Expanded spinal fusion cage

3D printed expandable spinal fusion cages address the challenge of limited passage sizes in minimally invasive surgery by expanding to a stable configuration at the surgical site, enhancing bone integration and offering drug delivery capabilities.

JP7871986B2Active Publication Date: 2026-06-09DEPUY SYNTHES PROD INC +1

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
DEPUY SYNTHES PROD INC
Filing Date
2022-01-06
Publication Date
2026-06-09

AI Technical Summary

Technical Problem

Existing minimally invasive spinal surgery procedures face challenges in using larger devices like fusion cages due to limited passage sizes, necessitating the development of devices that can be introduced through small openings and expand at the surgical site.

Method used

The use of 3D printed expandable spinal fusion cages that transition from a compressed state to a predetermined shape, utilizing elastic and metamaterial expansions, allowing insertion through small passages and expanding to a stable configuration at the surgical site, with features like controlled geometric shapes and materials promoting osseointegration and drug delivery.

Benefits of technology

Enables minimally invasive implantation with reduced incision size and healing time, providing structurally stable cages that promote bone integration and can act as drug delivery platforms, reducing foreign body presence post-fusion.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed herein are embodiments of an expansion spinal fusion cage that includes an expandable cage assembly configured to expand from a collapsed state to an expanded state within an intervertebral space when inflated with a material. The assembly can include an expandable section defining an interior volume, the expandable section configured to receive the material and expand the interior volume in response to pressure from the received material to transition the expandable cage assembly from the collapsed state to the expanded state, and a stabilizing section configured to restrain the expandable section during expansion.
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Description

Technical Field

[0001] The present disclosure relates to methods and devices for stabilizing spinal motion between two adjacent vertebrae, and more particularly, to such methods and devices that utilize an expandable spinal fusion cage that can be inserted into the intervertebral space in a collapsed state and then expanded or dilated within the intervertebral space.

Background Art

[0002] Minimally invasive surgical (MIS) and / or microscopic surgical procedures are increasingly being used to perform spinal surgery (e.g., resection, decompression, and fusion). These procedures can have several advantages, including reducing the risk of patient injury and shortening recovery time. Such procedures are typically performed using various access ports or retractors that provide a passage from the skin surface to the spine and the intervertebral disc space. These ports and retractors often provide a passage of a minimum size, perhaps with a diameter of about 30 mm or less, in order to minimize tissue trauma and successfully traverse narrow anatomical passages such as the anatomical window of Kambin's triangle in the spine.

[0003] These minimally invasive procedures and / or microscopic surgical procedures may require new instruments, devices, and methods suitable for use in the limited-sized passages provided by various ports or retractors. As an example, certain larger devices, whether implantable devices such as fusion cages or other related instruments, cannot pass through the narrow openings and thus cannot be used in minimally invasive procedures and / or microscopic surgical procedures.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Therefore, there is a need for improved surgical devices and methods, including improved spinal fusion cages, which can be used in minimally invasive procedures where it is necessary to pass the device to the surgical site through a small or restricted passage. [Means for solving the problem]

[0005] The devices and methods disclosed herein address the aforementioned need by providing devices that have a compressed state and an expanded state, thereby allowing introduction through a smaller working channel while in the compressed state and subsequent expansion at the surgical site. More specifically, the devices and methods described herein utilize advances in the ability to 3D print or additively manufacture highly complex geometric shapes and encapsulated structures, as well as multiple materials within a single structure, to enable the design of intervertebral disc replacement devices having advanced geometric shapes or mechanisms for uniform expansion into complex or asymmetric shapes through a highly controlled process.

[0006] Certain aspects of the present disclosure provide a 3D printed spinal fusion cage that expands from a compressed size to a predetermined shape and size for implanting the spinal fusion cage into the intervertebral space of a patient through a minimally invasive method.

[0007] Two exemplary embodiments of this disclosure include an expandable spinal fusion cage device that utilizes elastic expansion and metamaterial expansion. Other exemplary embodiments are within the scope of this disclosure and include, for example, implementations that utilize both elastic expansion and metamaterial expansion. In addition, other expansion configurations are described herein, and the two exemplary embodiments described above are provided merely as examples of this disclosure, and the differences between the exemplary embodiments are provided to aid in explaining the overall concept.

[0008] Specific embodiments of elastic expansion cage devices include, for example, integrated structures that include specific geometric shapes to ensure controlled expansion into a defined shape and structure. For example, a soft object that can be inserted between vertebrae using the current MIS method and can be expanded from a simple compressed shape to a complex, structurally stable cage device by inflating with a gas, fluid, or semi-solid material mixture.

[0009] Certain embodiments of metamaterial expansion cage devices include, for example, a multimaterial system in which a bag or pouch with surrounding 3D printed structures that provide structural stability and control is inserted between vertebrae and inflated. For example, a mesh bag in which a collapsible 3D printed structure or scaffold is printed directly onto a mesh material that acts as a physical support for the inflation of the mesh bag or pouch.

[0010] One exemplary embodiment of the present disclosure is an expandable cage assembly configured to expand from a collapsed state to an expanded state within an intervertebral space when inflated by a material. The expandable cage assembly includes an expandable section that defines an internal volume and is configured to receive a material and expand the internal volume in response to pressure from the received material, thereby transitioning the expandable cage assembly from a collapsed state to an expanded state; and a stabilizing section configured to restrain the expandable section during expansion.

[0011] In some cases, the stabilizing section surrounds the expandable section at least partially, and the stabilizing section is sized and molded to define at least a portion of the outer perimeter of the expandable cage assembly.

[0012] In some cases, the inflatable section surrounds the stabilizing section, and the stabilizing section is bonded to the stabilizing section so as to hold the inflatable section.

[0013] In some cases, at least one of the inflatable section and the stabilizing section includes 3D printed material. In some cases, at least one of the inflatable section and the stabilizing section includes a one-piece structure. In some cases, the one-piece structure includes 3D printed material. In some cases, the inflatable section includes a woven substrate. In some cases, the stabilizing section includes a 3D printed scaffold. In some cases, the stabilizing section includes a tubular woven structure configured to be filled with material.

[0014] In some cases, at least one of the expandable section and the stabilizing section includes a porous structure configured to allow interaction between the material and the intervertebral space.

[0015] In some cases, the expandable cage assembly defines one or more void channels, each void channel being formed continuously through a stabilizing section and an expandable section. In some cases, the void channels are configured to receive bone graft material.

[0016] In some cases, the stabilizing section includes a rigid structure. In some cases, the rigid structure defines one or more ribs positioned to facilitate the deflection or deformation of the stabilizing section around the expandable section when the expandable section moves the expandable cage assembly from a collapsed state to an expanded state. In some cases, the rigid structure defines one or more sections positioned to expand in a nesting manner when the expandable section moves the expandable cage assembly from a collapsed state to an expanded state.

[0017] In some cases, at least one of the expandable section and the stabilizing section includes a reabsorbable biomaterial configured to be reabsorbed into the body after fusion has occurred.

[0018] In some cases, at least one of the inflatable section and the stabilizing section includes an implantable organic material configured to promote osseointegration. In some cases, the implantable organic material includes at least one of hyaluronic acid, collagen, protein, and patient cells from a bone graft. In some cases, at least one of the inflatable section and the stabilizing section includes an implantable material configured to promote osseointegration, such as a phosphate.

[0019] In some cases, at least one of the expandable section and the stabilizing section contains the embedded active pharmaceutical compound.

[0020] In some cases, the expandable cage assembly has an asymmetrical shape when expanded.

[0021] In some cases, when extended, the upper surface of the expandable cage assembly is inclined relative to the lower surface of the expandable cage assembly.

[0022] In some cases, the expandable cage assembly is formed from multiple materials.

[0023] In some cases, the expandable section and the stabilizing section are formed from different materials.

[0024] The intervertebral disc implant according to claim 1, wherein the expandable section comprises a plurality of chambers, each of which chambers can be filled with material, and the expanded shape of the intervertebral disc implant is a function of which of the plurality of chambers is filled with material.

[0025] The intervertebral disc implant according to claim 1, comprising at least one additional structural component attached to the intervertebral disc implant, wherein the additional structural component is configured to improve fixation in the intervertebral space.

[0026] The intervertebral disc implant according to claim 1, wherein the expandable section includes a core expansion region configured to be filled with a material and an outer expansion region configured to be filled with a bioactive substance.

[0027] Another exemplary embodiment is an intervertebral disc implant that includes an expandable structure configured to elastically expand from a collapsed state to an expanded state within the intervertebral space when expanded by a material. The expandable structure includes sidewalls that define an internal chamber configured to receive a material and, in response to pressure from the received material, elastically expand at least a portion of the sidewalls to transition the expandable structure from a collapsed state to an expanded state. The sidewalls have a variable thickness across the surface of the expandable structure configured to control different expansion rates of the structure during expansion. In some cases, the implant includes a structured lattice configured to provide a conformal shape to the sidewalls at least at a given pressure. In some cases, the implant includes a damping mechanism that includes one or more independently filled lattice channels of the structured lattice.

[0028] In some cases, the expandable structure includes a porous outer layer configured to enable interaction between the material and the intervertebral space.

[0029] In some cases, the expandable structure defines one or more void channels configured to receive a bone graft material in an expanded state.

[0030] In some cases, the outer surface of the expandable structure defines protrusions configured to enhance fixation between the outer surface and the surface of the intervertebral space. In some cases, the expandable structure is monolithic.

[0031] In some cases, the internal chamber includes a plurality of chambers each of which is capable of being filled with a material, and the expanded shape of the intervertebral disc implant is a function of which of the plurality of chambers are filled with the material.

[0032] In some cases, the intervertebral disc implant includes at least one additional structural component attached to the intervertebral disc implant, the additional structural component being configured to improve fixation in the intervertebral space.

