Improved external fixation struts

Abstract

The present disclosure relates to an improved external fixation strut comprising: an elongated body comprising first and second hollow tubular shafts; opposite connectors coupled to the end of the first or second shafts respectively and each comprising a ball and socket joint; one shaft having an inner diameter slightly larger than the outer diameter of the other shaft so as to internally accommodate the other shaft in a slidable telescopic manner; the first and second shafts of said strut being realized in a synthetic radiotransparent plastic material; a clamping element provided in the vicinity of the overlapping ends of the first and second shafts for providing a quick clamping action preventing telescopic sliding of one shaft within the other; a manually operated clamping element acting on the clamping element for exerting said quick clamping action; a sleeve provided around the central portion of the strut where the first and second shafts overlap; and a clamping band surrounding said sleeve and comprising opposite and facing clamping portions connected by a threaded joint. Also disclosed is a fixation system comprising at least first and second fixation rings and / or at least one fixation arch interconnected by at least one of the above described fixation struts.

Description

Background Technology

[0001] This disclosure relates to an improved structure for external fixation systems and devices, and more specifically, to an improved external fixation support.

[0002] The invention is described in conjunction with an external fixation device, specifically a connecting strut and bar. External fixation devices are generally used in various surgical procedures, including limb fractures, limb lengthening, and deformity correction. The procedure involves a rigid frame comprising several rings or arches placed externally around the limb, and attached to the bone segments using sutures and half pins inserted into the bone segments and connected to relevant portions of the external rigid frame.

[0003] The opposing rings of the rigid frame are directly interconnected by threads and / or telescopic rods or by single-plane or multi-plane hinges, which allows the surgeon to adjust the position of the rings relative to each other longitudinally, rotatably, horizontally or angularly over a period of time.

[0004] For example, in limb lengthening, the bone is surgically divided into two segments, and sutures and half-needles are inserted into the bone segments above and below the surgical incision and attached to a ring of a rigid frame interconnected by struts or telescopic connecting rods.

[0005] For limb lengthening, opposing rings are directly interconnected by at least three or four threads or telescopic rods, the length of which is periodically adjusted, and to achieve gradual longitudinal separation of bone segments.

[0006] A rigid frame is used to gradually separate two bone segments longitudinally over a period of time (e.g., one millimeter per day). This allows bone to gradually form in the gap between the bone segments created by this separation technique. Once the desired elongation is achieved (e.g., 5-6 cm), the external device is stabilized in a fixed position and left on the bone segment until the newly formed bone is fully mineralized (e.g., 3-6 months, depending on the pathological nature and the amount of elongation).

[0007] Similarly, in deformity correction, the bone (usually at the apex of the deformity) is surgically divided into two segments, and then sutures and half-needles are inserted into the bone segments above and below the surgical incision and attached to the rings of a rigid frame. In this case, the opposing rings of the rigid frame are also connected together by threaded rods with attached hinges and angle traction devices, which are used to gradually separate the two bone segments at an angle over time.

[0008] Existing technology

[0009] A common fixation device is a circular metal structure called the Ilizarov device. When used for limb lengthening or deformity correction, the Ilizarov device consists of several rings or arches placed externally around the limb and attached to surgically separated bone segments using sutures and half-needles. For angular deformity correction, the opposing rings of the Ilizarov device are connected by a pair of hinges and an angular traction device. The hinges provide a rotational axis for the bone segment, and the angular traction device gradually separates the two rings and the associated bone segment.

[0010] Another common external fixation device is called the Taylor Spatial Frame, which is a hexapod external fixation device based on the so-called Stewart platform, but with many components and features of the Ilizarov device.

[0011] The Taylor space scaffold comprises two external fixation rings attached to the bone segments by sutures and half-needles, and connected by five or six telescopic struts with multi-plane hinges at both ends of the struts. Each strut can be lengthened or shortened as needed to pull the two interconnected ring segments toward each other or push them apart.

[0012] Each strut of the Taylor space stent has a screw partially housed within a hollow shaft, which includes an adjusting nut that mates with the screw. However, rapid or gradual adjustments to the strut length are time-consuming, and struts often need to be replaced with longer ones during treatment.

[0013] Furthermore, it is impossible to replace or remove the struts of the Taylor space scaffold during treatment without using external supports or other stabilizing mechanisms to support the rest of the frame, because if a strut is removed from the frame, the frame will become unstable and collapse.

[0014] Other examples of such fixtures are commercially known as TrueLok and Sheffield, the latter being shown in Figure 1, denoted as 100.

[0015] These solutions are frequently used to address bone trauma cases. For surgeons, it is crucial to quickly reduce fractures and verify the reduction results via X-ray imaging.

[0016] Both products feature a quick-connect strut to the corresponding ring, allowing for rapid release of the second ring relative to the first. This simple installation system enables fracture recovery and stabilization in a relatively short time and further allows for adjustment of the relative tilt between the rings.

[0017] However, both types of products have some drawbacks.

[0018] First, a pillar represents an obstacle in any X-ray image, typically obstructing the view of a fracture to the surgeon.

[0019] Secondly, although relatively easy to install, known solutions require a relatively long time to assemble and position on the patient, also because the pillars have inherent weight, making their application uncomfortable for the patient.

[0020] Furthermore, the transport and storage of known external fixators are always complicated due to their size and bulk.

[0021] External fixators based on the prior art are disclosed, for example, in prior art documents US2016 / 199099A1, CN103494634A and US2020 / 0000492A1.

[0022] The technical problem emphasized by this invention is to provide a new support for external fixation and a new fixation structure with functional and structural features to overcome the defects affecting existing technical solutions.

[0023] The primary objective of the improved external fixator strut disclosed herein is to enhance the surgeon's visibility of the fracture site, while simultaneously enabling easy axial movement of the strut to allow for possible microscopic dynamics. Summary of the Invention

[0024] The proposed solution based on this disclosure utilizes a radiation-permeable material to realize the main part of the ring of interconnected struts, so as to utilize the joint portion to support the fine adjustment of the strut length.

