• 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:
    spinal device with ratchet. the invention relates to a ratchet spinal device that includes a variable length member that includes a ratchet mechanism that has an operational configuration that allows a change in length of the variable length member in one direction and prevents a change in length of the member of variable length in an opposite direction, in which the variable length member includes fixation members of a polyaxial joint for fixation to the bone, which allows the articulation movement of the fixation members on more than one articulation axis.
    公开号:BR112013007370B1
    申请号:R112013007370-5
    申请日:2011-05-05
    公开日:2020-10-06
    发明作者:Uri Arnin
    申请人:Apifix Ltd；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention generally relates to spinal implants and prostheses and, particularly to a spinal stem that has a ratchet mechanism, and also that has a locked position and a released position. BACKGROUND OF THE INVENTION
    [002] Scoliosis is a spinal deformity that affects many people. Surgical treatment involves fixing long fusion rods to the spine using pedicle screws. The rod system is designed to force the deformed spine into a healthier position.
    [003] Unfortunately, there are several disadvantages regarding this procedure; deformation is rarely corrected perfectly, long-life fusion is not a desired clinical situation and failures are not uncommon. SUMMARY OF THE INVENTION
    [004] The present invention seeks to provide an improved ratchet spinal device that can be widened or shortened with the use of a ratchet mechanism. The device has a variable length member that can be connected to standard pedicle screws as well as other spinal rods, using appropriate connectors. The variable length member can also be directly connected to or supported by bone elements in the spine.
    [005] In one embodiment of the invention, the device can be set to three different configurations:
    [006] Ratchet mechanism active and the member of variable length can change in length (extend or contract) in one direction.
    [007] Ratchet mechanism not active and the variable length member can move in opposite directions corresponding to the contraction and extension directions.
    [008] Locked position, in which the length of the variable length member is fixed.
    [009] In an embodiment of the invention, the selection of these configurations can be made by rotating an internal element of the assembly. For example, the rotation of the inner element can be done using a helical gear mechanism. The helical gear can be activated by an axis, through a percutaneous procedure or by an implantable mechanism such as an electric motor, magnet arrangement or other means known to elements skilled in the art.
    [0010] In another embodiment of the present invention, the variable length member can have two portions with different stiffness. For example, the variable length member may have a flexible portion (for example, when the ratchet is constructed in such a way that the rod can only be shortened) such as a flexible cable, a rope, a flexible mechanical joint and other means known to the elements versed in the technique.
    [0011] In another embodiment of the invention, useful when the nail is supported directly by the bone structure of the spine, the hook that holds the bone can have a second hook to fix it in the ideal position.
    Accordingly, according to an embodiment of the present invention, a spinal device with ratchet that includes a member of variable length that includes a ratchet mechanism that has an operational configuration that allows a change in length of the member of variable length in one direction and prevents a change in length of the limb of varying length in an opposite direction, in which the limb of varying length includes fixing members of a polyaxial joint for fixing to the bone, which allows joint movement of the limbs of fixation on more than one articulation axis.
    [0013] According to an embodiment of the present invention, the ratchet mechanism has another operational configuration in which the variable length member is locked in place, and yet another operational configuration in which the ratchet mechanism is neutralized so that the variable-length member is free to change in length in either direction, and a controller controls the selection of one of the operational settings.
    [0014] In accordance with an embodiment of the present invention, the controller selectively moves a ratchet mechanism tongue in or out of the ratchet mechanism's toothed alignment, and selectively moves a locking element in and out. out of the locking hitch with the variable length member. The tongue and the locking element can be mounted on a spindle rotated by the controller. Alternatively, the tongue and the locking element can be mounted on an eccentric mechanism rotated by the controller.
    [0015] In accordance with an embodiment of the present invention, the polyaxial joint fastening members are located at or near the opposite ends of the variable length member.
    [0016] In accordance with an embodiment of the present invention, a guiding device is operative to apply an incentive force on the member of varying length.
    [0017] According to an embodiment of the present invention, at least one of the polyaxial joint fixing members includes a socket and ball joint. Additionally or alternatively, at least one of the polyaxial joint fixing members includes a hook.
