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    • 专利摘要:
    CLAMP FOR AN EXTERNAL ORTHOPEDIC FIXATION SYSTEM AND EXTERNAL ORTHOPEDIC FIXATION SYSTEM. Clamp (1) that can be used advantageously for both temporary and permanent external orthopedic fixation systems comprising: - a first coupling element (2), comprising a pair of opposing jaws (3, 4) that together define one or more seats that can accommodate at least one first component of the orthopedic external fixation system; - a second coupling element (8), comprising a pair of opposing jaws (9, 10) which together define one or more seats that can accommodate at least a second component of the orthopedic external fixation system; - an interconnecting pin (7) that passes through the first (2) and second (8) coupling elements and connects them along a main axis of rotation (x); - clamping means positioned to take the clamp (1) in a loose configuration, in which the first (2) and second (8) coupling elements can be relatively rotated at least along the main axis of rotation (x), up to a locked configuration, in which the first (2) and second (8) coupling elements can be relatively rotated with each other; this clamping means divided into - temporary clamping means, which can be operated manually to lock the clamp (1) temporarily; (...).
    公开号:BR112013020335B1
    申请号:R112013020335-8
    申请日:2011-09-09
    公开日:2021-02-02
    发明作者:Enrico Zandoná；Daniele Venturini；Denis Lorenzini；Marco Assom；Selvadurai Nayagam
    申请人:Orthofix S.R.L；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention refers to the field of orthopedic surgery and refers in particular to a clamp intended for the temporary or permanent fixation of the elements that make up an external fixation system.
    [002] The present invention also relates to an external fixation system comprising this clamp. BACKGROUND OF THE INVENTION
    [003] In orthopedics, external fixation techniques to stabilize, reduce and manipulate bone segments are known and commonly used. These techniques provide the surgical application of an external fixation system, composed in its simplest form of a set of associated nails using intraosseous pins or Kirschner wires in the patient's bone structure. The articulation of rods with each other and with the fasteners is left for proper clamps.
    [004] These fixation systems can be temporarily applied during an operation, or definitively applied in order to be removed only when the pathological condition treated is fully recovered.
    [005] The use of temporary fixation systems is required especially for the following reasons: - a patient may have serious injuries that require priority treatment; - a patient may have injuries that require interventions to be minimal; - local conditions in the region of the fracture could prevent the permanent fixation of the fracture due to a serious infection of the wound, or a lack of soft tissue covering, or a shortage in blood supply; - single fractures to be treated may not be particularly serious, but they may require long and complex surgical interventions for their treatment if they are suffered from other fractures that have occurred.
    [006] In the latter case, some or all of the fractures can be treated using external fixation systems. However, it is necessary to avoid the situation in which one is forced to abandon the fixation of the fracture: at the end of the initial treatment all long bones must be firmly fixed. In addition to these specific requirements, external fixation systems are mainly applied permanently. In such cases, however, a different performance when compared to temporary applications is required from the external fixation system. In particular, if an external fixation system for temporary application is required to present, above all, flexibility of use and fastness of fixation, a system that is permanently implanted must ensure a certain degree of rigidity (see, for example , the Orthofix device marketed under the name XCaliber, which allows the adjustment of lateral curvature and which supports torsion effort during the initial stages of treatment).
    [007] This stability derives in part from the alignment of the rods of the fixation system with the geometric axis of the long bones to be treated, and in part from the intrinsic stiffness of the device itself and the number of screws, and still in part due to the geometric configuration of the screw. Proper configuration allows for quick healing and prompt mobility recovery.
    [008] Given the different requirements of the fixation system for these two applications, systems that have been dedicated to either temporary or permanent treatment have been used so far.
    [009] This specificity in the treatment is undoubtedly one of the disadvantages of the external fixation systems known until now; for example, when it is necessary to apply a temporary fixation that subsequently has to be replaced by a permanent fixation, it is necessary to replace the entire fixing system.
    [0010] On the other hand, the main critical aspect that interferes with external fixation systems for mixed use is related to the clamp that is intended to hold connection elements such as rods, screws and Kirschner wires.
    [0011] In fact, in temporary fixation it is essential that this clamp allows the relative orientation of the elements it connects to be quickly blocked, possibly without using a tightening tool. In definitive fixation, the locking of the relative orientation, however, must be rigid and stable over time, characteristics that clash with the aforementioned tightening modes.
    [0012] Therefore, the technical problem behind the present invention is to provide a clamp that can be used in external fixation systems and that is suitable for both temporary and permanent use, that is, that can be locked in a way fast and manual, but at the same time ensures rigidity and stability over time. DESCRIPTION OF THE INVENTION
    [0013] The aforementioned technical problem is solved by a clamp for an external orthopedic fixation system comprising: - a first coupling element, comprising a pair of opposing jaws that together define one or more seats suitable for housing at least one first component of the external orthopedic fixation system; - a second coupling element, comprising a pair of opposing jaws that together define one or more seats suitable for housing at least a second component of the external orthopedic fixation system; - an interconnecting pin traversing and connecting the first and second coupling elements along a major axis of rotation; - clamping means positioned to take the clamp in a loose configuration, in which the first and second coupling elements can be relatively rotated at least along the main axis of rotation, to a locked configuration, in which the first and second second coupling elements are relatively integrated with each other, these clamping means comprising in particular: - temporary clamping means, which can be operated manually, positioned so as to bring the clamp temporarily into a locked position; - permanent clamping means, which can be operated by a clamping tool, positioned so as to bring the clamp definitively into a locked configuration.