[0025] Based on this conceptual design, the technical problem of the present invention is emphasized to be solved by an improved external fixation strut, which includes:

[0026] - An elongated body comprising first and second hollow tubular shafts;

[0027] - Opposite connectors, respectively coupled to the ends of the first or second shaft and each including a ball joint;

[0028] - One shaft has an inner diameter that is slightly larger than the outer diameter of another shaft so that the other shaft can be slidably and telescopically accommodated inside.

[0029] - The first and second axes of the support are made of a synthetic, radiation-permeable plastic material;

[0030] - Clamping elements, located near the overlapping ends of the first and second shafts, are used to provide a rapid clamping action to prevent one shaft from sliding telescopically inside the other shaft;

[0031] - A manually operated fixing element acts on the clamping element to apply the rapid clamping action.

[0032] This disclosure includes various embodiments of an improved external fixation strut. In one embodiment, the external fixation strut includes:

[0033] - A sleeve, disposed around the central portion of the strut where the first and second shafts overlap; and

[0034] A clamping band surrounds the sleeve and includes opposing and facing clamping portions, wherein at least one clamping portion has a central threaded hole for receiving a threaded shaft of a clamping bolt. The clamping bolt has a head coupled to a removable manual operating key.

[0035] This disclosure also includes various embodiments of a fixing system comprising at least first and second fixing rings and / or at least fixing arches interconnected by a plurality of fixing struts, wherein at least one of the fixing struts comprises:

[0036] - An elongated body comprising first and second hollow tubular shafts;

[0037] - Opposite connectors, respectively coupled to the ends of the first or second shaft and each including a ball joint;

[0038] - One shaft has an inner diameter that is slightly larger than the outer diameter of another shaft so that the other shaft can be slidably and telescopically accommodated inside.

[0039] - The first and second axes of the support are made of a synthetic, radiation-permeable plastic material;

[0040] - Clamping elements, located near the overlapping ends of the first and second shafts, are used to provide a rapid clamping action to prevent one shaft from sliding telescopically inside the other shaft;

[0041] - A manually operated fixing element acts on the clamping element to apply the rapid clamping action;

[0042] - A sleeve is provided around the central portion of the strut where the first and second shafts overlap;

[0043] - A clamping band surrounds the sleeve and includes opposing and facing clamping portions connected by threaded connectors.

[0044] Furthermore, in the aforementioned securing system, each support includes opposing male and female connectors, each including a ball joint, such that the corresponding support can move at an angular angle of up to at least 90° to fold the securing system for packaging and transport purposes. Attached Figure Description

[0045] To more fully understand the features and advantages of this disclosure, reference is now made to specific embodiments and accompanying drawings, in which:

[0046] Figure 1 is a perspective view of an embodiment of an external fixation system including a support column implemented according to the prior art;

[0047] Figure 2 This is a perspective view of an embodiment of the external fixed support column of this disclosure;

[0048] Figure 2A This is a perspective view of the components of the externally fixed support structure disclosed herein;

[0049] Figure 2B yes Figure 2A The diagram shows a cross-sectional view of the component mounted on an external fixed support column of this disclosure;

[0050] Figure 3 This is a three-dimensional schematic diagram of the central part of the pillar disclosed herein;

[0051] Figure 3A This is a perspective view of the central portion of the externally fixed support column of this disclosure, wherein the nuts and bolts securing the clamping strap to the central sleeve are removed;

[0052] Figure 4 This is another three-dimensional schematic diagram of the external fixed support under different constructions disclosed herein;

[0053] Figure 5 This is a perspective view of an embodiment of an external fixation system including a support column implemented according to the present disclosure;

[0054] Figure 6A This is another perspective view of another embodiment of an external fixation system comprising at least three pillars implemented according to the present disclosure;

[0055] Figure 6B yes Figure 6A The embodiment is shown in a perspective view of the folded structure;

[0056] Figure 7A and Figure 7B Cross-sectional views of the external fixed support of this disclosure taken from opposite perspectives are shown respectively;

[0057] Figure 8 This is a perspective view of the male connector associated with one end of the externally fixed support column disclosed herein;

[0058] Figure 9 yes Figure 8 Cross-sectional view of the male connector;

[0059] Figure 10 This is a perspective view of the female connector associated with one end of the externally fixed support column disclosed herein;

[0060] Figure 11A yes Figure 10 Cross-sectional view of the female connector;

[0061] Figure 11B yes Figure 11A Another cross-sectional view of the female connector taken from a vertical perspective;

[0062] Figure 12A yes Figure 10 Another perspective view of the female connector;

[0063] Figure 12B yes Figure 10 A three-dimensional view of the internal spring loading mechanism visible in the female connector;

[0064] Figure 12C yes Figure 12B A slightly enlarged cross-sectional view of the female connector;

[0065] Figure 13A , Figure 13B and Figure 13C Enlarged cross-sectional views of the female connector of this disclosure in different configurations are shown respectively;

[0066] Figure 14A , Figure 14B and Figure 14C Enlarged cross-sectional views of alternative embodiments of the female connector of this disclosure in different configurations are shown respectively;

[0067] Figure 15A , Figure 15B and Figure 15C Enlarged cross-sectional views of another embodiment of the female connector of this disclosure in different configurations are shown. Detailed Implementation

[0068] Although various embodiments of the present disclosure are discussed in detail below, it should be understood that the present disclosure provides many applicable inventive concepts that can be embodied in a variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways of making and using the invention and do not limit the scope of the invention.

[0069] Figure 2 A schematic diagram of an improved external fixation post 200 according to the present disclosure is shown. The external fixation post has an elongated shape and is provided with connectors 201, 202 at opposite ends, which are configured to be attached to corresponding fixing rings or arches of the external fixator.

