bone fixation set

专利摘要:
INTRAMEDULAR STEM WITH SELF-RETENTION COMPRESSION SLIT. The present invention relates to an intramedullary nail having a scalloped compression slit in order to define a plurality of pockets and intersections between the pockets that are narrower than the pockets. Consequently, a compression member can be inserted into a bone segment of a fractured bone and into the crack. The compression member can apply a force against the compression member that causes the compression member to move through pocket-to-pocket intersections, until the fracture has been approximated. Because the compression member is wider than the intersections, the compression gap retains the compression member and prevents fracture deviation.
公开号:BR112013020956B1
申请号:R112013020956-9
申请日:2012-02-14
公开日:2020-12-08
发明作者:Tom Overes
申请人:Synthes Gmbh；
IPC主号:

专利说明:

REMISSIVE REFERENCE TO RELATED ORDERS
[0001] This document claims the benefit of US patent application serial number 61 / 442,397 filed on February 14, 2011, its description being incorporated herein by reference as set out in its entirety in the present invention. BACKGROUND
[0002] Conventional intramedullary nails are configured to be inserted into the medullary canal of a long bone that has been fractured, in order to define a proximal bone segment and a distal bone segment that are separated from the proximal bone segment by a failure bone. Conventional intramedullary nails are elongated along a substantially central longitudinal axis, and include a plurality of holes for bone fixation that extend through the nail along the respective axes that are angularly displaced, for example perpendicular, with respect to the axis longitudinal length of the intramedullary nail, and configured to receive bone anchors. For example, the holes for bone fixation can be substantially smooth and configured to receive screws, or they can be threaded to fit with screws to increase axial stability. The bone fixation holes can be divided into a first plurality of proximal bone fixation holes that extend through the proximal portion of the intramedullary nail and a second plurality of distal bone fixation holes that extend through the distal portion of the intramedullary nail - home. Thus, the intramedullary nail can be inserted into the medullary canal of the fractured long bone so that the fixation holes of the proximal bone are aligned with the proximal bone segment and the fixation holes of the distal bone are aligned with the distal bone segment. on opposite sides of the bone failure. The bone screws can be directed into the bone segments and the corresponding holes for bone fixation in order to fix the intramedullary nail to the long fractured bone and stabilize the proximal and distal segments of the bone, thus promoting healing.
[0003] Certain conventional intramedullary nails include the compression resources that cause the proximal and distal bone segments to be compressed towards each other, thus approximating the bone failure. For example, screws can be inserted into the distal bone segment and into the fixation holes of the distal bone of the intramedullary nail, in order to secure the distal bone segment to the distal intramedullary nail, and the compression feature can be activated to cause the proximal bone segment moves in relation to the intramedullary nail towards the distal bone segment. However, certain conventional compression features, while facilitating the approximation of bone failure, do not show self-entertainment. Consequently, compression is maintained manually while fixing the distal bone segment to the distal portion of the intramedullary nail. Other compression features feature self-retention in order to maintain the approach of bone failure, while the distal bone segment is fixed to the distal portion of the intramedullary nail. However, conventional self-retaining compression features typically add moving components to the intramedullary nail and are time-consuming and complex to use. SUMMARY
[0004] According to one aspect, an intramedullary nail includes a body of the nail that defines a first portion that is positioned to attach to a first bone segment and a second portion that is spaced with respect to the first portion substantially over a longitudinal direction and positioned to attach to a second bone segment, which is separated from the first bone segment by a bone failure. The stem body defines a scalloped slit that extends within the first portion of the stem body, the slit defining at least a pair of longitudinally spaced pockets and an intersection between the pockets. The compression slot defines a first width substantially perpendicular to the longitudinal direction between the opposite parts of the intersections, and the compression defines a second width between the opposite parts of the pockets along a direction substantially parallel to the first width, so that a second width is larger than the first width. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The aforementioned summary, as well as the detailed description below of the preferred modalities of the application, will be better understood when read in conjunction with the attached drawings. In order to illustrate the present description, the preferred embodiments are shown in the drawings. It should be understood, however, that the request is not limited to specific modalities and methods presented, and reference is made to the embodiments for this purpose. In the drawings:
[0006] Figure 1 is a perspective view of a long fractured bone that defines a proximal bone segment and a distal bone segment separated from the proximal bone segment by a bone failure;
[0007] Figure 2A is a side elevation view of an intramedullary nail with a proximal portion, a distal portion, a plurality of proximal bone fixation holes extending through the proximal portion, a plurality of bone fixation holes distal extending through the distal portion, and a self-retaining compression slit that extends along the proximal bone segment;
[0008] Figure 2B is another side elevation view of the intramedullary nail illustrated in Figure 2A;
[0009] Figure 2C is an enlarged side elevation view of the compression slot shown in Figure 2A;
[00010] Figure 2D is a sectional elevation view of a proximal portion of the intramedullary nail illustrated in Figure 2A;
[00011] Figure 2E is a perspective view of the proximal portion of the stem body illustrated in Figure 2A, but constructed according to an alternative embodiment, showing the stem body, including an insert that is attached to the proximal portion;
[00012] Figure 2F is a perspective view of the proximal portion of the stem body illustrated in Figure 2A, showing the insert fixed in the proximal portion;
[00013] Figure 2G is a perspective view of a portion of the intramedullary nail, similar to the intramedullary nail illustrated in Figure 2A, but in which the compression slot, as illustrated in Figure 2A, is partially defined by the intersections constructed according to an alternative modality;
[00014] Figure 2H is a top plan view of the intramedullary nail portion, illustrated in Figure 2G;
[00015] Figure 3 is a side elevation view of a compression member configured to extend inside the compression gap of the intramedullary nail illustrated in Figure 2A;
[00016] Figure 4A is a perspective view of a fixation system, including an implantation set that includes a support structure and a clamp element, and a bone fixation set that includes the intramedullary nail illustrated in Figure 2A, showing the clamp element attached to the intramedullary nail;
[00017] Figure 4B is a sectional side elevation view of the fixation system illustrated in Figure 4A, with a cut-out portion;
[00018] Figure 5 is a perspective view of the fixation system illustrated in Figure 4, showing the intramedullary nail implanted in the medullary canal of the fractured long bone illustrated in Figure 1;
[00019] Figure 6 is a perspective view of the fixation system as illustrated in Figure 5, but showing the bone fixation set including a plurality of bone fixation screws inserted into the distal bone segment and respective bone fixation holes. distal of the intramedullary nail, in order to fix the distal portion of the intramedullary nail to the distal bone segment;
[00020] Figure 7A is a perspective view of the fixation system illustrated in Figure 6, but showing the implantation set including a cylindrical orientation fitting coupled to the support structure and operationally aligned with the compression gap of the intramedullary nail;
[00021] Figure 7B is a perspective view of the fixation system illustrated in Figure 7A, but showing the bone fixation set including a compression member configured as a bone screw inserted inside the proximal bone segment and inside the compression slot. ;
[00022] Figure 7C is a perspective view of the fixation system illustrated in Figure 7B, but showing the cylindrical orientation socket removed;
[00023] Figure 8A is a perspective view of the fixation system illustrated in Figure 7C, but showing the implantation set including a compression actuator aligned with the compression member;
[00024] Figure 8B is a perspective view of the fixation system illustrated in Figure 8A, but showing the compression actuator, operationally coupled to the support structure;
[00025] Figure 8C is a perspective view of the fixation system illustrated in Figure 8B, showing portions in cross section;
[00026] Figure 8D is a perspective view of the fixation system illustrated in Figure 8C, but showing the compression actuator in a compressed position that moves the compression member along the compression slot in order to approximate the bone gap;
[00027] Figure 8E is a perspective view of the fixation system illustrated in Figure 8D;
[00028] Figure 8F is a perspective view of the fixation system illustrated in Figure 8E, but showing the compression actuator removed, so that the bone failure remains approximate;
[00029] Figure 9A is a perspective view of the fixation system illustrated in Figure 8E, showing the cylindrical orientation socket aligned with one of the fixation holes of the proximal bone;
[00030] Figure 9B is a perspective view of the fixation system illustrated in Figure 9A, but showing a bone screw inserted into the proximal bone segment and one of the fixation holes in the proximal bone;
[00031] Figure 9C is a perspective view of the fixation system illustrated in Figure 9B, but showing a second bone screw inserted into the proximal bone segment and one of the fixation holes in the proximal bone;
[00032] Figure 10 is a perspective view of the fractured bone illustrated in Figure 1, but approached and attached to the intramedullary nail illustrated in Figures 2A and 2B, after the implantation set illustrated in Figure 9C has been removed from the intramedullary nail;
[00033] Figure 11A is a side elevation view of an intramedullary nail similar to the intramedullary nail illustrated in Figure 2A, but including a relief slit, according to another embodiment;
[00034] Figure 11B is a sectional elevation view of a proximal portion of the intramedullary nail illustrated in Figure 11A;
[00035] Figure 11C is an enlarged side elevation view of a portion of the intramedullary nail illustrated in Figure 11A. DETAILED DESCRIPTION
[00036] With reference to Figure 1, a long bone 20 that is substantially elongated along a longitudinal direction is fractured in order to define a first proximal bone segment 22 and a second distal bone segment 24 that is separated from the proximal bone segment 22 by a longitudinal bone defect 26 at a fracture site 28. It should be noted that the long fractured bone 20 can define a single fracture site 28 as illustrated, or it can define multiple fracture sites that separate the additional bone segments from one another in respective bone failures. While the long bone 20 is a humerus according to the illustrated embodiment, the long bone 20 can be any long bone in the body that defines a medullary canal 23 suitable for receiving an intramedullary nail, in order to fix the proximal bone segment 22 to the segment distal bone 24. However, because bone failure 26 defines a distance from bone failure D1 that extends along a longitudinal direction L and is greater than a desirable distance suitable for reliable fixation of the proximal bone segment 22 to the distal bone segment 24, it is desirable for the intramedullary nail to include a compression feature that is configured to approach bone gap 26 at a distance that allows reliable fixation of bone segments 22 and 24 through bone gap 26 during healing.
