Improved Arthrodesis Device
20230098345 · 2023-03-30
Inventors
- Federico Vicenzi (Verona, IT)
- Andrea Zaccaria (Tregnago (VR), IT)
- Daniele Venturini (Povegliano Veronese (VR), IT)
- Denis Lorenzini (Caprino Veronese (VR), IT)
Cpc classification
A61B17/7241
HUMAN NECESSITIES
A61B17/744
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to an improved orthopaedic device for athrodesis, in particular for the arthrodesis or fusion of a joint, for example an ankle joint, of the type comprising of a nail having head and tip ends opposed to each other; at least a first portion of the nail having an axis of symmetry; a single circular first transverse hole made in the first portion near the head of the nail and extended according to its own axis perpendicularly to the axis of symmetry; a slotted second transverse hole still made in the first portion of the nail and extended perpendicular to both the first axis of symmetry; and to the axis of the first transverse hole; and the slotted second transverse hole being made at a greater distance with respect to the head of the nail than the distance from the head of the first transverse hole.
Claims
1. Improved orthopaedic device for ankle arthrodesis, in particular for the arthrodesis or fusion of a joint, for example an ankle joint, of the type comprising: a nail having a distal head and a proximal tip ends opposed to each other; at least a distal first portion of the nail having an axis of symmetry; at least a proximal second portion of the nail; a single circular first transverse hole made in the first portion near the head of the nail and extended according to its own axis perpendicularly to said axis of symmetry; a slotted second transverse hole still made in the first portion of the nail and extended perpendicular to both said first axis of symmetry, and to the axis of the first transverse hole; the slotted second transverse hole being made at a greater distance with respect to the head of the nail than the distance from the head of said first transverse hole; wherein said single circular first transverse hole is arranged to accommodate a bone screw oriented along a mediolateral direction in a patient's calcaneus and said slotted second transverse hole is arranged to accommodate a fastening screw oriented along a posteroanterior direction in the patient's calcaneus.
2. The orthopaedic device according to claim 1, wherein said first portion of the nail has an internal cavity extended starting from the head along said axis of symmetry and internally comprising a thread extended up to at least said slotted second transverse hole.
3. The orthopaedic device according to claim 2, wherein said thread is extended up to at least 80% of the slotted second hole.
4. The orthopaedic device according to claim 1, comprising fastening means inserted in said circular first transverse hole passing through a locking element inserted inside the first portion of the nail.
5. The orthopaedic device according to claim 1, comprising a closing plug for the head of the nail structured with a first stage fastened to the free end of the head and an internal second stage in engagement with a sleeve locking element inserted in the first portion of the nail and provided with a transverse hole accessible through said circular first transverse hole.
6. The orthopaedic device according to claim 5, wherein said locking element is made of a bio-compatible and implantable material which works in the elastic field.
7. The orthopaedic device according to claim 5, wherein said sleeve locking element is internally threaded up to said transverse hole to be engaged by an external thread of said second stage.
8. The orthopaedic device according to claim 1, wherein said sleeve locking element comprises two guiding and stabilizing appendices opposed to each other provided for a frictional engagement in corresponding lateral concavities of an internal cavity of said first portion of the nail and extended starting from the head along said axis of symmetry up to passing said circular first transverse hole.
9. The orthopaedic device according to claim 2, comprising a compression mechanism with elastic element inserted in said first portion of the nail between a support dowel screwed into said thread of the internal cavity and a constriction of said first portion; a transverse hole being provided in a base portion of said mechanism to be accessible through said slotted second transverse hole.
10. The orthopaedic device according to claim 9, wherein said base portion of the compression mechanism partially comprises a longitudinal groove.
11. The orthopaedic device according to claim 10, wherein said elastic element is a helical spring integral with said base portion or associated in a structurally independent manner to said base portion.
12. The orthopaedic device according to claim 2, comprising a compression mechanism with sliding body inserted in said first portion of the nail between a support dowel screwed into said thread of the internal cavity and a constriction of said first portion; a transverse hole being provided in an elastic body of said mechanism to be accessible through said slotted second transverse hole, said dowel and said sliding body being rotably coupled with each other.
13. The orthopaedic device according to claim 12, wherein said sliding body is internally cannulated and it has an end portion with a diameter change to form a step while said dowel has an axial protrusion with an end annular edge with tooth profile to be snap-coupled to said end portion with rotatable coupling abutting said step.