    [0014] The alternative meanings "temporarily" and "definitely" are intended to discriminate, similarly to what was done in the description of the prior art, between temporarily attaching the clamp components and permanently attaching. It is possible to fasten temporarily, with moderately strong grip, it can be performed quickly without the use of a tightening wrench, this allows a relative fixation of the elements, but does not guarantee rigidity or stability of the chosen position over time. In turn, permanently attaching, which is stronger, is able to withstand the regular tension to which an external fixation system is exposed throughout a patient's hospital stay.
    [0015] A technician in the subject will immediately notice how the presence of the two clamping means on the clamp, the manuals and those that are attached by a tool, allows the device to be applied to systems for fixing an external fracture, and that the The result is that these systems will be suitable for both temporary and permanent use.
    [0016] Furthermore, it should be noted that, although the capabilities of the clamp according to the present invention are very well adapted to the context of an external fixation system for both temporary and permanent use, this clamp can be used advantageously in any other orthopedic application.
    [0017] The means for temporarily securing mentioned above may advantageously comprise an annular clamping nut, positioned so as to secure the first and second fastening elements to each other along the extension of the interconnecting pin of the clamp.
    [0018] In particular, the annular clamping nut may advantageously have a cylindrical surface for peripheral handling that is conveniently serrated.
    [0019] The loose jaws of at least one of the pair of jaws can be traversed by the interconnecting pin, so that this pair of jaws is not caught in the loose clamp configuration and stuck in the locked clamp configuration.
    [0020] This configuration results in an advantageous acceleration of the locking operations, since the same means are used both to secure the jaws and to fix coupling elements.
    [0021] The clamp can also comprise a spring placed between the first and second coupling elements, which can advantageously determine a pre-tightening action by the jaws of the coupling element at the respective seats.
    [0022] In a first embodiment of the clamp according to the present invention, the annular clamping nut can fit on a threaded end of the interconnect pin, the opposite end of said interconnect pin being restricted to the first coupling element, the second coupling element being positioned between the annular clamping nut and the first coupling element.
    [0023] In alternative embodiments of the clamp, on the contrary, the annular clamping nut is axially restricted to one end of the interconnecting pin, the opposite end being threaded and fitting into a hole at least partially threaded on the second coupling element said first coupling element being positioned between the annular clamping nut and the second coupling element.
    [0024] In one of these embodiments, which has the advantage of great structural simplicity, the annular clamping nut defines even a clamping head that is integrated with the interconnecting pin, said clamping means definitely comprising an empty space of said head that is intended to allow it to be coupled to a tightening tool.
    [0025] In particular, the annular clamping nut may surround a connecting rod head of the interconnecting pin, said definitive locking means comprising an eccentric body, pivotally mounted on the annular clamping nut that passes through said head of the connecting rod connection along a geometric axis perpendicular to the main geometric axis of rotation, the rotation of said eccentric body with respect to the annular clamping nut creating a translation of the end of the interconnecting pin engaged in the second coupling element in the direction of the annular clamping nut .
    [0026] In some embodiments of the clamp, said definitive clamping means comprises an eccentric body, pivotally mounted on a hinge member which is axially integrated with any of the first and second coupling elements, said eccentric body crossing a head of the connecting rod of the interconnecting pin along a geometric axis perpendicular to the main axis of rotation, the opposite end of said interconnecting pin being restricted to the other between the first and second coupling elements, the rotation of said eccentric body with respect to to the articulation body promoting a translation of the opposite end of the interconnecting pin in the direction of said articulation body and a subsequent relative approximation of the two coupling elements.
    [0027] In one of these embodiments, the annular clamping nut is positioned adjacent against the outermost jaw of the second coupling element, said articulation body corresponding to the first coupling element, the end of the interconnecting pin opposite the coupling head. connecting rod being threaded and restricted by threading to the annular clamping nut.
    [0028] In an alternative embodiment, said eccentric body articulates the first coupling element to the interconnecting pin along a secondary axis of rotation, advantageously defining a second degree of freedom of rotation between the first coupling element and the second coupling element in the loose clamp configuration.
    [0029] The eccentric body can then be articulated in a base portion that proceeds in the direction of the second coupling element as a protuberance of the innermost jaw of the first coupling element.
    [0030] In that case, a central joint crossed by the interconnecting pin can be advantageously positioned between the base portion and the second coupling element, said central joint having a sliding face along a concave periphery of the base portion and a flat face that is intended to mate with a surface of the inner jaw of the coupling element.
