The present invention relates in general to implantable medical devices, and specifically to apparatus and methods for bone fixation.
The following patents, which are incorporated herein by reference, may be of interest:
U.S. Pat. No. 5,207,678 to Harms et al.
U.S. Pat. No. 5,474,555 to Puno et al.
In some embodiments of the present invention, apparatus is provided, comprising a plurality of double-jointed bone fixation elements, which are each coupled to a rod. The double jointed nature of the bone fixation elements typically facilitates this coupling, while reducing bending of the rod. Typically, a method for using the apparatus comprises inserting a longitudinal bone insertion element such as a screw or a pin into a bone, and rotating a joint element to a desired orientation thereof, the joint element being coupled to the longitudinal bone insertion element. A rod holder for holding the rod is coupled to the joint element, and a desired angular orientation of the rod holder is identified. The rod holder is positioned at the desired angular orientation, and the rod is coupled to the rod holder when the rod holder is at the desired angular orientation, thereafter being tightened, such that the double-jointed bone fixation elements maintain the desired angular orientation.
There is therefore provided, in accordance with an embodiment of the invention, apparatus, including:
at least one double-jointed bone fixation element;
a rod, configured to be coupled to the bone fixation element; and
a rod retaining portion, configured to retain the rod in place with respect to the bone fixation element.
In an embodiment, the at least one double-jointed bone fixation element includes a plurality of double-jointed bone fixation elements, configured to be coupled to the rod.
In an embodiment, the apparatus further includes a single-jointed bone fixation element, configured to be coupled to the rod.
In an embodiment, the rod retaining portion includes at least one ring slidably coupled to the rod, configured to slide along the rod into a position that retains the rod in place with respect to the bone fixation element. Alternatively or additionally, the rod retaining portion includes a screw.
In an embodiment, the apparatus includes:
a longitudinal element configured for insertion into bone of a subject; and
a locking pin, configured to fix a position of the rod with respect to the longitudinal element.
In an embodiment,
the double-jointed bone fixation element defines first and second joints,
the double-jointed bone fixation element includes:
wherein at the first joint, the aperture element is configured to rotate with respect to the longitudinal bone insertion element.
In an embodiment,
the double-jointed bone fixation element includes a retaining connector, coupled to the mobile aperture element, shaped to define a support lip,
the mobile aperture element is shaped to define an interface lip thereof, and
the interface lip is configured to be in contact with the support lip.
In an embodiment, the interface lip is configured to articulate with the support lip.
In an embodiment, the longitudinal bone insertion element includes a screw. In an embodiment, the longitudinal bone insertion element includes a pin.
In an embodiment,
at the first joint, the mobile aperture element is configured to rotate such that a longitudinal axis of the mobile aperture element comes in alignment with a longitudinal axis of the longitudinal bone insertion element, and further rotates along a different axis to diverge from a longitudinal axis of the longitudinal bone insertion element,
the apparatus includes a retaining connector and a rod holder, configured to hold the rod, and
at the second joint, the retaining connector and the mobile aperture element facilitate further rotation of the rod relative to the bone fixation element by being rotated.
In an embodiment,
at the first joint, the mobile aperture element is configured to rotate such that a longitudinal axis of the mobile aperture element diverges from a longitudinal axis of the longitudinal bone insertion element,
the apparatus includes a retaining connector and a rod holder, configured to hold the rod, and
at the second joint, the retaining connector and the mobile aperture element facilitate further rotation of the rod relative to the bone fixation element by being rotated.
In an embodiment, the rod holder and the rod retaining portion are formed as an integral structure.
In an embodiment,
the double-jointed bone fixation element includes a retaining connector, rotatably coupled to the mobile aperture element,
at the second joint, the retaining connector is configured to rotate around the longitudinal axis of the mobile aperture element,
the apparatus includes a rod holder, configured to hold the rod,
the rod holder is configured to be rotated to facilitate placement of the rod in a desired alignment, and
In an embodiment,
at the first joint, the mobile aperture element is configured to rotate such that a longitudinal axis of the mobile aperture element diverges from a longitudinal axis of the longitudinal bone insertion element,
the bone fixation element includes a retaining connector, rotatably coupled to the mobile aperture element, and
at the second joint, the retaining connector is configured to rotate around the longitudinal axis of the mobile aperture element.
In an embodiment, prior to the diverging of the longitudinal axes, the mobile aperture element is rotatable around the longitudinal axis of the bone insertion element.
