Abstract
A bone reduction and fixation device (1, 70) comprises an elongated biplanar plate along most of its length having an L-shaped profile defined by a first plate surface (3A, 4A) and one or more second plates (3B, 4B), in which the first and second plates comprise a plurality of countersunk holes (8) configured for receipt of bone-fixing screws (10). The biplanar plate comprises two biplanar L-shaped end sections (3, 4) defined by end parts of the first plate and second end plates, and a monoplanar central section (2) defined by a central part of the first plate, in which the central part of the first plate has a thickness greater than the end parts. The L-shaped end sections help guide bone fragments into correct alignment and hold the alignment while the surgeon adjusts one of or both of the fragments laterally and medially to reduce the fragments. The L-shaped profile of the plate also provides for greater bending and torsional stiffness, allowing the plate to have a reduced thickness.
Claims
1. A bone reduction and fixation device (1, 70) comprising an elongated biplanar plate having an L-shaped profile along most of its length defined by a first plate (3A, 4A) and one or more second plates (3B, 4B) in which the first and second plates each comprise one or more holes (8) configured for receipt of bone-fixing screws (10), characterised in that the biplanar plate comprises two biplanar L-shaped end sections (3, 4) and a monoplanar central section (2) and is defined by a continuous first plate (3A, 4A) and two end second plates (3B, 4B), in which the first plate at the monoplanar central section (2) has a thickness at least 30% greater than the thickness of the first plate at the L-shaped end sections (3, 4).
2. A bone reduction and fixation device according to claim 1, in which the first and second plates at the L-shaped end sections (3, 4) have a thickness of less than 2.5 mm and the first plate at the monoplanar central section (2) has a thickness of greater 3 mm.
3. A bone reduction and fixation device according to claim 1, in which the first and second plates at the L-shaped end sections (3, 4) have a thickness of between 1.5 and 2.5 mm and the first plate at the monoplanar central section (2) has a thickness of 3.5 to 8 mm.
4. A bone reduction and fixation device according to any preceding claim, that is contoured along at least part of its length to match contours of a reduced human clavicle bone.
5. A bone reduction and fixation device according to any preceding claim, that is contoured along at least part of its length to match contours of a reduced human bone when the device is applied to the reduced bone in an anterior-inferior orientation.
6. A bone reduction and fixation device according to any of claim 1 to 4, that is contoured along at least part of its length to match contours of a reduced human bone when the device is applied to the reduced bone in an anterior-superior orientation.
7. A bone reduction and fixation device according to any of claim 5 or 6, in which the reduced human bone is a reduced human clavicle.
8. A bone reduction and fixation device according to any preceding claim, in which the monoplanar central section (2) extends along about 20% to 40% of the length of the device.
9. A bone reduction and fixation device as claimed in any preceding claim, in which the first plate (3A, 4A) and the second plates have a width of 5-12 mm.
10. A bone reduction and fixation device as claimed in any preceding claim, in which the first plate (3A, 4A) and the second plates have a width of 8-10 mm.
11. A bone reduction and fixation device according to any preceding claim, in which the first plate (3A, 4A) comprises at least four holes (8).
12. A bone reduction and fixation device according to any preceding claim, in which the first plate (3A, 4A) comprises at least six holes (8).
13. A bone reduction and fixation device according to any preceding claim, in which each second plate (3B, 4B) comprises at least two holes (8).
14. A bone reduction and fixation device according to any preceding claim, in which each second plate (3B, 4B) comprises at least three holes (8).
15. A bone reduction and fixation device according in any preceding claim, in which the elongated biplanar plate is curved to approximately correspond to a curve on an anterior surface of a human clavicle.
16. A bone reduction and fixation device according to any preceding claim, in which a width of the continuous first plate (3, 4) varies along its length.
17. A bone reduction and fixation device according to claim 16, in which the continuous first plate is wider at each end sections (3, 4) than at the monoplanar central section (2).
18. A bone reduction and fixation device according in any preceding claim, formed from a material selected from stainless steel, titanium, cobalt, and chrome.
19. A bone reduction and fixation device according in any preceding claim, in which one or more of the first plate (3A, 4A) and second plates (3B, 4B) include one or more small holes configured to receive fixing wires.
20. A bone reduction and fixation device according in any preceding claim, in which the holes (7, 8) are countersunk holes.
21. A bone reduction and fixation device according in any preceding claim, in which the second plate (3B) of the medial end plate (3) comprises a slot (8A).