[0070] The ring of the external fastener to which the support 200 is attached is shown in another figure that will be disclosed later.

[0071] The support 200 has an elongated body formed by a pair of aligned and coaxial hollow tubular shafts 210 and 220. In embodiments of this disclosure, these shafts have a cylindrical shape, but other shapes may also be used.

[0072] In the exemplary embodiments disclosed herein, the inner diameter of the first shaft 210 is slightly larger than the outer diameter of the second shaft 220, such that the second shaft 220 is slidably accommodated within the first shaft 210. In other words, the second shaft 220 can slide along the inner cavity of the first shaft 210.

[0073] This dimensional relationship between the first shaft 210 and the second shaft 220 gives the strut 200 an overall telescoping structure, which can adjust its length according to the need to maintain the interconnecting rings in a predetermined relative spatial relationship.

[0074] The shafts 210 and 220 of the support column 200 are made of a radiation-permeable, i.e., X-ray radiation-permeable, synthetic plastic material.

[0075] As a possible example, these shafts can be made from high-tech polymeric materials, such as PEEK (polyether ether ketone). This high-tech polymer is characterized by excellent heat and chemical resistance; furthermore, it possesses good tribological, mechanical, and dielectric properties, as it supports sterilization cycles and resists ionizing radiation, making it a good alternative to metallic materials. The sleeve 230 is disposed around the central portion of the support column 200, where the first shaft 210 and the second shaft overlap, or more preferably, near the overlapping ends of the first and second shafts.

[0076] The sleeve 230 has a recessed portion for receiving a clamping band 204, which has opposing and facing clamping portions 205, 206, which are brought closer together by the action of a removable manual key 250 (e.g., a butterfly key).

[0077] Clamping portions 205 and 206 have aligned through holes 211 through which the threaded shaft 215 of the clamping bolt 260 passes. The free end of the threaded shaft is received within a nut 207, which is positioned on the opposite side of the clamping portions 205 and 206 relative to the head 261 of the clamping bolt. In an alternative embodiment, the clamping bolt 260 may be received in a threaded hole in one of the clamping portions 205 and 206, instead of engaging with a loose nut.

[0078] The clamping bolt 260 within the fastening nut 207 brings the clamping portions 205 and 206 close together. The head 261 of the clamping bolt 260 is coupled to a removable manual operation key 250.

[0079] More specifically, the manual key 250 may be configured as a knob or a butterfly wrench, which can be manually operated to tighten the bolt, thereby forcing the two parts 205, 206 closer together. The threaded shaft 215 is part of the bolt 260 with a recessed head, and the manual key 250 is mechanically coupled to such bolt 260 in a removable manner.

[0080] By applying force to the butterfly wrench 250, the operator can prevent axial relative movement of one shaft 220 sliding within another shaft 210, thereby adjusting the axial main extension of the strut 200. This action is used for manual, quick pre-closing of the extension stroke of the strut 200.

[0081] The wing wrench 250 is removably associated with one of the two opposing clamping portions 205, 206, and can be removed to expose the recessed head of the bolt 260, which can receive and accommodate a key or fastening tool, as will be described in detail later with respect to another drawing.

[0082] The external fixing post 200 of this disclosure has connectors 201, 202, including ball joints associated with their opposite ends, and can be attached to the outer or inner surface of a fixing ring or arch member. These ball joint connectors 201, 202 are associated with final male and female connectors 280, 290, respectively, for faster connection to the corresponding ring of the ring retainer.

[0083] At least one of these ball joint connectors 201, 202 is housed in the adjustment mechanism 212, enabling independent, rapid, and progressive fine dynamic adjustment of the length of the support 200, as we will see in the following sections of this specification.

[0084] The adjustment mechanism 212 can be considered as a switching power component that enables the surgeon to change from a rigid strut that does not move under load to a flexible strut with an axial displacement of at least 3 mm. This agility is achieved through deformable elements, such as elastic elements, like springs housed within the end portion of the shaft, particularly female connectors. Two alternative embodiments of the agility mechanism 212 will be disclosed later.

[0085] Figure 2A A perspective view of an assembly of the external fixed support 200 of this disclosure is shown. More specifically, the assembly is a sleeve 230 disposed around the overlapping inner ends of the first and second shafts 210, 220.

[0086] The sleeve 230 is composed of a first sleeve portion 225 having an inner diameter that substantially corresponds to the outer diameter of the first shaft 210 and a second sleeve portion 235 having an inner diameter that substantially corresponds to the outer diameter of the second shaft 220.

[0087] The first and second sleeve sections 225 and 235 are integrally formed as a single-piece structure.

[0088] More specifically, the second sleeve portion includes two opposing semi-tubular wings 227 and 237 protruding from the first sleeve portion 225 and spaced apart from each other by an air gap 229. The inner surfaces of the two tubular wings 227, 237 face each other to substantially form the second sleeve portion 235, which appears to open longitudinally along the opposing air gap 229 and has a smaller diameter compared to the diameter of the first sleeve portion 225.

[0089] The smaller diameter of the second sleeve portion 235 creates a radial step 232 at the location where the second and first sleeves 235, 225 are connected to each other.

[0090] A collar 228 is provided at the free end of each tubular wing 227 and 237. The collar 228 from one side and the radial step 232 from the other side define an annular space with the tubular wings 227 and 237, in which the clamping band 204 is accommodated.

[0091] Figure 2B A cross-sectional view of the sleeve 230 mounted on the improved external fixed support of this disclosure is shown.

[0092] As can be understood from this cross-sectional view, the first sleeve portion 225 is fixed around and on the inner end 240 of the first shaft 210, while the other sleeve portion 235 corresponds to the radial step 232 adjacent to such an inner end 240.

[0093] The inner end 245 of the second shaft 220 faces the inner end 240 of the first shaft 210 and can slide telescopically within the first shaft. The inner end 245 of the second shaft is closed by a cover 248, which can be considered as the end of the stroke.

