US20120265247A1 - Flexible stabilization device for dynamic stabilization of bones or vertebrae - Google Patents
Flexible stabilization device for dynamic stabilization of bones or vertebrae Download PDFInfo
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- US20120265247A1 US20120265247A1 US13/425,153 US201213425153A US2012265247A1 US 20120265247 A1 US20120265247 A1 US 20120265247A1 US 201213425153 A US201213425153 A US 201213425153A US 2012265247 A1 US2012265247 A1 US 2012265247A1
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- rod
- sleeve
- stabilization device
- flexible stabilization
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- DGNORMGNXZBTMA-UHFFFAOYSA-N CC(C1)C=CC1C#C Chemical compound CC(C1)C=CC1C#C DGNORMGNXZBTMA-UHFFFAOYSA-N 0.000 description 1
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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
- A61B17/7019—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
-
- 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
- A61B17/702—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other having a core or insert, and a sleeve, whereby a screw or hook can move along the core or in the sleeve
-
- 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
-
- 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
- A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
-
- 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
- A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
- 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
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
-
- 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
Definitions
- the present disclosure relates to a flexible stabilization device for the dynamic stabilization of bones or vertebrae.
- a flexible stabilization device for stabilizing adjacent vertebrae is known from EP 0 669 109 B1.
- monoaxial bone screws placed in adjacent vertebrae are connected by an elastic strap.
- the strap is fastened to the bone screws in a pre-stressed manner.
- a support body which is resistant to compression surrounds the strap between the bone screws to transmit compressive forces.
- the support body, the heads of the bone screws and the elastic strap form a kind of joint allowing a limited motion of the vertebrae.
- US 2003/0220643 A1 discloses a device for connecting adjacent vertebral bodies in which monoaxial pedicle screws are interconnected by a spring.
- the spring allows spinal flexion and a limited degree of lateral bending and axial rotation while preventing spinal extension without the need of a transverse member.
- a sleeve is placed over the spring. Impingement between the sleeve and the pedicle screws assists the spring in preventing spinal extension.
- the length of the spring is predetermined. An adaptation in length by the surgeon is not possible.
- WO 2004/105577 A2 discloses a spine stabilization system with one or more flexible elements having an opening or slit in form of a helical pattern. Adjustments of the system with regard to its flexible characteristics are not possible during surgery.
- a bone anchoring device comprising a monoaxial bone screw and a flexible rod which is made of an elastic material is known from EP 1 364 622 A2.
- the elastic characteristics of the bone anchoring device are determined by material and the shape of the rod which cannot be modified by the surgeon. Furthermore, the use of monoaxial bone screws limits the possibility of adjustment of the position of the shaft relative to the rod.
- a flexible rod assembly including an inner rod and outer rod or sleeve made of an elastomeric material allows an adjustment of the elastic characteristics of the stabilization device to a large extent.
- a rod and a sleeve with appropriate elastic properties which can be different from each other an adaptation of the elastic properties of the rod construct to the motion of a specific spinal segment is possible.
- flexion and compression of the spine can be controlled by means of the elastic properties of the inner rod
- extension of the spine can be controlled by selection of an appropriate sleeve.
- the separation of the damping with regards to flexion/compression and extension movements results in a harmonic behaviour of the vertebral segments under motion control of the construct. As a consequence thereof loosening of the bone screws can be prevented.
- adjustment of the length of the inner rod and of the sleeve is possible.
- a modular system is provided which is allows adaptation at the time of surgery. In combination with polyaxial screws the possibilities of adjustment are further increased.
- FIG. 1 a shows a perspective exploded view of a rod construct according to an embodiment of the disclosure.
- FIG. 1 b shows the rod construct of FIG. 1 a in an assembled state.
- FIG. 2 shows an exploded view of a stabilization device comprising the rod construct of FIG. 1 a.
- FIG. 3 schematically shows in an exploded view the accommodation of the rod of FIG. 1 a in the receiving part of a polyaxial bone screw.
- FIG. 4 shows a sectional view of the assembled parts of FIG. 3 .
- FIG. 5 schematically shows the assembled stabilization device of FIG. 2 applied to adjacent vertebrae of the spinal column.
- FIG. 6 a schematically shows the stabilization device of FIG. 5 with the spinal column in flexion.
- FIG. 6 b schematically shows the stabilization device of FIG. 5 with the spinal column in extension.
- FIG. 7 schematically illustrates the directions of displacement of the rod construct of FIG. 1 b.
- FIG. 8 a schematically shows the rod construct in a state of flexion according to FIG. 6 a.
- FIG. 8 b schematically shows the rod construct in a state of extension according to FIG. 6 b.
- FIGS. 9 a and 9 b show a further example of application of the stabilization device in a top view.
- FIG. 10 shows modification of the rod construct in section.