22. A clavicle reduction and fixation device (1, 70) comprising an elongated monoblock biplanar plate having an L-shaped profile along most of its length defined by a first plate (3A, 4A) and one or more second plates (3B, 4B) in which the first and second plates each comprise one or more holes (8) configured for receipt of bone-fixing screws (10), characterised in that the biplanar plate comprises two biplanar L-shaped end sections (3, 4) and a monoplanar central section (2) and is defined by a continuous first plate (3A, 4A) and two end second plates (3B, 4B), in which the first plate of the monoplanar central section (2) has a thickness at least 30% greater than the thickness of the first plate at the L-shaped end sections (3, 4), in which the first plate and second plates at the L-shaped end sections have a thickness of 1.5 to 2.5 mm and in which the first plate at the monoplanar central section has a thickness of 4 to 6 mm.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0052] FIG. 1 is an illustration of a bone reduction and fixation plate according to the invention configured for anterior-superior reduction and fixation, shown attached to a fractured right human clavicle (superior view) in an anterior-superior orientation.
[0053] FIG. 2 is an anterior view of the fractured clavicle and bone reduction and fixation plate of FIG. 1.
[0054] FIG. 3 is a sectional, or sagittal view taken along the lines III-III of FIG. 2.
[0055] FIG. 4 is an illustration of the bone reduction and fixation plate of FIGS. 1-3 shown attached to the medial bone fragment with the bone nesting in the apex of the L-shaped end section, and prior to alignment of and fixation to the second lateral bone fragment.
[0056] FIG. 5 is an illustration of a typical 4-part comminuted clavicular fracture showing the medial and lateral main bone fragments and two smaller fragments. This is the most commonly seen type of fracture of the clavicle.
[0057] FIG. 6 is an illustration of the plate of the invention attached to the fractured clavicle of FIG. 5, showing how the medial and lateral sections of the plate attach to the main bone fragments, and how the lag window in the central section provides access for the surgeon to the smaller bone fragments allowing them to be reduced and fixed in position.
[0058] FIG. 7 is an inferior view of a bone reduction and fixation plate according to an alternative embodiment of the invention configured for anterior-inferior reduction and fixation, shown attached to a right human clavicle (inferior view).
[0059] FIG. 8 is a sectional, or sagittal view taken along the lines VIII-VIII of FIG. 7.
[0060] FIG. 9 is an anterior view of the plate of FIG. 7 in use in reducing and fixing a comminuted fracture of a clavicle, showing one L-shaped end portion of the device (medial end portion) attached to a medial clavicle fragment and prior to the attachment of the device to the lateral fragment.
[0061] FIG. 10 shows the other L-shaped end portion of the device (lateral end portion) attached to the lateral fragment and the bone reduced and fixed. It also illustrates how the lag window (monoplanar window section) provides access for the surgeon during reduction and fixing to the smaller bone fragments allowing them to be reduced and fixed in position.
[0062] FIG. 11 is an illustration of a 2-part undisplaced clavicular fracture showing the medial and lateral main bone fragments.
[0063] FIG. 12 is an illustration of the plate of the invention attached to the fractured clavicle of FIG. 11, showing how the elongated slot in the central side plate allows the surgeon access to the bone reduction point, in order to assess for anatomical reduction.
[0064] FIG. 13 is an illustration of the typical appearance of a fracture of the lateral end of the clavicle, showing the medial and lateral main bone fragments.
[0065] FIG. 14 is an illustration of the plate of the invention attached to the fractured clavicle of FIG. 13 (anterior view). In contrast to the plate for midshaft fractures, there are 4 holes anteriorly, and a further 4 superiorly at the distal, or acromial end of the plate, which allows for greater biomechanical load to failure, and the holes can be filled based on surgeon preference.
[0066] FIG. 15 is an illustration of the lateral plate of the invention attached to the fractured clavicle of FIG. 9 (superior view).
[0067] FIG. 16 and FIG. 17 are illustrations of a device according to the invention for reduction and fixation of an ankle (fibula) fracture. FIG. 16 is a lateral view of the device attached to the end of a fractured fibula, and FIG. 17 is a posterior view of the device attached to the end of the fractured fibula.
[0068] FIGS. 18-20 are illustrations of a device according to the invention for reduction and fixation of an olecranon (elbow) fracture. FIG. 18 is a lateral view of the device attached to one end of the fractured olecranon prior to bone reduction, FIG. 19 is a lateral view of the device attached to the fractured ulna after reduction, and FIG. 20 is an anterior view of the device in-situ.
[0069] FIG. 21 is an illustration of another device according to the invention for reduction.
