bone fixation instrument and bone fixation system

专利摘要:
BONE FIXING ASSEMBLY. The present invention relates to a bone fixation system that includes at least one bone fixation element (24) and a bone fixation instrument (22). The bone fastening element includes a belt (32) and a locking mechanism (38). The belt can be pulled through the locking mechanism to form a contour (55) around the target bone to secure the first and second bone segments in an approximate and compacted configuration. The bone fixation instrument is configured to apply tension to the contour around the target bone. The fixation instrument has a tension assembly (70) that is configured to secure a free end of the bone fixation element to the fixation instrument. The tension set is additionally configured to pull the free end in order to increase the tension in the contour, while the tension in the contour is less than a selected tension.
公开号:BR112013019645B1
申请号:R112013019645-9
申请日:2012-02-02
公开日:2020-12-29
发明作者:Stefan Knueppel
申请人:Synthes Gmbh；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[0001] This application is partly a continuation of U.S. Patent Application Serial No. 13 / 019,907, filed on February 2, 2011, the entire contents of which are hereby incorporated by reference. BACKGROUND
[0002] In order to provide access to a certain internal anatomy, such as the heart during an open heart surgery procedure, median sternotomies are typically performed. A median sternotomy creates a cut substantially along the midline of the sternum, thus dividing the rib cage into two halves and allowing the surgeon to move the rib cage to provide access to the heart. At the end of the open heart surgery procedure, it is desired to approach and compress the sternum and keep the sternum halves rigidly in their approximate position in relation to each other, so that the sternum halves are prevented from moving one in relation to the other to promote bone fusion in the weeks following the surgical procedure.
[0003] During normal anatomical function, for example, during breathing, body movement and the transport of objects, forces can be generated that act on the sternum. A fixation set for the conventional sternum system includes stainless steel wires that are placed parasternally (around the sternum) or transternally (using the sternum bone) using a cutting needle that is attached to the wire and subsequently twisted to tighten the string against the sternum. However, twisting the needle generates tensile forces on the threads that tend to weaken them, which can result in breaking them during closing or post-operationally. In addition, this type of system depends on the experience that the surgeon has in tightening the wires. If the threads are not tightened enough, compression of the sternum may be compromised. If the threads are too tight, the thread may cut, cross and / or break the sternum. summary
[0004] According to one embodiment, a bone fixation instrument is configured to apply tension to a bone fixation element, in order to tighten the bone fixation element around a target bone. The bone fixation instrument includes a structure that defines a front end and an opposite rear end, a handle configured to attach a free end of the fixing element to the fixation instrument, a displacement device that is connected to the handle so that the the handle moves backwards together with the displacement device to increase the tension in the bone fixation element, and an actuator operably coupled to the displacement device. The actuator can be configured to move from an initial position towards a tension position in response to an applied force, thereby driving the displacement device to move backwards. The bone fixation instrument may also include a voltage limiter connected between the actuator and the displacement device. The tension limiter allows the displacement device to move backwards when the tension in the bone fixture is less than the selected tension, and prevents the displacement device to move backwards when the tension in the bone fixation element reaches the selected voltage. BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The abovementioned summary, as well as the detailed description of the preferred modalities of the application below, will be better understood when read in conjunction with the attached drawings. For purposes of illustrating the present description, preferred embodiments are shown in the drawings. It should be understood, however, that the application is not limited to the specific modalities and methods presented and references to the claims for this purpose are made. In the drawings:
[0006] Figure 1 is a perspective view of a bone fixation instrument constructed according to one embodiment;
[0007] Figure 2A is a perspective view of a bone fixation element that includes a structure and a locking element, showing the bone fixation element in an initial configuration;
[0008] Figure 2B is an enlarged perspective view of a portion of the bone fixation element illustrated in Figure 2A, showing the structure inserted through the locking element in order to secure the bone fixation element to an underlying bone;
[0009] Figure 3A is a perspective view of a plurality of bone fasteners illustrated in Figure 2A, shown clamped to a target bone and cut;
[00010] Figure 3B is a perspective view of the bone fixation instrument shown in Figure 1 operably coupled to and clamping one of the elements of a plurality of bone fixation elements shown in Figure 3A;
[00011] Figure 3C is a perspective view of the bone fixation instrument illustrated in Figure 1 operatively coupled to and cutting through one of the tightened bone fixation elements shown in Figure 3B;
[00012] Figure 4 is a perspective view of the bone fixation instrument illustrated in Figure 1, with portions removed to illustrate the internal components, including a tension assembly and a cutter assembly;
[00013] Figure 5A is a perspective view of the bone fixation instrument illustrated in Figure 4, which shows the cutter assembly in a cutting position;
[00014] Figure 5B is a perspective view of a front end of the bone fixation instrument, as shown in Figure 5A;
[00015] Figure 6 is a perspective view of a rear end of the bone fixation instrument illustrated in Figure 4;
[00016] Figure 7A is a perspective view of the front end of the bone fixation instrument illustrated in Figure 4, showing the tension assembly in an unhooked position;
[00017] Figure 7B is a perspective view of the distal end of the bone fixation instrument illustrated in Figure 7A having portions removed and showing the tension assembly in an engaged position;
[00018] Figure 8A is a side elevation view of the bone fixation system, including the bone fixation instrument shown in Figure 4 showing the bone fixation element as shown in Figure 3A, with the target bone removed for purposes of illustration, shown loosely received on the bone fixation instrument with the tension set in the disengaged position;
[00019] Figure 8B is a side elevation view of the bone fixation system illustrated in Figure 8A, showing the tension set in the engaged position, so that the bone fixation instrument is attached to the bone fixation element;
[00020] Figure 8C is a side elevation view of the bone fixation system illustrated in Figure 8B, showing the tension set in a tight position;
[00021] Figure 8D is a side elevation view of the bone fixation system illustrated in Figure 8C, showing the tension set in a disengaged position after having previously been in the tightening position in Figure 8C;
[00022] Figure 8E is a side elevation view of the bone fixation system illustrated in Figure 8D, showing the operation of a tension limiter by which the activation of the tension set towards the tight position does not tighten the fixing element of bone received;
[00023] Figure 9 is a side elevation view of the bone fixation system illustrated in Figure 8D, but which shows the actuation of the cutter assembly;
[00024] Figure 10 is a perspective view of a bone fixation instrument similar to the bone fixation instrument illustrated in Figure 4, but constructed according to an alternative embodiment;
[00025] Figure 11 is a side elevation view of the constructed bone fixation system, according to another embodiment, which shows the tension set in a disengaged position, and which additionally shows the cutter arm in a disengaged position;
[00026] Figure 12A is a perspective view of the bone fixation system shown in Figure 11;
[00027] Figure 12B is an enlarged portion of Figure 12A, taken along line 12B;
[00028] Figure 13 is a side elevation view of the bone fixation system shown in Figure 11, showing the tension set in a tight position and the cutting arm in the disengaged position;
[00029] Figure 14 is a side elevation view of the bone fixation system shown in Figure 11, showing the tension set in a partially engaged position and the cutting arm in a engaged position, and additionally showing the safety mechanism in a position engaged to prevent the tension assembly from moving to the tight position;
[00030] Figure 15A is a perspective view of the bone fixation system shown in Figure 14; and
[00031] Figure 15B is an enlarged portion of the bone fixation system shown in Figure 15A, taken along line 15B. Detailed Description
[00032] Certain terminology is used in the following description for convenience only and is not limiting. The words "left", "right", "lower" and "upper" designate directions in the drawings to which reference is made. The words "proximally" and "distally" refer to and in the opposite direction of, respectively, the surgeon who uses the surgical instrument. The words, "anterior", "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. The terminology includes the words listed above, derived from those words and words of similar meaning.
[00033] With reference to Figures 1-3B, a bone fixation set 20 includes a bone fixation instrument 22 and at least one bone fixation element 24, as a plurality of bone fixation elements 24 that are configured to attach a first and a second bone segment 26a and 26b of a target bone 28, such as a sternum, which are separated at a fracture location 30 together in an approximate compacted position.
[00034] According to the illustrated embodiment, each bone fastening element 24 can be substantially configured as a cable loop, and can include a flexible belt 32 which defines a belt structure 33 and which has the first end 34a and a second end 34b opposite the first end 34a along the length of the belt 32, a needle tip 36 extending from the first end 34a, and a locking mechanism 38 extending from the second end 34b. The belt 32 can be produced from any suitable suitable biocompatible material, such as PEEK.
[00035] Each bone fixation element 24 may further include a first initiation region 40 that extends from the first end 34a towards the second end 34b over a portion of a belt length 32 (for example approximately 1/3 the length of the belt 32) and a second locking region 42 which extends between the first initiation region 40 and the second end 34b. According to the illustrated embodiment, the second locking region 42 extends from the first initiation region 40 to the second end 34b. The first initiation region 40 may include a plurality of small protrusions that extend out of the belt structure 33 and alternate with recessed regions disposed between adjacent protrusions. Alternatively, the initiation region 40 can be substantially smooth and devoid of protrusions or teeth. The second locking region 42 can include a plurality of locking teeth 48 that extend outwardly from the belt structure 33 further than the protrusions and are separated by recessed regions 51 disposed between adjacent locking teeth. It is to be understood that the locking region 42 can extend along any portion to the entire structure of the belt 33, if desired.