There is further provided, in accordance with an embodiment of the invention, a method, including:
inserting a longitudinal bone insertion element into a bone;
rotating a double-jointed element to a desired orientation thereof, the double-jointed element being coupled to the longitudinal bone insertion element;
coupling a rod holder to the double-jointed element;
identifying a desired angular orientation of the rod holder;
positioning the rod holder at the desired angular orientation;
coupling a rod to the rod holder; and
reducing motion among the rod holder, the longitudinal bone insertion element, and the rod by tightening the double-jointed element.
In an embodiment, the motion includes reducing the motion via a locking pin, coupled at one end thereof to the rod holder and the rod, and at another end thereof to the longitudinal bone insertion element.
There is yet further provided, in accordance with an embodiment of the invention, a method, including:
inserting at least a first and a second longitudinal bone insertion element into respective bone sites of a patient, at different angular orientations of insertion;
coupling the first and second longitudinal bone insertion elements to respective first and second rod holders;
reducing an angular divergence between the rod holders by (a) manipulating a first double-jointed element that is coupled to the first rod holder and to the first longitudinal bone insertion element, and (b) manipulating a second double-jointed element that is coupled to the second rod holder and to the second longitudinal bone insertion element;
coupling the first and second double-jointed elements via a rod; and
reducing motion among the first longitudinal bone insertion element, the second longitudinal bone insertion element, and the rod, by tightening the double-jointed elements.
For some applications, the second double-jointed element referred to in step (b) is, instead, a jointed element that is not double-jointed.
In an embodiment, reducing the motion includes reducing the motion via a locking pin, coupled at one end thereof to the first rod holder and the rod, and at another end thereof to the first longitudinal bone insertion element.
There is still further provided, in accordance with an embodiment of the invention, apparatus for treating bone, including:
at least two bone anchoring members;
at least two rod holders;
coupled to each rod holder, an integrated double articulation element that (a) provides mobility of the rod holder by being adapted to move in at least two axes relative to one of the bone anchoring members at a first joint, and (b) provides further mobility of the rod holder relative to the one of the bone anchoring members at a second joint;
for each rod holder, at least one rod retaining portion; and
a connecting rod, configured to be coupled to each of the rod holders.
There is also provided, in accordance with an embodiment of the invention, a method for treating bone, including:
a. providing a bone fixation system, including:
b. inserting the at least two bone anchoring members in at least one bone;
c. coupling each bone anchoring member to a respective one of the rod holders;
d. bringing each of the rod holders, via its respective integrated double articulation element, to an orientation suitable for coupling the rod holder to the connecting rod;
e. coupling the connecting rod to each of the rod holders via at least one rod retaining portion; and
f. tightening each of the rod holders to minimize motion between each rod holder and the respective bone anchoring member and to minimize motion between the connecting rod and each of the rod holders.
There is additionally provided, in accordance with an embodiment of the invention, apparatus, including:
a rod;
a rod holder shaped to define an opening through which the rod passes;
a longitudinal element configured for insertion into bone of a subject;
a jointed element which (a) facilitates motion of the rod relative to the longitudinal element, (b) is shaped to define a space therein configured for holding the longitudinal element, and (c) is configured to reduce a distance between a center of the jointed element and a center of the rod holder; and
a locking pin having first and second ends, the first end pushing the rod against the rod holder when the rod is in the opening, and the second end pushing a lateral portion of the longitudinal element against a portion of the jointed element.
In an embodiment, the jointed element includes a coupling mechanism selected from the group consisting of: a threaded coupling mechanism, a ratchet coupling mechanism, and a click-into-place coupling mechanism, and the selected coupling mechanism facilitates the reduction in distance between the center of the jointed element and the center of the rod holder.
In an embodiment, the apparatus includes a plurality of longitudinal elements, each configured for insertion into bone of a subject.
In an embodiment, the apparatus includes a plurality of rods.
In an embodiment, (a) the first end of the locking pin pushes the rod against the rod holder and the second end of the locking pin pushes the lateral portion of the longitudinal element against the portion of the jointed element, in response to (b) the reduction in distance between the rod and the longitudinal element.
In an embodiment, the jointed element includes a mobile aperture element and a retaining connector.
