SURGICAL FIXATION SYSTEM
Patent Information
- Application Number
- DE502021009711
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-04-17
- Filing Date
- 2021-04-15
- Publication Date
- 2026-02-12
- Estimated Expiration
- 2041-04-15
AI Technical Summary
Conventional fixation systems for spinal fractures face issues with unstable fixation due to varying distances and line or point contact between stabilizing and anchoring elements, leading to loosening and corrosion, especially when high fixing forces are applied.
A fixation system with a deformation area, such as a material recess, allows the stabilizing element to be fixed via a clamping force, enabling better adaptation to different stabilizing elements with varying materials and geometries, ensuring a uniform distribution of forces and a flat contact area for reliable fixation.
The system provides a versatile and reliable fixation by adapting to different stabilizing elements, maintaining consistent distances, preventing loosening and corrosion, and ensuring a stable fit through a more uniform force distribution.
Description
[0001] The present invention relates to a surgical fixation system comprising at least one anchoring element with an anchoring section for anchoring to a bone and with a receiving section for a stabilizing element for connection with a further anchoring element, wherein the stabilizing element can be arranged in the receiving section and fixed therein by means of a fixing element, wherein the fixation system comprises an application element arranged on the receiving section and abutting the anchoring section for applying the stabilizing element, wherein the application element has at least one deformation area for deformation depending on a fixing force of the fixing element acting on the stabilizing element, wherein the application element is designed at least partially in a sleeve-like form and has an application area for the stabilizing element on an end face.wherein at least one deformation area is arranged below the contact area of the system element for the stabilizing element.
[0002] Such a fixation system, comprising at least one anchoring element with an anchoring section for anchoring to a bone and with a receiving section for a stabilizing element for connection to another anchoring element, wherein the stabilizing element can be arranged in the receiving section and fixed therein by means of a fixing element, is used, for example, in the treatment of fractures in the spinal region. Anchoring elements, such as bone screws, particularly pedicle screws, can be provided. A rod-shaped stabilizing element, for example, can be inserted into the respective receiving section of the bone screw and clamped therein, for example, by means of a screw element. In practice, the receiving section can, for example, have two segments arranged at a distance from each other, between which an opening for the stabilizing element is arranged.The segments can, for example, have an internal thread for screwing onto an external thread of the screw element.
[0003] Depending on the treatment, it may be desirable or necessary to adapt stabilizing elements of different properties to the anchoring element. For example, the stabilizing elements may have different materials and / or, in the case of rod elements, different diameters.
[0004] US Patent 2005 / 0277928 A1 describes a fixation system in which a receiving section with a substantially U-shaped contact element is provided to adapt the anchoring element to different bar diameters. While bar elements of different diameters can be adapted better in this case compared to conventional fixation systems, the U-shaped contact element results in varying distances between the bar element and the anchoring element. This is undesirable for the treatment. Furthermore, the design of the contact element leads to line or point contact of the bar element, with the risk of unstable fixation in the receiving section. Due to high fixing forces, line and point contact with the fixing element can lead to loosening and / or corrosion.Fixing bent rod elements is often clinically necessary, but it can lead to an unfavorable alignment of the rod element with the support element. This can result in stress, loosening, breakage, and corrosion.
[0005] US 2005 / 0277928 A1 further describes that the device element can have legs which can be spread relative to each other to allow insertion of the stabilizing element and then brought closer together again after insertion. This allows the stabilizing element to be temporarily fixed in the receiving section.
[0006] US 2012 / 253408 A1 discloses a screw arrangement with a deformable bushing. US 2007 / 233078 A1 discloses pivotable joints with a predetermined resistance to movement for spinal implants, as well as a method for using such joints. US 2014 / 180346 A1 relates to devices and methods for the dynamic fastening of skeletal structures. A polyaxial screw for surgical implants is described in EP 3 174 482 A1.
[0007] The object of the present invention is to provide a generic fixation system that is more versatile.
[0008] This problem is solved according to the invention in a fixation system of the type mentioned at the outset by the fact that the at least one deformation area is formed by or includes at least one material recess on the attachment element.
[0009] The fixing system according to the invention allows the stabilizing element to be fixed to the receiving section via the fixing element using a fixing force, in particular a clamping force. A contact element is provided on the receiving section, which can be deformed at least at one deformation area as a result of the fixing force. Preferably, a defined deformation of the contact element can be achieved at the at least one deformation area. This allows for better adaptation of different stabilizing elements, which may differ from one another, for example, in terms of their material and / or geometry (e.g., diameter), to the receiving section. At the same time, the contact element rests against the anchoring section, so that a better fit of the stabilizing element to the anchoring element can preferably be achieved.Preferably, an anchoring element can be used with a variety of different stabilizing elements, preferably maintaining an identical distance to the anchoring element. This increases the versatility of the fixation system. Maintaining fixation systems for different treatments is significantly simplified. Preferably, the deformation of the contact element results in a more uniform distribution of the forces acting on the stabilizing element and / or a flat contact area with the contact element, particularly with a reliable fit to the anchoring element. This allows for more reliable fixation of the stabilizing element than with conventional fixation systems. According to the invention, the contact element is designed at least partially in a sleeve-like shape, with a contact area for the stabilizing element on one end face.The end face can, for example, face another end face over which the attachment element can bear against the anchoring section. Furthermore, according to the invention, at least one deformation zone is arranged below a contact area of the attachment element for the stabilizing element. The force of the fixing element can be directed, in particular via the stabilizing element, onto the contact area, especially the bearing area, or onto the at least one deformation zone of the attachment element below it. Moreover, according to the invention, the at least one deformation zone is formed by or includes at least one material recess on the attachment element.