[0070] FIG. 22A to 22D are illustrations of the various types of L-shaped profile applicable to the biplanar plate of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0071] All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.
Definitions and General Preferences
[0072] Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:
[0073] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term “a” or “an” used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein.
[0074] As used herein, the term “comprise,” or variations thereof such as “comprises” or “comprising,” are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term “comprising” is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.
[0075] In the context of treatment and effective amounts as defined above, the term subject (which is to be read to include “individual”, “animal”, “patient” or “mammal” where context permits) defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human.
[0076] As used herein, the term “biplanar” as applied to the device of the invention means that the device has a substantially L-shaped profile along most or all of its length, and generally along at least 60% of its length. Devices of the invention that include a lag window are generally monoplanar along a part of their length (generally along a central section)—these devices are suitable for reduction and fixiation of clavicle fractures, especially comminuted clavicle fractures where the lag window allows a surgeon access the smaller fragments of bone and reduce and fix the fragments. Other embodiments of the invention are biplanar along all or substantially all of their length, for examples the devices for reduction and fixing ankle or elbow fractures.
[0077] As used herein, the term “L-shaped” profile” as applied to the biplanar plate of the invention means that first plate is orthogonal or nearly orthogonal to the second plate along at least a part of its length, in particular the part of the plate that has holes for receiving bone-fixing screws. This provides structural rigidity and torsional stiffness to the plate, and also allows for fixing screws to be inserted in an orthogonal arrangement. It will be appreciated that the plates do not need to be exactly orthogonal provided that the angle between the plates serves to increase the stiffness of the device compared to monoplanar plates. Examples of L-shaped profiles applicable to the devices of the invention are illustrated in FIG. 22. In any embodiment, a transition zone between plates may be L-shaped (FIG. 22A) or curved (FIG. 22C) to provide a smooth transition from a first plate to an orthogonal second plate. In some embodiments, an inner profile of a plate at a transition zone may be curved and an outer profile at the transition zone may be angular (FIG. 22B). All of these embodiments provide plates that are of increased torsional stiffness compared with monoplanar plates.
[0078] As used herein, the term “monoblock” as applied to a plate means that the plate is formed in one piece, generally by casting or moulding. It is distinct from plates that are formed in multiple parts and assembled or contoured after formation.
Exemplification
[0079] The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.
[0080] Referring to the drawings, and initially to FIGS. 1 to 4, there is illustrated a bone reduction and fixation device according to the invention suitable for reduction and fixation of a clavicle, and indicated generally by the reference numeral 1. The device 1 has a central section 2, medial end section 3 and lateral end section 4. Each end section 3, 4 has an L shaped profile defined by ends of a first (superior) plate 3A, 4A and two second (anterior) plates 3B, 4B. The central section comprises a central part of the first plate 2A and no second plate, thus providing a lag window 5 which provides a surgeon access to the bone fracture. The first and second plates at the end sections are joined together along the full length of the end section without any gaps in the join. The plate is formed as a pre-contoured monoblock (i.e. cast in one piece).
[0081] The plate is formed from stainless steel or titanium, and the second plates (3B and 4B), and end sections of the first plate (4A, 3A), each have a thickness of about 2 mm. The central section of the first plate (2A) has a thickness of about 6 mm, to provide greater bending stiffness at the central (monoplanar) section of the plate. The plate is approximately 100 mm in length, with the central section approximately 30 mm and end sections being each approximately 35 mm. The first and second plates each have a width of about 10 mm.
[0082] The central section 2A of the first plate has two countersunk screw-receiving holes 7, and the end sections of each plate have 3 countersunk screw receiving holes 8. Smaller wire-receiving holes 9 are provided on the plates in between the screw-receiving holes. Screws 10 are shown in the holes in some of the illustrations. In FIG. 4, it can be seen that one of the holes on the second plate 3B has a slightly elongated configuration to form a slot 8A.
[0083] FIG. 1 is a superior view (from above) showing the device 1 attached to a fractured clavicle A, having a sternal end B and acromial end C, with a break D in the middle section of the bone. The plate 1 is designed to be attached to a clavicle in an superior-anterior orientation (which is best seen in FIG. 1 which is a view from above the clavicle), and has a slight pre-contoured curve along the anterior face which matches the curve on the anterior surface of the clavicle A. FIG. 2 is an anterior view (from the front). FIG. 3 is a cross-sectional sagittal view showing the L-shaped profile of the end sections of the plate, and how a bone fragment (in this case, the medial bone fragment) can nest within the apex of the L-shaped plate allowing easier alignment of the bone with the plate. FIG. 4 is an anterior view of the fractured bone and plate, showing how the medial fragment E can be first attached to the plate prior to attachment of the lateral fragment F.
