Patent Application
20220338907
The present disclosure relates to a surgical system for osteosynthesis of femoral fractures, individual parts of such system, and a related surgical procedure for osteosynthesis of femoral fractures.
Femoral fractures are typically treated by internal fixation using an intramedullary (IM) nail, possibly in mechanical connection with a hip screw in case of intertrochanteric or subtrochanteric fractures, see e.g. U.S. Pat. Nos. 6,221,074 or 6,562,042.
Obese patients with femoral fractures are difficult to osteosynthesize with IM nail and hip screw. The obesity makes the antegrade insertion of the intramedullary nail technical demanding or even impossible to insert from the usual entry point proximal to the greater trochanter of femur. The surplus amounts of fatty tissue block access to the point of entry for the surgical instruments, both when preparing the medullary canal (reamer, cutter, drill) and when inserting the IM nail (jig, IM nail and hammer)—all of which should be done under the correct angle. The obesity makes the insertion of the intramedullary nail technical demanding and even impossible to insert from the usual entry point proximal to the greater trochanter of the femur. The surgery requires a very extensive surgical approach to insert the conventional intramedullary nail with subsequent hip sliding screw. The consequences for these patients may be at worst severe surgical complications with wound leakage, deep infections and even fatal outcome, which is not uncommon. Complication rate is seriously high in this patient category. There is therefore a desire to reduce the risk for patients and the surgical complexity of the procedure.
U.S. Pat. No. 6,221,074 (also published as EP 1867294A2) describes a number of osteosyntheses with both antegrade and retrograde insertion of the IM nail. Retrograde nailing, where the IM nail is introduced via the knee joint is a known alternative that works well for obese patients. This retrograde approach is however not applicable for trochanteric and subtrochanteric fractures since no solutions for a mechanical connection with a hip screw exists.
Accordingly, there is a need for a surgical system for osteosynthesis of femoral fractures with ease of access on all patients.
An orthopaedic implant for osteosynthesis of femoral fractures is disclosed, comprising:
An intramedullary nail for osteosynthesis of femoral fractures is also disclosed, the intramedullary nail being configured for retrograde insertion in the femur, the intramedullary nail comprising a leading end part to be positioned proximally in the femur and a trailing end part to be positioned distally in the femur; wherein the leading end part of the intramedullary nail is configured to extend through a through-hole of a femoral neck screw in that it comprises a stop for engaging the femoral neck screw to prevent the leading end part from extending so far through the through-hole as to reach the cortex of the greater trochanter.
In the following, a number of preferred and/or optional features, elements, examples and implementations will be summarized. Features or elements described in relation to one embodiment or disclosure may be combined with or applied to the other embodiments or aspects where applicable. For example, structural and functional features applied in relation to a method may also be used as features in relation to a device or system and vice versa.
The intramedullary nail is designed for retrograde osteosynthesis of femoral fractures in that its leading end part is configured to—by means of its shape, dimensions, and/or the stop—form a mechanical connection with the femoral neck screw.
For both the orthopaedic implant and the intramedullary nail, the section of the leading end part of the IM nail that extends through the through-hole will typically not contribute to the stability provided by the osteosynthesis, and it should not continue so far as to reach and potentially damage the greater trochanter. As will be described later, there are embodiments where it is advantageous when the leading part can extend somewhat through the through-hole. Hence, in other embodiments, the intramedullary nail comprises a stop for engaging the femoral neck screw to prevent the leading end part from extending more than 3 centimeters through the through-hole, such as more than 2 centimeters through the through-hole or more than 1 centimeter through the through-hole.
In further embodiments, the stop of the intramedullary nail involves a tapering with a smaller cross section nearer its leading end part. Similarly, the through-hole of the neck screw has a tapering with a larger cross section on a side for accepting/receiving the leading end part. The taperings are complementary and positioned relative to the leading end part to stop the intramedullary nail from extending so far through the through-hole as to reach the cortex of the greater trochanter (or from extending more than 3 centimeters through the through-hole, such as more than 2 centimeters or more than 1 centimeter). The taperings are also complementary to laterally fixate the intramedullary nail relative to the femoral neck screw when the taperings engage.
