Source: https://patents.google.com/patent/ES2496178T3/en
Timestamp: 2019-12-05 22:29:34
Document Index: 726871603

Matched Legal Cases: ['art 5', 'art 5', 'art 52', 'art 52', 'art 50', 'art 52', 'art 67', 'art 67', 'art 67', 'art 67', 'art 670', 'art 670', 'art 670', 'art 670', 'art 92', 'art 5', 'art 5', 'arts 67', 'art 5', 'art 5', 'art.\n4']

ES2496178T3 - Bone anchoring device - Google Patents
ES2496178T3
ES2496178T3 ES09168328.4T ES09168328T ES2496178T3 ES 2496178 T3 ES2496178 T3 ES 2496178T3 ES 09168328 T ES09168328 T ES 09168328T ES 2496178 T3 ES2496178 T3 ES 2496178T3
ES09168328.4T
2014-09-18 Publication of ES2496178T3 publication Critical patent/ES2496178T3/en
2018-11-02 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41468846&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2496178(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Bone anchoring device that includes: an anchoring element (2) having an axis (3), intended to be anchored in a bone and a head (4), a receiving piece formed in a single piece, comprising a seat (52) intended to receive the head (4) and a channel (54) intended to accommodate a rod (20) that is connected to the anchoring element; a pressure element (6, 601, 602, 603) formed in a single piece, and which can move in the receiving part so that it can exert pressure on the head, the anchoring element being able to rotate with respect to the receiving part and be fixed at an angle by applying pressure on the head through the pressure element, and the pressure element (6, 601, 602, 603) having a cylindrical recess (62, 620) suitable for receiving the rod (20 ) within it, so that two free arms (63, 64) are formed that constitute the side walls of a channel to receive the rod (20), characterized in that the pressure element (6, 601, 602, 603) It comprises a spring element (66, 66 ') formed in a single piece in the outer wall of each of the arms, and which is provided with a retaining part (67, 67') and which is coupled to a part (58 , 59) of the receiving part so that the pressure element (6, 601, 20 602, 603) can be kept in a A position that allows the rotation of the anchoring element, and the spring element (66, 66 ') is formed by a part of the wall that is separated by a groove (69, 69', 690, 690 ', 691, 691' ).
The invention relates to a bone anchoring device for anchoring a stabilization rod in a bone or a vertebra. The bone anchoring device includes an anchoring element and a receiving piece to accommodate the head of the bone anchoring element and to accommodate a stabilization rod to be connected to the anchoring element. The anchoring element is rotatably connected to the receiving part and can be fixed at an angle by exerting pressure on the head through a pressure element that is arranged in the receiving part. The pressure element comprises a spring element that engages with a part of the receiving part so that it can be held in a position that allows the anchoring element to rotate.
US 5,716,356 describes a polyaxial bone screw that includes a screw and a receiving part that is rotatably connected to the screw, and a pressure element for exerting pressure on the screw head, in order to set the angle between the screw and the receiving part. The receiving part has a U-shaped channel to accommodate the stabilization rod. The pressure element comprises a cylindrical cavity that is to be aligned with the U-shaped channel to accommodate the rod therein. In order to keep the pressure element in a position aligned with the U-shaped channel, the position of the pressure element is fixed under pressure through holes provided in the receiving part.
US 5,672,176 describes another example of a polyaxial bone screw with a pressure element that is also held in place through pressure holes without hindering sufficient movement of the pressure element to immobilize the head.
US 2005/0080420 A1 describes a multiaxial bone screw that includes a screw and a receiving member, a base member for retaining the screw within the receiving member and a crown member that exerts pressure on the screw head. The crown element 30 comprises a retaining washer that helps keep it within the receiving piece by interfering with a stop surface of the receiving piece. The multiaxial bone screw consists of a so-called lower load type screw, in which the screw is inserted from below into the receiving piece.