[00037] Now with reference to figures 1 to 2D, an intra-medullary stem 30 constructed according to one embodiment includes a stem body 32 that is substantially elongated along a longitudinal axis 31 that extends substantially along the longitudinal direction. L. For example, it should be noted that the stem body 32 extends linearly along the longitudinal direction L or may be slightly curved along the longitudinal direction. The intramedullary nail 30 can be inserted into the medullary canal 23 of the long bone so that the longitudinal axis 31 extends along the medullary canal 23. According to one embodiment, the longitudinal axis 31 can define a central axis of the stem body 32. The stem body 32 can define any suitable shape as desired, and is substantially cylindrical in cross section along a plane that is substantially perpendicular to the longitudinal axis 31, according to the illustrated embodiment. The stem body 32 defines a proximal portion 34 and an opposite distal portion 36 that is spaced distally with respect to the proximal portion 34 along the longitudinal axis 31, and an intermediate portion 38 disposed between the proximal portion 34 and the distal portion 36.
[00038] The stem body 32 further defines a first portion 33 that is positioned to attach to the first or proximal bone segment 22, and a second opposite portion 35 that is spaced in relation to the first portion 33, along the longitudinal direction and positioned to attach to the second or distal bone segment 24, so that the intermediate portion 38 extends between the first and second portions 33 and 35. According to the illustrated embodiment, the first portion 33 defines the proximal portion 34 of the stem body 32, and the second portion 35 defines the distal portion 36 of the stem body 32. Alternatively, as will be described in detail below, the first vapor 33 can define the distal portion 36 of the stem body 32 and the second portion 35 can define the proximal portion 34 of the stem body 32.
[00039] The intramedullary nail 30 further defines a plurality of holes for bone fixation 40 which extend inside and can additionally extend through the body of the nail 32, for example, along a direction which is angularly displaced, as substantially perpendicular , with respect to the longitudinal axis 31. The bone fixation holes 40 can be sized to receive complementary bone anchors that are configured to attach the intramedullary nail 30 to the long bone 20. For example, the bone fixation holes 40 can receive any respective bone anchors suitable as nails or screws that fix the intramedullary nail 30 to the long bone 20. At least a portion of the bone fixation holes 40 can be threaded to fit with the complementary threaded portions of some selected to all bone screws . In this way, the bone fixation holes 40 can be threaded, unscrewed or threaded over a portion of its length along the transverse direction T. The bone fixation holes 40 can include at least one as a plurality of first holes for bone fixation 40a arranged in the first portion 33 of the stem body 32, and at least one as a plurality of second bone fixation holes 40b arranged in the second portion 35 of the stem body 32.
[00040] The intramedullary nail 30 is configured to be initially inserted into the medullary canal 23 of the long bone 20, so that the first portion 33 is arranged in the medullary canal 23 of the proximal bone segment 22, the second portion 35 is arranged in the medullary canal 23 of the distal bone segment 24, and the intermediate portion 38 extends through the bone gap 26 when the first portion 33 defines the proximal portion 34 of the nail body 32 and the second portion 35 defines the distal portion 36 of the nail body 32. Alternatively, the intramedullary nail 30 is configured to be initially inserted into the medullary canal 23 of the long bone 20, so that the first portion 33 is arranged in the medullary canal 23 of the proximal bone segment 24, the second portion 35 is arranged in the medullary canal 23 of the distal bone segment 22, and the intermediate portion 38 is striated through the bone defect 26 when the first portion 33 defines the proximal portion 36 of the stem body 32 and the second portion 35 defines the distal portion 34 of the stem body 32. In this way, the intermediate portion 38 can be dimensioned so as to define a length in the longitudinal direction L, which is greater than the distance from the bone gap D1. Certainly it should be noted that the proximal portion 34 or the distal portion 36 can extend through the bone gap 26 as long as the bone gap 26 is arranged longitudinally between at least one of the first bone fixation holes 40a and at least one of the second bone fixation holes 40b.
[00041] The stem body 32 defines the first and second inner surfaces 37a and 37b that are spaced along a lateral direction A that extends substantially perpendicular to the longitudinal direction L. The first and second inner surfaces 37a and 37b can be spaced substantially equidistant from the longitudinal axis 31, or can be spaced so that one of the first and second inner surfaces 37a and 37b is spaced closer or further from the longitudinal axis 31 than the other of the first and second internal surfaces 37a and 37b. The first and second inner surfaces 37a and 37b define a compression slot 39 which extends inside, and can additionally extend through the first portion 33 of the stem body 32 along a transverse direction T which is substantially perpendicular to the direction longitudinal L and lateral direction A.
[00042] The compression slit 39 can be elongated along the lateral direction L. The first portion 33 of the stem body 32 can define a cannulation 51 that extends at least from a longitudinally corresponding outer terminal end of the first vapor 33 of the stem body 32 through compression slot 39. It should be noted that second portion 35 can also define a second compression slot constructed as described here with respect to compression slot 39 in order to provide positional flexibility when the intramedullary nail 30 is inserted into the medullary canal of the fractured long bone 20. Thus, the description of the present invention of the first portion 33 including the compression groove 39 can also apply to the second portion 35 when the second portion 35 defines the groove of compression 39 or a second compression slot. For example, the stem body 32 can define a cannulation that extends from a longitudinally corresponding outer terminal end of the second portion 35 of the stem body 32 through the compression slot arranged in the second portion 35.
[00043] As described in more detail below, the compression slot 39 is a self-retaining compression slot that is configured to at least temporarily retain a compression member 53 (see Figure 3) that extends inside the compression slot 39 in a desirable longitudinal position that reduces bone failure 26. According to the illustrated embodiment, the compression slot 39 extends within the proximal portion 34 of the stem body 32, although it should be noted that the compression slot 39 can alternatively extend into the distal portion 36 of the stem body 32. The first portion 33 of the stem body 32 can define a distance in cross section, such as a diameter, that is greater than that of one or both of the second portion 35 and the intermediate portion 38 of the stem body 32. Otherwise specified, the portion of the intramedullary stem 30 that defines the compression slot 39, like the proximal portion 34, can define a distance in cross section, as a diameter that is larger than that of one or both of the other portions of the intramedullary nail 30.
[00044] As described above, the intramedullary nail 30 defines a plurality of holes for bone fixation 40 that extends inside, and can additionally extend through the body of the nail 32. The plurality of bone fixation holes 40 can include at least a first bone fixation orifice 40a as a plurality of first bone fixation orifices 40a which are disposed adjacent to the compression slit 39 in the first portion 33 of the intramedullary nail 30 defining the compression slit 39, and at least one second fixation orifice bone 40b as a plurality of second bone fixation holes 40b which are arranged in the second vapor 35 of the intramedullary nail 30. According to the illustrated embodiment, the plurality of the first bone fixation holes 40a are configured as proximal bone fixation holes that extend within the proximal portion 34 of the intramedullary nail 30, and the plurality of the second holes for Bone fixation 40b are configured as distal bone fixation holes that extend within the distal portion 36 of the intramedullary nail 30. One or more and even all of the pluralities of the first bone fixation holes 40a can be arranged longitudinally outwardly in the with respect to the compression slot 39, so that the compression slot 39 is arranged longitudinally between the first bone fixation holes 40a and the second end 35. Additionally, one or more and even all of the pluralities of the first bone fixation holes 40a may additionally be arranged longitudinally inward with respect to the compression slot 39, so that the first bone fixation holes 40a are arranged longitudinally between the compression slot 39 and the second end 35. For example, according to the illustrated embodiment, the plurality of the first bone fixation holes 40a may include bone fixation holes and 40a which are arranged proximally to the compression slot 39, although the plurality of the first 42 bone fixation holes 40a may additionally include bone fixation holes 40a which are disposed distally from the compression slot 39. If the compression slot 39 is disposed in the distal portion 36 of the stem body 32, the plurality of the first bone fixation holes 40a may include bone fixation holes 40a which are disposed distally from the compression slot 39, although the plurality of the first bone fixation holes 40a it can additionally include holes for bone fixation 40a that are arranged proximally to the compression slot 39.
