![]() BONE FIXATION DEVICE AND LOCKING MEMBER FOR BONE FIXATION DEVICE
专利摘要:
locking member for bone fixation device. The invention relates to a locking member for a bone fixation device which may include a locking body that defines an outer surface, an opposite bone-contacting surface and a slit extending from the bone-contacting surface. to the outer surface. the locking member may additionally include at least one locking tooth which extends into the slot and an inclination element which extends into the slot and defines a leveling surface which faces at least one tooth of crash. the slot can be configured to receive a toothed member along an insertion direction and the biasing element can be configured to bias the toothed member towards at least one locking tooth, so that at least one tooth of the toothed member engage the at least one locking tooth of the locking member for the purpose of preventing the toothed member from translating through the slot along a direction which is opposite to the insertion direction. 公开号:BR112015011072B1 申请号:R112015011072-0 申请日:2013-11-12 公开日:2021-08-10 发明作者:Marcello Memmolo;Kurtis Wheeler 申请人:Synthes Gmbh; IPC主号:
专利说明:
CROSS REFERENCE TO RELATED ORDERS [0001] This application claims priority over US Provisional Application Serial No. 61/726,797, filed November 15, 2012, the contents of which are hereby incorporated by reference as if presented in its entirety herein. document. BACKGROUND [0002] There are several surgical procedures that require the fixation of soft tissue to bone or bone to bone to produce healing such as the fixation of a bone flap or bone implant to the patient's skull. For example, craniotomies are surgical procedures conducted to treat various brain injuries, including tumors and aneurysms. As part of a craniotomy procedure, the surgeon creates an opening in the skull. One technique is to drill several adjacent holes to define the periphery of the opening and then use a tool to cut between the holes. The surgeon may remove an entire section of the skull, or cut off enough to flex the skull in the opposite direction to allow access to the brain or head region. The cut section is commonly called a bone flap. In other cases, an implant may be needed to replace a missing section of the skull. In both cases, the bone flap or implant must be attached or fixed to the surrounding region of the skull after the surgical procedure is completed. [0003] There are several existing devices to secure the bone flap or implant to the surrounding region of the skull. Several of these devices include external and internal discs that are connected by a rod, through which the bone flap (or implant) and the surrounding region of the skull are sandwiched between the external and internal discs. Typically, during use, the outer disc is slid along the stem towards the inner disc and is locked in place with a locking mechanism such as a rivet, a friction fit, or even a ratchet element. . Although the ratchet element was the most desired locking mechanism, as a result of its use, the outer disc has a profile related to the surrounding region of the skull that tends to irritate the surrounding tissue and/or have undesirable cosmetic effects on the patient. SUMMARY [0004] A bone fixation device configured to affix anatomical structures adjacent to one another may include a stem, an inner element, and an outer element. The rod is elongated along a first direction and may include a first end and a second end that is spaced apart from the first end along the first direction. The rod may additionally include a plurality of teeth. The inner element is coupled to the first end of the rod and defines a first outer surface and a first inner surface. The first inner surface is configured to be contiguous with respective inner surfaces of adjacent anatomical structures. The outer element is slid along the rod from the second end and towards the inner element. The outer element can define a second outer surface and a second inner surface. The second inner surface is configured to be contiguous with respective outer surfaces of adjacent anatomical structures. The outer member may include a shank-receiving slot extending from the second inner surface to the second outer surface, wherein the shank-receiving slot is defined, at least partially, by a surface including at least one tooth. and the outer member further includes an inclination member which extends into the slot that receives a rod and is configured to incline the rod toward the surface such that at least one of the teeth of the rod engages the at least one tooth. of the external element when the rod is inserted through the slot that receives a rod along an insertion direction for the purpose of preventing the rod from translating through the slot that receives a rod along a direction that is opposite to the direction of insertion . [0005] In another embodiment, a locking member for a bone fixation device may include a locking body that defines an outer surface, an opposite inner bone contact surface, and a slit extending from the inner contact surface with bone to the outer surface. The locking member may additionally include at least one locking tooth that extends into the slot and an inclination element that extends into the slot and defines a leveling surface that faces at least one tooth. of locking. The slot can be configured to receive a toothed member along an insertion direction and the biasing element can be configured to bias the toothed member towards at least one locking tooth, so that at least one tooth of the toothed member engage the at least one locking tooth of the locking member for the purpose of preventing the toothed member from translating through the slot along a direction which is opposite to the insertion direction. BRIEF DESCRIPTION OF THE DRAWINGS [0006] The above summary, as well as the following detailed description, will be better understood when read in conjunction with the accompanying drawings. For purposes of illustrating the present disclosure, illustrative embodiments are shown in the drawings. It should be understood, however, that the application is not limited to the specific embodiments and methods presented, and reference is made to the claims to this end. In the drawings: [0007] Figure 1A is a perspective view of a plurality of bone fixation devices that affix a bone flap to a portion of the surrounding region of the skull; [0008] Figure 1B is a cross-sectional view of one of the bone fixation devices of Figure 1A that affixes the bone flap to the portion of the surrounding region of the skull; [0009] Figure 2A is a perspective view of a bone fixation device according to an embodiment, the bone fixation device that has a toothed rod, a first gripping member coupled to a distal end of the toothed rod, and a second gripping member configured to translate along the tines from a proximal end of the tines which is opposite the distal end and toward the first gripping member; [00010] Figure 2B is a side elevation view of the bone fixation device shown in Figure 2A; [00011] Figure 2C is a top plan view of the bone fixation device shown in Figure 2A; [00012] Figure 3A is an anterior elevation view of the tines shown in Figure 2A, the tines having a disc and a shank body extending proximally from the disc; [00013] Figure 3B is a side elevation view of the toothed rod shown in Figure 3A; [00014] Figure 3C is a cross-sectional view of the toothed rod shown in Figure 3A through line 3C-3C; [00015] Figure 3D is a sharp side view of the