WO2009095451A1

WO2009095451A1 - Device and surgical method for reducing a fracture between the epiphyseal head and the diaphysis of a long bone, in particular a proximal humeral fracture

Info

Publication number: WO2009095451A1
Application number: PCT/EP2009/051030
Authority: WO
Inventors: Edwin Spencer; Emmanuel Lizee
Original assignee: Tornier
Priority date: 2008-01-29
Filing date: 2009-01-29
Publication date: 2009-08-06
Also published as: EP2244645A1; FR2930424A1

Abstract

This device claims to improve the reduction of a fracture between the epiphyseal head and the diaphysis of a long bone, limiting the detachment of biological tissue in the vicinity, and thus comprises: - an elongated plate which comprises, on either side of the fracture covered by the plate, an epiphyseal portion which can be fixed in a rigid manner to the head and a diaphyseal portion which can be fixed to the diaphysis both in a rigid manner and so as to be displaceable in the longitudinal direction of the plate, - a jacking rod for pushing against the head, which jacking rod penetrates the plate and thus extends lengthwise from the plate until it reaches a hard portion of the head, in such a way that the jacking rod pushes the head towards a first way, - mechanical guide means for reversibly guiding the jacking rod relative to the plate and in the longitudinal direction of said rod, and - pulling means for pulling the head, which pulling means pull the head towards a way opposite to the first way, in a direction largely parallel to the longitudinal direction of the jacking rod.

Description

DEVICE AND SURGICAL METHOD FOR REDUCING A FRACTURE BETWEEN

THE EPIPHYSEAL HEAD AND THE DIAPHYSIS OF A LONG BONE,

IN PARTICULAR A PROXIMAL HUMERAL FRACTURE

This application claims priority to:

- US provisional patent 61/024,327, filed January 29, 2008,

- French patent application FR 08 52803, filed April 25, 2008,

- US provisional patent 61/052,283, filed May 12, 2008, and

- US provisional patent 61/052,475, filed May 12, 2008, all herein incorporated by reference.

The present invention relates to a device and a method for reducing a fracture between the epiphyseal head and the diaphysis of a long bone. A particularly advantageous, but not exclusive, application of the invention is the reduction of proximal humeral fractures, that is to say fractures between the upper epiphyseal head and the diaphysis of a human humerus.

Instead of replacing the upper head of a humerus with a prosthesis when the neck of said head has been fractured, it is now increasingly common to reduce the fracture using a humeral osteosynthesis plate. However, satisfactory results are only obtained if the plate is fixed rigidly to the humerus on either side of the fracture, that is to say it must be fixed to the head and to the diaphysis of the humerus whilst the fracture is properly reduced and stabilized.

In other words, the treatment of proximal humeral fractures in shoulder surgery is aided with a stable construct that sustains early mobilization with high healing rates and low complication rates. A plate bridging the fracture between the head and the diaphysis of the humerus aids in fixation, but the head must be reduced before fixation.

In practice, in order to ensure a satisfactory reduction of the fracture, inserting this type of humeral plate currently leads to the detachment of biological tissues surrounding the upper portion of the humerus. This has damaging consequences and may even lead to post-operative complications for the patient.

The object of the present invention is to provide a device and a method for reducing this type of fracture which limit the detachment of biological tissue surrounding the fracture whilst also improving the reduced position of the head. The invention thus relates to a device for reducing a fracture between the epiphyseal head and the diaphysis of a long bone, as defined in claim 1.

The invention also relates to a surgical method for reducing a fracture between the epiphyseal head and the diaphysis of a long bone, as defined in claim 17.

An advantageous implementation of this method, which may be carried out using the device according to the invention, is defined in dependent claim 18.

The invention is based not on the idea of "forcing" the head in a single direction with the aim of pinning it against the diaphysis of the bone so as to reduce the fracture between said head and the diaphysis, but inversely of pushing the head in a direction tilted relative to the longitudinal direction of the bone whilst pulling the region of the head opposite the fracture in a substantially parallel but opposite direction. The head is thus subjected to a resultant tilting movement which makes it possible to put the head back in place in a satisfactory manner and to thus reduce the fracture without using excessive force, in particular without disturbing the biological tissue in the vicinity of the reduced fracture by means of detachment. With regard to reducing a proximal humeral fracture, the surgeon can thus control the jacking rod and the pulling means in order to correct especially the varus position of the humeral head by tilting it slightly outwardly, largely about a horizontal anteroposterior geometrical axis passing through said head.

The device and method according to the invention can be adapted to different sizes of fractured heads whilst also affording the surgeon a high level of precision with regard to the pushing forces exerted by the jacking rod and the pulling forces exerted by the pulling means so as to adjust the reduced position of the head as best as possible before firmly connecting the plate to the bone on either side of the reduced fracture, typically using conventional bone-anchoring means, such as screws.

In other words, in accordance with the invention, for a proximal humeral fracture fixed with the locking plate, pushing the head from an inferior aspect to rotate the head to reduce the fracture allows for positioning the head out of varus or other malalignment, obviating the need for multiple pins to provisionally reduce the fracture, and minimizing the soft tissue stripping. The humerus is reduced by pushing the head out of varus or other malalignment, thereby allowing fixation. In practice, the point at which the rod exerts a pushing force on the head of the bone may vary depending both on the malalignment to be corrected and on the state of the bone matter forming said head.

In a first embodiment, the point of the head, at which the jacking rod exerts its pushing force, is located at the fracture. The corresponding device and method according to the invention are defines in dependent claims 5 and 19. Furthermore, if the face of the head facing the fracture has a sufficient level of resistance to this pushing force, the distal end of the rod maintains a pressing contact with said face when the head of the bone is tilted. The surgeon may optionally also temporarily reinforce this bone face of the head using suitable reinforcement elements put in place via the trajectory of the push rod. If the bone matter forming the inside of the head is too soft, guiding the rod leads to the distal end thereof continuing inside said head until said end abuts a portion which is sufficiently resistant to absorb the pushing force. The distal end of the rod may thus possibly continue until it abuts the inner side of the bone cortical of the epiphyseal head which, by nature, is hard enough to withstand the pushing force. The total length of the push rod used must therefore be anticipated accordingly.

