Patent Application
20080119895
This application claims priority to French application no. 0610141, titled DISPOSITIF PROTHETIQUE OU D'OSTEOSYNTHESE A OLIVE FENDUE, filed on Nov. 20, 2006.
The present invention is directed to an improved bone plate with an expandable bushing, in which the rotation of the bushing about its main axis is blocked before expansion, and to a method of making and implanting such a device.
Bone plates allow fractures of the anatomical neck of the humerus or of the end of the humerus situated nearer the elbow and also fractures of the upper end of the tibia, or even other epiphyseal lesions of long bones to be minimised.
WO-A-2003/007832 discloses a plate that is fixed to the bone by screws which each comprise, on the one hand, a threaded rod for anchoring to the bone, inserted through a through-hole in the plate, and, on the other hand, a threaded head for immobilising the screw relative to the plate, screwed into the wall of the hole, which is threaded in a complementary manner. In practice, the anchoring direction of the screws is not always aligned with the axis of revolution of the threaded wall of the hole in the plate and, as a result, it is necessary to interpose, between the head of the screw and the wall of the hole, a bushing for accommodating the misalignment between the axis of the screw and the axis of the hole. The exterior of the bushing is shaped in such a way that, as long as the head of the screw is not screwed into the bushing, the bushing is movable against a smooth wall of the hole like a ball joint, whereas, when the head of the screw is progressively screwed into the bushing, the bushing deforms so as to push firmly against the wall of the hole until it rigidly connects the screw and the plate by wedging. In practice, in order to be deformable, the bushing is split completely apart in such a way that the edges of the corresponding slot are spaced from one another when the head of the screw is screwed. An example of this is given in DE-U-200 22 673.
In use, such bushings are difficult to handle: when the head is screwed into the bushing, it is difficult for the internal thread of the bushing to engage with the thread of the screw head since the bushing tends to turn round on itself in the hole in the plate due to the fact that the connection between the bushing and the wall of the hole is still movable. A surgeon thus has difficulties in effectively screwing the head of the screw into the bushing and this complicates surgical procedures and increases intervention time.
To overcome this drawback, it is proposed that, when the head of the screw is not yet engaged in the bushing, the rotation of the bushing about the axis of its orifice be blocked relative to the hole in the prosthetic or osteosynthesis body, using an enlargement projecting from the outer face of the bushing which is received in a hollow groove in the wall of the hole. This enlargement abuts into one or the other of the ends of the groove when the bushing tends to rotate about the axis of its orifice, which rotationally immobilises the bushing about the axis, without preventing it from tilting within the hole in order to accommodate any possible misalignment between the axis of the hole and the anchoring direction of the screw selected by the surgeon. An example of this type of expandable bushing with a local enlargement on its outer face is shown in FIG. 15 to 20 of document US-A-2005/0154392.
In practice, forming a rotation-blocking enlargement of this type causes difficulties in production since the presence of the enlargement must not adversely affect the geometric features of the rest of the outer face of the bushing, for example its spherical shape, without which the bushing tends to become wedged in the hole in undesirable positions. In order to obtain an acceptable level of reliability, production costs are therefore high.
Another solution which blocks the bushing in rotation is proposed by US-A-2005/085913, which discusses, without illustrating, a member or a projecting enlargement located inside the hole for receiving the bushing and provided for extending into the slot of the bushing. US-A-2005/085913, however, does not provide any corresponding details regarding production thereof and thus does not provide an actual practical and cost-effective solution.
The present invention is directed to an improved bone plate with an expandable bushing, in which the rotation of the bushing about its main axis is blocked before expansion, which is simple to produce, effective, and inexpensive.
The locking plate includes a plate with a body portion and at least one through-hole. At least one expandable bushing is engaged with the body portion. The bushing includes an exterior surface with at least one recess and a passageway including a threaded interior surface. The expandable bushing is initially in a first configuration that permits poly-axial rotation of the bushing within the through-hole. An elongated anchoring member is provided with a distal portion and a proximal portion including a head portion with threads complementary to the threads on the interior surface of the expandable bushing. The proximal portion expands the bushing to form a friction lock between the bushing and the plate in a selected polyaxial position in a second configuration. At least one discrete blocking member is fixedly engaged with the body portion of the plate and extends into the through-hole to engage with the recess on the expandable bushing. The blocking member inhibiting rotation of the expandable bushing relative to the through-hole.
In one embodiment, the recess is a slot extending completely through a wall of the expandable bushing. Radial expansion of the expandable bushing from the first configuration to the second configuration is typically plastic and/or elastic deformation of the expandable bushing. The exterior surface of the expandable bushing and walls of the through-hole are preferably substantially spherical in a complementary manner, except where the blocking member engages with the recess.