In an embodiment, the jointed element includes a first joint element shaped to define a first lip and a second joint element shaped to define a second lip, the first and second lips configured to articulate with each other.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
A round head 11 of screw 1 articulates with an inner surface of mobile aperture element 2. A portion of the inner surface forms a widened area 25 of mobile aperture element 2, which prevents head 11 of screw 1 from passing through the lower opening of the mobile aperture element.
Typically, an interface lip 21 of mobile aperture element 2 articulates with a support lip 32 of retaining connector 3.
Screw 1 is formed of three portions: (a) head 11, an upper segment, near head 11, which is unthreaded and is adapted to move inside an aperture 23 of mobile aperture element 2. Typically, mobile aperture element 2 is rotated around its longitudinal axis and then around another axis during the implantation procedure, such that aperture 23 thereof is aligned with respect to an axis 13 of screw 1 such that the direction of an axis 24 of mobile aperture element 2 can be changed, to cause axis 24 to diverge from axis 13 by a desired amount determined by the anatomy and/or pathology of the patient (e.g., by turning axis 24 through less than 60 degrees, 60-90 degrees, or more than 90 degrees). In addition, simultaneously, rotational mobility of mobile aperture element 2, around axis 13, is provided as well.
A locking pin 4, having a bowl-shaped head portion 41, is placed over round head 11 of screw 1, such that head portion 41 can rotate on round head 11. Locking pin 4 is placed within a lumen 52 of a rod holder 5. Rod holder 5 is free to rotate around its longitudinal axis prior to being rigidly coupled, via locking pin 4, to screw 1. During the implantation procedure, rod holder 5 is placed at a desired angular orientation, typically chosen such that a rod 6 lowered into rod holder 5 is oriented generally toward another bone fixation element (see
At least one rod retaining portion 7, comprising a head 71 and a body 72, is slid along rod 6. (As shown in
When rod 6 is securely disposed within rod holder 5 (as shown in
In this manner, double-jointed control of the bone fixation apparatus is attained, namely through (1) the movement of mobile aperture element 2 with respect to screw 1, and (2) the rotational control of mobile aperture element 2 with respect to retaining connector 3. It is noted that rotation of retaining connector 3 with respect to rod holder 5 reduces the distance between the center of the double-jointed bone fixation element and the center of the rod and the rod holder. In other words, screwing retaining connector 3 on rod holder 5 brings the center of the jointed element closer to the rod and the rod holder, squeezing locking pin 4 and achieving the desired tightening and rigid fixation of the rod with respect to screw 1.
For some applications, locking pin 4 moves freely within lumen 52 of rod holder 5 prior to tightening, but is constrained to not be able to exit the lumen (or to not be able to exit the lumen easily). As appropriate, a portion of locking pin 4 and/or of one of the pieces of the apparatus has a protrusion or is otherwise shaped to provide this constraining functionality. Similarly, other locking pins usable with this or with other embodiments of the invention (e.g., locking pin 104 described hereinbelow) may also be thus constrained.
The exploded view in
It is noted that
Although
In the embodiment shown in
At least one rod retaining portion 107 is formed integrally to the construction of rod holder 5 (unlike rod retaining portion 7, which is shown in
As appropriate based on the needs of a given procedure, screw 100 may be placed in hole 155 and rod 6 may be placed in 123.
When rod 6 is securely disposed within rod holder 5 (as shown in
It is noted that rotation of retaining connector 3 reduces the distance between the center of the jointed element and the center of the rod and the rod holder. In other words, screwing retaining connector 3 on rod holder 5 brings the center of the jointed element closer to the rod and the rod holder, squeezing locking pin 4 and achieving the desired tightening and rigid fixation of the rod with respect to screw 100.
It is to be appreciated that the various components described hereinabove may be replaced by other functionally similar components, or combinations thereof, which may be placed at different locations with respect to patient anatomy or other components of the apparatus. Similarly, the apparatus described hereinabove may be disposed in other configurations with respect to a patient's anatomy. For example, screw 1 may be placed into a non-vertebral bone, or rod 6 may be disposed outside of the patient's body, or a bone shown in a figure as being treated by particular apparatus may instead be treated by apparatus shown in a different figure.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present patent application claims priority from U.S. Provisional Patent Application 60/930,533 to Gotfried, filed May 17, 2007, entitled, “Multidirectional bone fixation assembly,” which is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IL08/00678 | 5/18/2008 | WO | 00 | 11/11/2009 |
Number | Date | Country | |
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60930533 | May 2007 | US |