JP2018528844A - Expandable intervertebral cage device with living hinge, system, and methods of manufacturing the same - Google Patents

Abstract

  An expandable intervertebral cage with a living hinge manufactured using 3D printing. The intervertebral cage is configured to expand from an unexpanded configuration to an expanded configuration. The intervertebral cage can include a deployment system, such as a variable volume pouch or deployment cable, for applying a force to the intervertebral cage to deploy the intervertebral cage.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a U.S. patent filed on September 29, 2011, entitled "INTERVERTEBRAL DEVICE AND METHODS OF USE," which claims priority to US Provisional Patent Application No. 61 / 389,986. Published application 13/248747, US provisional patent application 61/693738 filed on August 27, 2012, and US provisional patent application 61/778271 filed March 12, 2013. PCT application PCT / U.S. Patent Application Publication No. 2013/056500, filed on August 23, 2013, which is a national phase application under 35 U.S. Patent Law Section 371. "INTERVERTEBRAL CAGE APPARATUS AND SYSTE U.S. Patent Application Publication No. 14/422750 filed on February 20, 2015, entitled "MAND METHODS OF USING THE SAME", and U.S. Provisional Patent Application No. 61 filed on March 12, 2013. PCT application PCT / US application filed on Feb. 26, 2014, entitled “VERTICALLY EXPANDABLE INTERVERTEBRAGE CAGE, DEPLOYMENT DEVICES, AND METHODS OF USING THE SAME”, claiming priority to the US Pat. In relation to the 2014/018772 specification, the entire contents of all applications are expressly incorporated herein by reference.

  The present invention relates generally to expandable intervertebral cages or implants for use in spinal fusion procedures, and more specifically to an apparatus and system for manufacturing expandable intervertebral cages using 3D printing methods. And the method.

  The vertebrae are the individual irregular bones that make up the spinal column. Humans typically have 33 vertebrae, including 5 that fuse to form the sacrum (the other vertebrae are separated by an intervertebral disc) and 4 tail vertebrae that form the coccyx. The upper three regions include the remaining 24, and are classified by the names of the cervical vertebra (7 vertebrae), the thoracic vertebra (12 vertebrae), and the lumbar vertebra (5 vertebrae) according to the region occupied by those vertebrae The This number may increase in some areas with additional vertebrae, decrease in some areas, and the shortage in other areas is often provided by additional vertebrae. However, it is very rare for the number of cervical vertebrae to increase or decrease.

  A typical vertebra consists of two main parts: an anterior (anterior) portion that is the vertebral body and a posterior portion that is the vertebral (neural) arch that surrounds the vertebral foramen. A vertebral arch is formed by a pair of stems and a pair of thin plates, and supports seven processes, ie, four articular processes, two transverse processes, one spinous process, and one spinous process is also a nerve spine Are known.

  When the vertebrae are articulated together, the body forms a rigid column that supports the head and torso, and the vertebral foramen constitutes a tube for the protection of the spinal cord (spinal cord). On the other hand, between each pair of vertebrae, there are two openings, one intervertebral hole for transmission of spinal nerves and blood vessels, one side.

  Conventional spine cage assemblies are used in spinal fusion procedures that stabilize vertebrae. Spinal fusion typically employs the use of cage assemblies that cause adjacent vertebrae to be spaced apart and fused together. The spinal fusion technique involves removing the disc material that separates the vertebrae and packing the bone into the disc region. These cage assemblies are generally hollow and include openings on the sides of the cage assemblies to provide access for bone growth. These cages are often made of titanium and are available in various shapes and sizes.

  Current intervertebral or interbody cages come in contact with three major principles: anatomical limitations of surgical approach, optimization of bone graft volume to promote bone fusion, and vertebral endplate to prevent settlement It is designed based on the optimization of the equipment. Because current cages are generally static in that they cannot change shape or volume, these cages are limited by anatomy and technology, so that optimal bone graft volume or surface contact is achieved. Will not bring.

  Many conventional spinal cage assemblies utilize parallel distraction of opposing vertebrae prior to placement of the implant. However, not all vertebrae face each other in parallel. A normal and healthy spine has a natural curvature called the lordosis. As a result of the curvature, the opposing vertebrae are positioned with the endplates of the vertebrae arranged non-parallel, depending on their position in the spine.

  Intervertebral cages or implants that can be expanded to change shape and / or volume to provide optimal bone graft volume or surface contact to maintain or achieve the desired vertebral lordosis between opposing vertebrae There is a need for. The present invention attempts to solve these and other problems.