distal end of the toothed rod shown in Figure 3B; [00016] Figure 4A is a perspective view of the first gripping member shown in Figure 2A, the first gripping member defining a first slot that receives a rod that is configured to receive the toothed rod, so that the first gripping member can be attached to the distal end of the toothed rod; [00017] Figure 4B is a top plan view of the first gripping member shown in Figure 4A; [00018] Figure 4C is a cross-sectional view of the first gripping member shown in Figure 4B through line 4C-4C; [00019] Figure 5A is a bottom perspective view of the second gripping member shown in Figure 2A, the second gripping member defining a second slot that receives a rod, and includes at least one tooth extending from a surface defining the second shank-receiving slot, and further including an inclination member that extends into the second shank-receiving slot and defines a leveling surface that faces the at least one tooth, so that as the toothed member is received in the second slot which receives a rod, the biasing element tilts the toothed rod towards the at least one tooth; [00020] Figure 5B is a top plan view of the second gripping member shown in Figure 5A; [00021] Figure 5C is a cross-sectional view of the second gripping member shown in Figure 5B through line 5C-5C; [00022] Figure 5D is a sharp top view of the tilting element of the second gripping member shown in Figure 5B in a first or home position; [00023] Figure 5E is a sharp top view of the tilting element of the second gripping member shown in Figure 5D in a second or flexed position after the slot has received the toothed rod; [00024] Figure 6A is a side elevation view of the first gripping member positioned so that an inner surface of the first gripping member is adjacent to the inner surfaces of the respective first and second anatomical bodies and the toothed rod extending through a defined gap between the first and second anatomical bodies, so that a portion of the toothed rod projects from and is external to the first and second anatomical bodies; [00025] Figure 6B is a side elevation view of the second gripping member positioned on the portion of the toothed rod that is external to the first and second anatomical bodies; [00026] Figure 6C is a side elevation view of the second gripping member positioned along the toothed rod, such that an inner surface of the second gripping member is adjacent to the outer surfaces of the respective first and second anatomical bodies; [00027] Figure 6D is a side elevation view of the first and second anatomical bodies captured between the inner and outer discs and the reduced toothed rod at a location adjacent to the outer surface of the second gripping member; [00028] Figure 7A is a front plan view of a toothed rod according to another embodiment; [00029] Figure 7B is a cross-sectional view of the toothed rod shown in Figure 7A through line 7B-7B, the toothed rod including a tilt element; [00030] Figure 8A is a perspective cross-sectional view of a locking member according to another embodiment being translated along a toothed member, the locking member including a toothed body and an inclination element that is configured to tilt the toothed body around a pivot; and [00031] Figure 8B is a detailed cross-sectional view of the toothed body and locking body bias element shown in Figure 8A. DETAILED DESCRIPTION [00032] Certain terminology is used in the following description for convenience only and is not limiting. The words "right", "left", "bottom" and "top" designate directions in the drawings to which reference is made. The words "proximally" and "distally" refer towards and away from, respectively, the surgeon using the surgical instrument. The words "previous", "posterior", "superior", "inferior" and related words and/or phrases designate the preferred positions and orientations in the human body to which reference is made, and they should not be limiting. Terminology includes the words listed above, derivatives of those words and words of similar meaning. [00033] Referring to Figures 1A and 1B, a bone fixation assembly 10 includes at least one bone fixation device 14 as a plurality of bone fixation devices that are configured to affix or otherwise secure a first anatomical structure, such as an implant or bone flap 16a to a second anatomical structure such as a region surrounding the skull 16b that are separated by a bony gap 18 such as a fracture or cut. In the illustrated embodiment, five bone fixation devices 14 are used to affix the bone flap 16a to the region surrounding the skull 16b. It should be understood, however, that a number of bone fixation devices 14 can be used as desired. [00034] As shown in Figures 1B and 2A-2C, the bone fixation device 14 can be substantially configured as a claw, and extends horizontally along a longitudinal direction L and a lateral direction A, and vertically along a transverse direction T. The bone fixation device 14 includes a toothed member 20, illustrated as a toothed rod 22 which is elongated along the transverse direction T and defines a first or distal rod end D and a second or proximal rod end P which is spaced apart from the distal rod end D along the transverse direction T. The bone fixation device 14 may additionally include a first or inner gripping member 26 which extends from or is otherwise coupled to the distal rod end. D and a second or outer gripping member 30 which is slidable along the toothed rod 22 from the proximal rod end P towards the first gripping member 2 6. It should be understood that the first and second gripping members 26 and 30 can be considered the first and second gripping members. [00035] It should be understood, that although the longitudinal and lateral directions are described as extending horizontally and the transverse direction being described as extending vertically, that during use the plane in which the directions extend may change. For example, in use, the lateral direction can extend vertically and the longitudinal direction and transverse direction can extend horizontally. Therefore, it should be recognized that the directional terms are for description purposes only and are not intended to be limiting. Furthermore, it should be understood that the transverse direction T, the longitudinal direction L, and the lateral direction A can be referred to as the first, second, and third directions. [00036] As shown in Figure 1B, each bone fixation device 14 can be placed so that the first gripping member 26 is adjacent to the respective internal surfaces 40a and 40b of the bone flap 16a and the surrounding skull region 16b. When positioned, toothed shaft 22 extends through bone gap 18 and protrudes from bone gap 18 so that a portion of toothed shaft 22 is external to the surrounding skull region 16b. The second gripping member 30 may then be positioned over the proximal rod end P of the tines 22 and translated along the tines 22 towards the first gripping member 26. The second gripping member 30 should be translated until the second gripping member 30 is contiguous with the respective external surfaces 44a and 44b of the bone flap 16a and the surrounding skull region 16b, so that the bone flap 16a and the surrounding skull region 16b are sandwiched between the first and the second gripping members 26 and 30. It should be understood, however, that while the bone fixation devices 14 are illustrated as securing a bone flap 16a relative to the surrounding skull region 16b, the bone fixation devices 14 may affix or otherwise