Surgical implant

Abstract

The present disclosure relates to modular surgical implants that can be used to treat long bone defects. In particular, the disclosure relates to a surgical implant modular assembly comprising at least a first stent and a second stent, where the first stent and the second stent are identical.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of Singapore Patent Application No. 10202250375Y, filed on Jul. 6, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to surgical implants. In particular, the disclosure relates to a modular component of a surgical implant that includes at least a first stent and a second stent. Background Art

[0004] Bone voids or defects can be caused by traumatic events, surgical removal of cancerous or infected tissue. However, it is challenging to pre-determine the size of the bone void due to the severity of the injury and the amount of bone tissue to be removed.

[0005] Efforts have been made to develop and manufacture patient-specific or customized implants for patients to provide treatment options for bone defects that match the patient's anatomy, thereby achieving optimal healing due to better adaptation and conformance to the unique geometry of the bone void. However, currently available solutions require a long turnaround time from their design, development, testing to manufacturing.

[0006] In view of the above, there is a need to develop surgical implants and related methods that overcome or at least ameliorate the above limitations. Summary of the Invention

[0007] In one aspect, there is provided a modular component of a surgical implant. According to some embodiments, the modular component of the surgical implant can include a first stent and a second stent. The first stent can be structurally identical to the second stent. According to some embodiments, each of the first stent and the second stent can have a first portion and a second portion. For each of the first stent and the second stent, the first portion can be integrated into the second portion. In addition, the first portion of each of the first stent and the second stent can be located above the second portion of the same stent. Additionally, the second portion of the first stent can have a first opening. The second portion of the second stent can have a second opening. The second opening can be configured to be complementary to the first portion of the first stent such that when the second stent is stacked above the first stent, the first portion of the first stent fits into the second opening, thereby forming the modular component of the surgical implant.

[0008] Optionally, the modular component can be a cylindrical modular component. Each of the first opening and the second opening can be a lateral opening within the range of 60° to 120°. Optionally, the first bracket can further include a first pin disposed on the top of the first portion of the first bracket and a first groove disposed on the bottom of the second portion of the first bracket. Still optionally, the second bracket can further include a second pin disposed on the top of the first portion of the second bracket and a second groove disposed on the bottom of the second portion of the second bracket.

[0009] According to some embodiments of the disclosure, the surgical implant modular component can further include a replacement bracket having a third groove such that when the replacement bracket is stacked above the second portion of the second bracket, the first pin of the first bracket can be fitted into the third groove of the replacement bracket. Optionally, the surgical implant modular component described herein can further include a second replacement bracket having a third pin such that when the second replacement bracket is stacked below the second bracket, the third pin of the second replacement bracket can be fitted into the second groove of the second bracket. According to some embodiments of the disclosure, the first pin, the second pin, the third pin, the first groove, the second groove, and the third groove can each be rectangular in shape. The surgical implant modular component can optionally include a bioabsorbable material. The bioabsorbable material can be a porous bioabsorbable material having a pore size of 0.4 mm to 4 mm. The bioabsorbable material can be a polymer, a salt, or a composite material. Optionally, the polymer or composite material can include a polycaprolactone (PCL)-based polymer. Optionally, the composite material can be doped with one or more metals.

[0010] According to some embodiments of the disclosure, the surgical implant modular component described herein can be used to treat a bone defect of a subject. The bone defect can be a long bone defect selected from the femur, tibia, and humerus. Optionally, the size of each of the first bracket, the second bracket, the replacement bracket, and the second replacement bracket of the surgical implant modular component can be customized for an individual subject. The size of each of the first bracket, the second bracket, the replacement bracket, and the second replacement bracket can be determined by computed tomography (CT) scan. Optionally, the customized bracket can be prepared via additive manufacturing.

[0011] In another aspect, a method for treating a bone defect of a subject is provided, the method comprising inserting the surgical implant modular component described in the present disclosure into the subject. The bone defect can be a long bone defect selected from the femur, tibia, and humerus.