  Certain embodiments of the present application relate to expandable intervertebral cages and methods of making and using expandable intervertebral cages. Some embodiments can be configured to be positioned between two vertebrae, specifically, between two vertebral endplates, including but not limited to a patient-specific intervertebral cage. Regarding cages.

  Disclosed herein is a method of manufacturing an intervertebral cage expandable by additive manufacturing, also known as 3D printing. The expandable intervertebral cage can be molded as a single integral piece and can be constructed from bottom to top layer by layer so that the components are connected together by a living hinge.

  In one aspect of the invention, a method for making an expandable intervertebral cage with a living hinge using a 3D printable material for placement between adjacent vertebrae, the expandable intervertebral Providing 3D data of a cage to a 3D printer, wherein the expandable intervertebral cage is an annular body configured to bend or deform during transition of the annular body from an unexpanded configuration to an expanded configuration Providing an annular body having a plurality of side segments rotatably attached by an integrated living hinge, and using one or more 3D printable materials to provide a plurality of sides of the annular body Printing the segment and the integral living hinge.

  In some embodiments, the one or more 3D materials are selected from the group consisting of thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys, and combinations thereof. In some embodiments, the one or more 3D materials are selected from the group consisting of natural biocompatible materials, synthetic biocompatible materials, metal biocompatible materials, adaptive materials, 4D printing, and combinations thereof. The In some embodiments, the one or more 3D materials include polyetherketone (PEK), polyetherimide (PEI) such as Ultem, ultra high molecular weight polyethylene (UHMPE), polyphenylene, eg, memory PEEK material such as PEEK Altera. Selected from the group consisting of polyetheretherketone (PEEK), and combinations thereof. In some embodiments, the relatively soft 3D printable material comprises a non-metallic material and the relatively rigid 3D printable material comprises a metallic material.

  In some embodiments, the intervertebral cage includes an outer coating selected from the group consisting of plasma spraying, hydroxyapatite coatings, biologics, antibiotics, drug or gene therapy, nanotechnology platforms, and combinations thereof.

  In some embodiments, the integral living hinge includes a relatively soft 3D printable material and the side segments include a relatively rigid 3D printable material.

  In some embodiments, the 3D data is standard cage size predefined data. In some embodiments, the 3D data is 3D imaging data, and the method further includes pre-imaging the patient's adjacent vertebrae to generate 3D imaging data.

  In some embodiments, the living hinge includes a constricted portion of the annular body and / or a notch to the annular body configured to allow local bending or deformation of the annular body.

  In some embodiments, the annular body includes a proximal end and a distal end opposed to each other along the short axis, and in an unexpanded form, the proximal end and the distal end. Are spaced apart to the maximum, and in the expanded configuration, the proximal and distal ends are closer together, and the expandable intervertebral cage is in a non-expanded configuration to an expanded configuration between adjacent vertebrae. Configured to expand horizontally.

  In some embodiments, the annular body includes a top panel and a bottom panel, each top panel and bottom panel being rotatably attached to one or more side segments by an integral living hinge and expandable. The intervertebral cage is configured to expand vertically from an unexpanded configuration to an expanded configuration between adjacent vertebrae.

  In some embodiments, the expandable intervertebral cage further includes a variable volume pouch that is positionable within the internal volume of the intervertebral cage.

  In some embodiments, the expandable intervertebral cage further includes a deployment cable coupled to the annular body and applies force to the annular body to transition the annular body from the unexpanded configuration to the expanded configuration. Composed.

  In some embodiments, the expandable intervertebral cage further includes a deployer coupled to the annular body and applies force to the annular body to transition the annular body from the unexpanded configuration to the expanded configuration. Composed.

  In some embodiments, the expandable intervertebral cage is configured to be positioned between the endplates of two vertebrae, and changes in size and shape of the expandable intervertebral cage from an unexpanded configuration. And is further configured to transition to an expanded configuration that increases the alterable internal volume of the expandable intervertebral cage.