    [0031] The technical problem identified above is also solved by an external orthopedic fixation system comprising at least one of the clamps described above, in addition to known nails and fasteners.
    [0032] This external orthopedic fixation system can also comprise at least one wire-carrying element, positioned to allow at least one Kirschner wire or other fixator of limited diameter to be attached to one of the system clamps.
    [0033] It should be noted that this wire-carrying element can also be advantageously applied outside the scope defined by the present invention, since it has innovative characteristics in itself.
    [0034] The wire-carrying element may comprise a body with a threaded portion in which a clamping plate is threaded to an adjacent plate that is integrated with the body.
    [0035] The body may comprise a portion of the handle intended to be locked between the jaws of one of the system clamps.
    [0036] The clamping plate can also advantageously have four peripheral teeth on one of its faces facing the adjacent plate, spaced evenly along the circumference of said plate and positioned to touch a flat surface of the adjacent plate, thus defining, in collaboration with the body portion between the two plates, a seat for a Kirschner wire or for screws with limited diameter.
    [0037] Other features and advantages of the present invention will be clear from the following description of some preferred, but not exclusive, embodiments of the present invention, with reference to the accompanying drawings, given by way of non-limiting examples. BRIEF DESCRIPTION OF THE DRAWINGS
    [0038] Figure 1 is an axonometric view of a clamp according to the invention; Figure 2 is a sectional view along a vertical central plane of the clamp in Figure 1; Figure 3 is a sectional view, taken along line III-III in figure 2, of the clamp in figure 1; Figures 4 and 5 are respective axonometric views of a clamp according to an alternative embodiment of the present invention; Figure 6 is a sectional view, taken along line VI-VI of figure 7 of the clip in figures 4 and 5; Figure 7 is a sectional view, taken along line VII-VII of figure 6, of the clamp in figures 4 and 5; Figures 8 and 9 are respective axonometric views of a clamp according to a third embodiment of the present invention; Figure 10 is a sectional view along a vertical central plane of the clamp in Figures 8 and 9; Figure 11 is an axonometric view of an element of an external fixation system according to the invention; Figure 12 is a sectional view, taken along a vertical central plane, of the element of figure 11; Figure 13 is an axonometric view of an external fixation system according to the present invention applied to a patient's first bone region; and Figure 14 is an axonometric view of an external fixation system according to the present invention applied to a second region of bone in a patient. DESCRIPTION OF ACCOMPLISHMENTS OF THE INVENTION
    [0039] According to a first embodiment of the present invention, figures 1-3 show a first clamp, indicated as a whole by reference numeral 1, for an external modular fixation system suitable for use in the treatment of lower limbs , such as the tibia, femur, or pelvis. Through a simple dimensional adjustment it is possible to use this clamp also for upper limbs, for example, a humerus. In this first embodiment, the clamp allows a rod and a plurality of intraosseous pins to be fixed in a simple and stable manner, as will be clear from the description below.
    [0040] The clamp 1 comprises a first coupling element 2 with multiple seats for fixing intraosseous pins, comprising at least three seats for holding the same number of intraosseous pins.
    [0041] The coupling element 2 with multiple seats is preferably made of metal.
    [0042] According to the present invention, the multi-seat coupling element 2 comprises an upper jaw 3 and a lower jaw 4. The upper jaw 3 serves as a cap and has a pair of holes, at least partially hollow in threads, through which closing screws 13 pass. The lower jaw 4 comprises a corresponding pair of blind holes internally in threads to receive the ends of the two screws 13.
    [0043] At least one insert 5 is provided in at least one of the seats in order to fix the intraosseous pins. In particular, the use of inserts of a hemispherical shape is provided between the lower jaw 4 and the upper jaw 3 in order to define each seat of the intraosseous pin housing.
    [0044] These inserts 5 are made of a different material with respect to the jaws 3 and 4, for example, from a non-conductive material.
    [0045] More particularly, it is preferable that these inserts are made of a radiotransparent material that is compatible with MRI (magnetic resonance).
    [0046] In the example being shown, the three seats are equidistant, the central seat being positioned in correspondence with the central geometric axis and the two remaining seats on each side of the same.
    [0047] A base portion 6 that develops as a protrusion of the lower jaw 4 has a seat internally to house the head of an interconnecting pin 7 in the form of a connecting rod with a body extending along an axis main geometric of rotation x that is orthogonal to the seats defined by the first coupling element 2, in the direction of a second stem coupling element 8.
    [0048] The second stem coupling element 8 also has a lower jaw 9 and an upper jaw 10.
    [0049] This second rod coupling element 8 has a single C-shaped seat, lateral and orthogonal with respect to the main geometric axis of rotation x, for spring fitting to a fixing rod 100.
    [0050] The lower and upper jaws 9, 10 of the second coupling element have a central hollow hole through which the interconnect pin 7 passes.