WO 2006/116437 A2 describes a bone anchor for fixation of the spine in the form of a polyaxial bone screw that includes a screw, a housing, a sleeve and a clamp arranged in the housing for pressure on the head of the screw. The sleeve has retention tabs that engage in grooves arranged in opposite wall portions of the housing. 40
WO 2008/008511 A2 discloses a bone stabilization assembly comprising a fixation element adapted to engage with a bone and having a head and a stem; a coupling element having an internal bore sized to accommodate the rod of the fixing element and a conical seat to support the head of the fixing element. The coupling element is adapted to accommodate a stabilization rod.
US 2009/0069853 A1 discloses a surgical retaining screw as defined in the preamble of claim 1, comprising a rod with an outer thread 50, a head connected to the rod in a fixed or movable manner, having said head an open interior space towards the upper side located on the side opposite the stem and two openings located on opposite sides of the head. These openings are open towards the
upper side and branch into a receptacle for a rod type connection piece, and an immobilization screw adapted to be screwed into the interior space from the upper side, such that it immobilizes a connection piece located in said receptacle.
Normally, polyaxial bone screws of the type described above are supplied preassembled, for example by the manufacturer. In this state, a specific screw element, for example a screw element having a specific rod length and diameter or a specific thread shape, is connected to the receiving part and the pressure element is disposed within it. so you can't leave. For surgery, the quantity and types of these pre-assembled 10-bone polyaxial screws are selected and these are supplied in advance as a complete set of implants.
The object of the invention is to provide a bone anchoring device that can be handled easily by the surgeon or other personnel at the site of the operation or anywhere else.
This objective is achieved by a bone anchoring device according to claim 1. Other developments are indicated in the dependent claims.
The bone anchoring device has only a few pieces. The pieces have a simple design. This leads to lower manufacturing costs and comfortable handling without sophisticated tools or machinery. The bone anchoring device can be mounted by hand in any delivery situation, after the parts have been manufactured and before inserting the screw element into the bone. Therefore, anyone can assemble the polyaxial bone screw, in particular the surgeon or his assistant staff before or during surgery.
A modular system can be supplied with the bone anchoring device that allows various anchoring elements to be combined at will with any suitable housing depending on the actual clinical requirements. This reduces the cost of polyaxial screws, decreases inventory and offers the surgeon a considerable assortment of implants. In addition, some existing receiving parts can be reformed with the pressure element to form the bone anchoring device according to the invention.
The assembly tool is simple and its operation and handling are evident to the user. The correct mounting of the pressure element is easily recognizable. An insertion tool to be used to insert the bone anchoring device allows safe handling of the bone anchoring device during surgery.
Other features and advantages of the invention are apparent from the description of embodiments with reference to the attached drawings.
Figure 1 shows an exploded side view of a first embodiment of the bone anchoring device.
Figure 2 shows a side view of the bone anchoring device of Figure 1 mounted and rotated 90 °. fifty
Figure 3 shows a sectional view of the bone anchoring device according to Figure 2 along the line A-A.
Figure 4 shows a sectional view of the receiving part of the bone anchoring device of Figure 3.
Figures 5a-5c show a side view, a side view rotated 90 ° and a sectional view, respectively, of the pressure element of the bone anchoring device according to the first embodiment.
Figures 6a) to c) show a side view, a side view rotated 90 ° and a sectional view, respectively, of a pressure element according to a second embodiment of the bone anchoring device.
Figures 7a) to c) show a side view, a side view rotated 90 ° and a sectional view, respectively, of a pressure element of a third embodiment of the bone anchoring device. fifteen
Figures 8a) to c) show a side view, a side view rotated 90 ° and a sectional view, respectively, of the pressure element of a fourth embodiment of the bone anchoring device.
Figures 9 a) to h) show assembly steps of the bone anchoring device using an appropriate tool, each step being shown in a side view and a side view rotated 90 °, respectively.
Figure 10 shows a side view of the bone anchoring device together with a tool for inserting the bone anchoring device into the bone.