[0010] In a preferred embodiment of the invention, the attachment element can be formed separately from the receiving section and arranged within the receiving section. This increases the versatility of the fixation system. For example, different attachment elements can be provided, which can be selectively positioned within the receiving section depending on the treatment to be performed. In particular, this allows for a modular design of the fixation system. By manufacturing the receiving section and the at least one attachment element separately, the respective advantages of these two components can be highlighted with regard to providing the best possible treatment.
[0011] In another advantageous embodiment, the receiving section may encompass or form the attachment element. This allows, for example, for a structurally simple manufacturing process.
[0012] The system component is particularly prone to crumpling due to the fixing force of the fixing element.
[0013] It may be intended that the system element is designed to be elastically deformable at least in at least one deformation area.
[0014] It may be intended that the system element is designed to be plastically deformable at least in at least one deformation area.
[0015] In a preferred embodiment of the invention, the attachment element can be a single piece.
[0016] It can be advantageous if at least one deformation zone is arranged on a contact area of the support element for the stabilizing element. The force of the fixing element can be directed, in particular via the stabilizing element, onto the contact area, especially the bearing area, or onto the underlying at least one deformation zone of the support element.
[0017] Alternatively or additionally, at least one deformation zone can be arranged on or laterally adjacent to a lateral contact area for the stabilizing element. For example, the contact element has lateral support members for the stabilizing element, each comprising a contact area. The deformation of the support member allows the contact element to adapt laterally to the stabilizing element.
[0018] In a preferred embodiment of the invention, the attachment element may comprise a first attachment element section facing the stabilizing element and a second attachment element section facing the anchoring section. It is particularly advantageous if the first attachment element section comprises or forms the at least one deformation zone and, at least partially, exhibits a higher degree of deformation due to the fixing force than the second attachment element section. As mentioned, the first attachment element section can be adapted to the stabilizing element, and preferably to a plurality of stabilizing elements. In this context, the at least one deformation zone can deform to the size and / or shape of the stabilizing element depending on the fixing force, thereby adapting the attachment element to the stabilizing element.The second section of the component exhibits lower deformability than the first. In this context, this can be understood to mean, in particular, that the second section of the component is "harder" than the first. This allows for a more reliable fit at the anchoring section, preferably through frictional and / or positive locking.
[0019] The plant component sections can, for example, be made of different materials or, if manufactured from the same material, have different properties with regard to deformability.
[0020] The plant element sections can, for example, be formed separately and joined together. Alternatively, it can be provided that the plant element sections are formed together, in particular as a single piece.
[0021] For example, a discrete section boundary with respect to the deformability of the system element is provided between the first and second system element sections. This can, for instance, result in a stepwise change in deformability at the system element section.
[0022] The section boundary is, for example, oriented transversely and, in particular, perpendicularly to a fixing direction of the fixing element in the direction of the anchoring section.
[0023] In a preferred embodiment, it may be provided that a transition section is available with regard to the deformability of the attachment element, through which the first attachment element section and the second attachment element section transition into each other.
[0024] In a preferred embodiment, the at least one deformation area can have an extension parallel to a contact area of the contact element for the stabilizing element.
[0025] It can be provided that the at least one deformation area is arranged or formed symmetrically on the mounting element with respect to a plane of symmetry containing an axis of the receiving section. In particular, the mounting element can be positioned coaxially with the receiving section. The plane of symmetry is, for example, a median plane of the receiving section. A symmetrical arrangement of the deformation area can advantageously achieve a uniformity of the clamping forces.
[0026] The material recess is, for example, a recess on a surface of the fixture element, wherein the fixture element is deformable at the edge of the recess. Advantageously, the stabilizing element can be designed to engage positively in the recess.
[0027] In a preferred embodiment of the invention, the material recess is or comprises a through-opening of the mounting element. By forming one or, for example, several through-openings, the invention can be implemented in a structurally simple manner. For example, the mounting element is compressed under the influence of the clamping force, with the through-openings being shape-changeable.
[0028] The opening can, for example, have a circular, elliptical, oval, round, oblong, or non-circular cross-section. In this context, "round" can be understood to mean, in particular, non-angular.