In a second embodiment, the point of the head, at which the jacking rod exerts its pushing force, is located at the end frontal aspect of the head, just close to the fracture. The corresponding device and method according to the invention are defined in dependent claims 6 and 20. In one such embodiment, a jacking device pushes an inferior aspect of the head. Simultaneously, sutures pull the superior aspect of the head. After the head rotates into alignment, locking screws fix the head to a locking plate and the jacking device is removed. Advantageous features of the device and method according to the invention, taken in isolation or in any technically feasible combination, are defined in the other dependent claims.

Furthermore, proximal humeral fracture reduction and fixation is commonly performed with fluoroscopic visualization to aid in positioning and locating the various appliances as required. A radiolucent retractor allows access through soft tissue during reduction and fixation of the fracture, thereby allowing a scanner to "see" the humerus and the tools and appliances for reducing the fracture without being blocked by the retractor used to reduce the fracture. The invention will be better understood upon reading the following description, given solely by way of example and with reference to the drawings, in which:

- Fig. 1 is a perspective view of a first embodiment of a device according to the invention, in the process of being arranged on the upper end portion of a human humerus;

- Figs. 2 to 4 are schematic front elevation views of the device shown in Fig. 1 , with cut-away regions showing three successive steps of use of the device respectively; - Fig. 5 is a view similar to those shown in Figs. 3 and 4, showing on a larger scale a variant of the first embodiment of the device;

- Fig. 6 is a side view of a second embodiment of a device according to the invention, at an initial stage of fixation;

- Fig. 7 is a plan view of one embodiment of a locking plate for the second embodiment;

- Fig. 8 is a plan view of one embodiment of a jacking rod for the second embodiment;

- Fig. 9 is a partial cross-sectional view of one embodiment of a collar and a corresponding threaded opening for the second embodiment; - Fig. 10 is a partial cross-sectional view of another embodiment of a corresponding threaded opening;

- Fig. 11 is a partial top view of still another embodiment of the threaded opening;

- Fig. 12 is a side view of one embodiment of a radiolucent deltoid retractor; - Fig. 13 is a front view of the radiolucent retractor of Fig. 12;

- Fig. 14 is a perspective view of another embodiment of a radiolucent retractor; and

- Fig. 15 is a block diagram of one embodiment of the steps for the method of reduction and fixation. Various apparatuses and methods for the reduction and fixation of a fracture are disclosed. These apparatuses and methods are described with respect to treating a proximal humeral fracture, although they are suitable for treating other types of fractures. Treating a proximal humeral fracture during shoulder surgery includes reduction of the head out of varus or other malalignment and fixation of the diaphysis and head of the humerus.

Fig. 1 schematically shows the upper end portion of a humerus H, of which the epiphyseal head and the diaphysis are denoted by the references H1 and H2 respectively. For convenience, the description is based on the humerus H being oriented in its anatomical position for a patient standing up, so the terms "upper" and "top" for example refer to a direction directed upwardly in Figs. 2 to 5, whilst the terms "lower" and "bottom" refer to the opposite direction.

Furthermore, Figs. 2 and 4 also schematically show the scapula S connected to the humerus H as well as some soft parts M formed substantially of muscles and ligaments which surround and interconnect the humeral head H1 and the scapula S. The humeral head H1 , the scapula S and the soft parts M thus form the shoulder of a patient, in which on its outer side, the scapula S delimits a substantially hemi-spherical glenoid face G, inside which a largely complementary face H1A delimited by the upper side of the head H1 is articulated, the relative articulated movements between said faces G and H1A normally being controlled by the soft parts M which are engaged accordingly.

A fracture F separates the humeral head H1 from the diaphysis H2. Owing to this fracture F and the ligaments and muscles surrounding the head H1 and the scapula S, the fracture F is naturally opened by a varus position of the head relative to its normal anatomical position, that is to say that said head is tilted slightly inwardly, thus drawing away from the diaphysis H₂, in particular at the outer portion of the head, as can be seen clearly in Figs. 1 and 2, in which the extent of the opening of the fracture, in particular at the outer side of the shoulder, has been deliberately exaggerated.

In order to reduce this fracture F, it is proposed in this case to use a device 1 comprising a humeral osteosynthesis plate 10 which, in the embodiment shown in the figures, consists substantially of a main elongated body, shaped so as to extend lengthwise along the outer face of the humerus H, covering the fracture F. Said plate 10 thus comprises along its length an epiphyseal portion 11 and a diaphyseal portion 12 which extend over the humeral head H1 and the humeral diaphysis H₂ respectively. In its working portion, the plate portion 11 is completely penetrated by a hole 11 i which, when the plate 10 is arranged on the humerus H, opens onto the humeral head H1. Said hole 1 I ₁ is able to receive a bone-anchoring screw, as shown in Fig. 4 with a screw denoted by the reference numeral 20. In a manner know per se, the cross-section of the passage of the hole 111 is greater than the transverse cross-section of the threaded rod of the screw 20 whilst the wall delimiting the opening of the hole 11 i on the side opposite the humerus H is constructed so as to cooperate, by means of complementary shaping, in particular by contact pressing and/or by screwing, with the head of the screw 20 when the rod thereof is screwed completely into the humeral head H1 , as in the configuration shown in Fig. 4.

At its upper end, the plate portion 11 is also completely penetrated by a plurality of holes 11₂ distributed along the periphery of the plate portion 11 , said holes 11₂ totaling two in the embodiment shown in the figures. Each hole 11₂ receives, by means of threading, a resilient suture element in the form of a loop, as shown in Figs. 2 to 4 with a suture thread denoted by the reference numeral 21. For this purpose, the cross-section of the passage of each hole 11₂ is smaller than that of the hole 1 I ₁ and the walls delimiting the openings of each hole 11₂ are rounded so as to limit the risk of damaging the suture thread 21. In its working portion, the plate portion 12 is completely penetrated by a hole

12i having a passage cross-section which is oblong-shaped, the length of said passage extending in the longitudinal direction of the plate 10. When said plate is placed on the humerus H, the hole 12₁ opens onto the humeral diaphysis H₂ in such a way that a bone-anchoring screw, similar to the aforementioned screw 20, may be screwed into the diaphysis through the hole 12_{1 ;} as shown in Figs. 2 to 4 with a screw denoted by the reference numeral 22. By ensuring that the width of the cross-section of the passage of the oblong hole 12₁ is adjusted to the diameter of the transverse cross-section of the threaded rod of the screw 22, the presence of said screw 22 in the hole 12₁ thus fixes the position of the plate 10 relative to the humerus H over the width of the hole 12i, that is to say in an anteroposterior direction, whilst the position of the plate in the longitudinal direction thereof can be adjusted within the limits of the length of the hole 12i, as long as the head of the screw 22 is not engaged with the wall delimiting the opening of the hole ^*\ 2-_\ on the side opposite the humerus.