Figure 11 shows an enlarged sectional view of a part of the tool together with the bone anchoring device. 30
The bone anchoring device 1 according to a first embodiment shown in Figures 1 to 5 includes a bone anchoring element, in this case a screw 2 having a threaded rod 3 and a head 4. The head 4 is configured , for example, as a spherical segment. It has a 4 ’entree at its free end to attach a tool. The bone anchoring device also includes a receiving piece 5 to connect the screw 2 to a rod 20. A pressure element 6 is arranged in the receiving piece 5, above the head 4. To secure the rod 20 in the piece In order to exert pressure on the pressure element, a two-part locking device consisting of an outer screw 7 cooperating with the receiving part 5 and an inner screw 8 cooperating with the outer screw 7 is provided. It is to be understood that the locking device shown is an example and that it can be made with many other designs, in particular as a one-piece locking device and with different thread shapes.
The receiving part 5, as shown in particular in Figures 1 to 4, is formed in a single piece. In the example shown it is essentially cylindrical and has a first bore 51 at one of its ends, to pass the threaded rod 3 therethrough. The bore 105 is followed by a seat part 52 to accommodate the screw head 4. The seating part 52 may have a spherical or conical shape or it may have any other shape that allows the head 4 to be accommodated, so that it can rotate with respect to the receiving part. The seat part 50 may have a threaded part 52 'to facilitate the insertion of larger diameter threaded stems. A second hole 53 that opens to the opposite side of the first hole 51 is provided to introduce the threaded rod 3 together with the head 4. On the side of the second
hole 53, the receiving part has an essentially 54 U-shaped recess 54 by means of which two free arms 55, 56 are formed which constitute the side walls of a channel to accommodate the rod 20. In the arms an internal thread 57 is provided. to cooperate with the external thread 7 of the locking device. The second bore 53 can have a conical section 57 'and a transition between a larger diameter of the inner threaded part and a smaller diameter 5 of a central part that provides a stop for the downward movement of the pressure element. In addition, on opposite sides of the arms 55, 56, two holes 57, 58 are provided that extend through the receiving piece 5. The diameter and cross section of the holes 57, 58 are designed in such a way as to allow coupling. with a part of the pressure element described below. 10
The pressure element 6, according to the first embodiment, as shown in particular in Figures 1, 3 and 5a) to c) is formed in one piece. It has an essentially cylindrical construction and has an outer diameter that allows it to be moved in axial direction within the second bore 53 of the receiving piece 5. On its face 15 oriented towards the head 4 of the screw a spherical recess 61 is provided, adapted to the size of head 4. On its side opposite to head 4, the pressure element has a cylindrical recess 62, adapted to accommodate the rod 20 within it. By means of the recess 62 two free arms 63, 64 are formed which constitute the side walls of a channel to house the rod. In the embodiment shown, the depth of the recess 62 is greater than the diameter of the rod, so that the arms extend above the rod. At the end of the pressure element opposite the head 4, the pressure element may have an edge with an enlarged diameter that provides a shoulder 65 that bumps against the conical section 57 'of the receiving piece when the pressure element immobilizes the head Four.
The pressure element further comprises in the outer wall part of each of the arms 63, 64 a spring element 66, 66 'with a retaining part 67, 67' that cooperates with the receiving part, in particular with the hole 58 , 59. The spring element 66, 66 'is formed by means of a groove 69, 69' which is closed at the top and the bottom and which extends completely through the arms in a direction parallel to the longitudinal axis of the 30 channel, thus leaving a part of each arm separated from the main body of the pressure element. On the outer wall of the spring element is provided the retention part 67, 67 'projecting outwardly such that the outer diameter of the pressure element, in the retention part is greater than the inner diameter of the bore 53 of the part Receiver The overall size of the groove is larger than the cross section of the holes 35 58, 59 of the receiving piece. The overall depth and size of the groove are such that the spring element 66, 66 'can be elastically moved into the space provided by the groove to such an extent that the retaining part 67, 67' can be introduced into it . As can be seen in particular in Figures 5b) and c), the retaining part is asymmetrical in a direction of the drill shaft of the receiving piece to allow insertion but avoid removal of the pressure element. The retaining part 67, 67 'has an essentially circular base area that passes biasedly to an upper part having an edge 67a, which rests on the upper wall of the bore 58, 59, such that the part of retention, once subjected to pressure in the hole 58, 59, as shown in Figure 3, cannot be removed without using a specific tool. Four. Five
Finally, the pressure element 6 has a coaxial bore 6a that extends therethrough to allow access to the head 4 with a tool.
