Source: https://patents.google.com/patent/EP2734135B1/en
Timestamp: 2020-02-24 08:12:31
Document Index: 650502912

Matched Legal Cases: ['art 409', 'art 511', 'art 512', 'art 511', 'arts 511', 'arts 511', 'art 611', 'art 612', 'art 611', 'arts 611', 'arts 611']

EP2734135B1 - Spinal rod fixing device - Google Patents
Spinal rod fixing device Download PDF
EP2734135B1
EP2734135B1 EP12735909.9A EP12735909A EP2734135B1 EP 2734135 B1 EP2734135 B1 EP 2734135B1 EP 12735909 A EP12735909 A EP 12735909A EP 2734135 B1 EP2734135 B1 EP 2734135B1
EP12735909.9A
EP2734135A1 (en
2011-07-21 Priority to EP11305951 priority Critical
2011-12-13 Priority to EP11306652 priority
2012-07-20 Application filed by Zimmer Spine SAS filed Critical Zimmer Spine SAS
2012-07-20 Priority to EP12735909.9A priority patent/EP2734135B1/en
2012-07-20 Priority to PCT/EP2012/064285 priority patent/WO2013011125A1/en
2014-05-28 Publication of EP2734135A1 publication Critical patent/EP2734135A1/en
2018-03-21 Publication of EP2734135B1 publication Critical patent/EP2734135B1/en
The disclosure relates to a device for fixing a rod to an osseous structure. Such systems and methods may be helpful for holding together a bone and a rod in a desired configuration or in a particular relative position. In particular, said bone may be a transverse process or a lamina of a vertebra.
One field of application for the embodiments in this disclosure is coupling a rod to bones for holding bones in a relative position, for example to aid in the healing of breaks or the positioning of bones in the treatment of spinal deformities or spinal degenerative diseases or trauma diseases, or otherwise to correct abnormal curvatures of the spine. Other bone deficiencies and abnormalities may also benefit from embodiments in this disclosure.
One field of application for the invention is fixing bones in a desired position, for example to aid in healing of breaks or in the treatment of scoliosis or otherwise to correct abnormal curvatures of the spine. Other bone deficiencies and abnormalities may also benefit from the invention.
The spine is formed of superposed vertebrae, normally aligned along a vertebral axis, from the lumbar vertebrae to the cervical vertebrae, each having an anterior part, which is the vertebral body, and a posterior part, which is the vertebral arch (or neural arch), the anterior and posterior part enclosing the vertebral foramen. Each vertebral arch is formed by a pair of pedicles and a pair of laminae, and transverse processes and/or a spinous process (or neural spine) project therefrom.
The transverse processes and the spinous process project opposite to the vertebral foramen.
When the vertebrae are articulated with each other, the vertebral bodies form a strong pillar for the support of the head and trunk, and the vertebral foramen constitute a canal for the protection of the spinal cord (or medulla spinalis). In between every pair of vertebrae, there are two apertures, the intervertebral foramina, one on either side, for the transmission of the spinal nerves and vessels.
If the spine of a person has abnormal curvature, the vertebrae are typically inclined relative to one another and relative to said vertebral axis. The lateral edges of the vertebrae on one side are therefore closer together and define a concave outline, while the lateral edges on the other side are farther apart and define a convex outline.
In order to straighten the vertebral column as a remedy for this situation, the lateral edges of the vertebrae on the concave side can be moved away from one another and supported at distances from one another substantially equivalent to the distances between the lateral edges on the convex side. To do so, different kinds of devices may be used.
One such device is the system for fixing a bone to a rod disclosed in international patent application publication WO 2009/047352 . It comprises a rod, a blocking body and a conformable elongate member adapted to surround the bone, i.e. to form a loop around it. When using such a system, the elongate member is passed around said bone and through the blocking body and the rod is loaded into the blocking body. The ends of the elongate member are pulled so as to apply tension to the elongate member, and the elongate member and the rod are simultaneously fastened to the blocking body by means of the same fastening system, portion(s) of the elongate member being clamped between the rod and the blocking body. The elongate member and the rod are fastened to the blocking body in one single step.