- the flexible stabilization device includes a rod assembly including rod 20 made of an elastomeric material and a sleeve 40 which is also made of an elastomer material.
- the rod 20 has a cylindrical shape with a smooth surface. Due to the elastomer material, the rod is partially or fully flexible.
- the rod 20 can be made of a biocompatible plastic material such as a polymer on the basis of polyurethane, polysilicone or PEEK. A particularly suitable material is Polycarbonate Urethane.
- the material of the rod includes well-defined elastic properties and the rod shows bending elasticity, compressive elasticity and tensile elasticity.
- the elastomeric material of the sleeve 40 can also be a biocompatible plastic material such as a polymer on the basis of polyurethane, polysilicone or PEEK which includes elastic properties which can be selected independently of the elastic properties of the rod 20 .
- a biocompatible plastic material such as a polymer on the basis of polyurethane, polysilicone or PEEK which includes elastic properties which can be selected independently of the elastic properties of the rod 20 .
- Polycarbonate Urethane is particularly suitable.
- the sleeve 40 has a tube-like shape including a channel 41 the diameter of which is slightly larger than the outer diameter of the rod 20 so that the rod 20 can be inserted into the channel 41 as shown in FIG. 1 b .
- the length of the sleeve 40 is selected to be smaller than the length of the rod 20 such that a first connection section 20 a and a second connection section 20 b of the rod 20 protrude from the channel 41 in the assembled state as shown in FIG. 1 b .
- a section 20 c between the first connection section 20 a and the second connection section 20 b of the rod 20 is accommodated in the channel 41 of the sleeve 40 .
- the length of the sleeve 40 corresponds approximately to the distance between the receiving parts of the bone anchoring devices, or can be slightly larger.
- FIGS. 2 to 4 the connection of the rod 20 with the receiving part 6 of a bone anchoring element 1 is explained.
- the sleeve 40 is omitted in the illustration of FIG. 3 , for the purpose of describing the connection of the rod 20 with the receiving part 6 , the sleeve 40 is placed on the rod 20 before the latter is secured to the respective receiving parts 6 of the bone anchoring elements 1 .
- the bone anchoring element 1 in this embodiment is a polyaxial bone screw having a shank 2 with a bone thread, a tip 3 at one end and a spherical head 4 at the opposite end.
- a recess 5 for engagement with a screwing-in tool is provided at the side of the head 4 which is opposite to the shank.
- the receiving part 6 has a first end 7 and a second end 8 opposite to the first end and a longitudinal axis 9 intersecting the plane of the first end and the second end.
- a bore 10 is provided which extends from the first end 7 to a predetermined distance from the second end 8 .
- an opening 11 is provided the diameter of which is smaller than the diameter of the bore 10 .
- a spherical or otherwise tapering section 12 is provided adjacent of the opening 11 which forms a seat for the spherical head 4 .
- the receiving part 6 further has a U-shaped recess 13 which starts at the first end 7 and extends in the direction of the second end 8 to a predetermined distance from said second end 8 .
- a U-shaped recess 13 which starts at the first end 7 and extends in the direction of the second end 8 to a predetermined distance from said second end 8 .
- two free legs 14 , 15 are formed extending towards the first end 7 .
- Adjacent to the first end 7 the receiving part 6 comprises an internal thread 16 on said legs 14 , 15 .
- a first pressure element 17 which has a cylindrical construction with an outer diameter which is only slightly smaller than the inner diameter of the bore 10 to allow the first pressure element 17 to be introduced into the bore 10 of the receiving part 6 and to be moved in the axial direction.
- the pressure element 17 On its lower side facing towards the second end 8 , the pressure element 17 includes a spherical recess 18 the radius of which corresponds to the radius of the spherical head 4 of the bone screw.
- the first pressure element 17 On the opposite side, has a cylindrical recess 19 which extends transversely to the longitudinal axis 9 .
- the lateral diameter of this recess is selected such that the connection section 20 a or 20 b with a circular cross section, respectively, of the rod 20 which is to be received in the receiving part 6 can be inserted into the recess 19 and guided laterally therein.
- the depth of the cylindrical recess 19 is selected such that in an assembled state when the connection section 20 a or 20 b of the rod 20 is inserted and pressed against the bottom of the U-shaped recess 13 , the first pressure element 17 exerts a pressure on the head 5 . Further the depth is preferably about half of the diameter of the connection section 20 a or 20 b of the rod 20 .
- the first pressure element 17 has a coaxial bore 21 for guiding a screwing-in tool therethrough.
- the bone anchoring element 1 further comprises a second pressure element 23 with a first end 24 and a second end 25 .
- the width of the second pressure element 23 is such that the second pressure element 23 can be inserted into the U-shaped recess 13 of the receiving part 6 .