[0012] In another aspect, a method for manufacturing modular components of a surgical implant described in the present disclosure is provided. The method may include determining a suitable size of the surgical implant. The method may further include mixing one or more reagents to form each of a first scaffold and a second scaffold, and then stacking the second scaffold above the first scaffold to form a modular component of the surgical implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The present disclosure will be understood and better appreciated by reference to the following detailed description taken in conjunction with the accompanying drawings. Identical structures, elements, or parts that appear in more than one figure are generally labeled with the same or similar numerals in all the figures in which they appear, where:

[0014] Figure 1 is a perspective view of a first or second scaffold of a modular component of a surgical implant according to some embodiments of the disclosure;

[0015] Figure 2A is a top view of a first or second scaffold of a modular component of a surgical implant according to some embodiments of the disclosure;

[0016] Figure 2B is a front view of a first or second scaffold of a modular component of a surgical implant according to some embodiments of the disclosure;

[0017] Figure 2C is a side view of a first or second scaffold of a modular component of a surgical implant according to some embodiments of the disclosure;

[0018] Figure 3A is a perspective view of an assembled modular component of a surgical implant according to a first embodiment of the disclosure;

[0019] Figure 3B is a perspective view of a disassembled modular component of a surgical implant according to a first embodiment of the disclosure, showing a first scaffold, a second scaffold, a first alternative scaffold, and a second alternative scaffold;

[0020] Figure 4A is an illustration Figure 3A a perspective view of the assembled modular component of a surgical implant described in ;

[0021] Figure 4B is an illustration Figure 3A a top view of the individual components to be assembled of a modular component of a surgical implant described in, the individual components including a first scaffold, a second scaffold, a first alternative scaffold, and a second alternative scaffold;

[0022] Figure 4C is an illustration Figure 4B a perspective view of ;

[0023] Figure 5A is a perspective view of an assembled surgical implant modular component according to a second embodiment of the disclosure;

[0024] Figure 5B is a perspective view of a disassembled surgical implant modular component according to a second embodiment of the disclosure, showing a first bracket, a second bracket, a first alternative bracket, and a second alternative bracket;

[0025] Figure 6A is a diagrammatic illustration Figure 5A of an image of a perspective view of the assembled surgical implant modular component described in;

[0026] Figure 6B is a diagrammatic illustration Figure 5A of an image of a top view of the individual components of the surgical implant modular component to be assembled described in, the individual components including a first bracket, a second bracket, a first alternative bracket, and a second alternative bracket; and

[0027] Figure 6C is a diagrammatic illustration Figure 6B of an image of a perspective view of. DETAILED DESCRIPTION

[0028] The present disclosure provides a surgical implant modular component that can be used as a bone void filler. Such a bone void filler can be structured while allowing a user (e.g., a surgeon) to assemble the surgical implant modular component into its desired length and dimensions to fill a bone void. The surgical implant can be customized when it is created during surgery. This is beneficial because customization can allow for the production of individually manufactured fillers of various lengths and dimensions.

[0029] In some embodiments of the disclosure, the first stent and the second stent may be structurally the same or similar. The similarity between the first stent and the second stent may be greater than 80%, such as 82%, 85%, 86%, 88%, 90%, 92%, 95%, 96%, 97%, 98%, 99% or 100%. In some embodiments, the similarity between the first stent and the second stent is preferably 100%. The first stent may have a first portion and a second portion. In some embodiments, the first portion and the second portion are integrated or connected. In some embodiments, the first portion is located above the second portion. The first portion of the first stent may be different from the second portion of the first stent. Similarly, the first portion of the second stent may be different from the second portion of the second stent. When the first stent is structurally the same as the second stent, the second stent also has a first portion and a second portion, wherein the first portion and the second portion are integrated or connected. In some embodiments of the second stent, the first portion is located above the second portion. In some embodiments, the first portion of the first stent may be the same as the first portion of the second stent. Similarly, the second portion of the first stent may be the same as the second portion of the second stent.