Another device with the same purpose is described in international patent application publication WO 2011/012690 . This device comprises a main body, a flexible elongate member for fixing the main body to an osseous structure, a first fastening member for fastening a portion of the rod to the main body, ans a second fastening member for fastening the free end portions of the elongate member to the main body, wherein said second fastening member is distinct from the first fastening member.
In another, similar device known in the art, also comprising a main body, a flexible elongate member for fixing the main body to an osseous structure, a first fastening member for fastening a portion of the rod to the main body, and a second, distinct fastening member for fastening the free end portions of the elongate member to the main body, said second fastening member is laterally offset with respect to the first fastening member, so that the flexible elongate member is laterally offset with respect to the longitudinal axis of the rod. While such a device facilitates access to the fixation of the elongate member, any force transmitted by the flexible elongate member will induce a significant torsion torque on the rod or the connection of the rod to the fixing device, respectively.
A first object of the present disclosure is that of providing a device for fixing a rod to an osseous structure, wherein a rod and a flexible member for attaching the device to the osseous structure can be easily fastened to and unfastened from the device separately and substantially independently from each other, in order to facilitate the handling of the device, while preventing that tensions transmitted by the flexible elongate member generate torsion torques around a main axis of the rod.
For this purpose, in at least a first embodiment of the present disclosure, there is provided a device for fixing a rod to an osseous structure, comprising at least a main body, a socket for receiving a rod with a rod longitudinal axis oriented in a first direction, a first fastening member and a second fastening member. The socket is solid with the main body and the first and second fastening members are sized for attachment to the main body. The first fastening member is accessible from an outer surface of the main body and is arranged for fastening a rod received in the socket to the main body. The main body comprises a channel for receiving a flexible member, and the second fastening member which is accessible from an outer surface of the main body is channel for receiving a flexible member, and the second fastening member which is accessible from an outer surface of the main body is arranged for fastening a flexible member received by said channel, so as to attach the main body to the osseous structure. The first and second fastening members are operable separately from each other, offset with respect to each other in the first direction, and arranged so that the flexible elongate member can be fastened adjacent to the rod. By "adjacent" it is meant, in the present context, that essentially no solid material is interposed between the rod and the flexible member, which, in at least some embodiments, may be directly in contact with each other.
The axial offset and separate access to the first and second fastening members notably allows an operator to release and adjust the tension of the flexible member even while the rod remains fastened to the main body, thus allowing a more precise positioning of the rod with respect to the osseous structure.
However, since the second fastening member is arranged so that said force transmission line of the flexible member can intersect the longitudinal axis of the rod, it is possible to prevent significant torque generation around the rod by traction forces transmitted by the flexible member.
In at least some embodiments, said second fastening member is a compression member configured to fasten the flexible member to the main body by clamping at least one end or both ends of said flexible member against a surface of the main body. When the second fastening member is configured to clamp both ends of said flexible member, it may be configured to clamp both ends to a single surface of the main body, or a first end to a first surface and a second end to an opposite second surface. In particular, the main body may present a lateral orifice through which at least one end of the flexible member may be threaded. In this case, the second fastening member is configured to fasten the flexible member to the main body by clamping said at least one end of said flexible member within said lateral orifice. The flexible member can thus be more unobtrusively fastened. In order to drive the second fastening member against the flexible member when fastening it, and away from said flexible elongate member when unfastening it, while holding a clamping force while the flexible member remains fastened, the second fastening member may have an outer screw thread in engagement with an inner screw thread in the main body. To prevent however that the rotating motion of the second fastening member damages the flexible member by friction, an intermediate part may be interposed between the second fastening member and the flexible member. This intermediate part may be, for example, a ring centered around the screw axis and freely rotatable around the second fastening member.