[00036] The locking mechanism 38 includes a housing 50, a belt receiving slot 52 that extends through compartment 50 and is configured to receive the first end 34a of the belt 32. According to the illustrated embodiment, the first end 34a is inserted through slot 52 in order to define a contour 55 around target bone 28. Locking mechanism 38 is configured to allow belt 32 to travel unidirectionally through slot 52 along the direction of Arrow A in order to reduce the contour size 55 around the first and second segments 26a and 26b of target bone 28. For example, the tip of needle 36 can be inserted through slot 52 and subsequently removed, for example, by cutting a channel 56 of the structure of the belt 33 which defines the reduced thickness at a location adjacent to the needle tip 36, so that the belt 32 remains in the slot 52. According to the illustrated embodiment, the locking mechanism 38 includes an el locking element, such as a tongue 54 which is connected to compartment 50 and includes at least one complementary tooth, such as a plurality of locking teeth 58 extending into slot 52. Locking teeth 58 define a notched front edge 60 which is configured to bypass the complementary front chamfered edges 49 of the locking teeth 48 when the belt 32 is moved through the slot 52 along the direction of Arrow A. Locking teeth 58 and 48 further define rear edges 62 and 47 which are less inclined than the front chamfered edges 60, so that the rear edges 62 and 47 engage to prevent the belt 32 from moving through the slot 52 along the direction opposite Arrow A, which would increase the size of the contour 55.
[00037] During operation, the belt 32 is wrapped around the first and second segments 26a and 26b of target bone 28, and the tip of the needle 36 is inserted through the slot 52 and pulled through the slot 52 in order to make with the belt 32 subsequently moving through the slot 52. The tip of the needle 36 can be removed from the belt 32, and the belt 32 can then be additionally pulled, for example, manually, through the slot 52. As the belt 32 is moved through the locking mechanism 38 along the direction of Arrow A, the small protuberances of the initiation region 40 can slide through the slot 52 without interconnecting the locking teeth 58 of the locking mechanism 38. As the locking region 42 of belt 32 is moved through slot 52 along the direction of Arrow A, locking teeth 48 and 58 can interconnect to prevent the tension that is driven on belt 32 from causing belt 32 to recede and leave the fend 52 along a direction opposite Arrow A. For example, as the belt 32 moves through the locking mechanism 38 along the direction of Arrow A, the size of contour 55 around target bone 28 decreases until that tactile feedback indicates which tension was driven on the belt 32.
[00038] As shown in Figure 3B, the fixture 22 includes a tension assembly 70 that is configured to secure the fixture 22 to the belt 32, and is additionally configured to further pull the belt 32 through the locking mechanism 38 , thereby driving additional tension on the belt 32 until the belt 32 has safely compacted the first and second bone segments 26a and 26b of target bone 28 near the fracture location 30. As illustrated in Figure 3C, the fixation instrument 22 includes additionally a cutter assembly 72 which is configured to cut a free end 35 of the belt 32 that has passed through the locking mechanism 38 when a desired tension has been driven on the belt 32 around the first and second segments 26a and 26b of target bone 28 For example, the desired voltage may be within a range defined by and between a lower end that may be approximately 50 Newtons or a approximately 80 Newtons, and an upper end that can be approximately 150 to 160 Newtons or 200 Newtons. It should be understood that the desired tension can depend on bone quality and the surgeon's preference, and it can, for example, be any desired tension that securely holds the target bone 28 without overtightening the belt 32.
[00039] Now with reference to Figures 1 and 4, the fixation instrument 22 includes a structure 76 that defines a front end 78a and an opposite rear end 78b spaced in relation to the front end 78a along a longitudinal direction L and the sides opposites 80 which are spaced along a lateral direction A which is substantially perpendicular with respect to the longitudinal direction L. The fixture 22 further includes a cable 82 which is supported by frame 76, and which can extend downwardly from of structure 76 along a transverse direction that is substantially perpendicular to the longitudinal direction L and to the lateral direction A. According to the illustrated embodiment, the transverse direction T is oriented vertically and the longitudinal and lateral directions L and A are oriented horizontally, although it should be understood that the orientation of the fixation instrument may vary during use. According to the illustrated embodiment, structure 76 is elongated in the longitudinal direction L.
[00040] The fixing instrument 22 additionally includes a trigger 84 which extends from the frame 76 at a location spaced forward from the cable 82, and a nose 86 disposed at the front end 78a of the structure 76. The cable 82, the trigger 84 and nose 86 can be discreetly attached to frame 76 or integral with frame 76, if desired. The structure 76 can include an outer housing 88 which includes a pair of housing elements 90a and 90b which are laterally opposed and which define the respective external sides 92 and can be joined by fasteners such as screws 94, in order to support the various components of the fixing instrument 22.
[00041] It should be understood that the structure 76 of the fixing instrument 22 can be constructed in any suitable manner desired. For example, as illustrated in Figure 1, housing elements 90a and 90b may include a flange 93 that extends laterally inward, towards each other, from sides 80 at a location ahead of structure 76. Alternatively, as shown in Figure 10, flange 93 can further extend back and end adjacent to an actuator 100.
[00042] In addition, with reference to Figures 11-15, the fixation instrument can include an external housing 188 which can be constructed as described above with respect to external housing 88, or can be constructed according to any alternative modality proper. For example, as illustrated in Figures 11-15, the outer housing 188 may include the first and second housing elements 190a and 190b that are spaced from each other along the lateral direction A. The outer housing 188 may include, further, at least one spacer element as a plurality of spacer elements 145, 147 and 149 which are arranged between the first and the second housing elements 190a and 190b. The fixing instrument 22 may also include one or more fasteners, such as screws 94, which secure the first and second housing elements 190a and 190b to the spacer elements 145, 147 and 149. For example, screws 94 can partially pass through the spacer elements 145, 147 and 149, or can extend from the first and / or the second housing element 190a and 190b, completely through the spacer elements 145, 147 and 149, and making all the way to the element laterally opposite between the first and the second housing element 190a and 190b. The number of spacers, their respective geometric configurations and the locations in which the spacers are respectively positioned between the housing elements 190a and 190b can vary between different modalities, provided that each parameter is adequate to provide adequate structural support for the housing elements 190a and 190b.
[00043] According to the illustrated embodiment, the spacer element 145 can be arranged at a distal end of the cable 82. While the spacer element 145 is shown as a unitary part, in other embodiments the spacer 145 can be mounted, for example, from two laterally opposite halves that are joined. In addition, according to the illustrated embodiment, the spacer element 147 is arranged in a location that extends from the base of the cable 82 towards the rear along the longitudinal direction L towards the rear end 78b of the structure 76. The spacer element 147 can further include a tail 151 which is arranged on a portion of spacer 147 which is adjacent to the base of the cable 82 and distal to the rear end 78b of the structure 76, and additionally includes an elongated portion 153 which can extend in towards the rear from the tail 151. The tail 151 can extend at an angle that is displaced from a longitudinally elongated portion 153 towards the distal end of the cable 82. For example, the tail 151 can define an elongation direction which is angularly displaced from the elongation direction of the elongated portion 153, which can be defined by the longitudinal direction L, to define an angle between the elongation direction of the tail 151 and the elongation direction of the elongated portion 153 and thus the longitudinal direction L, from approximately 85 to approximately 95 degrees. While the spacer element 147 is shown as a unitary part, it should be understood that the spacer element 147 can be assembled, for example, from two laterally opposed halves that are joined.
[00044] The tail 151 and the elongated portion 153 are preferably formed from a single piece of material, but may alternatively comprise separate parts that are bonded, welded or otherwise attached to each other. The spacer element 149 can provide structural support for the portions of the first and second housing elements 190a and 190b which are located between the front end 78a and the rear end 78b of the structure 76. The spacer 149 can be mounted, for example, to from the two laterally opposed halves that are joined during the assembly of the structure 76, or alternatively may be a unitary component. When the opposite halves 149a and 149b are joined, the opposite halves 149a and 149b can define a channel 155 that extends completely through the spacer 149 along the longitudinal direction L. When the spacer element 149 comprises a unitary structure that is not assembled at from two laterally opposite halves, the spacer element 149 similarly defines a channel 155 that extends completely through the spacer element 149 along the longitudinal direction L. Channel 155 can define a cross-sectional dimension, such as a diameter, that it can be larger than a corresponding external dimension of the displacement device 98 that moves and extends longitudinally, so that the displacement device that extends longitudinally 98 can move in channel 155 along the longitudinal direction L and, thus , towards or away from the front end 78a and the rear end 78b, respectively, of frame 7 6. The fixing instrument 22 may also include at least one security element, such as at least one corresponding flap, which can be configured as the first and the second laterally flexible flexible flaps 161a and 161b extending from the housing external 188. According to the illustrated embodiment, the spacer element 149 defines a first end, or front end, 157 and an opposite second end, or rear end 159. As described in more detail below in conjunction with Figures 11-15, the first and second flaps 161a and 161b can extend from the spacer element 149, for example, at the rear end 159.
[00045] Returning to the modalities that are illustrated, for example, in Figures 1, 6 and 7A-B, the housing 88 can support the tension set 70 that is configured to tighten bone fixation element, thus boosting tension in the bone fastener 24, such as belt 32, and can additionally support cutter assembly 72 which is configured to remove a free end 35 from bone fastener 24 when tension assembly 70 has driven a desired level of tension in the bone fixing element 24. The tension set 70 includes a handle 96 that is movable between a disengaged position (Figure 7A), whereby the handle 96 is configured to loosely receive the belt 32, as the portion of the belt that it passed through the locking mechanism 38, and an engaged position (Figure 7B), whereby the handle 96 is configured to be attached to the received belt 32. The tension set 70 additionally includes a displacement device 98 that is operating coupled to handle 96 and extending backwardly from handle 96, so that the backward movement of displacement device 98 causes handle 96 to move backward in the secured configuration, thereby driving tension on the belt 32. The tension set 70 can also include an actuator 100 such as trigger 84 and a voltage limiter 102 (Figure 6) connected between trigger 84 and displacement device 98. Tension set 70 can also include a force transfer element 104 which is connected between the trigger 84 and the voltage limiter 102, thus operationally coupling the trigger 84 to the displacement device 98.