secure any anatomical structures as desired, such as a sternum, for example. [00037] The bone fixation device 14 which includes the toothed rod 22, the first gripping member 26, and the second gripping member 30 can be made from a biocompatible material such as PEEK or PEKK. Bone fixation device 14 can be molded as three separate components as illustrated. In that case, the toothed rod 22 and the first gripping member 26 may be coupled together by the manufacturer or alternatively by a physician or physician's assistant prior to use. It should be understood, however, that the bone fixation device 14 can be molded as two components whereby the toothed rod 22 and the first gripping member 26 are molded as a single monolithic component which is to be posteriorly coupled to the second member. of gripper 30. Furthermore, it should be understood that the bone fixation device 14 or at least one of the toothed rod 22, the first gripping member 26, and the second gripping member 30 may be made from a material in addition to PEEK or PEKK, like a metal, for example. [00038] Now, with reference to Figures 3A-3D, the tine shank 22 may include a shank body 50 that is separated into at least a first initiation region 54 that extends from the proximal shank end P towards the distal rod end D along a portion of the length of the toothed rod 22 (e.g. approximately % of the length of rod 22) and a second locking region 58 extending between the first initiation region 54 and the rod end distal D. In accordance with the illustrated embodiment, the second locking region 58 extends from the first initiation region 54 to a location that is spaced with respect to the distal stem D. The stem body 50 defines the first and second surfaces opposite surfaces 50a and 50b which are spaced apart from each other along the lateral direction A. As shown, the first and second surfaces 50a and 50b are connected together by a pair of lateral surfaces 51a and 51b. As shown, the first and second surfaces 50a and 50b are wider than the side surfaces 51a and 51b. It should be understood, however, that the first and second surfaces 50a and 50b may be narrower than the side surfaces 51a and 51b, as desired. [00039] As shown in Figures 3A and 3B, the first initiation region 54 of the toothed rod 22 may include a plurality of small protrusions 60 that extend outwardly from the first surface 50a of the rod body 50 and alternate with recessed regions 64 which are disposed between adjacent protrusions 60. The first initiation region 54 may additionally include a tapered end 68 that is proximal to the protrusions 60. The tapered end 68 may be substantially free of protrusions 60 and the opposing side surfaces 51a and 51b at the tapered end may converge towards each other as they extend proximally towards the proximal stem end P. It should be understood, however, that the first initiation region 54 may be completely nub 60 as desired and may be without tapered end 68 as desired. [00040] As shown in Figure 3A, the second locking region 58 of the toothed rod 22 may include a plurality of locking teeth 76 that extend outwardly from the first surface 50a of the rod body 50 for a greater distance. than that of the protrusions 60 and are separated by recessed regions 78 which are disposed between adjacent locking teeth 76. It should be understood that while the locking region 58 extends along a distal portion of the stem body in the illustrated embodiment, the locking region 58 may extend along any portion to the entire shank body 50, as desired. [00041] As shown in Figures 3A-3D, the locking teeth 76 extend from the shank body 50 only along the first surface 50a and are spaced apart from each other along the transverse direction T. Each Locking tooth 76 is elongated along the longitudinal direction and is spaced with respect to an adjacent tooth along the transverse direction T. Each tooth 76 defines a bevelled anterior or proximal edge 80 and a distal or posterior edge 84. The anterior edges 80 extend from the first surface 50a at an angle such that the leading edges 80 are configured to perform cam movement around the chamfered leading edges complementary to the complementary locking teeth of the second gripping member 30. The edges trails 84 extend from the first surface 50a along the lateral direction and are substantially perpendicular to the first surface 50a, so that the trailing edges 84 are configured to engage the complementary trailing edges of the locking teeth of the second gripping member 30. It should be understood, however, that the locking teeth 76 may have other configurations as desired. For example, the trailing edges 84 may also extend from the first surface 50a at an angle so long as the trailing edges 84 can engage the trailing edges complementary to the locking teeth of the second gripping member 30. Furthermore, it should be understood , that the protrusions 60 and the locking teeth 76 may extend from both the first and second surfaces 50a and 50b or alternatively from the at least one of the side surfaces 51a and 51b. [00042] As shown in Figure 3C, the shank body 50 may have a trapezoidal shape in cross section. For example, in the illustrated embodiment, the first surface 50a may have a longitudinal dimension d1 that is less than a longitudinal dimension d2 of the second surface 50b. The trapezoidal shape can assist a user during assembly of the bone fixation device 14. That is, the second gripping member 30 will include a slot that receives a rod that matches the trapezoidal shape of the rod body 50. Therefore, the slot that receives a shank of the second gripping member 30 will be able to receive the shank body 50 only when the shank body is in a correct orientation. This configuration will ensure that the second gripping member 30 is properly mounted with the toothed rod 22. It should be understood, however, that the rod body 50 may have any configuration as desired. For example, the rod body can have a rectangular shape in cross section as desired. [00043] As shown in Figure 3D, the toothed rod 22 can define a maximum distance dM from an outer surface, such as the second surface 50b, of the rod body 50 to an outermost surface of the at least one of the plurality of teeth 76 along a second direction that is substantially perpendicular to the first direction. It should be understood that the maximum distance dM is to be measured on a tooth 76 which is configured to be received by a slot defined by the second gripping member 30. Furthermore, it should be understood that the maximum distance dM may be any distance as desired. [00044] With continued reference to Figures 3A-3D, the toothed rod 22 may additionally include a first coupling member 90, illustrated as a disc, extending from the distal rod end D and at least one second coupling member 94 extending from the rod body 50 at a location spaced proximally from the distal rod end D. In the illustrated embodiment, the toothed rod 22 includes two second coupling members 94 each extending the from a respective one of the first and second surfaces 50a and 50b of the stem body 50. The first and second coupling members 90 and 94 are configured to mate with a portion of the first gripping member 26 to thereby couple the first gripping member. grip 26 to the distal rod end D of the toothed rod 22. As shown in Figure 3D, the first coupling member 90 defines a first catching surface 98 and each of the second coupling members. plate 94 defines respective second catching surfaces 102 that face the first catching surface 98. The