- two cylindrical projections 26 are provided which fit into the space limited by the internal thread 16 to slide along the internal thread 16 when the second pressure element 23 is inserted.
- the second pressure element 23 further includes a cylindrical recess 27 extending from the second end 25 in the direction towards the first end 24 the cylinder axis of which is perpendicular to that of the cylindrical projections 26 .
- the cylindrical projections 26 On the side of the second end 25 , the cylindrical projections 26 include lower edges 26 a .
- the diameter of the cylindrical recess 27 corresponds to the diameter of the connection section 20 a or 20 b of the rod 20 and its depth to half or less than half of the diameter of the connection section 20 a or 20 b.
- the bone anchoring element 1 further includes an inner screw 30 which can be screwed-in between the legs 14 , 15 .
- the internal thread 16 and the cooperating thread of the inner screw 30 can have any known thread shape. Using a flat thread or a negative angle thread can prevent splaying of the legs 14 , 15 .
- the receiving part 6 and the first pressure element 17 can have corresponding crimp bores 32 , 33 on opposite sides by means of which the screw 1 , the receiving part 6 and the first pressure element 17 can be loosely pre-assembled. As shown in FIGS. 3 and 4 the first pressure element 17 and the second pressure element 23 can have projections 22 , 28 , respectively, which can contribute to the fixation of the elastic rod 20 .
- the other parts of the flexible stabilization device except the rod 20 and the sleeve 40 can be made of the commonly used biocompatible materials, such as stainless steel or titanium or any other material suitable for a bone screw.
- the rod 20 and the sleeve 40 are selected and combined to achieve the desired elastic properties of the flexible stabilization device. If, for example, more than two vertebrae are to be connected, different sleeves 40 having different elastic properties can be selected and provided between different vertebrae. In this way, the elastic properties of the stabilization device can be adapted at the time of surgery.
- the sleeve 40 is selected to have a length corresponding to the distance of the two receiving parts when the pedicle screws are screwed into adjacent vertebrae. Since the rod 20 and the sleeve 40 are made of elastomeric material, shortening during surgery is possible.
- rod 20 with the sleeve 40 or, if more that one motion segment shall be stabilized via a single rod 20 , with a plurality of sleeves 40 is inserted into the receiving parts 6 of the bone anchoring elements.
- the sleeve 40 is in contact with the receiving parts 6 in the balanced position of the two adjacent vertebrae.
- the second pressure element 23 is inserted in the receiving part 6 and the inner screw 30 is screwed-in between the legs 14 , 15 .
- the inner screw 30 is tightened.
- the rod 20 is clamped between the first and the second pressure element 17 , 23 and simultaneously the head 4 of the bone screw is locked in its angular position.
- FIG. 5 the assembled stabilization device is shown with the rod 20 and the sleeve 40 arranged to connect two polyaxial pedicle screws which are placed in adjacent vertebrae W Ruining a motion segment.
- the positions of the shanks of the pedicle screws are indicated by dash-dotted lines.
- the receiving parts 6 of the bone anchoring elements 1 have a distance x in the balanced position in which the rod 20 and the sleeve 40 are in an unstressed state.
- FIG. 6 a shows the stabilization device when flexion takes place.
- tensile stress is applied to the rod 20 resulting in an elongation of the rod 20 .
- the distance between the bone anchoring elements is increased to x+ ⁇ X 1 .
- the increase ⁇ X 1 in the distance is limited by the restoring force produced by the rod 20 due to its elastic properties.
- the increase in the distance can be, for example, in the range of approximately 1.5 mm.
- flexion/compression is controlled mainly by the inner rod 20 .
- FIG. 6 b shows the stabilization device when extension takes place.
- a compressive force is applied to the rod 20 and the sleeve 40 by the receiving parts 6 of the bone anchoring elements 1 .
- the elasticity of the rod 20 and the sleeve 40 allows the distance between the receiving parts 6 to decrease to a distance x ⁇ x 2 .
- Due to the elastic properties of the rod 20 and the sleeve 40 a restoring force acts on the receiving parts 6 which limits the decrease of the distance.
- the distance can, for example, decrease by approximately 0.5 mm.
- extension is controlled by the compressibility of the inner rod 20 and is limited by the sleeve.
- the sleeve 40 can be pre-compressed in the balanced state and/or the rod 20 can be pre-stressed in the balanced state.
- FIG. 7 illustrates the possible deformations which the rod 20 and the sleeve 40 can undergo.
- FIGS. 8 a and 8 b show the deformation of the rod 20 and the sleeve 40 in flexion ( FIG. 8 a ) and in extension ( FIG. 8 b ).
- FIGS. 9 a and 9 b show an example of application of the stabilization device.
- FIG. 9 a shows two adjacent vertebrae V, V′ which are medio-laterally inclined with respect to each other in the case of the presence of scoliosis.