[00045] At least some and all of the first and second plurallities 42 and 44 of the bone fixation holes 40 may be longitudinally spaced in relation to each other, and may additionally be radially displaced in relation to the other. In addition, the holes for bone fixation 40 can extend along the respective central axes that are angularly displaced with respect to the longitudinal axis 31. According to the illustrated embodiment, at least one and all the holes for bone fixation 40 can extend along the respective central axes that are substantially perpendicular to the longitudinal axis 31. The central axes of one or more and even all the holes for bone fixation 40 can be substantially parallel to each other and, in addition, the central axes of one or more and even all the bone fixation holes 40 may be substantially angled away from each other.
[00046] Now with reference to Figures 2C and 2D in particular, the inner surfaces 37a and 37b can be substantially elongated in the longitudinal direction L. The inner surfaces 37a and 37b can be spaced apart from each other along the lateral direction A. one or both inner surfaces 37a and 37b can be scalloped along the lateral direction L, so that the compression gap 39 can also be called a scalloped compression gap. For example, at least one or both of the inner surfaces 37a and 37b can define a series of the first and second regions 43a and 43b, respectively, which are concave with respect to the compression gap 39, in order to define a respective plurality of pockets 45 in the compression slot 39. According to the illustrated embodiment, each of the inner surfaces 37a and 37b define four pockets 45, although it should be noted that the inner surfaces 37a and 37b can define any number of pockets 45, including two or more. According to an embodiment, at least one of the internal surfaces 37a and 37b can define at least three pockets 45 that are spaced along the lateral direction L in order to provide for fine increments of compression. The first regions 43a are spaced from each other along the lateral direction L and the second regions 43b are spaced from each other along the lateral direction L. The first regions 43a are spaced from the second regions 43b by the along the lateral direction A.
[00047] The first and second inner surfaces 37a and 37b can define the respective narrowed portions that can be defined by the intersections 48 connected between the adjacent of the first regions 43a, and narrowed portions that can be defined by the respective intersections 48 that are connected between the adjacent to the second regions 43b. The opposites of the first regions 43a and second regions 43b along side direction A can be aligned so that straight lines extending perpendicularly to longitudinal axis 31, for example along side direction A intersect, for example, pairs of bisected opposing pockets 45, and the straight lines extending perpendicularly to the longitudinal axis 31, for example along the lateral direction A cross, for example, the bisected opposite intersections 48 of the opposite internal surfaces 37a and 37b. Thus, it can be said that the compression gap 39 can define a plurality of holes 47 that overlap each other along the lateral direction L. The holes 47 can be cylindrical, so that the first and second regions 43a and 43b can be arc-shaped as they extend along the lateral direction L. Each of the first and second regions 43a and 43b can be curved around a respective axis extending along the transverse direction T, in so that each of the first and second regions 43a and 43b define a curvature that is the same as the others of the first and second regions 43a and 43b, or may be different from one or more and even all others in the first and second regions 43a and 43b.
[00048] The stem body 32 further defines longitudinally the first and the second internal opposite end surfaces 49a and 49b, respectively, which are connected between the opposite longitudinal ends of the first and second internal surfaces 37a and 37b. Consequently, the first and second inner surfaces 37a and 37b extend between the end surfaces 49a and 49b. The end surfaces 49a and 49b can each be curved about a respective axis extending along the transverse direction T, so that each of the end surfaces 49a and 49b defines a curvature that can be the same or different from the that the curvature of one or more and even all of the first and second regions 43a and 43b, respectively. The end surfaces 49a and 49b and the longitudinally outermost surfaces of the first and second inner surfaces 37a and 37b can cooperate in order to define a pair of longitudinal end pockets of the pockets 45 as a longitudinally outermost pocket 52a of the pockets 45 , and a longitudinally innermost pocket 52b of pockets 45. The first and second regions 43a and 43b of the first and second inner surfaces 37a and 37b, respectively, define at least one longitudinally intermediate pocket 46 of the pockets 45 as a plurality of pockets longitudinally intermediate 46, the intermediate pockets 46 arranged between the end pockets. Thus, at least one or both first and second inner surfaces 37a and 37b can define at least one intermediate pocket 46 as a plurality of intermediate pockets 46 arranged between the end pockets along the lateral direction L.
[00049] The first and second inner surfaces 37a and 37b, and thus the compression gap 39, define a first width W1 which is measured along the lateral direction A. For example, at least one of the first and second surfaces internal 37a and 37b define at least one intersection 48 as described above, and the compression gap defines the first width W1 between intersection 48 and the opposite of the first and second internal surfaces. According to one embodiment, the first and second inner surfaces can define opposite intersections 48, so that the first width A1 is defined between the opposites of intersections 48 along side direction A, along a direction substantially perpendicular to the axis longitudinal 31. For example, opposite intersections 48 may be arranged in an adjacent position or between intermediate pockets 46, and may additionally be arranged between one of the intermediate pockets 46 and one of the end pockets, as defined by the longitudinally outermost pocket 52a and the innermost longitudinal pocket 52b. The first and second inner surfaces 37a and 37b, and thus the compression gap 39, define a second width W2 which is measured along the lateral direction A (and is thus substantially parallel to the first widths W1) between the opposites pockets 45, and cross the opposites of the first and second regions 43a and 43b at a location spaced in relation to the respective intersections 48 along the lateral direction L. The second width W2 can thus extend along a direction parallel to the first width W1. According to the illustrated embodiment, the first width W1 is smaller than the second width W2. According to the illustrated embodiment, the first and second regions 43a and 43b are round and, for example, arc-shaped, so that the second width W2 defines a diameter of a circle. The second width W2 can be equal to, less than, or greater than the respective diameters of the bone fixation holes 40.
[00050] While both internal surfaces 37a and 37b can define the respective pockets 45 and the intersections 48, according to the illustrated modality, it should be noted, according to an alternative modality, that only one of the surfaces 37a and 37b defines pockets 45 and intersections 48, while the other surfaces 37a and 37b can be devoid of pockets and intersections, and can extend substantially linearly along the lateral direction, or define any shape as desired. Therefore, the compression slot 39 can define the first width W1 that extends between the opposite surfaces 37a and 37b through at least one intersection 48, and can additionally define the second width W2 that extends between the opposite surfaces 37a and 37b through at least one pocket 45 along a direction parallel to the first width, so that the pockets 45 and the intersections 48 are alternately arranged along the lateral direction L.
[00051] While the intersections 48 are positioned so that the first width W1 is substantially constant along the length of the compression slot 39 according to the illustrated embodiment, it should be noted that the first width W1 can vary along the lateral direction L along the compression slot 39. In addition, when the second width W2 is defined at a location of maximum lateral depth of the respective pockets 45, the second width W2 is substantially constant along the length of the compression slot 39, according to with the illustrated embodiment, although it should be noted that the second width W2 can alternatively vary along the lateral direction L along the compression gap 39. One or both widths W1 and W2 that vary along the compression gap 39 can produce increasing or decreasing polarized compression forces that are suitable for guiding the compression member 53 along the compression slot 39, for example when compressing the op rimeiro and the second bone segments 22 and 24 in relation to each other, in order to approximate bone failure 26, as described in more detail below. According to one embodiment, the difference between W2 and W1 can be as close to any range as desired, such as between and including a lower end of approximately 0.2 mm, and an upper end of approximately 2.0 mm. For example, the second width W2 may be sized as desired and may be close to the range between and including approximately 1.5 mm and approximately 10 mm. In addition, the first width W1 can be sized as desired, and can be close to the range of approximately 1.3 mm and 9.8 mm. For example, when W2 is 1.5 mm, W1 can be 1.3 mm. In another example, when W2 is 10 mm, W1 can be 8 mm. According to the illustrated mode, the length of each of the internal pockets 45 along the lateral direction can be defined as 2 * [(W2 / 2) 2 - (W1 / 2) 2] 1/2. According to the illustrated mode, the length of each of the outermost pockets 52a and 52b can be defined as [W2 / 2 - ((W2 / 2) 2 - (W1 / 2) 2) 1/2]. The intramedullary nail 30 can define any suitable external diameter along a direction substantially perpendicular to the longitudinal direction L as desired, as less than 17.5 mm.
[00052] As described above, the compression slot 39 is defined by the stem body 32. For example, in the embodiment illustrated in figures 2A to 2D, the first and second internal surfaces 37a and 37b of the stem body 32 and the first and the second end surfaces 49a and 49b of the stem body 32 can be integral and monolithic with the stem body 32. Consequently, the compression gap 39 can be defined by the surfaces of the stem body 32 that are integral and monolithic with the stem body 32. Alternatively, now with reference to figures 2E and 2F, the stem body 32 may include an insert 61 which is removably attachable to one or both distal portions 34 and 36, respectively, of the stem body 32 Insert 61 can define at least one or more, such as all of the first and second inner surfaces 37a and 37b and the first and second end surfaces 49a and 49b. Consequently, the compression slot 39 can be loaded through the insert 61. The stem body 32 can define an opening 63 that extends at least inside or through at least one or both of the first and second portions 33 and 35 , respectively, of the stem body 32. The opening 63 is dimensioned to receive the insert 61 so that the compression slot 39 is loaded by the respective or both of the first and second portions 33 and 35 of the stem body 32. The insert 61 can be inserted into the corresponding opening 63 in order to fix the insert 61 to one or both of the first and second portions 33 and 35, respectively. Consequently, the stem body 32 may include a pair of inserts 61 that are loaded through one or both of the proximal and distal portions 34 and 36, respectively, of the stem body 32.
