Surgical instruments for implanting primary and secondary elements
The lattice support structure effectively redistributes load from degenerated subchondral bone to healthy cortical bone, reducing pain and deformation while minimizing surgical invasiveness.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-12-23
- Publication Date
- 2026-03-13
AI Technical Summary
Existing implantable devices for degenerated subchondral bone fail to effectively redistribute load from affected areas to healthy bone regions, leading to persistent pain and deformation, and require invasive surgical procedures.
A lattice support structure comprising rod-shaped main elements and filamentous secondary elements intersecting obliquely, which are implanted minimally invasively to distribute load to healthy cortical bone, forming a lattice that absorbs and redistributes stress.
Reduces peak load on degenerated bone by over 30% and deformation by over 20%, significantly alleviating pain and requiring minimal bone removal, thus reducing invasiveness and promoting faster recovery.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to the field of implantable medical devices, particularly to a lattice support structure for one or more degenerated portions of the subchondral bone of a human or animal joint.
Background Art
[0002] Arthritis is a degenerative disease accompanied by pain symptoms caused by the progression of wear of the cartilage covering the ends of the bones and joints. This is one of the most common causes of joint pain, especially in the population over 50 years old, and most frequently occurs in joints that bear more load, such as the knee, hip joint, cervical spine, and lumbar spine. However, it may also occur in other joints such as the joints of the hand and shoulder.
[0003] The pain of arthritis mainly originates from the bone tissue and secondarily from the synovium covering one side of the joint surface of the joint capsule. These tissues, unlike the avascular and aneural articular cartilage, are innervated and have developed blood vessels. In the natural course of arthritis, the mineral and protein components of the bone tissue are lacking, and as a result, the mechanical strength and elasticity are lost. Among the subchondral bone and the bone ends, that is, the bone layer under the articular cartilage, is exposed to mechanical stress exceeding its strength, deformed beyond the physiological threshold, and as a result, the nociceptive nerve fibers are activated and pain occurs.
[0004] In fact, this is the exacerbation of pain, not the functional limitation of joint movement due to bone deformation caused by arthritis, which determines the need for surgery in most cases.
[0005] To date, total joint replacement is the gold standard for treating the most severe arthritis. By replacing the deformed joint surface with metal artificial components, an implant fixation rate of more than 75% after 25 years in the case of hip joint replacement and more than 90% after 20 years in the case of knee joint replacement is guaranteed (Evans JT; Lancet 2019).
[0006] The first major challenge associated with prosthesis surgery is the incidence of postoperative complications. Scientific literature reports postoperative complications in over 15% of cases, and 10% of these cases require reoperation (David Figueroa, Arthroplasty today 2019).
[0007] A second significant challenge highlighted by scientific literature is the considerable proportion of patients who continue to report pain and functional limitations after prosthesis implantation, even when no other identifiable cause exists—up to 34% in the case of knee implants. The causes of persistent pain after prosthesis surgery are diverse and, in some cases, cannot be accurately identified.
[0008] However, particularly from the perspective of the second important challenge emphasized above, improvements in the performance of artificial joints are hindered on the one hand by the design of the prosthesis and on the other hand by the materials used.
[0009] The design of artificial joints is based on geometric compromises extrapolated from anatomical and computational studies performed on anatomical samples, and is therefore a standard design that takes into account the mean variation of the sample under study. Regardless of sample size, it is inevitable that each individual's artificial joint represents an adaptation to the population mean.
[0010] Regarding materials, artificial joints are made of metallic materials, usually steel or titanium alloy, and are fixed into the epiphysis. The fixation of metal into the epiphysis creates a composite material with mechanical properties different from, and even incompatible with, natural articular surfaces. In reality, natural bone has a decreasing hardness gradient and increasing elasticity gradient from the dense cortical bone of the diaphysis through the cancellous bone-dominant metaphysis to the cartilage covering the articular surface. The weight of metallic artificial components is at least an order of magnitude heavier than the weight of the affected cartilage and bone replaced by the artificial component. Furthermore, they have higher hardness and lower elasticity than the subchondral bone, epiphysis, and articular cartilage, thus creating an antiphysiological composite material.
[0011] A more recently introduced method in orthopedics is so-called subchondroplasty, which involves reinforcing degenerated subchondral bone with the injection of composite materials, such as tricalcium phosphate cement, into the bone. This treatment is primarily indicated for the treatment of bone edema and not for the treatment of osteoarthritis. Subchondroplasty is not effective in reducing the load on the subchondral bone, nor is it effective in reducing stress in the load-bearing area of the subchondral bone.
[0012] Several methods and devices have also been developed that can be implanted into degenerated subchondral bone to reduce arthritis pain.
[0013] For example, RU2161929C1 discloses a surgical method involving the formation of a series of curved grooves along the subcortical femoral condyle at the prominence of the articular bone cyst site. A porous nickel-titanium plate of the corresponding shape and size is introduced into each groove. The cartilage can also be stabilized by inserting screws from the side of the articular surface to fix the cartilage to the plate.
[0014] US2011 / 125264A1 discloses a set of instruments and methods for treating degenerated joint bone tissue.
[0015] This document specifically envisions the use of a device that can be implanted in the subchondral bone to support an area affected by osteoarthritis. This device can take various shapes depending on the insertion area, the shape of the bone defect, and / or the mode of insertion, for example, having a substantially plate-like body or a straight or curved rectangular body. Insertion of the implantable device into the bone can be performed using a guidewire or a special surgical guide instrument.
[0016] The use of this device can be further enhanced by injecting bone cement or other carriers containing biological agents into the area surrounding the implant.
[0017] WO2017 / 091657A1 discloses an implantable orthopedic instrument for treating articular bone, comprising a first region having an overall cylindrical shape, having an articular end, a mating end facing a second region of the instrument, and a side wall extending between the two ends, the first region further comprising an axially extending central opening configured to engage with an insertable instrument.
[0018] The device comprises a second region having a mating end with the first region described above, an anterior end on the opposite side, and a side wall extending between the mating end and the anterior end. The side wall of the second region of the device is provided with threads configured to facilitate penetration into the subchondral articular bone during implantation of the device.
[0019] US2012 / 185044A1 illustrates a series of implantable devices configured to provide structural cushioning support to degenerated subchondral bone adjacent to a joint.
[0020] The device may be fabricated in the form of a shaped plate, possibly with holes. In other designs, the device may comprise an elongated base plate and a series of tapered support elements extending laterally from both sides of the base plate. In yet another form, the system may consist of a series of separate support elements of various geometric shapes (e.g., plate-like, tubular, or circular elements) configured to be modularly inserted into the subchondral bone.
[0021] The disclosed instrument has one or more holes or slots for accommodating guide pins to facilitate insertion of the instrument into the subchondral bone.
[0022] US2013 / 035561A1 also discloses methods and devices for treating arthritis-related joint pain. Among the various treatments described, this document also envisions mechanically reinforcing the subchondral region of osteoarthritis-affected bones with in-situ reinforcing members. These elements can be implanted or fixed to bone without constraint from the bone. This document generally discloses that the reinforcing members can have a variety of shapes, for example, they can be fabricated as substantially planar or elongated members.
[0023] The various documents on the prior art described above instruct how to support the arthritis portion of the subchondral bone by inserting elements of various shapes near the bone defect to bear part of the load on the bone defect.
[0024] However, the applicant has noticed that none of the devices disclosed in the above-mentioned publicly available technical documents can perform an effective "overall" redistribution of stress, such as transferring a portion of the load acting on the affected bone area to the healthy bone area. The disclosed devices act only locally, distributing the load to an area close to the defect and therefore almost entirely composed of damaged bone tissue, and thus cannot substantially reduce the deformation occurring in the affected bone, and consequently cannot reduce the pain felt by the patient. However, it has been found that when the bone defect extends to the surrounding area, such inserted devices need to be replaced with larger and / or differently shaped devices.
[0025] However, the applicant noted that implanting more complex shapes and larger dimensions of instruments, such as plate-shaped, cylindrical, or those with protruding support elements, requires particularly invasive surgical insertion procedures, which involve the removal of a significant portion of the patient's natural bone to create space for the instrument. However, in these cases, the surgical procedures for preparing the bone and inserting the support elements are also complex and difficult to replicate. [Overview of the project] [Problems that the invention aims to solve]
[0026] Thus, it would be advantageous if the load on the degenerated subchondral bone portion could be redistributed to a larger bone area than is possible with prior art devices, particularly by transmitting some of these loads to healthy bone regions, without increasing or even decreasing the invasiveness of the implantable device.
[0027] Thus, the technical problem underlying the present invention is to effectively reduce the load acting on the degenerated subchondral bone portion through the use of a minimally invasive device that can be implanted by medical personnel in a simple procedure.
Means for Solving the Problem
[0028] Thus, in a first aspect, the present invention is a lattice support structure for one or more degenerated portions of the subchondral bone of the bone end of a human or animal joint, comprising: - at least one rod-shaped substantially linear rigid main element configured to be received within the bone end and extending at least partially through the degenerated portion of the subchondral bone along a main extension direction; - a plurality of substantially linear filamentous secondary elements configured to be received within the bone end and extending at least partially through the degenerated portion of the subchondral bone along a secondary extension direction; wherein a first secondary element is configured to extend along a first secondary extension direction, a second secondary element is configured to extend along a second secondary extension direction, and the first secondary extension direction and the second secondary extension direction are obliquely intersecting with each other; at least one main element has a first transverse dimension that is greater than a second transverse dimension of the secondary elements. relates to a lattice support structure.
[0029] Advantageously, at least one main element and the secondary elements are configured to reach and at least partially intersect the cortical bone portion of the bone end at both ends.
[0030] In this specification and the appended claims, “degenerated bone portion” (hereinafter sometimes referred to as “degenerated bone portion”) or similar expression means affected bone tissue that has lost its physiological, mechanical, and elastic properties due to arthritis or a similar degenerative disease.
[0031] In this specification and the appended claims, “cortical bone portion,” “cortical bone,” and similar expressions mean the bone layers consisting mainly of dense, layered bone tissue that make up the outer cortex of the articular epiphysis, in which the lattice structure of the present invention is intended.
[0032] In this specification and the appended claims, the term “oblique” means a direction that is not parallel to or coincides with the second direction.