    [0018] According to another embodiment of the present invention, the ratchet mechanism is toothless. BRIEF DESCRIPTION OF THE DRAWINGS
    [0019] The present invention will be understood and observed more fully from the following detailed description, taken in conjunction with the drawings, in which:
    [0020] Figure 1 is a simplified illustration of a longitudinal cross section of the spinal device, constructed and operational in accordance with an embodiment of the invention;
    [0021] Figure 2 is a simplified illustration of a cross section perpendicular to that of figure 1;
    [0022] Figure 3 is another simplified illustration of a longitudinal cross section of the spinal device, which includes an orientation device, constructed and operational in accordance with another embodiment of the invention;
    [0023] Figures 4A, 4B and 4C are simplified illustrations of three controlled positions of the ratchet mechanism of figure 1;
    [0024] Figure 5 is a simplified photographed illustration of a spinal device, built and operational according to another embodiment of the invention, designed to be only shortened, which has a flexible portion;
    [0025] Figures 6A and 6B are simplified photographed illustrations of additional means that can be used together with the device to correct ideal deformity, according to an embodiment of the invention;
    [0026] Figures 7, 8, 9A and 9B are simplified photographed illustrations of spinal stem support elements placed directly against the bone elements of the spine, according to an embodiment of the invention;
    [0027] Figure 10 is a simplified illustration of a spinal device, built and operational according to another embodiment of the invention, connected to two bone screws;
    [0028] Figure 11 is a simplified photographed cross section of the spinal device of figure 10;
    [0029] Figure 12 is an enlarged simplified illustration of the control mechanism of the spinal device of figure 10;
    [0030] Figure 13 is a simplified photographed illustration of an eye joint for connecting the device of Figure 10 to a bone screw;
    [0031] Figures 14 and 15 are simplified illustrations of toothless ratchet mechanisms for spinal devices, according to the modalities of the invention. DETAILED DESCRIPTION OF MODALITIES
    [0032] Reference is now made to figure 1, which illustrates a spinal device with ratchet 10, constructed and operational in accordance with a non-limiting embodiment of the invention.
    [0033] The spinal device with ratchet 10 includes a member of variable length 12. In the illustrated embodiment, the member of variable length 12 is a rod. The term "rod" encompasses any thin element of any size and shape in cross-section, such as, but not limited to, a rod, bar, wire and the like.
    [0034] The ratchet spinal device 10 includes a ratchet mechanism 14, which has an operational configuration that allows a change in length of the variable length member 12 in one direction and prevents a change in length of the variable length member 12 in one direction. opposite direction, as will be further explained below.
    [0035] In the embodiment illustrated in figure 1, the ratchet spinal device 10 includes a ratchet mechanism 14 that has ratchet teeth 16 formed along an axial portion of the variable length member 12, and a tongue 18 arranged to capture a of the teeth 16. The tongue 18 is mounted on a drum 20 fixed to a spindle 22, which is rotated by a controller, which can be a helical gear drive 24 that is interposed with the gear teeth 26 formed at the end of the spindle 22 .
    [0036] An end 23 of the variable length member 12 is arranged to move linearly through an opening 28 formed in a housing 30. The variable length member 12 includes two polyaxial joint fixing members 32. In the illustrated embodiment, a polyaxial joint fixing member 32 is positioned at or near the end 23 of the variable length member 12 and another polyaxial joint fixing member 32 is positioned in the housing 30. Alternatively, the variable length member 12 could be constructed so that the second polyaxial joint fixation member 32 be mounted thereon, at or near an end opposite the end 23. Both polyaxial joint fixation members 32 are used to fix the device 10 to the available spine bone structure (as per pedicle screws passing through the limbs 32, as seen in figure 10). The polyaxial joint fixing members 32 allow articulation movement over more than one articulation axis, such as around the geometric axis 33 (which is perpendicular to the drawing sheet of figure 1) and the geometric axes 34 and / or 35. In the embodiment of figure 1, one or both of the polyaxial joint fixing members 32 have socket and ball joints. Additionally or alternatively, as shown in figure 3, one or both of the polyaxial joint fixing members 32 includes a hook 36.