  In another aspect of the invention, a method for making and using a patient-specific expandable intervertebral cage with a living hinge that uses a 3D printable material for placement between adjacent vertebrae. Pre-imaging the patient's adjacent vertebrae to generate 3D imaging data, providing 3D data to a 3D printer, and expandable vertebrae using one or more 3D printable materials An interstitial living body for printing an intercage, wherein the expandable intervertebral cage is an annular body and is configured to bend or deform during transition of the annular body from a non-expanded configuration to an expanded configuration Printing, including surgically positioning an expandable intervertebral cage between adjacent vertebrae, including an annular body having a plurality of side segments rotatably attached by hinges; From the non-expanded configuration between vertebrae and a thereby expanding the expandable intervertebral cage expanded configuration, is a method.

  In some embodiments, the one or more 3D materials are thermoplastic, photopolymer, metal powder, eutectic metal, titanium alloy, natural biocompatible material, synthetic biocompatible material, metal biocompatible material, Adaptable materials, polyetheretherketone (PEEK), including 4D printing, polyetherketone (PEK), polyetherimide (PEI) such as Ultem, ultra high molecular weight polyethylene (UHMPE), polyphenylene, for example memory PEEK materials such as PEEK Altera ), And combinations thereof.

  In a further aspect of the invention, a system for deploying an expandable intervertebral cage with a living hinge that uses a 3D printable material for placement between adjacent vertebrae, from an unexpanded configuration An expandable intervertebral cage made of one or more 3D printable materials configured to transition to an expanded configuration, having a proximal end and a distal end, and annular A body comprising an annular body having a plurality of side segments rotatably attached by an integral living hinge configured to bend or deform during transition of the annular body from a non-expanded configuration to an expanded configuration An expandable intervertebral cage and a variable volume pouch positionable within the intervertebral cage, wherein the expandable intervertebral cage is configured to move the expandable intervertebral cage from an unexpanded configuration to an expanded configuration Including a system.

  The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. With the understanding that these drawings merely depict a plurality of embodiments in accordance with the present disclosure and should not be considered as limiting the scope of the present disclosure, the present disclosure uses the accompanying drawings. More specifically and in detail.

FIG. 6 is a perspective view of one embodiment of an intervertebral cage in an unexpanded position. FIG. 6 is a top view of one embodiment of an intervertebral cage in an unexpanded configuration. FIG. 6 is a perspective view of one embodiment of an intervertebral cage in an expanded configuration. FIG. 6 is a top view of one embodiment of an intervertebral cage in an expanded configuration. It is a flowchart of a 3D model printing method. 1 is a perspective view of one embodiment of a variable volume pouch in a non-expanded configuration. FIG. 1 is a perspective view of one embodiment of a variable volume pouch in an expanded configuration. FIG. 1 is a perspective view of one embodiment of an intervertebral cage device including an intervertebral cage and a variable volume pouch in an unexpanded configuration. FIG. It is a side view of one Embodiment of a stopper. 1 is a perspective view of one embodiment of an intervertebral cage device including an intervertebral cage and a variable volume pouch in an expanded configuration. FIG. FIG. 6 is a cutaway top view of one embodiment of an intervertebral cage device in an expanded configuration. 1 is a perspective view of one embodiment of an intervertebral cage device including a variable volume pouch and an intervertebral cage having a side split in an expanded configuration. FIG. 1 is a schematic diagram of one embodiment of a deployment system. 1 is a perspective view of one embodiment of an intervertebral cage device including an intervertebral cage and a deployment cable in an unexpanded configuration. FIG. 1 is a perspective view of one embodiment of an intervertebral cage device including an intervertebral cage and a deployment cable in an expanded configuration. FIG. 1 is a top view of an embodiment of an intervertebral cage device including an intervertebral cage and a deployment cable in an expanded configuration. FIG. 1 is a perspective view of one embodiment of an intervertebral cage device including a variable volume pouch, a deployment cable and an intervertebral cage having a flow diagram side fissure in an expanded configuration. FIG. 6 is a flow chart illustrating one embodiment of a process for using an intervertebral cage and / or intervertebral cage device. 6 is a flowchart illustrating one embodiment of a method of using a variable volume pouch and an intervertebral cage as part of an intervertebral cage device. 6 is a flow chart illustrating one embodiment of a method of using an intervertebral cage device that includes an intervertebral cage and a deployment cable. 1 is a perspective view of one embodiment of an intervertebral cage device having a distal opening in an unexpanded position. FIG. FIG. 15B is a cross-sectional view of one embodiment of the intervertebral cage device along section AA shown in FIG. 15A. FIG. 16 is a cross-sectional view of one embodiment of an intervertebral cage device along section BB shown in FIG. 15B, showing slots in the distal opening. FIG. 10 is a partial cross-sectional view of one embodiment of an implant that can be used to convert an intervertebral cage device from an unexpanded position to an expanded position. FIG. 16B is an enlarged view of the distal end of one embodiment of the applier focusing on section AA shown in FIG. 16A. FIG. 5 is a view from the distal end side of one embodiment of the implant showing the distal end of an intervertebral cage device having a connector, teeth, and shaft. 1 is a cross-sectional view of one embodiment of an intervertebral cage device having a distal opening and one embodiment of an implant prior to being connected. FIG. 1 is a perspective view of one embodiment of a vertically expandable intervertebral cage. FIG. FIG. 19 is a side view of the intervertebral cage of FIG. 18 in a first position. FIG. 19 is a side view of the intervertebral cage of FIG. 18 in a second position. FIG. 19 is a side view of the intervertebral cage of FIG. 18 in a third position.