[0094] The clamping band 204 is accommodated in the annular space or groove of the second sleeve 235 between the radial step 232 and the collar 228.

[0095] In the figure, a clamping portion 205 of the clamping band 204 and a nut 207 for accommodating the threaded shaft of the wing wrench 250 can be seen.

[0096] When the clamping portions 205 and 206 are brought close together by the butterfly wrench 250, the clamping action performed by the clamping band 204 obtains a tightening pressure around the second sleeve 235. This clamping action performs a rapid clamping action, stopping the telescopic sliding of the second shaft 220 within the first shaft 210.

[0097] Figure 3 Another perspective view shows an embodiment of the external fixation strut of this disclosure for use in an external ring fixing device. The central portion of the external fixation strut 200 is shown, wherein two shafts 210 and 220 overlap in a telescopic manner.

[0098] The sleeve portion 230 encloses the central portion of the support column 200, in which the first concentric shaft 210 and the second concentric shaft 220 overlap.

[0099] The clamping band 204 is accommodated and disposed in the recess of the second sleeve portion 235, and the clamping portions 205, 206 facing it protrude laterally from the sleeve portion 230.

[0100] The nut 207, housed in the base on the clamping portion 205, receives the threaded shaft 215 of the fastening bolt 260 having a polygonal head (e.g., a hexagonal head).

[0101] The head of the wing wrench 250 overlaps with that of the bolt 260, and the protruding flange 270 is regularly arranged in a polygonal layout, which substantially corresponds to the surface of the polygonal head of the bolt 260.

[0102] Obviously, other constructions can be used. For example, the wrench 250 can be constructed to have a polygonal hole fit or be placed on the polygonal head of the fastening bolt 260.

[0103] In other words, the butterfly wrench 250 is a user adjuster for tightening the bolt 260, enabling the user to apply faster and stronger manual clamping action, forcing the two parts 205, 206 closer to each other through the thread action of the bolt 260.

[0104] By applying the butterfly wrench 250, the operator can stop the axial relative movement of one shaft sliding within another, thereby adjusting the axial main extension of the support 200.

[0105] Figure 3A Another perspective view shows an embodiment of the external fixation strut of this disclosure for use in an external ring fixing device. The central portion of the external fixation strut 200 is shown, wherein two shafts 210 and 220 overlap in a telescopic manner.

[0106] In this figure, the fastening bolts 260 and corresponding nuts 207 of the clamping portions 205 and 206 are shown in a disassembled state. Therefore, the alignment through holes 211 of the clamping portions are clearly visible; the holes on the clamping portion 205 are enlarged to form a base for accommodating the nuts 207.

[0107] Figure 4 A perspective view of the externally fixed support 200 of this disclosure is shown, wherein the butterfly wrench 250 has been removed after the manual pre-closing action of the extension stroke of the support 200 without engaging the external key. This is to reduce the time and complexity of the operation. Finally, the wrench 250 is manually removed, and the final locking is completed with the aid of the key.

[0108] Without a wing wrench 250, the bolt head is exposed, and the adopted construction can be tightened using a key.

[0109] Figure 5 This is a perspective view of an embodiment of an external fixing system 500 including a support column 200 implemented according to the present disclosure.

[0110] The fixing system 500 includes at least a pair of fixing rings 510 and 520. Alternatively, at least one of these fixing rings may be a fixing arch (not shown), for example, in the distal portion of the fixing system 500.

[0111] The retaining rings 510 and 520 are interconnected by some retaining struts 200 as previously disclosed, such as at least three or four struts. However, a system configuration including more struts (e.g., six struts) may also be adopted.

[0112] The structure of each support 200 is as disclosed in the preceding paragraphs of this disclosure. However, since at least one support is required to have special dynamic functions, at least one support with a different construction may be used.

[0113] In other words, the fixed system 500 may include at least one support 200 according to this disclosure.

[0114] Advantageously, the support 200 is connected to the rings 510 and 520 by opposite connectors 201 and 202; namely, male connector 201 and female connector 202.

[0115] The connector mates with holes (not shown) regularly arranged along the ring or arch, and is fixed to the ring or arch by fixing bolts 530.

[0116] Each connector is also associated with a ball joint to enable angular movement of the corresponding support, with a spherical angle of at least 90° and a working angle of at least 45°.

[0117] The angular degrees of freedom of connectors 201 and 202 allow the folding and securing system 500 to be used for packaging and shipping purposes.

[0118] In addition, System 500 can be configured as a pre-assembled structure, prepared in a sterile environment and packaged accordingly for later, faster use by surgeons.

[0119] Figure 6A A perspective view is shown of another embodiment of an external fixation system 600 including three pillars 200 implemented according to the present disclosure.

[0120] The absence of a butterfly wrench 250 in the support column 200 shown in this figure indicates that the telescopic length of the support column 200 has been adjusted. The entire structure is folded along the bending direction arrow 650 using opposite ball joint heads 201 and 202 to obtain a basically flat structure of the fixing system 600.

[0121] Therefore, due to the ball joint angle of up to 90°, it is possible to pre-assemble a fixation system comprising at least two rings and two to four pre-assembled and folded struts. This configuration is provided in a reduced-size aseptic package.

[0122] Figure 6B Show Figure 6A The embodiment is shown in a perspective view of the folded structure.

[0123] Combining elements 201 and 202 achieves angles up to 90° and allows the two rings 510 and 520 with connected struts 200 to be positioned almost in the same plane, as... Figure 6B As shown.

[0124] Due to the larger grooves on the connecting element (which will be disclosed in detail below), 90° angles can be achieved at both the male and female ends. The other grooves remain the same as those on the current support.

[0125] Figure 7A A cross-sectional view of the externally fixed support column of this disclosure is shown. Two shafts 210 and 220 overlap in a telescopic manner, and sleeve portions 225 and 227 enclose the central portion of the first concentric shaft 210 and the second concentric shaft 220 of the support column 200.