In at least some embodiments, the first fastening member may be attached to said socket. In particular, said socket may be formed by a recess in the main body, open at least at two opposite ends for receiving part of the rod longitudinally oriented between said two opposite ends for receiving said rod, and said first fastening member may be a pressure member configured to fasten the rod to the main body by clamping the rod against an inner surface of said recess. The rod can thus be introduced into said recess through one of the open ends and reliably fixed within it by the first fastening member. However, in order to also be able to introduce the rod transversally into this recess, said recess may also be laterally open between said two opposite ends. This greatly facilitates operations, in particular when several devices are fastened to the rod. Like the second fastening member, the first fastening member may have an outer screw thread in engagement with an inner screw thread in the main body, in order to drive the first fastening member against the rod when fastening it, and away from said rod when unfastening it, while holding a clamping force while the rod remains fastened.
Alternatively, however, in at least some other embodiments, the first fastening member may constitute at least part of said socket. In particular, said first fastening member may be a clamp with two hinged parts and a closing element configured to close the two hinged parts against each other, this clamp being configured to receive the rod between the two hinged parts. The closing element, which can be a screw, may be located between proximal ends of the hinged parts, to close the clamp by pushing on the proximal ends, or, alternatively, it may be located between distal ends of the hinged parts, to close the clamp by pulling at the distal ends. To simplify the device, one of said two hinged parts may be solid with the main body.
The present disclosure also relates to an assembly comprising such a fixing device, a rod fastened to the main body, by the first fastening member, with the rod longitudinal axis oriented in a first direction, and a flexible elongate member fastened to the main body, adjacently to the rod, by the second fastening member, for attaching the main body to the osseous structure.
The above summary of exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the invention. The technical features cited above as well as those of the exemplary embodiments described below may be combined with each other and then constitute further embodiments of the disclosed and claimed subject matter. In particular, selected features of any illustrative embodiment within this specification may be incorporated into an additional embodiment unless clearly stated to the contrary.
FIG. 1 is a perspective view of a fixing device according to a first embodiment;
FIG. 2 is a top view of a fixing device according to a second embodiment;
FIGS. 2A and 2B are transversal cut views of the fixing device of the second embodiment through planes IIA-IIA and IIB-IIB of FIG. 2 ;
FIG. 3 is a top view of a fixing device according to a third embodiment;
FIGS. 3A and 3B are transversal cut views of the fixing device according to the third embodiment through planes IIIA-IIIA and IIIB-IIIB of FIG. 3 ;
FIG. 4 is a transversal cut view of a fixing device according to a fourth embodiment;
FIGS. 5, 6 and 7 are, respectively, top, side and front views of a fixing device according to a fifth embodiment;
FIGS. 8 and 9 are, respectively, top and side views of a fixing device according to a sixth embodiment; and
FIGS. 9A and 9B are transversal cut views of the fixing device of the sixth embodiment through planes IXA-IXA and IXB-IXB of FIG. 9.
In the first embodiment illustrated in FIG. 1, a fixing device 101 is fastened to a rod 102 and an elongated flexible member 104 to form the illustrated assembly. This fixing device 101 comprises a main body 103. The main body 103 presents a recess, which is open at two opposite ends, forming a socket for receiving part of the rod 102 longitudinally between the two opposite ends. The recess is also open laterally between the two opposite ends, so that the rod 102 can be introduced laterally into said recess and not only axially through either one of the two opposite ends. The flexible elongate member 104, in the form of a flexible ligature band, is suitable for fastening the fixing device 101, with the rod 102, to an osseous structure (not illustrated), such as, for example, a vertebra, by tightening an intermediate segment of this flexible elongate member around at least part of said osseous structure.
This fixing device 101 also comprises a first fastening member 105 and a second fastening member 106, directly connected to the main body 103. The first and second fastening members 105, 106 being distinct and separately accessible from the outside of the main body 103, they can be tightened and untightened independently from each other, allowing independent fastening and unfastening of the rod 102 and the flexible elongate member 104.