The outer screw 7 of the locking device can be screwed into the threaded arms of the receiving piece until it exerts pressure on the upper edge of the pressure element, which moves the pressure element down until it presses on the head to lock it in the receiving piece The outer screw has a threaded bore 71 in which
you can screw the inner screw 8, to immobilize the rod 20. All parts of the bone anchoring device are made of a body compatible material, such as titanium or stainless steel, a metal alloy compatible with the body, for example a Ti-Ni alloy, or a plastic material compatible with the body, such as PEEK. In particular, the pressure element 6 can be made of a plastic material compatible with the body that allows easy production and safe operation of the spring element.
Next, a second embodiment of the bone anchoring device is described with reference to Figures 1 to 4 and 6. The description of the parts that are identical to those of the first embodiment will not be repeated. Similar parts have the same reference numbers. The second embodiment differs from the first embodiment only by the design of the pressure element. As can be seen in Figures 6a) to 6c), the pressure element 601 only differs from the pressure element 6 of the first embodiment by the shape of the retaining part 670, 670 '. The retaining part 670, 670 'is symmetrical in a direction of the drill shaft of the receiving piece to allow insertion and removal of the pressure element. In the specific embodiment shown, the retention part is configured as part of a sphere. Since it is continuous in an upward and downward direction, the retaining part can be pressurized inside the hole 58, 59 by a downward movement of the pressure element and removed therefrom by an upward movement. The recesses 58, 59 and the receiving part may be smaller and 20 adapted in shape to the shape of the retention part so that the retention part 670, 670 'can be fixed under pressure and remain within them. . The retention part may have any other symmetrical shape.
A third embodiment of the bone anchoring device is described below with reference to Figures 1 to 4 and 7. The description of the parts that are identical to those of the first embodiment will not be repeated. Similar parts have the same reference numbers. The third embodiment differs from the first embodiment only by the design of the pressure element. The pressure element 602 has grooves 690, 690 'which are open towards the top, so that the spring element 660, 660' consists of a lip 30 that can be moved elastically within the groove. This construction allows to increase the flexibility of the spring element. As in the first embodiment, the retention portion 67 is asymmetric.
Next, a fourth embodiment of the bone anchoring device is described with reference to Figures 1 to 4 and 8. The description of the parts that are identical to those of the first embodiment will not be repeated. Similar parts have the same reference numbers. The fourth embodiment differs from the second embodiment only by the design of the pressure element. The pressure element 603 does not have the extended shoulder edge 65. In addition, the grooves 691, 691 'in the arms are open towards the top, 40 thus forming elastic lips as spring elements. The retaining part 670, 670 'is symmetrical as in the second embodiment. The recess 620 that forms the rod channel has side walls that do not protrude above the rod. Therefore, the pressure element can be used with a one-piece locking device that simultaneously locks the rod and head acting on the pressure element. The pressure element according to the fourth embodiment is easy to manufacture, has a high flexibility of the spring elements and is removable.