[0033] In this specification and the appended claims, the terms “proximal” and “distal” are used to indicate, respectively, the locations near and far from the epiphysis where the lattice structure of the present invention is assembled.
[0034] In this specification and the appended claims, expressions such as “lateral” and “lateral direction” used with respect to an elongated body or element indicate a direction substantially perpendicular to the reference direction in which the body or element primarily extends.
[0035] In this specification and the appended claims, the terms “above,” “below,” “top,” and “bottom” refer to the relative positions of elements of a grid structure oriented as shown in an oblique view (e.g., Figures 1 and 5), a front view (e.g., Figures 3 and 6), or a side view (e.g., Figure 4).
[0036] In this specification and the appended claims, “direction of unfolding the main body of the template” means a direction in which the main body of the template includes curves and / or a number of linear segments passing from one free end to the other free end.
[0037] In this specification and the appended claims, “unfolding surface of the main body of the template” means a plane containing the unfolding direction of the main body of the template, such a plane substantially coincides with the horizontal plane in the perspective views of Figures 10 and 11.
[0038] In a second embodiment, the present invention relates to a lattice support structure for one or more degenerated portions of subchondral bone at the epiphysis of a joint in a human or animal, - At least one rod-shaped, substantially linear, rigid principal element housed within the epiphysis, extending at least partially through the degenerated portion of the subchondral bone along the principal direction of extension, - Multiple substantially linear, thread-like accessory elements housed within the epiphysis, extending at least partially through the degenerated portion of the subchondral bone along the accessory extension direction, Equipped with, The first sub-element extends along the first sub-extension direction, the second sub-element extends along the second sub-extension direction, and the first and second sub-extension directions intersect each other at an angle. At least one principal element has a first transverse dimension that is greater than the second transverse dimension of the secondary element. At least one principal and minor element reach and at least partially intersect the cortical bone portion of the epiphysis at both ends. Regarding lattice support structures.
[0039] In relation to the first two aspects of the present invention, the applicant has found that, by using at least one rigid principal element cooperating with a series of substantially filamentous sub-elements to form a lattice structure as defined above, a beneficial effect is achieved in reducing the load on the degenerated portion of the subchondral bone.
[0040] At least one rigid principal element, having a linear, rod-like shape with a transverse dimension larger than that of the secondary elements, provides mechanical stability to the structure and helps support the load of the surrounding degenerated bone.
[0041] The thread-like sub-elements extending along the oblique direction in the bone portion form an actual lattice substructure with particularly strong support "mesh," which elastically absorbs stress caused by loads acting on the joint and can effectively redistribute it throughout the subchondral bone of the epiphysis and the entire volume within the epiphysis where the lattice structure is embedded.
[0042] Advantageously, since both the principal and secondary elements extend to intersect with the cortical portion of the epiphysis at both ends, the lattice structure thus formed rests on the cortical portion, which is denser, more rigid, and therefore stronger than the cancellous bone that constitutes the subchondral region of the articular joint.
[0043] This contact with the cortex allows the load to bypass the degenerated cancellous bone in the mesophyllous and subchondral regions of the epiphysis, be transferred to the dense, healthy cortical bone, and then redistributed to the healthy subchondral bone, thus providing optimal structural support.
[0044] In practice, the applicant has experimentally verified that the lattice structure of the present invention can reduce the peak load acting on the degenerated joint bone portion by more than 30%. The reduction in load achieved by the structure according to the present invention can reduce the deformation of the degenerated bone portion by more than 20%, and the level of deformation occurring in the degenerated subchondral bone can be lowered below the physiological threshold. The reduction in load and deformation leads to a significant reduction (or even elimination) of pain felt by the patient when load is applied to the joint again, for example, when the patient stands up from a sitting or lying position, or when walking, if the joint in question is the knee or hip joint.
[0045] Furthermore, the lattice structure of the present invention is particularly lightweight and requires minimal installation space, and as a result does not require the removal of a significant portion of bone for its assembly. Therefore, it has significant advantages in terms of minimal invasiveness, preservation of natural tissue, and postoperative recovery of the patient.
[0046] In a third aspect, the present invention is a kit of components for assembling a lattice support structure for one or more degenerated portions of subchondral bone at the epiphysis of a joint in a human or animal, - At least one rod-shaped, substantially linear, rigid principal element, - A plurality of substantially linear, thread-like sub-elements, including the first sub-element and the second sub-element, - A surgical template comprising an elongated main body and at least one pin having a fixing member for at least one main element at one end thereof, Includes, At least one pin is configured to extend along the principal extension direction of at least one principal element within the degenerated portion of the subchondral bone when in use, and the principal body comprises a first secondary hole defining a first secondary extension direction of a first secondary element and a second secondary hole defining a second secondary extension direction of a second secondary element, the first and second secondary extension directions being oblique to each other. At least one principal element has a first transverse dimension that is greater than the second transverse dimension of the secondary element. At least one principal and minor element are configured such that at both ends they reach and at least partially intersect the cortical bone portion of the epiphysis. Regarding the kit.
[0047] A kit of components according to a third aspect of the present invention enables the simple and precise assembly of a lattice support structure, the advantages of which have been outlined above in relation to the first two aspects of the present invention.
[0048] In a fourth aspect, the present invention relates to a template assembly having an elongated main body comprising at least one fixing member configured to cooperate with at least one corresponding fixing seat of at least one rod-shaped, substantially linear, rigid main element.
[0049] The main body of the template comprises a first sub-through hole and a second sub-through hole configured to accommodate a filamentous, substantially linear first sub-element and a second sub-element, wherein the first sub-hole defines a first sub-extension direction of the first sub-element, and the second sub-hole defines a second sub-extension direction of the second sub-element, and the first and second sub-extension directions are oblique to each other.
[0050] As outlined in relation to the third and fourth aspects of the present invention, the provision of surgical templates and template assemblies makes it possible to easily and quickly define a secondary extension direction along which secondary elements are inserted, starting from a reference consisting of the extension direction of the main elements, up to the point where the template is fixed, thereby enabling the assembly of a clearly defined and geometrically accurate lattice structure.
[0051] This disclosure further relates to a method for assembling a lattice support structure for a degenerated subchondral bone portion of an epiphysis of a joint in a human or animal, - A step of arranging at least one rod-shaped, substantially linear, rigid principal element, - The steps of arranging a plurality of substantially linear, thread-like sub-elements, including a first sub-element and a second sub-element, Here, the at least one main element has a first transverse dimension that is larger than the second transverse dimension of the sub-element. - The step of arranging the template assembly according to the fourth aspect of the present invention described above, - The steps of forming at least one receiving seat for at least one principal element passing through the degenerated bone portion by bone coring, Here, the receiving seat extends across the epiphysis and has access portions at both ends that face the cortical bone portion of the epiphysis. - The step of inserting at least one main element into at least one receiving seat, - The steps of constraining the template assembly to at least one main element by fixing at least one fixing member of the template to at least one corresponding fixing seat of at least one main element, and accessing at least one fixing seat through one of the access portions of the receiving seat, - The steps include inserting the sub-element into the degenerated subchondral bone using a drill tool, and sliding the sub-element through the sub-hole in the template, - The steps of removing the template assembly by releasing at least one fixing member from at least one corresponding fixing seat of at least one main element, Regarding methods including
[0052] This disclosure further relates to a method for assembling a lattice support structure for a degenerated subchondral bone portion of an epiphysis of a joint in a human or animal, - A step of arranging at least one rod-shaped, substantially linear, rigid principal element, - The steps of arranging a plurality of substantially linear, thread-like sub-elements, including a first sub-element and a second sub-element, Here, the at least one main element has a first transverse dimension that is larger than the second transverse dimension of the sub-element. - A step of positioning a surgical template comprising an elongated main body and at least one pin having a fixing member for at least one main element at one end thereof, Here, at least one pin is configured to extend along the principal extension direction of at least one principal element within the degenerated portion of the subchondral bone when in use, and the principal body comprises a first secondary hole defining a first secondary extension direction of a first secondary element and a second secondary hole defining a second secondary extension direction of a second secondary element, the first and second secondary extension directions being oblique to each other. - The steps of forming at least one receiving seat for at least one principal element passing through the degenerated bone portion by bone coring, Here, the receiving seat extends across the epiphysis and has access portions at both ends that face the cortical bone portion of the epiphysis. - The step of inserting at least one main element into at least one receiving seat, - The steps of constraining the template to at least one main element by fixing a fixing member for the template's pins to a fixing seat provided at the end of at least one main element, and accessing the end through one of the access portions of the receiving seat, - The steps include inserting the sub-element into the degenerated subchondral bone using a drill tool and passing the sub-element through the sub-hole in the template, - The step of removing the template by releasing the pins from the edge of at least one principal element, Regarding methods including
[0053] The method described above makes it possible to obtain a lattice support structure for one or more degenerated portions of subchondral bone, having all the advantages outlined above in relation to a first aspect of the present invention.
[0054] In particular, this method enables the assembly of a lattice support structure with high precision and simplicity in positioning the main and sub-elements by aligning with pins or holes provided in a template that defines the extension direction of each element.
[0055] Furthermore, the disclosed method is minimally invasive to the patient because it requires the removal of a minimal portion of degenerated bone tissue, which essentially corresponds to the removal of a bone core extracted to form a seat for the main element and a minimal portion of bone removed during drilling to insert the secondary element.
[0056] The present invention is presented in one or more of the embodiments or preferred features described below, which can be combined in any way that is preferable in accordance with the application requirements.
[0057] Preferably, the first sub-extension direction of the first sub-element lies within the first plane.
[0058] Preferably, the second sub-extension direction of the second sub-element lies in the second plane.
[0059] Preferably, the first plane and the second plane are substantially parallel to each other.
[0060] Preferably, the first sub-extension directions of the first sub-elements are substantially parallel to each other.
[0061] Preferably, the second sub-extension directions of the second sub-elements are substantially parallel to each other.
[0062] Preferably, the first sub-element and the second sub-element are substantially aligned or in contact at the first intersection of the first sub-extension direction and the second sub-extension direction.
[0063] Preferably, the first sub-extension direction of the first sub-element is substantially perpendicular to the second sub-extension direction of the second sub-element.
[0064] This sub-element configuration is optimal from the standpoint of load redistribution and is the easiest to implement during the assembly of the grid structure.
[0065] Preferably, the main body of the template includes a central portion extending between two ends or free ends.