[0030] In some embodiments, the surgical implant modular component may be in a cylindrical shape. Other suitable shapes may be used as long as they have the same advantages as the cylindrical surgical implant modular component. In some embodiments, when the surgical implant modular component has a cylindrical shape, the surgical implant modular component may further include a cavity. Such a cavity may be provided in the form of an inner tube. Such an inner tube may use an intramedullary nail as an external fixation device.

[0031] In some embodiments, the second portion of the first stent has an opening referred to as the first opening. Similarly, the second portion of the second stent has an opening referred to as the second opening. When the first stent is the same as the second stent, it should be understood that the first opening is also the same as the second opening. For a cylindrical surgical implant modular component, the first opening or the second opening may be a lateral opening. For clarity, in the case of a cylindrical surgical implant modular component, the top view of such a surgical implant will have a cutout portion corresponding to the opening, such as Figure 1 or Figure 2AThe incision portion shown in [description]. Without being bound by theory, the lateral opening of the modular component of the cylindrical surgical implant may refer to an incision at the radial periphery of the cylinder. In some embodiments, the lateral opening of the first opening or the second opening may be formed at an angle in the range of about 60° to about 120° (e.g., 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, and 120° measured from the central radius of the cylinder). Any other angle not described but within the said range may also be used. The above angle range may advantageously allow the surgical implant to be inserted into the bone defect, whether or not an intramedullary nail or other suitable internal fixation device has been previously implanted.

[0032] In some embodiments, the first stent may be stacked above the second stent. In some embodiments, the second stent may be stacked above the first stent. When the first stent is stacked above the second stent, the first opening may be configured to be complementary to the first portion of the second stent, such that the first portion of the second stent can be fitted into the first opening, thereby forming the modular component of the surgical implant. In some embodiments, when the second stent is stacked above the first stent, the second opening may be configured to be complementary to the first portion of the first stent, such that the first portion of the first stent can be fitted into the second opening, thereby forming the modular component of the surgical implant.

[0033] In some embodiments of the modular component of the surgical implant, the first stent further includes a first pin disposed on the top of the first portion of the first stent and a first groove disposed on the bottom of the second portion of the first stent. In some embodiments, each of the first pin and the first groove is rectangular in shape.

[0034] In some embodiments of the modular component of the surgical implant, the second stent further includes a second pin disposed on the top of the first portion of the second stent and a second groove disposed on the bottom of the second portion of the second stent. In some embodiments, each of the second pin and the second groove is rectangular in shape.

[0035] In some embodiments, the modular component of the surgical implant may further include an alternative stent having a third groove, such that when the second stent is stacked above the first stent and the alternative stent is stacked above the second portion of the second stent, the first pin of the first stent can be fitted into the third groove of the alternative stent. In some embodiments, the third groove is rectangular in shape.

[0036] In some embodiments, the modular component of the surgical implant may further include a second alternative stent having a third pin such that when the second stent is stacked above the first stent and the second alternative stent is stacked below the first stent, the third pin of the second alternative stent can be fitted into the first slot of the first stent. In some embodiments, the third pin is in a rectangular shape. It should be understood that the first pin, the second pin, the third pin, the first slot, the second slot, and the third slot may each be other shapes than rectangular, including cylindrical, triangular, pentagonal, and hexagonal.

[0037] In an exemplary embodiment of the disclosure, as can be seen from Figure 1 in which the first or second stent of the modular component of the surgical implant disclosed herein is denoted as 100. In this embodiment, the first part 102 of the stent 100 is located above the second part 104 of the stent 100. For clarity, Figure 1 the first part 102 of the stent 100 shown in is located above the second part 104 of the stent 100 in the vertical direction. The first part 102 and the second part 104 of the stent 100 are integrated or joined. Also visible from Figure 1 are the pin 106 of the stent 100 as well as the lateral openings of the first part and the lateral openings of the second part. The lateral openings are characterized by the angles formed as described herein. As can be seen from Figure 2A which depicts a top view of the first or second stent 100, the angle characterizing the lateral opening of the second part 104 is H. In such an embodiment, the angle characterizing the lateral opening of the first part 102 is (360 - H) such that when the second stent is stacked above the first stent, the first part of the first stent will fit into the second opening of the second stent. For the modular component of the surgical implant composed of the first or second stent shown in Figure 1 the modular component of the surgical implant is substantially cylindrical. The top view of the first or second stent 100 depicts that the stent is composed of a mesh of a bioabsorbable material 110 which will be described below.