first and second catching surfaces 98 and 102 are spaced from one another along the transverse direction T, so that respective spans 106 are defined between each second catching surface 102 and first catching surface 98. The spans 106 are configured to receive a portion of the first gripping member 26 to thereby capture or otherwise couple the first gripping member 26 to the toothed rod. 22. It should be understood, however, that while the first coupling member 90 is illustrated as a disc, the first coupling member 90 can have any desired configuration. For example, the first coupling member 90 can be shaped as a block. Furthermore, it should be understood that the second coupling members 94 may extend from the side surfaces 51a and 51b as desired. [00045] Now, with reference to Figures 4A-4C, the first gripping member 26 is configured to be rigidly coupled to the distal rod end D of the tine rod 22. The first gripping member 26 includes a first grip or body clamp 110 which is substantially cylindrical in shape when viewed from above and defines a bone-contacting or inner surface 114 and an outer surface 118 that is opposite the inner surface 114 along the transverse direction T. As shown in Figure 4C, the inner surface 114 is concave and outer surface 118 is convex so that when inner surface 114 contacts inner surfaces 40a and 40b of first and second anatomical structures 16a and 16b, first body 110 flexes. It should be understood, however, that the first body 110 can have any configuration as desired. For example, the first body 110 can be rectangular in shape and/or the inner and outer surfaces 114 and 118 can be substantially flat, as desired. Referring again to Figure 2A, the first gripping member 26 is configured to be coupled to the distal rod end D of the toothed rod 22. In use, the first gripping member 26 is configured to be positioned such that the surface internal 114 is adjacent to the internal surfaces 40a and 40b of the first and second anatomical structures 16a and 16b. When the first gripping member 26 is moved to a gripping position, the inner surface 114 contacts or otherwise abuts the inner surfaces 40a and 40b of the anatomical structures 16a and 16b and the first body 110 flexes to outside. [00046] As shown in Figures 4B and 4C the first gripping member 26 further defines a first slot that receives a rod 122 that extends through the first body 110 from the inner surface 114 to the outer surface 118 along the transverse direction T. The first shank-receiving slot 122 is shaped to receive the shank body 50 along an insertion direction I so that the inner surface 114 faces the proximal shank end P. In the illustrated embodiment, a The first shank-receiving slot 122 is rectangular in cross-sectional shape, although it should be understood that the shank-receiving slot 122 can be of any configuration as desired. For example, the first slot that receives a shank 122 can have a trapezoidal shape in cross section, as desired. [00047] As shown in Figure 4C, the first body 110 further defines a recess 130 that extends to the outer surface 118 and toward the inner surface 114. The recess 130 extends to, but not completely through, the first body 110, so that a pair of snap fit members 134 is defined. As shown, the snap-fit members 134 are spaced from one another along the lateral direction A, so that the slot receiving a rod 122 is defined, at least partially, by the snap-fit members 134. Therefore, the slot receiving a rod 122 extends through the first body 110 from the inner surface 114 and into the recess 130. [00048] A recess 130 is dimensioned and shaped to receive the first coupling member 90 of the toothed rod 22 so that when the first coupling member 90 is received by the recess 130, the first coupling member 90 is substantially flush with the surface outer 118. In the illustrated embodiment, the recess is cylindrical in shape to match the disc shape of the first coupling member 90. It should be understood, however, that the recess 130 may have any shape as desired and that the first coupling member 90 it can protrude above outer surface 118 or be recessed from outer surface 118 as desired. [00049] With continued reference to Figure 4C, the snap-fit members 134 are configured to be received by the spans 106 of the toothed rod 22 when the first gripping member 26 is coupled to the toothed rod 22. As shown in Figure 4C, each one of the snap-fit members 134 has a transverse height H1 which is substantially equal to a transverse height H2 of the spans 106 of the toothed rod 22. Therefore, when the snap-fit members 134 are received by the spans 106, the first member of grip 26 will be rigidly coupled to the distal rod end D of the toothed rod 22. [00050] To couple the first gripping member 26 to the toothed rod 22, the proximal rod end P of the toothed rod 22 can be inserted into the first slot receiving a rod 122 along a direction from the outer surface 118 towards the inner surface 114 so that the first gripping member 26 slides along the rod body 50 towards the first coupling member 90. The first gripping member 26 must be moved towards the first coupling member 90 until the first coupling member 90 is received by the recess 130 and the snap-fit members 134 have snap-fitted into engagement with the spans 106. Once the snap-fit members 134 have engaged the spans 106 and are captured between the first and second catching surfaces 98 and 102 of the first coupling member 90 and the second coupling members 94, respectively, the first gripping member 26 will be coupled to rigid form to the distal rod end D of the tines 22. The first gripping member 26 and the tines 22 may together define a first locking member. It should be understood that the first gripping member 26 and the toothed rod 22 can be rigidly coupled together using any method or structure as desired. For example, the first gripping member 26 and the toothed rod can be welded together using, for example, ultrasonic welding. [00051] Now, with reference to Figures 5A-5E, the second gripping member 30 is configured to be slid along the stem body 50 from the proximal stem end P towards the first gripping member 26. The second gripping member 30 includes a second gripper or locking body 210 that is substantially cylindrical in shape when viewed from above and defines a bone-contacting or inner surface 214 and an outer surface 218 that is opposite the inner surface 214 along the direction. transverse T. As shown in Figures 5A and 5B, the second body 210 includes a central core 220 and a plurality of flexible extensions 222 that extend radially outwardly from the core 220. Each flexible extension 222 is separate from an extension adjacent flexible 222 by a radial slot 224. As shown in Figure 5C, the outer surface 218 which includes the outer surface of the core 220 and the flexible extensions 222 can be replaced. primarily convex. [00052] Each flexible extension 222 is coupled to the core 220 by a respective hinge 226. When the inner surface 214 is placed in contact with the outer surfaces 44a and 44b of the first and second anatomical structures 16a and 16b, the flexible extensions 222 flex to out around their respective hinges 226. In the illustrated embodiment, each flexible extension 222 has a trapezoidal shape, although it should be understood that the flexible extensions 222 may have any shape as desired. Furthermore, it should be understood that the second body 210 can have any configuration as desired. For example, second body 210 may be rectangular in shape and/or inner and outer surfaces 214 and 218 may be substantially flat. [00053] As shown in Figures 5A-5D, the second gripping member 30 further defines a second slot that receives a rod 232 that extends through the second body 210 from the inner surface 214 to the outer surface 218 along the direction. transverse T. The second rod-receiving slot 232 is shaped to receive the rod body 50 along the insertion direction I, so that the inner surface 214 faces the distal rod end P or the first gripping member. 