  The words “proximal” and “distal” are used to indicate specific ends of the components of the invention described herein. The proximal end refers to the end of the component that is closer to the medical professional when the component is implanted. The distal end refers to the end of the component that is remote from the medical professional when the component is implanted.

  Some details of the expandable intervertebral cage are provided herein, but further details are available from the US patent application published on April 5, 2012 entitled “Intervertive Devices and Methods of Use”. Published 2012/0083887, United States Patent Application Publication 2012/0083889 published on April 5, 2012, entitled “Intervertible Devices and Methods of Use”, and “Vertical Expandable Intervertebrate Intervertebrate Intervertebrate Intervertebrate. "International Devices, And Methods Of Using The Same" published on October 2, 2014 It can be found in No. 2014/158619 pamphlet, all of which incorporated by reference in its entirety herein.

  The present application discloses an embodiment of an expandable intervertebral cage that can be manufactured by additive manufacturing, also known as three-dimensional printing or 3D printing. 3D printing is a high-speed additive manufacturing technique capable of depositing various types of powder, liquid, or granular materials in a printer-like manner. The deposited layer can be cured layer by layer, or alternatively in granular deposition, an intervening adhesion step can be used to ensure that the layered grains are fixed together in a grain bed, for example, laser curing or Multiple layers can be cured together by photocuring.

  As used herein, 3D printing includes many types of printing techniques such as additive manufacturing, rapid manufacturing, additive manufacturing, rapid prototyping, laser sintering, electron beam melting (EBM), and the like. 3D printing also includes adaptive materials and 4D printing. In some embodiments, 4D printing adds time to the length, width, and height of the intervertebral cage printed by additive manufacturing. Over time, the intervertebral cage can become an adaptive change structure, ie a self-evolving structure.

  One feature of using a 3D printing process is that the expandable intervertebral cage need not be limited to conventional manufacturing constraints, such as those imposed by conventional machining or casting methods. . The expandable intervertebral cage 3D printing process can use a variety of materials including thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys and other materials.

  The expandable intervertebral cage 3D printing process can use a variety of materials including thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys and other materials. Since the expandable intervertebral cage is implanted in the body, preferred materials are biocompatible materials, such as natural biocompatible materials, synthetic biocompatible materials, metal biocompatible materials, adaptable materials, and / or any Other desired biocompatible materials. The implant can be polyetheretherketone (PEEK), polyetherimide (PEI) such as Ultem, polyetheretherketone (PEEK) containing a memory PEEK material such as ultra high molecular weight polyethylene (UHMPE), polyphenylene, eg PEEK Altera, or any It can be made of other desired biocompatible materials. The 3D printing process may also include a hybrid material design, ie PEEK and titanium.

  In some embodiments, the expandable intervertebral cage may be manufactured using a 3D printing process in which a metallic material having a relatively high density is deposited in a polymer substrate having a relatively low density. In some embodiments, the expandable intervertebral cage is manufactured with side segments made from a relatively rigid 3D printable material and an integral living hinge made from a relatively soft 3D printable material. May be. Other combinations may include any combination of metal, polymer, ceramic, or composite material for the side segments and the integral living hinge. In some embodiments, the expandable intervertebral cage may be manufactured using a combination of conventional manufacturing processes and 3D printing processes.

  The intervertebral cage can also include external coatings such as plasma spraying, hydroxyapatite coatings, biologics, antibiotics, drugs or gene therapy, nanotechnology platforms, and the like. The coating may be part of the 3D printing process, or may be applied secondarily to or integrated with the implant.