[0066] Preferably, the ends or free ends extend from the same side of the template relative to the central portion.
[0067] Preferably, the main body of the template is shaped to at least partially surround the epiphysis.
[0068] Preferably, the main body of the template is substantially C-shaped.
[0069] Preferably, the unfolding direction of the main body of the template is within the unfolding plane.
[0070] Preferably, the main body of the template is substantially flat, provided that the thickness in the direction traversing the unfolding surface is ignored.
[0071] Preferably, the first plane is substantially parallel to the unfolding plane of the main body of the template.
[0072] Preferably, the second plane is substantially parallel to the unfolding plane of the main body of the template.
[0073] Preferably, the third plane is substantially parallel to the unfolding plane of the main body of the template.
[0074] Preferably, the fourth plane is substantially parallel to the unfolding plane of the main body of the template.
[0075] Preferably, the main extending direction along which at least one pin of the template extends is parallel to the unfolding plane of the main body of the template.
[0076] Preferably, the main body of the template comprises a first straight section and a second straight section extending substantially perpendicular to the first straight section.
[0077] In some embodiments, the first straight section is defined in the center of the main body of the template.
[0078] In some embodiments, the second straight section is defined at one of the free ends of the main body of the template.
[0079] In some embodiments, the first and second straight sections are defined at the free ends of the main body of the template, respectively.
[0080] In some embodiments, the main body of the template includes a third straight section extending substantially perpendicular to the first straight section and substantially parallel to the second straight section.
[0081] Preferably, the first sub-hole is provided in the first straight section of the template, and the second sub-hole is provided in the second straight section of the template.
[0082] Preferably, the first and second sub-holes further extend in directions that traverse the first and second straight sections of the template, respectively.
[0083] In some embodiments, at least one pin is provided on a first straight section of the main body of the template.
[0084] Preferably, at least one pin of the template extends substantially parallel to the first sub-hole.
[0085] In some embodiments, the sub-elements further include a third sub-element configured to extend along a third sub-extension direction that intersects obliquely with a first sub-extension direction and / or a second sub-extension direction.
[0086] The presence of sub-elements of this third group, which has a third orientation relative to the first two groups, further strengthens the lattice structure and allows for a more effective redistribution of stress acting on the degenerated portion of the subchondral bone, thereby distributing the load on the degenerated portion of the subchondral bone.
[0087] Preferably, the third secondary extension direction lies in a third plane substantially parallel to the first and / or second planes in which the first and second extension directions exist, respectively.
[0088] Preferably, the third extension direction is oriented at approximately 45° with respect to the first sub-extension direction and / or the second sub-extension direction.
[0089] This configuration is particularly advantageous when the first sub-extension direction and the second sub-extension direction are orthogonal to each other.
[0090] When a third sub-element is present, the sub-elements also preferably include a fourth sub-element configured to extend along a third sub-extensioning direction and a fourth sub-extensioning direction oblique to the first and / or second sub-extensioning directions.
[0091] Preferably, the fourth sub-extension direction lies in a fourth plane substantially parallel to the third plane in which the third sub-extension direction lies, and to the first plane and / or the second plane in which the first and second sub-extension directions lies, respectively.
[0092] Preferably, the third sub-element and the fourth sub-element are substantially aligned or in contact at the second intersection of the third sub-direction and the fourth sub-direction.
[0093] By providing third and fourth sub-elements extending in mutually oblique directions, it becomes possible to form a second "mesh" substructure separate from the first substructure formed by the first and second sub-elements. This allows for the parallel redistribution of stress to two separate flat regions of the epiphysis.
[0094] Preferably, the fourth sub-extension direction is perpendicular to the third sub-extension direction.
[0095] Furthermore, the fourth extension direction is preferably oriented at approximately 45° with respect to the first sub-extension direction and / or the second sub-extension direction.
[0096] In this case, preferably, the main body of the template includes a third sub-hole that defines the third sub-extension direction of the third sub-element and a fourth sub-hole that defines the fourth sub-extension direction of the fourth sub-element, and the third sub-extension direction and the fourth sub-extension direction are oblique to each other.
[0097] In some embodiments, a third sub-hole is provided in a first straight section of the template, and a fourth sub-hole is provided in a second straight section of the template that extends substantially perpendicular to the first straight section of the template.
[0098] Preferably, the third and fourth sub-holes extend in directions that traverse the first and second straight sections of the template, respectively.
[0099] Preferably, in this case, at least one pin of the template extends at an angle of about 45° with respect to the third and fourth sub-holes of the template.
[0100] In some embodiments, the main body of the template includes a connecting portion extending between a first straight section and a second straight section.
[0101] Preferably, the connecting portion is oriented at approximately 45° with respect to the first and second straight portions of the template.
[0102] In some embodiments, at least one pin is located on the connection point of the main body of the template.
[0103] Preferably, the principal extension direction of at least one principal element is substantially perpendicular to the second secondary extension direction of the first sub-element.
[0104] Preferably, the first secondary direction coincides with the axis of the first secondary hole.
[0105] Preferably, the second secondary direction coincides with the axis of the second secondary hole.
[0106] Preferably, the third secondary direction coincides with the axis of the third secondary hole.
[0107] Preferably, the fourth secondary direction coincides with the axis of the fourth secondary hole.
[0108] Preferably, the template comprises a first fixing member configured to cooperate with a corresponding first fixing seat of a rod-shaped, substantially linear, rigid first principal element, and a second fixing member configured to cooperate with a corresponding second fixing seat of a rod-shaped, substantially linear, rigid second principal element.
[0109] Preferably, the template includes a first pin having a first fixing member at its proximal end.
[0110] Preferably, the first pin is substantially parallel to the unfolding surface of the main body of the template.
[0111] Preferably, the template includes a second pin having a second fixing member at its proximal end.
[0112] Preferably, the second pin is substantially parallel to the unfolding surface of the main body of the template and substantially parallel to the first pin.
[0113] In some embodiments, the template assembly according to a fourth aspect of the present invention further comprises a first filamentous, substantially linear sub-element inserted into a first sub-hole.
[0114] In some embodiments, the template assembly according to a fourth aspect of the present invention further comprises a second filamentous, substantially linear sub-element inserted into a second sub-hole.
[0115] In some embodiments, the template assembly according to a fourth aspect of the present invention further comprises a third filamentous, substantially linear sub-element inserted into a third sub-hole.
[0116] In some embodiments, the template assembly according to a fourth aspect of the present invention further comprises a fourth thread-like, substantially linear sub-element inserted into a fourth sub-hole.
[0117] A pre-assembled template assembly, in which the sub-elements are already inserted into the sub-holes of the template and supplied to the medical staff, is particularly advantageous because it saves time during surgical procedures and avoids potential errors in the relative positioning and attachment of the sub-elements on the template.
[0118] Preferably, at least one principal element has a substantially circular cross-section, and the first transverse dimension of at least one principal element is, in such cases, the first diameter.
[0119] Preferably, the sub-element further has a substantially circular cross-section, and the second transverse dimension of the sub-element is, in such cases, the second diameter.
[0120] For example, the secondary element is Kirschner steel wire.
[0121] Preferably, the first diameter of at least one main element is 3 to 10 mm, more preferably 4 to 8 mm.
[0122] Preferably, the second diameter of the sub-element is 0.3 to 2 mm, more preferably 0.8 to 1.6 mm.
[0123] Preferably, the ratio of the first diameter of at least one principal element to the second diameter of a secondary element is 1.5 to 34, more preferably 2.5 to 10.
[0124] Preferably, the sub-element is screwed into the bone at at least one insertion end.
[0125] Alternatively, or in addition, the secondary element is also screwed into the bone at the end opposite to the insertion end.
[0126] The threads allow for actual fixation to the cortical bone portion and help stabilize the position of the sub-elements within the lattice structure.
[0127] In a preferred embodiment, at least one main element comprises a tubular body.
[0128] The shape of this main element allows for the creation of a receiving seat in the subchondral bone in a manner easily accessible to medical staff through bone coring surgery.
[0129] Preferably, in this case, the first diameter of at least one principal element corresponds to the outer diameter of the tubular body.
[0130] Preferably, the tubular body of at least one main element is provided with multiple through-openings.
[0131] As will become clear from the following explanation, the presence of openings in the tubular body allows the principal elements to interact with the secondary elements, giving greater stability to the lattice structure. Furthermore, the presence of such openings stimulates bone to regrow through the openings into the lumen of the principal elements, promoting osseointegration and the grafting of removed bone volume.
[0132] In this case, preferably, the secondary extension direction of the secondary element intersects with the primary extension direction of at least one primary element. Therefore, at least a portion of the secondary element is preferably configured to extend through a through-opening in the tubular body of the corresponding at least one primary element.
[0133] In this case, the principal and secondary elements are interconnected, making the lattice structure more robust and stable.
[0134] In some embodiments, at least one principal element includes a first principal element configured to extend along a first principal extension direction and a second principal element configured to extend along a second principal extension direction.
[0135] The addition of further major elements can provide greater structural support to the degenerated subchondral bone, strengthening the structure and providing further possible interconnections for the minor elements.
[0136] More preferably, the first principal direction and the second principal direction are substantially orthogonal to each other.
[0137] Preferably, the first main extension direction of the first main element intersects with the second main extension direction of the second main element.
[0138] In such cases, the second main element is preferably configured to extend through a through-opening in the tubular body of the corresponding first main element.
[0139] In this case, the second principal element has a cross-section having a third diameter smaller than the first principal element, in particular, that matches the size of the opening in the first principal element into which it is inserted.
[0140] In this configuration, the opening of the first main element is advantageously used to connect the second main element to form a more robust structural assembly of the main elements, providing greater support to the degenerated subchondral bone.
[0141] Preferably, at least one main element is provided at one end with a fixed seat for the surgical template described above in relation to a second aspect of the present invention.
[0142] The aforementioned fixed seat portion is preferably configured to cooperate with the corresponding fixing member of the template.
[0143] More preferably, the fixing seat portion of at least one main element is provided with a screw hole, and the fixing member of the template is provided with a corresponding screw member.
[0144] In some embodiments, a fixation element may be provided in which one or both ends of the sub-element are fixed to the cortical bone portion.
[0145] For example, such a fixing element may include a locking band positioned around the end of a sub-element extending from the cortical bone portion.
[0146] In this case, the assembly method further includes the step of fixing one or both ends of each sub-element to the cortical bone portion by applying the fixing element.