In further embodiments, the leading end part of the intramedullary nail and the femoral neck screw involves structural features for preventing rotation of the intramedullary nail around the first direction and/or laterally fixating the intramedullary nail relative to the femoral neck screw after the leading end part has been received by the through-hole. These structural features may include the stop for engaging the femoral neck screw to prevent the leading end part from extending too far through the through-hole as described above.
In further embodiments, the neck screw is cannulated along at least part of the major axis and comprises, in a second end part opposite the first end part, an internal thread along the cannulation, further comprising a set screw having an external thread corresponding to the internal thread along the cannulation and having a primary end part adapted to engage the leading end part of the intramedullary nail when the leading end part is received by the through-hole and the set screw is screwed towards the first end part of the femoral neck screw. The engaging between the primary end part of the set screw and the leading end part of the intramedullary nail may provide one or more of the following functions: preventing the leading end part from extending too far through the through-hole as described above, laterally fixating the intramedullary nail relative to the femoral neck screw, preventing rotation of the intramedullary nail around the first direction when the leading end part is received by the through-hole.
In a further embodiment, the leading end part of the intramedullary nail comprises a recess or a hole for receiving the primary end part of the set screw to prevent rotation of the intramedullary nail around the first direction when the leading end part is received by the through-hole and the set screw is screwed towards the first end part of the femoral neck screw.
In a further embodiment, at least a section of the leading end part of the intramedullary nail may have a larger cross-sectional diameter than a middle part of the IM nail. Narrower or more pointy ends have a tendency to get wedged during insertion in the femoral canal (which is curved in both the frontal and the axial plane). Am IM nail with a bulkier leading end part and a thinner, more flexible middle part will provide the advantage of making the insertion easier and reduce the risk of wedging or jamming. In a further embodiment, the cross section of the middle part of the IM nail may have a flat aspect ratio, such as larger than 1.5:1, 2:1, or 2.5:1. The aim is to secure flexibility of the nail during insertion in the curved femoral canal while adding strength to the implant and avoid breakage.
A method of osteosynthesis of femoral fractures is disclosed. The method is a surgical procedure comprising
The method is preferably used in osteosynthesis of intertrochanteric or subtrochanteric femoral fractures where a combination of an intramedullary nail and a femoral neck screw is desired.
The orthopaedic implant and the intramedullary nail disclosed herein are preferably adapted for use in the disclosed method. In this respect, several features of the orthopaedic implant and the intramedullary nail are advantageous individually and in combination, including:
A system for osteosynthesis of femoral fractures is disclosed. The system comprises an orthopaedic implant as previously disclosed herein and a jig for inserting the intramedullary nail and aligning the femoral neck screw relative to the intramedullary nail, the jig being configured to form a rigid mechanical connection to a trailing end part of the intramedullary nail so that the leading end part of the intramedullary nail is held along a first direction, the jig comprising a first guide for drilling for the femoral neck screw, the first guide defining an aiming line intersecting the first direction; wherein the intersection between the aiming line and the first direction lies beyond the extension of the intramedullary nail, when the intramedullary nail is connected to the jig.
The disclosed system is preferably adapted for use in the disclosed method. In this respect, several features of the system—together with the features of the orthopaedic implant listed above—are advantageous individually and in combination, including:
The length of the femur varies with patient age and size, and the length of the IM nail should be selected to correspond to the length of the femur. Therefore, the system is preferably configured to use IM nails of different lengths. In further embodiments, the system comprises a set of instructions comprising instructions for a user to use a combination of a guide and intramedullary nail length for which an intersection between the aiming line and the first direction lies beyond the extension of the intramedullary nail, when the intramedullary nail is connected to the jig.
In further embodiments, the jig comprises at least a second guide for drilling for the femoral neck screw and defining an aiming line, a position of the second guide being a translation of the position of the first guide along a line at least substantially parallel to the first direction, the system further comprising a set of instructions comprising instructions for a user to, for a given a length of the intramedullary nail, use the one of the first and second guides that results in a distance between the intersection and the intramedullary nail being closer to, but larger than, a radius of the femoral neck screw at the position of the through-hole.