    [0051] An annular clamping nut 14, properly serrated on the outside for better grip, is threaded on the free end of the interconnect pin 7. In particular, this ring nut 14 has a central threaded hole that is threaded on the end of said interconnection pin 7.
    [0052] A washer 15 through which interconnect pin 7 is inserted between the lower jaw 9 of the second coupling element 8 and the annular nut 14.
    [0053] In summary, the first coupling element with multiple seats 2 is mounted on the head of the interconnect pin 7 and is able to move freely and angularly, while the second rod coupling element 8 is pivotally mounted on the interconnect pin 7.
    [0054] A spring 11 is inserted between the first multi-seat coupling element 2 and the second stem coupling element 8 around the interconnect pin 7. This spring 11 is compressed between the lower jaw 4 of the first coupling element 2 and the upper jaw 10 of the second coupling element 8 and is concealedly housed in impressions on the opposite surfaces of those jaws. The spring 11 defines a clamping preload exerted by the jaws on the elements inserted in the seats of the coupling elements before locking the clamp.
    [0055] In addition, a central joint 16 with a central hole for the passage of the interconnect pin 7 is positioned between the two coupling elements 2 and 3.
    [0056] In order to prevent slipping during the usual assembly operations, respective anti-rotation means 17 are present on the surface of the upper jaw 10 of the second coupling element 8 and on the surface of the central joint 16; in the example, these means are formed integrally with the part body itself and they comprise a plurality of grooves oriented radially in a crown positioned around the central hole.
    [0057] Advantageously, the head of the interconnect pin 7 has a hollow hole to allow an eccentric body 12 to be transversely inserted along a secondary axis of rotation y for a bushing 19. This eccentric body 12 has, on both sides opposites accessible from the outside, on the sides of the lower jaw 4 of the first coupling element 2, a respective empty socket head 18 for receiving a control socket wrench.
    [0058] The simple rotation of the eccentric body 12 allows it to be locked in its seat and at the same time bring the free end of the interconnect pin 7 closer to the first coupling element 2, thus defining a relative locking of the various elements of the which clip 1 is composed of.
    [0059] The clamp 1 can have a loose configuration in which the jaws of the second coupling element 8 are not tightened, the second coupling element 8 can be rotated with respect to the interconnect pin 7 along the main axis of rotation x and x interconnect geometry axis 7 can be rotated with respect to the first coupling element 2 along the secondary axis of rotation y. In this loose configuration, therefore, two degrees of freedom to rotate are present, allowing together an adequate relative positioning of the first coupling element 2 and the second coupling element 8. Alternatively, the clamp 1 can have a locked configuration in which the two coupling elements 2,8 are relatively integrated with each other and the jaws of the second coupling element 8 are tightened. It should be noted that the jaws of the first coupling element 2 are independent, since their tightening is done by the closing screws 13 which are autonomous with respect to the interconnecting pin 7.
    [0060] The manual tightening of the clamping ring nut 14 allows the entire clamp 1 to be quickly pre-closed without the need for the use of a wrench. This operation takes clamp 1 from the loose configuration to a temporarily locked configuration, which ensures the clamping of the jaws of the second coupling element and the relative locking of the two coupling elements, but does not guarantee rigidity or stability of these conditions over time.
    [0061] So, to change a definitely locked configuration, in which rigidity and stability over time are guaranteed, it is necessary to turn the eccentric body 12 by means of a control socket wrench.
    [0062] The clamp according to the first embodiment described above has several advantages, such as: - the use of a single clamp to connect the nail and the intraosseous pins; - the presence of two degrees of rotating freedom for easy relative positioning of the coupling elements; - the option of manual pre-closing; - the possibility of tightening by a single rapid movement of the control key; - compatibility with MRI techniques.
    [0063] When the clamp according to the first embodiment just described is used for upper limbs, it is possible to use the rod coupling element 8 in order to fix an intraosseous pin, simply by changing the size of the various elements .
    [0064] Therefore, where reference was made to a rod coupling element, it should be considered that this also includes intraosseous pin coupling elements.
    [0065] According to a second embodiment of the present invention, figures 4-7 show a second clamp, indicated generally by 20, suitable for use in the treatment of lower limbs, such as the tibia, femur or pelvis. After a simple modification of the dimensions, it is also possible to use this clamp for upper limbs, for example, humerus and forearm, as well as for foot and ankle treatments.
    [0066] The second clamp comprises a first coupling element with two seats 21 comprising an upper jaw 22 and a lower jaw 23, both provided with a central hollow hole for an interconnecting pin 24 that extends along a main geometric axis of rotation x '.
    [0067] The coupling element of two seats 21 has, opposed to each other on both sides of the central hole, two open seats in the form of C to house respectively an intraosseous pin and a rod. Once again it is possible to adapt the dimensions of said opposite open seats, so that both seats are able to accommodate a respective intraosseous pin.
    [0068] The open seats are therefore placed in an eccentric and orthogonal manner with respect to the main geometric axis of rotation x ’. An insert 25 is provided between the upper jaw 22 and the lower jaw 23 in the jaw portion that is intended to house the intraosseous pin.