[0147] When at least one main element is configured as a tubular element, it can be advantageously used as a carrier for a substance or material to promote bone regrowth in situ.
[0148] For example, in a preferred embodiment, the lumen of at least one main element contains a filler therein, and in a preferred embodiment, the filler is the patient's autologous bone graft in which the lattice structure is intended.
[0149] In this case, the tissue inserted into the main element can be the same tissue that is initially removed from the degenerated bone portion by bone coring to create a receiving seat for the main element.
[0150] Alternatively, the filler can be an allogeneic bone graft or an artificial bone graft.
[0151] In all of the above cases, the patient's own stem cells and / or growth factors can be supplemented with fillers to promote bone regrowth.
[0152] Preferably, at least one main element and / or sub-element is made of one or more materials selected from titanium, steel, tantalum, ceramic materials, polymer materials including composite polymer materials, ceramic materials including composite ceramic materials, carbon fiber, and graphene.
[0153] In some embodiments, at least one principal and / or secondary element is configured to transmit regenerative stimuli to degenerated portions of subchondral bone when exposed to one or more conditions selected from electric current, static magnetic field, and / or pulsed magnetic field, ultrasound, and heat.
[0154] These practices may further contribute to reducing patients' perception of nociceptive nerve stimulation.
[0155] Preferably, the epiphysis is selected from the epiphysis of the knee joint, hip joint, shoulder joint, ankle joint, foot joint, and vertebral body, more preferably from the epiphysis of the knee joint and hip joint, and more preferably from a part of the knee joint.
[0156] When the joint in question is the knee, the epiphysis from which the lattice structure is assembled is preferably selected from the tibial plateau, the distal femur, and the patella, and more preferably the tibial plateau.
[0157] Preferably, the first and second planes on which the first and second sub-extension directions of the first and second sub-elements of the aforementioned lattice structure exist, respectively, are substantially perpendicular to the longitudinal axis of the bone to which the epiphysis belongs.
[0158] When the affected joint is the knee and the epiphysis is the tibial plateau, the first and second planes substantially traverse the epiphysis.
[0159] Preferably, the components of the lattice structure assembly kit according to the present invention are patient-specific.
[0160] Therefore, the present invention preferably assumes an ad hoc definition of the configuration of the grid structure with respect to the dimensions and number of components of the assembly kit, and the position of the components during assembly.
[0161] Alternatively, a kit of parts can be created containing a standardized number and size of various components.
[0162] Preferably, the disclosed assembly method includes a preliminary step of identifying the degenerated subchondral bone portion within the epiphysis.
[0163] Preferably, the step of identifying the degenerated bone portion includes analyzing the load acting on the subchondral bone under known loading conditions.
[0164] For example, if the epiphysis is the tibial plateau of the knee joint, the known load-bearing situation could be the distribution of load acting on the tibial plateau during a constant gait of a subject with a known body weight.
[0165] Preferably, the step of identifying the degenerated bone portion further includes defining a three-dimensional model of the load acting under known load conditions, such as a CAD model, from the patient's diagnostic images, such as CT or magnetic resonance imaging.
[0166] Preferably, the step of identifying the degenerated bone portion further includes analyzing the three-dimensional model by finite element analysis (FEM).
[0167] Preferably, the disclosed assembly method further includes the step of modeling the components of the lattice structure based on evidence from FEM analysis.
[0168] Further features and advantages of the present invention will become more apparent from the following detailed description of certain preferred embodiments of the invention, with reference to the accompanying drawings. Various features in individual configurations can be combined as needed. [Brief explanation of the drawing]
[0169] [Figure 1] This is a schematic perspective view of a lattice support structure according to the first embodiment of the present invention, assembled at the epiphysis. [Figure 2] Figure 1 is a schematic top view of the lattice structure. [Figure 3] Figure 1 is a schematic front view of the lattice structure. [Figure 4] This is a schematic side view of the lattice structure shown in Figure 1. [Figure 5] This is a schematic perspective view of a lattice structure according to a second embodiment of the present invention, assembled at the epiphysis. [Figure 6] Figure 5 is a schematic front view of the lattice structure. [Figure 7] This is a schematic perspective view of a lattice support structure according to a third embodiment of the present invention, assembled at the epiphysis. [Figure 8] This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Figure 9]This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Figure 10] This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Figure 11] This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Figure 12] This figure illustrates the steps of a method for assembling a lattice support structure according to the present invention. [Figure 13] This figure illustrates the steps of a method for assembling a lattice support structure according to the present invention. [Figure 14] This figure illustrates the steps of a method for assembling a lattice support structure according to the present invention. [Figure 15] This figure schematically shows the epiphyseal model used in experimental tests related to the lattice structure of the present invention. [Figure 16] This figure schematically shows the epiphyseal model used in experimental tests related to the lattice structure of the present invention. [Figure 17] This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Figure 18] This figure schematically shows some components of a kit for assembling a lattice support structure according to the present invention. [Modes for carrying out the invention]
[0170] Here, with reference to Figures 1 to 4, a lattice support structure 10 for one or more degenerated portions of the subchondral bone at the epiphysis of a joint in a human or animal is described.
[0171] The lattice structure 10 is assembled, in particular, at the epiphysis E (sometimes abbreviated as epiphysis E), which is the tibial plateau of the knee joint, as shown in the illustrated example.
[0172] The epiphyseal region E includes one or more degenerated portions of subchondral bone, characterized by the presence of bone whose mechanical properties have deteriorated, for example, due to arthritis, and therefore which is unsuitable for bearing weight.
[0173] Various diagrams schematically show the degenerated portion D of the subchondral bone (sometimes abbreviated as degenerated bone portion D). For convenience, degenerated bone portion D is shown only on the articular surface S of the epiphysis E, but it also includes the subchondral bone portion located more than 1 centimeter below the articular surface S.
[0174] The lattice structure 10 comprises rod-shaped, linear, rigid main elements 12 that partially extend within the degenerated bone portion 12 along the main extension direction X.
[0175] In the illustrated example, the main extension direction X is substantially perpendicular to the longitudinal axis A of the bone to which the epiphysis E belongs (shown in Figure 4).
[0176] For example, if the epiphysis E is the tibial plateau, as shown in various drawings, the main extension direction X lies in the plane that transverses the epiphysis E. In particular, in the illustrated lattice structure 10, the main extension direction X corresponds to the anterior-posterior direction, as can be seen more clearly in the side view of Figure 4.
[0177] The main element 12, shown in an enlarged view in Figure 8, preferably comprises a tubular body 14 extending between ends 16, 18 and defining a lumen 20. The tubular body 14 preferably has a circular cross-section with a first outer diameter d1.
[0178] In the illustrated preferred embodiment, the main element 12 further comprises a plurality of through-openings 22 distributed throughout the tubular body 14. The openings 22 are preferably arranged along a linear row 24 extending parallel to the extending direction X of the main element 12, arranged in a 2x2 configuration opposite to the diametrically opposed positions of the tubular body 14, as illustrated.
[0179] The openings 22 belonging to the rows 24 facing each other in the diametrical direction are also preferably aligned in pairs along directions T1 and T2 perpendicular to the main extending direction X. For example, see the pair of openings 22a and 22b aligned in direction T1 and the pair of openings 22c and 22d aligned in direction T2, as shown in Figure 8.
[0180] The main element 12 is inserted into a corresponding receiving seat 26, which is fabricated by bone coring at the epiphysis E of the degenerated subchondral bone D. The receiving seat 26 for the main element 12 shown in Figure 1 is, in particular, a penetrating seat that extends to the epiphysis E along the extending direction X of the main element 12. Thus, the receiving seat 26 includes access portions 28, 30 facing the cortical portions C present in the regions of the epiphysis E on both sides with respect to the midline plane of the epiphysis E.
[0181] As described below, the specific positions of the principal elements 12 at the epiphysis E, particularly their orientation in the relative extension direction X, are selected according to a patient-specific assessment, followed by the design of the lattice structure 12.
[0182] The length of the main element 12 is pre-selected according to the position of the receiving seat 26 within the epiphysis E, such that both ends 16 and 18 of the main element 14 reach and intersect with the cortical portion C of the epiphysis E. Thus, as illustrated, the ends 16 and 18 of the main element 12 rest on the cortical bone tissue surrounding the access portions 28 and 30 of the receiving seat 26, with the ends 16 and 18 partially extending from there. Note in Figure 4 that the end 16 of the main element 12 is partially covered by the protruding structure of the epiphysis E, while the end 18 extends from the access portion 28 of the receiving seat 26.
[0183] The contact of this main element 12 with the cortex allows the relevant load to bypass the deteriorated cancellous bone tissue of the bone injury site D and be transmitted to the healthy subchondral bone tissue, particularly to the healthy cortical portion C.
[0184] The main element 12 further includes a fixing seat 32 (shown in Figure 8) at its end 18 for surgical templates 52, 152 used in assembling the lattice structure 10. In particular, the fixing seat 32 includes threads (not shown) fabricated on the inner wall of the tubular body 14, which are designed to cooperate with corresponding fixing members 70, 170 of the templates 52, 152, as will be detailed below.
[0185] The lattice structure 10 according to the first embodiment of the present invention, illustrated in Figures 1 to 4, further comprises a plurality of thread-like sub-elements 34.
[0186] Sub-element 34 has a circular cross-section with a second diameter d2, as further illustrated in Figure 7. Sub-element 34 is an elastic element that can bend to a certain extent.
[0187] The second diameter d2 of the sub-element 34 is smaller than the first diameter d1 of the main element 12, and the ratio of the first diameter d1 of the main element to the second diameter d2 of the sub-element 34 is preferably 1.5 to 34, more preferably 2.5 to 10.
[0188] The sub-elements 34 are distributed relative to each other to form an elastic lattice substructure for supporting and redistributing loads.
[0189] In practice, the example shown in Figures 1-4 includes three first sub-elements 34a, 34b, and 34c extending along the first sub-directions Ya, Yb, and Yc, and three second sub-elements 34d, 34e, and 34f extending along the second sub-directions Yd, Ye, and Yf. For simplicity, the sub-extension directions will sometimes be referred to collectively as Y below.
[0190] The first secondary directions Ya, Yb, and Yc preferably extend within the same first plane y1, which is perpendicular to the longitudinal axis A of the bone to which the epiphysis E belongs (shown in Figures 3 and 4). In the illustrated example, the first plane y1 is a plane that substantially transverses the epiphysis E.
