• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    compression device for fractures. it is a bone fixation device that includes a first element that extends from a first head to a first stem along a first longitudinal axis and that has a first channel that extends through it. the first head rests against a portion of bone adjacent to a first orifice through which the first nail is inserted. a second element includes a second rod that extends along a second longitudinal axis to a second head and has a second channel that extends through it, the second head resting against a portion of bone adjacent to a second orifice through which the second stem is inserted. the second channel is dimensioned to receive the first rod there. a tensioning element can be inserted through the first and second channels so that the tension applied to a second end of it gives a compressive force to a bone in which the first and second elements are inserted.
    公开号:BR112014014614B1
    申请号:R112014014614-4
    申请日:2012-12-04
    公开日:2021-03-23
    发明作者:George Mikhail；Glen Pierson
    申请人:Synthes Usa, Llc；
    IPC主号:
    专利说明:

    [0001] [0001] Fractures of the pelvis and, more specifically, of the sacroiliac joint, are often treated by inserting a fixation device at the fracture site. Current fixation systems and methods are generally aimed at inserting one or more sacral bars or spongy screws at the fracture site. Sacral bars are formed as elongated flat rods that pass through the posterior pelvis towards the sacrum until a free end of the rod extends outward from an opposite wall of the pelvis. Threaded nuts are then threaded at the ends of the sacral bar to create and maintain compression of the pelvis. The spongy screws can be inserted to pass through the pelvis or they can be inserted from one side of the pelvis to maintain the stability of the sacroiliac joint. However, these screws rely heavily on overall bone strength and thread adhesion to maintain compression of the pelvis. These devices are therefore susceptible to failure due to loss of bone strength (for example, due to osteoporosis, etc.), loosening of threaded screws and / or a loss of bone adhesion (for example, through rotational movement and / or longitudinal axis of the sacral bars within the bone). SUMMARY OF THE INVENTION
    [0002] [0002] The present invention relates to a bone fixation device that comprises a first element extending from a first head at a first end to a first rod at a second end along a first central longitudinal axis and which has a first channel extending through it, the first head extending transversely to the first rod providing a first shoulder-shaped part that, in an operational configuration, rests against a portion of bone adjacent to a first orifice through which the first rod is inserted to define a maximum extent in which the first element can be inserted into the orifice. The bone fixation device also comprises a second element that includes a second rod that extends along a second central longitudinal axis from a third end to a head at a fourth end of the same and that has a second channel that extends through it, the second head extending transversely to the second stem providing a second shoulder-shaped part which, in an operational configuration, rests against a portion of bone adjacent to a second orifice through which the second stem is inserted to define a maximum extension in which the second element can be inserted in the second orifice, the second channel being dimensioned to receive the first rod in a sliding way. The bone fixation device also comprises a tensioning element that can be inserted through the first and second channels, the tensioning element including a first end dimensioned to prevent the first end from entering one of the first and second channels, in so that the tension applied to a second end of the tensioning element imparts a compressive force to the first and second elements and, consequently, to a bone into which the first and second elements are inserted. BRIEF DESCRIPTION OF THE DRAWINGS
    [0003] [0003] Figure 1 shows a first perspective view of an exemplary bone fixation element, according to the present invention, in a first configuration;
    [0004] [0004] Figure 2 shows a perspective view of the bone fixation element of Figure 1 in a second configuration;
    [0005] [0005] Figure 3 shows a second perspective view of the bone fixation element of Figure 1;
    [0006] [0006] Figure 4 shows a perspective view of the bone fixation element of Figure 1 in an implanted configuration; and
    [0007] [0007] Figure 5 shows a side view of the bone fixation element of Figure 1 in an implanted configuration. DETAILED DESCRIPTION
    [0008] [0008] The present invention can be further understood with reference to the description below and the accompanying drawings, in which similar elements are referred to with equal reference numbers. The present invention relates generally to devices and methods for fixing a fractured or damaged pelvic bone, otherwise. Specifically, the present invention relates to methods and devices for inserting a bone fixation element into the bone. The exemplary bone fixation element, according to the invention, comprises a first elongated element and a second elongated element, each extending along a longitudinal axis. In an operational configuration, the first and second elements are inserted through the first and second side openings, provided that they are on opposite sides of a pelvic bone. In one embodiment, the first and second side openings can be two ends of a single orifice formed by complete perforation through the pelvis. In another embodiment, two openings can be drilled in opposite walls of the pelvis. A free end of the first element is then inserted into a channel that extends through the second element until the first and second elements are seated securely in the pelvic bone. A cable is then inserted through the first and second elements. A first end of the cable comprises a cable limiter configured to latch an opening in a side head of the first element. The cable is then locked in position at a lateral end of the second element with the use of a crimp to secure the first and second elements in a desired position in relation to each other and to compress the fractured bone, as will be described in more detail below. . It is observed that, although the exemplifying system and method are discussed in relation to a sacroiliac fixation system and method, the invention can be used in any other bone fixation procedure in any other bone in the body by modifying the dimensions and shape of the device to suit a specific anatomy. The term "central", as used here, refers to a direction that approaches a central plane of a body in an operational configuration, while the term "lateral" refers to a direction that extends in the opposite direction to the central plane to the right or left.