    [0069] This insertion is made of a material different from the material used to make the coupling element of two seats 21, in particular a non-conductive material, when the coupling element is preferably made of steel.
    [0070] More particularly, it is preferable that this insertion is made of a radiotransparent material that is compatible with MRI.
    [0071] The clamp according to the second embodiment of the present invention further comprises a second coupling element 31 having a lower jaw 33 and an upper jaw 34.
    [0072] The second coupling element has a single C-shaped side seat to exert a clamping action between the jaws.
    [0073] These lower and upper jaws 34 of the second coupling element 31 of the clamp 20 also have a central hollow hole to allow the interconnect pin 24 to pass through them.
    [0074] This interconnect pin 24 has at its free end a thread that matches a corresponding internal thread that is present at least partially in the hollow hole of the lower jaw 33 of the second coupling element 31. In this way the first coupling element with two seats 21 are pivotally mounted with respect to the interconnecting pin 24, while the second coupling element 31 is pivotally restricted to the interconnecting pin 24 to which it is screwed by means of its own lower jaw 33.
    [0075] Basically the lower jaw 33 acts as a nut to which the entire second clamp 20 can be screwed.
    [0076] A spring 26 is inserted between the first coupling element with two seats 21 and the second coupling element 31 around the interconnect pin 24. That spring 26 is compressed between the lower jaw 23 of the first coupling element with two seats 21 and the upper jaw 34 of the second coupling element 31, and concealedly housed in impressions on the opposite surfaces of those jaws. The spring defines a clamping preload exerted by the jaws on the elements inserted in the seats of the coupling elements before locking the clamp.
    [0077] To prevent slipping during normal assembly operations, respective anti-rotation means 27 are present on the opposite surfaces of the upper jaw 34 of the second coupling element 31 and the lower jaw 23 of the first coupling element 21; in the example, these means are formed integrally with the part body itself and they comprise a plurality of grooves oriented radially in a crown positioned around the central hole.
    [0078] Advantageously, the end of the interconnect pin 24 opposite to that which is screwed into the second coupling element 31 has an extension in the form of a connecting rod head. This connecting rod head has a hollow hole to allow an eccentric body 28 to be inserted transversely with the interposition of a bushing 30. This eccentric body 28 has, on both opposite sides, an empty socket head 29 to receive a spanner. control socket.
    [0079] An annular nut 35 that can be manually rotated, through which the eccentric body 28 also passes, surrounds the head of the interconnect pin 24. In particular, this annular nut 35 has a central slot within which the head of the pin interconnect 24 fits perfectly and a central hole through which the body of the interconnect pin passes.
    [0080] It should be noted that the rotation of the eccentric body 28 in the annular nut 35 allows it to be locked and, at the same time, that the second coupling element 31 is pressed against the first coupling element with two seats 21, defining thus a relative locking between the various elements that make up the clamp 20.
    [0081] A washer 32 through which the interconnect pin 24 is inserted between the annular nut 35 and the upper jaw 22 of the first coupling element with two seats 21.
    [0082] The clamp 20 can have a loose configuration in which the jaws of the coupling elements 21, 31 are not tightened and the first coupling element with two seats 21 is rotating with respect to the second coupling element 31 around the geometric axis main rotation x '. In this loose configuration, therefore, a degree of turning freedom is defined that allows the first coupling element with two seats 21 and the second coupling element 31 to be positioned appropriately with respect to each other. Alternatively, the clamp 20 can have a locked configuration in which the jaws are tightened and the two coupling elements 21, 31 are integrated with each other.
    [0083] The manual tightening of the annular clamping nut 35 allows the entire clamp 20 to be quickly pre-closed without the need to use a wrench. This operation takes the clamp 20 from the loose configuration to a temporarily locked configuration, which ensures the clamping of the jaws and the relative locking of the two coupling elements, but does not guarantee the rigidity and stability of these conditions over time.
    [0084] So, in order to change a definitive locked configuration, in which rigidity and stability over time are guaranteed, it is necessary to turn the eccentric body 28 by means of a control socket wrench.
    [0085] The clamp according to the second embodiment has several advantages, such as: - the use of a single clamp to connect two rods or a rod to an intraosseous pin; - the presence of a degree of freedom of rotation for a relatively easy positioning of the coupling elements; - the option of manual pre-closing; - the possibility of tightening by means of a single rapid movement of the control key; - compatibility with MRI techniques.
    [0086] According to a third embodiment of the present invention, figures 8-10 show a third clip, indicated as a whole by 40, suitable for use in the treatment of upper limbs, such as the wrist, shoulder, hands.
    [0087] The third clamp comprises a first coupling element with two seats 41 comprising an upper jaw 42 and a lower jaw 43, both provided with a central hollow hole to allow an interconnect pin 44 oriented along a main geometric axis of rotation x '' pass through them.