[00053] With reference also to Figure 3, the compression member 53 can be configured as a unscrewed rod or a threaded screw that can be configured as an anchor bone with the head 54 and a rod 56 extending out of the head 54 along a central axis A. The stem 56 may include threads 56a according to the illustrated embodiment, or may alternatively be unscrewed, and may be shaped as desired, for example cylindrical, and may be smooth and configured to move from from and between intermediate pockets 46 and outer pockets 52a and 52b. The compression member 53 can be sized and shaped substantially identical with respect to a plurality of bone anchors 86 (see Figure 10) which are sized to extend through the holes for bone fixation 40 so as to fix the intramedullary nail 30 to the long bone 20. For example, the compression member 53 can be selected from the plurality of bone anchors 86 in order to define one of the selected bone anchors 86. According to the illustrated embodiment, the stem 56 defines a maximum external dimension D in cross section (which can be a diameter). For example, the maximum external dimension D in cross section can be measured along the lateral direction A between the internal surfaces 37a and 37b when the stem 56 is arranged in the compression slot 39, so that the maximum external dimension D in cross section is larger than the first width W1 of the compression slot 39. Consequently, the intersection 48 disposed between the first and the second intersections in a position adjacent to the pockets 45 interferes with, and provides a resistance against, the movement of the stem 56 from the first intersection of pockets 45 to second intersection of pockets 45. The resistance increases as the difference between the maximum external dimension D in cross section and the first width W1 increases. As will be understood from the description below, an approximation force applied to the compression member 53 along the lateral direction L may be sufficient to overcome the resistance defined by the interference between the intersections 48 and the stem 56, in order to allow the compression member 53 moves to the adjacent pockets 45 of the compression slot 39. The maximum external dimension D in cross section of the stem 56 can be smaller or substantially equal to the second width W2, defined by at least one pocket 45, so that the stem 56 is dimensioned to accommodate inside the pockets 45. Alternatively, the distance in cross section D of the stem 56 may be greater than the second width W2, but greater than W2 an amount that is less than the amount that the external dimension Maximum cross-section D of stem 56 is greater than the first width W1.
[00054] At least one or both of the rods 56 and the inner surfaces 37a and 37b can be elastomeric, and thus temporarily elastically flexible so that the first width W1 is substantially equal to the cross-sectional dimension (e.g., diameter) of the shank 56, so that shank 56 can move from one of the first pockets 45, passing a corresponding intersection arranged between the first intersection of pockets 45 and a second intersection in a position adjacent to pockets 45, and within the second of pockets 45. In addition, the inner surfaces 37a and 37b can be inclined (for example in a curvilinear manner, as described above or substantially linear), while they extend along the longitudinal directions, in order to define the respective first and second regions 43a and 43b , respectively, in order to define a depth along the lateral direction, as measured from an adjacent intersection 48. The depth of the first and second Regions 43a and 43b can be at a maximum at their respective longitudinal midpoints, which can bisect the respective pockets 45. In this way, pockets 45 can be substantially deeper at their longitudinal midpoints. In this way, the resistance of the first and second regions 43a and 43b against the compression member 53 can increase while the compression member 53 moves from one of the pockets 45 towards a corresponding intersection 48. The resistance can be at a maximum while the compression member 53 moves at the intersection, and can decrease (and can be negative in order to aid movement) while the compression member 53 moves from the intersection 48 inside an adjacent pocket 45. According to the modality shown, the inner surfaces 37a and 37b are resilient and resiliently flexible away from each other, and the stem 56 is substantially rigid. For example, the compression member 53, and thus the stem 56, can be produced from any substantially rigid material as desired, including titanium or other suitable rigid metals.
[00055] As illustrated in figures 2A to 2D, the inner surfaces 37a and 37b can converge at the intersections 48 so that the intersections define an edge 27 that is elongated along the transverse direction T. Thus, the intersections 48 can be substantially V-shaped. It should be noted, however, that intersections 48 can define any suitable size and shape as desired. For example, as illustrated in figures 2G and 2H, intersections 48 can define surfaces 29 which are elongated along the transverse direction T, and additionally extend along a length of the respective internal surfaces 37a and 37b along the lateral direction L. Surfaces 29 can be substantially linear along the lateral direction L, or they can be curved as they extend along the lateral direction L. It should be noted that one or more of the intersections 48 can define the edges 27, and alternatively or additionally one or more of the intersections 48 can define the surfaces 29.
[00056] Referring again to Figures 2A to 2D and to Figure 4B, the stem body 32 may further include an engagement element 58 which is configured to be removably attached to a complementary engagement element 82 of an element clamp 78 (see Figure 7A), which is configured to support the intramedullary nail 30, so that a compression actuator 92 (see Figure 8A) that is movable relative to the clamp element 78 is configured to apply the approach force to the compression member 53 which causes the compression member 53 to translate along the compression slot 39. According to the illustrated embodiment, the en-gate element 58 can be configured as an orifice 57 which is defined by the intramedullary nail 30 and extends along the lateral direction L within the longitudinally outer terminal end of the first portion 33 of the stem body 32. Accordingly, according to the illustrated embodiment, the engaging element 58 defines an orifice 57 extending distally within the outer terminal end (e.g., the proximal end) of the proximal portion 34 of the stem body 32. According to an alternative embodiment, the compression slot 39 can be defined in the distal portion 36 of the stem body stem 32, and orifice 57 can extend proximally inside the longitudinally outer end (for example, the distal end) of the distal portion 36. The stem body that can define the internal threads 59 that limit the hole 57 can be threaded to fit with the threads of the complementary engagement element of the clamp element 78.
[00057] With reference also to figures 4A and 4B, a bone fixation system 60 can include an implant set 62 and a bone fixation set 64. The bone fixation set 64 can include the intramedullary nail 30, the limb of compression 53 (see Figure 3), and a plurality of bone anchors 86 (see Figure 10) that are configured to extend through the holes for bone fixation 40 in order to fix the intramedullary nail 30 to the fractured long bone 20. The implantation assembly 62 may include a support structure 76, one or more cylindrical guiding fittings 90 (see Figure 7A), the clamp element 78, and may also include the compression actuator 92 (see Figure 8A). A kit can therefore be provided that includes at least one of a plurality of any and even all components of the bone fixation system 60, so that the kit can include components of the bone fixation system 60, such as the intramedullary nail 30 , built in different sizes and shapes.
[00058] Continuing with reference to figures 4A and 4B, the support structure 76 includes an alignment structure 66 that is elongated along the lateral direction L, a cable 68 that extends out of alignment structure 66 along a first direction that can be angularly displaced, for example, perpendicular to the lateral direction, and a support arm 70 that extends outwardly from alignment structure 66 along an angularly displaced direction, for example substantially perpendicular to the longitudinal direction. The support arm 70 can extend from the alignment structure 66 along an opposite direction with respect to the direction that the cable 68 extends from the alignment structure 66. The alignment structure 66 includes at least one , as a plurality of attachment locations 72 that are longitudinally spaced in relation to each other and each configured to attach to the support arm 70, for example at a proximal end 71a of the support arm 70, so that the support arm support 70 can be attached to the alignment structure 66 in one selected from a plurality of longitudinally spaced attachment locations 72. For example, the attachment locations 72 can be configured as openings that extend inside or through alignment structure 66 and are sized to receive a coupler 73, like a button, which is configured to selectively extend inside or through the attachment locations and attach to the proximal end 71a of the support arm to thereby fix the support arm 70 to the alignment structure 66 in one of the fixation locations 72. Because the fixation locations 72 are spaced in relation to each other in the longitudinal direction, and because the support arm 70 is configured to support the intramedullary nail 30 at its distal end 71b, the fixation site 72 to which the support arm 70 is mounted can at least partially determine a longitudinal position of the intramedullary nail in relation to the support structure 76.
[00059] In accordance with the illustrated embodiment, the support arm 70 includes an engaging element that is configured to support the clamp element 78 so as to retain the intramedullary nail 30 at a predetermined location in relation to the alignment structure 66. For example, the support arm engaging element 70 can be configured as an opening 74 that extends longitudinally through the distal end 71b of the support arm 70 and is sized to receive the clamp element 78. The support arm 70 it can define a shoulder 75 which defines the opening 74 and provides a housing configured to support the clamp element 78.