[0033] In some cases, the internal chamber includes a core expansion region configured to be filled with material and an external expansion region configured to be filled with a bioactive substance.

[0034] Another exemplary embodiment is a surgical method which includes inserting a spinal fusion cage into the intervertebral space of a patient while the cage is in a collapsed state, expanding the spinal fusion cage from a collapsed state to an expanded state by injecting a certain volume of fluid material into the internal chamber of the inflatable section of the spinal fusion cage, and using a stabilizing structure coupled to the inflatable section to restrain the shape of the spinal fusion cage to the expanded state.

[0035] Another exemplary embodiment is a method for manufacturing a surgical implant, the method comprising forming an expandable substrate from a first material and forming a stabilizing structure on the substrate from a second material using an additive manufacturing process that deposits multiple layers of a second material onto each other.

[0036] In some cases, the expandable substrate is a woven tubular structure. In some cases, the woven tubular structure is elastically expanded on a mandrel before a stabilizing structure is formed on top of the woven tubular structure. In some cases, the formation of the expandable substrate is carried out using an additive manufacturing process. In some cases, the additive manufacturing process is one of the following: jetting, extrusion, and fused deposition modeling, powder bed fusion, vat photopolymerization, binder jetting, material extrusion, induction energy application, selective laser sintering, material jetting, and sheet lamination.

[0037] In some cases, the expandable structure includes an integrated expandable structure. In some cases, the expandable state defines a first expandable shape when the expandable structure expands in free space, and a second expandable shape when the expandable structure expands in an intervertebral space, wherein the first expandable shape is at least a function of the pressure of the expandable structure and material, and the second expandable shape is at least a function of the pressure of the expandable structure and material and the properties of the intervertebral space. In some cases, the first expandable shape is a function of the target shape of the second expandable shape in the intervertebral space. In some cases, the first expandable shape defines a first surface and a second surface, wherein the orientation between the first surface and the second surface is a function of the target orientation of the first surface and the second surface in the second expandable shape.

[0038] In some cases, some or all of the components of the extended spinal fusion cage are 3D printed using a butt extrusion process, thereby extruding the material into a butt of suspension.

[0039] In some cases, some or all of the components of the extended spinal fusion cage are 3D printed using a melt-deposition modeling process, thereby extruding thermoplastic material onto various flat or multi-planar substrates.

[0040] In some cases, some or all of the components of the extended spinal fusion cage are 3D printed, thereby spraying single or combined elastic and solid materials onto various substrates.

[0041] In some cases, the extended spinal fusion cage includes a 3D woven structure, which is first manufactured using a digital weaving process and then incorporated into a 3D printing process as a substrate for printing.

[0042] Certain embodiments of this disclosure offer advantages to surgeons and patients. For example, embodiments include cage-like devices with smaller compression / pre-insertion volumes that reduce the required incision size and, therefore, the required healing time. Some embodiments provide cage-like devices that expand to a final shape having multiple planes at various angles, e.g., lordotic, vertical, and horizontal. Some embodiments provide novel and functionally superior expansion cage devices that are sufficiently different from conventional solutions (e.g., mechanically actuated cages) and can act as platform technologies for future spinal and orthopedic products.

[0043] Some aspects of this disclosure include expansion cage devices having reabsorbable biomaterials. For example, certain implementations may include cage devices in which some or all of the materials that make up the device are reabsorbed into the body after sufficient fusion has occurred. This is an advantage over conventional spinal cage products, which remain in the patient's body as useless and non-functional foreign bodies once fusion has occurred.

[0044] Some aspects of this disclosure include expansion cage devices in which an embedded organic material is used in all or part of the structure of the cage device. In some examples of both elastic and metamaterial embodiments, the organic material and compound is incorporated into the printing material and / or substrate. The embedded organic material and compound allows for the addition of beneficial organic compounds and molecules such as hyaluronic acid, collagen, and proteins, which in some implementations help promote bone integration. In some implementations, the patient's own cells (graft) can be incorporated into the printing material that constitutes the patient's individual implant. In some implementations, an inorganic material such as calcium phosphate is embedded.

[0045] Some aspects of this disclosure include implantable medical components and expansion cage devices with active pharmaceutical ingredients. In some examples of embodiments of elastic and metamaterials, active pharmaceutical ingredients, molecules, and compounds can be incorporated into printing materials and / or substrates. Implementation forms including implantable medical components can enable the implant to have a secondary function as a drug delivery platform for anti-inflammatory agents, antibiotics, or other pharmaceuticals, with the aim of reducing the risk of infection and improving overall recovery time. [Brief explanation of the drawing]

[0046] This disclosure will be better understood by reading the following detailed description in conjunction with the attached drawings. [Figure 1A] Examples of two different embodiments of an extended spinal fusion cage according to aspects of this disclosure. [Figure 1B] Examples of two different embodiments of an extended spinal fusion cage according to aspects of this disclosure. [Figure 2A] These are examples of the collapsed and expanded states of an embodiment of an elastic expansion cage device, respectively. [Figure 2B] These are examples of the collapsed and expanded states of an embodiment of an elastic expansion cage device, respectively. [Figure 3A] This is an example of an embodiment of an elastic expansion cage device having different shape profiles. [Figure 3B] This is an example of an embodiment of an elastic expansion cage device having different shape profiles. [Figure 3C] This is an example of an embodiment of an elastic expansion cage device having different shape profiles. [Figure 4A] These are perspective and cross-sectional views of an embodiment of an elastic expansion cage device. [Figure 4B] These are perspective and cross-sectional views of an embodiment of an elastic expansion cage device. [Figure 5A] These are perspective and cross-sectional views of another embodiment of an elastic expansion cage device. [Figure 5B]These are perspective and cross-sectional views of another embodiment of an elastic expansion cage device. [Figure 6A] This is an example of an alternative embodiment of an elastically expandable cage device. [Figure 6B] This is an example of an alternative embodiment of an elastically expandable cage device. [Figure 6C] This is an example of an alternative embodiment of an elastically expandable cage device. [Figure 7A] This is an exemplary procedure for replacing an intervertebral disc with an elastic expansion cage device. [Figure 7B] This is an exemplary procedure for replacing an intervertebral disc with an elastic expansion cage device. [Figure 7C] This is an exemplary procedure for replacing an intervertebral disc with an elastic expansion cage device. [Figure 7D] This is an exemplary procedure for replacing an intervertebral disc with an elastic expansion cage device. [Figure 8A] This is an example of an embodiment of a metamaterial cage device that demonstrates an expansion process. [Figure 8B] This is an example of an embodiment of a metamaterial cage device that demonstrates an expansion process. [Figure 8C] This is an example of an embodiment of a metamaterial cage device that demonstrates an expansion process. [Figure 8D] This is an example of an embodiment of a metamaterial cage device that demonstrates an expansion process. [Figure 9A] These are schematic cross-sectional views of two alternative extension cage device embodiments having an external stabilization structure. [Figure 9B] These are schematic cross-sectional views of two alternative extension cage device embodiments having an external stabilization structure. [Figure 9C] These are schematic cross-sectional views of two alternative extension cage device embodiments having an external stabilization structure. [Figure 9D] These are schematic cross-sectional views of two alternative extension cage device embodiments having an external stabilization structure. [Figure 10A]These are schematic cross-sectional views of two alternative expansion cage device embodiments having an internal stabilization structure. [Figure 10B] These are schematic cross-sectional views of two alternative expansion cage device embodiments having an internal stabilization structure. [Figure 10C] These are schematic cross-sectional views of two alternative expansion cage device embodiments having an internal stabilization structure. [Figure 10D] These are schematic cross-sectional views of two alternative expansion cage device embodiments having an internal stabilization structure. [Figure 10E] These are schematic cross-sectional views of two alternative expansion cage device embodiments having multiple internal chambers. [Figure 10F] These are schematic cross-sectional views of two alternative expansion cage device embodiments having multiple internal chambers. [Figure 10G] This is a schematic cross-sectional view of an embodiment of an alternative expansion cage device in which additional structural components are attached to the top and bottom surfaces to improve fixation. [Figure 11A] This is an example of an exemplary procedure for replacing an intervertebral disc with a metamaterial expansion cage device. [Figure 11B] This is an example of an exemplary procedure for replacing an intervertebral disc with a metamaterial expansion cage device. [Figure 11C] This is an example of an exemplary procedure for replacing an intervertebral disc with a metamaterial expansion cage device. [Figure 11D] This is an example of an exemplary procedure for replacing an intervertebral disc with a metamaterial expansion cage device. [Figure 12A] This is an example of an exemplary extrusion process for manufacturing an expansion cage device. [Figure 12B] This is an example of an exemplary extrusion process for manufacturing an expansion cage device. [Figure 12C] This is an example of an exemplary extrusion process for manufacturing an expansion cage device. [Figure 13A] This is an example of an exemplary material injection process for manufacturing an expandable cage device. [Figure 13B] This is an example of an exemplary material injection process for manufacturing an expandable cage device. [Figure 13C] This is an example of an exemplary material injection process for manufacturing an expandable cage device. [Figure 14A] This is an example of an exemplary process for manufacturing a woven tubular structure for use within an expansion cage device. [Figure 14B] This is an example of an exemplary process for manufacturing a woven tubular structure for use within an expansion cage device. [Figure 15A] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 15B] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 15C] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 15D] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 15E] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 16A] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 16B] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 16C] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 16D] This is an example of an exemplary process for manufacturing an expansion cage device. [Figure 16E] This is an example of an exemplary process for manufacturing an expansion cage device. [Modes for carrying out the invention]

[0047] Herein, specific exemplary embodiments are described to provide an overall understanding of the structure, function, manufacturing and use principles of the apparatus and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatus and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of this disclosure is defined solely by the claims. Features illustrated or described in relation to one exemplary embodiment can be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of this disclosure.