14. The orthopaedic device according to claim 12, wherein said dowel is temporarily coupled sleeve locking element inserted in the first portion of the nail and provided with a transverse hole accessible through said circular first transverse hole.
15. The orthopaedic device according to claim 1, wherein, the first transverse hole and the second transverse hole are the only transverse holes provided in the distal first portion of the nail, no transverse hole being provided at the patient's talus.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0072] The invention relates to an improved device for arthrodesis and provided to be used for the arthrodesis of the ankle joint of a patient, in particular when the latter is in an advanced state of decay due to a series of pathologies such as for example a serious arthrosis.
[0073] The ankle arthrodesis device according to the invention is, more specifically, a Tibia-Talus-Calcaneus (TTC) arthrodesis device of the retrograded type. For example, the device for arthrodesis according to the invention can be advantageously used to treat a patient affected by an advanced form of degenerative arthrosis, port-traumatic arthrosis, inflammatory arthritis, talus necrosis, Charcot osteoarthropathy or even in case of failure of one or more surgical operations, such as an arthroplasty operation or in the previously remarked situation of substantial absence of talus.
[0074] As shown in
[0075] Normally, the implantation of the device 1 is preceded by a suitable preparation stage so as to completely or partly suppress the natural articular surfaces of the ankle joint to be treated, in order to facilitate the bone fusion. Furthermore, a suitable accommodation seat of the nail 1 is provided in the tibia TB, in the talus TL and in the calcaneus CA and is obtained according to conventional methods to make orthopaedic holes.
[0076] In the rest of the present description, reference will be made to a sagittal plane of the patient and the part or portion closest to the sole of the foot and the insertion side of the nail 1 will be defined as distal and the part or portion furthest away from the sole of the foot will be defined as proximal.
[0077] In a preferred embodiment, the nail 1 has an enlarged distal portion 2 and a proximal portion or shaft 3 with smaller diameter.
[0078] The enlarged distal portion 2 is the portion closest to the head 4 of the nail 1 and is the one which crosses calcaneus CA, talus TL and the part of the tibia TB associated with the talus TL.
[0079] The nail 1 also has a side tip end 5 (shown in
[0080] The innovations of the nail 1 of the present invention mainly relates to the distal portion 2 or head portion of the nail and, for this reason, the most part of the figures only relates to this portion of the nail 1.
[0081] The nail 1 is monolithic and thus formed in a single piece. The piece can be moulded, extruded and/or turned. Furthermore, the nail 1 is made of inherently bio-compatible material or material which was made bio-compatible after a treatment and able to withstand to the characteristic biomechanical stresses of the implantation area, i. e. an ankle, and for the time necessary to allow the bone fusion. The materials can be stainless steel, titanium alloy, chrome-cobalt alloy, or a polymeric material, such as for example loaded or not loaded polyether-ether-ketone (PEEK).
[0082] As shown in
[0083] According to the embodiment illustrated in the figures, the proximal part 2 and the distal part 3 are both elongated and substantially respectively straight according to said directions of the respective axes A-A and B-B of extension.
[0084] Preferably, both the distal part 2 and the proximal part 3 are cannulated and have respective extended internal cavities 6 and 7 for all the length of the corresponding portions 2 and 3.
[0085] The cavity 6 of the distal portion 2 is with circular section and a greater diameter with respect to the cavity 7 of the portion 3. The two cavities 6 and 7 are communicating and jointed with each other in a segment 38, practically a constriction, being still internally part of the distal portion 2.
[0086] Both the distal portion 2, and the proximal portion 3, of the nail 1 have a generally cylindrical shape with a circular section. Alternatively, both the portions could have a slightly conical shape always with a circular shape. Also a sectional oval shape is equally feasible as well as a combination of all these possible shapes.
[0087] Advantageously, the distal portion 2 of the nail 1 has an extended transverse hole 9 according to an own axis C-C perpendicular to the axis A-A of longitudinal extension of the distal portion 2.
[0088] With respect to the known solutions, this first transverse hole 9 is the only one circular hole provided in the distal portion 2 of the nail 1 at the calcaneus CA.
[0089] Due to the cylindrical shape of the distal portion 2, the end openings of the transverse hole 9 opposed to each other are concave as shown in
[0090] The transverse hole 9 is provided to accommodate a fastening means 19 in order to block the nail 1 rotating around the axis of extension A-A. Such fastening means 19 is a bone screw with Allen head 20 visible in
[0091] The screw fastening means 19 are inserted in said circular first transverse hole 9 and are passing through a locking element 14 inserted inside the first portion 2 of the nail 1 and described below.