[0029] It may be provided that the material recess extends along the stabilizing element arranged in the receiving section. Due to the design of the receiving section, particularly with two segments spaced apart from each other, the stabilizing element may have a preferred direction. The material recess may extend along this preferred direction. This allows for improved adaptation of the mounting element to the geometry of the stabilizing element with regard to the most advantageous deformation.
[0030] It may be intended that the material recess has a radial extension to an axis defined by the attachment element.
[0031] In a preferred embodiment of the invention, the material recess is a cavity formed in the receiving element and enclosed on all sides.
[0032] It can be advantageous if the system element comprises two or more deformation sections which comprise different materials with regard to their deformability or are made of different materials, wherein at least one deformation area is formed due to the different material properties of the two or more deformation sections.
[0033] For example, two deformation sections with different deformability border each other. As a result of the applied force, the component can deform at the softer deformation section and / or in the transition section between the softer and the less soft deformation section.
[0034] The two or more deformation sections can be separately formed and joined deformation sections of the system element.
[0035] Alternatively, it can be provided that the two or more deformation sections are formed in one piece.
[0036] It can be advantageous to provide a first deformation section that is at least partially surrounded by at least one second deformation section, wherein the deformability of the first deformation section is greater than the deformability of the at least one second deformation section. In particular, the second deformation section can completely surround the first deformation section.
[0037] In a preferred embodiment, three or more deformation sections may be provided, wherein the deformability of each deformation section, which at least partially surrounds another deformation section, is less than the deformability of the surrounded deformation section.
[0038] It may be provided that the deformation sections with different deformability are directly adjacent to each other, resulting in a discrete, stepwise change in the deformability of the system element.
[0039] Alternatively, it can be provided that a transition section exists between the deformation sections of different deformability, so that the deformability changes gradually and, in particular, continuously.
[0040] It can be advantageous if the system component includes a multiple deformation areas, especially with a multiple material cutouts.
[0041] In particular, it may be provided that two or more identically designed deformation areas are included.
[0042] Alternatively or additionally, two or more differently designed deformation zones can be provided.
[0043] For example, two or more through-openings on the system element can be arranged and aligned parallel to each other.
[0044] It may be planned that several passageways are arranged "spaced apart" from each other.
[0045] It can prove advantageous to have two deformation zones that are spaced apart from each other and aligned with each other on the system element.
[0046] For example, the component, such as a sleeve-shaped design, has two diametrically opposed deformation zones. These deformation zones, formed, for example, by through-openings or deformation sections of differing deformability, preferably align with each other. The direction of alignment advantageously corresponds to the extension direction of the stabilizing element in the receiving section.
[0047] For example, the aforementioned first section of the plant element can encompass or form the plant area at one end face.
[0048] In a preferred embodiment, the mounting element can comprise two support members arranged at a distance from each other, which laterally define a tapered recess, wherein the stabilizing element can be positioned between the support members in the recess. The support members allow the stabilizing element to be laterally supported and thus advantageously fixed in the receiving section.
[0049] Preferably, a deformation area is arranged at least on one support member, preferably on both support members.
[0050] The installation element can preferably be aligned or alignable coaxially with the receiving section and / or the anchoring section.
[0051] It is advantageous if the anchoring section and the mounting element comprise mutually adapted, and in particular at least partially spherical, contact areas. For example, the anchoring element is a polyaxial screw with a spherical anchoring section. The mounting element, adapted accordingly, can thus preferably engage the contact area of the anchoring section in a form-fitting manner and assume a defined position relative to the anchoring section.
[0052] For example, the aforementioned second component section can encompass or form the contact area on one end face. A reliable fit of the component, preferably with an optimized fit to the anchoring section, can be achieved via the contact area.
[0053] Advantageously, the attachment element is arranged in a form-fitting manner within the receiving section. For example, the attachment element is positioned in a form-fitting manner between two segments of the receiving section that are spaced apart from each other.
[0054] The fixation system can, for example, comprise two or more anchoring elements. The anchoring elements can preferably be identical in design.
[0055] The fixation system preferably comprises two or more attachment elements. These elements can be at least two identically designed and / or at least two differently designed attachment elements.
[0056] The fixation system preferably comprises at least one stabilizing element, and in particular a plurality of stabilizing elements. At least two stabilizing elements can be identical in design. Alternatively or additionally, at least two stabilizing elements can be differently designed.
[0057] The fixation system preferably comprises at least one fixation element, and in particular a plurality of fixation elements. At least two fixation elements can be identical in design. Alternatively or additionally, at least two fixation elements can be differently designed.
[0058] The at least one anchoring element is, for example, a bone screw. The bone screw can be a monoaxial screw. Alternatively, the bone screw can be a polyaxial screw, in which the receiving section is pivotable relative to the anchoring section.
[0059] The at least one stabilizing element is preferably a rod element.
[0060] The at least one fixing element is preferably a screw element that can be screwed to the receiving section.
[0061] Materials used for the system element include, for example, Ti 6 Al 4 V, titanium, PEEK, or a CoCr alloy. Combinations of the aforementioned materials are also possible.
