WO2012048690A1 - Dynamische stabilisierungseinrichtung für die wirbelsäule - Google Patents
Dynamische stabilisierungseinrichtung für die wirbelsäule Download PDFInfo
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- WO2012048690A1 WO2012048690A1 PCT/DE2011/050036 DE2011050036W WO2012048690A1 WO 2012048690 A1 WO2012048690 A1 WO 2012048690A1 DE 2011050036 W DE2011050036 W DE 2011050036W WO 2012048690 A1 WO2012048690 A1 WO 2012048690A1
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- WIPO (PCT)
- Prior art keywords
- dynamic
- stabilization device
- spring elements
- dynamic stabilization
- rigid
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/701—Longitudinal elements with a non-circular, e.g. rectangular, cross-section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
Definitions
- the invention relates to a dynamic stabilization device for bones, in particular for the spine.
- Degenerative diseases of the spine are today often treated by a stiffening operation.
- two or more vertebrae are rigidly connected to one another with the aid of an implant system, with the aim of achieving a bony connection of the vertebral bodies.
- An alternative way of treatment is to stabilize the vertebrae semi-rigidly (dynamically) with each other while allowing residual mobility without inducing immediate fusion.
- a device for dynamic stabilization of the spinal column is known.
- This device consists of at least two pedicle screws, a prestressed plastic band and a spacer surrounding the plastic band.
- the use of the combination of the prestressed band together with the spacer allows no or only a very limited positional correction of the vertebral bodies to each other.
- the intraoperative adjustment of the correct length of the spacer is expensive, an adaptation of the length of the spacer or the plastic band to the movement of the patient is virtually impossible.
- a system of this type therefore greatly limits the desired flexion, extension and lateral inclination movements, whereas it can hardly stabilize the actually limiting movements such as axial rotation and translation in the AP direction.
- an implant for fracture treatment consists of two bone anchors and a spacer mounted therebetween or a bush which serves for the (temporary) pretensioning of a connecting part located therein or as a rigid guide.
- the connecting part located between the bone anchors consists of one or more spring elements.
- the implant has the task of rigidly connecting bone fragments under tensile stress and accelerating fracture healing by maintaining a pressure force between the bone fragments.
- An implant with this arrangement allows only a bias of bone components or a minimal translation in the longitudinal direction. A dynamic stabilization of vertebral bodies is thus not possible.
- the object of the present invention is to provide a stabilization system, in particular for the spine, which on the one hand develops a sufficiently high stabilizing effect, on the other hand allows the physiological range of motion of one or more spinal segments and endures the loads or movements that occur without fatigue.
- the connecting element underlying the stabilizing device must in particular be insensitive to bending and significant changes in length.
- the connecting element should optionally be provided with a rigid connecting element, e.g. a rod or tube can be combined, which is used for the fusing supply of one or more vertebrae. With this combination, a dynamically stabilized transition between a fusion path and an untreated portion of the spine can be realized.
- the connecting element of the stabilization device consists of two or more spring elements arranged largely in the same direction which each have a high axial elasticity and can be connected to the spinal column via bone anchors.
- the same direction arrangement of the spring elements allowed by adjusting the number of spring elements, the adjustment of the stiffness against bending and change in length.
- the spring elements may consist of layered, corrugated strips and be arranged so that they experience different change in length relative to each other under bending stress. Since the spring elements are separated from each other there are no shear stresses between the individual layers which would reduce the fatigue strength.
- To connect the spring elements a distance can be provided between the individual layers, which allows the connecting elements to be inserted into one another or to be positively connected to a rigid connecting element or a bone anchor.
- An alternative coupling between dynamic and fusion supply can take place in that the elastic connecting element is passed through the rigid fixing element without being firmly connected.
- connection element in the present invention is the high elasticity in longitudinal and bending stress and a high fatigue strength with high stabilization effect. This allows a permanent, physiological stabilization of the spine and thus a reduction of stress on the treated segments and their neighboring segments.
- the connecting element according to the invention can be easily shortened intraoperatively or extended form-fitting by attaching further connecting elements. Due to the layered structure, the connecting element can also be adapted with little force to the contour of the spinal column, wherein a fixation of the contour is achieved, for example, by screwing with the bone anchors (for example pedicle screws).
- Fig. 1 shows the implantable invention for stabilizing two vertebrae.
- Fig. 2 illustrates various embodiments of the implantable dynamic rod, in which case the arrangements of the spring elements will be described. Furthermore, it is shown here how the rod according to the invention can be extended.
- Fig. 3 shows two further embodiments and an example of how the rod can be bent.
- Fig. 4 illustrates various mounting possibilities of the dynamic rod with pedicle screws.