In the first embodiment illustrated in FIG. 1, the first fastening member 105 and the second fastening member 106 are and offset, with respect to each other in the direction of the longitudinal axis X of the rod 102. However, both fastening members 105, 106 are arranged along said longitudinal axis X, so that the flexible elongate member 104 can be fastened so as to run adjacent to the rod 102. The first fastening member 105, which in this first embodiment is shaped as a lock screw with an outer screw thread in engagement with an inner screw thread in the lateral opening of the main body 103, also fastens the main body 103 to the rod 102 by clamping the rod 102 against a surface of the recess. The second fastening member 106, which is also shaped as a lock screw, with an outer screw thread in engagement with an inner screw thread in the lateral opening of the main body 103 fastens both ends of the flexible elongate member 104 by clamping them against opposite internal surfaces in the main body 103. The main body 103 presents a first orifice 107 at one side of the second fastening member 106, and a second orifice (not shown) at the opposite side of the second fastening member 106, forming channels for receiving the flexible member 104. A first end of the flexible elongate member 104 is threaded through said first orifice 107 , and a second end of the flexible elongate member 104 is threaded through the second orifice (not shown). Because in this first embodiment the flexible elongate member 104 is not significantly offset laterally with respect to the rod 102, torsional torques in the fixing device 101 are minimized. Within the main body 103, both ends of the flexible elongate member 104 can be threaded to the same side of the rod 102 within the recess, or, if necessary, each end may be threaded to one respective side of the rod 102, thus straddling the rod 102 within the recess and further minimizing torsional torques.
In a fixing device 201 according to a second embodiment, illustrated in FIGS. 2, 2A and 2B, the first fastening member 205 and the second fastening member 206 are also aligned and offset with respect to each other in parallel to the longitudinal axis 202 of the rod 202. However, in this second embodiment, the recess in the main body 203 is not completely open laterally between the two opposite ends, so that the rod 202 can only be introduced axially into the main body 203. The first and second fastening members 205, 206 are also shaped as lock screws in this second embodiment. In this second embodiment, their outer screw threads are in engagement with inner screw threads in respective lateral orifices of the main body 203. As in the previous embodiment, the first fastening member 205 fastens the main body 203 to the rod 202 by clamping the rod 202 against a surface of the recess, and the second fastening member 206 fastens both ends of the flexible member 204 by clamping them against opposite internal surfaces in the main body 203.
As in the first embodiment, a first end of the elongated flexible member 204 is threaded through a first orifice 207 at one side of the second fastening member 206 and a second end is threaded through a second orifice 208 at the opposite side of the second fastening member 206. Within the main body 203, both ends of the flexible elongate member 204 can be threaded to the same side of the rod 202 within the recess, or, if necessary, each end may be threaded to one respective side of the rod 202, thus straddling the rod 202 within the recess and further minimizing torsional torques.
However, as seen in the third embodiment illustrated in FIGS. 3, 3A and 3B, in another fixing device 301, the main body 303 may have a simplified shape with a channel for receiving the flexible member 304 comprising a single orifice 307 for both ends of the flexible member 304 at one side of the second fastening member 306. As in the first and second embodiments, however, within the recess it is still possible to choose between threading both ends of the flexible elongate member 304 to the same side of the rod 302, or threading each end to one respective side of the rod 302. The other elements of this third embodiment, such as the first fastening member 305, shown in particular in FIG. 3A, may be identical to those of the second embodiment.
An inconvenience of using a locking screw for fastening the flexible elongate member is that the rotation of the locking screw during fastening and unfastening may cause significant friction between the lockscrew and the flexible elongate member, possibly damaging the latter. To prevent, or at least minimize this friction, in a fourth embodiment, illustrated in FIG. 4, an intermediate part 409, shaped as a ring centered around the screw axis of the second fastening member 406 and freely rotatable around it, is interposed between said second fastening member 406 and the two ends of the flexible elongate member 404. This fourth embodiment can otherwise be analogous to the second embodiment.