26 as the second gripping member 30 is being slid along the stem body 50 from the proximal stem end P towards the first gripping member 26. The second slot receiving a stem 232 is configured to receive the end of proximal rod P of toothed rod 22 such that rod body 50 is configured to translate through the second slot receiving rod 232 unidirectionally along the insertion direction. not I. Therefore, the rod body 50 can translate through the second slot which receives a rod 232 along the insertion direction I, but not along a direction opposite to the insertion direction. [00054] In the cross section the second slot that receives a shank 232 has a trapezoidal shape and corresponds to the trapezoidal shape of the shank body 50. Therefore, the second slot that receives a shank 232 will be able to receive the shank body 50 only when rod body 50 is in correct orientation. It should be understood, however, that the second slot that receives a rod 232 can have any configuration as desired. For example, the second slot that receives a rod 232 may have a rectangular shape in cross section similar to that of the first slot that receives a rod 122 of the first gripping member 26. [00055] As shown in Figures 5C and 5D, the second slot that receives a rod 232 is partially defined by a slot or inner surface 240 that extends from the inner surface 214 to the outer surface 218 and the second gripping member 30 includes at least one locking tooth 244 as two locking teeth 244 extending outwardly from the inner surface 240 and into the second slot receiving a rod 232. Therefore, the at least one tooth can be said to locking tooth 244 defines, at least partially, the second slot that receives a shank 232. Each locking tooth 244 defines a bevelled leading edge 250 that is configured to cam movement around the complementary beveled leading edge 80 of the locking teeth 76 when the rod body 50 is translated through the second slot which receives a rod 232 along the insertion direction I. Each locking tooth 244 further defines a trailing edge 254 which is less sloped than the chamfered front edge 250 so that the trailing edges 254 engage the trailing edges 84 of the locking teeth 76 to prevent the rod body 50 from translating through the second slot receiving a rod 232 along a direction opposite to the insertion direction I. [00056] Referring to Figure 5C, the clamping device 14 may include a tilting member 260 that tilts the toothed locking rod 22 toward the locking teeth 76. In the illustrated embodiment, the second gripping member 30 includes inclination element 260 and inclination element 260 extends into the second slot which receives a rod 232 and faces the slot surface 240. In particular, inclination element 260 defines a leveling or incline surface. curved 264 that is opposite and faces the at least one locking tooth 244 of the second gripping member 30. As shown in Figure 5C, the tilt element 260 includes first and second legs 268 that are joined by a leveling member 272 The first and second legs 268 extend from opposing slot surfaces 276 that at least partially define the second slot receiving a rod 232. end from opposite ends of the slot surface 240 and face each other in the longitudinal direction L. Each leg 268 includes a straight section 280 that is substantially parallel to the slot surface 240 and a curved section 284 that curves toward the slot surface 240. Curved sections 284 are joined on leveling member 272 so that leveling member 272 defines leveling surface 264. As shown in Figure 5C, leveling surface 264 is opposite and faces toward the at least one locking tooth 244. It should be understood, however, that the bias element 260 may be of any configuration as desired. [00057] As shown in Figures 5D and 5E, the tilting element 260 is flexible between a first or starting position and a second or flexed position. Inclination element 260 has a flexibility that is greater than that of inner surface 240. When in the first position, second gripping member 30 defines a member distance db measured between inclination element 260 and inner surface 240 along of the lateral direction A which is less than the maximum distance dM from the tines 22. When the slot 232 receives the tines 22, the inclination element 260 flexes to the second position through which the member distance db is substantially equal to maximum distance dM. As a result, the bias element 260 biases the toothed rod 22 towards the inner surface 240 for the purpose of interlocking at least one of the plurality of teeth 76 with the at least one tooth 244. [00058] With continuous reference to Figures 5D and 5E, it can also be said that the member distance db measured from the leveling surface 264 to the slot surface 240 along the lateral direction A is less than the maximum distance dM of the rod body 50 measured along the lateral direction A when the tilt element 260 is in the first position. Therefore, when the rod body 50 is inserted through the second slot that receives a rod 232, the tilt element 260 will flex to the second position to thereby extend the distance of member db so that the rod body 50 can pass through. of the second slot receiving a rod 232. The tilting element 260 will, as a result, tilt or otherwise apply a force F against the second surface 50b of the rod body 50 to thereby force the rod body 50 towards the slit surface 240. The tilting element 260 may be configured to apply a tilting force F that is between about 05N and about 100N and in particular between about 10N and about 30N. , tilt element 260 applies a tilt force F of about 30 N. It should be understood, however, that tilt element 260 can be configured to apply any tilt force F as desired. [00059] As shown in Figure 5C, the second gripping member 30 is configured to have only two locking teeth 244 and therefore may have a lower profile compared to locking members that have three or more locking teeth . In particular, the second gripping member 30 is configured to have a height H3 which is measured along the transverse direction T which is between about 1.0 mm and about 2.0 mm. For example, in the illustrated embodiment, the second gripping member 30 has a height H3 that is about 1.25 mm. It should be understood, however, that the second gripping member 30 can have any height H3 as desired. [00060] The second gripping member 30 is configured to be positioned over the proximal rod end P, so that the proximal rod end P is inserted through the second slot receiving a rod 232 along the insertion direction I to from the inner surface 214 to the outer surface 218. The second gripping member 30 can then be slid along the rod body 50 towards the first gripping member 26. The second gripping member 30 can then be slid along the of the stem body until the second gripping member 30 abuts or otherwise contacts the outer surfaces 44a and 44b of the first and second anatomical structures 16a and 16b. As the second gripping member 30 is slid along the rod body 50, the locking teeth 76 of the tine rod 22 will engage the locking