[0038] Figure 2B depicts a front view of the first or second stent of the modular component of the surgical implant disclosed herein. In the same figure, A depicts the diameter of the second part. The pin 106 of the stent 100 is characterized by its height (E) and width (F). The pin 106 is provided on the top of the first part 104 of the stent 100. Additionally, the pin 106 may also be characterized by its thickness (G), as can be seen from Figure 2C which depicts a side view of the first or second stent of the modular component of the surgical implant disclosed herein. Those skilled in the art should appreciate that each of E, F, and G can be changed or adjusted as needed. Figure 2BAlso shown is a slot 108 disposed at the bottom of the second portion 104 of the bracket. To facilitate the assembly of the first bracket and the second bracket, the size of the slot is shaped to match the size of the pin. In Figure 2B both the pin and the slot have a width F and a height E, and as can be seen in Figure 2C both the pin and the slot have a thickness G.

[0039] Figure 2C A side view of the first or second bracket of the modular components of the surgical implant disclosed herein is depicted. In this figure, it can be seen that the first portion 102 and the second portion 104 are characterized by having a total height D. In some embodiments, the height of the second portion 104 is C. Thus, the height of the first portion 102 is (D - C). Those skilled in the art should appreciate that each of C and D can be varied or adjusted as needed.

[0040] Figure 3A A first embodiment of the modular components of the surgical implant 300 disclosed herein is described. In this figure, the components of the modular components of the surgical implant have been assembled and are ready for use. Thus, the modular components 300 of the surgical implant are composed of a first bracket 200, a second bracket 100, a first alternative bracket 140, and a second alternative bracket 240. The opening of the second bracket 100 is configured to be complementary to the first portion of the first bracket 200 such that when the second bracket 100 is stacked above the first bracket 200, the first portion of the first bracket 200 fits into the second opening. The first alternative bracket 140 is stacked above the second portion of the second bracket 100 such that the first pin ( Figure 3B (206 in (i)) of the first bracket 200 is fitted into the slot ( Figure 3B (148 in (ii)) of the first alternative bracket 140. The second alternative bracket 240 has a pin ( Figure 3B (246 in (i)) such that when the second alternative bracket 240 is stacked below the second bracket 100, the pin 246 ( Figure 3B (i)) of the second alternative bracket 240 is fitted into the slot 108 ( Figure 3B (ii)) of the second bracket 100.

[0041] Figures 4A - 4C Depicts Figures 3A - 3B the modular components of the surgical implant described in Figure 4A Depicts the modular components of the surgical implant with its components assembled. Figures 4B - 4C Top views and perspective views of the individual components of the modular components of the surgical implant described in Figure 4A are shown respectively.

[0042] Figure 5ADescribes a second embodiment of the surgical implant modular component 500 disclosed herein. As can be seen, the surgical implant modular component of the second embodiment is similar to that of the first embodiment, except that in the second embodiment, the modular component further consists of a cavity 550. This cavity is provided in the form of an inner tube 550. In this figure, the components of the surgical implant modular component have been assembled and are ready for use. Thus, the surgical implant modular component 500 consists of a first bracket 700, a second bracket 600, a first alternative bracket 640, and a second alternative bracket 740. The first alternative bracket 640 is stacked above the second part of the second bracket 600 such that the first pin ( Figure 5B (706 in (i)) of the first bracket 700 is fitted into the slot ( Figure 5B (648 in (ii)) of the first alternative bracket 640. The second alternative bracket 740 has a pin ( Figure 5B (746 in (i)) such that when the second alternative bracket 740 is stacked below the second bracket 600, the pin 746 ( Figure 5B (i)) of the second alternative bracket 740 is fitted into the slot 708 ( Figure 5B (ii)) of the second bracket 600.