[0126] The recessed portion 204 of the second sleeve portion 225 is used to accommodate the clamping strip.

[0127] Figure 7B Another cross-sectional view of the externally fixed support of this disclosure, taken from an opposite perspective, is shown.

[0128] In Figure 7B In the image, the clamping portion 205 through which the threaded shaft 215 of the clamping bolt passes is clearly visible.

[0129] The dynamic mechanism 212 is associated with the female connector 202. However, alternative reverse embodiments in which the dynamic mechanism is associated with the male connector 201 cannot be ruled out.

[0130] Figure 8 This is a perspective view of the male connector 201 associated with one end of the support column 200 according to this disclosure.

[0131] More specifically, the male connector 201 is associated with a free end 810 of the second shaft 220 and includes a pair of stages 840 and 850 mechanically coupled in sequence. The first stage 840 is an interconnecting stage for the ball joint stage 850, which leads out the threaded rod 280 of the male connector 201.

[0132] The first stage 840 is connected to the end 810 of the second shaft and includes a support element 845 for the rod 842, the end portion of which is configured as a ball cage 848 for the ball socket joint of the second stage 850.

[0133] The support element 845 is associated with the base 830 of the free end 810 fixed to the second shaft 220, and represents a central portion having at least two opposite flat surfaces 846 configured to accommodate an insertion operation key (not shown).

[0134] The rod 842 may be structurally independent of the support element 845 or may be integrally formed with the support element. In the first case, the rod 842 protrudes from the central hole of the support element 845 so as to be substantially coaxial with the second shaft 220.

[0135] The second stage 850 includes a ball 855 for a ball-and-socket joint and a threaded rod 280 integrally formed with the ball 855, wherein the ball cage 848 represents the ball-and-socket joint.

[0136] The more prominent portion of the threaded rod 280 represents a male connection for securing one or the other of the retaining rings 510 and 520 in the system 500. More specifically, the threaded rod 280 can be inserted into one of the holes typically provided in the retaining ring and then secured with a retaining bolt 530.

[0137] A special sealing cover 890 is installed on the screw 280 and seals the socket of the ball socket joint formed by the ball cage 848 and the ball 855.

[0138] The special closure 890 is formed by two cylindrical portions with different diameters. The first, higher or thicker portion 870 is provided with a pair of opposite flat surfaces 860 for allowing the insertion of an operating key (not shown).

[0139] The first part 870 has a knurled or milled surface 875 for improving adhesion between the male connector 201 and the corresponding ring 510 or 520 of the fixing system 500.

[0140] The second, smaller portion 880 of the closing cover 890 has a larger diameter and a knurled or milled circumferential surface 885 to allow the operator to rotate it manually.

[0141] A more detailed description of the internal structure of the male connector 201 is as follows Figure 9 The disclosure provides that it has the same characteristics as... Figure 8 Components and parts with the same structure and function as those disclosed herein are given with the same reference numerals.

[0142] Figure 9 It has been referenced Figure 8 A three-dimensional schematic diagram of the cross-section of the male connector 201.

[0143] The first stage 840 is connected to the end 810 of the second shaft 220 and includes a special shaft end element 940.

[0144] The shaft end element 940 has a first portion 942 that is interference-fitted or fixed to the end 810 of the second shaft, particularly inside the end. A second intermediate portion 944 wraps around the end 810 as a peripheral collar, while a third extension portion 946 is provided to interconnect to the support element 845 of the interconnect stage 840.

[0145] The second intermediate part 944 corresponds to Figure 8 The base 830 is shown.

[0146] In addition, the extension 946 has external threads and a through hole 948 for receiving the rod 842 that supports the ball joint stage 850.

[0147] Rod 842 passes through hole 948 and through another hole in support element 845.

[0148] The support element 845 is screwed onto the external thread portion of the extension portion 946 and abuts against the middle portion 944, i.e., the base 830, at the end of the stroke.

[0149] However, when connected to the opposing retaining rings 510 and 520, the screwing action of the support element 845 can be adjusted to obtain controlled microscopic axial movement of the entire support 200.

[0150] In other words, by the number of turns of the threaded coupling between the support element 845 and the external thread extension 946, the stroke of the entire support 200 can be controlled very precisely when installed between the two rings 510 and 520.

[0151] The ball cage 848 is the protruding part of the cue 842 and represents the base or socket of the ball socket joint 850.

[0152] The ball 855 and the threaded rod 280 form an integral structure. The threaded rod also has an enlarged diameter 960 that is closer to the ball 855 and is provided with an external threaded surface 965.

[0153] The special sealing cap 890 is screwed onto the external threaded surface 965 of the rod portion 280 with an enlarged diameter 960 until the second smaller portion 880 of the sealing cap 890 abuts against the ball cage 848.

[0154] from Figure 9 As can be seen from the cross-section, the inner portion of the closure cover 890 has a hemispherical shape 970, which defines a closure for the ball cage 848 and together with the ball cage 848 defines a spherical chamber in which the ball 855 of the ball socket can move at an angle.

[0155] Figure 10 This is a perspective view of the female connector 202 associated with one end of the support column 200 according to this disclosure.

[0156] More specifically, the female connector 202 is associated with a free end 1010 of the first shaft 210 and includes a pair of stages 1040 and 1050 mechanically coupled in sequence. The first stage 1040 is a connector stage of the final stage 1050, which includes a female element 1060.

[0157] The first connector stage 1040 is connected to the end 1010 of the first shaft 210 and includes a support element 1045 mounted on the end 1010 of the shaft 210 as a closure but coupled to the base 1020 of the ball joint 1030.

[0158] The support element 1045 has a closed collar 1046 close to the end 1010 of the shaft 210.

