "proximally" refers to a direction that is generally oriented from the distal end towards the proximal end. A "distal direction" or "distally" refers to a direction that is generally oriented from the proximal end towards the distal end.
[0027] Now referring to Figures 2A to 2C, the bone implant 24 includes at least one wire 100 which is shaped to define the implant body 30 which includes the plurality of openings 56 extending through the implant body 30 from from the upper surface 54 to the bone facing surface 52 along a central opening axis 59 which can be oriented in the transverse direction T. The bone implant 24 can be partially or completely produced from metallic wire, which can define any implant body and opening size and shape as desired. Metal wire 100 can define a first wire segment 102 and a second wire wire segment 104 which are shaped to define the bone implant. The first and second metallic strand segments 102 and 104 may be integral and monolithic to form the metallic strand 100. Alternatively, the first and second metallic strand segments 102 and 104 may be separated from each other and defined by two respective different metallic strands . Metal wire segments 102 and 104 can be defined by a respective single wire wire filament or can be defined by multiple wire wire filaments that can be braided, twisted, or otherwise secured together to define the respective wire segments 102 and 104. Wire wire 100 defines an outer wire surface 101 that defines the bone facing surface 52, the opposing upper surface 54, the sides 38 and 40, and at least one inner wall 53.
[0028] The at least one inner wall 53 may include a first inner wall 53a and a second inner wall 53b that faces the first inner wall 53a along the lateral direction A. For example, the first metal wire segment 102 is molded to define the first inner wall 53a, and the second wire segment 104 is molded to define the second inner wall 53b, so that the first and second inner walls 53a and 53b define the plurality of bone fixation openings 56, as detailed below. It should be noted that the metallic wire segments 102 and 104 may be defined by a single monolithic wire 100, or they may alternatively be defined by two different metallic wires which are disposed adjacent to each other so as to define the segments. of wire rope 102 and 104. Wire wire segments 102 and 104 can define a circular cross-sectional shape so that the inner walls 53a and 53b can be curved, e.g. convex, as they extend along the direction. transverse T. The inner walls 53a and 53b may further be curved as they extend along the lateral direction L. In addition, the first portions 42a of the first and second inner walls 53a and 53b are concave as they extend along the direction longitudinal L to define the bone fixation openings 56, and the second portions 42b of the first and second inner walls 53a and 53b, in position adjacent to the first portions 42a are contained. veins, as they extend along the longitudinal direction L so as to define necks 108 which are disposed between adjacent openings of the bone fixation openings 56.
[0029] The bone-facing surface 52 and the upper surface 54 can be positioned in respective planes that are spaced apart along the transverse direction T and are each defined by the longitudinal direction L and the lateral direction A. Although bone implant 24 can be defined by the first and second wire segments 102 and 104 as shown in Figures 1A to 4C, bone implant 24 can alternatively be defined by a bone plate shown in Figure 5 so that the action at least one inner wall 53 can be defined by a single inner wall, as described in more detail below. Except where otherwise indicated, reference in the present invention to "inner wall 53" may be used to identify at least one inner wall, which includes reference to first and second inner walls 53a and 53b, and reference to a single inner wall.
[0030] As described above, the bone implant 24 defines the plurality of bone fixation openings 56 extending through the implant body 30. For example, the first and second inner walls 53a and 53b may each define the plurality of openings 56 which include a first opening 56a and a second opening 56b that are spaced apart from the first opening 56a along the longitudinal direction L. The bone implant 24 can include any number of openings as desired. The first and second openings 56a and 56b are configured to receive respective openings of the bone anchoring member 26 therein. In particular, the bone fixation system 20 may include a plurality of bone fixation elements 26, which includes a first bone fixation member 26a that is configured to be inserted into the first bone fixation opening 56a and a second bone fixation member. 26b which is configured to be inserted into the second opening of the bony fixation 56b. For example, bone implant 24 can be positioned so that the first bone fixation opening 56a is aligned with the first bone fragment 27a, and the second bone fixation opening 56b is aligned with the second bone fragment 27b. In this way, the bone gap 27c is positioned between the first and second bone fixation openings 56a and 56b. The first bone fixation element 26a can be inserted into the first bone fixation opening 56a and into the first bone fragment 27a, so as to secure the bone implant 24 to the first bone fragment 27a, and the second bone fixation element 26b can be inserted into the second opening of the bone fixation 56b and into the second bone fragment 27b so as to secure the bone implant 24 to the second bone fragment 27b. Thus, the bone implant 24 can be secured to the fixation site 28 and in such a way as to promote fusion of the first bone fragment 27a to the second bone fragment 27b.
[0031] As described above, The first and second metal wire segments 102 and 104 define a plurality of necks 108 that may define one or both of the boundaries of the bone fixation openings 56 along the longitudinal direction L. The necks 108 may be defined by their respective locations, the first and second inner walls 53a and 53b being closer together in the respective second portions 42b. For example, the locations of the necks 108 may bifurcate the second portions 42b along the longitudinal direction L. According to one embodiment, the locations of the necks 108 define respective points of intersection where the first inner wall 53a and the second inner wall 53b they are bordering on each other. The first and second inner walls 53a and 53b may further be secured, e.g. glued, soldered, or otherwise secured, relative to one another at the locations of the necks 108. The first segment of metal wire 102 extends along the longitudinal direction L between adjacent necks 108 to define first inner wall 53a, and second metal wire segment 104 extends along longitudinal direction L between adjacent necks 108 to define second inner wall 53b. The first and second wire segments 102 and 104 extend along the longitudinal direction L to define the spaced apart longitudinal ends of the bone fixation openings 56 defined by a pair of adjacently positioned necks 108. Thus, each opening The bone anchor 56 extends between a first end of the longitudinal ends and a second end of the longitudinal ends that is spaced from the first end of the longitudinal ends along the central implant axis 32 between adjacent locations of the necks 108. necks 108 can be arranged on the central axis 32.
[0032] Continuing with reference to Figures 2A to 2C, the inner wall 53 of the implant body 30 is threaded along the respective bone fixation openings 56. In this way, it can be said that at least a portion of the inner wall 53, includes at least a portion of the first inner wall 53a and at least a portion of the second inner wall 53b is threaded. For example, the first and second inner walls 53a and 53b define respective threads 58 which may be helical in shape and configured to threadably mate with the respective threads of the bone fixation element 26 when the bone fixation element 26 is inserted. at the respective opening of the bone fixation 56. The threads of the first inner wall 53a, when continued to the threads of the second inner wall 53b opposite the threads of the first inner wall 53 along the lateral direction A, can define a helical path. As such, lines 58 can be referred to as internal threads. Threads 58 may be disposed in a respective first threaded region 60 defined by first wire segment 102 and a respective second threaded region 62 defined by second wire segment 104. Thus, first inner wall 53a defines first threaded region 60 and second inner wall 53b defines second threaded region 62. First threaded region 60 extends along first wire segment 102 from a respective proximal end to a respective distal end that is spaced from the proximal end. in the distal direction. Similarly, the second threaded region 62 extends along the second wire segment 104 from a respective proximal end to a respective distal end that is spaced with respect to the proximal end in the distal direction. Furthermore, the first and second threaded regions 60 and 62 extend along a portion of the inner walls 53a and 53b, respectively, along the longitudinal direction. For example, threads 58 extend along at least part of first portions 42a of respective first and second inner walls 53a and 53b. For example, threads 58 may extend along first and second portions 42a and 42b of respective first and second inner walls 53a and 53b, from a first neck of necks 108 to an adjacent neck of necks 108, if desired. .
[0033] Now with reference to Figure 2C in particular, the inner wall 53 may combine to define a single thread 58 that extends around at least a portion of the perimeter of each opening of the bony fixation 56, or may alternatively define multiple interlocking threads that define what is known in the art as a multi-start thread. In this way, it can be said that the inner wall 53 defines at least one thread 58. According to one embodiment, the at least one thread 58 of the first and second inner walls 53a and 53b may be continuous with each other along a a helical trajectory.
[0034] At least one thread 58 includes a first surface 72a and an opposing second surface 72b. At least one or both of the first and second surfaces 72a and 72b converge towards each other among the first and second surfaces 72a and 72b, as the first and second surfaces 72a and 72b extend towards the central opening axis 59 In particular, each of the first and second surfaces 72a and 72b converge from a root 72c of the thread 58 to a crest 72d of the thread 58. The implant body 30, and thus the bone implant 24, defines a major diameter D1 which is defined by root 72c and extends along a direction perpendicular to central opening axis 59 and crosses central opening axis 59. Implant body 30, and thus bone implant 24, defines a smaller diameter d1. which is defined by ridge 72d and extends along a direction perpendicular to central opening axis 59 and crosses central opening axis 59.