  The expandable intervertebral cage 3D printing process may also be directed to patient-specific and / or patient engineering implants. For such a system, the expandable intervertebral cage is designed from non-invasive imaging data of a patient undergoing a surgical procedure pre-operatively and its anatomical structure corresponds to the individual anatomy of the patient. It may be manufactured using information. This saves time and money by eliminating the need to stock multiple sized inventory cages prior to surgery, as is currently done.

  The intervertebral cages described herein include anterior lumbar interbody fusion (ALIF), posterior approach lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), side In the sense that an intervertebral cage can be used for multiple spinal fusion techniques, including one-way lumbar interbody fusion (XLIF), or can be applied from any direction, including transbone It is possible to be "independent of constraints".

  The present invention relates generally to an interbody spinal fusion implant and, more particularly, to an intervertebral cage configured to repair and maintain two adjacent vertebrae of the spine in a precise anatomical angular relationship. The intervertebral cage is configured to be positioned in an unexpanded configuration between the endplates of the two vertebrae and then expanded to an expanded configuration that results in a change in the size and shape of the intervertebral cage. The intervertebral cage serves to fuse opposing vertebrae while maintaining the lordosis.

  FIGS. 1A and 1B and FIGS. 2A and 2B illustrate one embodiment of an expandable intervertebral cage 100. Intervertebral cage 100 can be configured to be positioned between two vertebrae, specifically, between the endplates of two vertebrae to fuse opposing vertebrae. The intervertebral cage 100 can be positioned in the unexpanded configuration depicted in FIGS. 1A and 1B and can be positioned in the expanded configuration depicted in FIGS. 2A and 2B. In some embodiments, as depicted in FIGS. 1A and 1B and FIGS. 2A and 2B, the change in the intervertebral cage 100 from an unexpanded configuration to an expanded configuration results in the dimensions and shape of the intervertebral cage 100. Can bring about changes.

  The intervertebral cage 100 can include an annular body 102 that defines a peripheral edge and an internal volume. The body 102 is positioned so that the intervertebral cage is positioned between one of the two vertebrae between which the intervertebral cage 100 is positioned and in contact with the two vertebrae between which the intervertebral cage 100 is positioned. It can be configured to transmit force to the other of the two vertebrae. The body 102 can include a variety of shapes and sizes that approximate the dimensions between the two vertebrae, and can be made from a variety of materials.

  As seen in FIGS. 1A and 1B and FIGS. 2A and 2B, embodiments of the body 102 are rotatably connected to each other by an integral soft connector or living hinge 118 to form a changeable internal volume 126. Segments 116 may be included. The living hinge 118 need not be able to be bent many times, but is instead a true hinge in that it only needs to be sturdy enough to bend once from the unexpanded configuration to the expanded configuration. There is no need.

  In some embodiments, the living hinge 118 can be located on the inner surface of the body 102 proximate the interior volume 126, and in some embodiments, the living hinge 118 can be located on the outer surface of the body 102. . In some embodiments, the living hinge 118 can include a portion of the body 102 that is configured to be curved. In some embodiments, the living hinge 118 can be a separate element in that the curvature can be localized at one or more locations in the body 102, and in some embodiments, the living hinge 118 may be an element that is not separate in that the curvature is not localized, but rather may occur over the entirety or most of the body 102. In some embodiments where the living hinge 118 includes a separate element, the flexible connector can include shape, features, material properties, or any other manner of concentrating stress and / or deformation. As specifically depicted in FIGS. 1A and 1B and FIGS. 2A and 2B, in some embodiments, the living hinge 118 is the body when the body 102 is moved from the unexpanded configuration to the expanded configuration. A constricted portion of the body 102 and / or a notch into the body 102 to allow local deformation of the 102 can be included.

  The body 102 can have a proximal end 110 and a distal end 112. In some embodiments, the proximal end 110 and / or the distal end 112 can be an integral part of the body 102 and can partially define the internal volume of the body 102. In some embodiments, as seen in FIG. 2A, the proximal end 110 of the body 102 can include a proximal opening 124. In some embodiments, for example, the proximal opening 124 can extend through the proximal end 110 of the body 102 and into the interior volume 126 of the body 102. Advantageously, in embodiments where the proximal opening 124 extends through the proximal end 110 of the body 102 and into the interior volume 126 of the body 102, the proximal opening 124 is within the interior volume 126 and / or the interior volume 126. Access to the components or features of the intervertebral cage device located in Proximal end 110 can include a variety of shapes and sizes. Similarly, the proximal opening 124 can include various shapes and sizes.