    [0009] [0009] As shown in Figures 1 to 5, a bone fixation device 100, according to an exemplary embodiment of the invention, comprises a first element 102 and a second element 104. The first element 102 extends from a side end 106 to a central end 108 along a central longitudinal axis 110. The first element 102, according to this embodiment, is substantially cylindrical and comprises a lateral part of the body 112 which has a first outer diameter and a central part of the body 114 which it has a second outer diameter, the second outer diameter being smaller than the first outer diameter. A first elongated channel 116 extends through the first element 102 from the side end 106 to the central end 108. The first channel 116 is in longitudinal alignment with the longitudinal axis 110 and is configured and dimensioned to receive a cable 200 through it , as will be described in more detail below. The side end 106 comprises an enlarged diameter head 118 that has an oblong cross-sectional shape. It is observed, however, that any other shape in cross section (for example, oval, circular, rectangular, etc.) can be used, without deviating from the scope of the invention. The head 118 also comprises an opening 120 that extends through it, an orifice axis of the aperture 120 that extends substantially parallel to the longitudinal axis 110. In another exemplary embodiment, the axis of the orifice of the opening 120 can extend in any another angle in relation to the axis 110. The opening 120 is disposed in a position adjacent to the channel 116. As shown in Figures 4 and 5, the head 118 can also comprise a recessed part 121 configured to assist in handling the cable 200, as it will also be described in more detail below.
    [0010] [00010] second element 104 extends from a lateral end 122 to a central end 124 along the central longitudinal axis 110. The second element 104, according to this embodiment, is substantially cylindrical in shape and comprises a substantially uniform outer diameter which is substantially equivalent to the first outer diameter of the side part of the body 112. However, those skilled in the art will understand that the first and second elements 102, 104, respectively, can assume any desired shape as long as the central part of the body 114 is received slidingly inside a second elongated channel 126 that extends through the second element 104. The second channel 126 extends from the side end 122 to the central end 124 in longitudinal alignment with the longitudinal axis 110 and is configured and dimensioned for allow the insertion of the central part of the body 114 into it. In an exemplary embodiment, the channel 126 has a substantially uniform diameter, substantially equivalent to the outside diameter of the central part of the body 114 with a slight clearance to allow the central part of the body 114 to slide into it. In another exemplary embodiment, as shown in Figure 3, channel 126 comprises a central part of channel 128 and a side channel portion 130. The central part of channel 128 has a diameter substantially equivalent to or greater than the second outer diameter of the part central body 114 and smaller than the first outer diameter of the side part of the body 112. This configuration allows the insertion of the central part of the body 114 into the channel 126, while preventing the lateral part of the body 112 from being inserted into it . In an exemplary embodiment, the first and second portions 102, 104 are dimensioned so that, when inserted in an operational configuration, the central part of the body 114 is seated within the central part of the channel 128 with sufficient overlap to maintain stability. Varying the length of the overlap allows the length of the device 100 to be adjusted to accommodate variations in anatomy in different patients. In another embodiment, device 100 can be provided in a variety of lengths so that a physician can select a device that has a length range that suits the requirements of a specific procedure. In a preferred embodiment, the device 100 can be configured to prevent the central part of the body 114 from being completely seated in the central part of the channel 128. That is, having the central part of the body 114 only partially seated in the central part of the channel 128, a greater amount of compression can be applied through cable 200, as will be described in more detail below. The side channel portion 130 has substantially the same diameter as the first channel 116 so that the cable 200 inserted through the device 100 follows a smooth, substantially unobstructed path. The side end 122 comprises an enlarged diameter head 132 having an oblong cross-sectional shape similar to the shape of the head 118. It is noted, however, that the head 132 can comprise any other shape, without departing from the scope of the invention. The head 132 comprises an aperture 134 that extends through it, an axis of the aperture orifice 134 extending substantially parallel to the longitudinal axis 110. As with aperture 120, the axis of the aperture orifice 134 can also extend at any angle to the 110 axis.