[0062] The component exhibits, particularly in the deformation zone, a modulus of elasticity of approximately 50,000 to 150,000 MPa, for example, approximately 100,000 to 120,000 MPa for Ti6Al4V. The modulus of elasticity can be, for example, approximately 2,000 to 6,000 MPa (e.g., 3,000 to 4,000 MPa) for PEEK and, for example, approximately 200,000 to 300,000 MPa for CoCr, preferably approximately 230,000 to 270,000 MPa.
[0063] The fixing force acting on the stabilizing element can be approximately 3 kN to approximately 7 kN for spinal fixation systems in the lumbar region and approximately 0.8 kN to 2.5 kN for a spinal fixation system in the cervical region.
[0064] In contrast, the forces acting on the stabilizing element are typically significantly lower in the implanted state. For example, axial forces of up to approximately 300 N act on the stabilizing element. A bending moment can be up to approximately 8 Nm.
[0065] A deformation of the system element according to the invention can, for example, be in the range of approximately 0.1 mm to 3 mm, preferably between 0.2 mm and 1.5 mm.
[0066] The following description of preferred embodiments of the invention, in conjunction with the drawing, serves to explain the invention in more detail. The drawing shows: Figure 1: a schematic perspective view of a fixation system according to the invention for connecting two vertebrae; Figure 2: a perspective view of an attachment element of the fixation system made of Figure 1 Figure 3: a sectional view of the fixation system made of Figure 1in a partial representation, wherein a stabilizing element is attached to the system element according to Figure 2 is in contact with and is not yet subjected to a fixing force by a fixing element; Figure 4: a representation accordingly Figure 3 , wherein the stabilizing element is subjected to a fixing force by means of the fixing element and is thereby clamped in place; Figures 5 and 6: partial views corresponding to the Figures 3 and 4 , whereby a different type of system element is used; Figures 7 and 8: Partial representations corresponding to the Figures 3 and 4 , whereby a different type of system element is used; Figures 9 and 10: Partial representations corresponding to the Figures 3 and 4 , whereby a different type of system element is used; Figure 11: a perspective view of a different type of system element for the stabilizing element; Figures 12 and 13: partial views corresponding to the Figures 3 and 4 , wherein the plant element consists of Figure 11is used; Figures 14 to 18: a respective partial representation accordingly Figure 3 , each using different types of plant components.
[0067] Figure 1 Figure 10 shows a fixation system in a preferred embodiment of the present invention, designated as reference numeral 10. By way of example, the fixation system 10 includes anchoring elements 12 in the form of bone screws 14.
[0068] The fixation system 10 comprises four of these, wherein at least one bone screw 14 is provided according to the invention.
[0069] Furthermore, the fixation system 10 comprises at least one stabilizing element 16, wherein in this case two stabilizing elements 16, designed as rod elements 18, are provided. Two bone screws 14 are connected to each other via a rod element 18.
[0070] The fixation system 10 serves to stabilize bones, in this case adjacent vertebral bodies 20. For this purpose, the bone screws 14 are in particular pedicle screws.
[0071] The four bone screws 14 and the two rod elements 18 are each identically designed. Only one of the bone screws 14 and one rod element 18 will be discussed below.
[0072] The fixation system 10 further comprises at least one attachment element 22. A preferred embodiment of the attachment element 22 is described in the Figures 2 to 4 shown. Advantageously, each bone screw 14 is assigned an attachment element 22.
[0073] It may be provided, in particular, that the plant elements 22 are designed identically.
[0074] As can be seen particularly from the Figures 3 and 4As can be seen, the bone screw 14 comprises an anchoring section 24 for anchoring in the bone and a receiving section 26 for the rod element 18. The bone screw 14 is a polyaxial screw in which the receiving section 26 is pivotable relative to the anchoring section 24. For this purpose, the anchoring section 24 includes a spherical head 28. The head 28 defines a contact area 30 that is at least partially spherical.
[0075] The anchoring section 24 defines an axis 32. The receiving section 26 defines an axis 34. In the relative orientation of the anchoring section 24 and the receiving section 26 shown in the drawing, the axes 32 and 34 coincide.
[0076] The receiving section 26 has two segments 36 arranged at a distance from each other. An internal thread 38 is arranged on each segment 36.
[0077] A through-opening 40 is formed between the segments 36, through which the rod element 18 can be passed. Preferably, the direction of extension of the rod element 18 coincides with an axis 42 of the through-opening 40.
[0078] To fix the rod element 18 in the receiving section 26, the fixing system 10 comprises a fixing element 44. In this case, the fixing element 44 is a screw element 46. The screw element 46 can be screwed to the threads 38 of the segments 36. This allows the rod element 18 to be subjected to a fixing force directed towards the anchoring section 24 in a fixing direction 47.
[0079] In this case, the support element 22 is intended to support the rod element 18 relative to the anchoring section 24. The support element 22 and the screw element 46 are arranged on opposite sides of the rod element 18.