[0043] Figures 6A - 6C Depicts Figures 5A - 5B the surgical implant modular component described in Figure 6A Depicts the surgical implant modular component with its components assembled. Figures 6B - 6C Respectively show Figure 6A the top view and perspective view of the respective components of the surgical implant modular component described in

[0044] The pins and slots (or holes) described above can advantageously interlock the respective segments (first bracket, second bracket, alternative bracket, second alternative bracket) to achieve structural stability and strength against torsional and translational forces while being implanted within the bone void interface. These forces can be generated during movement. In an exemplary embodiment, when the alternative bracket is stacked above the second part of the second bracket, the pin of the first bracket is fitted into the third slot of the alternative bracket.

[0045] Without being bound by theory, the surgical implant described herein may further include a third bracket, a fourth bracket, a fifth bracket, a sixth bracket, etc. The number of brackets can be determined based on the size (such as length) of the desired surgical implant. The number of brackets used shall not impair the technical effects and benefits provided by the surgical implant consisting of the first bracket, the second bracket, the alternative bracket, and the second alternative bracket. The third bracket, the fourth bracket, the fifth bracket, the sixth bracket may be structurally the same as the first bracket and the second bracket.

[0046] For a surgical implant including a third stent, the third stent is also structurally identical to the first stent. Additionally, the third stent also has a first portion and a second portion similar to the first stent, with the first portion located above the second portion. The second portion of the third stent has a third opening. When the second stent is stacked above the first stent and the third stent is stacked above the second stent, the second opening is configured to be complementary to the first portion of the first stent such that the first portion of the first stent fits into the second opening, and the third opening is configured to be complementary to the first portion of the second stent such that the first portion of the second stent fits into the third opening, thereby forming the modular assembly of the surgical implant. In this configuration, the modular assembly of the surgical implant may further include an alternative stent having a third slot such that when the alternative stent is stacked above the second portion of the third stent, the second pin of the second stent can be fitted into the third slot of the alternative stent.

[0047] In some embodiments, the modular assembly of the surgical implant includes a bioabsorbable material. A bioabsorbable material can refer to any material including biodegradable or bioabsorbable metals, alloys, salts, polymers, or composite materials. Specifically, such materials can safely degrade within the subject's body. In some embodiments, the bioabsorbable material can be a porous bioabsorbable material. In some embodiments, the pore size of the porous bioabsorbable material can be from about 0.25 mm to about 4 mm, such as 0.25 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3 mm, 3.25 mm, 3.5 mm, 3.75 mm, and 4 mm. The pore size distribution can be homogeneous or heterogeneous throughout or in part of the modular assembly of the present disclosure. In some embodiments, the porous structure of the surgical implant can be in the form of fine filaments. Advantageously, the porous structure can provide the ability to incorporate autologous bone grafts and biomaterials derived from bone marrow aspirate (BMA), platelet-rich plasma (PRP) into the porous structure of the surgical implant.

[0048] In some embodiments, the bioabsorbable material can be a polymer, a salt, or a composite material. In some embodiments, the bioabsorbable material can be a medical-grade bioabsorbable material. Thus, the polymer, salt, or composite material is a medical-grade polymer or composite material (denoted as "m"). In some embodiments, the polymer can be a polymer including polycaprolactone (PCL) or hydroxyapatite (HA) monomers. In some embodiments, the polymer or composite material includes a polycaprolactone (PCL)-based polymer. In some embodiments, the salt or composite material can include tricalcium phosphate (TCP), particularly β-TCP. In some embodiments, the composite material can include β-TCP and PCL. In some embodiments, the composite material can include β-TCP and HA. In some embodiments, the composite material can include HA and β-TCP further mixed with PCL. In some embodiments, the composition of each component in the composite material can be adjusted or changed accordingly. In an exemplary embodiment, when the composite material is medical-grade PCL and β-TCP, PCL and β-TCP can be provided in a ratio of 10:90, 20:80, 30:70, 40:60, 50:50, 60:40, 70:30, 80:20, or 90:10 (by weight or volume). In some embodiments, the ratio between PCL and β-TCP is preferably 80:20 (by weight or volume). This ratio can be adjusted to provide suitable mechanical properties and desirable hydrolytic degradation kinetics. This feature is beneficial compared to the absorption of rapidly degrading natural and synthetic polymers.