The distal portion of the anchoring member can be smooth, or include threads adapted to engage with the bone. The threads on the head portion of the anchoring member and the threads on the interior surface of the bushing can be tapered or cylindrical. In one embodiment, the head portion includes an unthreaded tapered surface that expands the expandable bushing to the second configuration.
The blocking member is preferably a discrete component fixedly engaged with a recess in the body portion of the plate, such as for example a cylinder that engages with a hole in the body portion of the plate. A single blocking member can extend into a plurality of through-holes to simultaneously engage with the recesses of a plurality of expandable bushings. In some embodiments, the recess in the body portion of the plate includes a central axis that is parallel to, or at an angle with respect to, a central axis of the through-hole.
The present invention is also directed to a method of engaging a locking plate with a bone. The method includes positioning the locking plate against a bone. An expandable bushing is located in at least one through-hole in a body portion of the locking plate. An elongated anchoring member is inserted through a passageway in the expandable bushing. The bushing is poly-axially rotated within the through-hole to a desired angle. The distal portion of the anchoring member is inserted into the bone. At least one blocking member is engaged with the body portion of the plate so that the blocking member extends into the through-hole to engage with a recess on the expandable bushing and block rotation of the expandable bushing relative to the through-hole. Threads on a head portion of the anchoring member are engaged with a threaded interior surface of the passageway on the bushing to expand the bushing from a first configuration that permits poly-axial rotation of the bushing within the through-hole to a second configuration that comprises a friction lock between the bushing and the plate.
The bushing can be expanded plastically or elastically. In one embodiment, threads on a distal portion of the anchoring member engage with the bone. In another embodiment, tapered threads on one or more of the head portion and the threads on the interior surface of the bushing radially expand the bushing from the first configuration to the second configuration. In another embodiment, a tapered surface on a proximal portion of the head portion radially expands the bushing from the first configuration to the second configuration.
The blocking member is preferably a discrete component fixedly engaged with a recess in the body portion of the plate. For example, a cylindrical blocking member is inserted into a cylindrical hole on the body portion of the bone plate. A single blocking member can optionally extend into a plurality of through-holes to simultaneously engage with the recesses of a plurality of expandable bushings.
A better understanding of the invention will be facilitated by reading the following description, given by way of example only with reference to the drawings, in which:
In
On the humerus 1 is fitted a humeral plate 10 comprising a main elongate body 11 extending in the longitudinal direction of the humerus, both at the diaphysis 2 thereof and at the epiphysis 3 thereof. The body 11 thus includes a diaphyseal portion 12 and an epiphyseal portion 13 located at the diaphysis and the epiphysis respectively of the humerus.
A plurality of holes 14 pass through the thickness of the portion 12 and open onto the humeral diaphysis 2, including a threaded hole 141 and a hole 142 with an oblong cross-section. The holes 14 are not described in further detail, it being noted that their number and/or their geometry do not limit the invention in any way.
In the illustrated embodiment, four holes 15 pass through the thickness of the epiphyseal portion 13 and open onto the humeral epiphysis 3 and are identical to one another. The two lowest holes 15, seen in cross-section in
The exemplary humeral plate 10 also comprises two lateral projections 16 which extend on both sides of the epiphyseal portion 13 each in opposite directions, transverse to the longitudinal direction of the body. In cross-section, namely in a cross-sectional plane substantially perpendicular to the plane II, the arms 16 and the portion 13 are generally C-shaped and are sized to embrace the epiphysis 3 in order to improve the stability of the plate 10 on the humerus 1.
In order to fix the plate 10 to the humerus 1, a plurality of structures for anchoring to the bone may be used by each being inserted into the holes 14 of the diaphyseal portion 12, into the holes 16a provided at the free end of each lateral projection 16, and into the holes 15 of the epiphyseal portion 13. Only the anchoring structure associated with the holes 15 will be described in detail in the following, it being understood that the configuration of the plate 10 and the number and location of the holes 14, 15, 16a do not limit the invention.
As shown in more detail in
The axes X-X of each hole 15 are not necessarily parallel to one another, as shown by the two holes seen in cross-section in
The portion of the bushing 20 closes to the humerus 1 comprises an annular portion 21 with a circular base with an axis Y-Y and, at the opposite side, a ring-shaped portion 22 with a substantially spherical outer face 22A with its centre at a point C on the axis Y-Y. The annular portion 21 and the substantially spherical outer face 22A preferably do not contain any protrusions or other structures. Consequently, the bushing 20 can be manufactured using conventional machining operations.