[0035] The first surface 72a is spaced from the second surface 72b in the proximal direction. In this way, the second surface 72b is spaced with respect to the first surface in the distal direction. The first surface 72a may be called an anterior surface with respect to the insertion of the bone fixation element 26 into the respective opening of the bone fixation 56, and the second surface 72b may be called a posterior surface with respect to the insertion of the bone fixation element. 26 in the respective opening of the bone fixation 56. It should be noted, of course, that if the bone fixation element 26 is removed from the opening of the bone fixation 56, the second surface 72b becomes the anterior surface and the first surface 72a becomes the surface later. According to the illustrated embodiment, each of the first and second surfaces 72a and 72b, in cross section through a plane that is partially defined by the central opening axis 59, defines a first angle of less than 90 degrees with respect to the reference plane. which is oriented normal to the central opening axis 59. For example, the first and second surfaces 72a and 72b, in said cross section, can define equal and opposite initial angles with respect to the reference plane.
[0036] According to the illustrated embodiment, the inner walls 53a and 53b can define the desired number of interconnected threads 58, e.g., one, two, three, or more. Thus, the inner walls 53a and 53b define an advance L1, which is defined by the axial advance of the bone fixation element 26 along the central opening axis 59 when threadedly engaged with the at least one thread 58 and rotated in one revolution. 360 degree complete. The inner wall 53 further defines a pitch P1, which is the axial distance along the central opening axis 59 between adjacent ridges 72d, which may be defined by the same thread 58, for example if the inner surfaces 53 define a single thread. , or can be defined by different threads 58, for example if inner wall 53 defines multiple interlocking threads 58. Thus, lead L1 is a multiple of pitch P1 by the number of interlocking threads 58 defined by inner wall 53. When the wall internal 53 defines a single thread 58, the multiple is one, and the feed L1 is equal to the pitch P1.
[0037] Referring now also to Figures 3A to 3B, the bone fixation element 26 is elongated along a central axis 31 that can extend along the transverse direction T, and defines a proximal end 29a and a distal end 29b which is spaced from the proximal end 29a in a distal direction along the central axis 31. In this way, the proximal end 29a is spaced from the distal end 29b in a proximal direction. The central axis 31 is coaxial with the central opening axis 59 when the bone fixation element 26 is disposed in the bone fixation opening 56. The bone fixation element 26 can be an anchor, rivet, bone pin or screw configured to be secured at the attachment site 28.
[0038] The bone fixation element 26 may include a head 80 and a rod 82 that extends distally to the head 80. The rod 82 may define a length in the transverse direction T that is greater than the length of the head 80 in the transverse direction T. For example, rod 82 may extend directly from head 80, or bone fixation member 26 may include a narrowed region 83 that extends between head 80 and rod 82. The proximal end 29a of the bone fixation element 26 can be defined by the head 80, and the distal end 29b of the bone fixation element 26 can be defined by the stem 82. At least a portion of the stem 82 can be threaded along the transverse direction T , and may define at least one outer thread, such as a thread 84. The thread 84 may be helical and may extend from a root 85a to a crest 85b along a direction away from the central axis 31. The shank 82 in this way defines a main diameter D2 which is defined by crest 85b and extends along a direction perpendicular to central axis 31 and crosses central axis 31. Stem 82 may further define a smaller diameter d2 which is defined by root 85a and extends along from a direction perpendicular to the central axis 31 and crosses the central axis 31. The thread 84 may be helical and may define a pitch P2 and a feed L2. At least one thread 84 can be a single thread, so that lead L2 is equal to lead P2. Alternatively stem 82 may define multiple interconnected threads so that lead L2 is a multiple of step P2 as described above with respect to thread 58 of bone implant 24.
[0039] The smaller diameter d1 of the at least one thread 58 of the bone implant 24 may be larger than the main diameter D2 of the at least one thread 84 of the rod 82, so that the rod 82 can be advanced through the opening of the bone fixation 56 along the distal direction without rotating the bone fixation element 26 relative to the bone implant 24, and without causing at least one thread 84 to interfere with the at least one thread 58. Thus, during operation, the stem 82 can be advanced through one of the bone fixation openings 56 until stem 82 contacts the fixation site 28. The bone fixation element 26, including the stem 82, can be pivotally directed into the site. of underlying attachment 28, such that thread 84 engages with attachment site 28, e.g., bone 27, thereby securing rod 82 at attachment location 28. Thread 84 of stem 82 at distal end 29b may define one or more cutting grooves so that the fastening element is and 26 is configured as a self-tapping screw. Alternatively, the at least one thread 84 may be devoid of cutting grooves, so that the bone fixation element 26 defines a standard screw by which the threads 84 interpose with the bone 27 through a guide hole that has been pre-drilled in the bone 27, thereby securing rod 82 to attachment site 28.
[0040] Continuing with reference to Figures 3A-B, the head 80 can also be threaded along the transverse direction T, and can define at least one thread 88, which can be configured as an external thread. The at least one thread 88 may include a single thread or a plurality of interconnected threads as described above with respect to the inner wall 53 of the bone implant 24. Each of the threads 88 includes a first surface 89a and an opposing second surface 89b. At least one or both of the first and second surfaces 89a and 89b converge towards each other of the first and second surfaces 89a and 89b as the first and second surfaces 89a and 89b move away from the central axis 31. In particular, each of first and second surfaces 89a and 89b converge from a root 89c of thread 88 to a crest 89d of thread 88. Head 80 defines a main diameter D3 which is defined by crest 89d and extends along a direction perpendicular to the axis. central 31 and intersects with central axis 31. Head 80 may further define a smaller diameter d3 which is defined by root 89c and extends along a direction perpendicular to central axis 31 and intersects with central axis 31.
[0041] The narrowed region 83 defines an outer diameter D4 that is smaller than the main diameter D3 of the head 80. Both the outer diameter D4 of the narrowed region 83 and the main diameter D2 of the stem 82 are smaller than the smaller diameter d1 of the implant bone 24, so that the stem 82 and the narrowed region 83 can advance through the at least one opening of the bone fixation 56 without interfering with the respective at least one thread 58. The outer diameter D4 of the narrowed region 83 may be less than one or both of the main diameter D2 and the smaller diameter d2 of the shank 82, greater than one or both of the main diameter D2 and the smaller diameter d2 of the shank 82, or equal to one or both of the main diameter D2 and the diameter smaller d2 of rod 82 as desired.
[0042] The main diameter D3 of the head 80 is greater than the main diameter D2 of the stem 82 and the outer diameter D4 of the narrowed region 83. For example, the main diameter D3 of the head 80 is smaller than the main diameter D1 of the bone implant 24 and larger than the smaller diameter d1 of the bone implant 24. Furthermore, the smaller diameter d3 of the head 80 is smaller than the smaller diameter d1 of the bone implant 24. Thus, when the central axis 31 of the bone anchor 24 is aligned with the central opening axis 59, and the distal end of the at least one thread 88 is in contact with the at least one thread 58 of the inner wall 53, rotation of the bone anchor 24 in a first direction of rotation causes the at least a thread 88 threadably engages with the at least one thread 58 of the bone implant 24 which advances the bone fixation element 26 along the distal direction relative to the bone implant 24, thereby advancing the head 80 into the respective opening. of bone fixation 56 in the distal direction. It is noted that rotation of the bone fixation element 26 in the first direction can still direct the stem 82 to the underlying bone 27. It is recognized that rotation of the bone fixation element 26 in a second direction of rotation that is opposite to the first direction of rotation. rotation may cause the head 80 to retract from the respective opening of the bone fixation 56 along the proximal direction, until the head 80 is removed from the opening of the bone fixation 56. In addition, the rotation of the bone fixation element 26 in the second direction of rotation may cause rod 82 to retract from underlying bone 27 along the proximal direction until rod 82 is removed from underlying bone 27.
[0043] The bone fixation element 26 may further define an engagement element instrument that is configured to engage a steering instrument so as to receive a directed force that causes the bone fixation element 26 to rotate in one of the first and second directions of rotation. The engaging element tool may, for example, be configured as a socket 93 which extends into the head 80 in the distal direction along the central axis 31. The socket 93 may have any suitable shape configured to receive the targeting instrument . For example, socket 93 can be a square, hexagonal, crossed, slotted, flat, starry, hexalobular, or any other shape suitable for receiving a tool. In addition, bone fixation member 26 can be cannulated from socket 93 to head 80 and through rod 82 along central axis 31, and may further include one or more holes extending through rod 82 for cannulation. . The cannulation and holes can be configured to receive a temporary guide wire, such as a Kirschner wire that can be temporarily routed into the fixation site 28, so that the guide wire guides the bone fixation element 26 to the fixation site. fixation 28 during fixation of bone fixation element 26 within fixation site 28. The guidewire can then be removed from fixation site 28 and the cannulation. In addition, the holes can be configured to receive additional fasteners therethrough, such as a temporary guide wire or Kirschner wire, or an additional screw that can be inserted through socket 93 and the transverse hole to secure the bone 27 or the implant. The holes can also allow for bone ingrowth.