[0048] Certain aspects of this disclosure provide an expandable spinal fusion cage that expands from a compressed size to a predetermined shape and size, enabling implantation of the spinal fusion cage through a minimally invasive method.

[0049] In some embodiments, some or all of the components of the augmented spinal fusion cage are 3D printed. Also known as additive manufacturing, 3D printing of components allows for the creation of highly complex and / or encapsulated geometric shapes, which in certain embodiments provide additional control over the expansion or inflation bag, or balloon-like portion, of the augmented spinal fusion cage. As will be discussed in more detail below, 3D printing of components of an augmented spinal cage device offers benefits such as the creation of multiple materials with high precision within the same part, and the ability to calibrate expansion behavior through variable elasticity property control. Additionally, 3D printing systems can be reconfigured to print on multiple axes and on multiple substrates, which enables hybrid printing on other functional devices, materials, and substrates.

[0050] Overview Herein, two categories of embodiments are described as exemplary embodiments of the present disclosure. The first category includes expandable spinal fusion cages having elastically expandable structures. For example, a one-piece structure including a defined shape and specific geometric shape to ensure controlled expansion into the structure. For example, a soft object that can be inserted between vertebrae using current MIS methods and can be expanded from a simple compressed shape to a complex, structurally stable cage device by inflating with a gas, fluid, or semi-solid material mixture. The second category includes expandable spinal fusion cages including stabilizing structures arranged to allow expansion of expansion material (e.g., a woven bag or metamaterial). For example, a multi-material system in which a bag or pouch with a 3D printed structure surrounding it that provides structural stability and control is inserted between vertebrae and expanded. For example, a mesh bag in which a collapsible 3D printed structure or scaffold is printed directly onto a mesh material that acts as a physical support for the expansion of the mesh bag or pouch. These two categories do not need to be distinct from each other, and some aspects of this disclosure include embodiments that have features of both categories, for example, stabilizing structures arranged to allow expansion of elastic materials.

[0051] Certain aspects of the present disclosure include a "two-part" system having an expandable spinal fusion cage / pouch element of a system implanted and positioned between vertebrae, and a second main component and / or process which is the expansion and final fixation of the device in the intervertebral space. In some cases, the secondary component may be an injectable medium used to expand the expandable spinal fusion cage after it has been inserted into the intervertebral space. The injectable medium can provide the cage with the long-term stability and fixation required (e.g., resistance to intervertebral compression or collapse) and may be a bone cement known to those skilled in the art, such as DePuy Synthes SMARTSET PMMA bone cement, or other suitable medium. Aspects of the present disclosure also include an expandable spinal fusion cage configured to be used with an injectable medium accompanied by additional pharmaceutical compounds and / or antibiotics that enhance functionality while potentially mitigating any potential rejection / inflammation caused by the cage material. Furthermore, certain aspects include the use of 3D printed materials combined with elastic materials and complex geometric shapes to create a structure that deforms or expands in a controlled manner.

[0052] Figures 1A and 1B are examples of two different embodiments of an expandable spinal fusion cage according to aspects of the present disclosure. Figure 1A shows an expandable spinal fusion cage 100 including a body 110 defining an internal volume 120. The expandable spinal fusion cage 100 (also referred to herein as the expansion cage) is shown in an expanded state, thereby expanding from an initial collapsed state (not shown) as a result of expansion material being pumped into the internal volume 120. The body 110 also defines an access port 140 to the internal volume 120, which allows for the delivery of expansion material (e.g., bone cement, gas, liquid, etc.) into the internal volume 120 during the expansion operation. In some cases, the body 110 of the expansion cage 100 is configured to elastically expand from a collapsed state to an expanded state. In some cases, the body 110 of the expansion cage 100 is constructed from a single material and configured to elastically expand the expansion cage 100 from a collapsed state to an expanded state of intervertebral space.

[0053] Figure 1B shows another expandable spinal fusion cage 200 having an aspect of the present disclosure. The expandable spinal fusion cage 200 includes a textile substrate 230 defining an internal volume 220 and a stabilizing structure 210 defining the external size and shape of the expandable cage 200 by at least partially restraining the textile substrate 230 (e.g., the expansion structure). The expandable cage 200 is shown in an expanded state, thereby expanding from an initial collapsed state (not shown) as a result of the expansion material being pumped into the internal volume 220. The expandable cage 200 also defines an access port 240 to the internal volume 220, which allows for the delivery of the expansion material (e.g., bone cement, etc.) into the internal volume 220 during the expansion operation.

[0054] In practice, after preparing the patient's intervertebral space to receive the implant, the expansion cages 100 and 200 can be inserted into the intervertebral space in a collapsed state to pass through the limited spatial access dimensions to the intervertebral space. After insertion, expansion material can be injected into the internal volumes 120 and 220 of the expansion cages 100 and 200, thereby deforming the expansion cages 100 and 200 from their collapsed state to their final expanded state, which is not necessarily the initial expanded state shown in Figure 1A, due to the characteristics of the intervertebral space of a particular patient. Instead, Figures 1A and 1B can illustrate either a "free" expanded state in which the expansion cages 100 and 200 are expanded outside the intervertebral space, or a "designed" expanded state illustrating the designed size and shape of the expansion cages 100 and 200 when expanded within the intervertebral space. In some cases, the free expanded state and the designed expanded state may differ, while in other cases, they may be similar. In practice, the true final shape of the expansion cages 100 and 200 in the intervertebral space can be a combination of both free-expanded and designed-expanded states, depending on the geometric shape of the expansion cages 100 and 200, as well as the materials on which the main body 110 (Figure 1A), scaffolding 210, and / or textile base material 230 (Figure 1B) are constructed.

[0055] Examples of elastic expansion cages Figures 2A and 2B show examples of the collapsed and expanded states of an embodiment of an elastic expansion cage device, respectively. Figure 2A shows the expansion cage 100 in the collapsed state, and Figure 2B shows the expansion cage 100 of Figure 2A in the expanded state. In this example, the height 118 of the body 110 of the expansion cage 100 in the collapsed state (Figure 2A) is reduced compared to the height 119 of the body 110 in the expanded state (Figure 2B). In implementation, an expansion material (e.g., bone cement, etc.) can be pumped into the internal volume 120 of the body 110 in the collapsed state, and the pressure of the expansion material can deform the body 110 from the collapsed state to the expanded state, as shown in Figure 2B.

[0056] In some cases, the body 110 can be made from a material that is elastic enough to allow the expansion cage 100 to elastically expand from a collapsed state to an expanded state. In some cases, the body 110 can be constructed in a shape that allows the body 110 to expand and contract with only a portion of the body deformed. For example, the body 110 may have a bellows portion. In some cases, the body 110 can be constructed with one or more expansion joints such that the elasticity of the body material is not required to expand or contract the body 110. In some cases, the body can be constructed from a material that is elastic enough to allow the expansion cage 100 to elastically expand from a collapsed state to an expanded state. In some cases, the elastic expansion cage 100 can also define one or more void channels 170 passing through the body 110, which can allow materials such as bone grafts to be integrated with the expansion cage 100. Such channels can also allow natural bone growth of the patient (e.g., facilitating the fusion process) through implantation and subsequent surgical procedures.

[0057] In some embodiments, the expansion cage 100 may be configured to be initially in an expanded state, deform into a smaller, flattened state for insertion into the intervertebral space, and then expand to a new expanded state by an expansion material. In some embodiments, the body 110 may be constructed of a material that can be elastically deformed to allow the expansion cage 100 to be deformed into a flattened state (e.g., folded, rolled up, crushed, etc.). In some cases, the expansion cage 100 may be configured to initially deform from an initial expanded state to a flattened state during insertion into the intervertebral space, and then elastically expand to a final expanded state that at least partially exceeds the size of the initial expanded state (e.g., at least a portion of the body 110 of the expansion cage 110 may be elastically expand to the final expanded shape during the expansion operation). In some cases, the actual shape of the expansion cage 100 within the intervertebral space after the expansion operation is at least partially a function of the characteristics of the patient's spine (e.g., the body 110 forms up to the volume and / or shape of the vertebra), the final expansion pressure of the expansion medium, and the material and geometric properties of the body 110 (e.g., areas of thicker body 110 expand less than areas of relatively thinner body 110).

[0058] Figures 3A to 3C show examples of embodiments of elastic expansion cage devices having different shape profiles. The size and shape of the expansion cages 100, 200 can be configured in many different ways. For example, the expansion cages 100, 200 may have shapes specifically designed for the anatomical structure of the patient's bone. The expansion chambers 100, 200 may also have expansion shapes designed, for example, to modify the intervertebral space during expansion, or to interface with existing implants or devices present in the intervertebral space. The following are three examples illustrating parameters of the expansion cages 100, 200 that can be modified, but embodiments of this disclosure can be modified in many different ways, and these embodiments are merely non-limiting examples of the types of parameters that can be designed or customized for a given application or patient. In some cases, the expansion cages 100, 200 may have more than one chamber for expansion, and these chambers may or may not be connected to each other. This is illustrated in more detail in Figures 10E and 10F. In some cases, multiple chambers can be selectively filled to conform to or enhance a specific shape of the patient's anatomical structure (e.g., the patient's spine).

[0059] Figures 3A and 3B illustrate different aspects of the present disclosure for providing various options for lordosis angle, vertical angle, horizontal angle (occupancy area), and interfacial angle according to patient needs. Figure 3A shows, for example, an expansion cage 301 having a body 311 that is substantially cylindrical in shape and defines a top surface 351 and a bottom surface 361 of substantially the same size and orientation, with the height 318 of the body 311 extending between the bottom surface 361 and the top surface 351. The expansion cage 301 is shown in its expanded state, but compared to the height 119 of the expansion cage 100 in Figures 1A and 2B in its expanded shape, the expansion cage 301 in Figure 3A defines a reduced height 318, which may be designed to integrate with patients with lower intervertebral space height, for example.