  The distal end 112 of the body 102 can be configured to facilitate insertion of the intervertebral cage 100 between the vertebrae. In some embodiments, for example, the distal end 112 of the body 102 can include a tapered shape and / or a pointed shape to facilitate insertion of the body 102 into the intervertebral space. Advantageously, such a tapered and / or pointed shape at the distal end of the body 102 can facilitate achieving adequate separation between the vertebrae and / or the intervertebral cage 100. The insertion force required to insert the main body 102 into the intervertebral space can be minimized.

  As seen in FIG. 1A, the longitudinal axis 104 of the body 102 can extend between the proximal end 110 and the distal end 112 of the body. As further seen in FIG. 1A, the body 102 can include a top portion 120 and a bottom portion 122. In some embodiments, the top 120 and bottom 122 are each configured to interact with one of the two vertebrae between which the intervertebral cage 100 is positioned, in particular, the intervertebral cage 100 is in between Can be configured to interact with one of the endplates of one of the two vertebrae. Also, as seen in FIG. 1A, the body 102 can define a vertical axis 108 that extends between the top 120 and bottom 122 of the body 102 perpendicular to the longitudinal axis 104. As further seen in FIG. 1A, the body 102 can define a transverse axis 106 that extends perpendicular to both the longitudinal axis 104 and the vertical axis 108.

  As seen in FIGS. 1A and 1B and FIGS. 2A and 2B, the combination of the segment 116 and the living hinge 118 allows for the deployment of the body 102 of the intervertebral cage 100, which allows the proximal end 110 to be deployed. And the distance between the distal end 112 decreases and the width of the body 102 measured along the transverse axis 106 increases.

  The segment 116 and living hinge 118 can include various shapes and sizes. In some embodiments, for example, the shape and size of the segment 116 and / or living hinge 118 may be the desired size of the intervertebral cage 100, the desired deployment force, the resulting desired expanded shape, the desired non- It can be determined by the expanded shape, and / or many other considerations.

  The body 102 may be manufactured using known additive manufacturing or 3D printing methods. For example, the body 102 may be constructed from a biocompatible material from bottom to top, layer by layer, so that the segments 116 are connected together by a living hinge 118. The body 102 can be manufactured as a single integral piece that cannot be disassembled without dividing the body. A single piece can be manufactured by a 3D printing process. Similar manufacturing processes are known under names such as additive manufacturing, rapid manufacturing, additive manufacturing, rapid prototyping, laser sintering, electron beam melting (EBM) and the like. All of these fabrication processes utilize a similar operating principle of scanning the energy beam across the bath of material to solidify the precise pattern of material and form each layer until the entire component is complete.

  In some embodiments, the intervertebral cage 100 is configured such that when the intervertebral cage 100 is moved from the unexpanded configuration to the expanded configuration, the intervertebral cage 100 is dimensioned by one, two of the axes 104, 106, 108, Or it can comprise so that it may become a different dimension along three.

  FIG. 3 shows an embodiment of a flowchart of the 3D printing process. The data used in manufacturing the cage may be pre-defined data of standard cage size, or may be imaging data depicting a patient undergoing a surgical procedure. The data may be from a software program that sends the geometric representation to the 3D printer to generate a geometric representation of the 3D physical model in a data format supported by the 3D printer to create a 3D physical model. Good.

  A 3D printer requires a geometric representation of an object to produce the geometric shapes necessary to create a 3D physical model. A typical geometric representation of an object has the following form (ie, a list of 3D points for the entire object body with location information and material information defined at each 3D point, One or a combination of a group of 3D contours defining a shape, or a surface model consisting of triangles or polygons or curved patches that outline the body of the object.

  The 3D physical model of the cage may have one or more pieces and one or more colors, and may be made of one or more materials. The conversion process from the input image data set to the geometric representation understood by the 3D printer may either depend on the image diagnostic method or any other image information, or be independent of it. Good. The process may be executed as a software program on a computer, a computer processing board, or a control board of a 3D printer. The process is not limited, but for a script file of a program having processing instructions and parameters, a binary executable program having processing instructions and parameters, a dynamic link library (DLL), an application plug-in, or a printer It may be executed as a device driver. The print data program may be loaded locally on the computer of the 3D printer or may reside on a remote server connected through a computer network.