The plate portion 12 is also completely penetrated by holes 12₂, totaling two in the embodiment shown, which are of a similar construction to the hole 11 i and which, when the plate 10 is arranged on the humerus H, open onto the diaphysis

H₂. Each of these holes 12₂ is thus able to receive a bone-anchoring screw, as shown in Fig. 4 with screws denoted by the reference numeral 23.

At its top portion, that is to say above the oblong hole 12i, the plate portion 12 is completely penetrated by a threaded hole 12₃ which is centered on an axis X-X. Said axis X-X is not perpendicular to the longitudinal direction of the plate 10 but is tilted towards the top of the side of the plate 10 which is to face the humerus H, forming with the longitudinal direction of the plate an angle denoted by α in Fig. 2, measuring approximately 45° in the embodiment sh own in the figures.

As shown in Fig. 1 , the reduction device 1 also comprises a rod 30, of which the working portion is provided with a thread 31 which complements the internal thread of the hole 12₃. The proximal end of the rod 30, that is to say its longitudinal end which, when in use, will be facing the surgeon and thus opposite the humerus

H, is shaped as a manual guiding grip 32, in this case in the form of a knob for guiding the rod 30 in rotation about the central longitudinal axis thereof. The distal end of the rod 30 is shaped into a rounded tip 33, as can be seen clearly in Figs. 2 to 4.

With a view to reducing the fracture F, the device 1 is used as follows: Firstly, the surgeon cuts the biological tissue at the fracture F, preferably from a delto-pectoral approach. In a first step, the surgeon attempts to arrange the plate 10 along the humerus H in such a way that it covers the fracture F, whilst connecting the epiphyseal portion 11 of the plate to soft parts M. In order to do this, in accordance with a possible implementation of this first operating step, this mode of implementation also being of particular benefit in the sense that it is independent of the rest of the reduction method described, the surgeon first passes, by means of the incision which he made previously, suture threads 21 through some soft parts M and threads these suture threads through the holes 11₂ so as to thus connect, by means of suturing, the plate 10 to said soft parts M. The surgeon then inserts the plate 10 into the incision and slides it along the outer face of the humerus H until it is in the position shown in Fig. 2, in which said plate is held in a resilient manner by the loops formed by the suture threads 21. In other words, the surgeon "parachutes" the plate 10 along the humerus using suture threads 21 , which makes it easier to fit the plate in place and improves the initial positioning of said plate without excessively enlarging the incision in the patient's shoulder.

The surgeon then fixes the diaphyseal portion 12 of the plate 10 to the humeral diaphysis H2, it still being possible for said plate to move up or down freely in translation. In order to do this, the surgeon inserts the screw 22 into the working portion of the oblong hole 12i but does not screw in the rod of said screw completely, as shown in Fig. 2.

The surgeon then takes hold of the rod 30 and inserts its proximal end into the threaded hole 12₃. By guiding the rod 30 in rotation about its axis using its proximal grip 32, as indicated by the arrow 40 in Fig. 2, the surgeon progressively screws the thread 32 into the hole 12₃, thus guiding in accordance with the axis X- X the rounded tip 33 of the rod through the humeral diaphysis H2. In practice, this tip 33 passes fairly easily into the diaphysis H2 in the direction of the fracture F, depending on the sponginess of the bone matter to be penetrated. If necessary, before inserting the rod 30 into the hole 12₃, the surgeon may form a tunnel which is largely centered on the axis X-X, for example by inserting a pin or drill fairly deeply into the diaphysis H2 from the outer face of said diaphysis.

The rod 30 is screwed into the threaded hole 12₃ until the rounded tip 33 of the rod reaches the fracture F. By screwing in the rod, this tip 33 thus abuts the lower face H1 B of the humeral head H1 , as shown in Fig. 2. Whilst still screwing in the screw 30, the rounded tip 33 firmly abuts the bone face H1 B and exerts a pushing force upwardly on the humeral head H1 in the direction of the axis X-X, as indicated by the arrow 41 in Fig. 3. If, either by itself or owing to a reinforcement element which has been temporarily inserted by the surgeon, said bone face H1 B has a sufficient level of resistance to the force exerted, the entire head H1 is thus pushed in the same movement. However, depending on the state of the bone matter forming the head or even depending on the region of the face H1 B which is subjected to the pushing force, it is possible for the rod 30 to continue inside the head until its tip 33 abuts an inner portion which is sufficiently hard, in particular the inner side of the bone cortical of the head. In any case, the inner portion of the head H1 thus tends to be lifted up whilst the outer portion is lowered owing to the head being tilted largely about a horizontal anteroposterior geometrical axis. This tilting movement is partly controlled and monitored by the surgeon by adjusting the tension of the suture threads 21 , the soft parts M thus being engaged so as pull the outer portion of the head H1 downwardly in a direction substantially parallel to the axis X-X, as indicated by the arrow 42 in Fig. 3. The articulation of the face H1A against the glenoid face G may help to guide this tilting movement. Furthermore, the head of the screw 22 may, if necessary, outwardly hold the plate portion 12 in place, should said plate portion tend to move away from the outer face of the diaphysis H2 owing to resistance against the rod 30 being screwed in and contact pressing the head H1.

Tilting the entire humeral head H1 thus corrects the varus position of said head and also displaces it outwardly until it is in its normal anatomical position. The fracture F is thus reduced by drawing the humeral head towards the diaphysis H2. Closing the fracture F in this manner may slightly modify the vertical position, either upwardly or downwardly, of the plate 10 along the diaphysis H2. This slight change to the altitude of the diaphyseal portion 12 of the plate is enabled by means of a corresponding relative translatory movement of the screw 22 in the oblong hole 12i, as shown in Fig. 3.