[0191] Similarly, the second secondary directions Yd, Ye, and Yf also preferably extend within the same second plane y2, which is perpendicular to the longitudinal axis A of the epiphysis E and substantially parallel to the first plane y1.
[0192] As clearly shown in Figure 2, the first secondary directions Ya, Yb, and Yc are further parallel to each other, and the second secondary directions Yd, Ye, and Yf are parallel to each other.
[0193] In the embodiment shown in Figure 1, the second plane y2 extends slightly below the articular surface S than the first plane y1 (see, for example, Figure 3), and therefore the first sub-elements 34a, 34b, and 34c extend closer to the articular surface S than the second sub-elements 34d, 34e, and 34f. Of course, the reverse configuration can also be considered, where the second plane y2 extends closer to the articular surface S than the first plane y1.
[0194] Advantageously, the first subdirections Ya, Yb, Yc and the second subdirections Yd, Ye, Yf intersect each other obliquely. In other words, the first sub-elements 34a, 34b, 34c and the second sub-elements 34d, 34e, 34f intersect at a series of intersection points 36 (only one is shown in Figures 1-4 for simplification).
[0195] As can be seen more clearly in Figure 3, since the first plane y1 and the second plane y2 are close to each other, the first sub-elements 34a, 34b, 34c and the second sub-elements 34d, 34e, 34f are substantially aligned or, in some cases, in contact at the intersection 36.
[0196] As shown in Figure 1, the configuration of the sub-elements 34 in terms of number and arrangement is determined to produce thickness at the intersection 36 in the degenerated bone portion D. This creates greater elastic support in the most vulnerable bone regions.
[0197] In particular, as can be seen in Figure 2, the first secondary directions Ya, Yb, Yc and the second secondary directions Yd, Ye, Yf are orthogonal to each other.
[0198] Similar to the principal element 12, the length of the secondary elements 34 is also determined based on their positions within the epiphysis E, such that both ends 38, 40 of each secondary element 34 reach and intersect with respect to the midline plane of the cortical portion C of the epiphysis E on both sides, and partially extend beyond the cortical portion C of such epiphysis E.
[0199] In particular, the precise length of the sub-element 34 can be predetermined based on the bone segment into which the sub-element 34 is inserted, or alternatively, when the insertion end reaches the other side of the epiphysis E relative to the insertion end, the excess portion of the sub-element can be removed with a special cutting instrument.
[0200] Therefore, the secondary element 34 also utilizes support on the cortical bone to transfer the load from the damaged area D of the subchondral bone to the healthy subchondral bone and healthy cortical portion.
[0201] Preferably, a thread 42 is provided on the end 40 of the sub-element 34 corresponding to the insertion end of the sub-element 34 into the bone during assembly, as described later. The presence of the thread 42 allows the sub-element 34 to be fixed to the cortical bone portion C when the end 40 reaches the cortical bone portion C during insertion. Such fixation prevents the sub-element 34 from sliding along the sub-extension direction Y.
[0202] Of course, additional threads (not shown) can be provided on the other end 38 of the sub-element 34 to securely fasten it to both opposing cortical portions C.
[0203] The first secondary directions Ya, Yb, and Yc are preferably parallel to the main extension direction X of the main element 12 (see, for example, Figure 4). As a result, the second secondary directions Yd, Ye, and Yf are preferably perpendicular to the main extension direction X of the main element 12.
[0204] More specifically, in the preferred embodiment shown in Figure 1, the second secondary directions Yd, Ye, and Yf intersect with the main element 12. In other words, the second secondary elements 34d, 34e, and 34f extend through the tubular body 14 of the main element 12 and through a pair of openings 22a and 22b (only one pair is shown in Figure 1) which are aligned along the second secondary extension directions Yd, Ye, and Yf.
[0205] As a result, the main element 12 provides additional support points for the second sub-elements 34d, 34e, and 34f, in addition to the aforementioned support for the relative ends 38 and 40 in the cortical bone portion C. Therefore, the interlacing formed between the second sub-elements 34d, 34e, and 34f and the main element 12 greatly stabilizes the lattice structure 10.
[0206] Here, with reference to Figures 5 and 6, a lattice structure 100 according to a second embodiment of the present invention will be described.
[0207] Elements identical or similar to those in the previous embodiment are shown below with reference numerals incremented by 100.
[0208] The lattice structure 100 is further enhanced compared to the lattice structure 10 of the previous embodiment. In practice, it comprises a first principal element 112a and a second principal element 112b extending along the principal extension directions Xa and Xb in both the front-rear and rear directions. For simplicity, the two principal elements may be referred to collectively as 112 below, and the relative principal extension directions may be referred to collectively as X.
[0209] In particular, the secondary extension directions Xa and Xb of the first principal element 112a and the second principal element 112b are aligned with each other in a plane substantially parallel to the longitudinal axis A of the bone to which the epiphysis E belongs. In addition to providing the advantage of increasing the structural robustness of the lattice structure 100, the precision of the assembly of the lattice structure 100 can be further improved by including two principal elements that are arranged in parallel, as will become apparent from the following description of the assembly method with reference to Figures 12 to 14.
[0210] The lattice structure 100 comprises first sub-elements 134a, 134b, and 134c extending along first sub-directions Ya, Yb, and Yc, and second sub-elements 134d, 134e, and 134f extending along second sub-directions Yd, Ye, and Yf. For simplicity, the sub-elements as a whole may be referred to as 134 below, and the relative sub-extension direction as a whole may be referred to as Y.
[0211] Similar to the embodiments described above, the first parallel secondary directions Ya, Yb, and Yc are preferably in a first plane y1 perpendicular to the longitudinal axis A of the bone to which the epiphysis E belongs, and the second parallel secondary directions Yd, Ye, and Yf are also preferably in a second plane y2 perpendicular to the longitudinal axis A of the bone. The first plane y1 and the second plane y2 are parallel to each other.
[0212] Furthermore, the first secondary directions Ya, Yb, and Yc intersect obliquely with the second secondary directions Yd, Ye, and Yf, and more specifically, orthogonally with them, and the first secondary directions Ya, Yb, and Yc and the second secondary directions Yd, Ye, and Yf intersect at the first intersection point 136a (only one is shown in Figures 5 and 6 for simplification).
[0213] The second plane y2 extends slightly below the articular surface S relative to the first plane y1 (see, for example, Figure 6).
[0214] As can be seen more clearly in Figure 6, since the first plane y1 and the second plane y2 are close to each other, the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are substantially aligned or, in some cases, in contact at the first intersection 136a.
[0215] In the example shown in Figure 5, the lattice structure further comprises third sub-elements 134g, 134h, and 134i extending along third sub-directions Yg, Yh, and Yi, and fourth sub-elements 134j, 134k, and 134l extending along fourth sub-directions Yj, Yk, and Yl.
[0216] The mutually parallel third secondary directions Yg, Yh, and Yi preferably extend within the same third plane y3 that is perpendicular to the longitudinal axis A of the bone to which the epiphysis E belongs. Thus, the third plane y3 is essentially parallel to the first plane y1 and the second plane y2.
[0217] Similarly, the fourth secondary directions Yj, Yk, and Yl, which are parallel to each other, extend into the same fourth plane y4 which is also preferably perpendicular to the vertical axis A, and are therefore substantially parallel to the first plane y1, the second plane y2, and the third plane y3.
[0218] Furthermore, the third secondary directions Yg, Yh, and Yi intersect obliquely with the fourth secondary directions Yj, Yk, and Yl, and more specifically, orthogonally with them. The third secondary directions Yg, Yh, and Yi and the fourth secondary directions Yj, Yk, and Yl intersect at the second intersection point 136b (shown as only one in Figures 5 and 6 for simplification).
[0219] The fourth plane y4 extends slightly below the articular surface S relative to the first plane y1, compared to the third plane y3 (see, for example, Figure 6).
[0220] Since the third plane y3 and the fourth plane y4 are close to each other, the third sub-elements 134g, 134h, 134i and the fourth sub-elements 134j, 134k, 134l are substantially aligned or, in some cases, in contact at the second intersection 136b.
[0221] Furthermore, the third plane y3 extends further away from the articular surface S and at a distance P from the second plane y2, and below the second plane y2. The distance P is preferably on the order of the diameter of the main element 112. Thus, two lattice substructures are distinguished in the lattice structure 100: the first lattice substructure is formed by the juxtaposition of first sub-elements 134a, 134b, 134c and second sub-elements 134d, 134e, 134f, and the second lattice substructure is formed by the juxtaposition of third sub-elements 134g, 134h, 134i and fourth sub-elements 134j, 134k, 134l, and the lattice substructures are separated by a distance P.
[0222] Furthermore, the third secondary directions Yg, Yh, and Yi intersect obliquely with the first secondary directions Ya, Yb, and Yc and the second secondary directions Yd, Ye, and Yf. Similarly, the fourth secondary directions Yj, Yk, and Yl also intersect obliquely with the first secondary directions Ya, Yb, and Yc and the second secondary directions Yd, Ye, and Yf.
[0223] More specifically, the third subdirections Yg, Yh, and Yi are oriented at approximately 45° with respect to the first subdirections Ya, Yb, and Yc and the second subdirections Yd, Ye, and Yf. As a result, if there is orthogonality between the first subdirections Ya, Yb, and Yc and the second subdirections Yd, Ye, and Yf, and between the third subdirections Yg, Yh, and Yi and the fourth subdirections Yj, Yk, and Yl, then the fourth subdirections Yj, Yk, and Yl are also oriented at approximately 45° with respect to the first subdirections Ya, Yb, and Yc and the second subdirections Yd, Ye, and Yf.
[0224] In this embodiment, the second secondary directions Yd, Ye, and Yf intersect with the first main element 112a, and in particular, are perpendicular to the main extension direction Xa of the main element 112a. Thus, the second secondary elements 134d, 134e, and 134f extend through the tubular body 114a of the first main element 112a and through pairs of openings aligned along the second secondary extension directions Yd, Ye, and Yf. The third secondary directions Yg, Yh, and Yi and the fourth secondary directions Yj, Yk, and Yl intersect with the second main element 112b and are oriented at approximately 45° with respect to the first main extension direction Xa and the second main extension direction Xb of the main element 112. Therefore, the third sub-elements 134g, 134h, 134i and the fourth sub-elements 134j, 134k, 134l extend through the tubular body 114b of the second main element 112b, through pairs of openings aligned along the third sub-directions Yg, Yh, Yi and the fourth sub-directions Yj, Yk, Yl.