[00060] Continuing with reference to Figures 4A and 4B, the clamp element 78 includes a longitudinally elongated rod 80 that extends through the distal end 71b of the support arm 70, and defines a first proximal end 81a and an opposing second distal end 81b which is distally spaced relative to the first proximal end 81a substantially along the lateral direction L. Clamp member 78 may include a latch element at its distal end 81b which is configured to be attached to latch member 58 of the intramedullary nail 30. In particular, the clamp element 78 includes, for example at the distal end 81b of the clamp element 78, a latch element 82 that can be configured as external threads 89 that fit with the internal threads 59 of hole 57 of the intramedullary nail 30 in order to removably fix the intramedullary nail 30 to the clamp element 78. The clamp element 78 is thus c configured to removably attach the intramedullary nail 30 to the support structure 76 by engaging the threads 89 of the engagement element 82 with the threads 59 of the intramedullary nail 30.
[00061] The clamp element 78 may include a button 84 to which the proximal end 81a of stem 80 is attached. For example, button 84 may be integral and monolithic with stem 80, or it may be discretely attached to stem 80, so that button 84 is rotationally coupled to stem 80 around an axis that extends in the longitudinal direction L. For example, like button 84, and thus stem 80, are rotated along a first direction relative to to the intramedullary nail 30, the threads 89 of the clamp element 78 engage with the threads 59 of the nail body 32 so as to secure the clamp element 78 to the intramedullary nail 30. Like button 84, and thus the nail 80, are rotated along a second direction opposite to the first direction with respect to the intramedullary nail 30, the threads 89 of the clamp element 78 engage with the threads 59 of the stem body 32 so as to remove the clamp element 78 from the stem intramedullary 30.
[00062] The clamp element 78 additionally includes a second latch element that is configured to attach to the latch element of the support arm 70. The button 84 of the clamp element 78 can define an internal shoulder 83 that is configured to rest against the shoulder 75 of the support arm 70 in order to secure the clamp element 78 to the support structure 76 with respect to the distal movement along the lateral direction L in relation to the support structure 76. It should be noted that the clamp element 78 can be coupled to the support structure 67 using any suitable alternative connection as desired.
[00063] The intramedullary nail 30 can define a terminal end which defines a nail 41 at one or both longitudinally external ends of the first and second portions 33 and 35 of the nail body 32. According to the illustrated embodiment, the nail 41 extends from the outer end of the second portion 35 of the stem body 32. For example, according to the illustrated embodiment, the tip 41 is arranged at the longitudinally distal end of the distal portion 36 of the stem body 32 when the proximal portion 34 of the stem body 32 defines the compression gap 39. The tip 41 is configured to be directed into the interior of the long bone 20 substantially along the lateral direction L. According to the illustrated embodiment, the tip 41, and thus the stem intramedullary, can be activated in the proximal bone segment 22, for example through the head of the long bone 20, and in the medullary canal 23 of the long bone (see Figure 1) so that the proximal portion 34 of the ha's body ste 32 is arranged in the medullary canal 23 of the proximal bone segment 22, the distal portion 36 of the body of the nail 32 is arranged in the medullary canal 23 of the distal bone segment 24, and the intermediate portion 38 extends through the bone gap 26. The arm support bracket 70 can define a plurality of viewing windows that extend inside or through the distal end 71b in order to assist in allowing a visual determination of the depth of the intramedullary nail 30 in the long bone 20.
[00064] Referring to Figures 2A and 2B and Figure 6, the second portion 35 of the stem body 32 can be attached to the respective bone segment of the fractured long bone 20. According to the illustrated embodiment, the proximal portion 34 of the body of the nail shank 32 defines the compression slit 39, and the distal portion 36 of the shank 32 body is attached to the distal bone segment 34. For example, at least one anchor bone 86, such as a plurality of bone anchors 86, can be inserted inside the distal bone segment 24 and within or through the respective plurality of the second bone fixation holes 40b in order to fix the distal bone segment 24 to the second 35 of the stem body 32 with respect to relative movement, and in particular , with respect to the relative translation along the lateral direction L. According to the illustrated modality, a pair of bone anchors 86, which can be configured as bone screws, can be inserted inside or through a respective pair of plurality of the second bone fixation holes 40b. Bone anchors 86 can be inserted through any suitable orientation cylindrical socket aligned with the second bone fixation holes 40b using a guidance arm or any suitable system configured to align bone anchors 86 with the second bone fixation holes 40b and drive the bone anchors 86 inside the long fractured bone 20 and inside the second holes for bone fixation 40b. It should be noted that when the second bone fixation holes were directed inside the distal bone segment 24 and within the respective of the second bone fixation holes 40b, the distal bone segment 24, the intramedullary nail 30, and the clamp element 78 are all fixed to each other with respect to relative translation along the lateral direction.
[00065] Now with reference to figures 2A and 3A, and figures 7A to 7C, when at least one of the bone anchors 86 was attached to the second portion 35 of the stem body 32 to a first of the proximal and distal bone segments 22 and 24, like the distal bone segment 24 as illustrated, the compression member 53 can be inserted into the other between the first and second bone segments 22 and 24, like the proximal bone segment 22, which is aligned with the compression slot 39, and additionally inserted into or through the compression slot 39. It should be noted that the compression member 53 can alternately be directed into the long bone 20 and additionally inserted into or through the compression slot 39 before at least one bone anchor 86 the second portion 35 of the stem body 32 is attached to the long bone 20. Consequently, the compression member 53 can initially be directed within the distal bone segment 24 and within a selected pocket 45, so that the compression slot 39 defines at least one other pocket 45 which is disposed distally to the selected pocket (for example, along a direction from the first portion 33 of the stem body 32 towards the second portion 35 of the stem body 32), and spaced in relation to the selected pocket at any longitudinal distance as desired, as a distance at least substantially equal to the distance from the bone gap D1.
[00066] According to the illustrated embodiment, the support structure 76 defines at least one guide opening 88 as a plurality of guide openings 88 that are spaced along the alignment structure 66 in the longitudinal direction L and dimensioned to receive the cylindrical fitting orientation 90, which can be cannulated and positioned in a desirable guide opening 88, so as to be operationally aligned with one of the selected pockets 45 of the compression slot 39, so that at least one pocket 45 is arranged longitudinally inward selected pocket 45. According to the illustrated embodiment, the selected pocket 45 can be the longitudinally outer pocket 52a or any of the intermediate pockets 46 as desired. When the first portion 33 of the stem body 32 is the proximal portion 34 as shown, the longitudinally outermost pocket 52a is a pocket in the most proximal position. If the first portion 33 of the stem body 32 is the distal portion 36 according to an alternative embodiment, the longitudinally outermost pocket 52a is a pocket in the most distal position. According to one embodiment, the cylindrical guide insert 90 can be aligned with the selected pocket 45 so that the distance between the selected pocket 45 and the deepest pocket 52b along the lateral direction is at least equal to the distance from the bone gap D1 (see Figure 1), so that the movement of the compression member 53 in the compression slot 39 along the lateral direction can reduce the distance of the bone gap D1 to approximately zero.
[00067] With reference also to figures 8A to 8C, when the orientation en-casing cylindrical 90 is aligned with the selected pocket 45, the compression member 53 can be directed inside the bone segment that is aligned with the first portion 33 of the stem body 32. According to the illustrated embodiment, the compression member 53 is directed to the interior of the proximal bone segment 22 and to the interior or through the selected pocket 45, which may be the longitudinally outermost pocket 52a or one of the intermediate pockets 46. The cylindrical guide insert 90 can then be removed from the support structure 76 so that the compression member 53 is at least temporarily or permanently attached to the proximal bone segment 22 and inserted into the compression slot 39. Thus, the compression member 53 is fixed to the proximal bone segment 22 with respect to translation in the longitudinal direction.
[00068] When the compression member 53 was inserted into the proximal bone segment 22 and the compression slot 39, and the distal bone segment 24 was fixed to the distal portion 36 of the stem body 32 with respect to the relative longitudinal movement , the compression actuator 92 can be operationally engaged with the compression member 53 and subsequently moved in relation to the clamp element 78, and thus the stem body 32 and the distal bone segment 24, from a first position to a compressed position . The compression actuator 92 is configured to operationally engage the compression member 53 so that the movement of the compression actuator 92 along the lateral direction L, for example towards the bone gap 26, which can define the distal direction as illustrated, causes the compression member 53 to translate in a similar way along with the proximal bone segment 22 towards the distal bone segment in order to approximate the bone failure 26.
[00069] According to the illustrated embodiment, the compression actuator 92 can include a stem 93 with a proximal end 94 and a distal end 95 that is spaced from the proximal end 94 along the lateral direction L. The compression actuator 92 can include an engaging element, for example threads 96, which are carried by an outer surface of the stem 93. The clamp element 78 can carry a complementary engaging element, such as threads 77 that mate with threads 96 of the actuator of compression 92 in order to removably fix the compression actuator 92 to the clamp element 78, and thus also to the support structure 76, so that the compression actuator 92 is mobile with respect to the intramedullary nail 30. For example, the clamp element 78 can define a cannula 79 that can extend through one or both of the button 84 and the stem 80, and can feature the internal threads 77 that are configured to fit connect with the external threads 96 of the compression actuator 92. the stem 93 of the compression actuator 92 can extend along the lateral direction L at a distance that is greater than that of the stem 80 of the clamp element 78 and the cannulation 79, so that the stem 93 can be inserted through the cannulation 79 so that at least the distal end 95 of the compression actuator 92 extends longitudinally out of the clamp element 78. The compression actuator 92 can include a button 98 that extends proximally from stem 93. For example, button 98 can be integral and monolithic with stem 93, or it can be discreetly attached to stem 93, so that button 98 is attached to stem 93 with respect to respect to the relative rotation around an axis extending in the longitudinal direction L.