When the fracture F is reduced by simultaneously pushing the rod 30 upwardly against the humeral head H1 and by pulling downwardly using suture threads 21 , the surgeon fixes the position of the plate 10 along the humerus H on either side of the fracture F. The screw 20 is inserted into the hole 11₁ so as to anchor the epiphyseal portion 11 of the plate relative to the humeral head H1 whilst, on the one hand, the screw 22 is screwed all the way into the oblong hole

121 and, on the other hand, the screws 23 are inserted completely into the holes

12₂ so as to thus anchor the diaphyseal portion 12 of the plate relative to the humeral diaphysis H2. The plate 10 is thus completely immobilized along the humerus H on both sides of the reduced fracture F, as shown in Fig. 4.

The rod 30 may then be removed from the plate 10 by means of unscrewing, as indicated by the arrow 43 in Fig. 4. The threaded hole 12₃, as well as any other through-holes in the plate 10 which have not been used to receive bone-anchoring screws or the like, are advantageously sealed using a bone filling material. The sutures 21 are advantageously tied firmly to the epiphyseal portion 11 of the plate, by cutting and removing any unnecessary excess threads, as shown in Fig. 4.

Fig. 5 shows a variant embodiment of the reduction device 1 which involves removing the threaded hole 12₃ which is delimited in the diaphyseal portion 12 of the plate and replacing it with a through-passage 12₄ which is larger in terms of the cross-section of its passage, whilst also providing the device 1 with an assembly which makes it possible to control the inclination of the push rod 30 relative to the plate 10. As shown in Fig. 5, a platelet 50 is thus arranged on the outer face of the diaphyseal portion 12 of the plate by means of removable screws 51 in such a way that a through-hole 52, delimited in the platelet 50, opens onto the passage 12₄. Said hole 52 can receive the rod 30 with a largely tubular olive 53 having a longitudinal axis Y-Y being interposed. The main outer face 53A of the olive 53 is substantially spherical and centered on a point belonging to the axis Y-Y. When the olive is arranged in the hole 52, said spherical face 53A abuts, in a complementary manner, the main wall 52A delimiting the hole.

On its inner face, the olive 53 delimits a threaded through-hole 54 centered on the axis Y-Y. The olive also delimits, over a portion of its periphery, a slit 55 which extends over the entire olive in the direction of the axis Y-Y and completely penetrates the tubular wall of the olive in such a way that said slit radially connects the outer face 53A of the olive and its inner hole 54. The olive thus has a largely C-shaped cross-section owing to said slit 55.

The thread in the hole 54 is complementary to the thread 31 of the rod 30, it being noted that the inner diameter of said hole is slightly smaller than the outer diameter of the rod 30 when the olive 53 is in the resting state, that is to say when said olive is not subjected to any radial stress exerted so as to open out the edges of its slit 55.

In practice, it is necessary to lightly press the olive in a radially inwardly manner, bringing the edges of its slit 55 slightly closer together, in order to place the olive 53 inside the hole 52. The olive 53 is thus in a first configuration in which it is freely articulated inside the hole 52 by means of cooperation between the outer face 53A of the olive and the wall 52A of the hole 52. In contrast, once the rod 30 begins to be screwed into the threaded hole 54, the edges of the slit 55 move away from one another and the olive thus passes from its first configuration to a second configuration in which it is radially outwardly deformed relative to the axis Y-Y, causing the olive to be wedged inside the hole 52. The use of the variation of the reduction device 1 comprising the platelet 50 and the olive 53 is similar to that of the reduction device shown in Figs. 1 to 4, the difference being that, before the surgeon inserts and screws the rod 30 into the threaded hole 54, he has the option of adjusting the position of the axis Y-Y of said threaded hole relative to the platelet 50 and thus relative to the plate 10. Being able to adjust the position of said axis Y-Y allows the surgeon to modify the region of the lower face H1 B of the humeral head H1 , against which the rounded tip 33 of the rod 30 will press once the rod 30 has been screwed in. The direction of application of the pushing force exerted on the humeral head H1 is thus adjusted, in particular so as to modify the intensity with which the head H1 is outwardly tilted and/or so as to exert said force on a healthier region of said head, for example a less fragile region.

Adjusting the position of the olive 53 in the hole 52 is made easier by a lateral screw 56 which is able to reversibly hold the olive in the position selected by the surgeon. When the rod 30 then starts to be screwed into the hole 54, it is thus impossible to accidentally modify the prior adjustment made to the position of the olive.

Fig. 6 illustrates a side view of one embodiment of a jacking device 104 and a locking plate 102 at an initial stage of fixation. The plate 102 is shown attached to the diaphysis 112 of a fractured humerus 110 with a screw 106. A jacking device 104 attached to the locking plate 102 engages an inferior aspect of the head 108. Suture material 114 is stitched in the teres minor, infraspinatus, supraspinatus, and/or subscapulars 116.

Pulling the suture material 114 results in an outward force 120 applied to the superior aspect of the head 108. The jacking device 104 applies an inward directed force 122 to the most inferior aspect of the head 108. The two forces 120, 122 impart a rotary motion 124 to the head 108 that moves the head 108 out of varus. Varus is the inward angulation of the humerus 110. In other embodiments, the jacking device 104 is positioned to move the head 108 in alignment when the head 108 is malaligned other than being in varus, for example, when the head 108 is in valgus.

FIG. 7 illustrates a plan view of one embodiment of the plate 102. The plate 102 provides fixation of the fracture. The plate 102 includes an assortment of holes and openings 202, 204, 206. The plate 102 has a contoured shape that allows the plate 102 to mate to the humerus 110. Further, the superior end of the plate 102 is wider than the inferior end. The wider superior end accommodates the head 108, which is typically wider than the shaft 112.

The margins around the superior end of the plate 102 includes several pairs of suture holes 206. Each suture hole 206 is sized to receive suture material 114.

In the illustrated embodiment, several of the pairs of suture holes 206 have a channel 210 between the two holes 206 of the pair. The channel 206 receives the suture material 114 and its knot to avoid the suture material 114 from protruding above the distal surface of the plate 102. One method of using the plate 102 uses the most superior suture holes 206 for the suture material 114 that is stitched to the supraspinatus muscle and uses the pairs of suture holes 206 on the upper sides of the plate 102 for the suture material 114 that is stitched to the infraspinatus, subscapulars, and/or teres minor.