In further embodiments, a length of the jig below a position of the first guide can be adjusted so that the intersection between the aiming line and the first direction can be moved along the first direction, further comprising a set of instructions comprising instructions for a user to, for a given a length of the intramedullary nail to be connected to the jig, adjust the length of the jig so that a distance between the intersection and the intramedullary nail is as small as possible while being larger than a radius of the femoral neck screw at the through-hole.
A jig for inserting an intramedullary nail and aligning a femoral neck screw relative to the intramedullary nail in osteosynthesis of femoral fractures is disclosed. The jig has a J-shape with a short end part, a curved middle part, and a long end part, the short end part being configured to form a rigid mechanical connection to a trailing end part of an intramedullary nail so that the intramedullary nail is held along a first direction at least substantially parallel to the long end part, the long end part comprising a first guide for drilling for the femoral neck screw, the first guide defining an aiming line intersecting the first direction; wherein a length of the long end part can be adjusted so that an intersection between the aiming line and the first direction can be moved along the first direction.
In further embodiments, the long end part of the jig comprises a scale indicating the length to which the long end part should be adjusted for an intramedullary nail of a given length held at the short end part. Preferably, the scale is calibrated so that the intersection between the aiming line and the first direction lies beyond the extension of an intramedullary nail with the given length, when the intramedullary nail is held at the short end part.
The present disclosures allow for improved osteosynthesis of femoral fractures, in particular intertrochanteric or subtrochanteric femoral fractures where a combination of an intramedullary nail and a femoral neck screw is desired, but where antegrade insertion of the IM nail is difficult or impossible. The disclosed orthopaedic implant, IM nail, system and jig are all adapted for use in the disclosed surgical procedure which combine two different osteosynthesis techniques: the intramedullary hip screw for hip fractures and the retrograde femoral nail for femoral shaft fractures. These techniques were previously not combined since the antegrade insertion of the IM nail is standard when a combination with femoral neck screw is required.
The above and other features and advantages of the present invention will become readily apparent to those skilled in the art by the following detailed description of exemplary embodiments thereof with reference to the attached drawings, in which:
Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
There are other practical considerations regarding the extension of the leading end part 112 through the through-hole 125. During insertion, the surgeon monitors the position of the nail while hammering on the jig. The events when the leading end part 112 enters the distal rim 133 of the through-hole 125, when it exits the proximal rim 134 of the through-hole 125, and when the stop 115 engages the femoral neck screw are of particular interest. If the stop 115 is positioned too close to a tip of the leading end part, the leading end part will not exit the proximal rim 134 of the through-hole 125 before the stop engages the femoral neck screw. While the section of the leading end part 112 that has exited the proximal rim 134 of the through-hole 125 is typically not important for the stability of the osteosynthesis, it is advantageous if it extends at least somewhat beyond the proximal rim. Firstly, the section of the leading end part 112 that engages the proximal rim 134 does contribute to the stability, in particular to forces working on the angle between the first direction 111 and the major axis 121. Therefore, in one embodiment, the leading end part of the intramedullary nail is configured to, by means of its shape and the position of the stop, engage the proximal rim of the through-hole when the stop engages the femoral neck screw. This means that the leading end part touches the femoral neck screw along the proximal rim which provides the advantage of increased mechanical stability as described above. If, for example, the leading end part that extends through the proximal rim when the stop engages the femoral neck screw is tapered, it would not engage the proximal rim. Secondly, the surgeon only has a 2D projection of the osteosynthesis and the femur as guidance. The tip exiting the proximal rim 134 of the through-hole 125 is therefore an important visual clue for the surgeon, and the increment in the distance between the tip and the femoral neck screw for each hammer stroke may be the most precise indication of the progress. Naturally, one wants to progress slowly when the stop is about to engage the femoral neck screw, and not have them slamming together with a powerful hammer-stroke since that would increase the risk of jamming and damage to the parts. Therefore, in one embodiment, the stop is positioned to allow a tip of the leading end part to extend at least 3 mm, such as at least 5 mm or at least 1 cm beyond the proximal rim 134 of the through-hole when the stop engages the femoral neck screw. This provides the advantage of visual guiding to the surgeon as described above. As previously described in relation to another embodiment, the stop is preferably also positioned to prevent the leading end part from extending more than 3 centimeters such as more than 2 centimeters through the through-hole or more than 1 centimeter through the through-hole, when the stop engages the femoral neck screw. These embodiments are preferably combined to provide the shape and position of the stop.