[00070] Consequently, the rotation of the compression actuator 92 in a first direction, which can also be called an engaging direction in relation to the clamp element 78, causes the threads 96 to engage with the threads 77 in order to attaching the compression actuator 92 to the clamp element 78. Rotating the compression actuator 92 to a second direction, which can be called a disengagement direction that is opposite to the first direction in relation to the clamp element 78, causes the threads 96 engage with the threads 77 in order to remove the compression actuator 92 from the clamp element 78. It should be noted that the rotation of the compression actuator 92 in the first direction in relation to the clamp element 78 causes the compression actuator 92 advances in relation to the stem body 32 along the lateral direction L, from the first portion 33 of the stem body 32 towards the second portion 35 of the stem body, which defines a distal direction accordingly with the illustrated modality. The rotation of the compression actuator 92 in the second direction in relation to the clamp element 78 causes the compression actuator 92 to retract in relation to the stem body 32 along the lateral direction L, from the second portion 35 of the body of the stem 32 towards the first portion 33 of the stem body that defines a proximal direction according to the illustrated embodiment. In this way, the compression actuator 92 can be removably attached to the clamp element 78, and it can be removably attached to the compression member 53 with respect to the distal translation in the longitudinal direction L.
[00071] The compression actuator 92 is fixed to the clamp element 78 in order to be movable longitudinally in relation to the support structure 76, the intramedullary nail 30, and the distal bone segment 24 which is fixed to the second portion 35 of the intramedullary nail 30. It should be noted that the compression actuator 92 can be attached to the clamp element 78 in order to translate along the lateral direction L in relation to the clamp element 78, and thus to the support structure 67 and the intramedullary nail 30 , in any alternative way as desired. For example, according to one embodiment, the compression actuator 92 can be connected in a mobile manner to the clamp element 78, and thus the support structure 76 and the intramedullary stem 30, through a rack and pinion so that the rotation around an axis substantially perpendicular to the longitudinal direction L causes the compression actuator 92 to translate distally with respect to the clamp element 78 and the intramedullary stem 30. Alternatively, a distal translation force applied to the compression actuator 92 can cause the compression actuator 92 to translate distally with respect to the clamp element 78 and the intramedullary nail 30.
[00072] The distal end 95 of the compression actuator 92 defines an engaging element that can be configured as a support surface 97 that is at least partially aligned with the compression member 53 along the lateral direction L while the actuator compression plate 92 is attached to the clamp element 78 and moves distally with respect to the clamp element 78. As a result, the distal translation of the compression actuator 92 with respect to the clamp element 78 causes the support surface 97 from the distal end 95 of the compression actuator 92 makes contact with the compression member 53, and further rotation of the compression actuator 92 in relation to the clamp element 78 causes the support surface 97, and thus the distal end 95 of the compression actuator 92, apply a compression change force to the compression member 53 that drives the compression member 53 to move along the compression slot 39 in one direction from the first portion 33 of the stem body 32 towards the second portion 35 of the stem body 32, which can be distally as illustrated, in order to compress the proximal and distal bone segments 22 and 24, respectively, and approximate the bone failure 26.
[00073] The support surface 97 can be integral and monolithic in relation to the stem 93, or it can be discreetly attached to the stem 93 or any other part of the compression actuator 92. For example, the support surface 97 can be rotatable with respect to it concerns one or both of the button 98 and stem 93, so that as the compression actuator 92 rotates, the support surface 97 can remain stationary with respect to rotation while it applies the changing force to the compression member 53 For example, the support surface can be rotatable with respect to rod 93. Additionally, rod 93 can be rotatable with respect to button 98. Alternatively, support surface 97 can rotate along with button 98 while it applies the changing force to the compression member 53. Thus, the compression actuator 92 is configured to apply a changing force to the compression member 53 that is greater than a holding force applied to the compression member. 53 by mechanical interference between the compression member 53 and the inner surfaces 37a and 37b, for example at intersections 48. Consequently, the altering force can define an approximation force that causes the compression member 53 to move along the scalloped compression slit 39.
[00074] As described above, the inner surfaces 37a and 37b are inclined along a direction from the pockets 45, for example at the longitudinal midpoint of the pockets 45, towards the adjacent intersection 48. In addition, the width W1 between the adjacent inner surfaces 37a and 37b is less than the cross-sectional distance of the stem 56 from the compression member 53. Consequently, the inner surfaces 37a and 37b provide a reactive resistance force to the compression member 53 that is opposite to the changing force of the compression F of the compression actuator 92, while the altering force F drives the compression member 53 towards the intersection 48, for example from the midpoint of the corresponding pocket 45. When the altering force F of the compression actuator compression 92 achieves an approach force that is at a level greater than the resistance force of the compression member 53, for example when the compression actuator 92 is further rotated relative to the el clamp element 78, at least one or both of the stem 56 of the compression member 53 and the internal surfaces 37a and 37b may deform, thereby temporarily decreasing the maximum external dimension D in cross section of the stem 56 (Figure 3) and / or temporarily increasing the width W1 of the intersection 48 (Figure 2C), until the maximum dimension in outer cross section D of the stem 56 is substantially equal to the width W1 of the intersection 48. For example, one or both of the stem 56 and the inner surfaces 37a and 37b may elastically deform as the compression member 53 moves along the compression slot 39. Alternatively, one or both of the stem 56 and the inner surfaces 37a and 37b may plastically deform while the compression member 53 moves along the compression slot 39. Consequently, when the compression actuator 92 moves along the lateral direction L and is brought into engagement with the compression member, the additional translation of the comp actuator recess 92 with respect to the intramedullary nail 30 causes the support surface 97 to apply the approach force F to the compression member 53 which causes the compression member 53 to fit along the sequential pockets 45 of the compression slot 39 against the resistance force, as illustrated in figures 8C to 8D. According to one embodiment, for example when the long bone 20 is a humerus bone, the approach force can be approximately 100 N. When the long bone 20 is a femur, the compaction force can reach up to approximately 500 N. the long bone 20 is a tibia, the approach force can be between approximately 100 N and approximately 500 N. Thus, the approach force may be close to the range of approximately 100 N and approximately 500 N.
[00075] According to the illustrated embodiment, while the rod 56 moves along the intersections 48 of a first of the holes 47 within a second of the holes 47 which is adjacent to the first of the holes 47, one or both of the two inner surfaces 37a and 37b elastically deform from a neutral position to a deformed position with respect to the other inner surfaces 37a and 37b which is expanded along the lateral direction, with respect to the neutral position, so that the width W1 is substantially equal to the maximum cross-sectional dimension D of the stem 56 along the lateral direction. As the stem 56 moves within the second of the holes 47, the expanded or both of the inner surfaces 37a and 37b return to the neutral position, whereby the first width W1 is less than the maximum cross-sectional dimension D of the stem 56 Without adhering to theory, it is believed that in certain modalities, when the stem 56 is threaded, the threads 56a (see Figure 3) can cut inside the internal surfaces 37a and 37b, for example at intersection 48, and thus create deformation, for example in the form of a rail, on the inner surfaces 37a and 37b while the stem 56 moves from the first of the pockets 45 within the second of the pockets 45. However, when the stem 56 is in the second of the pockets 45, the threads 56a do not naturally align with the rail that was previously created on the inner surfaces 37a and 37b. As a result, the threads 56a would create a new rail on the inner surfaces 37a and 37b so that the stem 56 returns to the first of the pockets 45, according to one embodiment. Because the creation of a new rail would be associated with a large amount of force along one direction from the second of the pockets 45 towards the first of the pockets 45, interference between the threads 56a and the inner surfaces 37a and 37b assists in retention of the stem in the second of the pockets 45. While the stem 56 moves additionally along the intersections 48 of the second of the holes 47 within a third of the holes 47 which is in a position adjacent to the second of the holes 47, one or both surfaces internal 37a and 37b elastically deform from a neutral position to a deformed position with respect to the other internal surfaces 37a and 37b which are expanded along the lateral direction with respect to the neutral position, so that the width W1 is substantially equal to the maximum cross-sectional dimension D of the stem 56 along the lateral direction. As the stem 56 moves within the third hole 47, the expanded hole of one or both of the inner surfaces 37a and 37b returns to the neutral position, whereby the first width W1 is less than the maximum cross-sectional dimension D of the stem 56 .