    [0037] After installing device 10 on a patient, in a typical treatment plan, the patient will be asked to flex in a direction that will cause the end 23 of the variable length member 12 to move further out of the housing 30 until the ratchet teeth 16 engage an increment (or more than one increment, if directed by the physician) beyond the tongue 18. This extends the length of the variable length member 12. The tongue 18 retains the variable length member 12 in the after changing the incremental length. In this way, the variable length member 12 can be gradually extended without causing trauma to the patient.
    [0038] Alternatively, the ratchet mechanism 14 can be defined to allow the ratchet movement of the end 23 of the variable length member 12 in the housing 30, thereby shortening the length of the variable length member 12 for each incremental flexion of the patient, if the particular treatment plan calls for shortening the length.
    [0039] According to an embodiment of the present invention, the ratchet mechanism 14 has another operational configuration in which the variable length member 12 is locked in place. This can be done by means of a locking element 38, which can be positioned on the drum 20, as seen in figure 2, as 90 ° in the opposite direction to the tongue 18. The controller (helical gear drive 24) can rotate drum 20 / spindle 22 so that tongue 18 is moved in the opposite direction and out of engagement with ratchet teeth 16, while at the same time locking element 38 (which can be shaped similarly to tongue 18 ) is moved to the locking hitch with one or more of the ratchet teeth 16 (seen in figure 4B).
    [0040] According to an embodiment of the present invention, the ratchet mechanism 14 has yet another operational configuration in which the ratchet mechanism 14 is neutralized so that the variable length member 12 is free to change in length in either direction. This can be done by the controller (helical gear drive 24) that turns the spindle 22, so that both the tongue 18 and the locking element are moved in the opposite direction and out of the engagement with the ratchet teeth 16 (seen in the figure 4C). The helical gear drive 24 can be activated by an axis 40, through a percutaneous procedure or by an implantable mechanism such as an electric motor, magnet arrangement or other means known to those skilled in the art.
    [0041] Reference is now made to figure 3. According to an embodiment of the present invention, a guiding device 42 is operative to apply an incentive force to the member of variable length 12. The guiding device 42 can be a metal spring, plastic spring, an extensible rod actuated by gas or elastomer or shock absorber. The guidance device 42 encourages the variable length member 12 to follow the direction of movement dictated by the ratchet mechanism 14.
    [0042] Reference is now made to figure 5. In this embodiment, the variable length member 12 includes a rigid portion 44 and a flexible portion 46. The flexible portion 46 may be a cable, rope, plastic wire, flexible mechanical joint or any other means that transfers a pulling force, but does not transfer the impulses from the fixing member 32 to the rigid portion 44.
    [0043] Reference is now made to figures 6A and 6B, which illustrate the devices that can be used in conjunction with device 10 to ideally correct spinal deformity. In figure 6A, a flexion limiting member 48 is positioned around two or more vertebrae 49 to limit the amount of flexion or extension that the patient can begin in that portion of the spine. Flexion limiting member 48 can be a flexible band, wire, rope or any other means that prevents the spinal process from flexing too much.
    [0044] In figure 6B, one or more flexion limiting elements 50 are positioned between two or more vertebrae 48 to limit the amount of flexion or extension that the patient can begin in that portion of the spine. Bending limitation elements 50 (which can also be used in figure 6A) can be made of metal, plastic or any other rigid or semi-rigid material and can have a rectangular, round or elliptical cross section or any other cross section that suits to anatomy.
    [0045] Reference is now made to Figures 7 and 9A, which illustrate some support elements for supporting or retaining the device 10 directly against the bone elements of the spine. The support elements can be additional, or instead, the simple hooks illustrated in figure 3. The numeral 700 is a top section view of the spinal vertebra. A support element 52 is firmly connected to device 10 (not shown here). The support element 52 can be located above or below the transverse process. Usually one end of the rod will have a support element located above a transverse process and the second end will have a support element located on a second transverse process. A hook 54 holds the blade of the same vertebra and a connecting element 56 secures the support element 52 to the hook 54. This arrangement allows the support element 52 to be attached as close as possible to the origin of the transverse process, its strongest point .