    [0011] [00011] According to an exemplary method according to the invention, a doctor or another user opens incisions in the side walls on the right and left of the pelvis. The fracture is then reduced and provisionally stabilized with the use, for example, of Kirschner wires, as those skilled in the art will understand. A drill can then be used to form at least one longitudinal hole through the pelvis. A guidewire can be inserted first into the desired portion of the bone in a target insertion orientation. A cannula drill can then be guided by the guidewire to open the bone to a desired diameter selected to accommodate device 100, as those skilled in the art will understand. In an exemplary embodiment, two holes can be drilled through the pelvis at the fracture to receive two devices 100, although any number of holes can be drilled according to the requirements of the specific procedure, as those skilled in the art will understand. The cable 200, which has the cable limiter 202 at a first end thereof, is then inserted into the opening 120 of the first element 102. The cable limiter 202 can be an enlarged end portion of the cable 200 having a diameter greater than a diameter of the opening 120. In an exemplary embodiment, the cable limiter 202 is inserted into the opening 120 from a central direction so that when the first element 102 is positioned on the bone, the cable limiter 202 is positioned towards the bone. As those skilled in the art will understand, this configuration minimizes the efforts applied to the cable limiter 202 in an operational configuration and helps to prevent the cable 200 from loosening in relation to the bone. The first and second elements 102, 104 can then be inserted into the drilled hole from the left and right walls of the pelvis, respectively, until the central part of the body 114 is seated within the central part of the channel 128, as described in more details previously. In this configuration, the heads 118, 132 are in contact with the pelvis and the cable limiter 202 is positioned adjacent to the bone, as shown in Figure 3. The cable limiter 202 is seated within the concave portion of the head 118 so that the head 118 is in direct contact with the bone, without interference from the cable limiter 202. The free end of the cable 200 (not shown) is then inserted into the channel 116 from the side end 106, forming a loop 204 adjacent to the head 118. As those skilled in the art will understand, cable 200 can be configured and dimensioned to minimize a protrusion of handle 204 out of the head 118, thereby minimizing an implanted device profile 100. Handle 204 assists in removing device 100 from the body , as will be described in more detail below. The cable 200 is guided through the channel 116 and the channel 126 until the free end leaves the side end 122. The free end of the cable 200 is then inserted into the opening 134 of the side end. A frieze is then advanced over the free end of the cable 200 and advanced until it comes in contact with the head 132 of the second element 104. The frieze can be any frieze known in the art. A threaded tensioning mechanism at the free end of the cable 200 is then operated, as would be understood by those skilled in the art, to apply a desired tension to the cable, consequently applying a desired compressive force to the bone. The crimp is then crushed in a known manner to maintain the desired tension in the cable and the free portion of the cable 200 that extends out of the crimp is trimmed. As would be understood by those skilled in the art, the recessed part 121 provides a space in which the cable cutter can be advanced to allow a cable cutter to cut the cable close, minimizing the protrusion of the free end of the cable 200.