The different stops 115, the protrusion 116 and the notch 126, the set screw 140, and the recess 119 described in relation to
At least a section of the leading end part 112 of the IM nail may have a larger cross-sectional diameter than a middle part of the IM nail in order to make the insertion easier and reduce the risk of wedging or jamming. Preferably, a cross section of the middle part of the IM nail may even have a flat aspect ratio, such as larger than 1.5:1, 2:1, or 2.5:1 in order to increase flexibility of the IM nail during insertion in the curved femoral canal. The trailing end part 113 preferably then has a larger cross-sectional diameter than the middle part to allow for the mechanical coupling to the jig and to absorb and distribute the impact of the hammering on the jig during insertion.
Orthopaedic implants for osteosynthesis of femoral fractures are well known in the field. The implants of the present disclosures are generally based on similar implants available in the prior art when it comes to materials, shapes and dimensions of parts that are not influenced by the disclosed features. The person skilled in the art of orthopaedic implant design will therefore be able to design and produce implants according to the present disclosures based on the descriptions provided herein.
Naturally, a complete surgical procedure involves many more steps which are known from the prior art. For example, drilling out the femoral canal prior to insertion of the IM nail (not shown), stabilizing the nail-jig construct using a drill through a drill hole in the IM nail closer to the fracture site (not shown), drilling for the femoral neck screw using a first guide for drilling in a jig (shown in
After completion of the osteosynthesis and a prescribed healing period, the patient may stand up, resulting in a load on the femoral neck. At this stage, the bone may or may not have grown together completely, and load on the femoral neck may result in a downward force on the femoral neck screw. The stop comprised by the disclosed orthopaedic implant and IM nail prevents the femoral neck screw from sliding downwards on the IM nail. Prior art configurations with through-hole in neck screw such as U.S. Pat. No. 6,221,074 use a set screw inside the neck screw that goes through the nail to stop such sliding of the neck screw. A set screw only pressing on the nail could not prevent this sliding. Since the disclosed IM nail “comes from below”, the stop provides a simple and strong solution preventing the IM nail from being pushed further up through the through-hole of the neck screw.
The jig 150 is configured to form a rigid mechanical connection 156 to the trailing end part 113 of the intramedullary nail so that the leading end part 112 of the intramedullary nail is held along the first direction 111. The jig comprising a first guide 154 for drilling for the femoral neck screw, the first guide defining an aiming line 151 intersecting the first direction 111 at intersection 152. Preferably, the angle between the aiming line 151 and the first direction 111 is equal to the angle between the first direction 111 and the major axis 121 of the neck screw 120, see also
To see why the intersection 152 lies beyond the extension of the intramedullary nail 110 we return to
In a preferred embodiment of the method of osteosynthesis of femoral fractures, the step of retrogradely inserting an intramedullary nail 110 in a femur comprises providing a jig 150 for inserting the intramedullary nail 110, the jig being configured to form a rigid mechanical connection to the trailing end part 113 of the intramedullary nail so that the leading end part 112 of the intramedullary nail is held along a first direction 111, the jig comprising a first guide 154 for drilling for the femoral neck screw, the first guide defining an aiming line 151 intersecting the first direction, wherein the intersection 152 between the aiming line and the first direction lies beyond the extension of the intramedullary nail, when the intramedullary nail is connected to the jig. The step further comprises inserting the IM nail using the jig until the aiming line at least substantially overlaps with the extended line from the center of caput femoris and parallel to the collum axis in the AP plane.
Intramedullary nails of different lengths will be used for different patients, and thus the position of the first guide on the jig may depend on the length of the nail. In one embodiment, the first guide may be fixed at a position where the intersection 152 lies beyond the extend of the longest IM nail produced. This has the advantage of simplifying the jig and the use of the system.