[00076] Thus, with reference to figures 8D and 8E, since the distance in cross section of the stem 56 is substantially equal to the width W1 of the intersection 48, the approach force applied to the compression member 53 by the compression actuator 92 causes the compression member 53 transferred from a first pocket 45, passing to the adjacent distal intersection 48, and within a second pocket 45 that is adjacent to the first pocket and spaced in relation to the first pocket along a direction from from the first portion 33 of the stem body 32 towards the second portion 35 of the stem body 32. Because the compression member 53, and in particular the stem 56, is additionally attached to the bone segment that corresponds to the first portion 33 of the stem body stem 32 with respect to relative longitudinal movement, the movement of the compression member 53 causes the respective bone segment to translate towards the opposite bone segment. According to the illustrated modality, the compression member 53 is attached to the proximal bone segment 22 with respect to the relative longitudinal movement, and the distal movement of the compression member 53 in this way causes the proximal bone segment 22 to translate distally into towards the opposite distal bone segment 24, thus approaching the bone gap 26 to a second distance from the longitudinal spacing that is less than the distance from the D1 spacing. The continued translation of the compression member 53 inside the compression slot 39 can cause the compression member 53 to move inwardly sequentially in the distal position of the pockets 45, thus resulting in an additional reduction in the spacing distance. The compression member 53 can be transferred to a final pocket of pockets 45, for example, until the first and second segments 22 and 24 are in a position bordering each other and the bone gap 26 has been reduced to a desired longitudinal distance less than the distance from the bone gap D1. When bone failure 26 has been reduced, the interference between one of the intersections 48 that is immediately placed in a proximal position with respect to the compression member 53 provides a reactive resistance force to the compression member 53 against forces that may tend to tilt. of the proximal and distal bone segments 22 and 24 distant from each other along the lateral direction L, which can increase bone failure 26.
[00077] According to an alternative embodiment, as described above, the first portion 33 of the stem body can define the distal portion 36 of the stem body, so that the compression slot 39 can be defined through, and thereby arranged in the distal portion 36 of the stem body 32. Consequently, the compression member 53 can initially be directed within the bone segment 24 and within a selected pocket 45, so that the compression slot 39 defines at least one other pocket 45 that is arranged proximally to the selected pocket (for example, along a direction from the first portion 33 of the stem body 32 towards the second portion 35 of the stem body 32) and spaced in relation to the selected pocket any longitudinal distance as desired, as a distance at least substantially equal to the distance from the bone gap D1. The clamp element 78 can thus be secured to the proximal 34 of the stem body 32 with respect to the relative proximal movement along the lateral direction L as described above, and the compression actuator 92 can be attached to the clamp element 78 and configured to tilt the compression member 53 proximally along the compression slit 39, thereby translating the distal bone segment 24 proximally towards the proximal bone segment 22 in order to approximate the bone failure 26.
[00078] It should be noted that the clamp element 78, when connected to the intramedullary nail 30, can stabilize the intramedullary nail 30 against movement due to the changing force F of the compression actuator 92 acting on the intramedullary nail 30 through the limb compression clamp 53. While the clamp element 78 is attached to the same end of the intramedullary nail 30 that receives the compression actuator 92 according to the illustrated embodiment, the clamp element 78 can be attached to the intramedullary nail 30 at any location along of the stem body 32, and can alternatively be fixed to the bone segment that is fixed to the intramedullary nail 30 with respect to the relative longitudinal movement (the distal bone segment 24, according to the illustrated modality), so that the clamp 78, through bone anchors 86 and bone segment 24, stabilizes the intramedullary nail 30 against movement in response to the altering force applied by the compression actuator 92.
[00079] Still alternatively, the implantation set 62 can be devoid of the clamp element 78, so that the human anatomy resists the force of alteration applied by the compression actuator 92. For example, according to an illustrated modality, the articulation anatomical adjacent to the distal bone segment 24 and the adjacent anatomical structure can stabilize the intramedullary nail 30 through the distal bone nail 24 which is attached to the intramedullary nail 30 by bone anchors 86. If the implantation set 62 is devoid of the clamp element 78, the compression actuator 92 can be movably attached to the support structure 76 in the manner described above with respect to the clamp element 78 or any suitable alternative mode.
[00080] It should be noted that because some of the first plurality of holes for bone fixation 40a of the first portion 33 of the stem body 32 can be arranged longitudinally outward with respect to the compression slot 39 and aligned with the compression member 53 when the compression member 53 is inserted into the compression slot 39, the stem 93 of the compression actuator 92 can interfere with some of the bone anchors 86 that can be directed through the first plurality of bone fixation holes 40 before the actuator compression 92 be released from compression member 53 and removed from intramedullary nail 30. In this way, compression actuator 92 and clamp element 78 can alternatively or additionally, one or more of the first bone fixation holes 40a can be arranged in one longitudinally into compression slot 39 if desired. Alternatively, one or more of the first bone fixation holes 40a can be displaced relative to the compression member 53 along a direction substantially perpendicular to the longitudinal direction L, so that the stem 93 is removed from the interference with bone anchors 86 which they are activated through the first holes for bone fixation 40a.
[00081] It should be further noted that although the compression actuator 92 applies the altering force F directly to the compression member 53 according to the illustrated embodiment, the supporting surface 97 of the compression actuator 92 can alternatively apply the altering force F to the compression member 53 indirectly, for example to apply the altering force F to the bone segment that is aligned with the first portion 33 of the nail body (for example, the proximal bone segment 22, according to the illustrated embodiment). The distal force applied to the proximal bone segment 22 can be communicated to the compaction member 53, which tilts the compression member 53 to translate along the compression slit 39 in the manner described above in order to approximate the bone failure 26.
[00082] Now with reference to Figure 8E, when the bone gap 26 has been reduced, for example so that the bone segments 22 and 24 are in a position bordering each other, the compression actuator 92 can be removed. According to the illustrated embodiment, the compression actuator 92 can be rotated in a disengaging direction which is opposite to the engaging direction, which causes the support surface 97 at the distal end of the stem 93 to translate in a way proximal along the lateral direction L and retracts far from the compression member 53. The continued rotation of the compression actuator 92 in the disengagement direction causes the compression actuator 92 to separate from the clamp element 78, and thus from the support structure 76 and intramedullary nail 30. When the compression actuator 92 has been separated, the intersection 48 adjacent to the compression member 53 interferes with the compression member 53 and prevents the compression member 53 from moving proximally out of the pocket end of pockets 45, thereby avoiding the anatomical bypass forces of increasing bone failure 26. Consequently, the compression slot 39 retains the compression member 53 in the end pocket of pockets 45, d this shape keeping the first and second bone segments 22 and 24 in a contiguous relationship.
[00083] Now with reference to figures 9A to 9C, when the compression actuator 92 was removed from the intramedullary nail 30, the nail 93 is also removed from interference with respect to the first bone fixation holes 40a which are arranged longitudinally outward , or in a proximal position, with respect to the compression slit 39. Consequently, a plurality of bone anchors 86 can be directed into the proximal bone segment 22 corresponding to the first portion 33 of the stem body 32 and within the first corresponding bone fixation holes 40a that extend inside or through the first portion 33 of the stem body 32. Because bone anchors 86 previously joins the distal bone segment 24 to the second portion 35 of the stem body 32 as illustrated in Figure 6, a fixation of the proximal bone segment 22 to the first portion 33 of the intramedullary nail 30 holds the intramedullary nail 30 to the proximal and distal bone segments 22 and 24 separated p it bone failure 26 previously approximated. For example, as shown in Figure 9A, a guide cylindrical insert 90 can be inserted through one of a plurality of guide openings 88 which extend through the frame member 87 to align the guide insert 90 with one of the first plurality of holes for bone fixation 40 extending inside or through the first portion 33 of the stem body 32. Consequently, a bone anchor 86 can be inserted into a cannulation of the 90-oriented socket and directed into the proximal bone segment 22 and subsequently to the interior or through the bone fixation hole 40 in order to fix the first portion 33 of the stem body 32 to the bone segment 22. While many bone anchors 86 can be attached to the bone segment 22 and the intramedullary nail 30 as desired until the intramedullary nail 30 is adequately joined to the first or proximal bone segment 22. The support structure 76 and the brace element 78 can then be removed from the intramedullary nail 30 as shown in Figure 10. Compression member 53 can remain implanted in long bone 20 and compression slot 39 as shown in Figure 10, or can be removed from compression slot 39 before completing the surgical procedure.
[00084] According to one embodiment, and with reference to figures 1 to 10 in general, a method 33 can be provided to reduce bone failure 26 from long bone 20, bone failure 26 separating the first bone segment 22 from the second segment bone 24 that is spaced in relation to the first bone segment 22 along the lateral direction L. The method includes the step of inserting the intramedullary nail 30 into the medullary canal 23 of the long bone 20 so that a portion, such as the intermediate portion 38, of the intramedullary nail 30 extends through the bone gap 26. The method may also include the step of fixing the intramedullary nail 30 to one of the first and second bone segments 22 and 24, respectively, with respect to longitudinal movement in relation to the fixed within the first and second bone segments 22 and 24, respectively. The method may further include the step of inserting the compression member 53 at least into the others into the first and second bone segments 22 and 24 and additional at least into a first pocket 45 of the scalloped compression slot 39 which is defined by the intramedullary nail 30. The method can also include the step of applying a distal approximation force to the compression member 53 while surrounding the intramedullary nail 30 in order to make the compression member 53 move from the first pocket 45, through a narrowed portion, which can be defined by one of the intersections 48 as described above, the narrowed portion with a cross-sectional dimension smaller than a corresponding cross-sectional dimension of the compression member 53 , for example along side direction A, and within a second pocket 45 that is spaced from the first pocket 45 along side direction L in order to reduce bone failure 26. The method may include r any additional steps as described here.