[0044] The first surface 89a is spaced with respect to the second surface 89b in the proximal direction. In this way, the second surface 89b is spaced with respect to the first surface 89a in the distal direction. The second surface 89b may be called an anterior surface with respect to the insertion of the bone fixation element 26 into the respective opening of the bone fixation 56, and the first surface 89a may be called a posterior surface with respect to the insertion of the bone fixation element. 26 in the respective opening of the bone fixation 56. In this way, the anterior surface of the at least one thread 88 of the head 80 faces the anterior surface of the at least one thread 58 of the bone implant 24 as the head 80 threadedly engages the bone implant 24 in the bone fixation opening 56. It should of course be noted that if the bone fixation element 26 is removed from the bone fixation opening 56, the first surface 89a becomes the anterior surface and the second surface 89b becomes the posterior surface. In accordance with the illustrated embodiment, each of the first and second surfaces 89a and 89b, in cross section through a plane that is partially defined by the central axis 31, defines a second angle of less than 90 degrees with respect to the reference plane which is oriented normal to the central axis 31. For example, the first and second surfaces 89a and 89b, in said cross section, can define equal and opposite second angles with respect to the reference plane. The second angle defined by at least one thread 88 is substantially equal to the first angle defined by at least one thread 58 of the bone implant 24.
[0045] According to the illustrated embodiment, the outer surface of the head 80 can define the number of desired interconnected threads 88, e.g., one, two, three, or more. Thus, the head 80 defines an advance L3, which is defined by the axial advance of the bone fixation element 26 along the central opening axis 59 when it threadedly engages with the at least one thread 58 and rotated in a full revolution of 360 degrees. The head 80 further defines a pitch P3, which is the axial distance along the central axis 31 between adjacent crests of the crests 89d, which may be defined by the same thread 88, for example if the head 80 defines a single thread, or it may be defined by different threads 88, for example if head 80 defines multiple interlocking threads 88. Thus, lead L3 is a multiple of pitch P3 by the number of interlocking threads 88 defined by head 80. When head 80 defines a single thread 88 , the multiple is one, and the lead L3 is equal to the step P3. Advance L3 is substantially equal to advance L1 of bone implant 24, and step P3 is substantially equal to step P1 of bone implant 24. In addition, advances L1 and L2 of head 80 and bone implant 24, respectively, may be substantially equal equal to the advance L3 of the rod 82. Thus, the rod 82 advances into the bone 27 in the distal direction at the same speed (for example, the distance per revolution of the bone fixation element 26 relative to the bone 27) as the speed of the head 80 advances through the opening of the bone fixation 56 in the distal direction (eg, distance per revolution of the bone fixation element 26 relative to the bone implant 24). The steps P1 and P2 of the head 80 and the bone implant 24, respectively, can still be substantially equal to the step L3 of the stem 82 when, for example, the at least one thread 58 of the respective opening of the bone fixation 56, the at least one thread 88 of head 80, and the at least one thread 84 of stem 82 define the same number of threads.
[0046] The main diameter D1 of the at least one thread 58 of the bone implant 24 may be greater than the main diameter D2 of the at least one thread 84 of the rod 82, so that the rod 82 can be advanced through the opening of the bone fixation 56 along the distal direction without rotating the bone fixation element 26 relative to the bone implant 24, and without causing at least one thread 84 to interfere with the at least one thread 58. Consequently, during operation, the rod 82 can be advanced through one of the bone fixation openings 56 until the rod 82 contacts the fixation site 28. The bone fixation element 26, including the rod 82, can be pivotally directed into the fixation site. underlying fixation 28, such that thread 84 engages with fixation site 28, e.g., bone 27, thereby securing rod 82 at fixation site 28. Thread 84 of stem 82 at distal end 29b may define a or more cutting grooves, so that the bone fixation 26 is configured as a self-drilling screw. Alternatively, the at least one thread 84 may be devoid of cutting grooves, so that the bone fixation element 26 defines a standard screw by which the threads 84 interpose with the bone 27 through a guide hole that has been pre- drilled into bone 27, thereby securing rod 82 to attachment site 28.
[0047] Continuing with reference to Figures 3A and B, head 80 defines a ridge 92 that is positioned adjacent to at least one thread 88 of head 80 so as to be spaced apart from at least one thread 88 along the proximal direction. . In this way, the at least one thread 88 can be spaced with respect to the ridge 92 along the distal direction. For example, an entirety of the at least one thread 88 may be spaced apart from the ridge 92 along the distal direction. Alternatively, the at least one thread 88 may be partially defined by the ridge 92 such that a portion of the at least one thread 88 extends distally to the ridge 92. The ridge 92 defines an outer cross-sectional dimension D5 along a plane defined by the longitudinal direction L and the lateral direction A. The outer cross-sectional dimension D5 is greater than the main diameter D3 of the head 80 and even greater than at least the smallest diameter d1 of the bone implant 24. Still , the outer cross-sectional dimension D5 may be greater than the main diameter D1 of the bone implant 24. The crest 92 may be circular in shape in a cross section with respect to a plane extending along the longitudinal and lateral directions of so that the outer cross-sectional dimension D5 is a diameter. Alternatively, ridge 92 may define any suitable alternative shape in said cross-section as desired. The ridge 92 defines a retaining surface that is aligned with a portion of the bone implant 24 along the transverse direction T. Thus, as described in detail below, the ridge 92 is configured to be in a boundary position to the bone implant 24 when the The head 80 threadably engages the bone anchor 24 in the respective attachment opening 56. The crest 92 can be continuous around the perimeter of the head 80 or segmented around the perimeter of the head 80.
[0048] Now referring to Figures 4A to 4C, during operation the bone implant 24 is positioned in a location as desired in relation to the underlying bone 27, so that the surface facing the bone 52 faces the fixation site underlying attachment 28 or bone 27, and the upper surface 54 is away from underlying attachment site 28 or bone 27 (see also Figure 1A). For example, the location can be such that the bone implant 24 is positioned against the underlying bone 27 or such that the bone implant 24 is spaced from the underlying bone as desired. The bone implant is positioned so that the bone gap is disposed between the first and second bone fixation openings 56 in the manner described above. A first bone fixation element 26 is directed through the first opening of the bone fixation openings 56 and into the first fixation site 28a, and a second bone fixation element 26 is directed through the second opening of the bone fixation openings 56 and into the second attachment location 28b. In particular, as each bone fixation element 26 is directed through the respective bone fixation opening 56 and into the underlying fixation site 28 and rotated relative to both the fixation site 28 and the bone implant 24, the threaded shaft 82 can be threadedly directed into underlying bone 27 in the manner described above. The bone fixation element 26 is directed into the underlying bone 27 until the at least one thread 88 of the head 80 begins to threadably engage with the at least one thread 58 of the bone implant 24. bone fixation 26 relative to fixation site 28 and bone implant 24 causes the at least one thread 88 to still threadably engage with the at least one thread 58 of the bone implant 24 as the head 90 advances in the distal direction. at the opening of the bone fixation 56.
[0049] As illustrated in Figures 4B to 4C since the main diameter D3 of the head 80 is smaller than the main diameter D1 of the bone implant 24, a gap 90 can be defined between the at least one thread 88 of the head 80 and the at least one thread 58 of the bone implant 24 along a line extending in the transverse direction T, and thus parallel to the central axis 31 and the central opening axis 59. For example, the gap 90 can be defined between the first surface 89a of the head 80 and a at least one thread 58, between the second surface 89b and the at least one thread 58, or a first portion of the gap 90 may be defined between the first surface 89a and the at least one thread 58, and a second portion of gap 90 may be defined between the second surface 89b and the at least one thread 58. For example, the gap 90 or the first portion of the gap 90 that is defined between the first surface 89a and the at least one thread 58 can in particular be defined between the first surface. and 89a and second surface 72b. The gap 90 or the second portion of the gap 90 that is defined between the second surface 89b and the at least one thread may in particular be defined between the second surface 89b and the first surface 72a. It may further be said that the gap 90 may be defined between the first surface 89a of the head 80 and the inner wall 53, between the second surface 89b and the inner wall 53, or a first portion of the gap 90 may be defined between the first surface. 89a and inner wall 53, and a second portion of gap 90 may be defined between second surface 89b and inner wall 53.
[0050] In addition, with respect to Figures 1B to 1C and Figures 4A to 4C, the rod 82 of the fixation element 26 is directed through the respective opening of the bone fixation 56 along the distal direction, and can be rotated in the first direction of rotation, and thereby causes the at least one thread 84 to threadably engage the first attachment site 28a, as the rod 82 is directed into the first attachment site 28a, which can be defined by the underlying bone 27. As the rod 82 is advanced into the first fixation site 28a, the at least one thread 88 of the head 80 threadedly engages with the at least one thread 58 in the respective opening of the bone fixation 56 of the bone implant 24, as illustrated. in Figure 4A. Continued rotation of the bone fixation element 26 in the first direction causes the crest 92 to move distally relative to the bone implant 24 until the crest 92, and in particular the crest retention surface 92, contacts the bone implant. 24 at a contact location 95 as illustrated in Figures 4B and 4C. The contact location 95 may be defined by the inner wall 53. It should be noted that at least a portion of the bone implant 24, for example at least a portion of the inner wall 53, is disposed between the ridge 92 and a threaded region of the head 80, which can be defined by a at least one thread 88.