In another embodiment, the system further comprises a set of instructions comprising instructions for a user to use a combination of a guide and intramedullary nail length for which the intersection 152 between the aiming line and the first direction lies beyond the extension of the intramedullary nail, when the intramedullary nail is connected to the jig. A distance 153 from the intermedullary nail 110 to the intersection 152 should be larger than the cross-sectional radius of the neck screw at the position of the through-hole, please refer to
In a further embodiment, also illustrated in
In another embodiment of the system, a length of the jig 150 below a position of the first guide 154 can be adjusted so that the intersection 152 between the aiming line 151 and the first direction 111 can be moved along the first direction. Hence, the jig 150 can be adjusted to fit a range of IM nail lengths, providing the advantage that the distance 153 between the intersection and the IM nail can be adjusted continuously or in smaller increments than in the above embodiment comprising a second guide. The system may further comprise instructions for a user to, for a given a length of the intramedullary nail to be connected to the jig, adjust the length of the jig so that the distance 153 between the intersection and the intramedullary nail is as small as possible while being larger than a radius of the femoral neck screw at the through-hole. Again, the user need not try to estimate the distance 153 since it can be determined as a function of set jig length and IM nail length at fabrication. The instructions may simply list the proper jig length for a given length of IM nail, e.g. in the form of color codes or IM nail lengths written as a scale on the adjustable part of the jig.
In the following, a method for designing an IM nail according to the disclosure that is customized for a given patient is described.
Based on 3D-CT scan of the complete femur with an intertrochanteric fracture it is possible to design a nail that gives the maximal fit and strength of the nail. Opposite, it will also be possible to delineate those patients, who may not be candidates for this implant. For example, there has been a former fracture, which has healed in malalignment, there may be too much bone formation at the former fracture site, or there may be a total knee implant which may hinder osteosynthesis of the femur.
The retrograde femoral metallic nail will be made of Cobalt-28 Chromium-6Molybdenum alloys for surgical implants (Wrought) (UNS R31537, UNS R31538, and UNS R31539).—The maximal thickness of the nail can be measured. The load to failure of the implant can be estimated and plan for weight loading during rehabilitation can be estimated. In cases with leg length discrepancy the implant may able to dynamize i.e. further shortening of the femoral bone should be expected and the dynamization should be adjusted to avoid the nail of re-entering the knee joint. The implant thickness will typically be at least 7-10 mm in thickness for humans.
The 3D-CT scan of the femoral anatomy will make it possible to produce a custom-made IM nail. The following parameters may be relevant to obtain the best IM nail fit together with best IM nail geometry: outer diameter and inner diameter of femur, centre of inner and outer surface of the IM nail, thickness of the IM nail, same thickness versus asymmetric thickness of the IM nail along the first direction.
The 3D-CT scanning of the femur hip will outline the bony parts of the pelvis/acetabulum and the femoral head. The digital data are downloaded in pixels and voxels with Hounsfield scale values and 3D geometric parameters can be determined based on digital 3D-programs such as Philips Intellispace Portal (ISP) or 3D Slicer 4.6, which is an open program from harvard.edu, only approved for research. The cortocal bony parts of the femur can be image segmented from the trabecular bony part. With two-dimensional CT-images the geometry of the space between the two bony parts can be determined. All the above-mentioned parameters will be validated to give the best fit and subsequently also make assessment of the possibility of an implant that can possess sufficient material strength (thickness). The CT-scanners have a detection limit of 0.5 mm regarding cartilage (Anderson et al, 2010 Radiology) and bone.
The free digital movement of the two segmented bony parts of the femur makes it possible to assess the fit of the implant. For routine use the 3D-CT may be converted, so the non-cortical bony part of the scanning can be visualized in 3D to construct the implant. The processing of the data may initially be “hand-made” based on slicing of the 3D image to obtain the separate bone structures in 3D.
The use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order but are included to identify individual elements. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa. It is to be noted that the word “comprising” does not necessarily exclude the presence of other elements or steps than those listed. It is to be noted that the words “a” or “an” preceding an element do not exclude the presence of a plurality of such elements. It should further be noted that any reference signs do not limit the scope of the claims.
Although features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19195177.1 | Sep 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/074607 | 9/3/2020 | WO |