  Once the data is received, the 3D printer prints the cage and then the cage may be sent to the operating room for implantation into the patient.

Variable Volume Pouch Some embodiments of the intervertebral cage device can include a variable volume pouch. 4A depicts a perspective view of one embodiment of a variable volume pouch 400 in an unexpanded state, and FIG. 4B depicts one embodiment of a variable volume pouch 400 in an expanded state. The variable volume pouch 400 can be configured to expand upon receipt of material into the interior portion of the variable volume pouch 400. In some embodiments, the variable volume pouch 400 can be configured to resist compressive forces when the variable volume pouch 400 is filled with material. An example of a variable volume pouch is available from Spinology, Inc. OptiMesh (R) deployable transplant system available from Although some details of the variable volume pouch 400 and methods of use are provided herein, further details are published on March 1, 1995, entitled “Expandable Fabric Implant For Stabilizing the Spinal Motion Segment”. U.S. Pat. No. 5,549,679, and U.S. Pat. No. 5,571,189, published Nov. 5, 1996, entitled "Expandable Fabric Implant For Stabilizing the Spinal Motion Segment". Are incorporated herein by reference in their entirety.

  The variable volume pouch can include a variety of shapes and sizes. In some embodiments, for example, the variable volume pouch 400 may be shaped to allow uniform expansion of the variable volume pouch 400 when material is added into the interior portion of the variable volume pouch 400. it can. In some embodiments, for example, the variable volume pouch can be generally spherical, oval, elongated, cylindrical, rectangular, or have any other desired shape. In the embodiment depicted in FIGS. 4A and 4B, the variable volume pouch 400 is generally balloon shaped. 4A and 4B, the variable volume pouch 400 includes a first end 402 and a second end 404 positioned opposite the first end 402. As shown in FIG. As seen in FIGS. 4A and 4B, the variable volume pouch 400 further includes a single opening 406 located at the first end 402.

  In some embodiments, the variable volume pouch 400 can include features configured to allow selectable sealing and / or closing of the opening 406. These features may be, for example, one or more straps, one or more drawstrings, one or more plugs, or any configured to allow sealing and / or closing of the opening 406 Other mechanical features or other features may be included.

  The variable volume pouch 400 can include a variety of materials. In some embodiments, the variable volume pouch can include natural materials, synthetic materials, artificial materials, polymers, composite materials, elastic materials, inelastic materials and / or any other desired material. In some embodiments, as depicted in FIGS. 4A and 4B, the variable volume pouch 400 can include a woven material. Advantageously, the woven material may allow expansion of the variable volume pouch 400 to a desired maximum size.

  The variable volume pouch 400 can include various sizes. In some embodiments, the variable volume pouch 400 can be sized to allow placement between two vertebrae. Specifically, in some embodiments, the variable volume pouch 400 can be sized to fit between two vertebrae, specifically between the endplates of the two vertebrae.

Intervertebral Cage Device FIG. 5A depicts a perspective view of one embodiment of an intervertebral cage device 500. Intervertebral cage device 500 includes an intervertebral cage 100 and a variable volume pouch 400 located within an internal volume 126 of the intervertebral cage 100. In some embodiments, the variable volume pouch 400 can be secured to all or a portion of the intervertebral cage 100. In some embodiments, for example, the variable volume pouch 400 includes the second end 404 of the variable volume pouch 400 proximate the distal end 112 of the intervertebral cage 100 and the first end 402 is the intervertebral cage. The intervertebral cage 100 can be inserted into the interior volume 126 proximate the proximal end 110 of the 100. In some advantageous embodiments where the first end 402 is proximate to the proximal end 110 of the intervertebral cage 100, the opening 406 of the variable volume pouch 400 is a proximal opening 124 of the body 102 of the intervertebral cage 100. Located close to. Thus, in some embodiments, the variable volume pouch 400 can be inserted through the proximal opening 124 into the internal volume 126 of the body 102 of the intervertebral cage 100. In such an embodiment, after the variable volume pouch 400 is inserted into the internal volume 126 of the body 102 via the proximal opening 124, the variable volume pouch 400 is partially or fully attached to the body 102 of the intervertebral cage 100. Can be fixed. In some embodiments, the variable volume pouch 400 can be secured to the body 102 of the intervertebral cage 100 such that expansion of the variable volume pouch 400 can result in deployment of the body 102 of the intervertebral cage 100; In some embodiments, fixation of the variable volume pouch 400 to the body 102 of the intervertebral cage 100 can result in expansion of the variable volume pouch 400 when the body 102 of the intervertebral cage 100 is expanded.