- segment rods 200 , 200 ′ with different sleeves 400 , 400 ′ can be used on the left side and on the right side.
- the sleeve 400 used on the left side rod 200 has a length which is greater than the length of sleeve 400 ′ used on the right side rod 200 ′. In this manner, it is possible to eliminate the inclination of two vertebrae on the left side.
- the outer diameter of the sleeve 400 can be different from that of the sleeve 400 ′ in order to have a different motion control with respect to the left side and the right side.
- the sleeve 40 has the shape of a hollow cylinder; however, different shapes of the sleeve are possible. For example, a barrel-shape is possible.
- the length of the sleeve can differ from the embodiment shown.
- the rod 20 may also have a rectangular, square, oval or triangular cross-section or any other appropriate shape of the cross-section.
- the shape of the sleeve 40 is appropriately adapted.
- the rod 20 and the sleeve 40 can be formed to be highly flexible or hardly flexible.
- FIG. 10 shows an example of an inner rod 201 having a corrugated surface, with corrugations 300 provided in the circumferential direction.
- the inner wall of the sleeve 401 has corresponding corrugations cooperating with that of the rod. This prevents or reduces a displacement of the sleeve relative to the rod.
- connection of the shanks 2 of the bone anchoring elements 1 to the respective receiving parts 6 is polyaxial.
- the bone anchoring element 1 is introduced from the top into the receiving part 6 .
- the bone anchoring element 1 can also be introduced from the bottom of the receiving part 6 if the receiving part 6 is constructed to allow this.
- the head of the bone anchoring element and the shaft can be constructed as separate parts which can be connected.
- the present disclosure is not limited to screws as bone anchoring elements but can be realized with bone hooks or any other bone anchoring element.
Abstract
A flexible stabilization device for dynamic stabilization of bones or vertebrae is provided comprising a rod construct including a rod made of an elastomeric material the rod having a first connection section, a second connection section and a third section therebetween, the first and second connection sections being connectable with a bone anchoring device, respectively, and a sleeve provided on at least a portion of the third section of the rod such that at least the first and second connection sections are exposed.
Description
- This application is a continuation of allowed U.S. patent application Ser. No. 11/642,566, filed Dec. 19, 2006, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/753,620, filed Dec. 23, 2005, and claims priority from European Patent Application EP05028283, filed Dec. 23, 2005, the entire disclosures of which are incorporated herein by reference.
- The present disclosure relates to a flexible stabilization device for the dynamic stabilization of bones or vertebrae.
- A flexible stabilization device for stabilizing adjacent vertebrae is known from EP 0 669 109 B1. In this stabilization device monoaxial bone screws placed in adjacent vertebrae are connected by an elastic strap. The strap is fastened to the bone screws in a pre-stressed manner. A support body which is resistant to compression surrounds the strap between the bone screws to transmit compressive forces. The support body, the heads of the bone screws and the elastic strap form a kind of joint allowing a limited motion of the vertebrae.
- US 2003/0220643 A1 discloses a device for connecting adjacent vertebral bodies in which monoaxial pedicle screws are interconnected by a spring. The spring allows spinal flexion and a limited degree of lateral bending and axial rotation while preventing spinal extension without the need of a transverse member. A sleeve is placed over the spring. Impingement between the sleeve and the pedicle screws assists the spring in preventing spinal extension. The length of the spring is predetermined. An adaptation in length by the surgeon is not possible.
- WO 2004/105577 A2 discloses a spine stabilization system with one or more flexible elements having an opening or slit in form of a helical pattern. Adjustments of the system with regard to its flexible characteristics are not possible during surgery.
- A bone anchoring device comprising a monoaxial bone screw and a flexible rod which is made of an elastic material is known from EP 1 364 622 A2. The elastic characteristics of the bone anchoring device are determined by material and the shape of the rod which cannot be modified by the surgeon. Furthermore, the use of monoaxial bone screws limits the possibility of adjustment of the position of the shaft relative to the rod.
- Based on the above, there is a need for a flexible stabilization device for dynamic stabilization of bones or vertebrae which allows modification of the elastic characteristics of the device and at the same time the adaptation of the length of the rod construct during the surgical operation.
- A flexible rod assembly including an inner rod and outer rod or sleeve made of an elastomeric material allows an adjustment of the elastic characteristics of the stabilization device to a large extent. By means of selection of a rod and a sleeve with appropriate elastic properties which can be different from each other an adaptation of the elastic properties of the rod construct to the motion of a specific spinal segment is possible. In particular, flexion and compression of the spine can be controlled by means of the elastic properties of the inner rod, whereas extension of the spine can be controlled by selection of an appropriate sleeve. The separation of the damping with regards to flexion/compression and extension movements results in a harmonic behaviour of the vertebral segments under motion control of the construct. As a consequence thereof loosening of the bone screws can be prevented. Additionally, adjustment of the length of the inner rod and of the sleeve is possible. Hence, a modular system is provided which is allows adaptation at the time of surgery. In combination with polyaxial screws the possibilities of adjustment are further increased.