- Fig. 5 shows various variants of the combination of an elastic rod with a rigid rod.
- Fig. 6 shows a further variant of the combination of an elastic rod with a rigid rod for increasing the range of movement of a neighboring segment following the rigid rod
- Fig. 7 illustrates an alternative embodiment in which the spring elements can be moved and fixed in a desired position.
- FIG. 8 shows a two or more segmental dynamic supply with the implant shown in FIG. 7.
- the connecting element (3) serves for the dynamic connection of at least two vertebrae (1) and is used with at least two bone anchors (2) (FIG. 1).
- the pedicle screw (2) consists essentially of a screw shaft (22) with bone thread (21), a head (23) and a locking device (24) for fixing with the connecting element (3).
- the connecting element also referred to below as rod (3), consists of at least two spring elements (31) arranged in parallel. In a preferred arrangement, there is a gap (32) between the spring elements.
- the spring elements (31) can be encased (30) (FIG. 2) for stabilization with one another, to prevent tissue growing in and for improved handling with an elastic material (for example silicone, PCU, PE).
- the spring elements (31) are preferably made of a material with high elasticity and / or strength such as Nitinol, PEEK, carbon fibers, titanium or a titanium alloy, a high strength implant steel or CoCr or a CoCrNi alloys.
- the spring elements (31) are preferably designed as a wave-shaped pattern.
- connection (33) of two bars an overlapping area (333) is created, in which a positive connection between the two bars (331 and 332) is created.
- the intermediate spaces (32) must either be freed from the casing before a joining operation or be encased from the outset.
- a clamping mechanism (334) can be applied, which exerts a clamping force or an external positive connection on the connection region (333).
- the spring elements (31) can be arranged in different numbers and distances (34).
- Preferred variants are a simple parallel arrangement (341), a parallel arrangement of spring element pairs (342) and the parallel arrangement of spring elements in both orthogonal directions to the rod axis (343) (FIG. 2). Due to the division of the spring elements in a second plane, the variant (343) has a high bending elasticity in a second bending direction transversely to the rod axis.
- the spring elements (31) can be designed so that the waveform at one or both ends have a different amplitude than in the middle. For connection to a bone anchor, it may also be advantageous to set the amplitude of the waveform at the ends to zero.
- the material thickness and the pitch of the wave form can vary in individual layers or over the longitudinal direction of the spring elements so that the bending stiffness, longitudinal stiffness and buckling tendency can be specifically varied or adjusted.
- the spring elements can be separated via one-piece (324) or two-part (321) gap elements (FIGS. 3, 351, 352).
- the two-part intermediate space elements (321) on the one hand have the negative profile of the spring element (31, 311), on the other, the second space profile side facing they are either flat or have a finer toothing (312).
- This arrangement allows the slight bending of the rod, since the individual layers of the spring elements can thereby move virtually shear forces against each other and thus can adapt to the radius of curvature.
- the locking of the desired curvature is effected by a clamping mechanism (334), as e.g. within a pedicle screw head (23) can be easily realized.
- these are designed such that they divide the differences of the spring elements (31), as inevitably arise in a curvature of the rod, e.g. by joints (323) or an inherent material elasticity (3520).
- the implant rod (3) according to the invention can be attached to heads of different design with bone anchors or pedicle screws.
- 4 shows different variants for connecting spring elements with wave-shaped ends in (411, 412, 421, 422)
- FIGS. 6 and 7 show possible connection variants with flat ends of the spring elements and slotted rod receptacles (5611, 5622, 5711, 5734).
- the heads (23) can be fixed (monoaxial) (42) as well as adjustable in angle (polyaxial) (41) connected to the bone anchor shaft (22).
- the rod (3) in any, with respect to its axis of symmetry but preferably in a rotated by 0 ° or 90 ° orientation to the head (23) are attached.
- the head (23) of the polyaxial pedicle screw (41) has, in an exemplary embodiment, a recess (232) for the spherical screw shaft head (221), a clamping element (231) congruent with the screw shaft head (221) and a thread (233) for a fixing screw (23). 241).
- the support or recess (232) and the attachment to the fixing screw (241) are designed to be positively connected to the profile of the rod, e.g. through appropriate mold inserts.
- the screw shaft (22) has, for example, a head (234) which has the negative contour of the spring elements (31) of the rod (3).
- These profiles vary depending on the orientation, for example (2341) for the 0 ° and (2342) for the 90 ° orientation of the rod (3).
- the rod can be inserted into the profile of the pedicle screw, so that the rod is prefixed due to the positive connection.
- the rod can be connected to the pedicle screw in a form-fitting manner, as shown in (421 and 422), for example, by means of a cap.
- the spinal segments can be stabilized purely dynamically, as shown for a single segment (51) and for two (or more) segments (52).