[00046] During operation and as described in more detail below, the free end 35 of the belt 32 is received in the handle 96, the nose 86 is placed against the housing 50 of the locking mechanism 38, and the actuator 100 is moved from from a first initial position to a second handle position, which causes the handle 96 to repeat from the disengaged position to the engaged position, and is further moved from the second handle position to a third tension position, which causes with the displacement device 98 to move backwards, thereby boosting tension on the belt 32 when the tension on the belt 32 is less than a selected tension, which can be a maximum desired tension, as determined by tension limiter 102. When the belt tension 32 reaches maximum tension, tension limiter 102 prevents displacement device 98 from moving backwards when actuator 100 is moved to the tension position.
[00047] The cutter assembly 72 includes a cutter arm 106 movably supported by the structure 76 and a cutter blade 108 which is guided by the cutter arm 106. The cutter arm 106 is movable from a fixed disengaged position (see Figure 4), by which the cutter blade 108 is spaced from the free end 35 of the belt 32 which is received at the handle 96 to an engaged position (see Figures 5A-B), whereby the cutter blade 108 cooperates with a complementary cutter blade 87 of the nose 86 , in order to cut the free end 35 of the belt 32 (see Figure 9). The clamping instrument 22 and, in particular, the cutter assembly 72, additionally include a safety mechanism 110 that moves from a disengaged position, whereby the cutter arm 106 can move from the fixed disengaged position towards the engaged position, and an engaged position that prevents the cutter arm 106 from moving from the fixed disengaged position towards the engaged position.
[00048] Now with reference to Figures 4 and 7A-B, the displacement device 98 of the clamping instrument 22 can be supplied as a rod of the displacement device which extends longitudinally 111 forward from the tension limiter 102 and which supports handle 96 at its front end. The rod of the displacement device can define a rectangular cross section, as shown in Figure 4, a substantially circular cross section, as shown in Figure 10, or any desired alternative size and shape. The handle 96 includes a first lower gripping element 112 and a second upper gripping element 114 spaced in relation to the lower gripping element 112, so as to define a gap 116 disposed between the lower and upper gripping elements 112 and 114. The lower gripping element 112 defines the first gripping surface 118 which faces the upper gripping element 114, and which can further define a plurality of teeth 120 extending outwardly from the first gripping surface 118 towards the gripping element upper 114. The teeth 120 are configured to help securely attach the handle 96 to the belt 32. The upper gripper 114 is supported by the rod of the displacement device 111 and defines a second gripper surface 115 that faces the first gripping surface 118. The first and second gripping surfaces 118 and 115 can be dimensioned and shaped as desired. According to the illustrated embodiment, the first gripping surface 118 is curved and substantially arc shaped, according to the illustrated embodiment, so that the first gripping surface 118 is convex with respect to the upper gripping element 114 In addition, according to the illustrated embodiment, the second gripping surface 115 is substantially flat.
[00049] The stem of the displacement device 111 defines a first forked front end 117a which defines a pair of laterally spaced side walls 122. The upper gripping element 114 can be rigidly supported by the stem of the displacement device 111, and the lower grip 112 can be pivotally coupled to the rod of the displacement device 111 at an articulated location 113 on a pivot pin 115 which extends laterally and which defines a lateral pivot axis, and can be additionally disposed between the side walls 122. The handle 96 may further include a tilt element such as a torsion spring 124 that impels the lower gripping element to revolve forward at the pivot location 113 towards the nose 86 from the disengaged position of the handle 96 until the engaged position of handle 96. Gripping surface 118 can extend eccentrically around the location of pivot 113, so that the gripping surface 118 moves upward toward the upper grip element 114 as the lower grip element 112 rotates forward to the engaged position.
[00050] The lower gripping element 112 defines a first or front holding surface 126 and the nose 86 defines a second complementary or rear holding surface 127. When the stem of the displacement device 111 is in a forward position , the handle 96 is in the disengaged position by which the torsion spring 124 pushes the front retaining surface 126 against the rear retaining surface 127. When the handle is in the disengaged position, the gap 116 is dimensioned greater than the thickness of the free end 35 of the belt 32, as shown in Figure 7A. Consequently, the free end of the belt 35 can be received in the gap 116 between the first and second gripping surfaces 118 and 115 as shown in Figure 8A. As the rod of the displacement device 111 moves backward, the lower gripper 112 rotates forward around the pivot location 113, so that the gripper surface 118 moves towards the gripper surface 115 of the upper gripping element 114 as illustrated in Figure 7B, thereby reducing the gap 116 until handle 95 captures the free end 35 of the belt 32 which is received in the gap 116 between the first and second gripping surfaces 118 and 115 under the torsion spring force 124 (Figure 8B). It should therefore be understood that as the rod of the displacement device 111 moves further back, the free end 35 of the belt 32 will move backwards along with the handle 95 and the rod of the displacement device 111.
[00051] Now with reference to Figures 4 and 6, the stem of the displacement device 111 defines a second rear end 117b opposite the front end 117a. The rear end 117b of the stem of the displacement device 111 is connected to the tension limiter 102. The tension limiter 102 includes a spring element 128 as a helical compacting spring defining a first end or front end 130a and a second end or rear end 130b. The spring element 128 is fixed with respect to movement with respect to the stem of the displacement device 111 at its rear end 130b, and movable with respect to the stem of the displacement device 111 at its front end 130a. The spring element 128 is additionally coupled to the trigger 84 at its front end. In this way, the spring element 128 is coupled to the trigger 84 at its end which is also movable with respect to the stem of the displacement device 111 to generate a force for the stem of the displacement device 111 that drives the stem of the displacement device. displacement back and away from the locking mechanism 38 of the bone fastener 24.
[00052] According to the illustrated embodiment, the voltage limiter 102 includes a stationary plug 129 that can be threaded on or otherwise attached to the stem of the displacement device 111, for example, to the rear end 117b of the stem of the displacement device displacement 111. The rear end 130b of the spring element 128 is attached to the cap 129 to secure the spring element 128 to the stem of the displacement device 111 at its rear end 130b, so that the rear end 130b is fixed with respect to to movement in relation to the stem 111. Thus, as the rear end 130b of the spring element 128 moves backwards, the stem of the displacement device moves back together with the rear end 130b of the spring element 128. The tension limiter 102 may further include a movable spring seat 132 which is attached to the movable front end 130a of the spring element 128. According to the illustrated embodiment, the stem of the device The displacement device 111 extends through the spring seat 132, so that the spring seat 132 is movable in the longitudinal direction L along with the stem of the displacement device 111. The stem of the displacement device 111 can define a longitudinally elongated slot. 134 that extends through it and that can receive a projection of the spring seat 132. In this way, the slot 134 defines a length that allows the movable spring seat 132 to move from its forward position to its rearmost position .
[00053] The tension set 70 additionally includes the force transfer element 104 illustrated as a force transfer arm 136 which is pivotally connected between the movable spring seat 132 and the trigger 84. In other words, the movable front end 130a of spring element 128 is coupled to trigger 84 via the force transfer arm 136. According to the illustrated embodiment, the power transfer arm 136 defines a front end 138a and an opposite rear end 138b. The force transfer arm 136 is hingedly coupled, for example, at its rear end 138b to the spring seat 132 at an articulated location 139 that defines a lateral pivot axis. The force transfer arm 136 is further hingedly coupled, for example, at its front end 138a to the trigger 84 at an articulated location 140 that defines a lateral pivot axis.
[00054] Again with reference to Figure 4, the tension assembly 70 additionally includes trigger 84 which includes a lower handle portion 85 extending downwardly from housing 88 a space spaced ahead of cable 82 and a portion of upper guard 89 hingedly connected to the force transfer arm 136 and additionally hingedly connected to the housing 88. Trigger 84 defines an opening 91 that extends longitudinally through the upper protection portion 89 and receives the stem of the displacement device extending through the opening and thus through the upper protective portion 89. The protective portion 89 of the trigger 84 is pivotally connected to the force transfer arm 136 at the pivot location 140, which defines a first lower pivot location of the trigger 84. The protective portion 89 of the trigger 84 is additionally hingedly coupled to the housing 88 at a second upper hinged location 142 which defines u m lateral pivot axis. The user can hold the handle 82 and the handle 85 of the trigger 84 with one hand and pull the trigger 84, which causes the trigger 84 to revolve backwards over the second upper pivot location 142. Due to the fact that the pivot location lower 140 being arranged between the upper pivot site 142 and the handle 85, the lower pivot site 140 moves backward when the trigger 144 is moved backward by the user. The tension assembly 70 additionally includes a spring element 146 which is connected between the cable 142 and the trigger 144 which tilts the trigger 144 forward, to its initial position. The fixture 22 includes a stop element illustrated as a pin 148 which extends laterally between the housing elements 90a and 90b. The front edge of the protective portion 89 of the trigger 84 is contiguous with the pin 148 to position the trigger 144 in its first initial position under the force of the spring element 146.
[00055] The operation of the fixation instrument will now be described with more reference to Figures 8A-E. For example, as illustrated in Figures 7A and 8A, the trigger 84 and, thus, the tension assembly 70, are in a first initial position whereby the front end 117a of the stem of the displacement device 111 is arranged in an adjacent position and close to the nose 86, so that the front retaining surface 126 of the lower gripping element 112 is contiguous with the rear complementary retaining surface 127 of the nose 86, thus causing the gap 116 to define a greater transverse thickness than that of the end free end 35 of the belt 32. The free end 35 is inserted into the gap 116 and the nose 86 is positioned so as to be in a position bordering the locking mechanism 38. The nose 86 thus provides a connecting element that prevents the locking mechanism 38 moves back when the fixture 22 applies a force from the rear towards the free end 35.