- Further features and advantages of the disclosure will become apparent and will be best understood by reference to the following detailed description of embodiments taken in conjunction with the accompanying drawings.
-
FIG. 1 a shows a perspective exploded view of a rod construct according to an embodiment of the disclosure. -
FIG. 1 b shows the rod construct ofFIG. 1 a in an assembled state. -
FIG. 2 shows an exploded view of a stabilization device comprising the rod construct ofFIG. 1 a. -
FIG. 3 schematically shows in an exploded view the accommodation of the rod ofFIG. 1 a in the receiving part of a polyaxial bone screw. -
FIG. 4 shows a sectional view of the assembled parts ofFIG. 3 . -
FIG. 5 schematically shows the assembled stabilization device ofFIG. 2 applied to adjacent vertebrae of the spinal column. -
FIG. 6 a schematically shows the stabilization device ofFIG. 5 with the spinal column in flexion. -
FIG. 6 b schematically shows the stabilization device ofFIG. 5 with the spinal column in extension. -
FIG. 7 schematically illustrates the directions of displacement of the rod construct ofFIG. 1 b. -
FIG. 8 a schematically shows the rod construct in a state of flexion according toFIG. 6 a. -
FIG. 8 b schematically shows the rod construct in a state of extension according toFIG. 6 b. -
FIGS. 9 a and 9 b show a further example of application of the stabilization device in a top view. -
FIG. 10 shows modification of the rod construct in section. - As shown in
FIGS. 1 a and 1 b, the flexible stabilization device includes a rodassembly including rod 20 made of an elastomeric material and asleeve 40 which is also made of an elastomer material. In the embodiment shown, therod 20 has a cylindrical shape with a smooth surface. Due to the elastomer material, the rod is partially or fully flexible. For example, therod 20 can be made of a biocompatible plastic material such as a polymer on the basis of polyurethane, polysilicone or PEEK. A particularly suitable material is Polycarbonate Urethane. The material of the rod includes well-defined elastic properties and the rod shows bending elasticity, compressive elasticity and tensile elasticity. - The elastomeric material of the
sleeve 40 can also be a biocompatible plastic material such as a polymer on the basis of polyurethane, polysilicone or PEEK which includes elastic properties which can be selected independently of the elastic properties of therod 20. Also for thesleeve 40, Polycarbonate Urethane is particularly suitable. Thesleeve 40 has a tube-like shape including achannel 41 the diameter of which is slightly larger than the outer diameter of therod 20 so that therod 20 can be inserted into thechannel 41 as shown inFIG. 1 b. The length of thesleeve 40 is selected to be smaller than the length of therod 20 such that afirst connection section 20 a and asecond connection section 20 b of therod 20 protrude from thechannel 41 in the assembled state as shown inFIG. 1 b. Asection 20 c between thefirst connection section 20 a and thesecond connection section 20 b of therod 20 is accommodated in thechannel 41 of thesleeve 40. Preferably the length of thesleeve 40 corresponds approximately to the distance between the receiving parts of the bone anchoring devices, or can be slightly larger. - With reference to
FIGS. 2 to 4 the connection of therod 20 with thereceiving part 6 of a bone anchoring element 1 is explained. Although thesleeve 40 is omitted in the illustration ofFIG. 3 , for the purpose of describing the connection of therod 20 with thereceiving part 6, thesleeve 40 is placed on therod 20 before the latter is secured to the respective receivingparts 6 of the bone anchoring elements 1. - The bone anchoring element 1 in this embodiment is a polyaxial bone screw having a
shank 2 with a bone thread, atip 3 at one end and a spherical head 4 at the opposite end. A recess 5 for engagement with a screwing-in tool is provided at the side of the head 4 which is opposite to the shank. Thereceiving part 6 has a first end 7 and asecond end 8 opposite to the first end and alongitudinal axis 9 intersecting the plane of the first end and the second end. Coaxially with the longitudinal axis 9 abore 10 is provided which extends from the first end 7 to a predetermined distance from thesecond end 8. At thesecond end 8 anopening 11 is provided the diameter of which is smaller than the diameter of thebore 10. A spherical or otherwise taperingsection 12 is provided adjacent of theopening 11 which forms a seat for the spherical head 4. - The receiving
part 6 further has aU-shaped recess 13 which starts at the first end 7 and extends in the direction of thesecond end 8 to a predetermined distance from saidsecond end 8. By means of theU-shaped recess 13 twofree legs part 6 comprises aninternal thread 16 on saidlegs - As can be seen in