[0225] In this configuration, each principal element 112a, 112b provides additional support points to the first and second lattice substructures described above.
[0226] With respect to the aforementioned lattice structure 10, the lattice structure 100 provides a denser lattice of sub-elements 134 in the degenerated bone portion D, determined by the presence of a greater number of intersections 136 between the sub-elements 134, which further enhances the overall stability of the structure 100.
[0227] In this embodiment, the main element 112 and the sub-element 134 reach and intersect with the cortical bone C at both ends, in exactly the same manner as described in the embodiments of Figures 1 to 4, and are partially exposed.
[0228] Figure 7 illustrates a lattice structure 200 according to a third embodiment of the present invention.
[0229] The lattice structure 200 comprises a first principal element 212a extending along the principal front-to-back extension direction Xa. The lattice structure 200 further comprises a second principal element 212b extending along a second principal extension direction Xb, and a third principal element 212c extending along a third principal extension direction Xc. The first principal extension direction Xa, the second principal extension direction Xb, and the third principal extension direction Xc lie substantially within the same first plane y1. For simplicity, the three principal elements as a whole may be referred to as 212 below, and the relative principal extension directions as a whole may be referred to as X.
[0230] As shown in the figure, the second principal element 212b and the third principal element 212c have a third diameter d3 that is smaller than the first diameter d1 of the first principal element 212a, and in particular, is equivalent to the diameter of the opening obtained in the tubular body 214a of the first principal element 212a. As a result, the second principal element 212b and the third principal element 212c extend through the tubular body 214a of the first principal element 212a and through pairs of openings 222a, 222b and 222c, 222d which are aligned along the second principal extending direction Xb and the third principal extending direction Xc.
[0231] The lattice structure 200 further comprises three first sub-elements 234a, 234b, and 234c extending along the first sub-directions Ya, Yb, and Yc, and two second sub-elements 234d and 234e extending along the second sub-directions Yd and Ye. For simplicity, the sub-elements as a whole may be referred to as 234 below, and the relative sub-extension direction as a whole may be referred to as Y.
[0232] As described in the previous embodiment, the first secondary directions Ya, Yb, and Yc are parallel to each other and preferably coplanet with a first plane y1 perpendicular to the longitudinal axis of the bone to which the epiphysis E belongs, and the second secondary directions Yd and Ye are parallel to each other and preferably coplanet with a second plane y2 perpendicular to the longitudinal axis A of the bone to which the epiphysis E belongs. As described in the previous embodiment, the second plane y2 is parallel to the first plane y1 and close to the first plane y1. The first secondary directions Ya, Yb, and Yc intersect the second secondary directions Yd and Ye obliquely, and in particular perpendicularly, to determine an intersection point 236 (shown as one in Figure 7).
[0233] The first secondary directions Ya, Yb, and Yc are parallel to the first main extension direction Xa of the first main element 212a and perpendicular to the second main extension direction Xb of the second main element 212b and the third main extension direction Xc of the third main element 212c. The second secondary directions Yd and Ye are instead parallel to the second main extension direction Xb of the second main element 212b and the third main extension direction Xc of the third main element 212c and perpendicular to the first main extension direction Xa of the first main element 212a.
[0234] In this embodiment, the second secondary directions Yd and Ye intersect with the main element 212a, and the first secondary directions Ya, Yb, and Yc intersect with the second main element 212b and the third main element 212c.
[0235] As with all previous embodiments, the main element 212 and the secondary element 234 of this embodiment reach and intersect with the cortical bone C at both ends, and are partially exposed.
[0236] The assembly of the main elements 212a, 212b, and 212c of the lattice structure 200 forms a true reinforced frame supported on the cortical portion C, which is particularly stable, and the point where the sub-element 234 penetrates the main element 212 provides multiple additional support points for the sub-element 234.
[0237] Here, with reference to Figures 8 to 11, a kit 50 of parts for assembling the lattice structures 10, 100, and 200 according to any of the embodiments described above will be explained.
[0238] The parts kit 50 comprises one or more main elements 12 and multiple sub-elements 34, as illustrated in Figures 8 and 9 described above. In particular, the number and size of the main and sub-elements 34 are determined based on patient-specific analysis to assess the load-bearing conditions of the degenerated joints, in order to design a lattice structure that meets the patient's needs.
[0239] The parts kit 50 according to the present invention further comprises a template assembly 51 schematically shown in Figures 10 and 17, which is configured to facilitate the assembly of the lattice structures 10, 100, and 200 according to the present invention.
[0240] The template assembly 51 includes a surgical template 52 having an overall elongated main body 54, which comprises a first straight section 56 and a second straight section 58 extending substantially perpendicular to the first straight section 56. The template 52 also preferably comprises a third straight section 60 extending substantially perpendicular to the first straight section 56 and substantially parallel to the second straight section 58.
[0241] The unfolding direction SV of the main body 54 of the template 52, shown by the dashed line in Figure 10, is contained within the unfolding surface Psv. Therefore, the main body 54 of the template 52 is substantially flat, provided that the thickness in the direction transverse to the unfolding surface Psv is ignored.
[0242] The first straight section 56 extends between the second straight section 58 and the third straight section 60, the second straight section 58 and the third straight section 60 being at the free ends of the main body 54 of the template 52. The second straight section 58 and the third straight section 60 extend along the same sides as the first straight section 56, and as a result, the main body 54 of the template 52 takes on a substantially C-shape, with three sides surrounding the bone ends E for assembling the lattice structures 10, 100, and 200.
[0243] The main body 54 of the template 52 further includes linear connecting portions 62 and 64 extending between the first linear portion 56 and the second linear portion 58, and between the first linear portion 56 and the third linear portion 60. In particular, the connecting portion 62 is oriented at approximately 45° with respect to the first linear portion 56, the second linear portion 58, and the third linear portion 60.
[0244] The template 52 further comprises a first pin 66a provided in the main body 54 of the template 52, particularly in the first straight section 56, and fixed in a corresponding first through hole (not shown) that extends substantially parallel to the second straight section 58 and the third straight section 60 of the main body 54 of the template 52.
[0245] The first pin 66a has a first fixing member 70 at its proximal end 68 which cooperates with a fixing seat 32 formed on the end 18 of the main element 12 as illustrated in Figure 8. The first fixing member 70 is, for example, a threaded element which cooperates with the threads provided on the end 18 of the main element 12 in Figure 8.
[0246] Preferably, the template 52 also includes a second pin 66b, which is fixed in a corresponding second through-hole (not reference numeral) that is also provided in the first straight section 56 of the main body 54 of the template 52 and is parallel to the first through-hole that accommodates the first pin 66a in a plane transverse to the first straight section 56, as illustrated in Figure 10. The second pin 66b has a second fixing member (not reference numeral) at its proximal end (not reference numeral) which is configured to cooperate with a fixing seat 32 fabricated on the end 18 of a further main element 12. For example, the first pin 66a and the second pin 66b of the template 52 can also be fixed to the first main element 112a and the second main element 112b of the lattice structure 100 as illustrated in Figures 5 and 6.
[0247] Advantageously, the main body 54 of the template 52 has first sub-holes 72a, 72b, 72c, the longitudinal axis of which determines the first sub-extension directions Ya, Yb, Yc of the first sub-elements 32a, 32b, 32c at the subchondral bone injury D, which are oriented parallel to each other and extend within the same plane y1 during the assembly of the lattice structures 10, 100, 200. The first sub-extension directions Ya, Yb, Yc are also parallel to the first pin 66a and the second pin 66b.
[0248] The main body 54 of template 52 also has second sub-holes 72d, 72e, 72f, whose longitudinal axes define the second sub-extension directions Yd, Ye, Yf of the second sub-elements 32d, 32e, 32f at the subchondral bone injury D, which are oriented parallel to each other during the assembly of the lattice structures 10, 100, 200 and extend into the same plane y2 parallel to and near the first plane y1.
[0249] Preferably, the template 52 further comprises first guides 74a, 74b, 74c and second guides 74d, 74e, 74f, which are inserted into first sub-holes 72a, 72b, 72c and second sub-holes 72d, 72e, 72f, respectively, and are fabricated in the form of tubular elements designed to facilitate the proper alignment of sub-elements 34, 134, 234 at the epiphysis E. Adjustment screws 76 (only one is shown in Figure 10) may be provided for adjusting and / or fixing the positions of the first guides 74a, 74b, 74c and the second guides 74d, 74e, 74f.
[0250] Template 52 may comprise a further group of holes, as shown in the figure, which are collectively indicated by reference numeral 73, and which determine the possible further extension directions of further sub-elements based on the assumed configuration of the lattice structure to be assembled.
[0251] The template assembly 51 may include sub-elements 134 that are pre-assembled in the template 52, as schematically shown in Figure 17.
[0252] In the illustrated embodiment, the template assembly 51 comprises first sub-elements 134a, 134b, 134c inserted into first sub-holes 72a, 72b, 72c of the template 52, and second sub-elements 134d, 134e, 134f inserted into second sub-holes 72d, 72e, 72f.
[0253] More specifically, the first sub-elements 134a, 134b, and 134c are inserted into the first guides 74a, 74b, and 74c, which are then inserted into the first sub-holes 72a, 72b, and 72c of the template 52, and the second sub-elements 134d, 134e, and 134f are inserted into the second guides 74d, 74e, and 74f, which are then inserted into the second sub-holes 72d, 72e, and 72f.
[0254] Specifically, the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are recessed into the hole, that is, they protrude further distally from the template 52 and only partially protrude proximally from the template 52. This makes it sufficient during the surgical procedure to bring the pre-assembled template assembly 51 close to the epiphysis E, introduce the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f into it, and then slide them proximally. The first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f can be fabricated in advance to the appropriate length, for example, so that when inserted, both ends reach and intersect the cortical bone C of the epiphysis E.
[0255] By providing pre-assembled sub-elements 134 to template 52, the assembly process, which can become very complex during surgical procedures, can be advantageously avoided, thus speeding up the surgical procedure and significantly reducing the risk of structural assembly errors.