[0060] Figure 3B shows an expansion cage 302 having a body 312 that is substantially cylindrical in shape and defines a top surface 352 and a bottom surface 362 that are substantially the same size as but have different orientations compared to the arrangement in Figure 3A. In Figure 3B, the expansion cage 302 is shown in an expanded state, and the top surface 352 defines an inclined surface 382 which may be designed to integrate with the adjacent vertebral surface of the patient having a similarly inclined angle with respect to the opposing vertebral surface (for example, to integrate with the bottom surface 362 of the expansion cage 302). In other words, in some embodiments, the various surfaces or faces of the expansion cage may be parallel to each other, while in other embodiments, the various surfaces or faces may be non-parallel to each other, e.g., inclined, perpendicular, etc. In the illustrated embodiment in Figure 3B, as an example, the top surface or top surface 352 of the cage 302 may be inclined with respect to the bottom surface or bottom surface 362 of the cage. Furthermore, in some embodiments, the cage 302 may have an asymmetrical shape, or a shape that is asymmetrical in at least one view. For example, from the perspective of the diagram, the right half of cage 302 in Figure 3B is not symmetrical to the left half of the cage.

[0061] Figure 3C shows an expansion cage 303 having a main body 313, which has a roughly conical shape and defines a top surface 353 and a bottom surface 363 that are of a similar orientation but of a different size compared to the arrangement in Figure 3A. In Figure 3C, the expansion cage 303 is shown in its expanded state and defines a conical circumferential surface 338 that defines the corresponding size difference between the top surface 353 and the bottom surface 363.

[0062] In some cases, one or more of the height 318, incline 328, or taper 338 of the expansion cage (or parameters certainly known to those skilled in the art) can be designed as a function of the specific patient's anatomical structure, which can be measured or determined before insertion of the expansion cage to manufacture a custom expansion spinal fusion cage for the patient, for example.

[0063] Figures 4A and 4B are perspective and cross-sectional views of an embodiment of an elastic expansion cage device in an expanded state. Figure 4A shows an elastic expansion spinal fusion cage 400, which includes a body 410 made of a material having elastic properties that allows the elastic expansion cage 400 to elastically expand from a collapsed state (not shown) to the expanded state shown in Figures 4A and 4B. The body 410 of the elastic expansion cage 400 defines a substantially hexaplane shape, with five flat surfaces 450 in contact at the corners, and a sixth side defining an expansion valve 440 configured to allow expansion material to be delivered to the internal volume 420 of the body 410, as shown in Figure 4B. Figure 4B shows the expansion valve 440 connected to the internal volume 420 by an expansion channel that penetrates the body 410. The body 410 defines a plurality of internal wall protrusions 411 that form the internal volume 420. The inner wall projection 411 defines the variable thickness of the main body 411, and the variable thickness controls the different expansion rates of the elastic expansion cage 400 during the expansion operation.

[0064] Figures 5A and 5B are perspective and cross-sectional views of another elastic expansion cage embodiment having additional features for enhanced fixation of the expansion cage within the intervertebral space. Figure 5A shows an elastic expansion cage 500, which includes a body 510 (e.g., balloon) made of a material having elastic properties that allows the elastic expansion cage 500 to elastically expand from a flattened state (not shown) to the expanded state shown in Figures 5A and 5B. The body 510 of the elastic expansion cage 500 defines a substantially hexagonal shape, with five flat surfaces in contact at the corners, and a sixth side defining an expansion valve 540 configured to allow expansion material to be delivered into the internal volume 520 of the body 510, as shown in Figure 5B. The top surface 550 and bottom surface (560 in Figure 5B) of the main body 510 include a plurality of intersecting projections 551 that define a texture on the surface of the top surface 550, which can improve fixation and prevent movement of the cage after implantation (for example, a textured surface can better grip or provide more friction with the vertebral end plate on which they are placed). The cage also includes a plurality of void channels 571 extending from the top surface 550 to the bottom surface (560 in Figure 5B). As described above, these void channels can be used to promote bone growth through the implant, as well as to package and deliver various bone induction agents or otherwise therapeutic agents. In some cases, the main body 510 is configured to have additional structural components attached to the main body 510 and configured to improve fixation in the intervertebral space. For example, top and bottom plates, such as metal and plastic components, attached to the corresponding top and bottom surfaces of the main body 510.

[0065] Figure 5B shows an expansion valve 540 connected to an internal volume 420 by an expansion channel 541 that penetrates the main body 510. The main body 510 defines a plurality of internal wall projections 511 that form the internal volume 520. The internal wall projections 411 define a variable thickness of the main body 511, which controls different expansion rates of the elastic expansion cage 500 during the expansion operation. The main body 510 also defines a plurality of void channels 571 that span between the top surface 550 and the bottom surface 560. As described above, the void channels 571 can allow direct material connections to exist throughout the elastic expansion cage 500 in the intervertebral space, for example, between two opposing vertebral surfaces. Direct material connections can be used to allow, for example, packaging of bone grafts and delivery of bone graft material into the intervertebral space to promote ossification around the elastic expansion cage 500 after implantation.

[0066] Figures 6A–6C illustrate examples of alternative embodiments of elastic expansion cage devices in which a lattice structure is incorporated in the center of an elastically expandable annular (e.g., donut-shaped) body to control the variable expansion rate and to enable final bone integration. Figure 6A shows an elastically expandable spinal fusion cage 600 including an annular body 610 in a collapsed state. In the center of the body 610 is a lattice structure 680 coupled to the body 610. Figure 6B shows the elastic expansion cage 600 in an expanded state, where the body 610 has elastically expanded after being filled with an expansion medium. In some embodiments, the lattice structure 680 can be stretched or otherwise deformed during the expansion process.

[0067] In practice, the structural and material properties of the lattice structure 680 can control the expansion rate and / or final shape of the body 610, for example, by allowing greater vertical expansion than horizontal expansion, or by several other combinations of dynamic dimensional relationships that are functions of the lattice itself and / or the connection of the body 610 to the lattice 680. Figure 6C shows a perspective view of the elastic expansion cage 600 with the internal volume 620 of the body visible. Figure 6C shows the lattice 680 from the initial collapsed state in Figure 6A, and that overall, the device expands vertically (V) and the corresponding expansion of the lattice 680 is less (or negative) in the horizontal direction (H). Other suppressions during the expansion of the body 610 can be achieved by changing the properties or structure of the lattice structure 680, for example, by allowing horizontal expansion with limited vertical expansion.

[0068] Figures 7A–7D illustrate exemplary procedures for replacing an intervertebral disc with an elastic expansion cage device. Figure 7A shows a section of the patient's spine 790 from which degenerated intervertebral disc material 799 is removed from the intervertebral space 791. Next, as shown in Figure 7B, an elastic expansion spinal fusion cage 100 is implanted and positioned in the intervertebral space 791 from which the waste material has been removed, while it is in a collapsed or suppressed state, using an implant instrument 780. Next, as shown in Figure 7C, an expansion medium 719 (e.g., medical cement or bone cement) is pumped into the elastic expansion spinal fusion cage 100 to cause elastic expansion of the expansion cage 100. When the expansion medium 719 is filled into the expansion cage 100, the expansion medium can provide a solid weight support structure for the intervertebral space 791. Figure 7D shows the patient's spine 790 after surgery, where the elastic material of the main body 110 of the expansion cage 100 is bioreabsorbed over time, and the hardened cement 719 is used as a scaffold to bring forth the patient's own bone material 798 that forms between adjacent vertebrae.

[0069] Exemplary materials The selection of materials for embodiments of the elastic expansion cage 100 is, at least in part, a function of the desired design requirements. For example, the material must withstand internal pressure, chemicals, and heat from the injected medium. In some cases, expansion can generate pressures of up to 800 N, and in other cases up to 100 N, and in other cases up to 1500 N. In addition, the material must be elastically expandable to provide the desired expansion from a compressed state to an expanded state. In some implementations, the body material of the elastic cage may be able to expand to up to about 280% without rupturing. In some cases, the elastic expansion cage 100 may be able to withstand expansion pressures of up to about 25 bar. In some cases, the elastic expansion cage 100 may be able to withstand pressures of up to about 16,000 N at the point of final position, and the subsequent hardening of bone cement. In some cases, the material may not be very robust. For example, the expansion cage 100 is expanded under low pressure and then the expansion material (e.g., bone cement) hardens. In this case, the expansion cage 100 does not need to withstand internal pressures as high as those seen when the expanding material is a fluid. In these cases, only the compressive stress capacity of the material of the body walls is tested, in contrast to the structural integrity of the entire cage device.

[0070] In some implementations, the expansion body 110 may be manufactured in a collapsed state (e.g., a pre-expanded state) and then configured to withstand expansion to an expanded state (e.g., expansion) without rupturing. In some implementations, the elastic body 110 may be configured to expand without rupturing when expanding within the intervertebral space. In some cases, the body 110 of the elastic expansion cage 100 may grow to more than twice its original size (e.g., measured by volume or external line dimensions). In some implementations, the body 110 may be manufactured in an expanded state and configured to withstand compression to a collapsed state without tearing or otherwise breaking. In some implementations, the material of the body 110 may be able to withstand any expected temperature or chemical factor without decomposition (e.g., during sterilization). In some implementations, the chemical factor may be a function of the expansion medium used with the body. In some implementations, the material of the expansion cage 100 may be biocompatible, for example, meeting the United States Pharmacopeia (USP) Class VI criteria for biocompatibility.