The characteristics of the different pressure elements described in Figures 5 to 8 can be combined with each other to construct various other pressure elements. fifty
A tool for mounting the bone anchoring device and the assembly steps with reference to Figures 9a) to h) is described below. The first figure of each step
shows a side view in the direction of the rod axis and the second figure below shows a side view perpendicular to the rod axis. The tool 90 includes a base 91 that is essentially cylindrical with a diameter that allows it to be placed on a support, for example a table or the like (not shown). A cylindrical intermediate part 92 extends in a coaxial direction from the base 91. The outer diameter of the intermediate part is such that the intermediate part 5 can be introduced into the receiving part as shown in Figure 9g). At the opposite end of the base 91 a false rod 93 is provided in the intermediate part. The false rod 93 has the diameter of the rod 20, such that it fits into the channel formed by the recess 62 in the pressure element 6. The rod axis of the false rod extends perpendicular to the cylinder axis from the base. 10
In step 1, as shown in Figures 9a) and 9b), first the tool is placed on a support such that the false rod 93 is located at the top. Then, as shown in Figures 9c) and 9d), the pressure element is arranged on the false rod 93 with the U-shaped recess 62 facing down. In step 2, the screw 15 2 and the receiving part 5 that have been previously mounted are moved towards the tool with the U-shaped recess 54 of the receiving piece facing down and aligned with the axis of the false rod 93. The pre-assembly of the screw and the receiving part is carried out beforehand by inserting the screw from the top, that is, from the second hole 53 in the housing until the head 4 is seated in the seat 52. In the 20 step 3, the false rod 93, with the pressure element 6, is inserted into the receiving part by pressing it down. The spring elements 66, 66 'in the arms of the pressure element as described above are pressed into the grooves 69, 69' until they reach the recesses 58, 59 of the receiving part, which allow the expansion of the spring elements and the grip of the retention parts 67, 67 '. The grip of the retention parts is audible, so that the user can ensure that the pressure element is in the correct position. Using the tool, the pressure element can be easily inserted in the correct orientation, so that its rod receiver inlet (62) is aligned with the U-shaped inlet (54) of the receiving piece. In addition, the pressure element is maintained in the aligned position by coupling the spring elements in the 30 inlets of the receiving part. In this position, the head is still rotating inside the receiving piece. The pressure element is held so tightly that it cannot leave the receiving part during handling, but remains mobile if a force is exerted to immobilize the head.
If a pressure element with a symmetrical retaining part is used as described above, the pressure element can be removed from the pre-assembled position by pressing it out of the receiving part with the screw.
Therefore, a surgeon or any other person can easily pre-assemble a suitable combination of an anchoring element and a receiving piece in situ according to the needs.
The following describes a tool for inserting the bone anchoring device into the bone and using it, with reference to Figures 10 and 11. The tool 100 includes a rotationally guided transmission element 101 within an element opposite clamp 102 as a tube which is fixedly connected to a handle 103. The transmission element 101 includes a tip 101 'which can be coupled with the recess 4' of the head 4 of the screw element. The overall length of the transmission element 101 is such that it extends through the opposite clamping element 102 and through the receiving part 5 and the pressure element 6, into the recess 4 'of the screw head. Therefore a rigid connection is established between the bone anchoring device and the transmission element. The opposite clamping portion 102 has a tip 102 'that can be connected with
the receiving part 5. For this purpose, a threaded shoulder 122 is provided on the tip, which cooperates with the inner thread 57 of the arms of the receiving piece 5. Between the threaded shoulder 122 and the tip 102 'a shoulder 123 is formed , which acts as a stop when the opposite clamping element is connected to the receiving part. The threaded boss has a length such that it touches the upper edge of the pressure element when the opposite clamping element 5 is connected to the receiving part. This prevents the pressure element from being displaced upwards by the opposite force of the bone when the screw is inserted into the bone.
In practice, after assembly of the bone anchoring device, the receiving piece is coupled with the opposite clamping element and the transmission element is connected with the incoming 4 'of the head 4. Then, the screw is inserted into bone. The tool is then removed and the receiving part is rotated until it acquires the correct orientation to pick up the rod. The rod is then inserted, which connects several bone anchoring devices, and the locking device is squeezed to move the pressure element down in order to immobilize the head. The rod is then fixed using the inner screw of the locking device.