FIG. 3 , afirst pressure element 17 is provided which has a cylindrical construction with an outer diameter which is only slightly smaller than the inner diameter of thebore 10 to allow thefirst pressure element 17 to be introduced into thebore 10 of the receivingpart 6 and to be moved in the axial direction. On its lower side facing towards thesecond end 8, thepressure element 17 includes aspherical recess 18 the radius of which corresponds to the radius of the spherical head 4 of the bone screw. On the opposite side, thefirst pressure element 17 has acylindrical recess 19 which extends transversely to thelongitudinal axis 9. The lateral diameter of this recess is selected such that theconnection section rod 20 which is to be received in the receivingpart 6 can be inserted into therecess 19 and guided laterally therein. The depth of thecylindrical recess 19 is selected such that in an assembled state when theconnection section rod 20 is inserted and pressed against the bottom of theU-shaped recess 13, thefirst pressure element 17 exerts a pressure on the head 5. Further the depth is preferably about half of the diameter of theconnection section rod 20. As can be seen inFIG. 3 , thefirst pressure element 17 has acoaxial bore 21 for guiding a screwing-in tool therethrough. - As shown in
FIGS. 3 and 4 , the bone anchoring element 1 further comprises asecond pressure element 23 with afirst end 24 and asecond end 25. The width of thesecond pressure element 23 is such that thesecond pressure element 23 can be inserted into theU-shaped recess 13 of the receivingpart 6. On opposite sides of thesecond pressure element 23 twocylindrical projections 26 are provided which fit into the space limited by theinternal thread 16 to slide along theinternal thread 16 when thesecond pressure element 23 is inserted. - As can be seen in
FIG. 2 , thesecond pressure element 23 further includes acylindrical recess 27 extending from thesecond end 25 in the direction towards thefirst end 24 the cylinder axis of which is perpendicular to that of thecylindrical projections 26. On the side of thesecond end 25, thecylindrical projections 26 includelower edges 26 a. The diameter of thecylindrical recess 27 corresponds to the diameter of theconnection section rod 20 and its depth to half or less than half of the diameter of theconnection section - The bone anchoring element 1 further includes an
inner screw 30 which can be screwed-in between thelegs internal thread 16 and the cooperating thread of theinner screw 30 can have any known thread shape. Using a flat thread or a negative angle thread can prevent splaying of thelegs - The receiving
part 6 and thefirst pressure element 17 can have corresponding crimp bores 32, 33 on opposite sides by means of which the screw 1, the receivingpart 6 and thefirst pressure element 17 can be loosely pre-assembled. As shown inFIGS. 3 and 4 thefirst pressure element 17 and thesecond pressure element 23 can haveprojections elastic rod 20. - The other parts of the flexible stabilization device except the
rod 20 and thesleeve 40 can be made of the commonly used biocompatible materials, such as stainless steel or titanium or any other material suitable for a bone screw. - In use, at least two bone anchoring devices are anchored into the bone. Next, the
rod 20 and thesleeve 40 are selected and combined to achieve the desired elastic properties of the flexible stabilization device. If, for example, more than two vertebrae are to be connected,different sleeves 40 having different elastic properties can be selected and provided between different vertebrae. In this way, the elastic properties of the stabilization device can be adapted at the time of surgery. Preferably, thesleeve 40 is selected to have a length corresponding to the distance of the two receiving parts when the pedicle screws are screwed into adjacent vertebrae. Since therod 20 and thesleeve 40 are made of elastomeric material, shortening during surgery is possible. Then,rod 20 with thesleeve 40 or, if more that one motion segment shall be stabilized via asingle rod 20, with a plurality ofsleeves 40 is inserted into the receivingparts 6 of the bone anchoring elements. Preferably, in the balanced position of the two adjacent vertebrae, thesleeve 40 is in contact with the receivingparts 6. - Thereafter, the
second pressure element 23 is inserted in the receivingpart 6 and theinner screw 30 is screwed-in between thelegs inner screw 30 is tightened. By the pressure exerted by theinner screw 30 onto thesecond pressure element 23, therod 20 is clamped between the first and thesecond pressure element - Next, with reference to
FIGS. 5 to 8 b the elastic properties of the flexible stabilization device are described. InFIG. 5 the assembled stabilization device is shown with therod 20 and thesleeve 40 arranged to connect two polyaxial pedicle screws which are placed in adjacent vertebrae W Ruining a motion segment. The positions of the shanks of the pedicle screws are indicated by dash-dotted lines. As can be seen inFIG. 5 , the receivingparts 6 of the bone anchoring elements 1 have a distance x in the balanced position in which therod 20 and thesleeve 40 are in an unstressed state. -
FIG. 6 a shows the stabilization device when flexion takes place. During flexion, tensile stress is applied to therod 20 resulting in an elongation of therod 20. The distance between the bone anchoring elements is increased to x+ΔX1. The increase ΔX1 in the distance is limited by the restoring force produced by therod 20 due to its elastic properties. The increase in the distance can be, for example, in the range of approximately 1.5 mm. Hence, flexion/compression is controlled mainly by theinner rod 20. -