[0051] As described above, at least a portion of the gap 90 may be disposed between the first surface 89a and the at least one thread 58 of the bone implant 24, for example, the second surface 72b of the at least one thread 58. Thus, with reference to Figures 4D and 4E, it is possible to prevent the bone implant 24 from moving in relation to the bone fixation element 26 along the transverse direction T, both in the proximal and in the distal direction, due to the free space provided by the gap 90, also known in the art as clearance. For example, further rotation of the bone fixation element 26 in the first direction of rotation causes the ridge 92, and in particular the ridge retaining surface 92, to hold against implant body 30 at the contact location 95, thereby directing the bone implant 24 distally with respect to the at least one thread 88 until the at least one thread 58 contacts the first surface 89a. In this way, the implant body 30, and in particular the inner wall 53, and thus the bone implant 24, is compacted between the retaining surface, for example, the ridge 92, and the at least one thread 88, for example, the front surface of a at least one thread. In particular, the proximal end of the implant body 30 holds against the retaining surface, which can be defined by the ridge 92, and the at least one thread 58 holds against the at least one thread 88. The implant body 30 is compacted between the ridge 92 and the at least one thread 88 while the at least one thread 88 is threadedly engaged with the at least one thread 58 of the bone implant 24. Thus, an entire gap 90 is disposed between the second surface 89b and the at least one thread 58, for example, the first surface 72a of the at least one thread 58. In this way, the contact between the ridge 92 and the bone implant 24 prevents the bone implant 24 from moving in the proximal direction in relation to the bone fixation element 26. In addition, the contact between the first surface 89a of the at least one thread 88 of the head 80 and the second surface 72b of the at least one thread 58 of the bone implant 24 prevents the bone implant 24 from move in the distal direction relative to the el bone fixation element 26. In this way, relative movement is impeded between the bone fixation element 26 and the bone implant 24 along the transverse direction T.
[0052] The ridge 92 can define a height along the transverse direction T from the contact location 95 to the surface closest to the ridge 92 that is no greater than the height of the bone implant from the contact location 95 to the end closest to the top surface 54. For example, the end closest to the top surface 54 may be in a first plane which is defined by the lateral direction A and the longitudinal direction L. The contact location 95 may be in a reference plane which is defined by the lateral direction and the longitudinal direction L. The reference plane is spaced from the first plane along the transverse direction T a first height. The end closest to the ridge 92 may be in a second plane which is defined by the lateral direction A and the longitudinal direction L. The third plane is spaced from the reference plane along the transverse direction T a second height which is not greater than the first height. For example, the second height of crest 92 may be less than the first height. Thus, when the ridge 92 is in contact with the bone implant 24 at the contact location 95, the ridge 92 does not protrude outwardly with respect to the closest end of the upper surface 54 along the proximal direction.
[0053] In addition, the crest 92 can define a height along the transverse direction T from the contact site 95 to the most distal surface of the head 80 that is no greater than the height of the bone implant 24 from the contact site 95 to the most distal end of the bone-facing surface 52. For example, the most distal end of the upper surface 54 may be in a third plane that is defined by the lateral direction A and the longitudinal direction L. The third plane is spaced in relation to the reference plane in the transverse direction T a third height. The most distal end of the ridge 92 may be in a fourth plane that is defined by the lateral direction A and the longitudinal direction L. The fourth plane is spaced from the reference plane so as to define a fourth height that is no greater than the third height. For example, the fourth height of crest 92 may be less than the third height. Thus, when ridge 92 is in contact with bone implant 24 at contact site 95, ridge 92 does not protrude outwardly with respect to the most distal end of the bone-facing surface 52 along the distal direction. Since the head 80 does not protrude outwardly with respect to the bone implant 24 along the transverse direction T according to a modality, the head 80 does not irritate soft tissue that is in close proximity to the bone implant 24.
[0054] According to one modality, because the advancement L1 of the bone implant 24 and the advancement L3 of the head 80 are substantially equal to the advancement L2 of the nail 82, the rotation of the bone anchor 24 in the first direction of rotation does not cause the bone implant 24 moves substantially toward or away from underlying bone 27 as stem 82 threadsly engages underlying bone at its attachment site 28, while head 80 threadsly engages bone implant 24 at its fixation opening 56. Alternatively, it is noted that the advancement L2 of the stem 82 may be different from the advancement L1 of the bone implant 24 and the advancement L3 of the head 80. In this way, the bone implant 24 may move relative to the underlying bone 27 along the transverse direction T as stem 82 threadsly engages the underlying bone at its attachment site 28, while the head 80 threadsly engages bone implant 24 in the respective attachment opening tion 56. For example, the advance L2 of the stem 82 may be greater than the advance L1 of the bone implant 24 and the advance L3 of the head 80. In this way, the rod 82 can advance into the fixation site in the distal direction during rotation of the bone fixation element at a first speed that is greater than a second speed at which the head 80 advances distally into the opening of the bone fixation 56. In this way, the bone implant 24 can move towards the underlying bone 27 in the direction distally as the stem 82 threadsly engages the underlying bone at its attachment site 28, while the head 80 threadsly engages the bone implant 24 at its attachment opening 56. In this way, the bone implant 24 can be placed in position adjacent to the underlying bone 27, so that the bone implant 24 is pressed against the underlying bone 27 as the stem 82 threadedly engages the underlying bone 27 at its attachment site 28, while the head 8 0 threadsly engages the bone implant 24 in the respective fixation opening 56. Alternatively, the advancement L2 of the stem 82 can be less than the advancement L1 of the bone implant 24 and the advancement L3 of the head 80. Thus, the implant Bone 24 can move away from underlying bone 27 along the transverse direction T as rod 82 threadsly engages underlying bone at its attachment site 28, while head 80 threadsly engages bone implant 24 in the respective fixing opening 56.
[0055] Again with reference to Figure 1C, at least a first bone fixation element 26a is attached to both the first fixation site 28a and the bone implant 24, in a respective at least one first opening of the bone fixation 56a as described above, and at least one second bone fixation element 26b is affixed to the second fixation site 28b and the bone implant 24 in a respective at least one second bone fixation opening 56b. The bone anchor system may include as many first bone anchors 26a as desired, and as many second bone anchors 26b as desired.
[0056] It should therefore be noted that coupling the bone fixation elements 26 to the bone implant 24 and the underlying bone 27 provides 1) angular stability between the bone fixation element 26 and the bone implant 24, and 2) prevents relative movement between the bone fixation element 26 and the bone implant 24 along the transverse direction T. For example, when a plurality of bone fixation elements 26 are coupled to the bone implant 24 and secured to a corresponding fixation site 28, the fixation is stable angle is achieved as the bone implant 24 forms a stable closing structure with the bone fixation elements 26 passing through the LF fracture site. Furthermore, the bone fixation element 26 can be coupled to the bone implant 24 such that at least a portion of the bone implant 24, for example a portion of the inner wall 53, is trapped between 1) a fixation element retaining surface. bone 26, for example the head 80, and 2) a threaded region of the head 80. For example, the retaining surface may be defined by the ridge 92, and the threaded region may be disposed distally from the ridge 92, and can be defined by a at least one thread 88 of the head 80.
[0057] Now with reference to Figure 5, it should be noted that, except where otherwise indicated, the bone implant 24 can be constructed according to any suitable alternative modality. For example, although bone implant 24 may be defined by first and second wire segments 102 and 104 as described above, bone implant 24 may alternatively be defined by a bone plate 97 defining implant body 30. implant 30, and thus bone plate 97, defines the bone facing surface 52 and upper surface 54 as described above, and further defines a plurality of inner surfaces 53 defining respective bone fixation apertures 56 extending through of an implant body 30 from the upper surface 54 to the bone facing surface 52. At least a portion of the inner wall 53 defines the at least one thread 58 in the manner described above, so that the at least one thread 88 of the The head 80 of the bone fixation element 26 can be threadedly secured to the at least one thread 58 of the bone implant 24 in the manner described above.
[0058] The bone fixation system 20 as constructed in the present invention can be formed using any suitable biocompatible materials or combination of materials. For example, bone implant 24 can be formed from metallic materials such as cobalt chromium molybdenum (CoCrMo), stainless steel, titanium, titanium alloys, magnesium, glass metals, ceramic materials, and polymeric materials including plastics, fiber-reinforced plastics , polymeric materials including poly(ether ether ketone) (PEEK), poly(ether ketone ketone) (PEKK), and bioabsorbable materials or materials with shape memory effect. In one embodiment, bone implant 24 can be formed from a combination of metallic and polymeric materials. For example, bone implant 24 can be formed from polymeric wire segments, metallic wire segments, or a combination of polymeric and metallic wire segments. Bone implant 24 can be coated with an antibacterial coating, drug elution coating, or surface modifier such as a diamond-like carbon coating. In another example, the bone implant 24 can be chemically processed using, for example, anodizing, electropolishing, chemical vapor deposition, plasma treatments, or any process to modify or improve surface characteristics of the bone implant. Bone fixation elements 26 can also be formed from metallic materials such as cobalt chromium molybdenum (CoCrMo), stainless steel, titanium, titanium alloys, nitinol and Gummetal®, magnesium, glass metals, ceramic materials, and polymeric materials including plastics , fiber reinforced plastics, polymeric materials including poly(ether-ether-ketone) (PEEK), poly(ether-ketone-ketone) (PEKK), and bioabsorbable materials or materials with shape memory. Bone fixation elements 26 can also be metallic or formed from metallic alloys such as titanium. The bone fixation element 26 can also be formed from a combination of metallic and polymeric materials. For example, the bone fixation elements 26 can have a polymeric head and a metal rod. The bone fixation elements 26 can be coated with an antibacterial coating, drug-eluting coating, or surface modifier such as a diamond-like carbon coating. In another example, the bone fixation elements 26 can be chemically processed using, for example, anodizing, electropolishing, chemical vapor deposition, plasma treatments, or any process to modify or improve feature elements of bone fixation surfaces.