[0071] In some implementations, the material of the body 110 of the elastic expansion cage 100 can prevent the expansion material from contaminating the implantation area or leaking uncontrollably. In some cases, the material of the body 110 can be configured to expose the expansion medium to the patient's body, but the expansion medium needs to be biocompatible. For example, the body 110 of the expansion cage 100 can contain pores, or the material of the body 110 itself can be a porous material.

[0072] Exemplary materials for embodiments of the expanded spinal fusion cage include polymers that can satisfy both medical and functional requirements for the device. For example, polyisoprene (e.g., Calyflex polyisoprene) can satisfy biocompatibility requirements and exhibit high elongation properties, thereby enabling the required expansion rate (e.g., up to about 280%). Polyisoprene (e.g., synthetic latex) can also exhibit a sufficient Young's modulus for use in the expansion cage. In some cases, the polyisoprene body 110 of the expansion cage 100 can be 3D printed using vat polymerization and / or material jetting techniques.

[0073] Additionally, in some cases, polyisoprene can be sprayed using a method of printing picodot-sized deposits, which allows the sprayed polyisoprene of the body 110 to retain its mechanical properties. In some cases, a semi-porous geometric microstructure can be constructed within the 3D sprayed polyisoprene to better engineer the bioreabsorption rate. Polyester and PET are other biocompatible and biodegradable materials commonly used in medical applications that can be utilized in various aspects and embodiments of this disclosure. Examples include aliphatic polyesters (e.g., PLLA, PLA, PLGA, PGA, PDS, PCL, etc.) that are known to be biocompatible and absorbable. In some cases, additional materials included with the printed structure can induce a response from the surrounding tissue to improve or accelerate the osseointegration of the cage device. In some cases, the additional materials may be used in small amounts throughout the printing process to provide a desirable effect, but may cause other problems, such as biocompatibility, if used in large quantities. In some cases, photocurable structures (e.g., acrylate scaffolding with urethane linkages, etc.) and silicone materials are used in combination with or instead of the above materials.

[0074] 3D printing technology Certain aspects of this disclosure include methods for 3D printing some or all of the structures of an expanded spinal fusion cage according to embodiments disclosed herein. With respect to the elastic expansion cages identified above, several different 3D printing techniques may be used, including, but not limited to, but but including butt extrusion, selective laser sintering, material jetting, and stereolithography.

[0075] Examples of extended cages having metamaterials Figures 8A to 8D show an example of one embodiment of a metamaterial cage (i.e., formed from or having hybrid properties of multiple materials) illustrating the expansion process. Figure 8A shows the expansion cage 200 in a pre-expansion or collapsed state, which has a substantially tubular shape with an inner diameter 280 that is approximately the same size as the expansion valve 240 disposed in the body of the expansion cage 200. In this pre-expansion state, the expansion cage 200 is sized and molded so that it can be inserted into an intervertebral space (e.g., 791 in Figure 7A) via an existing minimally invasive surgical procedure. The expansion cage 200 may include an expansion structure shown as a textile substrate 230 and a stabilizing structure wrapped around the textile substrate 230, shown as a network of 3D scaffolds 210. In some cases, the textile substrate 230 may be a woven textile substrate. The textile substrate 230 defines an internal volume 220 that can be configured to receive an expansion medium for expanding the textile substrate 230. The textile substrate 230 may be expandable to a larger size, and the 3D scaffold 210 may be configured to expand together with the textile substrate 230, or otherwise to allow the expansion of the textile substrate 230 until the 3D scaffold 210 restricts further expansion of the textile substrate 230.

[0076] In their compressed state, both the textile substrate 230 and the 3D scaffold 210 can be compressed to a small volume, allowing the expansion cage 200 to be inserted into the intervertebral space, and then expanded to a larger size using an expansion medium, as shown in Figure 8B. In some cases, the 3D scaffold can control different expansion rates of the textile substrate 230 during the expansion process. In some cases, the 3D scaffold can at least partially define the size and shape of the expansion cage 200 by limiting further expansion of the textile substrate 230, as shown in Figures 8C and 8D.

[0077] In Figure 8B, the expansion medium is injected into the internal volume 220 of the expansion cage 200 (as indicated by arrow 271). The expansion cage 200 can be filled with the expansion medium, and the pressure from the expansion medium can expand the textile substrate 220. When the textile substrate 230 expands within the 3D scaffold 210, the 3D scaffold also expands, grows, opens, or otherwise controls the expansion of the textile substrate 230. In some cases, the expansion cage 200 includes a dual expansion system, which includes a core expansion region configured to be filled with an expansion material and an outer expansion region configured to be filled with an anti-inflammatory agent or other medium to provide a biological effect.

[0078] Figure 8C shows the expansion cage 200 in an expanded state, where the textile substrate 230 and 3D scaffolding 210 have expanded to the designed size and shape as a result of the pressure of the expansion material pumped into the expansion cage 200 reaching the design pressure. Figure 8C shows the expansion cage 200 with a given length scale 818, which in some cases is a function of the material properties, size and shape of the textile substrate and 3D scaffolding 210, as well as the pressure of the expansion material. For example, Figure 8D shows another expansion cage 201, which has the same textile substrate 210 as the expansion cage 200 in Figure 8C, but has a different 3D scaffolding 211, resulting in a different length scale 819 for the expansion cage 201 in an expanded state. Depending on the specific structure of the textile substrate 230 and 3D scaffolding 210, any number of final shapes and sizes of the expansion cage 200 are possible. In some embodiments, pores are present on the outer surface of the expansion cage 200, which, in some examples, remain closed to allow material to seep into the intervertebral space until the internal pressure of the expansion cage 200 reaches a threshold or final pressure.

[0079] However, in some cases, the 3D scaffold 230 can be a rigid stabilizing structure that can be configured to suppress, control, or otherwise limit the expansion of the expansion cage 200 and / or its final shape and size, depending on the required parameters of the expansion cage. In some cases, the textile substrate 230 can be an elastic expansion material. In some cases, the textile substrate 230 can be inelastic and can be configured to expand from a compressed state to an expanded state by expanding from a "compressed" or otherwise compacted shape to a maximum volume shape. In some cases, the textile substrate 230 can be porous and can allow for the transfer of the expansion medium across the textile substrate 230, for example, to facilitate the fusion of the expansion medium with the surface of the intervertebral space.

[0080] Figures 9A to 9D are schematic cross-sectional views of two alternative expansion cage devices having an external 3D scaffold formed as a rigid external stabilizing structure. Figure 9A shows an expansion cage 900 having a rigid external structure 910 that at least partially surrounds a woven textile substrate 230. The rigid external structure 910 includes a rigid top container 918 and a rigid bottom container 919, as shown in Figure 9B, which can expand away from each other via an extending joint 910 when the woven textile substrate 230 is expanded. In some cases, the rigid top container 918 and the rigid bottom container 919 are box-shaped structures that slide against each other with a single degree of freedom during the expansion of the woven textile substrate 230, and the extending joint 910 is an overlapping portion between the box-shaped structures configured to prevent separation beyond the extension shown, for example, in Figure 9B. In some cases, the rigid top vessel 918 and the rigid bottom vessel 919 are top and bottom members, and they are connected by two or more individual extending joints 910 configured to at least restrict the rigid top vessel 918 and the rigid bottom vessel 919 with a single degree of freedom extension as shown in Figures 9A and 9B.

[0081] Figure 9C shows an embodiment of an expansion cage 901 having a rigid external stabilizing structure including a rigid top element 928 connected to a rigid bottom element 929 via two or more nesting extension mechanisms 912. The expansion cage 901 includes a woven textile substrate 230 between the rigid top element 928 and the rigid bottom element 929, which, as shown in Figure 9D, translates the rigid top element 928 and the rigid bottom element 929 away from each other during expansion via the extension of the nesting extension mechanisms 912. In some cases, the nesting extension mechanisms 912 can be made of three or more nesting elements 913a-c, allowing the rigid top element 928 and the rigid bottom element 929 to expand away from each other by a distance greater than twice the collapsed length of the nesting extension mechanisms 912, as shown. The nesting elements may be either one rectangular nesting element on each side, or multiple cylindrical nesting elements on each side.

[0082] Figures 10A to 10D are schematic cross-sectional views of two alternative expansion cage devices having an internal stabilizing structure in the form of a scaffold to restrain the expansion and shape of an external woven textile substrate. Figure 10A shows an expansion cage 1000, including an internal expansion scaffold 1010 surrounded by an external woven textile substrate 1030 in a collapsed state. The external woven textile substrate 1030 can be connected to the internal expansion scaffold 1010 by a plurality of threads 1060. The internal expansion scaffold 1010 can be configured to expand by the expansion of the external woven textile substrate 1030 until the internal expansion scaffold 1010 reaches its design maximum extended size, as shown in Figure 10B. Figure 10B shows the expanded external woven textile substrate 1030 restrained in an expanded state by the fully expanded internal expansion scaffold 1010. In implementation, the shape of the fully expanded internal expansion scaffold 1010 can define the shape of the expanded external woven textile substrate 1030. In some cases, the extension of the internal extension scaffolding 1010 can be configured to control the overall extension of the extension cage 1000.

[0083] Figure 10C shows an expanded cage 1001, including a fixed internal scaffold 1011 surrounded by an external woven textile substrate 1030 in a collapsed state. The external woven textile substrate 1030 can be connected to the fixed internal scaffold 1011 by a plurality of threads 1060. The fixed internal scaffold 1011 can be configured to limit the expansion of the external woven textile substrate 1030 to a designed maximum extended size, as shown in Figure 10C. In Figure 10C, the shape of the expanded external woven textile substrate 1030 may be a function of the shape of the fixed internal scaffold 1011 and the length of the threads 1060.