FIG. 6 b shows the stabilization device when extension takes place. During extension, a compressive force is applied to therod 20 and thesleeve 40 by the receivingparts 6 of the bone anchoring elements 1. The elasticity of therod 20 and thesleeve 40 allows the distance between the receivingparts 6 to decrease to a distance x−Δx2. Due to the elastic properties of therod 20 and thesleeve 40, a restoring force acts on the receivingparts 6 which limits the decrease of the distance. The distance can, for example, decrease by approximately 0.5 mm. Hence, extension is controlled by the compressibility of theinner rod 20 and is limited by the sleeve. - In an alternative manner of application, the
sleeve 40 can be pre-compressed in the balanced state and/or therod 20 can be pre-stressed in the balanced state. -
FIG. 7 illustrates the possible deformations which therod 20 and thesleeve 40 can undergo.FIGS. 8 a and 8 b show the deformation of therod 20 and thesleeve 40 in flexion (FIG. 8 a) and in extension (FIG. 8 b). -
FIGS. 9 a and 9 b show an example of application of the stabilization device.FIG. 9 a shows two adjacent vertebrae V, V′ which are medio-laterally inclined with respect to each other in the case of the presence of scoliosis. To dynamically stabilize and correct such a motion,segment rods different sleeves sleeve 400 used on theleft side rod 200 has a length which is greater than the length ofsleeve 400′ used on theright side rod 200′. In this manner, it is possible to eliminate the inclination of two vertebrae on the left side. In addition, the outer diameter of thesleeve 400 can be different from that of thesleeve 400′ in order to have a different motion control with respect to the left side and the right side. - Further modifications of the above described embodiments are possible. In the embodiment described before, the
sleeve 40 has the shape of a hollow cylinder; however, different shapes of the sleeve are possible. For example, a barrel-shape is possible. The length of the sleeve can differ from the embodiment shown. Therod 20 may also have a rectangular, square, oval or triangular cross-section or any other appropriate shape of the cross-section. In this case, the shape of thesleeve 40 is appropriately adapted. In particular, it is possible to form therod 20 and/or thesleeve 40 with the shape varying in the longitudinal direction. Therod 20 and thesleeve 40 can be formed to be highly flexible or hardly flexible. - The surface of the
rod 20 and/or thesleeve 40 can be textured or structured.FIG. 10 shows an example of aninner rod 201 having a corrugated surface, withcorrugations 300 provided in the circumferential direction. The inner wall of thesleeve 401 has corresponding corrugations cooperating with that of the rod. This prevents or reduces a displacement of the sleeve relative to the rod. - In the example of the bone anchoring element described above, the connection of the
shanks 2 of the bone anchoring elements 1 to therespective receiving parts 6 is polyaxial. However, it is also possible to provide a monoaxial connection. - For the
inner screw 30, all known modifications can be used. This includes also the use of an outer ring or nut. - In the embodiments described, the bone anchoring element 1 is introduced from the top into the receiving
part 6. However, the bone anchoring element 1 can also be introduced from the bottom of the receivingpart 6 if the receivingpart 6 is constructed to allow this. - The head of the bone anchoring element and the shaft can be constructed as separate parts which can be connected.
- The present disclosure is not limited to screws as bone anchoring elements but can be realized with bone hooks or any other bone anchoring element.
Claims (22)
1. A flexible stabilization device for dynamic stabilization of bones or vertebrae comprising:
a rod assembly including
a rod made of an elastomeric material and structured such that its length is adjustable, the rod configured to transmit compressive forces in the axial direction, the rod having a first connection section, a second connection section and a third section therebetween, the first and second connection sections being connectable with a bone anchoring device, respectively, and
a sleeve provided on at least a portion of the third section of the rod, the length of the sleeve being smaller than a length of the rod, such that at least the first and second connection sections are exposed.
2. A flexible stabilization device according to claim 1 , wherein the sleeve is made of an elastomeric material.
3. A flexible stabilization device according to claim 2 , wherein the elastic properties of the rod and the sleeve are different.
4. A flexible stabilization device according to claim 2 , wherein the elastomeric material of any one of the rod and the sleeve is a biocompatible plastic material such as polyurethane or polysilicone.
5. A flexible stabilization device according to claim 1 , wherein the inner wall of the sleeve is in contact with the surface of the rod.
6. A flexible stabilization device according to claim 5 , wherein the inner wall of the sleeve has a structure which engages with a structure on the surface of the rod.