While in these first four embodiments the first fastening member is a lockscrew, alternative means can also be used, as shown for example in the fifth embodiment, illustrated in FIGS. 5 to 7. In the rod fixing device 501 of this fifth embodiment, the socket for receiving the rod 502 is formed by a first fastening member 505, shaped as a clamp, which comprises a first part 511 solid with the main body 503, and a second part 512 hinged to the first part 511. The rod 502 can be received between the first and second parts 511,512 which can then be closed against each other and around the rod 502 by tightening a screw 513 located behind the hinge, between the proximal ends of the first and second parts 511, 512, to fasten the main body 503 to the rod 502. As in the second embodiment, the rod fixing device 501 also comprises a second fastening member 506, shaped as a lockscrew, to fasten both ends of the flexible member 504 by clamping them against opposite internal surfaces in the main body 503, within respective orifices 507, 508 forming channels through which those ends are threaded.
A sixth embodiment with an alternative clamp shape for the first fastening member is illustrated in FIGS. 8, 9A and 9B. In this rod fixing device 601, a first fastening member 605 is also shaped as a clamp comprising a first part 611 solid with the main body 603, and a second part 612 hinged to the first part 611. As in the fifth embodiment, the rod 602 can be received between the first and second parts 611,612 which can then be closed against each other and around the rod 602 by tightening a screw 613. However, in this sixth embodiment, the screw 613 is located opposite to the hinge, linking the distal ends of the first and second parts 611, 612. As in the third embodiment, the rod fixing device 601 also comprises a second fastening member 606, shaped as a lockscrew, to fasten both ends of the flexible elongate member 604 by clamping them against an internal surface in the main body 603, within a channel comprising a single orifice 607 through which both ends are threaded.
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope of the present invention as described in the appended claims.
A fixing device (101,201...601) for fixing a rod (102,202...602) to an osseous structure, the device comprising at least:
a main body (103,203...603),
a rod (102,202,...602)
a socket for receiving the rod (102,202...602) with a rod longitudinal axis (X) oriented in a first direction, the socket being solid with the main body,
a flexible member (104,204,....604)
a first fastening member (105,205...605), and
a second fastening member (106,206...606),
wherein the first and second fastening members (105,205...605; 106,206...606) are sized for attachment to the main body (103,203...603),
wherein the first fastening member (105,205...605) is accessible from an outer surface of the main body (103, 203...603) and is arranged for fastening a rod (102,202...602) received in the socket to the main body (103,203...603),
wherein the main body (103,203...603) comprises a channel for receiving a flexible member (104,204...604),
the second fastening member (106,206...606) being accessible from an outer surface of the main body (103, 203...603) and being arranged for fastening the flexible member (104,204...604) received by the channel,
wherein the first and second fastening members are operable independently from each other,
wherein the first and second fastening members (105,205...605; 106,206...606) are offset with respect to each other in the first direction, and
wherein the second fastening member (106, 206...606), the channel for receiving a flexible member (104,204...604) and the socket are arranged such that the flexible member can be fastened adjacent to the rod (102,202...602).
The fixing device (101, 201...601) of claim 1, wherein said second fastening member (106,206...606) is a compression member configured to fasten the flexible member (104, 204...604) to the main body (103, 203...603) by clamping at least one end of said flexible member (104, 204...604) against a surface of the main body (103, 203...603) with the rod
The fixing device (101,201...601) of claim 2, wherein said second fastening member (106,206...606) is a compression member configured to fasten the flexible member (104,204...604) to the main body (103,203...603) by clamping two opposite ends of said flexible member (104,204...604) against a surface of the main body (103,203...603) with the rod.
The fixing device (301,601) of claim 3, wherein the second fastening member (306,606) is configured to fasten both opposite ends of said flexible member (304,604) together against a single surface of the main body (303,603).
The fixing device (101,201,401,501) of claim 3, wherein the second fastening member (106,206,406,506) is configured to fasten a first end of said flexible member (104,204,404,504) against a first surface of the main body (103,203,403,503), and a second end of said flexible member (104,204,404,504) against a second surface of the main body (103,203,403,503), opposite to the first surface, with the rod.
The fixing device (101, 201...601) of any one of claims 2 to 5, wherein at least one end of the flexible member (104,204...604) is threaded through a lateral orifice in the main body (103,203...603).
The fixing device (101, 201...601) of claim 6, wherein the second fastening member (106, 206...606) is configured to fasten the flexible member (104,204...604) to the main body (103,203...603) by clamping said at least one end of said flexible member (104,204...604) within said lateral orifice.