[0084] In some cases, the yarn 1060 may be inelastic. In other cases, the yarn 1060 may be elastic, and the expanded shape of the external woven textile base material 1030 may also be a function of the elastic properties of the yarn 1060.

[0085] Figures 10E and 10F are schematic cross-sectional views of two alternative expansion cage device embodiments having multiple internal chambers. Figure 10E shows the expandable portion of the expansion cage 1002, which includes a core expandable structure 1031 and an outer expandable structure 1030. The core expandable structure 1031 may be configured to be filled with an expansion material, and the outer expansion structure 1030 may be configured to be filled with an anti-inflammatory agent or other medium to provide a biological effect.

[0086] Figure 10F shows the inflatable portion of the expansion cage 1003, which includes an outer inflatable structure 1030 containing a plurality of different chambers 1032a-d that can be individually inflated to change the overall shape of the outer inflatable structure 1030. In some cases, the different chambers 1032a-d are in fluid communication with each other. In some cases, the different chambers 1032a-d are separated from each other.

[0087] Figure 10G is a schematic cross-sectional view of an embodiment of an alternative expansion cage device 1004 in which an additional structural component 1090 is attached to the top and bottom surfaces of the outwardly expandable structure 1030 to improve fixation. The additional structural component 1090 can be detachably attached to the outwardly expandable structure 1030. The additional structural component 1090 can be configured to engage with the vertebral surface.

[0088] Figures 11A–11D show an example of an exemplary procedure for replacing an intervertebral disc with an expanded spinal fusion cage device 200 constructed using metamaterials (e.g., a 3D scaffold 210 and a woven textile substrate 230). Figure 11A shows a section of the patient's spine 790, where the degenerated intervertebral disc material 799 is removed from the intervertebral space 791. Next, as shown in Figure 11B, the expanded spinal fusion cage 200 can be implanted and positioned in the intervertebral space 791 from which the waste material has been removed using an implant instrument 780. Next, as shown in Figure 11C, an expansion medium 719 (e.g., medical cement or bone cement) can be pumped into the expanded spinal fusion cage 200 to cause expansion of the expansion cage 200. Once the expansion cage 200 is filled with the expansion medium 719 (and in some embodiments, the expansion medium is subsequently cured), the expansion medium can provide a solid weight support structure for the intervertebral space 791. Figure 11D shows the spine 790 of a patient after surgery, where fusion and osseointegration result in the patient's own bone material 798 being formed between adjacent vertebrae, using a woven textile substrate 230 and a hardened expansion medium as the skeletal structure.

[0089] Exemplary materials Existing 3D printing applications and technologies can enable 3D printing on fabric substrates, allowing for the incorporation of complex printed structures onto fabrics. For example, in the fashion industry, garments can be 3D printed, combining rigid geometric shapes (e.g., 3D printed structures) with soft, draping substrates (e.g., fabrics) to offer new ergonomic and aesthetic possibilities. As a further example, such technologies can enable control over how garments move on the body through the precise design of 3D-printed and woven components and the interfaces between those components. Additionally, such technologies can utilize 3D printing on textiles to create programmable textiles, such as fabrics with shape-memory properties.

[0090] As a further example, in some embodiments, material tracks can be printed with variable thickness onto a pre-stressed textile substrate. When the textile is relaxed, the printed geometric shapes suppress shrinkage, thereby guiding the fabric into a designed, predetermined shape.

[0091] In some cases, the material for the metamaterial solution may be a combination of woven polyester for the textile substrate (e.g., extended structure or textile substrate 230 in Figures 8A-8D) and polyester composite or polyisoprene for the 3D printed scaffold (e.g., stabilizing structure 210 or 3D scaffold 210 in Figures 8A-8D). In some implementations, the material may be biocompatible (or formulated to meet such standards), for example, meeting the United States Pharmacopeia (USP) Class VI criteria for biocompatibility.

[0092] In some cases, cement may be used as a fixation method. For example, in some embodiments, existing medical cement may be suitable. In some cases, the final expanded position of the expansion cage device can be fixed using a solid solidifying compound, such as medical bone cement, to prevent the device from remaining permanently expanded in the body under pressure. In some cases, hydrogels and other gelatinous materials are used as fillers, which can be inserted at high temperatures and solidified at body temperature, for example. In some cases, the phase change temperature of the filler material is adjusted to suit the specific application. In some cases, an electronic device is added to heat the material to change the compressibility of the filler, which can be done in a selective channel, for example, to change the local compressibility of the filler.

[0093] In some cases, the material of the metamaterial expansion cage 200 may be able to be compressed, rolled, or folded to a small form factor without damaging the 3D printed scaffold or the woven substrate. In some cases, the woven textile substrate 230 (e.g., the expansion structure) may be able to expand or open up from a flattened state to an expanded state by at least about 280% in volume. In some cases, the 3D printed scaffold (e.g., the stabilizing structure of the 3D scaffold 210 in Figures 8A-8D) may be sized and molded to provide some degree of flexibility to allow the cage to expand.

[0094] In some cases, the weave of the textile substrate (e.g., expansion structure or textile substrate 230 in Figures 8A-8D) can be sized and shaped to allow for precise control of weave density, ensuring that the injectable expansion medium (e.g., bone cement) does not leak rapidly or uncontrollably through the weave of the textile substrate. In some cases, the woven textile substrate can be constructed from polyester fibers. In some cases, the polyester fibers can have a tensile strength exceeding about 580 MPa and an elongation of at least about 50% to withstand the high pressures that may be experienced during the injection of bone cement.

[0095] 3D printing technology Certain aspects of this disclosure include methods for 3D printing some or all of the structures of the extended spinal fusion cage according to the embodiments disclosed herein. With respect to the embodiments of the metamaterial cages revealed above, several different 3D printing techniques can be used, including, but not limited to, melt deposition modeling, material jetting, and 3D digital weaving. Other 3D printing techniques or combinations thereof described herein can also be used to produce various structures of the extended cage according to aspects of this disclosure.

[0096] Kirchhoff-Plateau surface One exemplary method of 3D printing, specifically for the embodiments of the metamaterials described above, for use in the manufacture of an extended spinal fusion cage, is the use of a Kirchhoff-Plateau surface. In some cases, the textile substrate of this disclosure (e.g., 230 in Figures 8A-8D) can define or utilize a Kirchhoff-Plateau surface with or without a 3D scaffold. An exemplary method using Kirchhoff-Plateau involves creating a 3D structure by engineering and 3D printing a programmable 2D net or Kirchhoff-Plateau surface. This method may include simulating and planarizing the 3D components of the extended cage design to be 3D printed into a 2D net structure in a digital design environment. The 3D printed geometric shape or system track (e.g., 3D scaffold 230) can then be set on the woven substrate (e.g., textile substrate 230) under tension. Once the tension is released, the 3D printed structure can control the shrinkage and deformation of the polyester substrate. This variation can be programmed and simulated during the initial computer-aided design (CAD) stage.

[0097] One exemplary method for manufacturing a Kirchhoff-Plateau surface is to flat-knit a 3D net, thereby allowing a 2D manufacturing process to create a 3D structure. This method provides an alternative solution for 3D printing tracks onto a conformal woven substrate, as opposed to directly manufacturing a 3D structure, since the 2D material is manufactured first and then the 3D net is formed. In this case, a 3D digital object (e.g., an extension or stabilization structure for an extended spinal fusion cage) can be flattened into a net, followed by 2D weaving of the conformal woven substrate. Then, in a programmable textile process, the three-dimensional tracks can be printed onto the substrate. In some embodiments, the 3D woven structure can be manufactured by weaving a flat net shape and then, in a secondary process, drawing or forming the net into a final 3D product. In implementation, the net can be 3D printed onto a flat textile substrate under tension, and controlled deformation of the net into the desired three-dimensional shape can be achieved by releasing the tension from the substrate. From 2D woven nets, a high degree of complexity can be achieved in terms of woven structures, mechanical behavior, and 3D geometric shapes.

[0098] Another exemplary method for producing a Kirchhoff-Plateau surface involves the fusion deposition of a thermoplastic material for 3D printing a scaffold or track network onto a textile substrate. This method can provide an additional step to a function having a 2D net shape by programming the 3D net to take its final form independently of external forces or secondary processes. A high level of complexity can be achieved through a combination of 3D printing suppression tracks and a textile substrate under tension.

[0099] Another exemplary method for manufacturing a Kirchhoff-Plateau surface is by material jetting, thereby creating a 3D relief structure on a fabric using a jet of ink or other material. In some cases, the ink may be jetted at a high temperature and solidify as it cools, or it may contain a photocatalyst and be cured into a solid by a UV light source. In some cases, one or more materials can be jetted onto a polyester substrate to achieve extremely high layer height resolution (e.g., about 14 microns) to create complex geometric shapes, scaffolds, and tracks of certain embodiments of the extended spinal fusion cage of the present disclosure.

[0100] Tubular braided structure Another exemplary method for 3D printing the structure of an extended spinal fusion cage involves using a tubular woven structure. In some cases, the extension structure is a woven textile base material 230 constructed from one or more tubular woven structures, and the stabilizing structure 210 is a scaffold that is 3D printed onto the tubular woven structure.

[0101] One exemplary method for generating a 3D scaffold structure on a tubular woven structure involves using a two-stage hybrid manufacturing technique. First, a 3D knitting machine can weave a tubular structure to create a conformal balloon or pouch that forms the tubular woven structure. In some cases, this tubular woven structure can be made of polyester. The tubular woven structure can then be removed from the 3D knitting system and placed on a mandrel, thereby allowing a secondary 3D printing process to print the geometric shape of the 3D scaffold across the tubular woven structure. The 3D printed components (e.g., 3D scaffold or stabilizing structure 210) can function as mechanisms to control and ensure the precise expansion of the tubular woven structure (e.g., expansion structure) when it is expanded through the injection of medical cement or other expanding medium.