The superior end of the plate 102 also includes locking holes 204 that receive locking screws 106. The locking holes 204 are threaded openings at various locations and at various angles to accommodate fixing the head 108 to the plate

102. Locking screws 106 are inserted through the locking holes 204 and into the head 106 to fix the head 108 to the locking plate 102. In various embodiments, one or more of the locking holes 204 are configured to receive a jacking device 104.

The most inferior hole 202 at the superior end of the plate 102 is located adjacent the surgical neck. The inferior hole 202 is the jacking device hole, that is, it is the hole that receives the jacking device 104. The jacking device hole 202 has an angle that positions the jacking device 104 at an inferior aspect of the head 108.

The inferior end of the plate 102 includes a series of elongated holes 208 that are threaded. The elongated holes 208 receive screws 106, either locking or nonlocking, that fix the shaft 112 to the plate 102. The most superior of the elongated holes 208 is configured to allow an extended superior-inferior translation of the plate 102 when the first locking screw 106 is used to initially attach the plate 102 to the shaft 112.

FIG. 8 illustrates a plan view of one embodiment of the jacking device 104. The jacking device 104 includes a jacking screwed rod 306 and a collar 302. The jacking screw 306 moves longitudinally through the collar 302 when the jacking screw 306 is rotated, or screwed, about its longitudinal axis.

The jacking screw 306 is an elongated threaded member. The proximal end of the jacking screw 306 includes a driver tip 310 that is configured to engage a driver. The driver rotates the jacking screw 306. In various embodiments, the driver is a manual or a powered rotary device that allows the jacking screw 306 to be precisely located by screwing the jacking screw 306 relative to the collar 302. The distal end of the jacking screw 306 includes a spherical end 308 for engaging an inferior aspect of the head 108. In other embodiments, the proximal end of the jacking screw 306 has other shapes for engaging the head 108, for example, a spiked or cupped end. The spherical end 308 of the jacking screw 306 is sized to pass through the jacking screw hole 202 in the plate 102.

The distal end of the collar 302 includes a threaded fitting 304. The illustrated embodiment shows a threaded fitting 304 that has a conical thread that engages corresponding threads in a jacking device hole 202. In other embodiments the fitting 302 is configured to engage a hole 202, 204, 208 in the locking plate 102. In such embodiments, the threaded fitting 304 may not have threads that are conical. The collar 302 has a configuration that allows the collar 302 to be screwed into the plate 102 securely and to be removed from the plate 102 after fixation. For example, the proximal end of the collar 302 has a slot for receiving a turning tool or the proximal end has a hexagonal shape for engaging a turning tool.

FIG. 6 illustrates the stage of shoulder surgery where reduction is complete with the head 108 out of varus and aligned with the shaft 112. The fracture 118 has been reduced and the humerus is ready for fixation. To achieve the illustrated reduction, sutures are placed in the rotator cuff 116. For example, inverted mattress stitches of a non-absorbable braided suture material 117 are placed in the teres minor, infraspinatus, supraspinatus, and/or subscapulahs 116. The ends of the suture material 114 are passed through suture holes 206 in the plate 102. The plate 102 is then parachuted down onto the humerus 110. The plate 102 is then provisionally secured to the shaft 112 of the humerus 110 by a screw 106 inserted through an elongated hole 208 that allows for superior and inferior translation of the plate 102. Using a non-locking screw 106 allows the shaft 112 to be drawn tight against the plate 102. In the illustrated embodiment, the most superior elongated hole 208 is configured to allow the greatest superior and inferior translation. The other holes 208 are available for provisionally securing the shaft 112.

Pulling the suture material 117 away from the head 108 applies a force 120 away from the head. Screwing the jacking screw 306 into the collar 302 moves the proximal end 308 of the screw 306 inward and applies a force 122 to the inferior end of the head 108. The two forces 120, 122 apply a rotational force 124 to the head 108, thereby causing the head 108 to rotate in the direction of the force 124 and out of varus or other malalignment. The fine threads of the jacking screw 306 allow the precise position and height of the head 108 to be dialed in to re-establish the anatomic neck/shaft angle. The head 108 is positioned by being pushed from the inferior aspect and pulled from one or more of the suture material 114 attached to the superior aspect of the head 108. The jacking device 104 rotates the head 108 in the coronal plane, that is, the axis of rotation of the head 108 is perpendicular to the coronal plane. Different sections of the suture material 114 are pulled with varying force to steer or guide the head 108 within the transverse plane.

When the desired position of the head 108 is achieved, locking screws 106 are placed in the head 106 through the locking holes 204. With the locking plate 102 securely fixed to the head 102, the jacking device 104 is removed from the plate 102. Additional locking screws 106 are then inserted through the elongated holes 208 and in the shaft 112.

FIG. 9 illustrates a partial cross-sectional view of one embodiment of a collar 302 and a corresponding threaded opening 202A. The collar 302 includes a threaded fitting 304. In the illustrated embodiment, the threaded fitting 304 has conical threads that engage the corresponding threads in the jacking device hole 202A. The jacking device hole 202 is formed in the locking plate 102 with an angle preset to direct the jacking screw 306 toward the inferior aspect of the head 108. In various embodiments, the jacking device hole 202A is a single threaded opening as illustrated, one of several threaded openings grouped together, or a multiple threaded opening, such as illustrated for the elongated holes 208 at the inferior end of the locking plate 102. The additional options for the jacking device hole 202A allows for variations in the angle of the jacking screw 306.

FIG. 10 illustrates a partial cross-sectional view of one embodiment of a collar 302 and another embodiment of a corresponding threaded opening 202B. The illustrated embodiment of the jacking device hole 202B includes a swivelling plug 502 in a plug opening 504. As shown in the longitudinal cross-section of FIG. 10, the swivelling plug 502 is spherical with a circular cross-section that is slightly smaller in diameter than the circular cross-section of the plug opening 504. Accordingly, the swivelling plug 502 rotates within the plug opening 504, thereby allowing the angle of the jacking device hole 202B to be adjusted as needed. The concave sidewalls of the plug opening 504 hold the swivelling plug 502 captive in the opening 504. Axial pressure exerted by the jacking screw 306 when it engages the head 108 forces the outer surface of the swivelling plug 502 against the corresponding wall of the plug opening 504, and the fhctional engagement minimizes unintentional angular movement of the jacking screw 306.