[00085] It should be noted that the intramedullary nail 30 can be constructed according to any suitable alternative modality as desired. For example, with reference to figures 11A to 11C, the intramedullary nail 30 includes at least one relief groove that extends outward from the compression groove 39 and ends in the nail body 32. According to the illustrated embodiment, the intramedullary nail 30 may include at least one relief groove, such as a first or proximal relief groove 99a and a second or distal relief groove 99b which extends inside or through the body of the nail 32 along the transverse direction T The first relief slot 99a is open to the compression slot 39, and is open to the outermost pocket 52a according to the illustrated embodiment. The second relief slot 99b is open to the compression slot 39, and is open to the deepest pocket 52b according to the illustrated embodiment. The first relief slot 99a can define a main portion 100a that extends proximally from the compression slot 39, and ends at a terminal end 101a that extends proximally from main portion 100a and is spaced apart in a proximal position with respect to the compression slot 39, and spaced distally from at least one or more and all of the first holes 40a. The second relief slot 99b can define a main portion 100b that extends distally from the compression slot 39, and ends at a terminal end 101b that is spaced distally with respect to the compression slot 39.
[00086] The first and second relief slots 99a and 99b define the respective widths W3 and W4 along the lateral direction A, and thus substantially parallel to the first and second widths W1 and W2, respectively, for example in their respective main portions 100a and 100b. The widths W3 and W4 can be substantially the same or different. For example, the width W3 of the main portion 100a can be greater or less than the width W4 of the main portion 100b. In addition, widths W3 and W4 can be substantially constant over the length of the first and second main portions 100a and 100b, respectively. Alternatively, the width W3 may increase or decrease along the proximal direction away from the compression slot 39. Similarly, the width W4 may alternatively increase or decrease along the distal direction away from the compression slot 39. The end ends respective 101a and 101b can define cylindrical holes that overlap the proximal and distal ends, respectively, of the main portions 100a and 100b, and can alternatively define any suitable shape.
[00087] The first and second relief slits 99a and 99b can reduce the stiffness of the stem body 32 immediately adjacent to the outermost and deepest pockets 52a and 52b along the lateral direction L. For example, the first and second relief slots 99a and 99b can define respective joints at the corresponding terminal ends 101a and 101b. In response to a force applied to the compression member 53 that inclines the inner surfaces 37a and 37b away from each other, the joints defined by the first and second relief slots 99a and 99b can expand along the lateral direction A, thereby increasing the third and fourth widths W3 and W4, which in turn reduce the force required to be applied to the compression member 53 in order to overcome the holding force and expand one or both of the first and second inner surfaces 37a and 37b with respect to it concerns the others of the first and the second internal surfaces 37a and 37b at a distance that increases the first width W1 at a distance substantially equal to the maximum cross-sectional dimension D (see Figure 3) of the shank of the compression member 56, compared to the force required to be applied to the compression member 53 in order to expand one or both of the first and second inner surfaces 37a and 37b with respect to the others of the prime and the second internal surfaces 37a and 37b a distance that increases the first width W1 by a distance substantially equal to the maximum cross-sectional dimension D (see Figure 3) of the compression member rod 56 during the intramedullary rod 30 does not include the first and second relief slots 99a and 99b. It should be noted that the first and second inner surfaces 37a and 37b can reduce both the approach forces and the holding force, and can also reduce debris that can be created due to translation of the stem 56 along the first and second surfaces internal 37a and 37b. The first and second relief slots 99a and 99b can be dimensioned, for example in the third and fourth widths W3 and W4, in order to determine a predictable approach force, while providing a sufficiently high holding force with a minimum amount of debris during operation.
[00088] Although the description has been described in detail, it should be understood that various changes, substitutions and changes can be made in the present invention without departing from the spirit and scope of the invention as defined by the embodiments. In addition, the scope of this description is not intended to be limited to the specific modalities described in the specification. In addition, the structure, characteristics and methods described in combination with one embodiment, as described here, may apply to any other embodiments described herein in the absence of a statement to the contrary. As will be readily understood by the person skilled in the art from the description of the present invention, processes, machines, manufacturing, substance composition, means, methods, or steps presently existing or to be further developed, that perform substantially the same function or obtain substantially the same. same result as the corresponding modalities described herein can be used in accordance with the present description.

权利要求:
Claims (14)
[0001]
1. Bone fixation set comprising: an intramedullary nail (30) having a nail body (32) which is elongated along a longitudinal axis that extends along a longitudinal direction, the nail body (32) defining a first portion positioned to attach to a first bone segment (22) and a second portion that is spaced in relation to the first portion along the longitudinal direction and positioned to attach to a second bone segment (24) that is separated from the first segmental bone (22) due to a bone defect, the stem body (32) defining a compression gap (39) extending within the first portion of the stem body (32), the compression gap (39) defining a plurality of pockets (45) including at least one pair of longitudinally spaced end pockets (52a, 52b) and an intermediate pocket (46) arranged between the end pockets (52a, 52b), and an intersection (48) between adjacent ones the pockets (45), where the comp slot recess (39) defines a first width perpendicular to the longitudinal direction of one of the intersections (48), and the compression slot (39) defines a second width in one of the pockets (45) along a direction parallel to the first width, in so that a second width is greater than the first width, characterized by the fact that: at least one at least one relief slot (99a, 99b) extends outwardly from the compression slot (39) and ends at stem body (32), where the relief slot (99a, 99b) defines a width parallel to the first and second widths, the width of the relief slot (99a, 99b) being less than the first width.
[0002]
2. Bone fixation set according to claim 1, characterized by the fact that the pockets (45) still include at least one pair of intermediate pockets (46) arranged between the end pockets (52a, 52b).
[0003]
3. Bone fixation set according to claim 1, characterized in that the stem body (32) defines a pair of opposing internal surfaces (37a, 37b) that are lengthwise elongated, and at least one of the internal surfaces (37a, 37b) defines the pockets (45).
[0004]
4. Bone fixation set according to claim 3, characterized by the fact that each of the internal surfaces (37a, 37b) defines some of the plurality of pockets (45).
[0005]
5. Bone fixation set according to claim 3, characterized in that the at least one internal surface (37a, 37b) is inclined along a direction from each pocket (45) to an intersection corresponding among the intersections (48).
[0006]
6. Bone fixation set according to claim 1, characterized by the fact that at least one of the first and second internal surfaces (37a, 37b) includes regions that are arc-shaped, in order to define the plurality of pockets (45).
[0007]
7. Bone fixation set according to claim 1, characterized by the fact that the compression gap (39) defines a first width that extends perpendicular to the longitudinal direction and is defined by the internal surfaces (37a, 37b) in a from the intersections (38), and a second width that extends parallel to the first width and is defined by the internal surfaces (37a, 37b) in one of the pockets (45), so that the second width is greater than the first width.
[0008]
8. Bone fixation set according to claim 7, characterized by the fact that it also comprises a compression member (53) having a cross-sectional dimension that is greater than the first width.
[0009]
9. Bone fixation set according to claim 8, characterized by the fact that at least one of the compression member (53) or one of the first and second of the internal surfaces (37a, 37b) is compressible so that the compression member (53) can travel from one of the pockets (45), beyond the intersection (48) and to the other of the pockets (45).
[0010]
10. Bone fixation set according to claim 1, characterized by the fact that the relief slot is a first relief slot (99a), further comprising a second relief slot (99b) extending out of the slot of compression (39) and ends at the nail body (32), so that the first relief slot (99a) extends proximally to the compression slot (39) and the second relief slot (99b) extends distally from the slot compression (39).
[0011]
11. Bone fixation set, according to claim 1, characterized by the fact that the intramedullary nail (30) further defines a plurality of holes for bone fixation (40) configured to receive the respective bone anchors (86), so fixing the intramedullary nail (30) to bone.
[0012]
12. Bone fixation set according to claim 1, characterized by the fact that the intersections (48) define an edge (27) that extends along a direction perpendicular to the longitudinal direction.
[0013]
13. Bone fixation set according to claim 1, characterized by the fact that the intersections (48) define a surface (29) that is elongated along a direction perpendicular to the longitudinal direction, and the surface (29) is extends along the longitudinal direction.
[0014]
14. Bone fixation set according to claim 1, characterized by the fact that the compression gap (39) defines a first width perpendicular to the longitudinal direction.

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-08-18| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161442397P| true| 2011-02-14|2011-02-14|

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US61/442,397|2011-02-14|

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PCT/US2012/024978|WO2012112495A1|2011-02-14|2012-02-14|Intramedullary nail having self-retaining compression slot|

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