[00056] When the tension set 70 is in the first starting position, the spring element 128 can be in a starting position which can be a neutral position, or the movable spring seat 132 can be arranged in a front location with respect to with respect to the neutral position, so that the initial position of the spring element 128 can be flexed, as slightly extended, from its neutral position. For example, the force of the spring element 146 that pushes the trigger 84 forward may be greater than the force of the spring element 128 that pushes the trigger 84 backward when the movable spring seat 132 is moved forward from its neutral position. When the spring element 128 is extended from its neutral position, the spring element can apply a backward compressive force on the cap 129 and thereby on the stem of the displacement device 111, which pushes the element lower grip 112 forward against nose 86. It should be understood that the torsion spring 124 that pushes lower grip element 112 forward against nose 86 creates an equal and opposite force against the stem of the displacement device 111 that pushes the stem of the rear displacement device. Thus, the forward force of the spring element 128 applied to the stem of the displacement device 111 when the spring element 128 is slightly extended is greater than the changing force of the torsion spring 124 backwards against the stem of the displacement device. 111. Because the forward shifting force of spring element 128 is greater than the shifting force back of torsion spring 124 when spring element 128 is slightly extended, spring element 128 can actively hold handle 96 in disengaged position.
[00057] Alternatively, the movable spring seat 132, and thus the spring element 128, can be in a neutral position when the tension assembly 70 is in the first initial position, so that the spring element 128 does not apply forward shifting force or back shifting force for the stem of the displacement device 111. As described above, the torsion spring 124 can apply a force to the stem of the displacement device 111 that pushes the displacement rod backward 111. However, the backward movement of the stem of the displacement device 111 would cause the rear end 130b of the spring element 128 to move in the opposite direction of the front end 130a of the spring element 128, thereby causing the spring element 128 if it extended from its neutral position. The spring element 128 can have a spring constant that is greater than the spring constant of the torsion spring 124 so that the spring element 128 resists extension under the forces of the torsion spring 124 and thus passively maintains the lower grip element 112 in its disengaged position by which the forward retaining surface 126 rests against the rear complementary retaining surface 127 of the nose 86 and the gap 116 is thus thicker in the transverse direction T than at the free end 35 of the belt 32 is received in the gap 116.
[00058] Now with reference to Figures 4 and 8B, when the user applies an actuation force, such as a force directed backwards F, to the grip portion 85 of trigger 84, trigger 85 and, thus, also the set of tension 70 moves from the first initial position to the second gripping position, which causes handle 96 to repeat from the disengaged position to the engaged position. According to the illustrated embodiment, the backward force applied to the gripping portion 85 of the trigger 84 causes the trigger 84 to revolve backwards at the location of the upper pivot 142, which causes the location of the lower pivot 140 to move towards back. It should be understood that the location of the lower pivot 140 moves backward in an arc-shaped displacement path at the location of the upper pivot 142. The backward movement of the location of the lower pivot 140 causes the force transfer arm 136 to similarly move backwards, thus transferring the trigger force to the movable spring seat 132 and to the front end 130a of the spring element 128. It should be understood that the force transfer arm 136 revolves in relation to the trigger 84 at the location of the lower pivot 140 as the force transfer arm 136 moves backward.
[00059] As the force transfer arm 136 moves backwards, the force transfer arm 136 additionally causes the movable spring seat 132 and the front end 130a of the spring element 128 to move back together with the stem of the displacement device 111 in the longitudinal direction L towards the rear end 130b of the spring element 128, thereby flexing the spring element 128 from the first initial position. It is to be understood that the force transfer arm 136 revolves in relation to the movable spring seat 132 around the pivot 139 location. As the front end 130a of the spring element 128 moves backwards towards the rear end 130b of the spring element 128, the spring element 128 flexes from its neutral position to apply a rear changing force to the stem of the displacement device 111. According to the illustrated embodiment, the spring element 128 compresses when the end 130a of the spring element 128 moves backwards and thus pushes the end 130b, the plug 129 and also, therefore, the stem of the displacement device 111 so that they move backwards. Alternatively, the movement of the end 130a of the spring element 128 may be sufficient to reduce the force of the spring 128 that drives the stem of the displacement device 111 to a level that is less than the force of the torsion spring 124 that drives the stem of the spring. displacement device 111 to the rear. The fixing instrument 22 can define an opening 119 which extends through the end 78b of the structure 76. The opening 119 is sized to receive the plug 129 so that the plug 129 can extend beyond the housing 88 due to the backward movement of the rear end 130b of spring element 128.
[00060] Consequently, with reference also to Figures 7A-B, the stem of the displacement device 111 is pulled, under the changing force applied by the torsion spring 124, the spring element 128 or both to move backwards and away from the nose 86. As the stem 111 moves away from the nose 86, the torsional force of the torsion spring 124 causes the lower gripping element 112 to revolve forward around the location of the pivot 113 along the direction of Arrow B to reduce span 116 until handle surfaces 118 and 115 capture free end 35 of belt 32 in span 116, thereby attaching free end 35 to the fixture 22 while the nose 86 is contiguous with the contour 55, and in particular the housing 50 of the locking mechanism 38. Thus, it can be said that moving the trigger 84 from the first neutral position to the second neutral position causes the handle 96 repeat from your disengaged position to its engaged position.
[00061] Now with reference to Figures 4, 6 and 8C, the continuous application of the force F to the handle portion 85 of the trigger 84 causes the trigger 84 to revolve even more around the location of the upper pivot 142, thus doing , causing the trigger 84 and thus the tension set 70 to move from the second grip position to a third tension position, which causes the displacement device 98 to move backwards, thus applying tension at the free end 35 of the belt 32 when the tension in the belt 32 is less than the desired tension, as a maximum tension, as determined by the tension limiter 102. Due to the engagement of the nose 86 of the fixation instrument 22 with the contour 55 and in particular, with the housing 50 of the locking mechanism 38 providing a connection that prevents the contour 55 from moving backwards along with the free end 35, when the tension assembly 70 puts the free end 35 in tension, the belt 32 and in particular, the locking region 42 is added nally pulled through the locking mechanism 38. As described above with reference to Figure 2B, the locking teeth 58 and 48 engage to allow the locking region 42 to be pulled through the locking mechanism to reduce the size of the contour 55 or to place the contour 55 under more tension around the bone segments that are arranged in the contour 55. Whether the size of the contour 55 is reduced or the contour 55 is tighter around the bone segments arranged in the contour, it can be said that the fixation instrument puts the bone fixation element 24 under tension when the tension assembly moves from the second grip position to the third tension position.
[00062] Consequently, when a trigger stroke has been completed so that trigger 84 has been moved to its rearmost position, as shown in Figure 8C, the user can release trigger 84, which causes the trigger element to spring 146 push trigger 84 to its forward position, shown in Figure 8D. When the trigger 84 has moved to its forward position, the trigger 84 and, thus, the tension set 70 are in the first initial position, so that the lower gripping element 112 is pushed against the nose 86, thus placing , the handle 96 in its disengaged position, as described above. Consequently, while the free end 35 of the belt 32 is no longer attached to the clamping instrument 22, engaging the locking teeth 58 and 48 prevents the increased tension driven in the contour 55, allowing the free end 35 to move through the housing in a direction opposite Arrow A, which would reduce the stress on the contour 55.
[00063] It should be understood that the movement of the trigger 84 from the second handle position to the third tension position can be a continuation of the movement from the first initial position to the second handle position. In this way, trigger 84 can move from the first start position to the second handle position to the third tension position in a single fluid movement.
[00064] The nose 86 can again be brought into contact with the locking mechanism 38 and the free end 35 can be received in the gap 116 of the handle 96, and the tension set 70 can be repeated from the first initial position to the second position of take the third tension position as many times as desired, for example, until the tension driven in contour 55 reaches a predetermined maximum tension. When the tension in the contour 55 reaches the maximum tension, the tension limiter 102 prevents the displacement device 98 from moving backwards when the actuator 100 is moved to the tension position.
[00065] For example, now with reference to Figures 4, 6 and 8E, it should be understood that the spring element 128 has a spring constant that is configured to apply a predetermined force of change to the stem of the displacement device 111 when the front end 130a of spring element 128 has moved backward by a distance corresponding to the full backward actuation of trigger 84. Consequently, as long as the tension in contour 55 is less than the desired force as defined by spring element 128 and the displacement length of the front end 130a of the spring element 128, the compaction of the spring element 128 will cause the force applied by the spring element 128 to move the stem of the displacement device 111 backwards. However, when the tension driven in the contour 55 reaches the desired force, the compression of the spring element 128 due to the backward movement of the front end 130a will cause the spring element 128 to apply a backward changing force against the stem of the device displacement 111 which is insufficient to overcome the force necessary to further tighten the contour 55.
[00066] It should be understood that the spring element 128 can be configured to apply a backward changing force against the stem of the displacement device 111 which is greater than the tension driven in the contour 50 around target bone 28. For example , the spring element 128 can apply a force that is sufficient to overcome the contour tension 50 and the additional force, which causes one or both locking teeth 48 and 52 to deflect as the teeth rise one over the another when the contour is tightened 55. Consequently, the tension limiter 102 can be configured to apply a force which is greater than, but which corresponds to, the tension in the contour 55 around the target bone. In this way, the maximum force applied by the tension limiter 102 can correspond to the maximum desired tension in contour 55, it being understood that when teeth 48 and 52 rise over and pass each other, the tension in contour 55 may decrease a little as that teeth 48 and 52 intertwine. According to one embodiment, the stress limiter 102 can apply a maximum force as desired, for example, up to approximately 430 Newtons or any other desired force that corresponds to the maximum desired tension in contour 55 around target bone 28. As a result, when the maximum desired tension in contour 55 has been driven around target bone 28, the force applied by tension limiter 102 when trigger 84 is fully engaged is insufficient to cause teeth 48 and 58 to climb over and pass one through another and further tighten contour 55. Consequently, when the maximum tension in contour 55 has been driven around target bone 28, the force applied by tension limiter 102 will be insufficient to cause the stem of the displacement device 111 to move back a sufficient distance to further tighten contour 55 around target bone 28.