[0049] Adding TCP to the fabrication of a medical-grade PCL-TCP (mPCL-TCP) composite material can enhance the osteoconductivity of the scaffold. This, in turn, can lead to the production of a scaffold that provides structural support for cell attachment and tissue development and is suitable for clinical applications in combination with autologous bone grafts. In some embodiments, when the composite material includes TCP and PCL, the composite material can further include one, two, three, or more metals. The metals used can be metals found in Groups I and II of the periodic table. Preferably, the metal is selected from calcium, magnesium, sodium, potassium, and strontium. In some embodiments, the composite material is PCL-TCP that further includes magnesium, and this is denoted as PCL-TCP-Mg. In some embodiments, the metals used can be provided in the form of oxides, peroxides, or salts. In an exemplary embodiment, PCL-TCP further includes magnesium sulfate (MgSO4).

[0050] In some embodiments, the surgical implant modular components of the present disclosure can be used to treat bone defects in a subject. Thus, in some embodiments, a method for treating bone defects in a subject is provided.

[0051] The present disclosure also provides a modular component of a surgical implant for treating a bone defect of a subject, wherein the modular component of the surgical implant comprises:

[0052] a first stent and a second stent, the first stent and the second stent being identical in structure, each of the first stent and the second stent having a first portion and a second portion, wherein for each of the first stent and the second stent, the first portion is integrated into the second portion,

[0053] wherein the first portion of each stent is located above the second portion of the same stent;

[0054] the second portion of the first stent has a first opening;

[0055] the second portion of the second stent has a second opening;

[0056] wherein the second opening is configured to be complementary to the first portion of the first stent such that when the second stent is stacked above the first stent, the first portion of the first stent fits into the second opening, thereby forming the modular component of the surgical implant.

[0057] In some embodiments, the bone defect may be a long bone defect, wherein the long bone is selected from the femur, tibia, and humerus. In some embodiments, the surgical implant of the present disclosure may promote bone fusion of a critical-sized defect, bone formation inside and outside a fully interconnected scaffold architecture. Additionally, the surgical implant of the present disclosure may provide an osteoinductive and conductive environment paired with mechanical stability (referred to as the diamond concept), which is a key requirement for curing critical-sized defects. In some embodiments, the surgical implant of the present disclosure may be osteoinductive when combined with growth factors or biologics.

[0058] In some embodiments, the size of each of the first stent, the second stent, the alternative stent, and the second alternative stent may be advantageously customized or personalized for an individual subject. Thus, the present disclosure provides a treatment solution for bone defects that matches the patient's anatomy to achieve optimal healing due to better adaptation and conformance to the unique geometry of the bone void. Customization (including sizing) of each of the first stent, the second stent, the alternative stent, and the second alternative stent may be performed via computed tomography (CT) scan. This applies to the third stent, the fourth stent, the fifth stent, the sixth stent, etc. It should be understood that other suitable scanning methods may be used. In some embodiments, additive manufacturing (e.g., 3D printing) may be used to fabricate or manufacture customized stents. This feature may advantageously shorten the surgical time by standardizing a general module that can be assembled by a surgeon to construct a surgical implant of variable size as needed. In some embodiments, a desired length or size other than the separately fabricated lengths and sizes of the stents may thus be manufactured.