[0159] The base 1020 has an external threaded portion 1025 and is connected to the support element 1045 via a threaded adjusting ring 1035. The ring 1035 is part of the adjusting mechanism 212, which will be described in detail with reference to FIG11 below, and has a knurled or milled circumferential surface for manual rotation by the operator.

[0160] Advantageously, the regulating ring is made of a reinforced plastic material that is permeable to X-ray radiation.

[0161] The ball joint 1030, protruding from the base 1020, has a plurality of regularly spaced holes 1037, for example, four holes. One of these holes 1033 is larger than the others 1037.

[0162] The final stage 1050 of the female connector 202 has a more distal portion 1055 coupled to the ball joint 1030 and a final cylindrical portion 1090 including a proximal end of a female element 1060 with internal threads for receiving interconnecting bolts (not shown) to connect one end of the support 200 to the ring of the fixing system 500.

[0163] The proximal cylindrical portion 1090 has an opposite flat surface 1070 for inserting an operating key, while the distal portion 1055 has an enlarged annular collar 1080 with a knurled or milled circumferential surface for manual rotation by the operator.

[0164] Figure 11A Show Figure 10 A perspective view of the cross-section of the same female connector 202 is shown, but the already mentioned adjustment mechanism 212 is shown in more detail, which enables independent, rapid and gradual fine-tuning of the length of the entire support 200.

[0165] Typically, components and assemblies with the same structure and function that have been disclosed are represented by the same reference numerals.

[0166] As can be seen from this cross-sectional view, the ball joint 1030 protrudes from the base 1020, which has external threads.

[0167] This special structure, including the ball joint 1030 and its base 1020, is mounted on a support element 1045 fixed at the end 1010 of the shaft 210, and has a through hole 1110 for receiving a pin 1120, which has a T-shaped inner shaft 1125 that slides in a hole 1135 in the support element 1045 and an enlarged portion 1140 that slides along the through hole 1110.

[0168] The first transverse pin 1148 is secured by a support element 1045 and passes through a rod at its distal end through the inner shaft 1125.

[0169] The support element 1045 is made of an X-ray radiation-permeable synthetic plastic material and can be considered as a plastic sleeve for the end 1010 of the closed shaft 210, while providing a base for the dynamic mechanism to be disclosed below.

[0170] More specifically, the support element 1045 is configured as a double sleeve, a portion of which is inserted into the shaft end 1010, a collar 1046 abuts against the shaft end 1010, and a protruding portion 1047 slidably supports the interior of the base 1020 of the first stage 1040.

[0171] The T-shaped inner shaft 1120 is advantageously realized by a ray-permeable metal component, such as aluminum, or, alternatively, a reinforced plastic material.

[0172] The elastic element 1150 is disposed inside the support element 1045. More specifically, the spring 1150 is wound around the rod 1125 of the inner shaft 1120 inside the support element 1045 to produce an elastic action in conjunction with the tightening action of the threaded adjusting ring 1035 of the external threaded portion 1025 of the base 1020.

[0173] The second transverse pin 1142 is secured by the base 1020 and passes through the enlarged portion 1140 of the T-shaped inner shaft 1120. This second transverse pin 1142 is slidable within the elongated groove 1122, similar to a buttonhole formed at the center of the T-shaped inner shaft 1120, and is aligned along the main axis of the T-shaped inner shaft 1120. The relative movement between the support element 1045 and the base 1020 of the first stage 1040 is accompanied by a corresponding relative movement of the second transverse pin 1142 within the elongated groove 1122.

[0174] The following components—support element or plastic sleeve 1045, base 1020, threaded portion 1025, threaded adjusting ring 1035, T-shaped inner shaft 1120, and spring 1150—together constitute the dynamic adjustment mechanism 212.

[0175] The dynamic mechanism 212 of this embodiment includes a T-shaped inner shaft 1120 made of plastic material, which is assembled to the plastic support element 1045 together with a first transverse pin 1148 for assembling the two plastic parts. The second transverse pin 1142 serves as a mechanical stop for the compression spring 1150 and prevents any accidental disassembly of the support.

[0176] Manually applying force to the threaded adjusting ring 1035 allows adjustment of the offset of the base 1020 relative to the end 1010 of the shaft 210 via the ball joint 1030, resisting the elastic force of the spring 1150. In this way, the entire length of the support 200 can be smoothly, independently, quickly, and gradually finely adjusted via this adjusting mechanism 212.

[0177] In a preferred embodiment, this length adjustment is at least 3 millimeters.

[0178] The structure of the female connector 202 is completed by a spring loading mechanism 1100 disposed in the final stage 1050 surrounding the female element 1060.

[0179] More specifically, the female element 1060 of the female connector 202 is realized at the end of the rod 1160, which can slide within the tubular hole 1180, which is formed by first and second coaxial tubular cavities 1180, 1190 with different diameters, and is realized inside the final proximal cylindrical portion 1090.

[0180] The rod 1160 has a distal portion 1195 that is threaded to screw into a corresponding base provided in the ball joint 1030.

[0181] The spring loading mechanism 1100 includes a spring 1111, which is housed inside a first tubular cavity 1180 and winds around the proximal portion of the forming female element 1060 of the rod 1160.

[0182] The rod 1160 extends through the hole 1133 of the ball joint 1030, and the hole 1133 communicates with the larger hole 1033 of the ball joint 1030, such that the final stage 1050, which includes the proximal cylindrical portion 1090 of the female element 1060, rotates at least 90° about the ball joint 1030.

[0183] By manually applying force to the enlarged annular collar 1080 of the distal portion 1055, the threaded distal portion 1195 of the adjusting rod 1160 can penetrate into the corresponding base of the ball joint, thereby adjusting the relative distance between the final stage 1050 and the first stage 1040. This also achieves a 90° “foldable” configuration for the connector 202, unlike the working configuration where the angular movement between the first stage 1040 and the final stage 1050 is in the range of 0° to 45°.