[0092] Advantageously, it is provided a non-circular second through hole 10 in turn extended perpendicularly to the axis A-A of longitudinal extension of the distal portion 2.
[0093] Aside from the first and second transverse holes 9 and 10, the distal portion 2 is not traversed by any further hole for accommodating bone screws.
[0094] The second transverse hole 10 has its own axis of symmetry D-D, visible in particular in
[0095] The second transverse hole 10 is slotted and is obtained in a more proximal position with respect to the first transverse hole 9, i. e. in a position further away with respect to the head 4 of the nail 1, but always at the calcaneus CA when the device 1 is implanted in the patient.
[0096] The first transverse hole 9 can be defined as distal mediolateral while the second transverse hole 10 is a proximal slot perpendicular to the first transverse hole 9.
[0097] Furthermore, always according to the present description, the internal cavity 6 of the distal portion 2 of the nail 1 is internally threaded starting from the head 4.
[0098] The thread 12 of the internal cavity 6 is extended from the head end 4 of the nail 1 up to the most part of the slotted second hole 10; up to at least around 80 or 90% of the extension of the slot.
[0099] In
[0100] The screw 19 is internally threaded and has an Allen head 20.
[0101] The external thread of the screw 19 is engaged by the openings of the transverse hole 9 opposed to each other. In this way, the screw 19 is firmly transversally held in the distal portion 2 of the nail 1 and can be further screwed in the calcaneus CA via the self-threading tip 21.
[0102] Advantageously, it is also provided a locking element 14 to firmly block the screw 19 inside the first transverse hole 9 such that it cannot slide when the device is implanted in the joint of the patient.
[0103] The locking element 14 is made of a bio-compatible and implantable material and comprises a sleeve 11 crossed by a transverse hole 13. The locking element 14 has an own elastic deformation capability inherent to the used material.
[0104] Two guiding and stabilizing appendices 16, 17 opposed to each other are also provided, of which only the first is visible in
[0105] A closing plug 15 of the head 4 of the nail 1 is further provided. The plug 15 has a structure with two stages with a first stage 8 with countersunk end inserted in a flushed and vanishing way in the mouth of the internal thread 12 of the cavity 6 at the head 4 of the nail and a second coaxial stage 18 but with smaller diameter and which is externally threaded in order to be screwed in the locking element 14, as will be seen here below.
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[0107] The locking element 14 is structured with a sleeve 11 from which the two appendices 16 and 17 opposed to each other are projecting.
[0108] Each of such appendices ends with a tab-like tip 16a, 17a in order to increase the friction and facilitate the holding in seat of the locking element 14 inside the cavity 6 with the appendices 16 and 17 accommodated and held in the lateral concavities 40.
[0109] The sleeve 11 has an internal thread 22 provided to be engaged by the second stage 18 of the closing plug 15 of the head 4 of the nail 1.
[0110] In
[0111] The thread 22 is extended up to the transverse hole 13.
[0112] When the second stage 18 of the plug 15 is screwed in the internal thread 22 of the locking element 14, it advances towards the distal direction, i. e. towards the head of the nail 1. At the same time, this screwing action presses the screw 19 between the locking element 14 and the first transverse hole 9.
[0113] By completing the screwing, the plug 15 takes its definitive position with the first stage 8 inserted to close the mouth of the head 4 of the nail 1.
[0114] In this way, the screw 19 remains blocked thanks to the interaction between the locking element 14 and the plug 15.
[0115] Advantageously, as already shown in
[0116] As shown in
[0117] The transverse hole 25 can be internally threaded, as shown in figure, or without any thread.
[0118] In the base portion 27, a longitudinal groove 26 is made which would cut the cylindrical base portion along generatrixes opposed to each other if it were not for the fact that there is an upper annular element 28, with greater diameter, which is like a junction between the base portion 27 and a longitudinally extended helical spring 29.
[0119] In a first embodiment, the spring 29 can be integral with the elements 28 and 27 through a helical material removal starting, for example, from a hollow cylinder.
[0120] Alternatively, and it is the other embodiment showed in
[0121] In both the embodiments, the groove 26 is a cut which interrupts the continuity of the hole 25.
[0122] The cut 26 has the purpose to allow a lateral elastic deformation of the hole 25 such that a screw and a pin inserted inside it are stabilized in order to avoid unwanted movements.