As an anchoring element, any type of anchoring can be used and combined with the receiving part. These anchoring elements consist, for example, of screws of different lengths, with different diameters, cannulated screws, screws with different thread shapes, nails, etc.
It is also possible to use any type of receiving piece, in particular those that have different locking devices, for example one-piece locking devices, such as a single fixing screw that locks the rod and head simultaneously, outer nuts, plugs 25 exterior, bayonet locking devices or others. It is not necessary that the coupling recesses for the spring elements of the pressure element pass through the wall completely, but can only be provided in the inner wall. The shape of the receiving part is not limited to the embodiment shown. For example, it may have an asymmetric end portion to allow a greater angle of rotation of the screw to one side.
The shape of the pressure element is also not limited to that of the embodiments shown. By way of example only, we will say that the pressure element can be constructed in such a way that it exerts pressure on the head from the side thereof, for example through a part that conically narrows, and / or can have a grooved part that immobilizes the head or other shapes.
Modifications can also be conceived in the tools described above. For example, the mounting tool can be constructed so as to immobilize the pressure element. 40
1. Bone anchoring device that includes:
an anchoring element (2) having an axis (3), intended to be anchored in a bone and a head (4), 5
a receiving piece formed in a single piece, comprising a seat (52) intended to receive the head (4) and a channel (54) intended to accommodate a rod (20) that is connected to the anchoring element;
a pressure element (6, 601, 602, 603) formed in a single piece, and which can move in the receiving piece so that it can exert pressure on the head, 10
the anchoring element can rotate with respect to the receiving part and be fixed at an angle by applying pressure on the head through the pressure element, and
the pressure element (6, 601, 602, 603) having a cylindrical recess (62, 620) suitable for receiving the rod (20) therein, so that two free arms 15 (63, 64) are formed which they constitute the side walls of a channel for receiving the rod (20), characterized in that the pressure element (6, 601, 602, 603) comprises a spring element (66, 66 ') formed in one piece in the outer wall of each of the arms, and which is provided with a retaining part (67, 67 ') and which is coupled to a part (58, 59) of the receiving piece so that the pressure element (6, 601, 20 602, 603) can be held in a position that allows the anchoring element to rotate, and the spring element (66, 66 ') is formed by a part of the wall that is separated by a groove (69, 69', 690, 690 ', 691, 691').
2. Bone anchoring device according to claim 1, wherein the retention portion (67, 67 ') can be elastically inserted into the groove and can be coupled to a recess (58, 59) formed in the inner wall of the receiving piece.
3. Bone anchoring device according to claim 1 or 2, wherein the retaining part (67, 67 ') has an asymmetrical configuration with respect to the direction of movement of the pressure element (6, 601, 602, 603) to allow assembly but prevent disassembly of the pressure element (6, 601, 602, 603) of the receiving part.
4. Bone anchoring device according to claim 3, wherein the retaining part (67, 67 ') comprises an edge (67a) that rests on the wall of the recess (58, 35 59).
5. Bone anchoring device according to one of claims 1 or 2, wherein the receiving part (670) is symmetrically configured with respect to the direction of movement of the pressure element to allow its assembly and disassembly. 40
6. Bone anchoring device according to one of claims 1 to 5, wherein the groove (69, 69 ') is open on two opposite sides.
7. Bone anchoring device according to one of claims 1 to 6, wherein the groove (690, 691) is open on three sides, the third side being preferably oriented towards the side of the pressure element oriented in the opposite direction to the head (4).
8. Bone anchoring device according to one of claims 1 to 7, wherein the receiving piece has a first bore (51) on the opposite side of the channel (54) for the rod (3) to pass through it. ) of the anchoring element, and a second bore (53) on the opposite side to introduce the rod (3) and the head (4).
9. Bone anchoring device according to one of claims 1 to 8, wherein a locking device (7, 8) is provided which cooperates with the receiving piece to block the head and the rod separately or simultaneously.
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ES09168328.4T Active ES2496178T3 (en) 2009-08-20 2009-08-20 Bone anchoring device
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