    [0088] The coupling element with two seats 41 has, close to the central hole and opposite each other, open seats in the form of C to house respectively an intraosseous pin 101 and a rod. It is also possible to modify the dimensions of these seats, so that both are able to accommodate an intraosseous pin.
    [0089] The open seats are, therefore, placed in an eccentric and orthogonal manner with respect to the main geometric axis of rotation x ’’. An insert 45 is provided between the upper jaw 42 and the lower jaw 43 in the jaw portion that is intended to house the intraosseous pin.
    [0090] This insert is made of a material different from the material being used to make the coupling element 41, in particular a non-conductive material, when the coupling element 41 is preferably made of steel.
    [0091] More particularly, it is preferable that this insert 45 is made of a radiolucent material that is compatible with MRI.
    [0092] The third clamp 40 according to the present invention further comprises a second coupling element 46 having a lower jaw 47 and an upper jaw 48.
    [0093] This second coupling element has a single opening for stapling a rod 100 between the jaws.
    [0094] These lower jaws 47 and upper 48 of the second coupling element 41 of the third clamp 40 also have a central hollow hole to allow the interconnect pin to pass through them.
    [0095] This interconnect pin 44 has at its free end a thread that matches a corresponding internal thread that is present at least partially in the hollow hole of the lower jaw 47 of the second coupling element 46.
    [0096] In this way the first coupling element with two seats 41 is pivotally mounted with respect to interconnect pin 44, while the second coupling element 46 is pivotally restricted to interconnect pin 44 to which it is screwed by means of its own lower jaw 47.
    [0097] Basically the lower jaw 47 functions as a nut to which the entire second clamp 40 can be screwed.
    [0098] A spring 49 is inserted between the first coupling element with two seats 41 and the second coupling element 46 around interconnect pin 44. That spring 49 is compressed between the lower jaw 43 of the first coupling element with two seats 41 and the upper jaw 48 of the second coupling element 46, and concealedly housed in impressions on the opposite surfaces of those jaws. The spring 49 defines a clamping preload exerted by the jaws on the elements inserted in the seats of the coupling elements before locking the clamp.
    [0099] To prevent slipping during normal assembly operations, respective anti-rotation means 50 are present on the surface of the upper jaw 48 of the second coupling element 46 and on the surface of the lower jaw 43 of the first coupling element 41; in the example these means are formed integrally with the body of the part in which they are formed and they comprise a plurality of grooves oriented radially in a crown positioned around the central hole.
    [00100] The end of the interconnect pin 44 opposite that which is screwed into the second coupling element 46 has an expansion that is similar in shape to a flat clamping nut 51 that can be operated manually from the outside. In the middle of its free surface this annular clamping nut 51 has an empty space 53 for the socket to receive a control socket wrench.
    [00101] A washer 52 through which the interconnect pin 44 passes is inserted between the annular clamping nut 51 of the interconnect pin 44 and the upper jaw 42 of the first two-seat coupling element 41.
    [00102] The third clamp 40 can have a loose configuration in which the jaws of the two coupling elements 41, 46 are not tightened, and the first coupling element with two seats 21 can be rotated with respect to the second coupling element 46 around the main geometric axis of rotation x ”. In this loose configuration, therefore, a degree of freedom is defined that allows the first coupling element with two seats 41 and the second coupling element 46 to be positioned appropriately with respect to each other. Alternatively, the clamp 40 can have a locked configuration in which the two coupling elements 41, 46 are integrated with each other and their jaws are tightened.
    [00103] The manual tightening of the annular clamping nut 51 allows the entire clamp 40 to be quickly pre-closed without the need to use a control socket wrench. This operation takes the clamp 40 from the loose configuration to a temporarily locked configuration, which ensures the clamping of the jaws and the relative locking of the two coupling elements, but does not ensure the rigidity and stability of these conditions over time.
    [00104] Then, in order to change to a definitive locked configuration, in which rigidity and stability are ensured over time, it is necessary to insert a wrench into the control socket in the void 53 of the annular clamping nut 51 and tighten her using this tool.
    [00105] The clamp according to the third embodiment has several advantages, such as: - the use of a single clamp to connect two rods or a rod to a bone pin; - the presence of a degree of freedom of rotation for a relatively easy positioning of the coupling elements; - the option of manual pre-closing; - compatibility with MRI techniques.
    [00106] The modular external fixation system 200, 300 according to the present invention, shown in Figures 13 and 14, can comprise one or more of the clips 1, 20, 40 described above; moreover, it may comprise a wire carrier element 60 of the type shown in the attached figures 11-12.
    [00107] The wire carrier element 60, which is particularly useful in fixation systems for points of the wrist and shoulder bones, allows one or more Kirschner wires to be supported or alternatively an equal number of screws 102 of reduced diameter (D = 2.5mm), totally or partially in thread.
    [00108] The wire carrier element 60 comprises a body 61 and a clamping plate 62.
    [00109] The main body has a threaded portion 63, to which said clamping plate is screwed, and a non-threaded handle portion 64; the two portions are divided by an adjacent plate 65.