teeth 244 of the second gripping member 30. The engagement between the locking teeth 244 and the teeth locking elements 76 will prevent the second gripping member 30 from moving along the rod body 50 in the opposite direction to the first gripping member. In this way, the second gripping member 30 can also be called the second locking member. [00061] It should be understood that the second locking member or at least some of the features of the second locking member can be incorporated into other bone fixation devices. For example, the second locking member can be incorporated into a bone fixation member such as a sternum line that has a flexible strap configured to be formed in a loop around the first and second bone structures. In this embodiment, the slit of the second locking member can be configured to receive the flexible strip so that the tilting element applies a force against the flexible strip in order to cause the locking teeth of the flexible strip to engage the teeth. of the second locking member. For example, a second locking head may be incorporated into any of the locking members disclosed in Provisional Application No. US 61/616,555 filed March 28, 2012, the disclosure of which is hereby incorporated by reference herein. Referring to Figures 6A-6D, in operation the first locking member can be positioned so that the first gripping member 26 is adjacent to the inner surfaces 40a and 40b of the first and second anatomical structures 16a and 16b and the rod toothed shaft 22 extends through bony gap 18 so that a portion of toothed shaft 22 is external to anatomical structures 16a and 16b. Once the first locking member is in position, the second locking member (i.e., the second gripping member 30) can be positioned so that the rod body 50 is inserted through the second receiving slot. a rod 232 along the insertion direction I, so that the biasing member 260 tilts the rod body 50 towards the locking teeth 244. The second gripping member 30 may then be slidable or otherwise translated. along the rod body 50 towards the first gripping member 26, so that at least one tooth of the toothed rod 22 engages the at least one tooth 244 of the second gripping member 30 to thereby prevent the second gripping member from translating. along the toothed rod 22 in the direction opposite the first gripping member 26. As shown in Figure 6C, the second gripping member 30 is slidable along the rod body 50 until the first and second gripping members 26 and 30 have contiguous with the inner surfaces 40a and 40b and outer surfaces 44a and 44b of the first and second anatomical structures 16a and 16b respectively, so that the first and second anatomical structures are sandwiched or otherwise captured between the first and second grip members 26 and 30. This process can be repeated as many times as desired. Therefore, the first anatomical framework 16a can be affixed relative to the second anatomical framework 16b with a bone fixation device 14 or a number of bone fixation devices 14 as desired. [00062] In another embodiment and with reference to Figures 7A and 7B, the clamping device 14 can be configured so that the tilting element extends from a toothed rod 322. In this modality, the tilting element will exert pressure over a second slot surface that is opposite slot surface 240 to thereby incline the sprocket teeth toward the sprocket teeth 244. As shown in Figure 7A, the sprocket 322 may include a shank body 350 that is separated by at least a first initiation region 354 which extends from the proximal rod end P towards the distal rod end D along a portion of the length of the toothed rod 322 (e.g., approximately % of the rod length 22) and a second locking region 358 extending between the first initiation region 354 and the distal rod end D. In accordance with the illustrated embodiment, the second region of locking 358 extends from the first initiation region 354 to a location that is spaced with respect to distal stem D. Stem body 350 defines opposite first and second surfaces 350a and 350b that are spaced apart from one another along of the lateral direction A. As shown, the first and second surfaces 350a and 350b are connected together by a pair of lateral surfaces 351a and 351b. As shown, first and second surfaces 350a and 350b are broader than side surfaces 351a and 351b. It should be understood, however, that the first and second surfaces 350a and 350b may be narrower than the side surfaces 351a and 351b, as desired. [00063] As shown in Figures 7A and 7B, the second locking region 358 of tine shank 322 may include a plurality of pegging teeth 376 that extend outwardly 350 from the first surface of shank body 350 for a greater distance than that of the protrusions and are separated by recessed regions 378 which are disposed between adjacent locking teeth 376. It should be understood that the locking region 358 may extend along any portion to the entire stem body 350, as desired. [00064] Locking teeth 376 extend from shank body 350 only along the first surface 350a and are spaced apart along the transverse direction T. Each locking tooth 376 is elongated along the direction longitudinal and is spaced with respect to an adjacent tooth along the transverse direction T. Each tooth 376 is similar to the locking teeth 76 and defines a proximal or anterior edge or a distal or posterior edge. The leading edges extend from the first surface 350a at an angle such that the leading edges are configured to cam movement around the chamfered leading edges complementary to the complementary locking teeth of the second gripping member 30. trailing edges extend from the first surface 350a along the lateral direction and are substantially perpendicular to the first surface 350a so that the trailing edges are configured to engage the trailing edges complementary to the locking teeth of the second gripping member 30. It will be understood, however, that the locking teeth 376 may have other configurations as desired. [00065] As shown in Figure 7B, the bone fixation device may include a tilt element 380 that extends from the second surface 350b. The incline element 380 includes at least one, such as a pair of flexible fingers 384 that extends from the second surface 350b so that the fingers 384 are spaced apart from one another along the longitudinal direction. Each finger 384 extends at least partially toward the other so that an inner surface 392 of each finger 384 faces and is spaced apart from the second surface 350b. Fingers 384 extend along at least a portion like the entire second locking region 358 of shank body 350. Therefore, when shank body 350 is translating through the second slot it receives a shank 232 along the direction of insertion I, the bias element 380 will tilt the rod body 350 towards the locking teeth 244. [00066] Now, with references to Figures 8A and 8B, the gripping member may be a locking member 410 that is configured to include a locking body 414, at least one tooth as two teeth 418 configured as a toothed body 420 that is rotationally coupled to the locking body 414, and a tilting element 422 which extends from the locking body 414 and is configured to tilt the tines 420. Like the tilting element 260, the tilting element 422 is separate of toothed body 420 and therefore does not have any locking teeth. Tilting element 422 is configured to apply a tilting force to tines 420 for the purpose of causing tines 420 to rotate or otherwise rotate toward the tines. [00067] As shown in Figure 8A, the locking member 410 is similar to the second gripping