[00067] It should be understood that the spring element 128 can alternatively be configured as an extension spring. For example, according to an alternative embodiment, the front end 130a can be connected to the rod of the displacement device 111 and fixed with respect to the rod of the displacement device 111, and the rear end 130b can be movable with respect to the rod of the displacement device 111. For example, the rear end 130b can be coupled to the trigger 84 via the force transfer element 104 in the manner described above. The pulling force applied to the rear end 130b and the corresponding backward displacement of the rear end 130b can therefore cause the spring force to drive the stem of the displacement device 111 so that it moves backwards, thereby driving , belt tension 32 in the manner described above. In this way, the initial position of the spring element 128, an initial position that can be a neutral position, as described above, or the initial position of the spring element 128 can be flexed, as if slightly compacted, from its neutral position.
[00068] Now with reference to Figures 4-5B, the fixture 22 includes a cutter assembly 72 that includes a cutter arm 106 that has a front end 107a and a rear end 107b, and a movable cutter blade 108 driven by the cutter arm 106, for example, at the front end 107a. The cutter arm 106 can be sized and shaped as desired, and is constructed according to the illustrated embodiment, so that the front and rear ends 107a and 107b extend substantially longitudinally. The cutter arm 106 can also include a bypass segment 107c that extends laterally outwardly in a forward direction from the rear end 107b towards the front 107a. In this way, the front end 107a can be offset laterally outwardly with respect to the rear end 107b. For example, the rear end 107b can be arranged between the opposite sides 80 and the front end 107a can be coupled to one of the sides 80 at a location laterally out of the side 80. The cutter arm 106 may further include a longitudinal segment intermediate 107d which extends forward from the displaced segment 107c and thus extends substantially parallel to the front and rear ends 107a and 107b. The cutter arm can also include a transversely displaced segment 107e that extends between the intermediate longitudinal segment 107d and the front end 107a, and that extends transversely downward in a forward direction. Consequently, the front end 107a can be displaced transversely with respect to the rear end 107b. The cutter arm 106 may further include a handle 150 disposed at the rear end 107b.
[00069] With reference also to Figure 6, the cutter assembly 72 may include a seat 158 that receives the cutter arm 106 at an upper end of the frame 76 when the cutter arm 106 is in the disengaged position. According to the illustrated embodiment, the seat 158 is dimensioned and shaped to receive the cutter arm 106. Consequently, when the cutter arm 106 is seated on the seat 158, it can be said that the cutter arm 106 is in a disengaged seated position. The seat 158 may further include at least one retainer element 162, as a pair of laterally opposing retainer elements 162 that are spaced slightly apart from each other slightly less than a side thickness of the cutter arm 106. The retainer elements 162 can be spring-driven to the spaced position a little less than the lateral thickness of the cutter arm 106. For example, the cutter arm 106 can define a recess 164 that is sized to receive the retaining elements 162 when the cutter arm 106 is in position disengaged. Consequently, when the cutting arm moves 106 to and from its disengaged seated position, an engaging force along the direction of Arrow C can be applied to the cutting arm 106 which is sufficient to overcome the holding force of the retaining elements 162 , which causes the retaining elements 162 to come out of the recess 164 and release the cutter arm 106 from the seat 158.
[00070] With reference also to Figures 7A-B, the cutter arm 106 can be fixedly articulated to the structure 76, for example, on one side 80. According to the illustrated embodiment, the cutter arm 106 is fixed pivotally at its front end 107a to nose 86 at a location of pivot 152 that defines a lateral pivot axis. For example, the cutter assembly 72 may include a blade support body 154 that is substantially cylindrical and extends through a side wall of the nose 86 and is rotatable about its central axis to allow the cutter arm 106 to revolve between its engaged position and its disengaged position. When the cutter arm 106 is in its disengaged position, the cutter blade 108 is spaced above a complementary and substantially stationary cutter blade 87 of the nose 86, in order to define a span 156 that has a transverse dimension greater than the span of the free end 35 of the belt 32, so that the free end 35 is received in the gap loosely 156, which is disposed ahead with respect to the handle 96 and, thus, the gap 116.
[00071] Again with reference to Figures 5A-B, the cutter arm 106 can be rotated up and forward around the location of pivot 152 along the direction of Arrow C to its engaged position, which causes the blade cutter 108 travels along an arc-shaped path towards the cutter blade 87, in order to reduce the size of the gap 156. The cutter blade 108 is lowered backwards with respect to the complementary cutter blade 87, so that the cutter blade 108 slides and passes the cutter blade 87. Consequently, the cutter blades 108 and 87 cooperate in order to cut the free end 35 of the belt 102 which is received in the gap 156 as the cutter blade 108 slides past the cutter blade 87 (see Figure 9). Consequently, when the nose 86 adjoins the locking mechanism 38 of the bone fixing element 24, so that the gap 156 is aligned with the outlet end of the slot that receives the belt 52 of the housing 50 of the locking mechanism ( see Figures 2B and 3C) and the arm 106 is moved to its engaged position, the cutter assembly 72 can cut the free end 35 in a location that is spaced in relation to the case 50 in a distance substantially equal to the distance between the front end of the nose 86 and cutting blade 108. Therefore, when the clamping instrument 22 has applied the desired amount of tension to the belt 32, the free end 35 can be cut in the manner described above to substantially remove the free end 35 from the contour 55.
[00072] Now with reference to Figures 4 and 6, the cutter assembly 72 additionally includes a safety mechanism 110 that moves from a disengaged position, whereby the cutter arm 106 can move from the fixed disengaged position towards the engaged position, and an engaged position that prevents the cutting arm 106 from moving from the fixed disengaged position towards the engaged position. According to the illustrated embodiment, the cutter assembly 72 includes a first engaging element 166 that extends downwardly from the cutting arm 106 and a second engaging element 168 that extends upwardly from the movable spring seat 132. When the tension assembly 70 is in the first starting position, the first engaging element 166 is spaced back from the movable spring seat 132. In other words, the first engaging element 166 is spaced from the spring seat movable 132 in the direction the spring seat 132 moves when the tension assembly 70 is moved from the first initial position towards the third tension position. Consequently, the second engaging element 168 can move towards the first engaging element, as the movable spring seat 132 moves backwards. Alternatively, the second engaging member 168 may extend from the stem of the displacement device 111 and move along with the stem of the displacement device 111 so as to intertwine with the engaging element 166.
[00073] The first and second coupling elements 166 and 168 are configured so that they interlock when they overlap longitudinally. For example, the second engagement element 168 can be configured as a housing 170 that has a slot 172 that receives the first engagement element 166. The first engagement element 166 can define a flange 174 that overlaps the housing 170 in the transverse direction , so that flange 174 adjoins housing 170 when an engaging force is applied to the cutter arm 106 along the direction of Arrow C, so as to move the cutter arm 106 from its disengaged seated position towards its position engaged. According to the illustrated embodiment, the first and second engaging elements 166 and 168 interfere in order to prevent the cutter arm 106 from being removed from seat 158. It should be understood that the first engaging elements 166 and 168 can alternatively be dimensioned and shaped as desired to selectively interfere with one another in the manner described herein.
[00074] Referring also to Figure 8A, when the tension assembly 70 is in the first initial position, the first and second engaging elements 166 and 168 are spaced longitudinally so that the cutter arm 106 can be moved from the disengaged seated position to the engaged position along the direction of Arrow C. When the tension assembly 70 moves to the second handle position, the movable spring seat 132 moves longitudinally backwards, thus also moving the second engaging element 168 longitudinally backwards towards the first engaging element 166. According to the embodiment illustrated in Figure 8B, the engaging elements 166 and 168 remain spaced longitudinally from each other when the tension set 70 is in the second grip position, allowing, thus, the cutter arm 106 is moved and moves from the disengaged position towards the engaged position. Consequently, with reference to Figure 9, after the fixing instrument 22 induces a desired amount of tension in the contour 55, the tension assembly 70 can be moved to the handle position to capture the free end 35 in the gap 116 before cutting the free end 35 in the manner described above. Thus, as illustrated in Figure 3A, the plurality of bone fasteners 24 can be tightened around target bone 28 by activating tension set 70 as described here, and can subsequently be cut by activating cutter set 72, as described here.
[00075] According to the illustrated embodiment shown in Figure 8C, the engaging elements 166 and 168 are positioned so that they overlap when the tension set 70 has moved from the second handle position towards the third tension position. Thus, when the tension set 70 has advanced beyond the second handle position, the engaging elements 166 and 168 interfere when the engaging force is applied to the cutter arm 106 along the direction of Arrow C. Therefore, the locking mechanism safety 110 prevents the clamping instrument 22 from cutting the free end 35 while the tension assembly 70 is applying tension to the belt 32. Alternatively, the engaging elements 166 and 168 can be positioned so that they at least partially overlap and intertwine when the tension set 70 is in the second handle position, thus defining an interference that prevents the cutter arm 106 from moving and moving to the engaging position along the direction of Arrow C.
[00076] Now with reference to Figures 11-15, the fixture 22 may include the safety mechanism 110, which in turn includes the first engaging element 166 and the second engaging element 168 (the interaction that is described in detail above), and may also include a second safety mechanism 195 that prevents the tension assembly 70 from moving to the tight position while the cutter assembly 72 is in the activated position. For example, the second safety mechanism can prevent the tension assembly from moving from the partially engaged position to the tight position as illustrated, and can alternatively prevent the tension assembly 70 from moving from the disengaged position to the tight position while the assembly cutter 72 is in the activated position. It can thus be said that the second safety mechanism 195 can prevent the tension assembly 70 from moving in a direction from the disengaged position to the tight position while the cutter assembly 72 is in the activated position. In this sense, it should be understood that the security mechanism 110 can be called a first security mechanism. The second safety mechanism 195 may include at least one security element 196, such as the first and second flaps 161a and 161b extending from the rear end 159 of the spacer element 149, for example, backwards along the longitudinal direction L in towards the rear end 78b of the structure 76. In other embodiments, the flaps 161a and 161b do not extend from a spacer and are otherwise present in the fixture 22 and provide the same functionality as the flaps 161a and 161b that are extend from the spacer element 149.