[0059] In some embodiments, the surgical implant of the present disclosure can be used in combination with an intramedullary nail (or rod) as the mechanically strongest implant for long bone stabilization and / or load sharing with critical-sized defects. Any other suitable fixation technique other than an intramedullary rod can also be used. When using an intramedullary nail, custom printing based on a CT scan can allow for a personalized and optimal fit of the scaffold within the defect and around the nail. Additionally, the layer-by-layer 3D printing technique allows for the creation of a scaffold with high porosity and interconnected pores. The porosity of the scaffold can be from about 50% to about 80%, such as 50%, 55%, 60%, 65%, 70%, 75%, and 80% (by weight or volume). In some embodiments, 3D printing can use fused deposition modeling (FDM). In some embodiments, the modular components of the surgical implant of the present disclosure can be used in combination with a fixation device including an intramedullary nail (or rod) and plates and screws.

[0060] In some embodiments, the surgical implant of the present disclosure can be used in long bone reconstruction surgery. In some embodiments, the surgical implant of the present disclosure can be used as a bone void filler.

[0061] In addition, a method for manufacturing modular components of a surgical implant is provided, wherein the modular components of the surgical implant include:

[0062] a first scaffold and a second scaffold, the first scaffold being structurally identical to the second scaffold, each of the first scaffold and the second scaffold having a first part and a second part, wherein for each of the first scaffold and the second scaffold, the first part is integrated into the second part,

[0063] wherein the first part of each scaffold is located above the second part of the same scaffold;

[0064] the second part of the first scaffold has a first opening;

[0065] the second part of the second scaffold has a second opening;

[0066] wherein the second opening is configured to be complementary to the first part of the first scaffold such that when the second scaffold is stacked above the first scaffold, the first part of the first scaffold fits into the second opening, thereby forming the modular components of the surgical implant;

[0067] The method includes:

[0068] providing an image of the bone defect of the subject;

[0069] determining the appropriate size of the surgical implant;

[0070] mixing one or more reagents to form each of the first scaffold and the second scaffold; and

[0071] Stack the second stent above the first stent.

[0072] In some embodiments, after the step of mixing one or more reagents but before forming the first and second stents, there may be an intermediate step of forming a composite material in particulate form. The forming step may include grinding the composite material. The formed particles may be heterogeneous or homogeneous particles. After forming the composite material in particulate form, the composite material may undergo a melting process by heating the composite material and then extruding the molten composite material. Melting may be performed layer by layer within different axes (including the x, y, and z axes) of a 3D printer via a nozzle. In some embodiments of the present disclosure, when the surgical implant modular component is in a cylindrical shape, the method further includes pressing the surgical implant circumferentially onto the pins to fill the defect space.

[0073] In some embodiments, there is provided a method for manufacturing a surgical implant modular component as described above herein, the method comprising:

[0074] (i) determining a suitable size of the surgical implant;

[0075] (ii) mixing one or more reagents to form each of the first and second stents; and

[0076] (iii) stacking the second stent above the first stent.

[0077] In some embodiments, before step (i), the method further includes providing an image of the bone defect of the subject. In some embodiments, after the step of mixing one or more reagents but before forming the first and second stents, there may be an intermediate step (iia) of forming a composite material in particulate form. In some embodiments, the forming step in step (ii) may include grinding the composite material. In some embodiments, the formed particles may be heterogeneous or homogeneous particles. After forming the composite material in particulate form, the composite material may undergo a melting process by heating the composite material and then extruding the molten composite material. In some embodiments, melting may be performed layer by layer within different axes (including the x, y, and z axes) of a 3D printer via a nozzle. In some embodiments of the present disclosure, for a surgical implant modular component in a cylindrical shape, the method further includes pressing the surgical implant circumferentially onto the pins to fill the defect space.

[0078] In some embodiments, the image of the bone defect may be obtained by any suitable imaging technique (including CT scan). In some embodiments, the size (or dimensions) of the surgical implant (including the stent) may be determined based on the scan results.