[0102] One exemplary method for 3D printing scaffolding onto a textile substrate is material extrusion, which allows the textile substrate to be placed on a mandrel, and as the mandrel rotates, a fused deposition modeling (FDM) head can extrude the geometric shape of the 3D scaffolding onto the textile substrate of a tubular woven structure.

[0103] Another exemplary method for 3D printing scaffolding onto a textile substrate is to use material spraying, thereby replacing the extrusion head in the material extrusion method described above with a material spraying head. Material spraying can provide higher precision in material deposition, layer height resolution, and printing speed. Furthermore, the material spraying process can print multiple materials simultaneously, which can enhance the functionality of the design by providing the printing of multiple embedding materials.

[0104] An exemplary method of 3D printing textile substrates is to create woven substrates using a digital weaving system. Three-dimensional weaving technology provides the ability to design and manufacture conformal tubular woven structures to function as bags and substrates for secondary 3D printed track components. For example, 3D looms and weaving machines can create complex, customized tubular meshes or structures by weaving multiple filaments in 3D space. By picking up or dropping stitches, the circumference of the tube can be varied over the length of the component, thereby enabling the design of complex tubular structures. Additionally, digital weaving methods can create multi-tubular and multi-branched geometric shapes, which enables the manufacture of multi-branched spinal cage designs.

[0105] In some cases, complex nets or balloons of textile substrates can be manufactured in 3D using 3D electrospinning as an alternative to the textile weaving described above. Electrospinning can involve generating an electrical potential between a mandrel (e.g., acting as a cathode) and a fiber emitter (e.g., acting as an anode) to deposit fibers (e.g., nanofibers) onto the mandrel. Electrospinning can create bio-scaffolds and extremely fine and strong fibers, suitable for use as the substrate for the textile substrate 230 of the expanded cage 200 shown in Figures 8A-8D. Electrospinning 3D textile substrates can also enable the complete replacement of polyester fibers with organic materials (e.g., collagen and hyaluronic acid).

[0106] As described below, some embodiments of additive manufacturing on woven substrates can use a spinning mandrel to hold the substrate while the additive material is deposited thereon. In some embodiments, instead of using a rotating cylindrical, cubic, or spherical shape to create expandable sections of a cage, 3D printing or additive manufacturing can be used to create mandrels of a desired shape, for example, geometrically complex mandrels that may be asymmetrical in some respects. Specifically with reference to electrospinning, a conductive layer can be added to the mandrel to create a cathode, enabling the deposition of fibers. The use of 3D printed mandrels, in conjunction with electrospinning or any of the other deposition techniques described herein, can enable more complex expandable section shapes.

[0107] 3D printing process The following is an illustrative description of various embodiments of 3D printing or additive manufacturing processes that can be used to manufacture the above-described embodiments of the expansion cage device.

[0108] Figures 12A–12C illustrate an exemplary extrusion process for manufacturing an expansion cage device. Figures 12A–12C show a production apparatus 1200 for the extrusion process, using a 3D printing system 1220 and a separate parts cleaning station 1290. The 3D printing system 1220 may include a build chamber 1207, an extruder 1204 containing a suspension or support material 1206 and polyisoprene 1203, and a computer 1201 that controls the 3D printing system 1220. In some cases, the 3D printing system 1220 may allow the support container 1205 to be within an acceptable range.

[0109] In practice, the computer 1201 can convert the CAD model into a build command, which can then be sent to the 3D printing system 1220 (1202), where the printed part 1208 can be created. Subsequently, the extruder 1204 can be removed (1209), allowing the finished part 1210 to harden before being transferred to the washing station 1290. At the washing station 1290, any remaining support material 1212 can be removed by a manual washing tool 1291 and by washing fluid 1293 distributed from a washing jet nozzle 1292.

[0110] Figures 13A–13C illustrate an exemplary material injection process for manufacturing an expansion cage device. Figures 13A–13C show a production apparatus 1300 for the material injection process, using a 3D printing system 1320 and a separate parts cleaning station 1290. The 3D printing system 1320 includes a build plate 1306, a build material delivery device 1303, a support material delivery device 1305, a material supply unit 1304, and a computer 1201 that controls the 3D printing system 1320.

[0111] In implementation, the computer 1201 can convert the CAD model into a build command, which can then be sent to the 3D printing system 1320 via connection 1202, where a printed part 1308 can be created on the build plate 1306 using a material jetting method. The printed part 1308 can then be removed (1309) and transferred to the cleaning station 1290.

[0112] Figures 14A and 14B illustrate an exemplary process for manufacturing a woven tubular structure for use in an expansion cage device. Figure 14A shows a tubular woven structure 1402 being printed by a material sprayer 1401 onto an expansion substrate 1403 in an expansion configuration. Figure 14B shows the tubular woven structure 1402 in a flattened state after the substrate 1403 has been shrunk to remove the tubular woven structure 1402.

[0113] Figures 15A to 15E illustrate an exemplary process for manufacturing an expansion cage device. Figures 15A to 15E show a 3D printing system 1501 for use in a metamaterial injection process 1500, designed to work with an existing 3D weaving system to manufacture a woven substrate 1502. The 3D printing system 1501 includes a mandrel 1505 for holding the woven substrate 1502 (e.g., a polyester substrate in some embodiments), and a printing apparatus including an injection head 1503 and a curing head 1504.

[0114] In implementation, computer 1201 can convert a CAD model into build commands for manufacturing both a woven substrate and a 3D scaffolding track, which can be transmitted (for example, via connection 1202) to the 3D printing system 1501 and the 3D weaving system 1506. The 3D weaving system 1506 can mount the manufactured woven substrate onto the mandrel 1505 of the 3D printing system 1501, the spray head 1503 can spray polyisoprene or other material onto the mandrel 1505, and the curing head 1504 can cure the newly sprayed polyisoprene or other material as the mandrel rotates downwards in the printing apparatus. A single layer of polyisoprene or other material can be placed with each rotation, and the printing apparatus can be raised with each rotation (1507). After 3D printing is complete, the finished 3D printed parts 1508, which may include the print tracks and the woven substrates 1502 to which they are mounted, can be removed (1509). Component 1508 can shrink when removed from the tension around the mandrel 1505.

[0115] Figures 16A–16E illustrate an exemplary process for manufacturing an expansion cage device. Figures 16A–16E show a 3D printing system 1601 for use in a metamaterial extrusion process 1600, designed to work with an existing 3D weaving system to manufacture a woven substrate 1502. The 3D printing system 1601 may include a printing apparatus comprising a mandrel 1505 that holds the woven substrate 1502 (for example, a polyester substrate in some embodiments) and an extrusion head 1602 that moves on an extrusion head gantry 1605 and can contain the 3D printing material 1602.

[0116] In implementation, computer 1201 can convert a CAD model into build commands for manufacturing both the woven substrate and the 3D scaffolding track, which can be transmitted (for example, via connection 1202) to the 3D printing system 1601 and the 3D weaving system 1506. The 3D weaving system 1506 can mount the manufactured woven substrate onto the mandrel 1505 of the 3D printing system 1601, and the extruder head 1602 can print the track 1606 onto the woven substrate 1502 by moving along the gantry 1605 (1607) and indexing away from the mandrel 1505 after printing each layer. After 3D printing is complete, the finished 3D printed part 1608, including the woven substrate 1502 and the printed track 1606, can be removed (1609). The part 1608 may shrink when removed from the tension around the mandrel 1505.

[0117] Other alternatives In addition to the materials described above that can be used to fabricate the expansion cage devices described herein, other materials may be used in some embodiments. For example, in some embodiments, certain metallic materials may be used in the process described above. Examples of such materials include, among others, stainless steel, cobalt-chromium, titanium, tantalum, and nitinol.

[0118] Furthermore, in some embodiments, additional features can be integrated with the 3D printed components described herein. For example, additively manufactured components can be individually tracked using unique identifiers such as geometric keys or tags printed on the product. In the case of tags, for example, a unique serial number, a QR (quick response) code, or other identifier can be automatically printed on the tag embedded in the structure or on the surface of any structure. Moreover, reliefs can be printed on the components to accommodate RFID (radio frequency identification) tags or other types of tracking components.

[0119] In some embodiments, the filler material may include multiple materials so that the elastic properties of the filler material can also be adjusted. For example, creating an emulsion of bone cement and a liquid or fluid can change the elastic modulus of the cement in its final hardened state. In addition, some embodiments include incorporating elastic beads or ceramic beads into the mixture, which can achieve similar results by changing the elastic modulus of the cement in its final hardened state.

[0120] In addition to covering specific combinations of the features claimed below, this disclosure also covers embodiments having other combinations of the dependent features claimed below and other combinations of the features described above.

[0121] Those skilled in the art will understand the further features and advantages of the present disclosure based on the embodiments described above. Therefore, this disclosure is not limited to what is specifically shown and described, except as indicated by the appended claims. This specification suggests many variations and alternatives to those skilled in the art. All such alternatives and variations are intended to be included within the scope of the claims. Those skilled in the art may recognize other equivalents to the specific embodiments described herein, and such equivalents are also intended to be included within the scope of the claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

[0122] [Implementation Method] (1) Intervertebral disc implant, The expandable cage assembly is configured to expand from a compressed state to an expanded state within the intervertebral space when expanded by a material, and the expandable cage assembly is An expandable section defining an internal volume, configured to receive the material, expand the internal volume in response to pressure from the received material, and transition the expandable cage assembly from the collapsed state to the expanded state; An intervertebral disc implant comprising: a stabilizing section configured to restrain the expandable section during expansion. (2) The intervertebral disc implant according to Embodiment 1, wherein the stabilizing section at least partially surrounds the expandable section, and the stabilizing section is sized and molded to define at least a portion of the outer circumference of the expandable cage assembly. (3) The intervertebral disc implant according to Embodiment 1, wherein the expandable section surrounds the stabilizing section, and the stabilizing section is coupled to the stabilizing section so as to hold the expandable section. (4) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section comprises a 3D printed material. (5) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section includes an integrated structure.