[0123] The junction annular element 28 has a shape provided to be coupled inside the cavity 6 of the nail 1 such that the translation of the compression mechanism 30 or 30′ is allowed, but not the relative rotation between such mechanism and the nail 1.
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[0125] The mechanism 30 is inserted such that the hole 25 is accessible from the slotted transverse second hole 10.
[0126] The mechanism 30 is held in position by a threaded dowel 35 which is screwed inside the nail 1 in the thread 12 of the cavity 6 until supporting the mechanism 30 with the hole 25 at the slot 10.
[0127] Advantageously, the device 1 is assembled, the compression mechanism 30 leans onto the dowel 35 and is held in position by the elastic force exerted by the spring 29 which is in turn held between the dowel 35 and an internal surface of the nail 1, for example the junction segment 38 between the two communicating cavities 6 and 7 in the distal portion 2.
[0128] This expedient allows the alignment between the hole 25 in the component compression mechanism 30 and the lower part of the slot 10 to be guaranteed during the operation. Since the surgical operation of internal fastening requires the use of tools and targeting procedures in order to ensure that the holes are centred from the outside, it is appropriate that the device according to the invention remains stable during the operating stages.
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[0130] In the figure, the base portion 27 of the compression mechanism 30 and the respective groove 26 can be seen in section.
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[0132] The dowel 35 has an Allen seat 37 for inserting a manoeuvre wrench (not shown) which allows the surgeon to position the dowel in a screwed manner inside the cavity 6.
[0133] Acting with the manoeuvre wrench on the threaded dowel 35, the positioning of the transverse hole 25 of the base portion 27 with respect to the slot 10 can be moved.
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[0135] In this way it is possible to transversally insert a fastening screw 39 which passes through the slot 10 and the transverse hole 25 of the base portion 27 of the mechanism 30.
[0136] In
[0137] This entailed a more proximal support of the mechanism 30 with respect to the constriction 38 inside the distal portion 2 with respective compression of the spring 29.
[0138] The image shows how the fastening screw 39 has been brought near the opposite end to the slot 10 by compressing the spring 29 and also compacting the bones which are meant to be fused and in which the screw 39 is screwed.
[0139] Basically, the movement of the screw 39 with respect to the slot 10 determines the entity of the compression allowed by the spring 39.
[0140] In the following
[0141] An alternative embodiment of the compression mechanism, which will be indicated with the number 30″, is now described with reference to
[0142] In relation to the previous embodiment of
[0143] The sliding body 47 has an almost cylindrical distal portion 48 with a transverse hole 45 provided to accommodate the screw 39 of the fastening means and a more proximal cap portion 49 having a greater diameter, substantially corresponding to the internal diameter of the cavity 6.
[0144] A second component of the compression mechanism 30″ is a dowel 55 having a cylindrical short axial protrusion 57 coaxially projecting from a side. This protrusion 57 has a free annular end having an edge 58 with tooth profile in order to engage with a snap-fit in a corresponding circular seat 43 obtained in the distal part 46 of the previous component 47, as will be described in detail below.
[0145] The dowel 55 is externally threaded and has an Allen end as the dowel 35 of
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[0147] In other words, two components 47 and 55 are interconnected in a stable way but are able to rotate in a relative way.
[0148] This is made possible by their respective structure since the sliding body 47 is cannulated and has an internal cylindrical cavity 44, which is coaxial to its longitudinal axis and, at the distal end 46, has a diameter reduction which defines the circular seat 43 with limited height and creates an internal step 41 or stair with the cavity 44 with greater diameter.
[0149] As previously said, the dowel 55 has an axial protrusion 57 which faces in the proximal direction with the edge 58 with tooth profile which is facing the circular seat 43 of the distal part 46 of the sliding body 47.
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[0151] The edge 58 with tooth profile passed the circular seat 43 in proximal direction and is accommodated in the distal part of the cylindrical cavity 44 but it can no longer return in distal direction because of the step 41.
[0152] The result is that the dowel 55 is free of rotating with respect to the sliding body 47 but the two components are stably coupled with each other.
[0153] It should be mentioned that, in an operating configuration, the sliding body 47 is crossed by the fastening screw 39 which is implanted by screwing in the respective portion of the calcaneus CA.
[0154] The two components 47 and 55 act as one and can be inserted in the previously described same nail 1 by rotating the threaded dowel 55 with a manoeuvre wrench and causing it to advance in proximal direction in the thread 12. In this way, a compression not only of the sliding body 47 but also of the transverse screw 39 crossing the hole 45 and the slot 10, when the device is implanted in the foot of the patient, takes place.