FIG. 11 illustrates a partial top view of another embodiment of the threaded opening 202B' of FIG. 5. The swivelling plug 502' has a spherical shape with the lateral sides flattened. The plug opening 504' has a corresponding shape. The flattened sides of the swivelling plug 502' prevent the swivelling plug 502' from rotating when the threaded fitting 304 of the collar 302 is screwed into the jacking device hole 202B'. Likewise, the flattened sides prevent the swivelling plug 502' from rotating when the jacking screw 306 is rotated. The flattened sides of the swivelling plug 502' are substantially parallel with the longitudinal axis of the locking plate 102, thereby allowing the angle of the jacking screw 306 to be adjusted in the coronal plane when the locking plate 102 is attached to the shaft 112. FIG. 12 illustrates a side view of one embodiment of a radiolucent deltoid retractor 702A. FIG. 13 illustrates a front view of the radiolucent retractor 702A of FIG. 7. The deltoid retractor 702A includes a flat handle 704A attached to an extension 708A that terminates in a blade 706A. The extension 708A has a neck 802 that transitions the wider flat handle 704A to the narrow blade 706A. The retractor 702A includes a handle rib 710 that reinforces the connection of the handle 704A to the extension 708-A. The retractor 702A also includes a blade rib 712 that reinforces the connection of the blade 706A to the extension 708A. The reinforcement ribs 710, 712 provide structural strength for the radiolucent material to withstand the pulling and levering forces applied to the retractor 702A.

FIG. 14 illustrates a perspective view of another embodiment of a radiolucent retractor 702B. The retractor 702B includes a rounded handle 704B attached to a curved extension 708B that terminates in a curved blade 706B. The curved handle 704B and the transition to the curved extension 708B have a thickness that results in sufficient strength for the radiolucent material to withstand the pulling and levering forces applied to the retractor 702B. The thickness and configuration of the curved blade 706B is such that the radiolucent material withstands the forces applied to the curved blade 706B. Placing the plate 10 or 102, operating the jacking rod 30 or device 104, and placing the locking screws 20, 22 and 23 or 106 requires working around the soft tissue of the patient's shoulder. To avoid stripping the tissue during the surgery, retractors 702 are used. Fluoroscopy is used to allow the surgeon to visualize the procedure in real-time. The illustrated retractors 702A, 702B are made of a radiolucent material that is transparent to the imaging rays of the fluoroscopic device. By being radiolucent, the retractor 702 does not block the surgeon's view of areas of interest. In another embodiment, the retractor 702 is made of two materials with the handle 704 being a first material and the blade 706 and a portion of the extension 708 being a second, radiolucent material. In this way only the portion of the retractor 702 that potentially would block the surgeon's view is made of a radiolucent material. In various embodiments, the first material is chosen for its strength, durability, grip, and/or characteristic other than being radiolucent.

FIG. 15 illustrates a block diagram of one embodiment of the steps for the method of reduction and fixation. The illustrated method results in shorter surgery time for the patient and eliminates the need for provisionally reducing the fracture with multiple pins. The illustrated method also minimizes soft tissue stripping, thereby improving healing rates. Although the following steps are described with respect to the reduction and fixation of a proximal humeral fracture, the method is applicable to reducing and fixing other fractures.

The first step 1002 is to position the plate 10 or 102 adjacent the humerus H or 110 with the superior end of the plate proximate the head H1 or 108. For a deltopectoral approach, suture material 21 or 114 is stitched to the tissue adjacent the superior aspect of the head H1 or 108. The suture material is then passed through the appropriate suture holes 112 or 206 in the plate 10 or 102. The plate is then parachuted down onto the humerus. In one such embodiment, inverted mattress stitches of a non-absorbable braided suture material, such as #2 Fiber- wire, are placed in the supraspinatus, infraspinatus, subscapulars, and/or teres minor.

The next step 1004 is to provisionally secure the plate 10 or 102 to the diaphysis H2 or 112 of the humerus 110. In one embodiment, the non-locking screw 22 or 106 is inserted through the elongated hole

or 208 that provides for superior and inferior translation of the plate 10 or 102. The screw 22 or 106 is placed in the diaphysis H2 or 112 with the plate 10 or 102 at an appropriate height relative to the humerus H or 110. The height or position of the plate relative to the humerus is changed by loosening the screw 22 or 106 and translating the plate along the humerus. The next step 1006 is to position the head H1 or 108 out of varus or other malalignment and in alignment with the plate 10 or 102. The positioning step 1006 includes attaching the jacking rod 30 or device 104 to the plate 10 or 102, positioning the jacking rod 30 or screw 306 such that the distal end 33 or 308 is angled up into the head H1 or 108, more specifically either the lower fracture face H1 B of the head H1 or an inferior aspect of the head 108, and adjusting the jacking rod 30 or screw 306 to apply a force 41 or 122 to the head. Positioning the jacking rod or screw to contact the most inferior aspect of the head provides maximum leverage for rotating the head, although other positions are suitable for use. If there is no communication or hole for the jack rod or screw to pass through the cortex of the humerus H or 110, the cortex is perforated with a drill, such as one used for the locking screws 22 or 106.

After being positioned, the jacking rod 30 or device 104 is operated to advance the jacking thread 31 or screw 306. At the same time the suture material 21 or 114 is pulled to guide or steer the head H1 or 108 into position adjacent the superior end of the plate 10 or 102. The jacking rod 30 or screw 306 is rotated to dial in the appropriate head height to re-establish the anatomic neck/shaft angle.

The positioning step 1006 is performed under fluoroscopic guidance. The radiolucent retractor 702 aids in positioning the head H1 or 108, along with pulling the suture material 22 or 114 and advancing the jacking rod 30 or screw 306.