member 30 and includes similar structure except where otherwise specified. For example, locking member 410 is configured to be slid along stem body 50 from proximal stem end P toward distal end D as toward a first gripping member. The locking body 414 is substantially cylindrical in shape when viewed from above and defines a bone-contacting or inner surface 428 and an outer surface 432 that is opposite the inner surface 428 along the transverse direction T. [00068] As shown in Figures 8A and 8B, the locking member 410 further defines a second slot that receives a rod 440 that extends through the locking body 414 from the inner surface 428 to the outer surface 432 along. of the transverse direction T. The second shank-receiving slot 440 is shaped to receive the shank body 50 along the insertion direction I, so that the inner surface 428 faces the distal shank end P or the first member. of gripping as the locking member 410 is being slid along the rod body 50 from the proximal rod end P towards the first gripping member. The second slot receiving a rod 440 is configured to receive the proximal rod end P of the toothed rod 22 such that the rod body 50 is configured to translate through the second slot receiving a rod 440 unidirectionally along the direction of insertion I. Therefore, the rod body 50 can translate through the second slot which receives a rod 440 along the insertion direction I, but not along a direction opposite the insertion direction. [00069] As shown in Figure 8B, the second slot that receives a rod 440 is partially defined by a first slot or inner surface 444 that extends from the inner surface 428 to the outer surface 432, a second inner surface 448 that is opposite the first inner surface 444, and a pair of side surfaces 452 that are opposed to each other and extend from the first inner surface 444 to the second inner surface 448. The locking body 414 additionally includes a platform 454 that extends to out from at least one of side surfaces 452 and second inner surface 448 and toward first inner surface 444. [00070] The toothed body 420 is movably coupled to at least one of the side surfaces 452. In the illustrated embodiment the toothed body 420 is rotationally coupled to at least one of the lateral surfaces 452 in a pivot 456. The toothed body 420 defines a engaging side 460 and an opposite sloping side 464. Engaging side 460 defines locking teeth 418 so that locking teeth 418 face the first inner surface 444. Each locking tooth 418 defines an edge chamfered front edge 470 which is configured to cam movement around the complementary chamfered front edge 80 of the locking teeth 76 when the shank body 50 is translated through the second slot receiving a shank 440 along the insertion direction I. Each lock tooth 418 additionally defines a trailing edge 474 that is less sloped than the chamfered leading edge 470 so that the trailing edges 474 engage the trailing edges. There are edges 84 of the locking teeth 76 to prevent the rod body 50 from translating through the second slot which receives a rod 440 along a direction opposite to the insertion direction I. [00071] The incline element 422 extends upwards from the platform 454 so that the incline element 422 is spaced from the second inner surface 448. The incline element 422 defines an incline surface 486 that is at contiguous with the incline side 464 of the tines 420 for the purpose of inclining the tines 420 towards the first inner surface 444. As shown, the incline surface 486 is spaced with respect to the pivot 456 along the insertion direction I In the illustrated embodiment, pivot 456 is disposed adjacent to inner bone-contacting surface 428 and tilting surface 486 abuts tilting side 464 adjacent to outer surface 432. It should be understood, however, that pivot 456 and slope surface 486 may be disposed anywhere along insertion direction I into slot 440. For example, pivot 456 may be disposed adjacent the surface. outer surface 432 and the bias surface may be disposed adjacent to the inner surface 428. When the rod body 50 translates through the slot 440, the rod body 50 will be biased relative to the inner surface 444 by the bias element 422. [00072] As shown in Figure 8B, the tilting element 422 is flexible between a first or initial position and a second or flexed position. Tilt element 422 has a flexibility that is greater than that of inner surface 444. When in the first position, locking member 410 defines a measured member distance db2 between tilt element 422 and inner surface 444 along the lateral direction A. When the slot 440 receives the rod body 50, the inclination element 422 flexes to the second position through which the member distance db2 increases. As a result, the bias element 422 biases the toothed rod 22 towards the inner surface 444 for the purpose of interlocking at least one of the plurality of teeth 76 with the at least one tooth 418. [00073] For example, when the rod body 50 is inserted through the second slot that receives a rod 440, the tilt element 422 will flex to the second position to thereby extend the distance of member db, so that the rod body 50 can pass through the second slot receiving a rod 440. The bias element 422 will, as a result, bias or otherwise apply a force F against the bias side 464 of the toothed body 420 in order to cause it to tine body 420 rotates around pivot 456 and urges shank body 50 toward slot surface 444. Engagement of at least one tine 418 with tines 76 of shank body 50 will prevent shank body 50 from translating through slot 440 along a direction opposite to insertion direction I. It should be understood that locking member 410 can be configured to receive any toothed member and is not limited to rod bodies 50. [00074] The bone fixation set 10 can include a number of bone fixation devices 14. Additionally, the bone fixation set 10 can include an implant that must be affixed to the surrounding region of the skull 16b by the bone fixation devices 14. Therefore , bone fixation assembly 10 can be a kit that includes an implant and a plurality of bone fixation devices 14. Additionally, bone fixation devices 14 can include any of the locking members and toothed members described. [00075] While the foregoing description and drawings represent preferred embodiments of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions can be made thereto without departing from the spirit and scope of the invention as defined in the claims in attachment. In particular, it will be clear to those skilled in the art that the invention can be incorporated into other specific forms, structures, arrangements, proportions and with other elements, materials and components, without departing from the spirit or essential characteristics of the same. The person skilled in the art will recognize that the invention can be used with many modifications of structure, arrangement, proportions, materials and components, which are particularly adapted to specific environments and operational requirements without departing from the principles of the invention. In addition, the features described herein can be used singularly or in combination with other features. For example, features described in conjunction with one modality can be used and/or interchanged with features described in another modality. The modalities presented herein are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited by the aforementioned description. invention may be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be evident to those skilled in the art.