    [00110] The clamping plate 62 has on its surface facing towards the adjacent plate 65, when in use, four peripheral teeth 68, spaced equally across the circumference of said plate.
    [00111] When screwing the clamping plate 62 into the threaded portion 63 of the body 61, the four peripheral teeth 68 touch a flat surface of the adjacent plate 65, thus defining wire seats in collaboration with the body portion 61 connecting the two plates.
    [00112] Both the body 61 and the clamping plate 62 comprise portions in hexagonal shape 66 on the external surface of the clamping / adjacent plates for the insertion of a control key. The body 61 also comprises a hexagonal void 67 located at the end of its handle portion 64.
    [00113] In order to insert a wire or a screw into the wire carrier element 60, the wire or screw is inserted into the channel defined by two peripheral teeth 68 on one side and by the body 61 on the other side; a second wire or a second screw is then inserted into the channel defined on the other side of the body by the peripheral teeth 68 opposite to the first. A pair of screws or parallel wires can thus be associated with the wire carrier element 60.
    [00114] In order to associate the wire carrier element 60 with the rest of the external fixation system, it is sufficient to lock the handle portion 64 inside a coupling element of one of the system clamps.
    [00115] The wire-carrying element described above has several advantages, such as: - the possibility of using a normal clamp to connect rods or intraosseous pins to Kirschner wires or screws of limited diameter; - the possibility of a relatively easy positioning of the elements to be connected; - the secure fixation of wires or screws locked by the wire carrier element; - the high structural simplicity of the wire-carrying element, which consists of only two components.
    [00116] Modular external fixation systems 200, 300 according to the present invention, which can be seen in two alternative embodiments in Figures 13 and 14 comprise, in addition to the innovative components described above, rods 100 and intraosseous pins 101, 102 of the type known.
    权利要求:
    Claims (15)
    [0001]
    1. CLAMP (1; 20) FOR AN EXTERNAL ORTHOPEDIC FIXATION SYSTEM (200, 300), the system comprising: - a first coupling element (2; 21); comprising a pair of opposing jaws (3, 4; 22, 23; 42,43) which together define one or more seats that can accommodate at least one first component of the external orthopedic fixation system (200, 300); - a second coupling element (8; 31), comprising a pair of opposing jaws (9, 10; 33, 34; 47, 48) which together define one or more seats that can accommodate at least a second component of the fastening system external orthopedic (200, 300); - an interconnecting pin (7; 24) that passes through the first (2; 21) and seconds (8; 31) coupling elements and connects them along a major axis of rotation (x; x '') ; - clamping means positioned to take the clamp (1; 20) in a loose configuration, in which the first (2; 21) and second (8; 31) coupling elements can be relatively rotated at least along the main geometric axis from rotation (x; x '') to a locked configuration, in which the first (2; 21) and the second (8; 31) coupling elements are relatively integrated with each other; wherein the clamping means comprises: - temporary clamping means, manually operable, positioned to bring the clamp (1; 20) temporarily to the locked configuration; - definitive clamping means, operable by means of a clamping tool, positioned to bring the clamp (1; 20) definitively to the locked configuration, in which the temporary clamping means comprises an annular clamping nut (4; 35) positioned to fasten together the first (2; 21) and the second coupling elements (8; 31) along the interconnecting pin (7; 24), characterized by the definitive fastening means comprising an eccentric body (12; 28) rotatably mounted in an articulated body that is axially integrated with any of the first (2; 21) or second coupling elements (8; 31), the eccentric body (12; 28) passing through a connecting rod head of the interconnect (7; 24) along a geometric axis that is perpendicular to the main axis of rotation (x), the opposite end of the interconnect pin (7,24) restricted to the other interconnect pin (7; 24) between the first (2; 21) and second coupling elements (8; 31), the rotation of the eccentric body (12; 28) in relation to the articulated body providing a translation of the opposite end of the interconnecting pin (7; 24) in the direction of the articulation body and taking the two coupling elements (2, 8 ; 21, 31) to be closer to each other.
    [0002]
    2. CLAMP (1; 20), according to claim 1, characterized in that the annular clamping nut (14; 35) has a cylindrical peripheral handling surface.
    [0003]
    3. CLAMP (1; 20), according to claim 2, characterized in that the cylindrical peripheral handling surface is serrated.
    [0004]
    4. CLAMP (1; 20) according to any one of claims 1 to 3, characterized in that the interconnecting pin (7; 24) passes through both individual jaws of at least one of the pair of jaws (3, 4; 22, 23; 9, 10; 33, 34), the pair of jaws is not tightened in the loose clamp configuration (1; 20) and is tightened in the locked clamp configuration (1; 20).
    [0005]
    5. CLAMP (1; 20), according to claim 4, characterized in that it further comprises a spring (11; 26) positioned between the first (2; 21) and the second coupling elements (8; 31).