[0079] It should be appreciated that the above surgical implants and methods of use thereof can be varied in many ways, including omitting or adding elements or steps, changing the order of steps, and the types of devices used. It should be appreciated that different features can be combined in different ways. In particular, not all of the above features shown in a particular embodiment are required in every embodiment of the disclosure. Further combinations of the above features are also considered to be within the scope of some embodiments of the disclosure.

[0080] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above. Instead, the scope of the present invention is defined by the appended claims.

Claims

1. A modular component of a surgical implant, comprising: A first bracket and a second bracket, the first bracket and the second bracket being identical in structure, each of the first bracket and the second bracket having a first part and a second part, wherein for each of the first bracket and the second bracket, the first part is integrated into the second part, wherein the first part of each bracket is located above the second part of the same bracket; The second part of the first bracket has a first opening; The second part of the second bracket has a second opening; wherein the second opening is configured to be complementary to the first part of the first bracket, such that when the second bracket is stacked above the first bracket, the first part of the first bracket fits into the second opening, thereby forming the modular component of the surgical implant.

2. The modular component of the surgical implant according to claim 1, wherein the modular component is a cylindrical modular component.

3. The modular component of the surgical implant according to claim 2, wherein each of the first opening and the second opening is a lateral opening within the range of 60° to 120°.

4. The modular component of the surgical implant according to claim 1, wherein the first bracket further comprises a first pin disposed on the top of the first part of the first bracket and a first groove disposed on the bottom of the second part of the first bracket.

5. The modular component of the surgical implant according to claim 1, wherein the second bracket further comprises a second pin disposed on the top of the first part of the second bracket and a second groove disposed on the bottom of the second part of the second bracket.

6. The modular component of the surgical implant according to claim 4, further comprising a replacement bracket having a third groove, such that when the replacement bracket is stacked above the second part of the second bracket, the first pin of the first bracket fits into the third groove of the replacement bracket.

7. The modular component of the surgical implant according to any one of claims 5 and 6, further comprising a second replacement bracket having a third pin, such that when the second replacement bracket is stacked below the second bracket, the third pin of the second replacement bracket fits into the second groove of the second bracket.

8. The modular component of the surgical implant according to any one of claims 4 to 7, wherein the first pin, the second pin, the third pin, the first groove, the second groove and the third groove are each rectangular in shape.

9. The modular component of the surgical implant according to any one of the preceding claims, wherein the modular component of the surgical implant comprises a bioabsorbable material.

10. The modular component of the surgical implant according to claim 9, wherein the bioabsorbable material is a porous bioabsorbable material, and the pore size of the porous bioabsorbable material is 0.4 mm to 4 mm.

11. The surgical implant modular component according to claim 9 or 10, wherein the bioabsorbable material is a polymer, a salt, or a composite material.

12. The surgical implant modular component according to claim 11, wherein the polymer or the composite material comprises a polycaprolactone (PCL)-based polymer.

13. The surgical implant modular component according to claim 12, wherein the composite material is doped with one or more metals.

14. The surgical implant modular component according to any one of claims 1 to 13, for treating a bone defect of a subject.

15. The surgical implant modular component according to claim 14, wherein the bone defect is a long bone defect selected from the femur, tibia, and humerus.

16. The surgical implant modular component according to claim 14, wherein the size of each of the first stent, the second stent, the alternative stent, and the second alternative stent is customized for an individual subject.

17. The surgical implant modular component according to claim 16, wherein the size of each of the first stent, the second stent, the alternative stent, and the second alternative stent is determined by computed tomography (CT) scan.

18. The surgical implant modular component according to claim 16, wherein the customized stent is prepared by additive manufacturing.

19. A method for treating a bone defect of a subject, comprising inserting the surgical implant modular component according to claim 1 into the subject.

20. The method according to claim 19, wherein the bone defect is a long bone defect selected from the femur, tibia, and humerus.

21. A method for manufacturing the surgical implant modular component according to claim 1, the method comprising: determining a suitable size of the surgical implant; mixing one or more reagents to form each of the first stent and the second stent; and stacking the second stent above the first stent, thereby forming the surgical implant modular component.

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