7. A flexible stabilization device according to claim 1 , further comprising at least a first and a second bone anchoring device connected with the rod assembly.
8. A flexible stabilization device according to claim 7 , wherein at least one of the bone anchoring devices is constructed so as to allow a polyaxial connection between a shank of the bone anchoring device and the rod.
9. A flexible stabilization device according to claim 1 , wherein the rod comprises a plurality of connection sections and a plurality of sleeves therebetween.
10. A rod assembly for a flexible stabilization device, the rod assembly comprising:
a rod made of an elastomeric material, the rod having a first connection section, a second connection section and a third section therebetween; and
a sleeve provided on at least a portion of the third section of the rod such that at least the first and second connection sections are exposed;
wherein an inner wall of the sleeve has a structure which engages with an inner structure on a surface of the rod.
11. A rod assembly according to claim 10 , wherein the sleeve is made of an elastomeric material.
12. A rod assembly according to claim 11 , wherein the elastic properties of the rod and the sleeve are different.
13. A rod assembly according to claim 11 , wherein the elastomeric material of any one of the bar and the sleeve is a biocompatible plastic material such as polyurethane or polysilicone.
14. A rod assembly according to claim 10 , wherein the rod comprises a plurality of connection sections and a plurality of sleeves therebetween.
15. A flexible stabilization device for dynamic stabilization of bones or vertebrae comprising:
a rod assembly comprising:
a rod made of an elastomeric material and having a first connection section, a second connection section and a third section therebetween; and
a sleeve provided on at least a portion of the third section of the rod, the length of the sleeve being smaller than a length of the rod, such that at least the first and second connection sections are exposed;
a bone anchoring device connectable with any one of the first connection section and the second connection section of the rod, the bone anchoring device comprising:
a shank portion configured to be anchored in a bone or in a vertebra;
a head portion having a recess including an opening, the recess configured to receive a portion of any one of the first connection section and the second connection section of the rod; and
a securing element configured to secure the portion in the recess by pressure exerted on the portion.
16. A flexible stabilization device according to claim 15 , wherein the sleeve is made of an elastomeric material.
17. A flexible stabilization device according to claim 16 , wherein the elastic properties of the rod and the sleeve are different.
18. A flexible stabilization device according to claim 16 , wherein the elastomeric material of any one of the bar and the sleeve is a biocompatible plastic material such as polyurethane or polysilicone.
19. A flexible stabilization device according to claim 15 , wherein the inner wall of the sleeve is in contact with the surface of the rod.
20. A flexible stabilization device according to claim 19 , wherein the inner wall of the sleeve has a structure which engages with a structure on the surface of the rod.
21. A flexible stabilization device according to claim 15 , wherein at least on of the first bone anchoring device and the second bone anchoring device is constructed so as to allow a polyaxial connection between the shank thereof and the rod.
22. A flexible stabilization device according to claim 15 , wherein the rod comprises a plurality of connection sections and a plurality of sleeves therebetween.
Priority Applications (2)
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US13/891,141 US20140031868A1 (en) | 2005-12-23 | 2013-05-09 | Flexible stabilization device for dynamic stabilization of bones or vertebrae |
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US11/642,566 US8157843B2 (en) | 2005-12-23 | 2006-12-19 | Flexible stabilization device for dynamic stabilization of bones or vertebrae |
US13/425,153 US20120265247A1 (en) | 2005-12-23 | 2012-03-20 | Flexible stabilization device for dynamic stabilization of bones or vertebrae |
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US13/891,141 Abandoned US20140031868A1 (en) | 2005-12-23 | 2013-05-09 | Flexible stabilization device for dynamic stabilization of bones or vertebrae |
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US13/891,141 Abandoned US20140031868A1 (en) | 2005-12-23 | 2013-05-09 | Flexible stabilization device for dynamic stabilization of bones or vertebrae |
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EP (1) | EP1800613B1 (en) |
JP (1) | JP5215553B2 (en) |
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Also Published As
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KR20070066877A (en) | 2007-06-27 |
TW200726429A (en) | 2007-07-16 |
DE602005008265D1 (en) | 2008-08-28 |
CN1985770A (en) | 2007-06-27 |
ES2309646T3 (en) | 2008-12-16 |
JP5215553B2 (en) | 2013-06-19 |
US20140031868A1 (en) | 2014-01-30 |
KR101279085B1 (en) | 2013-06-26 |
EP1800613A1 (en) | 2007-06-27 |
EP1800613B1 (en) | 2008-07-16 |
JP2007167642A (en) | 2007-07-05 |
TWI432171B (en) | 2014-04-01 |
US20070233085A1 (en) | 2007-10-04 |
US8157843B2 (en) | 2012-04-17 |
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