[0080] The mounting element 22 is formed separately from the receiving section 26 and arranged within the receiving section 26. In this case, the mounting element 22 is dimensioned such that it is positively engaged between the segments 36 in the through-opening 40. An outer contour of the mounting element 22 is preferably adapted to an inner contour of the segments 36. In this case, these respective contours are circular or arc-shaped. This allows the mounting element 22 to be positioned immovably in a plane transverse and, in particular, perpendicular to the axis 34 within the receiving section 26.
[0081] As from the Figures 2 to 4As further shown, the attachment element 22 in the present example is designed in a sleeve-like shape with a central through-opening and defines an axis 48. In the receiving section 26, the attachment element 22 is arranged and aligned coaxially with it, with axes 34 and 48 being aligned with each other. Depending on the relative orientation of the anchoring section and the receiving section 26, the attachment element 22 can also be aligned coaxially with the anchoring section 24.
[0082] The system element 22 comprises an outer circumferential surface 50, an inner circumferential surface 52, a contact area 54 on an end face facing the rod element 18 and a contact area 56 on an end face facing the head 28.
[0083] The installation element 22 comprises a first installation element section 55 and a second installation element section 57. The first installation element section 55 faces the rod element 18 and forms the contact area 54 at its end face. The second installation element section 57 faces the anchoring section 24, in particular its head 28. At its end face, the second installation element section 57 forms the contact area 56.
[0084] With respect to the fixing direction 47, the first attachment element section 55 is arranged proximal to the rod element 18 and the second attachment element section distal to the rod element 18. The opposite applies with respect to the anchoring section 24, in particular the head 28.
[0085] For the purpose of explanation, the following is included: Figures 3 and 4A fictitious dividing line between the system element sections is indicated by a dashed line 59. However, system element sections 55 and 57, particularly with regard to their deformability, merge into one another along the fixing direction 47. A corresponding transition section is not shown separately in the drawing.
[0086] In a different advantageous embodiment, a discrete section boundary could be provided between the plant element sections 55 and 57, particularly with regard to their deformability. The section boundary is, for example, oriented transversely and, in particular, perpendicularly to the fixing direction 47 (in this case, transversely and, in particular, perpendicularly to the plane of the drawing).
[0087] The contact area 56 is designed in a spherical shell shape and its form is adapted to the contact area 30. When the receiving section 26 is pivoted relative to the anchoring section 24, as long as the fixing element 44 is unfixed, the contact element 22 is also pivoted, whereby the contact area 56 always remains in planar contact with the head 28.
[0088] The mounting area 54 is planar in this case and is formed by the annular end face of the mounting element 22. The rod element 18 can abut the mounting area 54 and, in particular, rest on it ( Figures 3 and 4 ).
[0089] The system element 22 comprises at least one deformation area 58. In this case, two deformation areas 58 are provided, which are arranged on sections of the system element 22 that are diametrically opposite each other with respect to the axis 48.
[0090] In the case of the system element 22, the first system element section 55 comprises the deformation area 58 or forms at least one deformation area 58. In contrast, the second system element section 57 does not comprise or form a deformation area in this case.
[0091] As a result of at least one deformation zone 58 (in this case, two deformation zones), the first section of the support element 55 exhibits a higher degree of deformability than the second section of the support element 57. The deformation occurs due to the clamping force of the clamping element 44 and enables the support element 22 to adapt to the rod element 18. This is explained below.
[0092] In contrast, the second component section 57 is "harder" or "stiffer" than the first component section 55. This enables a reliable fit on the head 28, which, for example, ensures the aforementioned surface contact over the contact area 56.
[0093] The second component section 57 can be particularly undeformed or substantially undeformed under the fixing forces typically occurring with the fixing element 44, as explained above.
[0094] The deformability can decrease gradually from the first plant element section 55 to the second plant element section 57 via the aforementioned transition section. If, as mentioned above, a section boundary is provided, a stepwise change in deformability from the first to the second plant element section 55, 57 can occur.
[0095] The deformation zones 58 are symmetrically designed relative to each other with respect to a first plane containing axes 34 and 48. This plane runs in the Figures 3 and 4in the drawing plane. Furthermore, the deformation areas 58 are symmetrical with respect to a plane containing axes 34 and 48. This is a plane 60 perpendicular to the drawing plane in the Figures 3 and 4 , wherein the plane of symmetry 60 is a median plane of the recording section 26 in the intended use of the fixation system 10.
[0096] The deformation areas 58 are arranged below the attachment area 54.
[0097] Each deformation area 58 has at least one material recess. In this case, each deformation area 58 comprises three material recesses, designed as through-openings 62 of the system element 22. The through-openings 62 have a round, and in particular circular, cross-section.
[0098] Two of these through-openings 62 are identical in design and arranged symmetrically with respect to the plane 60. A third through-opening 62 is spaced apart from these two through-openings 62 and is itself symmetrical with respect to the plane 60. The latter through-opening 62 has a larger diameter than the first two through-openings 62.