- rigid fixation distances can be combined with dynamic ranges (53, 54 and 55).
- the rigid rod segment (5321) has at its ends a possibility of connection to the spring elements (311), e.g. by a negative contour (5322) of the spring elements (311).
- the rigid rod (5321) shows the two dynamically stabilized terminal segments (5312 and 5334).
- the rigid bar segment (5321) may also have the same or compliant contour on the outer surfaces as the spring elements (311) of the bar of the present invention so that the rigid bar segment can be used with the same pedicle screws (e.g., 41).
- connection segments are mechanically decoupled from the rigid section (5423) on the basis of a passage opening (5422) of the rigid implant section.
- the dynamic connecting rod (3) is mounted between the superior (541) and inferior pedicle screw (544).
- the rigid section (5423) is located between the pedicle screws (541 and 544) and is exemplified by the pedicle screws (542 and 543).
- the rigid fixing element (5421) is characterized in that it has an end opening (5422) for the passage of a dynamic connecting element, without itself being firmly connected to it.
- a combination of variants (53) and (54) is shown, wherein a terminal segment is dynamically connected (5512) to a rigid rod section (5523).
- the extensibility of the dynamic portion (5512) can be extended by the length of the rigid portion (5523).
- the fatigue-free transmissible relative movement between the vertebral bodies can thereby be increased.
- the dynamic connecting element (3) is connected to the inferior pedicle screw (553) or the part of the rigid rod (5521) located there by means of a clamping piece (5524).
- Fig. 7 shows another embodiment (56) with wave-shaped spring elements (3) which are connected to the bar sections (5611 and 5622) via respective slots (5631 and 5632).
- the ends of the spring elements (3, 31, 5612) are formed flat and the rod sections (5611, 5622) provided with slots (5631, 5632).
- the slot width corresponds approximately to the strength of the spring elements (3, 31, 5612) to be accommodated therein.
- the spring elements with the rod portion of this can also include one or more centering means such as feather keys or pins (5640, 5740), which align the spring elements via corresponding recesses with the rod portion. In order to adapt the dynamic section (5612) to the anatomical conditions, this should be easily flexible.
- the resulting curvature results in a relative shifts of the spring elements (3) to each other and within the slots of the rod sections (5611, 5622).
- the rod sections are fixed with the aid of locking devices (24) located on the pedicle screw heads (23). This can be done for example by a force exerted by a screw on the rod portion force which compresses the slots and thereby spring elements (3), rod portion and head (23) non-positively and / or positively connected.
- a bi-segmental dynamic supply (57) according to the version shown in Fig. 7 is described.
- a bi-segmental assembly (57) consists of at least three pedicle screws (571, 572, and 573), with the rigid portion (5734) providing connectivity for additional pedicle screws (574).
- the remaining rigid section (5744) can be shortened in a conventional manner.
- the dynamic section is divided into two dynamic sections (5712 and 5723) by the attachment of a middle pedicle screw (572).
- the rod curvature can be flexibly adjusted with the provided rod guides (5731, 5732 and 5733) for the spring elements (3) with unfixed pedicle screw heads. The fixation of the heads ensures the position and orientation of the spring elements (3).
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Abstract
Description
Claims (15)
- Dynamische Stabilisierungseinrichtung (3) für Knochen, insbesondere für Wirbel, mit wenigstens zwei Bereichen die eine Verbindung mit einem Knochenverankerungselement (2) erlauben, dadurch gekennzeichnet dass die Stabilisierungseinrichtung (3) aus wenigstens zwei federelastischen Elementen (31) besteht die in Längsrichtung weitgehend wellenförmig ausgebildet sind und dabei mehrlagig geschichtet angeordnet sind, wobei die Richtung der Schichtung senkrecht zur Oberfläche verläuft die durch die Wellenberge definiert wird.
- Dynamische Stabilisierungseinrichtung nach Anspruch 1, dadurch gekennzeichnet dass die Federelemente (31) aus Blechstreifen oder Drähten mit rechteckigem oder rundem Querschnitt bestehen.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass die federelastischen Elemente (31) mit einem elastischen Werkstoff, insbesondere einem Polymer oder Silikon ummantelt oder darin eingebettet sind.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass die Amplitude der Wellenform zwischen einzelnen Federelementen oder zwischen verschiedenen Positionen in Längsrichtung der Federelemente unterschiedlich hoch ist.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass die Materialstärke oder Breite zwischen einzelnen Federelementen oder zwischen verschiedenen Position in Längsrichtung der Federelemente unterschiedlich ist.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass mindestens zwei Federelemente (31) innerhalb einer Stabilisierungseinrichtung (3) nebeneinander angeordnet sind (343), wobei die Richtung der Anordnung senkrecht zur Oberfläche verläuft die durch die Wellenberge- und Täler definiert wird.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass sich zwischen den Schichten der Federelemente (31) mindestens ein Abstandshalter (32) befindet.