The outer diameter of the annular portion 21 is strictly less than the inner diameter of the portion 17 of the hole 15, whereas the outer diameter of the portion 22 is substantially equal to the inner diameter of the portion 18 of the hole. In this way, when the bushing 20 is received in the hole 15, a not-insignificant radial clearance j is present between the portions 21 and 17, whereas the spherical face 22A of the portion 22 and the spherical wall 18A of the portion 18 are juxtaposed in a complementary manner, the points 0 and C thus substantially coinciding.
At its interior, the bushing 20 delimits a through-orifice 24 centred on the axis Y-Y and threaded over a portion of its length along the axis. In the illustrated embodiment, the bushing includes slot 25 on a portion of its periphery, which extends over the entire bushing in the direction of the axis Y-Y and which passes completely through the tubular wall of the bushing in such a way that the slot radially connects the outer face of the bushing and the inner orifice 24 thereof. The slot 25 thus imparts a shape in the general form of a C to the bushing when viewed in cross-section, as well as when viewed along the axis Y-Y, as shown in
Along its length, the anchoring member 30 comprises, on the one hand, a distal threaded rod 31 to be screwed into the thickness of the bone of the humeral epiphysis 3 and, on the other hand, a proximal threaded head 32 to be screwed into the inner orifice 24 of the bushing 20. The screw head is adapted to allow the anchoring member 30 to be rotationally driven about its axis Z-Z, both to screw the rod 31 into the humeral bone and to screw its head 32 into the orifice 24 of the bushing. For this purpose, the head 32 has, for example, on the proximal side thereof, a cavity (not shown in the figures) with a hexagonal or similar profile, which allows the anchoring member 30 to be rotationally-driven by using an appropriate tool.
In one embodiment, the outer threaded face 32A of the head 32 is in the form of truncated-cone-shaped casing with an axis Z-Z converging towards the axis as it approaches the rod 31. The wall 24A of the threaded orifice 24 of the bushing 20 is also optionally in the form of truncated-cone-shaped casing with an axis Y-Y, converging towards the axis as it approaches the distal side of the bushing. The truncated-cone shapes of the outer face 32A and the wall 24A are substantially complementary, the angles at the apexes α32 and α24 of these two truncated-cone shapes being substantially equal. In another embodiment, only one of the threaded face 32A or the wall 24A comprise a truncated cone and the other comprises a cylindrical configuration without a taper.
In addition, the outer diameter of the distal end of the head 32 is substantially equal to the inner diameter of the proximal end of the orifice 24 in such a way that, as the head 32 is screwed into the bushing 20, the inner diameter of the orifice 24 increases until the inner diameter of the proximal end of the orifice is substantially equal to the outer diameter of the proximal end of the head 32 when the head is completely screwed into the bushing. Increasing the inner diameter of the orifice 24 is enabled by the fact that the bushing 20 is split. When the head 32 is screwed into the orifice 24, the edges of the slot 25 move away from one another, and thus allow the bushing to pass from a first configuration, shown in dashed lines in
In order to block the bushing 20 from rotating about the axis Y-Y in the hole 15 when it is in its first configuration, a member 40 is inserted fixedly into the body 11 of the plate 10. In the illustrated embodiment, the member is in the form of a cylinder with a circular base and having a central longitudinal axis U-U, formed in particular from a metal similar to that of the body of the plate 11. The blocking member 40 is joined to the plate 10 by being received and immobilised, in particular by welding, in a complementary recess 19 formed, for example by machining, in the body of the plate 11, at a peripheral portion of the hole 15. In practice, the recess 19 is smaller than the hole 15 in that the diameter thereof is smaller than that of the hole. The blocking member 40 may be other shapes, such as for example with a narrowing configuration that tapers in the direction of the centre of the hole 15 that they occupy in part, so as not to obstruct the partial closure of the slot during introduction of the bushing into the hole, while being adjusted closest to the edge of this slot once the bushing is received in this hole.
The central longitudinal axis of the recess 19 may be parallel to or, as for example shown in the figures, slightly inclined so as to converge towards the humerus, preferably at an angle of about 15° or less with respect to the axis X-X of the hole, opens radially into the hole 15. In other words, the hole 15 and the recess 19 are not respectively closed over all of their periphery, but respective portions of the peripheries are provided so as to communicate with one another, in particular in the plane of
Producing and implanting the plate 10, the bushing 20, the anchoring member 30 and the member 40, will now be discussed in more detail.