[0099] The through-openings 62 at the deformation areas 58 opposite each other with respect to the axis 48 are aligned. The through-openings 62 are each aligned in the extension direction of the rod element 18. Preferably, the through-openings 62 are aligned parallel to the axis 42.
[0100] The passage openings 62 run parallel to a plane defined by the plant area 54.
[0101] In the use of the fixation system 10, the rod element 18 is subjected to a fixing force by the screw element 46 directed towards the support element 22 and via this towards the head 28 ( Figure 4 The clamping force leads to a deformation of the fixture element 22 at the deformation areas 58. Preferably, a targeted deformation can be achieved.
[0102] The deformation allows rod elements 18 of different properties, in particular different materials and / or diameters, to be adapted to the bone screw 14. Separate bone screws 14 are not required. This increases the versatility of the fixation system 10.
[0103] The deformation of the mounting element 22 allows for a more even contact area between the rod element 18 and the mounting element 22. This promotes a more uniform pressure and helps to avoid point and line contacts. In this way, a more reliable fixation of the rod element 18 is ensured. Potential corrosion is also prevented.
[0104] The stiffer section 57 of the system element ensures a reliable fit with respect to the head 28.
[0105] The deformation of the system element 22 can be plastic or elastic.
[0106] The system element 22 is preferably formed in one piece.
[0107] With regard to advantageous materials and the forces occurring when using the fixation system 10, reference is made to the preceding statements.
[0108] The following refers to the Figures 5 to 18 Further preferred embodiments of the invention were discussed. In each case, a different embodiment is used instead of the one described in the Figures 1 to 4 The depicted attachment element 22 is used in conjunction with a different type of attachment element. The depiction shows the use of the bone screw 14 and the rod element 18.
[0109] The advantages explained above can also be achieved using the system components described below, so reference can be made to the preceding explanations in this regard. The presentation of the Figures 5 and 6 , 7 and 8, 9 and 10, as well as 12 and 13 corresponds to the representation in the Figures 3 or 4 in a partial view.
[0110] The representations of Figures 14 to 18 correspond to the representation according to Figure 3 in a partial view. Here, the respective system element 22 is not subjected to the fixing force, but is shown in the unloaded state for a clearer illustration.
[0111] The in the Figures 5 to 18 The embodiments shown each have a support element 22, which preferably has the support element sections 55 and 57 for the rod element 18 and for the anchoring section 24, respectively, in particular the head 28. The deformability at support element section 55 is higher than at support element section 57, with the support element section 55 each comprising or forming at least one deformation area 58.
[0112] The plant element 22 according to the Figures 5 and 6 The device has only one through-opening 62 at the respective deformation area 58. In the unloaded state, the through-opening 62 is approximately in the shape of a rounded, horizontally stretched isosceles triangle, roughly a Wankel shape. In the loaded state, the through-opening 62 is, for example, arc-shaped, depending on the clamping force.
[0113] Even in the Figures 7 to 10In the illustrated embodiments, only one through-opening 62 of the deformation area 58 is provided.
[0114] In the embodiment according to the Figures 7 and 8 The through-opening 62 is elliptical in the unloaded state. In the loaded state, the through-opening 62 is, for example, arc-shaped, depending on the clamping force.
[0115] The through-opening 62 in the embodiment according to the Figures 9 and 10 In its unloaded state, the opening 62 is approximately C-shaped, with each end of the "C" pointing towards the rod element 18. In its loaded state, the opening 62 is approximately U-shaped, with legs pointing towards the rod element 18.
[0116] Figure 11Figure 1 shows an embodiment of the support element 22, which comprises a sleeve-shaped section 64. Two support members 66 project from the section 64 opposite each other with respect to the axis 48. Each support member 66 forms a lateral contact area 68 for the rod element 18.
[0117] A deformation area 58 is arranged on each support member 66. The deformation area 58 has a through-opening 62 with an elongated cross-section, which runs parallel to the axis 42.
[0118] A recess 70 is arranged between the support members 66, which tapers in the insertion direction of the rod element 18. The recess 70 ensures that the rod element 18 is centered relative to the receiving section 26.
[0119] The rod element 18 can contact the contact areas 68. Contact between the rod element 18 and the contact area 54 (not shown) is also possible.
[0120] In the embodiments described so far, the deformation area 58 comprises at least one material recess, in particular in the form of the through-opening 62.
[0121] In contrast, the respective one in the Figures 14 to 18 The depicted system element 22 does not have a material recess. Instead, the respective deformation area 58 is formed by deformation sections of the system element 22 with different deformabilities.
[0122] In the representations according to the Figures 14 to 17 Two deformation zones 58 are provided, each opposite the other with respect to axis 48. The drawing shows only one of these deformation zones 58.