[0123] (6) The intervertebral disc implant according to Embodiment 5, wherein the integrated structure includes a 3D printed material. (7) The intervertebral disc implant according to Embodiment 1, wherein the expandable section includes a woven base material. (8) The intervertebral disc implant according to Embodiment 1, wherein the stabilization section includes a 3D printed scaffold. (9) The intervertebral disc implant according to Embodiment 1, wherein the stabilizing section includes a tubular woven structure configured to be filled with the material. (10) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section includes a porous structure configured to allow interaction between the material and the intervertebral space.

[0124] (11) The intervertebral disc implant according to Embodiment 1, wherein the expandable cage assembly defines one or more void channels, each void channel being formed continuously through the stabilizing section and the expandable section. (12) The intervertebral disc implant according to embodiment 11, wherein the void channel is configured to receive bone graft material. (13) The intervertebral disc implant according to Embodiment 1, wherein the stabilizing section includes a rigid structure. (14) The intervertebral disc implant according to Embodiment 13, wherein the rigid structure defines one or more fissures arranged to facilitate the deflection or deformation of the stabilizing section around the expandable section when the expandable section moves the expandable cage assembly from the collapsed state to the expanded state. (15) The intervertebral disc implant according to Embodiment 13, wherein the rigid structure defines one or more sections arranged to expand in a nested manner when the expandable section moves the expandable cage assembly from the compressed state to the expanded state.

[0125] (16) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section comprises a reabsorbable biomaterial configured to be reabsorbed into the body after fusion has occurred. (17) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section comprises an implantable organic material configured to promote osseointegration. (18) The intervertebral disc implant according to Embodiment 17, wherein the implanted organic material comprises at least one of hyaluronic acid, collagen, protein, and patient cells from a bone graft. (19) The intervertebral disc implant according to Embodiment 1, wherein at least one of the expandable section and the stabilizing section comprises an implantable active pharmaceutical compound. (20) The intervertebral disc implant according to Embodiment 1, wherein the expandable cage assembly has an asymmetric shape in the expanded state.

[0126] (21) The intervertebral disc implant according to Embodiment 1, wherein in the expanded state, the upper surface of the expandable cage assembly is inclined with respect to the lower surface of the expandable cage assembly. (22) The intervertebral disc implant according to Embodiment 1, wherein the expandable cage assembly is formed from multiple materials. (23) The intervertebral disc implant according to Embodiment 1, wherein the expandable section and the stabilizing section are formed from different materials. (24) The intervertebral disc implant according to Embodiment 1, wherein the expandable section comprises a plurality of chambers, each of which can be filled with the material, and the expanded shape of the intervertebral disc implant is a function of which of the plurality of chambers is filled with the material. (25) The intervertebral disc implant according to Embodiment 1, comprising at least one additional structural component attached to the intervertebral disc implant, wherein the additional structural component is configured to improve fixation in the intervertebral space.

[0127] (26) The intervertebral disc implant according to Embodiment 1, wherein the expandable section includes a core expansion region configured to be filled with the material and an outer expansion region configured to be filled with a bioactive substance. (27) Intervertebral disc implant, The expandable structure comprises an expandable structure configured to elastically expand from a collapsed state to an expanded state within the intervertebral space when inflated by a material, wherein the expandable structure includes a side wall, and the side wall defines an internal chamber configured to receive the material and elastically expand at least a portion of the side wall in response to pressure from the received material, thereby transitioning the expandable structure from the collapsed state to the expanded state. An intervertebral disc implant having a variable thickness across the surface of the expandable structure, wherein the side wall is configured to control different expansion rates of the structure during expansion. (28) The intervertebral disc implant according to embodiment 27, wherein the expandable structure comprises a porous outer layer configured to allow interaction between the material and the intervertebral space. (29) The intervertebral disc implant according to Embodiment 27, wherein the expandable structure defines one or more void channels configured to receive bone graft material in the expanded state. (30) The intervertebral disc implant according to embodiment 27, wherein the outer surface of the expandable structure defines projections configured to enhance fixation between the outer surface and the surface of the intervertebral cavity.

[0128] (31) The intervertebral disc implant according to embodiment 27, wherein the expandable structure is monolithic. (32) An intervertebral disc implant of Embodiment 27, wherein the internal chamber comprises a plurality of chambers, each of which can be filled with the material, and the expanded shape of the intervertebral disc implant is a function of which of the plurality of chambers is filled with the material. (33) The intervertebral disc implant according to embodiment 27, comprising at least one additional structural component attached to the intervertebral disc implant, wherein the additional structural component is configured to improve fixation in the intervertebral space. (34) The intervertebral disc implant according to Embodiment 26, wherein the internal chamber includes a core expansion region configured to be filled with the material and an external expansion region configured to be filled with a bioactive substance. (35) Surgical methods, The procedure involves inserting the spinal fusion cage into the patient's intervertebral space while the cage is in a collapsed state, The spinal fusion cage is expanded from the collapsed state to the expanded state by injecting a certain volume of fluid material into the internal chamber of the expandable section of the spinal fusion cage, A surgical method comprising using a stabilizing structure coupled to the inflatable section to restrain the shape of the spinal fusion cage to the expanded state.

[0129] (36) A method for manufacturing a surgical implant, Forming an expandable substrate from a first material, A method comprising forming a stabilizing structure on a substrate from the second material using an additive manufacturing process that deposits multiple layers of the second material onto each other. (37) The method according to embodiment 36, wherein the expandable substrate is a woven tubular structure. (38) The method of embodiment 37, wherein the woven tubular structure is elastically expanded on a mandrel before the stabilizing structure is formed on the woven tubular structure. (39) The method according to embodiment 36, wherein the expansionable substrate is formed using an additive manufacturing process. (40) The method according to embodiment 36, wherein the additive manufacturing process is one of injection, extrusion, and fused deposition modeling.

Claims

1. It is a disc implant, The expandable cage assembly is configured to expand from a compressed state to an expanded state within the intervertebral space when expanded by a material, and the expandable cage assembly is An expandable section defining an internal volume, configured to receive the material, expand the internal volume in response to pressure from the received material, and transition the expandable cage assembly from the collapsed state to the expanded state; It comprises a stabilizing section configured to restrain the expandable section during expansion, The expandable section includes a textile substrate, An intervertebral disc implant comprising a 3D scaffold, wherein the stabilizing section is printed on the textile substrate and configured to restrict further expansion of the textile substrate when in the expanded state.

2. The intervertebral disc implant according to claim 1, wherein the stabilizing section at least partially surrounds the expandable section, and the stabilizing section is sized and shaped to define at least a portion of the outer circumference of the expandable cage assembly.

3. The intervertebral disc implant according to claim 1, wherein the expandable section surrounds the stabilizing section, and the stabilizing section is coupled to the expandable section.

4. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section comprises a 3D printed material.

5. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section includes an integrated structure.

6. The intervertebral disc implant according to claim 5, wherein the integrated structure includes a 3D printed material.

7. The intervertebral disc implant according to claim 1, wherein the stabilizing section includes a tubular woven structure configured to be filled with the material.

8. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section includes a porous structure configured to allow interaction between the material and the intervertebral space.

9. The intervertebral disc implant according to claim 1, wherein the expandable cage assembly defines one or more void channels, each void channel being formed continuously through the stabilizing section and the expandable section.

10. The intervertebral disc implant according to claim 9, wherein the void channel is configured to receive bone graft material.

11. The intervertebral disc implant according to claim 1, wherein the stabilizing section includes a rigid structure.

12. The intervertebral disc implant according to claim 11, wherein the rigid structure defines one or more fissures arranged to facilitate the deflection or deformation of the stabilizing section around the expandable section when the expandable section moves the expandable cage assembly from the collapsed state to the expanded state.

13. The intervertebral disc implant according to claim 11, wherein the rigid structure defines one or more sections arranged to expand in a nested manner when the expandable section moves the expandable cage assembly from the compressed state to the expanded state.

14. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section comprises a reabsorbable biomaterial configured to be reabsorbed into the body after fusion has occurred.

15. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section comprises an implantable organic material configured to promote osseointegration.

16. The intervertebral disc implant according to claim 15, wherein the implanted organic material comprises at least one of hyaluronic acid, collagen, protein, and patient cells from a bone graft.

17. The intervertebral disc implant according to claim 1, wherein at least one of the expandable section and the stabilizing section contains an implantable active pharmaceutical compound.

18. The intervertebral disc implant according to claim 1, wherein in the expanded state, the upper surface of the expandable cage assembly is inclined with respect to the lower surface of the expandable cage assembly.

19. The intervertebral disc implant according to claim 1, wherein the expandable cage assembly is formed from a plurality of materials.

20. The intervertebral disc implant according to claim 1, wherein the expandable section and the stabilizing section are formed from different materials.

21. The intervertebral disc implant according to claim 1, wherein the expandable section comprises a plurality of chambers, each of which can be filled with the material.

22. The intervertebral disc implant according to claim 1, comprising at least one additional structural component attached to the intervertebral disc implant, wherein the additional structural component is configured to improve fixation in the intervertebral space.

23. The intervertebral disc implant according to claim 1, wherein the expandable section includes a core expansion region configured to be filled with the material and an outer expansion region configured to be filled with a bioactive substance.