[00077] Each flap 161a and 161b may include a respective flap body #ae #b, respectively, and a hook 163a and 163b, respectively, which extend, for example, substantially perpendicularly downward, from the corresponding flap body. #ae #b substantially along the transverse direction T. As shown in Figure 12B, each flap 161a and 161b defines a respective laterally outer face 165a and 165b and an opposite laterally inner face 167a and 167b that is spaced from the laterally outer face 165a and 165b along side direction A. Each hook 163a, 163b defines a longitudinally external, or front end, 169a and 169b, respectively, and an opposite rear end 171a and 171b that is spaced from the front end 169a and 169b to the along the longitudinal direction L.
[00078] With reference to Figure 12A, the fixation instrument 22 defines a gap 173 that extends between the first and second flaps 161a and 161b along the lateral direction A, as well as between the inner faces 167a and 167b. The gap 173 is dimensioned to receive the cutter arm 106 when the cutter arm 106 is in the disengaged position. For example, the inner faces 167a and 167b can define respective seats that can support the cutter arm 106 when the cutter arm 106 is in the disengaged position. For example, the inner faces 167a and 167b can be contoured to be in a position bordering a complementary outer surface of the cutter arm 106 when the cutter arm 106 is in the disengaged position on the upper transverse face of frame 76. Consequently, when the cutter arm 106 is seated in the gap 173, it can be said that the cutter arm 106 is in a disengaged seated position.
[00079] As shown in Figures 14 and 15A-B, the cutter arm 106 can be pivotally attached to the structure 76, for example, in the housing element 190b. According to the illustrated embodiment, the cutter arm 106 is hingedly attached at its front end 107a to the nose 86 at a location of the pivot 152 that defines a lateral pivot axis. This arrangement is described above and shown, for example, in Figures 7A-B. As shown in Figures 5A-B, 14 and 15A-B, the cutter arm 106 can be rotated up and forward around the location of pivot 152 along the direction of Arrow C to its engaged position, which causes the cutter blade 108 travels down along an arc-shaped path towards the complementary cutter blade 87 in order to reduce the size of the gap 156. This process is described above. In the embodiments shown in Figures 14 and 15A-B, rotation of the cutting arm 106 from its seated and disengaged position to its engaged position involves removing the cutting arm 106 from the gap 173. Consequently, when the cutting arm 106 is removed from the gap 173, it can be said that the cutting arm 106 is in an engaged position.
[00080] At least one or both of the first and second flaps 161a and 161b can be flexible and can, for example, be constructed from a flexible material. Consequently, at least one or both of the first and second flaps 161a and 161b may be movable between an unflagged (or neutral) state and an outwardly deflected (e.g., laterally deflected) state. In the non-deflected position, shown in Figure 15B, the first and second flaps 161a and 161b are substantially parallel to each other and the gap 173 defines a first distance. The first and second flaps 161a and 161b are in their respective non-deflected position when the cutter arm 106 is removed from the gap 173, for example, when it is rotated around the pivot location 152 along the direction of Arrow C to its position engaged. The first and second flaps 161a and 161b are in their deflected position when the cutter arm 106 is disposed between the first and second flaps 161a and 161b in the gap 173. For example, when the cutter arm 106 is in the seated and disengaged position, it adjoins the laterally internal face 167a of the first flap 161a and the laterally internal face 167b of the second flap 161b. As illustrated in Figure 12B, due to the fact that the cross-sectional dimension of the cutting arm 106 along the lateral direction A is greater than the gap 173, when the first and second flaps 161a and 161b are in the deflected position, when the arm cutter 106 is moved to the seated and disengaged position, the cutter arm 106 pushes at least one or both of the first and second flaps 161a and 161b in the opposite direction of the other first or second flaps 161a and 161b to thereby increase the lateral dimension of the gap 173, so that the cutter arm 106 can be seated in gap 173, as described above. To facilitate the deflection of the flaps 161a, 161b by the cutting arm 106, the laterally internal face 167a of the flap 161a and the laterally internal face 167b of the flap 161b can extend laterally inward, towards each other, as they extend down along the transverse direction T, so that the inner faces 167a and 167b can define a non-zero angle with respect to the transverse direction T.
[00081] When the cutter arm 106 is in the seated and disengaged position, and the flaps 161a, 161b are deflected laterally inward, the distance between the laterally internal face 167a of the flap 161a and the laterally internal face 167b of the flap 161b along the lateral direction A, and thus the lateral dimension of span 173, is greater than the corresponding outer width of the second engaging element 168 along the lateral direction A. Figure 15B shows the lateral width w of the second engaging element and a Figure 12B shows that the distance between the laterally internal face 167a of the flap 161a and the laterally internal face 167b of the flap 161b is greater than the lateral width of the second engaging element 168, so that the second engaging element 168, together with the movable spring seat 132, can move in one direction along the longitudinal direction L towards the rear end 78b of the structure 76 through the passage through the gap 173 between the laterally internal face 167a of the flap 161a and the laterally internal face 167b of the flap 161b.
[00082] By contrast, as shown in Figure 15B, when the cutter arm 106 moves from the seated and disengaged position to the engaged position, one or both of the first and second flaps 161a and 161b return to their respective non-deflected positions, and the distance between the laterally internal face 167a of the flap 161a and the laterally internal face 167b of the flap 161b becomes less than the lateral width of the second engaging element 168. As described in more detail below, in this configuration, it is not possible for the second engaging member 168 passes between the laterally inner face 167a of the flap 161a and between the laterally inner face 167b of the flap 161b and therefore it is not possible for the movable spring seat 132 (from which the second engaging element 168 extends to up) to move beyond a certain point towards the rear end 78b of the structure 76 in a direction along the longitudinal direction L. It should be understood that when one or both flaps 161a and 161b are in the respective non-deflected position, one or both of the corresponding flaps 161a and 161b are at least partially aligned with the second engaging element 168 along the longitudinal direction L. Consequently, one or both of the corresponding flaps 161a and 161b are positioned to be in a position bordering the second engaging element 168 and preventing the second engaging element 168 from moving through the gap 173. When one or both of the flaps 161a and 161b are in the respective deflected position, the flaps 161a and 161b are deflected with respect to with respect to the second engaging element 168 along the lateral direction A, so that the second engaging element 168 is aligned with the gap 173 along the longitudinal direction L and is thus positioned to move at least inward or through gap 173, through the first and second flaps 161a and 161b.
[00083] As illustrated in Figure 11, when the tension set 70 (described previously) is in the first starting position, both hooks 163a and 163b and the first engaging element 166 are spaced along the longitudinal direction L, for example, backwards, from the movable spring seat 132 and the second engaging element 168, which extends upwards from the movable spring seat 132. When the user applies the actuating force, for example, the force directed backwards F, to the handle portion 85 of the trigger 84, the trigger 85 and thus also the tension set 70 move from the first initial position to the second handle position, which causes the movable spring seat 132 to move move backwards along the rod of the displacement device 111 in the longitudinal direction towards the rear of the end 78b of the structure 76. As shown in Figures 14 and 15A-B, when the cutter arm 106 is in the engaged not engaged position, the first and second tabs 161a and 161b are in their respective non-deflected positions. Consequently, when the tension assembly 70 moves from the first initial position to the second handle position, the movable spring seat 132 moves towards the rear end 78 until the second engaging element 168 is contiguous with one or the other. both the first and second flaps 161a and 161b, for example, at the respective front longitudinal ends 169a and 169b of the hooks 163a and 163b. When the second engaging element 168 adjoins the hooks 163a and 163b, for example, at the front longitudinal ends 169a and 169b, interference between one or both flaps 161a and 161b and the second engaging element 168 prevents the set of tension 70 moves to the third tension position, for example, from the second grip position, thus preventing the tension assembly 70 from increasing the tension on the belt 32 while the cutter arm 106 is in the unsettled and engaged position.
[00084] On the other hand, as illustrated in Figures 12A-B and 13, when the cutter arm 106 is in the seated and disengaged position, the flaps 161a and 161b are in their respective deflected positions. Consequently, when the tension set 70 moves from the first initial position to the second handle position, the movable spring seat 132 is movable along the longitudinal direction L, for example, back towards the rear end 78b, until the second engaging element 168 passes at least inside or through the gap 173 between the flaps 167a and 167b, for example, between the respective laterally internal faces 167a and 167b. Because the tabs 161a and 161b are offset from the second engaging element 168 when the tabs 161a and 161b are in the deflected position, the second engaging element 168 is not in a position bordering the front longitudinal edges 169a and 169b of the hooks 163a and 163b, respectively, in order to prevent the second engaging element 168 from traveling into the gap 173. As a result, when the flaps 161a and 161b are in the deflected position, the tensioning assembly 70 can be moved from the second handle position to the third tight position, thereby increasing the tension on the belt 32.
[00085] As previously described, the first and second engaging elements 166 and 168 are positioned so that they interlock when they overlap longitudinally. Thus, in the modalities shown in Figures 11-15, the first and second coupling elements 166 and 168 at least partially overlap when the tension set is in the third tension position, thus defining an interference that prevents the cutter arm 106 moves and moves to the engaging position along the direction of Arrow C.
[00086] Although the present description has been described in detail, it should be understood that various changes, substitutions and modifications can be made to the present invention without departing from the spirit and scope of the present invention, as defined by the appended claims. In addition, the scope of this description is not intended to be limited to the specific modalities described in the specification. As will be readily understood by the person skilled in the art from the description of the present invention, the processes, machines, manufacture, substance composition, means, methods or steps, currently existing or to be developed that perform substantially the same function or achieve substantially the same As a result, the corresponding modalities described herein can be used according to the present description.