[0155] Accordingly, a corresponding compression is obtained in mutual approaching of the bones, in which the screws 19 and 39 are implanted.
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[0157] An alternative embodiment of the compression mechanism, which will be indicated with the number 30′″, is now described with reference to
[0158] With reference to the embodiment of
[0159] As discussed in the previous embodiment, two components 47 and 55 are interconnected in a stable way but they are able to rotate in a relative way, and the dowel can be engaged by a wrench in order to regulate the position of the fastening screw 39 accommodated by the sliding body.
[0160] Further, the compression mechanism 30″ comprises a sleeve locking element 14 like the one previously described and shown in
[0161] However, in the present embodiment of the compression mechanism the dowel 55 and the sleeve 11 of the sleeve locking element 14 are provided with releasable latching means 60, which temporarily interconnect the two components in an initial setup of the device.
[0162] The releasable latching means 60 comprise, on one side, a plurality of elastic teeth 61 and, on the other side, a seat 62 where the elastic teeth 61 can engage with snap-fit. In the represented embodiment, the elastic teeth 61 are engaged along the distal annular periphery of the dowel 55, whereas the seat 62 is an annular groove provided on an internal surface of the proximal end of the sleeve 11. However, the elastic teeth 61 could be provided on the proximal annular periphery of the sleeve 11 and the groove could be made on the dowel 55.
[0163] Thanks to the releasable latching means 60, the sliding body 47, the dowel 55 and the sleeve 11 form a single assembly, and they can be manipulated together when the device is implanted. The releasable latching means do not hinder relative rotation of the dowel 55 and sleeve 11, so that the dowel 55 can be rotated by means of a wrench even when it is coupled to the sleeve 11. However, when the dowel 55 is rotated and translated along the nail 1 together with the sliding body 47, allowing compression to take place, the releasable latching means 60 disengage, so that the dowel 55 and sliding body 47 are no longer constrained to the sleeve 11.
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[0166] Advantageously, the device according to the present invention is implanted by a surgical method which provides that the distal portion 2 is oriented towards the rear part of the ankle of the patient, with the first hole 9 arranged and orientated to receive and guide the first fastening means 19 along a first fastening direction which extends through the calcaneus CA.
[0167] The nail 1 is positioned in the ankle joint of the patient. Advantageously, this first installation step can be preceded by a preparatory step during which a housing crossing calcaneus CA, talus TL (if present) and tibia TB is created, using any known means (for example a drill), in order to subsequently receive the nail 1. Preferably, this housing is made so as to allow the implantation of said nail 1 in a retrograded plantar way.
[0168] Preferably, the positioning of the nail 1 takes place such that the screwing direction of the first screw fastening means 19 is oriented in a mediolateral direction, as can be seen in
[0169] Preferably, the second screw fastening means 39 are extended in a direction perpendicular to the first screw fastening means 19 so as to be always able to implant themselves in the calcaneus CA, as shown in
[0170] It will be actually practically noted that the terms “first”, “second”, “third”, etc. used in the present description preferably have no ordinal or cardinal connotation, i.e. they do not imply here any notion of order, quantity or qualification of the elements or components to which these terms are attached. Their purpose in this case is only to ease the understanding of the invention, making it possible to differentiate some technical features from each other which the arthrodesis device according to the invention can have, as well as the various stages which can advantageously include the surgical method which advantageously aimed to the implementation of said arthrodesis device.
[0171] Furthermore, the terms “rear”, “front”, “medial” and “lateral” are preferably used in the present invention in order to qualify the elements or the features related to their respective orientation with respect to the body of the patient, in the normal use of the arthrodesis device according to the invention, and in particular of the nail 1 of the latter. Therefore, the term “medial” is preferably used in order to define an element or component of the arthrodesis device which is provided to be positioned and oriented on the side closest to the mid-sagittal plane (or mid axis) of the body of the patient, in other words the side facing inside the ankle and the leg of the patient. Conversely, the term “lateral” is used in relation to the side furthest away from the mid-sagittal axis. Following the same logic, the terms “rear” and “front” respectively preferably refer to a positioning towards the rear part, respectively towards the front part, with respect to the front plane of the patient.
[0172] The invention finds its application in designing and manufacturing devices provided to be used for carrying out an arthrodesis and, more specifically, in designing and manufacturing devices provided to be used for carrying out an arthrodesis of the joint of an ankle, especially in the context of orthopaedic treatment.