[0123] The plant element 22 according to Figure 14The assembly comprises a first deformation section 72 and a second deformation section 74. The second deformation section 74 is formed by the sleeve-shaped base body of the attachment element 22, from which a concave recess is partially cut out on the side facing the rod element 18. This recess is filled by the first deformation section 72.
[0124] The deformability of the first deformation section 72 is higher than the deformability of the second deformation section 74. When a force is applied, the support element 22 deforms more at the first deformation section 72 than at the second deformation section 74, thus adapting the rod element 18.
[0125] In the case of the plant element 22 according to Figure 15 Two deformation sections 72 and 74 are also provided.
[0126] While the second deformation section 74 deforms the first deformation section 72 in the embodiment according to Figure 14 only partially surrounds the deformation section 72 from the deformation section 74 in the embodiment according to Figure 15 completely surrounded in the circumferential direction. However, the deformation section 72 can, for example, extend from the outer circumferential surface 50 to the inner circumferential surface 52.
[0127] In cross-section, the deformation section 72 has an approximately elliptical shape.
[0128] The embodiment according to Figure 16 differs from the embodiment according to Figure 14by the fact that the first deformation section 72 is arranged within a recess of the second deformation section 74, which in turn is arranged within a recess of the base body of the attachment element 22 forming a third deformation section 76. The second deformation section 74 forms, in a sense, a transition section from the first deformation section 72 to the third deformation section 76, wherein this deformation section 76 is connected to the second deformation section 74 in the embodiment according to Figure 14 corresponds.
[0129] In particular, the deformability at the second deformation section 74 is lower than at the first deformation section 72, and the deformability of the third deformation section 76 is lower than at the second deformation section 74.
[0130] The embodiment according to Figure 17 differs from the embodiment according to 15 in that, as in the embodiment according to Figure 16Three deformation sections 72 to 76 are provided. Deformation section 72 is completely surrounded by deformation section 74, and deformation section 74 is completely surrounded by deformation section 76. The deformability of the system element 72 increases from the first deformation section 72 through the second deformation section 74 to the third deformation section 76.
[0131] It may be intended that the deformability increases discretely between adjacent deformation sections. A continuous increase in deformability may be provided.
[0132] The system element 22 according to the embodiment according to Figure 18 has a basic body 78, the shape of which largely corresponds to the shape of the plant element according to the Figures 11 to 13This is consistent. The sleeve-shaped section 64 with the support members 66 is provided. However, no deformation area 58 and, in particular, no through-opening 62 are arranged on the support members 66.
[0133] In the recess 70, a further section 80 of the system element 22 is positioned, against which the rod element 18 rests. Section 80 has a higher deformability than the base body 78 and forms a trough-shaped recess for the rod element 18.
[0134] In the embodiments according to the Figures 14 and 18 It is possible that the individual sections of the system element 22 are formed separately and connected to each other. Alternatively, a single-piece design of the respective system element 22 is conceivable. Reference symbol list:
[0135] 10 Fixation system 12 Anchoring element 14 Bone screw 16 Stabilizing element 18 Rod element 20 Swivel body 22 Mounting element 24 Anchoring section 26 Receiving section 28 Head 30 Mounting area 32, 34 Axis 36 Segment 38 Internal thread 40 Through opening 42 Axis 44 Fixing element 47 Fixing direction 46 Screw element 48 Axis 50, 52 Circumferential surface 54, 56 Mounting area 55, 57 Mounting element section 58 Deformation area 59 Separation plane 60 Plane of symmetry 62 Through opening 64 Section 66 Support member 68 Mounting area 70 Recess 72, 74, 76 Deformation section 78 Base body 80 Section
Claims
1. Surgical fixation system, comprising at least one anchoring element (12) with an anchoring portion (24) for anchoring to a bone (20) and with a receiving portion (26) for a stabilization element (16) for connecting to a further anchoring element (12), wherein the stabilization element (16) is arrangeable in the receiving portion (26) and is fixable therein by means of a fixing element (44), wherein the fixation system (10) comprises an abutment element (22) that is arranged on the receiving portion (26) and abuts against the anchoring portion (24) for the placement of the stabilization element (16), wherein the abutment element (22) has at least one deformation region (58) for deforming in dependence on a fixing force of the fixing element (44) acting on the stabilization element (16), wherein the abutment element (22) is of sleeve-shaped configuration at least in sections and has on an end face an abutment region (54) for the stabilization element (16), wherein at least one deformation region (58) is arranged beneath the abutment region (54) of the abutment element (22) for the stabilization element (16), characterized in that the at least one deformation region (58) is formed by or comprises at least one material recess on the abutment element (22).
2. Fixation system in accordance with Claim 1, characterized in that the abutment element (22) a) is formed separate from the receiving portion (26) and is arranged in the receiving portion (26) or in that the receiving portion (26) comprises or forms the abutment element (22) and / or b) is of elastically or plastically deformable configuration at the at least one deformation region (58).
3. Fixation system in accordance with any one of the preceding Claims, characterized in that at least one deformation region (58) is arranged at an abutment region (54) of the abutment element (22) for the stabilization element (16).