权利要求:
Claims (15)
[0001]
1. Bone fixation instrument (22) configured to apply tension to a bone fixation element (24), in order to tighten the bone fixation element (24) around a target bone, the fixing (22) comprises: a body (76) defining a front end (78a) and an opposite rear end (78b); a handle (96) configured to fix a free end (35) of the fixing element (24) to the fixing instrument (22); a displacement device (98) which is connected to the claw (96) so that the handle (96) moves backwards along with the displacement device (98) in order to increase the tension in the bone fixation element (24) ; an actuator (100) operatively coupled to the displacement device (98), the actuator (100) configured to move from an initial position towards a tension position in response to an applied force, thus driving the device displacement (98) to move backwards; and a voltage limiter (102) connected between the actuator (100) and the displacement device (98), where the voltage limiter (102) allows the displacement device (98) to move backwards when the voltage in the bone fixation element (24) is less than a selection tension, and prevents the displacement device (98) from moving backwards when the tension in the bone fixation element (24) reaches the selection tension, where the voltage limiter (102) comprises a spring element (128) connected between the actuator (100) and the displacement device (98), characterized by the fact that the movement of the actuator (100) from the initial position towards at the tension position, the spring element (128) compresses, and the compression of the spring element (128) causes the spring element (128) to propel the displacement device (98) to move backwards under a force of change.
[0002]
2. Bone fixation instrument (22) according to claim 1, characterized by the fact that the handle (96) is movable between a disengaged position and an engaged position, so that when the handle (96) is in the disengaged position, the handle (96) defines a gap (116) dimensioned to receive the bone fixing element (24), and when the handle (96) is in an engaged position, the gap (116) is reduced so that the handle (96) secures the bone fixation element (24) to the bone fixation instrument (22).
[0003]
Bone fixation instrument (22) according to claim 1 or 2, characterized in that the handle (96) still comprises a first and a second handle element (112,114), so that one of the elements Grip (112) is movable between a disengaged position and an engaged position, so that the movable gripping element (112) is spaced farther from the other gripping element (114) in the disengaged position than in the engaged position.
[0004]
4. Bone fixation instrument (22) according to claim 3, characterized by the fact that the mobile gripping element (112) moves from the disengaged position to the engaged position when the displacement device (98) moves backwards from a forward position.
[0005]
5. Bone fixation instrument (22), according to claim 4, characterized by the fact that the mobile gripping element (112) is propelled towards the engaged position and engages the body (76) in order to prevent the movable gripping element (112) moves from the disengaged position to the engaged position when the displacement device (98) is in the forward position.
[0006]
6. Bone fixation instrument (22) according to claim 5, characterized in that when the displacement device (98) moves backwards from the forward position, the mobile gripping element (112) it becomes disengaged from the body (76) and is pushed into the engaged position.
[0007]
Bone fixation instrument (22) according to any one of claims 1 to 6, characterized in that the displacement device (98) moves backwards when the changing force is greater than the tension in the element bone fixation (24).
[0008]
8. Bone fixation instrument (22) according to claim 7, characterized in that the displacement device (98) remains stationary when the force of change is not greater than the tension in the bone fixation element ( 24).
[0009]
Bone fixation instrument (22) according to any one of claims 1 to 8, characterized in that it further comprises a force transfer element (104) coupled between the actuator (100) and the spring element (128), the movement of the actuator (100) moving the force transfer element (104) to flex the spring element (128).
[0010]
10. Bone fixation instrument (22) according to claim 9, characterized by the fact that the spring element (128) is coupled to a movable spring seat (132) which is connected to the force transfer element (104).
[0011]
Bone fixation instrument (22) according to any one of claims 1 to 10, characterized in that the actuator (100) is movable from the initial position to a second position which causes the spring (128) flexes to a position that pushes the displacement device (98) backwards and causes the handle (96) to clamp to the bone fixation element (24) before increasing the tension on the fixation element of bone (24).
[0012]
Bone fixation instrument (22) according to any one of claims 1 to 11, characterized in that the actuator (100) is movable from an initial position to a second position that causes the handle (96) attaches to the bone fixation element (24), and moves from the second position to the tension position that causes the displacement device (96) to move and increase the tension in the bone fixation element (24), in which the actuator (100) preferably moves from the initial position to the second position and the tension position in a continuous movement.
[0013]
Bone fixation instrument (22) according to any one of claims 1 to 12, characterized in that it still comprises a cutter assembly (72) configured to move from a disengaged position to an engaged position, whereby the cutter assembly (72) cuts the free end (35) of the bone fixing element (24) when in the engaged position.
[0014]
14. Bone fixation instrument (22) according to claim 13, characterized by the fact that it still comprises a safety mechanism (110) that prevents the cutter assembly (72) from moving from the disengaged position to the engaged position when the displacement device (98) has moved backwards, in order to increase the tension in the bone fixation element (24), it preferably still comprises a second safety mechanism (195) that prevents the actuator (100) from moving move to the tension position when the cutter assembly (72) is in the engaged position.
[0015]
15. Bone fixation system, characterized by the fact that it comprises: at least one bone fixation element (24) including a belt (32) and a locking mechanism (38), the belt (32) being able to be pulled through the locking mechanism (38) along a first direction to form a contour (55) around a target bone, and the locking mechanism (38) prevents the belt (32) from moving through the same along a second direction opposite to the first direction, the belt (32) defining a free end (35) that extends out of the locking mechanism (38); it is a. bone fixation instrument (22) as defined in any one of claims 1 to 14.