    [0046] Reference is now made to Figures 8 and 9B, which illustrate another means of support when the spinal stem is directly retaining the bone elements of the spine. The numeral 800 is a top section view of the spinal vertebra. A support element 58 is firmly connected to device 10 (not shown here). The support element 58 can be located above or below the transverse process. Usually, one end of the rod will have a support element located above a transverse process and the second end will have a support element located under a second transverse process. A support element 60 is located on the opposite side of the spinal process of the same vertebra and a connecting element 62 secures support element 58 to support element 60. This arrangement also allows support element 58 to be attached as close as possible the origin of the transversal process, its strongest point.
    [0047] Reference is now made to figures 10 to 13, which illustrate a spinal device with ratchet 100, constructed and operational in accordance with another non-limiting embodiment of the invention. Similar to the embodiment of figure 1, the ratchet spinal device 100 includes a ratchet mechanism 114, which has an operational configuration that allows a change in length of a member of variable length 112 in one direction and prevents a change in length of the member of variable length 112 in an opposite direction. The ratchet mechanism 114 has ratchet teeth 116 formed along an axial portion of the variable length member 112, and a tongue 118 arranged to capture one of the teeth 116. The tongue 118 extends from a controller element 120 mounted on a pivot 122 and provided with an eccentric cam 124. The rotation of the eccentric cam 124 moves the tongue 118 to one of three positions: a) in ratchet engagement with teeth 116 so that the variable length member 112 can move additionally in one direction, b) in engagement locked with teeth 116 so that the variable length member 112 cannot actually move, and c) moved out of engagement with teeth 116 so that the variable length member 112 can move move in both directions freely.
    [0048] An end 123 of the variable length member 112 is arranged to move linearly through an opening 128 formed in a housing 130. The variable length member 112 includes two polyaxial joint fixing members 132. As similarly described above, both polyaxial joint fixation members 132 are used to fix the device 100 to the available bone structure of the spine, as by means of pedicle screws 133 passing through members 132, as seen in figure 10. Figure 13 illustrates a head 135 of the pedicle screw 133 passed through the polyaxial joint fixing member 132 (e.g., an eye joint), in which a nut 134 firmly holds the pedicle screw 133 in place while allowing for polyaxial rotation.
    [0049] In the above modalities, the ratchet mechanism has ratchet teeth. According to another embodiment of the present invention, the ratchet mechanism is toothless (continuous "ratchet"), which provides infinite positions as opposed to distinct incremental steps. Two examples are shown in figures 14 and 15. In figure 14, a stem 140 is arranged for linear movement in the direction of arrow 141. A disk 142 is eccentrically mounted on a pivot 144. Disk 142 comes into contact with stem 140 in point 146 above a line 148, which is perpendicular to the stem 140 and passes through the center of pivot 144. The stem 140 cannot move downwards (opposite arrow 141), because it is chamfered on the disk 142 at point 146.
    [0050] In figure 15, a chamfer 150 comes into contact with the stem 140. The stem 140 cannot move downwards (opposite the arrow 141), because it is chamfered in the chamfer 150.
    [0051] Other toothless ratchet mechanisms can be used, such as, but not limited to, the toothless clutch and ratchet mechanism of US Patent No. 5152197.
    [0052] It will be noted by those skilled in the art that the present invention is not limited by what has been shown and described above above. Preferably, the scope of the present invention includes both combinations and subcombination of the features described above as well as modifications and variations of the same that would occur for an element skilled in the art upon reading the aforementioned description and which is not in the prior art.