It is proposed that the four members 40, each associated with the four holes 15, are initially joined to the plate 10 by welding each of the members in the corresponding recess 19 previously formed in the body of the plate 11, as shown by the arrow F1 in
In practice, fitting each bushing 20 requires that the externally spherical portion 22 is gently radially compressed towards the interior by bringing the edges of its slot 25 slightly closer together until the maximum outer diameter of the bushing is less than the proximal diameter of the hole 15. The whole of the bushing may then be axially inserted into the hole, the portion of the member 40A being received in the slot 25. If necessary, the slot 25 may be partially closed again until the edges thereof contact the lateral wall of the portion of the member 40A. The cylindrical shape of the lateral wall has been found to be practical as it does not obstruct the partial closure of the slot 25 and it can even guide the insertion of the bushing into the hole by sliding contact of the edges of the slot thereof along the lateral wall.
The surgeon then fits the plate 10 along the humerus 1, the portion 13 of the body 11 and the lateral projections 16 embracing the epiphysis 3 thereof, as shown in
The anchoring member 30 is thus axially inserted into each hole 15 by rotationally driving the anchoring member about its axis Z-Z in such a way that the rod 31 thereof penetrates into the bone matter of the epiphysis 3 in order to be securely anchored therein. The anchoring member 30 is inserted and screwed in while the bushing 20 is received in the hole 15, the anchoring member 30 passing through the orifice 24 thereof. In this configuration, the spherical face 22A of the bushing slides freely against the spherical wall 18A of the hole 15 in order to adjust for misalignment between the axes X-X and Z-Z if the surgeon inserts the anchoring member 30 in an inclined longitudinal direction relative to the axis of the hole, in particular as a function of the state of the bone matter at his disposal. The movable connection between the bushing and the wall of the hole 15 is similar to that of a ball joint with, however, its freedom of movement restricted by the presence of the member 40.
The member 40A prevents the bushing 20 from turning on itself so that the passageway 24 is inaccessible. In other words, in order to accommodate any potential misalignment of the axes X-X and Z-Z, the bushing 20 is able to pivot inside the hole 15 about an axis which is substantially perpendicular to the axis X-X and passing through the point O, by sliding contact of the face 22A against the wall 18A, as shown by the arrow 26 in
When the head 32 is axially directly adjacent to the bushing 20 and when the surgeon continues to rotationally drive the anchoring member 30 about its axis Z-Z, the thread of the outer face 32A of the head 32 engages simply and easily in the thread of the orifice 24, causing the bushing to pass from its first to its second configuration. Initially engaging the thread of the anchoring member head in the internal thread of the bushing is facilitated by the fact that the rotation of the bushing 20 about its axis Y-Y is immobilised by the member 40.
As the head 32 is screwed into the threaded orifice 24, the outer face 22A of the bushing 20 is pressed against the wall 18A of the hole 15 until the bushing is wedged inside the hole, thus rigidly connecting the bushing, and therefore the anchoring member 30, to the plate 10.
As shown in
In order to receive and immobilise the member 40′, the plate body 11 delimits a recess 19′ which includes, on the proximal side of the plate body, an elongate portion 19′1 which extends lengthwise between the two holes 15 in the plane passing through the axes X-X of the holes, generally in a direction radial to the holes. The longitudinal ends of the portion of recess 19′1 open respectively into the two holes 15.
On the distal side of the plate body 11, the recess 19′ includes a cylindrical portion 19′2 opening onto the portion of the recess 19′1 in such a way that the portions of the recess 19′1 and 19′2 are respectively complementary to the proximal portion 41′ and the distal portion 42′ of the member 40′.
In order to insert the member 40′ into the recess 19′, the distal portion 42 is coaxially inserted into the portion of the recess 19′2 as indicated by the arrow F′1, while the proximal portion 41′ is inserted in an adjusted manner into the portion of the recess 19′2, thus preventing the member 40′ from turning about the axis U′-U′. The longitudinal ends 41′A of the proximal portion 41′ thus occupy a portion of each of the holes 15 in the same way as the peripheral portion 40A of the member 40 occupies a portion of the hole 15 in the embodiment in FIGS. 1 to 3. Advantageously the longitudinal ends 41′A are shaped as cylinder portions, the respective longitudinal axes of which are shown in the layout in
The manufacture and use of the variant in
The present expandable bushing and anti-rotation member can be used with a variety of other orthopaedic implants, such as for example a base plate for a glenoid implant. Examples of such base plates are illustrated in U.S. Pat. Nos. 6,969,406, 6,761,746, 5,702,447 and U.S. Patent Publication No. 2005/0278032, which are hereby incorporated by reference.
Patents and patent applications disclosed herein, including those cited in the Background of the Invention, are hereby incorporated by reference. Other embodiments of the invention are possible. Although the description above contains many specificities, these should not be construed as limiting the scope of the invention, but as merely providing illustrations of some of the presently preferred embodiments of this invention. Thus the scope of this invention should be determined by the appended claims and their legal equivalents. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0610141 | Nov 2006 | FR | national |