The fixing device (101, 201...601) of any one of claims 2 to 7, wherein said second fastening member (106,206...606) has an outer screw thread in engagement with an inner screw thread in the main body (103,203...603).
The fixing device (401) of claim 8, further comprising an intermediate part (410) between the second fastening member (406) and the flexible member (404).
The fixing device (101,201...401) of any one of claims 1 to 9, wherein the first fastening member (105, 205...405) is attached to said socket.
The fixing device (101,201...401) of claim 10, wherein said socket is formed by a recess in said main body (103, 203...403), said recess being open at least at two opposite ends for receiving part of the rod (102,202...402) longitudinally oriented between said two opposite ends for receiving said rod (102,202...402), and said first fastening member (105,205...405) is a pressure member configured to lock the rod (102,202...402) to the main body by clamping the rod (102,202...402) against an inner surface of said recess.
The fixing device (101) of claim 11, wherein said recess is also open laterally between said two opposite ends.
The fixing device (101,201...601) of claim 12, wherein said first fastening member has an outer screw thread in engagement with an inner screw thread in the main body (103, 203...603) .
The fixing device (501,601) of any one of claims 1 to 9, wherein the first fastening member (505,605) constitutes at least part of said socket.
The fixing device (501,601) of claim 14, wherein said first fastening member (505,605) is a clamp with two hinged parts (511,512;611,612) and a closing element configured to close the two hinged parts (511,512;611,612) against each other, this clamp being configured to receive the rod (502,602) between the two hinged parts (511,512;611,612) .
The fixing device (501) of claim 15, wherein said closing element is located between proximal ends of the hinged parts (511,512;611,612).
The fixing device (601) of claim 15, wherein said closing element is located between distal ends of the hinged parts (511,512;611,612).
The fixing device (501,601) of any one of claims 15 to 17, wherein one of said two hinged parts (511,512;611,612) is solid with the main body (503,603).
The fixing device (501,601) of any one of claims 11 to 18, wherein said closing element is a screw (513,613).
EP12735909.9A 2011-07-21 2012-07-20 Spinal rod fixing device Active EP2734135B1 (en)
EP11305951 2011-07-21
EP11306652 2011-12-13
EP12735909.9A EP2734135B1 (en) 2011-07-21 2012-07-20 Spinal rod fixing device
PCT/EP2012/064285 WO2013011125A1 (en) 2011-07-21 2012-07-20 Spinal rod fixing device
EP2734135A1 EP2734135A1 (en) 2014-05-28
EP2734135B1 true EP2734135B1 (en) 2018-03-21
ID=46516782
EP12735909.9A Active EP2734135B1 (en) 2011-07-21 2012-07-20 Spinal rod fixing device
US (1) US10238433B2 (en)
EP (1) EP2734135B1 (en)
CN (1) CN103717158B (en)
WO (1) WO2013011125A1 (en)
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US20130123841A1 (en) * 2009-09-30 2013-05-16 Thomas Lyon Apparatus and Method for a Suture Button
2012-07-20 US US13/554,196 patent/US10238433B2/en active Active
2012-07-20 WO PCT/EP2012/064285 patent/WO2013011125A1/en active Application Filing
2012-07-20 EP EP12735909.9A patent/EP2734135B1/en active Active
2012-07-20 CN CN201280036200.1A patent/CN103717158B/en not_active IP Right Cessation
EP2734135A1 (en) 2014-05-28
WO2013011125A1 (en) 2013-01-24
US20130023878A1 (en) 2013-01-24
CN103717158B (en) 2016-08-17
CN103717158A (en) 2014-04-09
US10238433B2 (en) 2019-03-26
US8636770B2 (en) 2014-01-28 Bone anchoring device
EP0878171A1 (en) 1998-11-18 Clamping connnector for spinal fixation systems
US8734446B2 (en) 2014-05-27 External fixation surgical clamp with swivel
US8162946B2 (en) 2012-04-24 Instrument for tensioning a flexible tie
2015-07-01 17Q First examination report despatched
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