    权利要求:
    Claims (13)
    [0001]
    1. Ratchet spinal device (100) comprising: a variable length member (112) comprising a ratchet mechanism (114) having an operational configuration that allows a change in length of said variable length member (112) in one direction and prevents a change in length of said member of variable length (112) in an opposite direction, wherein said member of variable length (112) comprises fixing members of a polyaxial joint (132) for fixing to the bone, which allows articulation movement of said fixation members (132) around more than one articulation axis, characterized by the fact that pedicle screws (133) that pass through said fixation members (132), and in which for each of said pedicle screws (133), a nut (134) securely holds the pedicle screw (133) in place while allowing the polyaxial rotation of the pedicle screw (133).
    [0002]
    2. Ratchet spinal device (100), according to claim 1, characterized in that said ratchet mechanism (114) has another operational configuration in which said variable length member (112) is locked in place .
    [0003]
    3. Ratchet spinal device (100), according to claim 1, characterized in that said ratchet mechanism (114) has another operational configuration in which said ratchet mechanism (114) is neutralized so that said variable length member (112) is free to change in length in any of said directions.
    [0004]
    4. Ratchet spinal device (100), according to claim 1, characterized in that said ratchet mechanism (114) has another operational configuration in which said variable length member (112) is locked in place and in yet another operational configuration in which said ratchet mechanism (114) is neutralized so that said variable length member (112) is free to change in length in any of said directions, and which additionally comprises a controller (24, 120) which controls the selection of one of the said operational configurations.
    [0005]
    5. Ratchet spinal device (10), according to claim 4, characterized in that said controller (24) selectively moves the tongue (18) of said ratchet mechanism (14) in or out of alignment operational with the teeth (16) of said ratchet mechanism (14), and selectively moves a locking element (38) in and out of the locking engagement with said variable length member (12).
    [0006]
    6. Ratchet spinal device (10), according to claim 5, characterized in that said tongue (18) and the locking element (38) are mounted on a spindle (22) rotated by said controller (24 ).
    [0007]
    7. Ratchet spinal device (100) according to claim 5, characterized in that said tongue (118) and the locking element are mounted on an eccentric mechanism (124) rotated by said controller (120).
    [0008]
    8. Ratchet spinal device (100), according to claim 1, characterized by the fact that one of said polyaxial joint fixing members (132) is located at or near one end of said variable length member (112) ).
    [0009]
    9. Ratchet spinal device (10) according to claim 1, characterized by the fact that it additionally comprises a guiding device (42) operational to apply an incentive force on said variable length member (12).
    [0010]
    10. Ratchet spinal device (100), according to claim 1, characterized by the fact that said variable length member (112) comprises two portions with different stiffness.
    [0011]
    11. Ratchet spinal device (100), according to claim 1, characterized by the fact that at least one of said polyaxial joint fixing members comprises a socket and ball joint (32).
    [0012]
    12. Ratchet spinal device (100) according to claim 1, characterized by the fact that at least one of said polyaxial joint fixing members comprises a hook (36).
    [0013]
    13. Ratchet spinal device (100), according to claim 1, characterized by the fact that said ratchet mechanism is toothless.
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    同族专利:
    公开号 | 公开日
    US10245081B2|2019-04-02|
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    CA2811562A1|2012-04-05|
    JP2013537834A|2013-10-07|
    JP5856174B2|2016-02-09|
    EP2621386A1|2013-08-07|
    CA2811562C|2017-11-21|
    KR20130108366A|2013-10-02|
    KR101739741B1|2017-06-08|
    BR112013007370A2|2017-05-30|
    EP2621386B1|2016-07-27|
    RU2563591C2|2015-09-20|
    CN103179913B|2016-05-18|
    RU2013115629A|2014-11-10|
    US20130282064A1|2013-10-24|
    WO2012044371A1|2012-04-05|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-09-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-07-21| B09A| Decision: intention to grant|
    2020-10-06| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/05/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US34474110P| true| 2010-09-27|2010-09-27|
    US61/344,741|2010-09-27|
    US201161457335P| true| 2011-03-03|2011-03-03|
    US61/457,335|2011-03-03|
    PCT/US2011/035278|WO2012044371A1|2010-09-27|2011-05-05|Ratcheted spinal device|
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