[0084] In use, and referring to FIG. 4, the medial fragment E is aligned with the medial end 3 of the plate, with the bone nestling in the L shaped profile as shown in FIG. 3. Once in position, the bone is fixed to the plate by drilling a hole in the bone through the slot 8A, and inserting a screw into the hole and tightening to fix the medial end of the plate to the medial fragment. The lateral fragment F can then be manipulated to align it with the lateral end 4 of the plate, with the bone nestling in the L-shaped profile of the plate. Once aligned, the lateral position of the fragment F and plate 1 can then be easily adjusted until the fragments of bone reduce together. As the bone fragments both nestle within co-aligned L or C-shaped plates, the only adjustment necessary is lateral adjustment to bring the bones together to reduce. Once they are in position, the lateral fragment F can be fixed to the lateral end section 4 of the plate. At this point, or prior to fixing the lateral fragment of the plate, the position of the medial fragment E with respect to the plate can be fine adjusted by loosening the screw in the slot 8A and slightly adjusting the position of the medial fragment E and plate 1.
[0085] FIG. 5 shows a comminuted clavicular fracture with a medial bone fragment E, lateral bone fragment F, and comminuted fragments G. The bone reduction and fixing device of
[0086] FIGS. 1-4 is shown attached to the fractured bone in FIG. 6, with a medial end 3 of the plate 1 attached to the medial fragment E and a lateral end 4 of the plate 1 attached to the lateral fragment F with screws 10. Additional lag screws 11 have been employed to fix the comminuted fragment G′ to the end of the lateral fragment F and the comminuted fragment G″ to the end of the medial fragment E. The use of this embodiment is substantially the same as that described with reference to FIGS. 1 to 4.
[0087] Referring to FIGS. 7 to 10 an alternative embodiment of the invention is described, indicated generally by the reference numeral 70, in which parts described with reference to the previous embodiment are assigned the same reference numerals. In the previous embodiments described with reference to FIGS. 1 to 6, the plate is configured to align with the clavicle in a superior-anterior orientation. In the embodiment of FIGS. 7 to 10, the plate is designed and contoured to align with a clavicle in an inferior-anterior orientation which is best illustrated in FIG. 7 which is a view from underneath the clavicle, or in FIGS. 9 and 10 which are anterior views of the plate attached to the clavicle. In this embodiment, the plate has a slight pre-contoured curve along the anterior face which matches the sigmoid curve on the anterior surface of the clavicle A.
[0088] In use, and referring to FIGS. 9 and 10, the medial fragment E is aligned with the medial end 3 of the plate, with the bone nestling in the L-shaped profile as shown in FIG. 9. Once in position, the bone is fixed to the plate by drilling a hole in the bone through a countersunk hole 8, and inserting a screw into the hole and tightening to fix the medial end of the plate to the medial fragment. The lateral fragment F can then be manipulated to align it with the lateral end 4 of the plate, with the bone nestling in the L-shaped profile of the plate. Once aligned, the lateral position of the fragment F and plate 1 can then be easily adjusted until the fragments of bone reduce together. Additional lag screws 11 have been employed to fix the comminuted fragment G′ to the end of the lateral fragment F and the comminuted fragment G″ to the end of the medial fragment E. As the bone fragments both nestle within co-aligned L or C-shaped plates, the only adjustment necessary is lateral adjustment to bring the bones together to reduce. Once they are in position, the lateral fragment F can be fixed to the lateral end section 4 of the plate. At this point, or prior to fixing the lateral fragment of the plate, the position of the medial fragment E with respect to the plate can be fine adjusted by loosening the screw in the countersunk hole 8 and slightly adjusting the position of the medial fragment E and plate 1.
[0089] FIG. 11 shows an undisplaced fractured clavicle with a break, or fracture in the midshaft. FIG. 12 shows an alternative embodiment of the bone reduction and fixation plate of the invention attached to the fractured clavicle of FIG. 11, indicated generally by the reference numeral 20, in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the device is biplanar along its length, and a central part 2B of the second (anterior) plate has an elongated slot 12 that allows surgical access to the ends of the bone fragments and allow vascularisation of the healing bone. The central part of the first plate 2A has the same thickness (about 2 mm) as the ends of the first plate, and second plate. The use of this embodiment is substantially the same as that described with reference to FIGS. 1 to 4. Although not illustrated, the central part of the first plate 2A may have a greater thickness than the end sections of the first plate 2A.