4. Fixation system in accordance with any one of the preceding Claims, characterized in that at least one deformation region (58) is arranged at or laterally next to a lateral abutment region (68) for the stabilization element (16).
5. Fixation system in accordance with any one of the preceding Claims, characterized in that the abutment element (22) comprises a first abutment element portion (55) facing toward the stabilization element (16) and a second abutment portion (57) facing toward the anchoring portion (12), wherein the first abutment element portion (55) comprises or forms the at least one deformation region (58) and has a higher deformability as a result of the fixing force than the second abutment element portion (57).
6. Fixation system in accordance with Claim 5, characterized by a) a portion boundary, which is discrete with respect to the deformability of the abutment element (22), between the first abutment element portion (55) and the second abutment element portion (57), wherein, in particular, the portion boundary is oriented transversely and, in particular, perpendicularly to a fixing direction of the fixing element (44) in the direction of the anchoring portion (24), or b) a transition portion, which is present with respect to the deformability of the abutment element (22), by way of which the first abutment element portion (55) and the second abutment element portion (57) merge into one another.
7. Fixation system in accordance with any one of the preceding Claims, characterized in that the at least one deformation region (58) has an extent in parallel to an abutment region (54) of the abutment element (22) for the stabilization element (16).
8. Fixation system in accordance with any one of the preceding Claims, characterized in that the at least one deformation region (58) is arranged or formed symmetrically on the abutment element (22) with respect to a symmetry plane (60) containing an axis (34) of the receiving portion and / or the abutment element (22).
9. Fixation system in accordance with Claim 8, characterized in that the material recess a) is a recess on a surface of the abutment element (22), wherein the abutment element (22) is deformable at the rim of the recess. or b) is or comprises a through-opening (62) of the abutment element (22), wherein, in particular, the through-opening (62) has a circular, elliptical, oval, round, elongate hole-shaped, or non-round cross section, or c) is a cavity that is formed in the abutment element (22) and is enclosed on all sides, wherein, in particular, the cavity has a circular, elliptical, oval, round, elongate hole-shaped, or non-round cross section.
10. Fixation system in accordance with Claim 8 or 9, characterized in that the material recess a) has an extent along the stabilization element (16) arranged in the receiving portion (26) and / or b) has an extent radially to an axis (48) defined by the abutment element (22).
11. Fixation system in accordance with any one of the preceding Claims, characterized in that the abutment element (22) comprises two or more deformation portions (72, 74, 76), which comprise or are made of different materials with respect to their deformability, wherein the at least one deformation region (58) is formed as a result of the materially different quality of the two or more deformation portions (72, 74, 76), wherein, in particular, a) the two or more deformation portions (72, 74, 76) are deformation portions of the abutment element (22) that are formed separate from one another and are joined to one another, wherein, in particular, a first deformation portion (72) is provided, which is at least partially surrounded by at least one second deformation portion (74), wherein the deformability of the first deformation portion (72) is greater than the deformability of the at least one second deformation portion (74), and / or b) three or more deformation portions (72, 74, 76) are provided, wherein the deformability of a respective deformation portion (72, 74, 76) that at least partially surrounds a further deformation portion (72, 74, 76) is lesser than the deformability of the surrounded deformation portion (72, 74, 76).
12. Fixation system in accordance with any one of the preceding Claims, characterized in that the abutment element (22) comprises a plurality of deformation regions (58), in particular with a plurality of material recesses, wherein, in particular, a) two or more identically configured deformation regions (58) are provided and / or wherein two or more differently configured deformation regions (58) are provided and / or b) two deformation regions (58) are provided, which are arranged on the abutment element (22) at a distance from one another and in alignment with one another.
13. Fixation system in accordance with any one of the preceding Claims, characterized in that the abutment element (22) a) has two diametrically opposed deformation regions (58) and / or b) comprises two support members (66) arranged at a distance from one another, which laterally delimit a tapering depression (70), wherein the stabilization element (16) is positionable between the support members (66) in the depression (70), wherein a deformation region (58) is preferably arranged on at least one support member (66), and / or c) is oriented or orientable coaxially to the receiving portion (26) and / or to the anchoring portion (24).
14. Fixation system in accordance with any one of the preceding Claims, characterized in that the anchoring portion (24) and the abutment element (22) comprise abutment regions (30, 56) that are adapted to one another and, in particular, are spherical cup-shaped at least in sections.
15. Fixation system in accordance with any one of the preceding Claims, characterized in that a) the fixation system comprises at least one of the following: - two or more anchoring elements (12); - two or more abutment elements (22); - at least one stabilization element (16), in particular a plurality of stabilization elements (16); - at least one fixing element (44), in particular a plurality of fixing elements (44); and / or b) at least one of the following applies: - the at least one anchoring element (12) is a bone screw (14); - the at least one stabilization element (16) is a rod element (18); - the at least one fixing element (44) is a screw element (46) that is screwable to the receiving portion (26).