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同族专利:

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公开号 | 公开日

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US20150305792A1|2015-10-29|

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TWI555499B|2016-11-01|

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KR101925771B1|2018-12-06|

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JP2014511221A|2014-05-15|

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CN103458813A|2013-12-18|

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US20120197256A1|2012-08-02|

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JP6193128B2|2017-09-06|

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US10307196B2|2019-06-04|

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CA2826130C|2020-06-30|

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EP2670325B1|2018-12-26|

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US9084644B2|2015-07-21|

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US20120197257A1|2012-08-02|

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EP3482705A1|2019-05-15|

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EP3482705B1|2020-04-22|

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US9084645B2|2015-07-21|

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KR20140010388A|2014-01-24|

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TW201244685A|2012-11-16|

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CA3078651A1|2012-08-09|

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EP2670325A1|2013-12-11|

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CA2826130A1|2012-08-09|

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CN103458813B|2016-02-10|

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BR112013019645A2|2017-09-26|

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WO2012106505A1|2012-08-09|

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US11020149B2|2018-02-28|2021-06-01|Globus Medical Inc.|Scoliosis correction systems, methods, and instruments|

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EP3815640A1|2019-11-04|2021-05-05|Stryker European Holdings I, LLC|Surgical instrument for tightening a bone fixation member around bone|

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RU2746825C1|2020-06-17|2021-04-21|Руслан Асхатович Хисамутдинов|Sternum fixation system after median sternotomy surgery|

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CN111772760B|2020-08-18|2021-07-27|西安康拓医疗技术股份有限公司|Binding gun for sternal suture|

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

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2020-07-07| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2020-10-27| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-29| 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 02/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US13/019,907|US9084644B2|2011-02-02|2011-02-02|Bone fixation assembly|

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US13/019,907|2011-02-02|

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PCT/US2012/023608|WO2012106505A1|2011-02-02|2012-02-02|Bone fixation assembly|

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