    [0006]
    6. CLAMP (20) according to any one of claims 1 to 5, characterized in that the annular clamping nut (35) is axially restricted to one end of the interconnecting pin (24), the opposite end in thread and fitting into a at least partially threaded hole of the second coupling element (31), the first coupling element (21) is positioned between the annular clamping nut (35) and the second coupling element (24).
    [0007]
    7. CLAMP (20), according to claim 6, characterized by the annular clamping nut (35) surrounding a connecting rod head of the interconnecting pin (24), the definitive locking means comprising an eccentric body (28) , rotatably mounted on the annular clamping nut (35), which passes through the head of the connecting rod along a geometric axis that is perpendicular to the main axis of rotation (x), the rotation of the eccentric body (28 ) in relation to the annular clamping nut (35) promoting a translation of the end of the interconnecting pin (24) fitted in the second coupling element (31) towards the annular clamping nut (35).
    [0008]
    8. CLAMP (1), according to any one of claims 1 to 5, characterized by the annular clamping nut (14) touching the outermost jaw (9) of the second coupling element (8), the articulated body corresponding to the first coupling element (2), in which the end of the interconnecting pin (7) opposite the head of the connecting rod is screwed and restricted by threading on the annular clamping nut (14).
    [0009]
    9. CLAMP (1), according to claim 8, characterized by the eccentric body (12) articulating the first coupling element (2) to the interconnecting pin (7) along a secondary axis of rotation (y), defining a second degree of rotational freedom between the first coupling element (2) and the second coupling element (8) in the loose configuration of the clamp (1).
    [0010]
    10. CLAMP (1), according to claim 9, characterized in that the eccentric body (12) is articulated on a base portion (6) that evolves towards the second coupling element (8) as a protuberance of the innermost jaw (4) of the first coupling element (2).
    [0011]
    11. CLAMP (1), according to claim 10, characterized in that a central joint (16) is positioned between the base portion (6) and the second coupling element (8), through which the interconnecting pin ( 7) passes, the central joint (16) having a sliding face along a concave periphery of the base portion (6) and a flat face that is intended to mate with a surface of the internal jaw (10) of the coupling element ( 8).
    [0012]
    12. EXTERNAL ORTHOPEDIC FIXATION SYSTEM (200, 300), characterized in that it comprises at least one clamp, the clamp as defined in any one of claims 1 to 11.
    [0013]
    13. FIXING SYSTEM (300), according to claim 12, characterized in that it also comprises at least one wire-carrying element (60), positioned so as to allow at least one of a Kirschner wire or another fastener (102) ) of limited diameter is tightened on one of the system clamps, the wire carrier element (60), comprising a body (61) with a threaded portion (63) to which a clamping plate (62) is screwed until touch against an adjacent plate (65) that is integrated into the body (61).
    [0014]
    FIXING SYSTEM (300) according to claim 13, characterized in that the body (61) comprises a handle portion (64) intended to be locked between the jaws of one of the system clamps.
    [0015]
    FIXING SYSTEM (300), according to claim 14, characterized in that the clamping plate (62) has, on one of its faces towards the adjacent plate (65), four peripheral teeth (68), spaced equally along the circumference of the plate, and positioned to lean against a flat surface of the adjacent plate (65), defining, in collaboration with the body portion (61) comprised between the two plates (62, 65), a seat for a deKirschner wire or other fastener (102) of limited diameter.
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    同族专利:
    公开号 | 公开日
    US8728079B2|2014-05-20|
    EP2672907A1|2013-12-18|
    CA2823579C|2018-10-16|
    JP6031046B2|2016-11-24|
    JP2014512854A|2014-05-29|
    US20120209264A1|2012-08-16|
    HK1186948A1|2014-03-28|
    WO2012107060A1|2012-08-16|
    ES2546178T3|2015-09-21|
    CN103354734B|2016-03-02|
    EP2672907B1|2015-07-01|
    US8540713B2|2013-09-24|
    CO6801665A2|2013-11-29|
    DK2672907T3|2015-09-14|
    IL227875D0|2013-09-30|
    IL227875A|2018-03-29|
    AR085061A1|2013-08-07|
    MX2013008959A|2013-11-04|
    AU2011358377A1|2013-05-02|
    US20140025077A1|2014-01-23|
    BR112013020335A2|2017-07-18|
    BR112013020335B8|2021-02-17|
    CN103354734A|2013-10-16|
    AU2011358377B2|2014-11-13|
    CA2823579A1|2012-08-16|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-07-28| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2020-12-01| B09A| Decision: intention to grant|
    2021-02-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/09/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-02-17| B16C| Correction of notification of the grant|Free format text: REF. RPI 2613 DE 02/02/2021 QUANTO AO ENDERECO. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161441953P| true| 2011-02-11|2011-02-11|
    US61/441,953|2011-02-11|
    PCT/EP2011/004549|WO2012107060A1|2011-02-11|2011-09-09|Clamp for temporary or definitive external orthopaedic fixation, and external fixation system comprising said clamp|
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