[0256] Figures 11 and 18 show a second modification of template assembly 151, which can be used in combination with or as an alternative to template assembly 51, which includes template 52 of Figures 10 and 17, to assemble a lattice structure according to the present invention, such as lattice structure 100, when template 152 is used in combination with template 52.
[0257] The template assembly 151 includes a surgical template 152 having a main body 154, which comprises a first straight section 156 and a second straight section 158 extending substantially perpendicular to the first straight section 156 and connected by a linear connecting section 162 oriented at approximately 45° with respect to the first straight section 156 and the second straight section 158.
[0258] Similar to the description of template 52 in the previous embodiment, the unfolding direction SV of the main body 154 of template 152, shown by the dashed line in Figure 11, is contained within the unfolding surface Psv. Therefore, the main body 154 of template 152 is substantially flat, neglecting the thickness in the direction transverse to the unfolding surface Psv.
[0259] The first straight section has third sub-holes 172g, 172h, and 172i that define third sub-extension directions Yg, Yh, and Yi, together with associated third guides 174g, 174h, and 174i, while the second straight section 158 has fourth sub-holes 172j, 172k, and 172l that define fourth sub-extension directions Yj, Yk, and Yl, together with associated fourth guides 174j, 174k, and 174l.
[0260] Unlike template 52 in Figure 10, in template 152, the first pin 166a and the second pin 166b, which have a fixing member 170, are fixed to the connection portion 162 of the main body 154 of template 152, and are therefore oriented at approximately 45° with respect to the third sub-holes 172g, 172h, 172i and the fourth sub-holes 172j, 172k, 172l.
[0261] For example, template 152 is configured to fix third sub-elements 134g, 134h, 134i and / or fourth sub-elements 134j, 134k, 134l of lattice structure 100, as illustrated in Figures 5 and 6, which extend along third sub-extension directions Yg, Yh, Yi and fourth sub-extension directions Yj, Yk, Yl, which are oriented at approximately 45° with respect to the first main extension direction Xa and the second main extension direction Xb.
[0262] For example, by providing holes in the connector 62 of the template 52 that are configured to accommodate pins 166a and 166b if necessary, it is possible to envision a template that includes the features of both template 52 and template 152.
[0263] The template assembly 151 may include sub-elements 134 that are pre-assembled in template 152, as schematically illustrated in Figure 18.
[0264] The template assembly 151 comprises first sub-elements 134a, 134b, and 134c inserted into first sub-holes 172a, 172b, and 172c of the template 152, and second sub-elements 134d, 134e, and 134f inserted into second sub-holes 172d, 172e, and 172f.
[0265] More specifically, the first sub-elements 134a, 134b, and 134c are inserted into the first guides 174a, 174b, and 174c, which are then inserted into the first sub-holes 172a, 172b, and 172c of the template 152, and the second sub-elements 134d, 134e, and 134f are inserted into the second guides 174d, 174e, and 174f, which are then inserted into the second sub-holes 172d, 172e, and 172f.
[0266] Specifically, the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are recessed into the hole, that is, they protrude further distally from the template 152 and only partially protrude proximally from the template 152. This allows that during the surgical procedure, it is sufficient to bring the pre-assembled template assembly 151 close to the epiphysis E, introduce the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f into it, and then slide them proximally. The first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f can be fabricated in advance to the appropriate length, for example, so that when inserted, both ends reach and intersect the cortical bone C of the epiphysis E.
[0267] By providing pre-assembled sub-elements 134 to template 152, the assembly process, which can become very complex during surgical procedures, can be advantageously avoided, thereby speeding up the surgical procedure and significantly reducing the risk of structural assembly errors.
[0268] Here, referring to FIGS. 12 to 14, a method for assembling the lattice structure according to the present invention will be described.
[0269] In the following, the assembly of the lattice structure 100 of FIGS. 5 and 6 will be specifically mentioned, but it will be understood that what will be described hereinafter will also apply to other embodiments of the lattice structure disclosed in this specification with necessary modifications.
[0270] When the configuration of the lattice structure to be assembled at the bone end E is established according to the specific requirements of the patient, and a kit 50 of related parts including one or more main elements 112, a plurality of sub-elements 134, and template assemblies 51, 151 including surgical templates 52 and 152 respectively is prepared, two receiving seats 126a, 126b for two main elements 112a, 112b are prepared by a bone core drilling through the degenerated bone portion D. The receiving seats 126a, 126b are through seats across the bone end E, and thus have access portions 128a, 130a; 120b, 130b facing the cortical bone C of the bone end E at both ends. The receiving seats 126a, 126b are made by aligning with each other in a plane substantially parallel to the longitudinal axis A of the bone to which the bone end E belongs.
[0271] Next, the first main element 112a and the second main element 112b are inserted into the receiving seats 126a, 126b (FIG. 12).
[0272] Next, by screwing fixing members of the first pin 66a and the second pin 66b (not visible here) into corresponding fixing seats (not visible here) provided at the end 118a of the first main element 112a and the end 118b of the second main element 112b, the template 52 of the template assembly 51 is constrained to the first main element 112a and the second main element 112b. By fixing the template 52 with the two pins 66a, 66b, the stability of the template 52 is enhanced, and the rotation of the template 52 during the subsequent insertion of the sub-elements 134 is prevented.
[0273] Next, if the template 52 is not pre-assembled as illustrated in Figure 17, the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are introduced into the first guides 74a, 74b, 74c and the second guides 74d, 74e, 74f, respectively, which are housed in the first and second holes (not reference numerals here) of the template 52. This automatically assigns the first sub-directions Ya, Yb, Yc to the first sub-elements 134a, 134b, 134c and the second sub-directions Yd, Ye, Yf to the second sub-elements 134d, 134e, 134f.
[0274] Once introduced into the first guides 74a, 74b, 74c and the second guides 74d, 74e, 74f, the first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are inserted into the degenerated portion D of the subchondral bone by a drilling tool, such as a drill. The first sub-elements 134a, 134b, 134c and the second sub-elements 134d, 134e, 134f are pushed into the bone until they reach the cortical portion located on the opposite side of the epiphysis E from the insertion side (Figure 13). This insertion assembles a first lattice substructure formed by first sub-elements 134a, 134b, 134c and second sub-elements 134d, 134e, 134f arranged orthogonally to each other, in which case the second sub-elements 134d, 134e, 134f intersect with the first principal element 112a.
[0275] Once this insertion is complete, the template assembly 51 is removed, and the first pin 66a and the second pin 66b of the template 52 are released from the end 118a of the first main element 112a and the end 118b of the second main element 112b.
[0276] Next, the second type of template assembly 151 is constrained to the first main element 112a and the second main element 112b, which are provided at the ends 118a of the first main element 112a and the end 118b of the second main element 112b, respectively, by screwing the fixing member 170a of the first pin 166a and the fixing member 170b of the second pin 166b of the template 152 into the corresponding fixing seats 32a and 32b.
[0277] Next, if the template 152 is not pre-assembled as illustrated in Figure 18, the third sub-elements 134g, 134h, 134i and the fourth sub-elements 134j, 134k, 134l are introduced into the third guides 174g, 174h, 174i and the fourth guides 174j, 174k, 174l, which are housed in the third and fourth holes (no reference numerals here). Thus, the third sub-directions Yg, Yh, Yi are automatically assigned to the third sub-elements 134g, 134h, 134i, and the fourth sub-directions Yj, Yk, Yl are automatically assigned to the fourth sub-elements 134j, 134k, 134l.
[0278] Once the first guides 174g, 174h, 174i and the second guides 174j, 174k, 174l are introduced, the third sub-elements 134g, 134h, 134i and the fourth sub-elements 134j, 134k, 134l are inserted into the degenerated portion D of the subchondral bone using the drill tool already used in the previous step. The third sub-elements 134g, 134h, 134i and the fourth sub-elements 134j, 134k, 134l are pushed into the bone until they reach the cortical portion located on the opposite side of the epiphysis E from the insertion side (Figure 14). This insertion assembles a second lattice substructure formed by third sub-elements 134g, 134h, 134i and fourth sub-elements 134j, 134k, 134l, which are arranged orthogonally to each other, in which case the third sub-elements 134g, 134h, 134i and fourth sub-elements 134j, 134k, 134l intersect with the second principal element 112b.
[0279] Once this insertion is complete, the lattice structure 100 is fully assembled. Next, the template assembly 151 is also removed, and the first pin 166a and the second pin 166b of the template 152 are released from the ends 118a of the first principal element 112a and the ends 118b of the second principal element 112b.
[0280] The applicant conducted experiments to verify the performance of the lattice structure according to the present invention in terms of reducing the peak load acting on the damaged portion of the epiphysis and reducing the deformation occurring in such damaged portion. Some results of such experiments, intended to illustrate and not limit the present invention, are described below with reference to Figures 15-16.
[0281] From the patient's diagnostic MRI images, two three-dimensional models of the tibia were constructed in a CAD environment: a first model E1 (Figure 15) without a lattice structure, and a second model E2 (Figure 16) with a lattice structure similar to structure 100 illustrated in Figure 5 but partially seen in Figure 16, comprising a single principal element 112. Both models E1 and E2 include the femoral head region T and a portion of the distal tibia extending between the femoral head T and end B. Model E2 in Figure 16 considered sub-elements with a diameter of 1 mm and principal elements with an outer diameter of 6 mm.
[0282] The two models, E1 and E2, were analyzed and compared using finite element simulation (FEM) with an interlock constraint imposed at end B of the tibial portion, employing the FEM module of Creo Elements software (PTC Inc.).
[0283] In both models E1 and E2, a load F of 3200 N was applied perpendicularly to the tibial head region H. This is equivalent to the load exerted on the tibia by a male weighing approximately 75 kg during walking. From this simulation and the distribution of local deformation on the surface of the tibial head region T, the distribution of local equivalent stress values according to von Mises (MPa) was extracted.
[0284] From the equivalent stress distribution by von Mises, the peak value of such equivalent stress acting on the tibial head region H was determined. In Model E1, the equivalent stress peak exceeded 100 MPa, while in Model E2, with the lattice structure assembled, the equivalent stress peak remained within 70 MPa.
[0285] Based on the distribution of local deformation of the bone tissue, Model E1 showed an overall deformation of approximately 1 mm in the femoral head region H, while Model E2, with the lattice structure assembled, showed a reduction in the overall deformation of the femoral head region H to approximately 0.77 mm.