[0059] Now with reference to Figures 6A and 6B, it should be noted that one or more or even all of the bone fixation elements 26 can be constructed according to an alternative modality. For example, as described above, bone fixation member 26 includes head 80 and rod 82 extending distally to head 80 along central axis 31. Rod 82 may define a length in the transverse direction T which is greater than the length of the head 80 in the transverse direction T. For example, the rod 82 may extend directly from the head 80, or the bone fixation member 26 may include a narrowed region 83 which extends between the head 80 and stem 82. Thus, the proximal end 29a of the bone fixation element 26 can be defined by the head 80, and the distal end 29b of the bone fixation element 26 can be defined by the stem 82. The head 80 can include the crest 92 which may be defined as a first ridge, and the head 80 may further include a second ridge 94 which is spaced distally from the first ridge 92 in the distal direction along the central axis 31. The head further defines a groove 96 what if it extends between the first ridge 92 and the second ridge 94. The groove 96 is configured to receive a portion of the inner wall 53 of the bone implant 24 to secure the bone fixation element 26 to the bone implant 24. The groove 96 is recessed in the interior of head 80 toward central axis 31 between first and second ridges 92 and 94. Thus, the outer cross-sectional dimension of head 80 at groove 96 along a direction that crosses and is perpendicular to central axis 31 is less than the outer cross sectional dimension of head 80 at first ridge 92, and may be even less than the outer cross sectional dimension of head 80 at second ridge 94. In the illustrated embodiment, groove 96 is unthreaded although it should be noted that groove 96 can alternatively be threaded as desired. The cross-sectional dimension of groove 96 may vary along its length along the transverse direction T. For example, the cross-sectional dimension of groove 96 may be 3.0 mm, or any suitable alternative dimension between 1.0 mm and 15.0 mm.
[0060] The first ridge 92 is configured to engage a portion of the bone implant 24. The first ridge 92 may be generally convex with respect to the central axis 31 so that the first ridge 92 extends outwardly from the central axis 31. In addition, first ridge 92 may be circumferentially disposed around head 80 and may be round or circular. Crest 92 can be continuous around head 80 or segmented as desired. The external cross-sectional dimension of the first crest 92, along a direction that is perpendicular to the central axis 31 and crosses the central axis 31, is greater than that of the external diameter of the opening of the bone fixation 56, so that at least a portion of the first ridge 92 is aligned with the bone implant 24 along the transverse direction T parallel to the central axis 31. The outer cross-sectional dimension of the first ridge 92 may be in the range between about 1 mm and about 15 mm. mm, like about 3.5 mm. When the bone fixation element 26 is fully inserted through the opening of the bone fixation 56, the surface closest to the head 80 a more proximally positioned portion of the upper surface 54 may be in a similar plane extending in the longitudinal direction L and in the lateral direction A. In alternative embodiments, at least a portion of the first ridge 92 may be linear. Other crest configurations are possible as desired.
[0061] The second ridge 94 is threaded, and thus configured to threadably engage with at least one thread 58 of the bone implant 24 as the bone fixation element 24 is inserted into the opening of the bone fixation 56. The second ridge 94 also it may be generally convex with respect to the central axis 31 so that the second ridge 94 extends outwardly from the center axis 31. The second ridge 94 may be circumferentially disposed around the head 80, and may be continuous or segmented. Second ridge 94 may define an outer diameter that is substantially equal to the outer diameter of first ridge 92, although it should be noted that the outer diameter of second ridge 94 may alternatively be less than the outer cross-sectional dimension of first ridge 92. The outer cross-sectional dimension of the second ridge 94 may be in the range between about 1 and about 15 mm, such as around 3.5 mm.
[0062] At least a portion of the second ridge 94 may be threaded to threadably engage at least one thread 58 as the bone fixation element 26 is advanced through the opening of the bone fixation 56. For example, the second ridge 94 may define at least one thread 97 that is configured as described above with respect to at least one thread 88 of head 80 described above. When the bone fixation element 26 is fully inserted into the bone fixation opening 56, as illustrated in Figure 6B, the at least one thread 97 threadably disengages from the at least one thread 58, and is spaced with respect to the at least a thread 58 along the distal direction. When the at least one thread 97 disengages the at least one thread 58, at least a portion of the inner wall 53 of the bone implant 24 is trapped or seated between the first crest 56 and the second crest 94. 26 can be coupled to the bone implant 24 such that at least a portion of the bone implant 24, for example a portion of the inner wall 53, is trapped between 1) a retaining surface, which can be defined by the bone fixation element 26 , for example the head 80, and 2) a threaded region of the head 80. For example, the retaining surface may be defined by the ridge 92, and the threaded region may be disposed distally from the ridge 92, and may be defined by a at least one thread 97 of the second crest 94.
[0063] Continuing with reference to Figures 6A and 6B, the groove 96 is configured to receive a portion of the bone implant 24. For example, at least a portion of the inner wall 53 may be received by the groove 96 between the first and second ridges 92 and 94. As discussed above, groove 96 may generally conform to curved inner wall 53 such that groove 96 is disposed adjacently and may be bordered with the at least one thread 58 when the bone fixation element 26 is inserted into the bone fixation opening 56. In the illustrated embodiment, the groove 96 is concave and may conform to the convex inner wall 53 as well as portions of the upper surface 54 and bone facing surface 52. For example , the concavity of the groove 96 can be defined by a radius of curvature that corresponds to the radius of curvature of the inner wall 53. The second crest 94 defines a main diameter D6 defined by the crest of at least one thread 97 that is greater than the diameter. the smallest d1 of a at least one thread 58. Thus, when the second ridge 94 is disposed adjacent to the at least one thread 58 along the distal direction, the at least one thread 97 of the second ridge 94 is aligned with the at least one thread 58, thereby preventing the head from being removed from the bone implant 24 by moving the bone fixation element 26 along the transverse direction T.
[0064] During operation, the rod 82 of the bone fixation element 26 is directed into the fixation site 28. For example, the bone fixation element 26 can be rotated in the first direction of rotation in order to advance the rod 82 at the fixation site 28 in the distal direction, such that the at least one thread 84 threadsly engages the fixation site 28. As the bone fixation element 26 advances in the distal direction during rotation in the first direction of rotation, the at least one thread 97 of the second ridge 94 threadably engages with at least one thread 88 of the head 80. As the bone fixation element 26 rotates in the first direction of rotation after the at least one thread 97 has engaged the at least one thread 54 while the central axis 31 is aligned with the central opening axis 59, the second ridge 94 threads distally with respect to the at least one thread 54 to the at least one thread 54, and thereby a portion of the inner wall 53 is trapped in groove 96. When the inner wall portion 53 is trapped in groove 96, the first and second ridges 92 and 94 movably couple the bone implant 24 to the bone fixation element 26. For example, the bone fixation element 26 may furthermore be rotated so as to reposition the bone implant 24 along the transverse direction T with respect to the fixation site 28. In this way, the alignment between the bone implant 24 and the fixation site 28 along the transverse direction T can be adjusted when the bone fixation element 26 is coupled to the bone implant 24.
[0065] It should be noted that, in accordance with one aspect of the present description, a surgical kit may include a plurality of bone implants 24 constructed in accordance with any one or more, or even all, of the modalities described herein, and a plurality of bone fixation elements 26 constructed in accordance with any one or more, to all, embodiments described herein. The kit can also include a drill and drill guide, and a guide wire. The drill guide can have a threaded end configured for insertion into the openings of the bone implant 24 so that the drill can be used to pre-drill a hole into which the bone fixation elements 26 can be inserted.
[0066] Although the disclosure has been described in detail, it is to be understood that various changes, substitutions and alterations may be made to the present invention without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of the present disclosure is not intended to be limited to the specific modalities described in the specification. As will be readily understood by the person skilled in the art from the processes, machines, manufacturing, composition of substance, means, methods, or steps presently existing, or to be developed later, that perform substantially the same function or achieve substantially the same results of the corresponding embodiments described herein which can be used in accordance with the present description.