[0184] Figure 11BShow Figure 11A A three-dimensional cross-sectional view of the same female connector 202 taken from a vertical perspective.

[0185] The components shown in this diagram are the same, and are given as... Figure 11A Same reference numerals as shown in the attached figures.

[0186] In this figure, it is particularly evident that the T-shaped inner shaft 1120 is made of plastic material and is assembled in the plastic support element 1045 together with the first transverse pin 1148 for connecting the two plastic parts. The second transverse pin 1142 is also evident and serves as a mechanical stop for the compression spring 1150 and to prevent any accidental disassembly of the support.

[0187] The threaded adjusting ring 1035 is shown closer to the base 1020, and a gap is provided relative to the end 1010 of the shaft 210 and the spring 1150 is released.

[0188] A comparison is also shown between the larger hole 1033 of the ball joint 1030 and the opposite smaller hole 1037.

[0189] Figure 12A These are screenshots taken from different perspectives. Figure 10 Another perspective view of the female connector.

[0190] Figure 12B yes Figure 10 A perspective view of the female connector shows that the internal spring loading mechanism 1100 includes a spring 1111 wound around the rod 1160.

[0191] The rotation of the annular collar 1080 at the distal end 1055 can adjust the compression of the spring 1111.

[0192] Figure 12C yes Figure 12B A slightly enlarged cross-sectional view of the female connector, more specifically, a cross-sectional view of its final stage 1050, in which it can be clearly seen that the distal threaded portion 1195 of the rod 1160 is screwed into the base provided in the ball joint 1030.

[0193] The ring 1080 is rotated between the final stage 1050 and the first stage 1040, which includes the ball joint 1030, and the final stage 1050 is rotated toward a greater angular motion to achieve a 90° "foldable" configuration.

[0194] Figure 13A The diagram shows a cross-sectional view of the first stage 1040 of the female connector 202 and the adjustment mechanism 212, which enables independent, rapid, and gradual fine-tuning of the length of the support column 200.

[0195] It is understood that when the adjusting ring 1035 abuts against the closed collar 1046 of the support element 1045, the turning action of the adjusting ring can be applied to the external thread portion 1025 of the base 1020, thereby forcing the base 1020 to move toward the support element 1045.

[0196] The maximum extension of this twisting action can be adjusted as needed. Without limiting the applicant's rights, in the preferred embodiment disclosed herein, this maximum extension has been selected as 3 mm, such as... Figure 13B As shown.

[0197] exist Figure 13A and Figure 13B In the maximum extension configuration, the second transverse pin 1122 is located at one end of the elongated groove 1042, and the spring 1150 is its maximum relaxation extension.

[0198] Figure 13C Another cross-sectional view of the first stage 1040 is shown, in which the adjusting ring 1035 is screwed onto the largest portion of the external threaded portion 1025 of the base 1020, while the enlarged portion 1140 of the T-shaped inner shaft 1120 protrudes deeper toward the ball joint 1030, thereby reducing the overall extension of the strut 200.

[0199] In Figure 13C In this context, it's understandable that if compared to other... Figure 13A and Figure 13B In contrast, in the final retraction configuration, the second transverse pin 1122 abuts against the opposite end of the elongated groove 1046.

[0200] Now, for more specific reference Figures 14A to 14C Alternative embodiments of the female connector 202 disclosed herein are presented.

[0201] More specifically, alternative embodiments involve a dynamic adjustment mechanism 1412 associated with the female connector 202.

[0202] Figure 14A This is a cross-sectional view of an alternative embodiment of the dynamic mechanism 1412 associated with the first stage 1440 of the female connector 202, wherein it has the same characteristics as the previous one. Figure 10 The same reference numerals are given to the same structural and functional components and assemblies disclosed in Figures 11, 12 and 13.

[0203] The alternative dynamic mechanism 1412 is provided with an inner shaft 1410, which is made of a radiation-permeable alloy, such as aluminum, and is fixed to the support element 1045 by a first distal transverse pin 1149.

[0204] Bushing 1420 is disposed around inner shaft 1410 at the bottom of base housing resilient element 1150. This bushing allows easy movement between the two parts 1045 and 1410. Furthermore, a first distal transverse pin 1149 is secured by inner shaft 1410 and slides together with it within a groove 1414 provided in sleeve support element 1045. This transverse pin 1149 serves to prevent any accidental disassembly of the support column.

[0205] The terminal portion 1430 of the inner shaft 1410 is shaped to be internally coupled to the base 1020 and presents an enlarged portion through which the proximal second pin 1441, which secures the shaft to the base 1020, passes. Therefore, the dynamic mechanism 1412 associated with the first stage 1440 of this female connector embodiment provides at least 3 mm of length fine-tuning compared to the compression of the spring 1150 and the distal lateral pin 1149 sliding within the groove 1414.

[0206] Even in this embodiment, when the adjusting ring 1035 abuts against the closing collar 1046 of the support element 1045, the turning action of the adjusting ring 1035 can be applied to the external thread portion 1025 of the base 1020, thereby forcing the base 1020 to move toward the support element 1045.

[0207] The maximum extension of this twisting action can be adjusted as needed. Without limiting the applicant's rights, in the preferred embodiment disclosed herein, this maximum extension has been selected as 3 mm, such as... Figure 14B As shown.

[0208] Figure 14C Another cross-sectional view of the first stage 1440 is shown, in which the adjusting ring 1035 is screwed onto the largest portion of the external threaded portion 1025 of the base 1020, while the first distal transverse pin 1149 has reached one end of the groove 1414, pressing the base 1020 and the support element 1045, thereby reducing the overall extension of the strut 200.

[0209] Now, for more specific reference Figures 15A to 15C Alternative embodiments of the female connector 202 of this disclosure are disclosed. More specifically, the alternative embodiments involve a dynamic adjustment mechanism 1512 associated with the female connector 202.