- Dynamische Stabilisierungseinrichtung nach Anspruch 7, dadurch gekennzeichnet dass der bzw. die Abstandshalter (32) Aussparungen, Nuten oder eine Verzahnung beinhalteten.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass zwischen zwei dynamischen Stabilisierungseinrichtungen (3, 5312, 5334) und einer weitgehend rigiden Stabilisierungseinrichtung (5321) Verbindungsmöglichkeiten derart bestehen, so dass mit beiden Enden der rigiden Stabilisierungseinrichtung je eine dynamische Stabilisierungseinrichtung verbunden werden kann.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass eine dynamische Stabilisierungseinrichtung (3) an jeweils einem Ende mit einem Knochenanker verbunden ist und in einem dazwischenliegenden Bereich durch eine weitgehend rigide Stabilisierungseinrichtung (5421) hindurch führt ohne mit dieser fest verbunden zu sein.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass eine dynamische Stabilisierungseinrichtung (3) an jeweils einem Ende mit einem Knochenanker verbunden ist und in einem dazwischenliegenden Bereich durch eine weitgehend rigide Stabilisierungseinrichtung (5521) hindurch führt, wobei die dynamische Stabilisierungseinrichtung (3) an einer Stelle innerhalb der rigiden Stabilisierungseinrichtung fest mit selbiger verbunden ist.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass zur Verbindung der dynamischen Stabilisierungseinrichtung (3) mit dem Kopf (23) eines Knochenankers (2 bzw. 22) eine Stabaufnahme (5611, 5622, 5711, 5734) dient, die Stabaufnahme über Schlitze (5631, 5632, 5731, 5732, 5733) zur Aufnahme der Federelemente (31, 5612, 5712, 5723) verfügt, und der Umfang der Stabaufnahme hinsichtlich seiner Geometrie auf eine Aussparung (232) innerhalb des Kopfes (23) abgestimmt ist.
- Dynamische Stabilisierungseinrichtung nach Anspruch 12 dadurch gekennzeichnet, dass die Stabaufnahme (5611, 5622, 5711, 5734) Mittel (5640, 5740) beinhaltet, die die Federelemente (3, 31, 5612, 5712, 5723) mittig ausrichtet und führt.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass zur Verbindung der dynamischen Stabilisierungseinrichtung (3) mit dem Kopf (23, 234) eines Knochenankers (2 bzw. 22) eine formschlüssige Verbindung (2341, 2342) dient, wobei der Formschluss im Wesentlichen durch eine Negativkontur zur Wellenform der Federelemente (31) entsteht.
- Dynamische Stabilisierungseinrichtung nach einem der vorherigen Ansprüche, dadurch gekennzeichnet dass die Federelemente (31) durch eine Klammer (334) verbunden oder damit verstärkt werden können.
Priority Applications (1)
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DE112011104221.3T DE112011104221A5 (de) | 2010-09-23 | 2011-09-22 | Dynamische Stabilisierungseinrichtung für die Wirbelsäule |
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DE201010041264 DE102010041264A1 (de) | 2010-09-23 | 2010-09-23 | Dynamische Stabilisierungseinrichtung für die Wirbelsäule |
DE102010041264.3 | 2010-09-23 |
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WO2012048690A1 true WO2012048690A1 (de) | 2012-04-19 |
WO2012048690A4 WO2012048690A4 (de) | 2012-08-09 |
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Cited By (2)
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US20150080955A1 (en) * | 2013-09-16 | 2015-03-19 | Aesculap Ag | Connection element and spine stabilization system |
CN118044870A (zh) * | 2024-04-16 | 2024-05-17 | 四川大学华西医院 | 一种脊柱脱位复位装置 |
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US20150080955A1 (en) * | 2013-09-16 | 2015-03-19 | Aesculap Ag | Connection element and spine stabilization system |
US9532808B2 (en) * | 2013-09-16 | 2017-01-03 | Aesculap Ag | Connection element and spine stabilization system |
US10285736B2 (en) | 2013-09-16 | 2019-05-14 | Aesculap Ag | Connection element and spine stabilization system |
CN118044870A (zh) * | 2024-04-16 | 2024-05-17 | 四川大学华西医院 | 一种脊柱脱位复位装置 |
Also Published As
Publication number | Publication date |
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DE102010041264A1 (de) | 2012-03-29 |
WO2012048690A4 (de) | 2012-08-09 |
DE112011104221A5 (de) | 2014-02-20 |
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