[0286] Based on the above data, it was verified that the lattice structure according to the present invention, when assembled, reduces the equivalent tension peak acting on the tibial head region when a load is applied to the tibia by at least 30%. Similarly, it was verified that the lattice structure can reduce the deformation of bone tissue in the tibial head region supporting this structure by more than 20%.
[0287] Clearly, those skilled in the art can make numerous modifications and variations to the present invention, within the scope of protection defined by the following claims, in order to meet specific, incidental needs.
Claims
1. A template assembly comprising a surgical template (52, 152) having an elongated main body (54, 154) having at least one fixing member (70, 170) configured to cooperate with at least one rod-shaped, substantially linear, rigid main element (12, 112, 212) and at least one corresponding fixing seat (32), wherein i) The main body (54) is provided with first sub-through holes (72a, 72b, 72c) and second sub-through holes (72d, 72e, 72f) configured to accommodate filamentous, substantially linear first sub-elements (34a, 34b, 34c; 134a, 134b, 134c; 234a, 234b, 234c) and second sub-elements (34d, 34e, 34f; 134d, 134e, 134f; 234d, 234e), wherein the first sub-through holes (72a, 72b, 72c) are configured to accommodate the first sub-elements (34 The first sub-extension direction (Ya, Yb, Yc) of a, 34b, 34c; 134a, 134b, 134c; 234a, 234b, 234c) is determined, and the second sub-through holes (72d, 72e, 72f) are determined, and the second sub-extension direction (Yd, Ye, Yf) of the second sub-element (34d, 34e, 34f; 134d, 134e, 134f; 234d, 234e) is determined, and the first sub-extension direction (Ya, Yb, Yc) and the second sub-extension direction (Yd, Ye, Yf) are oblique to each other, and / or ii) The main body (154) is provided with third sub-through holes (172g, 172h, 172i) and fourth sub-through holes (172j, 172k, 172l) configured to accommodate filamentous, substantially linear third sub-elements (134g, 134h, 134i) and fourth sub-elements (134j, 134k, 134l), wherein the third sub-through holes (172g, 172h, 172i) The third sub-extension direction (Yg, Yh, Yi) of the sub-elements (134g, 134h, 134i) is defined, and the fourth sub-through hole (172j, 172k, 172l) defines the fourth sub-extension direction (Yj, Yk, Yl) of the fourth sub-element (134j, 134k, 134l), and the third sub-extension direction (Yg, Yh, Yi) and the fourth sub-extension direction (Yj, Yk, Yl) are oblique to each other. i) The first secondary extension directions (Ya, Yb, Yc) are substantially parallel to each other and lie in the first plane (y1), the second secondary extension directions (Yd, Ye, Yf) are substantially parallel to each other and lie in the second plane (y2), the second plane (y2) is substantially parallel to the first plane (y1), and / or ii) The third sub-extension directions (Yg, Yh, Yi) are substantially parallel to each other and lie within the third plane (y3), and the fourth sub-extension directions (Yj, Yk, Yl) are substantially parallel to each other and lie within the fourth plane (y4), and the fourth plane (y4) is substantially parallel to the third plane (y3). Template assembly.
2. The main body (54, 154) of the surgical template (52, 152) has a central portion extending between two free ends, and the free ends extend from the same side of the surgical template (52, 152) relative to the central portion. The deployment direction of the main body (54, 154) of the surgical template (52, 152) is within the deployment surface. The template assembly according to claim 1, wherein the first plane (y1) and / or the second plane (y2) and / or the third plane (y3) and / or the fourth plane (y4) are substantially parallel to the unfolding surface of the main body of the surgical template.
3. The first secondary through-holes (72a, 72b, 72c) or the third secondary through-holes (172g, 172h, 172i) are provided in the first straight section (56, 156) of the surgical template (52, 152), and the second secondary through-holes (72d, 72e, 72f) or the fourth secondary through-holes (172j, 172k, 172l) are provided in the second straight section (58, 158) of the surgical template (52, 152) which extends substantially perpendicular to the first straight section (56, 156). The first secondary through-holes (72a, 72b, 72c) or the third secondary through-holes (172g, 172h, 172i) extend in a direction that transverses the first straight section (56, 156) of the surgical template (52, 152), The second secondary through-holes (72d, 72e, 72f) or the fourth secondary through-holes (172j, 172k, 172l) extend in a direction that transverses the second straight section (58, 158) of the surgical template (52, 152). The template assembly according to claim 1 or 2.
4. The first straight section (56) is defined in the central part of the main body (54) of the surgical template (52), and the second straight section (58) is defined at one of the free ends of the main body (54) of the surgical template (52), or The template assembly according to claim 3, wherein the first straight section (56, 156) and the second straight section (58, 158) are defined at the free ends of the main body (54, 154) of the surgical template (52, 152).
5. The template assembly according to any one of claims 1 to 4, wherein the surgical template (52, 152) comprises at least one pin (66a, 66b; 166a, 166b) having at least one fixing member (70, 170) at its proximal end (68), and the at least one pin (166a, 166b) extends along a principal extending direction (X, Xa, Xb) parallel to the unfolding surface of the main body (54, 154) of the surgical template (52, 152).
6. - The at least one pin (166a, 166b) is installed on the first straight section (56) of the main body (54) of the surgical template (52) and is parallel to the first secondary extension direction (Ya, Yb, Yc), or - The template assembly according to claim 5, wherein the at least one pin (166a, 166b) is installed on a connecting portion (162) extending between a first straight portion (156) and a second straight portion (158) of the main body (154) of the surgical template (152), and is oriented at approximately 45° with respect to the third sub-extension direction (Yg, Yh, Yi) and the fourth sub-extension direction (Yj, Yk, Yl).
7. The template assembly according to any one of claims 1 to 6, wherein the surgical template (52, 152) comprises a first fixing member (70, 170a) configured to cooperate with a corresponding first fixing seat (32) of a rod-shaped, substantially linear, rigid first main element (112a), and a second fixing member (70, 170b) configured to cooperate with a corresponding second fixing seat (32) of a rod-shaped, substantially linear, rigid second main element (112b).
8. The aforementioned surgical templates (52, 152) The first pin (66a, 166a) has a first fixing member (70, 170a) at its proximal end (68) and is substantially parallel to the unfolding surface of the main body (54, 154) of the surgical template (52, 152), The template assembly according to claim 7, comprising a second pin (66b, 166b) having a second fixing member (70, 170b) at its proximal end, substantially parallel to the unfolding surface of the main body (54, 154) of the surgical template (52, 152), and substantially parallel to the first pin (66a, 166a).
9. - Further comprising thread-like, substantially linear first sub-elements (34a, 34b, 34c; 134a, 134b, 134c; 234a, 234b, 234c) inserted into the first sub-through holes (72a, 72b, 72c), or further comprising thread-like, substantially linear third sub-elements (134g, 134h, 134i) inserted into the third sub-through holes (172g, 172h, 172i), and / or - Further comprising thread-like, substantially linear second sub-elements (34d, 34e, 34f; 134d, 134e, 134f; 234d, 234e) inserted into the second sub-through holes (72d, 72e, 72f), or further comprising thread-like, substantially linear fourth sub-elements (134j, 134k, 134l) inserted into the fourth sub-through holes (172j, 172k, 172l), The template assembly according to any one of claims 1 to 8.
10. A kit (50) of parts for assembling a lattice support structure (10, 100, 200) for one or more degenerated portions (D) of the subchondral bone of the epiphyseal portion (E) of a joint in a human or animal, At least one rod-shaped, substantially linear, rigid principal element (12, 112, 212), A plurality of substantially linear, filamentous sub-elements (34, 134) including a first sub-element (34a, 34b, 34c; 134a, 134b, 134c; 234a, 234b, 234c) and a second sub-element (34d, 34e, 34f; 134d, 134e, 134f; 234d, 234e), A template assembly according to any one of claims 1 to 9, Includes, The at least one rod-shaped, substantially linear, rigid main element (12, 112, 212) has a second transverse dimension (d) of the sub-elements (34d, 34e, 34f; 134d, 134e, 134f; 234d, 234e, 234f). 2 The first horizontal dimension (d) is larger than ) 1 ) has, The at least one rod-shaped, substantially linear, rigid principal element (12, 112, 212) and the secondary element (34, 134, 234) are configured to reach and at least partially intersect the cortical bone portion (C) of the epiphysis (E) at both ends (18, 20; 38, 40). A kit of parts (50).
11. The kit of parts (50) according to claim 10, wherein the plurality of substantially linear filamentous sub-elements (134) further include a third sub-element (134g, 134h, 134i) and a fourth sub-element (134j, 134k, 134l).
12. The kit of components (50) according to any one of claims 10 to 11, wherein the at least one rod-shaped substantially linear rigid main element (12, 112, 212) comprises a tubular body (14, 114, 214) having a circular cross-section, and the lumen (20) of the at least one rod-shaped substantially linear rigid main element (12, 112, 212) is configured to receive a filler selected from autologous bone grafts, allogeneic bone grafts, and artificial bone grafts.
13. The component kit (50) according to claim 12, wherein the filler comprises autologous stem cells and / or growth factors.
14. The tubular body (14, 114, 214) of the at least one rod-shaped, substantially linear, rigid main element (12, 112, 212) is provided with a plurality of through-openings (22, 22a, 22b, 22c, 22d), A kit of parts (50) according to any one of claims 10 to 13, wherein at least a portion of the sub-elements (34) is configured to extend through corresponding through-openings (22, 22a, 22b, 22c, 22d) of the tubular bodies (14, 114, 214) of the at least one rod-shaped substantially linear rigid main element (12, 112, 212).
15. The at least one rod-shaped, substantially linear, rigid principal element (12, 112, 212) includes a first principal element (212a) and a second principal element (212b), The kit of parts (50) according to any one of claims 10 to 14, wherein the second main element (212b) is configured to extend through corresponding through-openings (222, 222a, 222b, 222c, 222d) of the tubular body (214a) of the first main element (212a).
16. The kit of parts (50) according to any one of claims 10 to 15, wherein the at least one rod-shaped, substantially linear, rigid main element (12, 112, 212) is provided at one end (18, 118) with a fixed seat (32) for the surgical template (52, 152), the fixed seat (32) being configured to cooperate with the fixing members (70, 170) of the surgical template (52, 152).
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