    [0012] [00012] A doctor may decide to remove device 100 from the body after a predetermined period of time has elapsed (for example, once the bone has healed, etc.). To remove the device, a cable cutting mechanism can be used to cut the handle 204, thereby removing the compression force applied to the bone by the device 100. The device 100 and the cable 200 can then be removed from the body.
    [0013] [00013] It will be apparent to those skilled in the art that various other modifications and variations can be made in the structure and methodology of the present invention, without departing from the spirit or scope of the invention. For example, the exemplifying system and method shown in the present invention can be used for the treatment of any bone fracture where compression is required and the opposite ends of the fractured bone are accessible to the physician. For example, the exemplifying system and method can be used to fix fractures of the patella, condyle, etc., where compression can be aided by any number of additional bone fixation devices (eg, intramedullary pin) without deviate from the scope of the invention. Thus, it is intended that the present invention encompasses modifications and variations of the same as long as they are within the scope of the appended claims and their equivalents.
    权利要求:
    Claims (7)
    [0001]
    Bone fixation device (100) characterized by the fact that it comprises: a first element (102) extending from a first head (118) at a first end (106) to a first rod (112) at a second end (108) along a first central longitudinal axis (110) and having a first channel (116) extending through it, the first head (118) extending transversely to the first rod (112) providing a first shoulder-shaped part which, in an operational configuration, rests against a portion of bone adjacent to a first orifice (120) through which the first nail is inserted to define a maximum extent into which the first element (102) can be inserted into the first orifice (120); a second element (104) including a second rod (114) extending along a second central longitudinal axis (110) from a third end (124) to a second head (132) at a fourth end (122) of the same and that has a second channel (126) that extends through it, the second head (132) extending transversely to the second stem (114) providing a second shoulder-shaped part that, in a configuration operational, it rests against a portion of bone adjacent to a second orifice (134) through which the second rod (114) is inserted to define a maximum extent into which the second element (104) can be inserted into the second orifice (134), the second channel (126) being dimensioned to receive the first rod (112) in it in a sliding way; and a tensioning element (200) that can be inserted through the first and second channels (116, 126), the tensioning element (200) including a first end dimensioned to prevent the first end from entering one of the first and the second second channels (116, 126), so that the tension applied to a second end of the tensioning element gives a compressive force to the first and second elements (102, 104) and, consequently, to a bone in which the first and second the second elements (102, 104) are inserted.
    [0002]
    Bone fixation device (100) according to claim 1, characterized in that the first head (118) comprises a first opening (120) disposed adjacent to the first channel (116), the first opening being (120) ) configured and dimensioned to receive a second end of the tensioning element (200) through it and to prevent movement of the first end of the tensioning element (200) that passes through it.
    [0003]
    Bone fixation device (100) according to claim 2, characterized in that the second head (132) comprises a second opening (134) positioned adjacent to the second channel (126), the second opening being (134) ) configured and dimensioned to receive the second end of the tensioning element (200) through it.
    [0004]
    Bone fixation device (100) according to claim 2, characterized by the fact that the first opening (120) is angled less than 90 ° in relation to the first central longitudinal axis (110).
    [0005]
    Bone fixation device (100) according to claim 3, characterized in that the second opening (134) is angled less than 90 ° in relation to the second central longitudinal axis (110).
    [0006]
    Bone fixation device (100) according to claim 1, characterized in that it additionally comprises a first recessed part (121) in the first shoulder-shaped part.
    [0007]
    Bone fixation device (100) according to claim 6, characterized in that it additionally comprises a second recessed part (121) in the second shoulder-shaped part.
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-08| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2021-01-12| B09A| Decision: intention to grant|
    2021-03-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161570527P| true| 2011-12-14|2011-12-14|
    US61/570,527|2011-12-14|
    PCT/US2012/067748|WO2013090059A1|2011-12-14|2012-12-04|Device for compression across fractures|
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