权利要求:
Claims (12) [0001] 1. A bone fixation device (14) comprising: a rod (22, 322) that is elongated along a first direction and includes a first end and a second end that is spaced apart from the first end along the first direction. , wherein the rod (22, 3220) further includes at least one first tooth (76, 376); a first clamping member (26) secured to the first end of the rod (22, 322) relative to the translation related to the rod ( 22, 322) along the first direction; and a second fastening member (30) including a body (210) defining an inner surface (214) and an outer surface (218) opposite the inner surface (214), wherein the second fastening member (30) includes a inner surface (240) which at least partially defines a slit (232) extending through the body (210) from the inner surface (214) to the outer surface (218), wherein the slit is sized to receive the rod (22, 322) such that the second clamping member (30) is slidable along the rod (22, 322) in the first direction, wherein the second clamping member (30) further includes at least one second tooth. (244) extending from the inner surface (240); and an inclination element (260, 380) configured to incline the rod (22, 322) toward at least one second tooth (244) when the rod (22, 322) extends through the slot (232) so that the at least one first tooth (76, 376) engages the at least one second tooth (244) for the purpose of i) allowing the at least one second tooth (244) to slide along the at least one first tooth (76, 376) when the second clamping member (30) translates along the rod (22, 322) towards the first clamping member (26) and ii) causes the at least one second tooth (244) to interlock with the hair. at least one first tooth (76, 376) to prevent the second clamping member (30) from translating along the rod (22, 322) in the opposite direction to the first clamping member (26) characterized by the fact that the biasing element (260, 380) has greater flexibility than that of the inner surface (240). [0002] 2. Bone fixation device (14), according to claim 1, characterized in that the inclination element (260) extends from the body (210) into the slit (232) and remains facing the at least one second tooth (244). [0003] 3. Bone fixation device (14), according to claim 2, characterized in that the inclination element (260) defines a curved leveling surface (264) that faces at least one second tooth ( 244) of the second attachment member (30). [0004] A bone fixation device (14) according to claim 3, characterized in that the tilting element (260) includes first and second curved legs (268) which are joined by a leveling member (272 ) defining the leveling surface (264), wherein the first and second legs (268) extend from opposing surfaces that at least partially define the slit (232). [0005] 5. Bone fixation device (14), according to any one of claims 2 to 4, characterized in that the rod (22, 322) has first and second surfaces (50a, 50b) that are opposite along a a second direction that is perpendicular to the first direction, and wherein the rod (22, 322) includes a plurality of teeth (376) extending only from the first surface (50a) and the tilt element (260) is configured to apply a force against the second surface (50b) when the rod (22, 322) is inserted through the slot (232) along the first direction. [0006] A bone fixation device (14) according to claim 5, characterized in that the rod (22, 322) additionally includes a first coupling member (90) at the first end and a pair of second members of coupling members (94) extending from the first and second surfaces (50a, 50b) respectively at a location spaced apart from the first coupling member (90) such that the first and second spans (106) are defined between the first coupling member (90) and second coupling member (94) respectively, and wherein the first and second span (106) receive a portion of the first attachment member (26) to thereby engage the first member. fastening (26) to the rod (22, 322). [0007] 7. Bone fixation device (14), according to claim 1, characterized in that the rod (22, 322) has first and second surfaces (350a, 350b) that are opposite along a second direction which is perpendicular to the first direction, and wherein the rod (22, 322) includes a plurality of teeth (376) that extend only from the first surface (350a) and the tilt element (380) extends outwardly of the second surface (350b). [0008] 8. Bone fixation device (14) according to claim 7, characterized in that the tilting element (380) includes a pair of flexible fingers (384) extending outwardly from the second surface. (350b) so that the fingers (384) are spaced apart and extend toward each other. [0009] 9. Locking member (410) for a bone fixation device (14), characterized in that it comprises: a locking body (414) defining an outer surface (432), an inner bone contact surface (428 ) opposite the outer surface (432), an inner surface (444) that extends between the inner bone-contacting surface (428) and the outer surface (432); a toothed body (420) that is movably coupled to the locking body (414), wherein the toothed body (420) has an engagement side (460) that faces the inner surface (444) and a slope side (464) that is opposite the engagement side (460 ); an incline element (422) which is supported by the locking body (414), wherein the incline element (422) defines an incline surface (486) that faces the incline side (464), at that the locking body (414) is configured to receive a toothed member (22, 322) so that the slope surface (486) f is flush with the tilt side (464) to thereby move the toothed body (420) towards the toothed member (22, 322) for the purpose of i) allowing the toothed member (22, 322) to translate through the locking body (414) along a direction extending from the inner bone-contacting surface (428) to the outer surface (432), and ii) prevent the toothed member (22, 322) from translating through the locking body (414) along a direction extending from the outer surface (432) to the inner bone-contacting surface (428). [0010] 10. Locking member according to claim 9, characterized in that the toothed body (420) is rotationally coupled to the locking body (414) in a pivot (456), so that when the locking body (414) receives the toothed member (22, 322), the tilt surface (486) is flush with the tilt side (464) to thereby cause the toothed body (420) to rotate about the pivot (456). [0011] 11. Locking member according to claim 10, characterized in that the pivot (456) is disposed adjacent to the inner bone contact surface (428), and the slope surface (486) is flush with the side slope (464) adjacent to the outer surface (432). [0012] 12. Locking member according to claim 10, characterized in that the toothed body (420) includes at least one tooth (418) extending from the engagement side (460) towards the inner surface ( 444).
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同族专利:
公开号 | 公开日 US9622784B2|2017-04-18| CN104918568A|2015-09-16| US9433438B2|2016-09-06| JP2015534879A|2015-12-07| IN2015DN04166A|2015-10-16| CA2891908A1|2014-05-22| KR20150085835A|2015-07-24| US20160338736A1|2016-11-24| EP2919684A1|2015-09-23| JP6258343B2|2018-01-10| WO2014078265A1|2014-05-22| US20140135852A1|2014-05-15| BR112015011072A2|2017-07-11| EP2919684B1|2018-01-10| CN104918568B|2018-06-01| KR102205052B1|2021-01-22| CA2891908C|2020-07-28|
引用文献:
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Kg|A skull bone fixation device for attaching a cranial bone portion to a positioning device| CN108720917B|2017-04-18|2021-05-14|合硕生技股份有限公司|Skull fixing device and surgical tool thereof| TWI679003B|2018-09-18|2019-12-11|合碩生技股份有限公司|Bone drilling cover device| CN109528279B|2018-11-18|2021-01-26|赵建磊|Skull breaking and repairing device suitable for neurosurgery clinic| CN110960339A|2019-11-26|2020-04-07|广州迈普再生医学科技股份有限公司|Skull repairing body and skull repairing system|
法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-12-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-08-10| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/11/2013, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 US201261726797P| true| 2012-11-15|2012-11-15| US61/726,797|2012-11-15| PCT/US2013/069559|WO2014078265A1|2012-11-15|2013-11-12|Locking member for a bone fixation device| 相关专利
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