[0210] Figure 15A This is a cross-sectional view of an alternative embodiment of the dynamic mechanism 1512 associated with the first stage 1540 of the female connector 202, wherein it has the same characteristics as the previous one. Figure 10 The same reference numerals are given to the same structural and functional components and assemblies disclosed in Figures 11, 12 and 13.

[0211] As in the preceding embodiments, the ray-permeable shaft end 1010 is closed by a support element 1545 formed as a double sleeve, wherein the main portion is inserted into the shaft end 1010, a collar 1546 abuts against the shaft end, and a protruding portion 1547 slidably supports the interior of the base 1520 of the first stage 1540.

[0212] The alternative dynamic mechanism 1512 is provided with an inner shaft 1510, which is made of a radiation-permeable alloy, such as aluminum.

[0213] The inner shaft 1510 has an end 1530 with a threaded portion that is fixed to the base 1020 of the first stage 1540.

[0214] There is a groove 1542 on the opposite distal end 1570 of the inner shaft 1510, which is axially aligned along the longitudinal extension direction of the shaft 1510.

[0215] The main portion of the support element 1545 has a transverse pin 1548 that passes through a groove 1542 located in an inner shaft near its distal end. During dynamic adjustment, the transverse pin 1548 is guided along the groove 1542.

[0216] A collar 1560 is formed at a predetermined distance from the inner shaft end 1570 to support an elastic element, i.e., a spring 1550, which is held between such a collar 1560 and a transverse pin 1548.

[0217] from Figure 15C As can be understood from the example, when the base 1520 of the first stage 1540 is fully retracted against the collar 1546 of the support element 1545, the pin 1548 is located at one end of the groove 1542 and the spring 1550 is compressed.

[0218] Figure 15A , Figure 15B and Figure 15C The dynamic mechanism features an inner shaft made of aluminum, which is secured to the final female of the support column via a first stage 1560. An elastic element is housed in the distal main portion of a plastic support sleeve 1545, thus allowing for a more robust plastic sleeve due to the increased material in the critical area. This structure and construction help keep the component axially aligned and prevent any accidental bending that may occur.

[0219] In addition, the transverse pin 1548 serves as a mechanical stop for the compression spring 1550 to prevent any accidental disassembly of the strut.

[0220] The embodiments previously disclosed in their various configurations share a common and significant advantage: providing a support that is easy for surgeons to use and highly practical for transport in sterile packaging.

[0221] Using reinforced plastic materials for the connectors and telescopic shafts 210 and 220 reduces the overall weight of the support, and the result is a lighter structure compared to other similar devices in the prior art.

[0222] It should be understood that the specific embodiments described herein are shown by way of illustration and not as a limitation of this disclosure. The main features of this disclosure can be used in various embodiments without departing from the scope of this disclosure. Those skilled in the art will recognize or be able to determine many equivalents of the specific processes described herein using only conventional experimentation. Such equivalents are considered to be within the scope of this disclosure and are covered by the claims.

[0223] When used in conjunction with the word "comprising" in the claims and / or description, the use of the word "a" or "an" may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more." The word "or" as used in the claims is used to mean "and / or," unless explicitly stated that it refers only to alternatives or that the alternatives are mutually exclusive, although this disclosure supports the definition of "and / or" referring only to alternatives. Throughout this application, the word "about" is used to indicate that a value includes variations in the inherent error of the means or method used to determine that value, or variations existing between the objects of study.

[0224] As used in this specification and claims, the words “comprising” (and any form of inclusion, such as “comprising”), “having” (and any form of having, such as “having”), “including” (and any form of inclusion, such as “comprising”), or “containing” (and any form of inclusion, such as “containing”) are inclusive or open-ended and do not exclude additional, unlisted elements or method steps.

Claims

1. An improved externally fixed support (200), comprising: - An elongated body, including a first hollow tubular shaft (210) and a second hollow tubular shaft (220); - Opposite connector (201; 202), respectively coupled to the end of the first hollow tubular shaft (210) or the end of the second hollow tubular shaft (220) and each includes a ball socket joint; - The inner diameter of the second hollow tubular shaft (220) is slightly larger than the outer diameter of the first hollow tubular shaft (210) so as to accommodate the first hollow tubular shaft (210) in a sliding and telescopic manner. - The first hollow tubular shaft (210) and the second hollow tubular shaft (220) of the support (200) are made of a synthetic, radiation-permeable plastic material; - A clamping element is disposed near the overlapping end of the first hollow tubular shaft (210) and the second hollow tubular shaft (220) to provide a quick clamping action to prevent the first hollow tubular shaft (210) from sliding within the second hollow tubular shaft (220). The clamping element is a clamping band (204). - A manually operated fixing element acts on the clamping element to apply the rapid clamping action; the manually operated fixing element is a threaded connection. Its characteristic is that it further includes: A sleeve (230) is disposed around the central portion of the support column (200), wherein the first hollow tubular shaft (210) and the second hollow tubular shaft (220) overlap at the central portion; and The clamping band (204) surrounds the sleeve and includes opposing and facing clamping portions (205; 206), which are connected by the threaded connector.

2. The improved external fixing support (200) according to claim 1, wherein, The threaded connector is a clamping bolt (260), which passes through the through hole (211) of the clamping portion (205; 206) and is accommodated in the nut (207).

3. The improved external fixing support (200) according to claim 2, wherein, The clamping bolt (260) has a head (261) coupled to a removable manual butterfly wrench (250).

4. The improved external fixing support (200) according to claim 2, wherein, The sleeve (230) is constructed with a first sleeve portion (225) and a second sleeve portion (235), the inner diameter of the first sleeve portion substantially corresponding to the outer diameter of the first hollow tubular shaft (210), and the inner diameter of the second sleeve portion substantially corresponding to the outer diameter of the second hollow tubular shaft (220); the clamping band (204) surrounds the second sleeve portion (235).

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