The next step 1008 is to secure the plate 10 or 102 to the humerus H or 110. With the head H1 or 106 positioned, locking screws 20 or 106 are inserted through the locking holes 1 I ₁ or 204 and into the head H1 or 108. The jacking rod 30 or device 104 is removed after the head is secured to the plate. The suture material 21 or 114 is tied. In the embodiment with the channels 210, the suture material 114 is tied and positioned in the appropriate channel 210. The securing step 1008 also includes securing the diaphysis 112 to the locking plate 102 with locking screws 106. Various developments and variations of the reduction devices and the associated surgical methods may also be envisaged. For example:

- resilient suture elements other than the threads 21 and the material 114 may be used to connect the epiphyseal portion of the plate 10 or 102 to some soft parts M and 116, as long as said suture elements can withstand the pulling force exerted thereupon by the surgeon so as to displace the humeral head from its incorrect position when reducing the fracture F;

- instead of pulling the humeral head using suture elements connecting some soft parts M and 116 to the epiphyseal portion of the plate 10 or 102, the surgeon may, either alternatively or in addition, use suture systems comprising a bone anchor which is mechanically independent of the plate, that is to say an anchor which the surgeon engages in the bone matter of the humeral diaphysis H2 or 110 independently of fitting the plate in place; this type of anchor is generally screwed into or impacted in the bone matter; the surgeon then connects said bone anchor to some soft parts by means of suture elements, in particular threads, in such a way as to be able to pull on said suture elements and thus guide the humeral head, largely with the same movement, by tilting it and by using the suture elements described above; - another possibility, which may be used alternatively or in addition, for pulling the humeral head involves engaging an anchor of the type described above in the bone matter of said humeral head and in pulling a tie which is attached to said anchor so as to pull the humeral head directly without disturbing the soft parts; - as an option, a second jacking rod or device is secured to the plate 10 or

102 to better position the head H1 or 108 and reduce the fracture F or 118;

- as a variation of the method, the humeral head H1 cannot be pulled using suture elements or other suture or pulling elements as described above at the same time as being pushed by the rod 30 or the screw 36, but the pulling and pushing operations are carried out successively, or are even repeated several times one after the other, in particular depending on the surgeon's manipulative skill;

- the illustrated method is suitable for being performed with a superior approach; for this superior approach, guides are used to place the screws percutaneously;

- in the embodiment shown in the figures, the plate 10 or 102 constitutes an isolated osteosynthesis element; the invention may be integrated with more elaborate osteosynthesis assemblies as well as with prosthetic assemblies which are simultaneously arranged so as to reduce a bone fracture of the same type as the fracture;

- the rod 30 may optionally be provided, in its working part, with an outer collar similar to the collar 302, which the surgeon may grip with one hand, said collar being freely screwed about the thread 31 and thus displaced at leisure by the surgeon when the device 1 is being used; said sleeve makes it easier to grip and handle the rod 30, in particular when said rod is screwed in and unscrewed;

- more generally, when technically feasible, the features which are described here above for the first main embodiment shown in figures 1 to 5 can be integrated in the second main embodiment shown in figures 6 to 11 , and vice-versa;

- although the example described in this case is used to reduce a proximal humeral fraction, the reduction device 1 may be used on other long bones which are fractured between an epiphyseal head thereof and the diaphysis thereof; and/or - instead of guiding the jacking rod 30 or screw 306 relative to the plate 10 or 102 by means of screwing/unscrewing, other mechanical means which can be used by the surgeon may be used to exert a force for guiding said jacking rod so as push against a bone head, such as the humeral head. While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concept.

Claims

1. Device for reducing a fracture between the epiphyseal head and the diaphysis of a long bone, comprising: - an elongated osteosynthesis and/or prosthesis plate which is adapted to extend lengthwise along the bone, covering the fracture, and which has along its length, on either side of the fracture when said fracture is covered by the plate, an epiphyseal portion which can be fixed to the head of the bone in a rigid manner, and a diaphyseal portion which can be fixed to the diaphysis of the bone both in a rigid manner and so as to be displaceable in the longitudinal direction of the plate,

- a jacking rod for pushing the head of the bone, which jacking rod is adapted to penetrate through the plate and thus to extend lengthwise, when the plate covers the fracture, at least from the plate until the jacking rod reaches a hard portion of the head, so that the jacking rod is thus able to push the head towards a first way,

- mechanical guide means for reversibly guiding the jacking rod relative to the plate in the longitudinal direction of said rod, and

- pulling means for pulling the head of the bone, which pulling means are adapted to pull the head towards a second way opposite to the first way, in a direction which is largely parallel to the longitudinal direction of the jacking rod.

2. Device according to claim 1 , wherein the pulling means comprise at least one suture material for connecting and being tensioned between the epiphyseal portion of the plate and soft parts, such as muscles and ligaments, which surround and are connected to the head of the bone.

3. Device according to either claim 1 or claim 2, wherein the pulling means comprise a bone anchor in the diaphysis of the bone, which anchor is mechanically independent of the plate, and at least one suture material for connecting and being tensioned between said anchor and soft parts, such as muscles and ligaments, which surround and are connected to the head of the bone.

4. Device according to any one of the preceding claims, wherein the pulling means comprise a bone anchor in the head of the bone, which anchor is mechanically independent of the plate and is attached to a tensioning tie.

5. Device according to any one of the preceding claims, wherein the jacking rod is adapted to penetrate through the diaphyseal portion of the plate and thus extends lengthwise, when the plate covers the fracture, at least from said diaphyseal portion, through a portion of the diaphysis of the bone until the jacking rod reaches the side of a hard portion of the head facing the fracture, so that the jacking rod is thus able to push the head away from the diaphysis.

6. Device according to any one of claims 1 to 4, wherein the jacking rod is adapted to penetrate through the epiphyseal portion of the plate and thus extends lengthwise, when the plate covers the fracture, at least from said epiphyseal portion, until the jacking rod reaches a frontal aspect of a hard portion of the head, next to the fracture, so that the jacking rod is thus able to push the head away from or towards the diaphysis.

7. Device according to any one of the preceding claims, wherein the guide means comprise, or even consist of screwing/unscrewing means for screwing/unscrewing the jacking rod through the plate.

8. Device according to claim 7, wherein the screwing/unscrewing means comprise, on the one hand, a thread which is delimited along the jacking rod and, on the other hand, at least one hole for receiving the jacking rod, which hole is threaded in a manner which is complementary to the thread of the jacking rod and, at least when the jacking rod is being screwed in/unscrewed, is rigidly connected to the plate in such a way that, relative to the longitudinal direction of the plate, the central axis of the hole is tilted towards the first way on the side of the plate facing the bone.

9. Device according to claim 8, wherein the threaded hole is delimited by the plate and penetrates completely therethrough.