权利要求:
Claims (18)
[0001]
1. Bone fixation system (20) comprising: a bone implant (24) elongated along a longitudinal direction (L), the bone implant (24) defining a longitudinal axis (32) oriented along the longitudinal direction (L) , the bone implant (24) including an implant body (30) defining an upper surface (54) and a bone facing surface (52) opposite the upper surface (54) and spaced from the upper surface (54) along of a transverse direction (T) that is perpendicular to the longitudinal direction (L) and a bone fixation opening (56) that extends through the implant body (30) from the upper surface (54) to the bone facing surface ( 52) along a transverse axis (59) oriented along the transverse direction (T), the bone fixation opening (56) at least partially defined by a threaded inner wall (53); and a bone fixation element (26) including a head (80) and a rod (82) which extends with respect to the head (80) in a distal direction and is configured to be guided to an fixation location, wherein the bone fixation element (26) further defines a retaining surface and the head (80) defines at least one thread (88) which is spaced from the retaining surface along the distal direction and the at least one thread (88) is configured. threadedly engaging the threaded inner wall (53) when the bone fixation element (26) rotates to advance the head (80) distally into the opening (56), characterized by the fact that: the threaded inner wall (53) has a threaded portion and an outer surface portion extending between the threaded portion and the upper surface (54), the outer surface portion being formed convexly to the transverse axis (59), the bone implant (24) comprises the first and second wire segments (102,104) defining the first and second inner threaded walls (53a, 53b), respectively, facing to define the inner threaded wall (53), each of the first and second wire segments (102,104) defining the outer surface portion convexly. and when the at least one thread (88) is engaged with the threaded inner wall (53) of the bone implant (24), at least a portion of the convexly shaped outer surface is captured between the retaining surface and the at least one thread (88).
[0002]
2. Bone fixation system, according to claim 1, characterized in that the retention surface is aligned with the bone implant (24) in the distal direction.
[0003]
3. Bone fixation system according to any one of claims 1 to 2, characterized in that the rotation of the fixation element (26) after at least one thread (88) has threadedly engaged with the threaded inner wall (53) places the retention surface in contact with the bone implant (24).
[0004]
4. Bone fixation system according to claim 3, characterized in that an additional rotation of the bone fixation element (26) when the retention surface is in contact with the bone implant (24) leads to the retention surface in the distal direction, thereby compressing the threaded inner wall (53) against the at least one thread (88).
[0005]
5. Bone fixation system according to claim 4, characterized in that at least one thread (88) has a rear surface (89a) and a front surface (89b) disposed distally to the rear surface ( 89a), and further rotation of the fastener (26) drives the retaining surface in the distal direction, thus compressing the threaded inner wall (53) against the main surface (89b).
[0006]
6. Bone fixation system according to claim 4, characterized in that 1) the contact between the bone implant (24) and at least one thread (88) prevents the bone implant (24) from moving in relation to the bone fixation element (26) in the distal direction and 2) the contact between the bone implant (24) and the retaining surface prevents the bone implant (24) from moving relative to the bone fixation element (26) in a proximal direction that is opposite to the distal direction.
[0007]
7. Bone fixation system according to claim 5, characterized in that the retention surface is defined by a crest (92) that defines an external cross-sectional dimension (D5) and at least one thread (88) of the head (80) defines a main diameter (D3) smaller than the dimension of the outer cross section (D5).
[0008]
8. Bone fixation system, according to claim 7, characterized in that the head (80) defines the crest (92).
[0009]
9. Bone fixation system according to any one of claims 7 to 8, characterized in that after the crest (92) is in contact with the bone implant (24), the head (80) defines a closer surface and one distal. Over most of the surface, the most distal surface does not project to the bone implant (24) in the distal direction and the most proximal surface does not project to the bone implant (24) in a proximal direction that is opposite to the distal direction. .
[0010]
10. Bone fixation system according to any one of claims 1 to 2, characterized in that the head (80) defines a groove (96) that is arranged between the retention surface and at least one thread (88) , the groove (96) configured to capture the bone implant (24) between the retaining surface and at least one thread (88).
[0011]
11. Bone fixation system according to any one of claims 1 to 2 and 10, characterized in that at least one thread (88) is away from the threaded inner wall (53) in the distal direction when the at least one portion The inner wall (53) is trapped between the retaining surface and at least one thread (88).
[0012]
12. Bone fixation system, according to any one of claims 10 to 11, characterized in that the groove (96) is not threaded.
[0013]
13. Bone fixation system, according to any one of the preceding claims, characterized in that the bone implant comprises a bone plate.
[0014]
14. Bone fixation system according to any one of the preceding claims, characterized in that the rod (82) is threaded so as to be configured to be threaded at the fixation site, as the head (80 ) threads through the bone fixation opening ( 56)
[0015]
15. Bone fixation member (26) extends along a central axis (31), the bone fixation member (26) comprising: a head (80); and a rod (82) which extends with respect to the head (80) in a distal direction and is configured to be guided to an attachment location, wherein the head (80) defines a ridge (92) and at least one thread. (88) which is spaced from the ridge (92) along the distal direction, the ridge (92) defines an outer cross-sectional dimension (D5) in a direction that crosses the central axis (31) and is perpendicular to the central axis ( 31), and at least one thread (88) defines a larger diameter (D3) in the direction and the larger diameter (D3) of the at least one thread (88) is smaller than the dimension of the outer cross section (D5) of the crest ( 92), wherein the ridge (92) is configured to compress a threaded inner wall (53) of a bone implant (24) between the ridge (92) and the at least one thread (88) of the head (80) as the head (80) ) is threaded forward distally into a bony fixation opening (56) that is at least partially defined by the threaded inner wall (53), wherein at least one thread (88) of the head (80) comprises a first surface (89a) that becomes a posterior surface during advancement and a second surface (89b) that becomes a main surface during advancement, characterized by the fact that the larger diameter ( D3) of the head (80) which is defined by a ridge (89d) of at least one wire (88) being smaller than a larger diameter (D1) of the bone implant (24) which is defined by a root (72c) of a thread (58) in the threaded inner wall (53), so that a space (90) is defined between at least one thread (88) of the head (80) and the thread (58) in the threaded inner wall (53) of the implant bone (24) along a line extending parallel to the central axis (31), and the head (80) is movable in the bone fixation opening (56) with compression, from (i) a first position in the in which a first portion of the gap 90) is defined between the first surface (89a) and the thread (58) in the threaded inner wall (53) and a second portion of the gap (90) is defined. Between the second surface (89b) and the thread (58) in the threaded inner wall (53), (ii) a second position in which a total clearance (90) is disposed between the second surface (89b) and the thread ( 58) on the threaded inner wall (53).
[0016]
16. Bone fixation element according to claim 15, characterized in that the nail (82) defines at least one thread (84) so as to be threadedly attached to the underlying bone as the nail (82) ) is pivotally directed into the underlying bone.
[0017]
17. Bone fixation element according to claim 16, characterized in that at least one thread (88) of the head (80) defines a derivation and the at least one thread (84) of the stem (82) defines a tap which is equal to the advancement of at least one thread (88) of the head (80).
[0018]
18. Bone fixation element according to claim 16, characterized in that at least one thread (88) of the head (80) defines a conductor, and at least one thread (84) of the stem (82) defines a conductor that is greater than the advancement of at least one thread (88) of the head (80).