[0090] FIG. 13 shows a lateral fracture of the clavicle. FIG. 14 shows an alternative embodiment of the bone reduction and fixation plate of the invention attached to the fractured clavicle of FIG. 13, indicated generally by the reference numeral 30, in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the device is biplanar along its length, and a central part 2B of the second (anterior) plate has an elongated slot 12 on the which allows surgical access to the ends of the bone fragments and allow vascularisation of the healing bone. The central part of the first plate 2A has the same thickness (about 2 mm) as the ends of the first and second plates. The use of this embodiment is substantially the same as that described with reference to FIGS. 1 to 4.
[0091] The embodiments of FIGS. 1 to 15 are especially suited to reduction and fixation of clavicles. The following embodiments exemplify devices according to the invention suitable for reduction and fixation of other bones, such as the ankle (FIGS. 16 and 17) and elbow (FIGS. 18-21).
[0092] FIGS. 16 and 17 show an embodiment of the bone reduction and fixation plate of the invention for fixing the fibula, indicated generally by the reference numeral 40, in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the device 40 is a biplanar plate having an L-shaped profile along its full length, and comprising a first (lateral) plate 41 and second (posterior) plate 42. The plate is shown attached to an end of a fractured fibula A, and the other bones of the ankle, namely the tibia B, talus C, calcaneus D, navicular E and cuboid F are illustrated. A distal end 41A of the lateral plate 41 is widened (FIG. 16) to approximately conform to a lateral surface of the fibula A, and includes an elongated slot 12A that in use overlies the fracture allowing access to it. Likewise, a distal end 42A of the posterior plate 42 is widened (FIG. 17) to approximately conform to a posterior surface of the fibula A, and also includes an elongated slot 12B that in use also overlies the fracture allowing access to it, but also allowing the use of an interfragmentary lag screw. The end of the plates distal of the slots comprises three countersunk holes 8 and one wire-receiving hole 9, and the end of the plates proximal of the slots comprises six countersunk holes 8 and three wire-receiving hole 9. The use of this embodiment is substantially the same as that described with reference to FIGS. 1 to 4.
[0093] FIGS. 18 to 20 show an embodiment of the bone reduction and fixation plate of the invention for fixing an olecranon (ulna bone), indicated generally by the reference numeral 50, in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the device 50 is a biplanar plate having an L-shaped profile along its full length, and comprising a first (lateral) plate 51 and second (anterior) plate 52. Both plates include a plurality of screw-receiving holes 8 and smaller wire holes 9, and an elongated slot 12. A proximal hooked end of the biplanar plate 53 comprises an end plate 54, and the anterior plate 52 and end plate 54 are contoured to conform to the end of the ulna (as shown in FIG. 18). In FIG. 18, the plate is shown at the start of a reduction part of the procedure, attached to a first end 55 of a fractured ulna 58, by wires (not shown). FIG. 19 shows the next stage of reduction in which the second end of the fractured ulna 56 is reduced to the first end using the L-shaped profile of the device as a guide. Once the bones have been reduced as shown in FIG. 19, bone-fixing screws 10 are put in place, including a long intermedullary screw 57. The use of this embodiment is substantially the same as that described with reference to FIGS. 1 to 4.
[0094] FIG. 21 shows another embodiment of the bone reduction and fixation plate of the invention for fixing an olecranon (ulna bone), indicated generally by the reference numeral 60, in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the device 60 is substantially identical to the device described with reference to FIGS. 18-20, with the exception that the device includes a lag window 61 to allow access to reduce and fix comminuted bone fragments. The use of this embodiment is substantially the same as that described with reference to FIGS. 5 and 6.
[0095] The plates of the invention, by virtue of their L shaped profile which extends along one or both ends of the plate, and in some cases, along the full length of the plate, allow for easier alignment of bone fragments with the plate, providing easier and more accurate bone reduction and fixation, while also providing a plate with better bending and torsional stiffness and having a lower profile. The embodiment with a L shaped profile at the end sections only, provides an access window to the central, anterior surface of the bone, allowing access to comminuted bone fragments and inhibiting devascularisation of the healing bone fragments. The loss of bending and torsional stiffness due to the lack of an L shaped profile in the central section is compensated for by increasing the thickness of the plate at the central section. Examples of L-shaped profiles applicable to the biplanar plates of the present invention are provided in FIG. 22.
Equivalents
[0096] The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto.