10. Device according to claim 8, wherein the guide means further comprise a collar, in which is delimited the threaded hole and which has a distal end provided with a fitting adapted to be rigidly connected to the plate.

11. Device according to claim 8 or 10, wherein the guide means further comprise adjustment means for adjusting the position of the axis of the threaded hole relative to the plate before screwing the jacking rod into said threaded hole.

12. Device according to claim 11 , wherein the adjustment means comprise:

- a platelet which delimits a through-hole for receiving the jacking rod and can be removably connected to the plate in such a way that the through-hole opens onto a through-passage which is delimited by the plate,

- an olive for mechanically connecting the platelet and the jacking rod, which olive delimits on its inner face the threaded hole, the width of which olive delimits a slit connecting its outer face and the threaded hole, and, when the jacking rod is being screwed in, the olive is adapted to pass, by separating the edges of its slit, from a first configuration in which the olive is displaceably arranged in the through-hole, to a second configuration in which the olive rigidly connects the jacking rod to the platelet by wedging the olive inside the through- hole, and

- a blocking means for holding the olive in the through-hole when the olive is in its first configuration.

13. Device according to claims 10 and 11 taken together, wherein the adjustment means comprise a swiveling plug for mechanically connecting the plate and the fitting of the collar, which swiveling plug delimits on its inner face a fitting opening in which the fitting of the collar can be secured, the swiveling plug is received in a complementary plug opening of the plate and, when the fitting of the collar is engaged in, the swiveling plug is adapted to pass from a first configuration in which the swiveling plug is rotatable in the plug opening, to a second configuration in which the outer face of the swiveling plug is in a frictional engagement with the plate.

14. Device according to any one of the preceding claims, wherein the diaphyseal portion of the plate is provided with an oblong through-hole, of which the length is substantially parallel to the longitudinal direction of the plate, which oblong through-hole is arranged, when the jacking rod is assembled through the plate, on the side of said jacking rod opposite the epiphyseal portion of the plate and can receive an elongated bone-anchoring means, of which a rod has a transverse cross-section which is substantially adjusted to the width of the oblong hole and of which a head has a transverse cross-section which is larger than that of the jacking rod.

15. Device according to any one of the preceding claims, wherein the epiphyseal portion and/or the diaphyseal portion of the plate are provided with through-holes respectively for receiving elongated bone-anchoring means in a substantially complementary manner.

16. Device according to any one of the preceding claims, wherein the jacking rod is provided, on the one hand, at its proximal end with a manual guiding grip, in particular a knob for guiding the jacking rod in rotation about the central axis thereof and, on the other hand, at its distal end with a rounded or spherical tip for abutting the hard portion of the head.

17. Surgical method for reducing a fracture between the epiphyseal head and the diaphysis of a long bone, in which the following steps are carried out successively:

- an elongated osteosynthesis and/or prosthesis plate is arranged along the length of the bone so that said plate covers the fracture;

- a diaphyseal portion of the plate is fixed to the diaphysis of the bone, which diaphyseal portion is arranged along said diaphysis so as to be displaceable in the longitudinal direction of the plate,

- the head of the bone is tilted so as to reduce the fracture, on the one hand by pushing said head towards a first way and in a rectilinear direction and, on the other hand, by pulling said head towards a second way opposite to the first way and in a direction largely parallel to said rectilinear direction, and

- whilst both pushing and pulling the head of the bone, an epiphyseal portion and the diaphyseal portion of the plate are rigidly fixed to the head and the diaphysis of the bone respectively.

18. Method according to claim 17, wherein, so as to be able to push the head of the bone, a jacking rod is inserted through the plate, then said jacking rod is mechanically guided in the longitudinal direction thereof relative to the plate until a distal end of the jacking rod abuts a hard portion of the head, and wherein, after having rigidly fixed the diaphyseal portion of the plate to the diaphysis of the bone, the jacking rod is removed.

19. Method according to claim 18, wherein the jacking rod is successively inserted through the diaphyseal portion of the plate and the diaphysis of the bone, so that said jacking rod is mechanically guided in the longitudinal direction thereof relative to the plate until the distal end of the jacking rod abuts the side of a hard portion of the head facing the fracture so that the jacking rod pushes the head away from the diaphysis.

20. Method according to claim 18, wherein the jacking rod is inserted through the epiphyseal portion of the plate so that the jacking rod is mechanically guided in the longitudinal direction thereof relative to the plate until the distal end of the jacking rod abuts a frontal aspect of a hard portion of the head, next to the fracture, so that the jacking rod pushes the head away from or towards the diaphysis.

21. Method according to claim 18, wherein before inserting the rod through the plate, the position of the axis of insertion of said rod is adjusted relative to the plate.

22. Method according to claim 21 , wherein in order to adjust the position of the axis of insertion of the jacking rod, a deformable olive is used for mechanically connecting the jacking rod to a platelet which is removably connected to the plate.

23. Method according to claim 21 , wherein in order to adjust the position of the axis of insertion of the jacking rod, a deformable swiveling plug is used for mechanically connecting the plate to a collar in which is engaged the jacking rod.

24. Method according to claim 17, wherein, so as to be able to pull the head of the bone, the epiphyseal portion of the plate is connected via at least one suture material to soft parts, such as muscles and ligaments, which surround and are connected to the head of the bone, then the tension of the or each suture material is adjusted, and wherein, after having rigidly fixed the epiphyseal portion of the plate to the head of the bone, the or each suture material is tied to the epiphyseal portion of the plate.

25. Method according to claim 17, wherein, so as to be able to pull the head of the bone, a bone anchor which is attached to the diaphysis of the bone independently of the plate is connected via at least one suture material to soft parts, such as muscles and ligaments, which surround and are connected to the head of the bone, then the tension of the or each suture material is adjusted.

26. Method according to claim 17, wherein, so as to be able to pull the head of the bone, a bone anchor is engaged in the head of the bone, independently of the plate, and a tie attached to said anchor is then pulled.

27. Method according to claim 17, wherein, the head of the bone is pulled and pushed at the same time.

28. Method according to claim 17, wherein the head of the bone is pulled and pushed successively.

29. Method according to claim 17, carried out so as to reduce a fracture between the upper epiphyseal head and the diaphysis of a human humerus.