类似技术:

公开号 | 公开日 | 专利标题

BR112015003734B1|2021-08-03|BONE FIXATION SYSTEM AND BONE FIXATION ELEMENT

US10716606B2|2020-07-21|Bone fixation system

US9597130B2|2017-03-21|Bone fixation system including K-wire compression

JP4468814B2|2010-05-26|Fixation system consisting of nails and screws to improve the fixation of proximal fractures of the humerus

US8518090B2|2013-08-27|Fastener with serrated thread for attachment to a bone plate at a selectable angle

KR20120013319A|2012-02-14|Multiplexed screws

EP2389884B1|2013-07-31|Implant for bone fixation

US8679121B2|2014-03-25|Intramedullary nail with oblique openings

US20180235681A1|2018-08-23|Adjustable angle bone fixation assembly

BG104402A|2001-02-28|Implant for stabilizing a fracture and screw for use in surgery

WO2010062379A1|2010-06-03|Bone fracture fixation screws, systems and methods of use

US20200100823A1|2020-04-02|Implantable compression screws

US10085779B2|2018-10-02|Intramedullary device for mid-shaft clavicle fractures

US10028779B2|2018-07-24|Mandibular bone plate

EP3530225A1|2019-08-28|Mandibular bone plate

CN213249618U|2021-05-25|Fibula bone fracture plate

WO2017213613A1|2017-12-14|Size adjustable locking compression screw

同族专利:

公开号 | 公开日

IN2015DN01484A|2015-07-03|

BR112015003749A2|2019-12-17|

KR102190533B1|2020-12-16|

RU2648850C2|2018-03-28|

CN107252343A|2017-10-17|

BR112015003734A8|2021-04-06|

KR20150047532A|2015-05-04|

CN107252344A|2017-10-17|

TWI605787B|2017-11-21|

CA2882631C|2021-11-09|

JP6293754B2|2018-03-14|

CN104736081B|2017-07-28|

WO2014031935A1|2014-02-27|

BR112015003734A2|2017-07-04|

DE202013012517U1|2017-03-07|

TWI638635B|2018-10-21|

KR20150047531A|2015-05-04|

CA2882631A1|2014-02-27|

CN104736080A|2015-06-24|

EP3181076A1|2017-06-21|

KR102183272B1|2020-11-27|

JP2015526204A|2015-09-10|

CN104736081A|2015-06-24|

EP2887895B1|2016-09-21|

IN2015DN01479A|2015-07-03|

TWI698219B|2020-07-11|

CN104736080B|2017-08-04|

TW201417765A|2014-05-16|

EP2887895A1|2015-07-01|

WO2014031938A1|2014-02-27|

JP2018158174A|2018-10-11|

JP6656920B2|2020-03-04|

EP2887894A1|2015-07-01|

CA2882630A1|2014-02-27|

TW201422195A|2014-06-16|

RU2015110060A|2016-10-10|

CA2882630C|2021-05-04|

JP2015526203A|2015-09-10|

RU2015110019A|2016-10-10|

TW202002905A|2020-01-16|

CO7270464A2|2015-05-19|

CN107252343B|2020-11-17|

EP2887894B1|2017-03-22|

JP6991937B2|2022-01-13|

CO7280474A2|2015-05-29|

RU2641859C2|2018-01-22|

引用文献:

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

GB9701994D0|1997-01-31|1997-03-19|Surgical Technology Uk Limited|Surgical fixation peg|

RU2133593C1|1997-03-11|1999-07-27|Кобзев Эрнест Васильевич|Device foe osteosynthesis|

FR2766353B1|1997-07-28|1999-11-26|Dimso Sa|IMPLANT, ESPECIALLY ANTERIOR CERVICAL PLATE|

NZ513747A|1999-03-09|2002-12-20|Synthes Ag|Bone plate with conical screw threads|

US6436099B1|1999-04-23|2002-08-20|Sdgi Holdings, Inc.|Adjustable spinal tether|

US7695502B2|2000-02-01|2010-04-13|Depuy Products, Inc.|Bone stabilization system including plate having fixed-angle holes together with unidirectional locking screws and surgeon-directed locking screws|

US7695472B2|2003-03-26|2010-04-13|Swiss Orthopedic Solutions Sa|Locking bone plate|

US7776076B2|2004-05-11|2010-08-17|Synthes Usa, Llc|Bone plate|

AT473702T|2003-08-26|2010-07-15|Synthes Gmbh|BONE PLATE|

US20050049595A1|2003-09-03|2005-03-03|Suh Sean S.|Track-plate carriage system|

US7179260B2|2003-09-29|2007-02-20|Smith & Nephew, Inc.|Bone plates and bone plate assemblies|

US20050101961A1|2003-11-12|2005-05-12|Huebner Randall J.|Bone screws|

US20050136764A1|2003-12-18|2005-06-23|Sherman Michael C.|Designed composite degradation for spinal implants|

US20060058796A1|2004-09-14|2006-03-16|Hartdegen Vernon R|Compression brace|

US8118846B2|2005-01-28|2012-02-21|Orthohelix Surgical Designs, Inc.|Orthopedic plates for use in clavicle repair and methods for their use|

SE528331C2|2005-04-08|2006-10-24|Eulogic Ab|Surgical pin|

US7931681B2|2005-04-14|2011-04-26|Warsaw Orthopedic, Inc.|Anti-backout mechanism for an implant fastener|

US20060276793A1|2005-05-26|2006-12-07|Amedica Corporation|Bone fixation plate with self-locking screws|

US8075604B2|2006-02-16|2011-12-13|Warsaw Orthopedic, Inc.|Multi-thread bone screw and method|

US20070225715A1|2006-03-24|2007-09-27|Depuy Products, Inc.|Fastening system for internal fixation|

CN2922820Y|2006-06-15|2007-07-18|常州邦德医疗器械有限公司|Locking bone-setting board screw auxiliary assembly|

US8398690B2|2007-02-07|2013-03-19|Apex Biomedical Company, Llc|Rotationally asymmetric bone screw|

CA2693540A1|2007-08-07|2009-02-12|Synthes Usa, Llc|Dynamic cable system|

MY154229A|2007-08-27|2015-05-15|Adler Mediequip Private Ltd|Bone plate and bone palte assemblies|

CN101808589B|2007-10-12|2014-06-25|斯恩蒂斯有限公司|Reconstruction device|

US20110009912A1|2008-08-07|2011-01-13|Eduardo Gonzalez-Hernandez|Fixed angle dual prong pin fixation system|

AU2010248816B2|2009-05-15|2015-11-05|Smith & Nephew, Inc.|Polyaxial fastener systems and methods|

US20120004690A1|2010-06-25|2012-01-05|Eduardo Gonzalez-Hernandez|Screw fixation system|

CN102008347A|2010-11-23|2011-04-13|马丽昕|Ponze steel plate with lock and aiming fixing device|

RU108948U1|2011-04-05|2011-10-10|Государственное образовательное учреждение высшего профессионального образования Военно-медицинская академия им. С.М. Кирова |SCREW FOR REPOSITION AND IMMOBILIZATION OF FRAGMENTS OF BONES OF THE FACIAL REGION OF THE SKULL IN VIOLATION OF THEIR INTEGRITY|

US9433452B2|2012-08-03|2016-09-06|Nextremity Solutions, Llc|Bone fixation device and method|

US9452005B2|2012-08-23|2016-09-27|DePuy Synthes Products, Inc.|Bone fixation system|

BR112015003734B1|2012-08-23|2021-08-03|Synthes Gmbh|BONE FIXATION SYSTEM AND BONE FIXATION ELEMENT|

KR101471627B1|2013-04-02|2014-12-11|주식회사 제일메디칼코퍼레이션|Locking angle adjustable bone plate system|US9107716B2|2009-11-23|2015-08-18|DePuy Synthes Products, Inc.|Flexible maxillo-mandibular fixation device|

BR112015003734B1|2012-08-23|2021-08-03|Synthes Gmbh|BONE FIXATION SYSTEM AND BONE FIXATION ELEMENT|

US10004603B2|2012-08-23|2018-06-26|DePuy Synthes Products, Inc.|Bone implant|

US9452005B2|2012-08-23|2016-09-27|DePuy Synthes Products, Inc.|Bone fixation system|

US9820777B2|2014-07-09|2017-11-21|DePuy Synthes Products, Inc.|Flexible maxillo-mandibular fixation device|

JP6580667B2|2014-07-09|2019-09-25|デピュイ・シンセス・プロダクツ・インコーポレイテッド|Flexible upper and lower jaw fixation device|

US10779811B2|2014-12-11|2020-09-22|Smith & Nephew, Inc.|Bone anchor having improved fixation strength|

WO2017150535A1|2016-02-29|2017-09-08|メドトロニックソファモアダネック株式会社|Set screw for antibacterial device to be implanted in vivo|

CN106037917A|2016-06-29|2016-10-26|宁波慈北医疗器械有限公司|Temporomandibular joint titanium-alloy anchor nail|

FR3082417B1|2018-06-19|2021-06-25|Arnaud Destainville|MODULAR BONE PLATE MODULE AGENCY TO RECEIVE AN ANCHORING DEVICE, MODULAR BONE PLATE THUS CONSTITUTED AND SYSTEM INCLUDING THE PLATE AND ANCHORING DEVICE|

CN109730758B|2019-02-22|2020-06-02|艾奥斯医疗科技有限公司|Trilobal locking bone fracture plate beneficial to stability increase|

RU2765329C1|2021-09-07|2022-01-28|Игорь Георгиевич Киселев|Bone fixation system|

法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-12-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-06-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-08-03| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201261692673P| true| 2012-08-23|2012-08-23|

US61/692,673|2012-08-23|

US201361786937P| true| 2013-03-15|2013-03-15|

US201361787082P| true| 2013-03-15|2013-03-15|

US61/787,082|2013-03-15|

US13/832,518|US10004603B2|2012-08-23|2013-03-15|Bone implant|

US13/832,518|2013-03-15|

US13/832,364|US9452005B2|2012-08-23|2013-03-15|Bone fixation system|

US13/832,364|2013-03-15|

US61/786,937|2013-03-15|

PCT/US2013/056348|WO2014031938A1|2012-08-23|2013-08-23|Bone fixation system|

[返回顶部]