  In some embodiments, the intervertebral cage device 500 can further include a plug 502. The plug 502 secures the first end 402 of the variable volume pouch 400 to the proximal end 110 of the intervertebral cage 100 and seals the proximal opening, and the variable volume pouch opening 406. Can be configured to fit tightly within the proximal opening 124. In some embodiments, the plug 502 can be further configured to facilitate deployment of the intervertebral cage 100. The plug 502 can include a variety of shapes and sizes, and can be made from a variety of materials, including, for example, all of the materials from which the intervertebral cage 100 can be made.

  In some embodiments, the plug 502 can include a proximal shaft 504 and a distal head 506. Proximal shaft 504 can include a variety of shapes and sizes. In some embodiments, the proximal shaft 504 can be sized and shaped to seal the proximal opening 124, specifically, having a size and dimension that is larger than the proximal opening 124. It can be a shape. In some embodiments, the configuration of the proximal shaft 504 with dimensions greater than the dimensions of the proximal opening 124 can facilitate retention of the plug 502 within the proximal opening 124.

  In some embodiments, the distal head 506 can include various shapes and sizes. In some embodiments, the distal head 506 can have a conical shape with a distal base 508 and extending in the direction of the proximal shaft 504 toward the apex. Distal head 506 may be shaped to facilitate deployment of intervertebral cage 100 in some embodiments.

  FIG. 6A depicts one embodiment of an intervertebral cage device 500 in an expanded configuration, with the body 102 of the intervertebral cage 100 expanded and the variable volume pouch 400 in the expanded configuration. As seen in FIG. 6A, the variable volume pouch 400 in the expanded configuration fills and / or substantially fills the internal volume 126 of the intervertebral cage 100.

  6B is a cutaway top view of the intervertebral cage device 500 in an expanded configuration. As seen in FIG. 6B, the proximal shaft 504 of the plug 502 is located within the proximal opening 124 of the body 102 of the intervertebral cage 100. Also, as seen in FIG. 6B, the proximal shaft 504 of the plug has an enlarged diameter of the proximal opening 124 and is thereby secured within the proximal opening 124. Also, as seen in FIG. 6B, the plug 502 is within the proximal opening 124 such that a portion of the first end 402 of the variable volume pouch 400 is located between the proximal shaft 504 and the wall of the proximal opening. So that the variable volume pouch 400 is securely fixed.

  6B further depicts the distal head 506 of the plug 502 extending into the interior volume 126 of the intervertebral cage 100. FIG. As seen in FIG. 6B, distal head 506 engages a portion of body 102 and thereby biases body 102 of intervertebral cage 100 into an expanded configuration.

  In some embodiments where the plug 502 is used in the context of the intervertebral cage device 500, the variable volume pouch 400 is inserted into the intervertebral cage 100 through the proximal opening 124 and the first end of the variable volume pouch 400. 402 and opening 406 can be positioned proximate proximal opening 124. In some embodiments, the variable volume pouch 400 can be at least partially secured to the intervertebral cage 100. After the variable volume pouch 400 is inserted into the intervertebral cage 100, positioned and optionally at least partially secured to the intervertebral cage 100, the variable volume pouch 400 can be filled and / or the intervertebral cage. 100 can be expanded.

  FIG. 7 depicts an alternative embodiment of the intervertebral cage device 500. Specifically, FIG. 7 depicts an embodiment of an intervertebral cage device 500 that includes a variable volume pouch 400 shown in an expanded state in this figure and an intervertebral cage 300 that includes a side crevice 302 shown in a fully expanded configuration. ing. As seen in FIG. 7, the intervertebral cage 300 is also expanded in the short direction 106 measured along the short axis 106 and is also expanded in the vertical direction measured along the vertical axis 108. As seen in FIG. 7, the variable volume pouch 400 substantially fills and / or fills the internal volume 126 of the intervertebral cage 300.

Deployment System Some embodiments relate to a system and device for insertion and deployment of the intervertebral cage device 500 and / or the intervertebral cages 100, 300 (described further with respect to FIG. 11). FIG. 8 depicts one embodiment of an insertion and deployment system 800. As can be seen in FIG. 8, the deployment system 800 can include a deployment tool 802. The deployment tool 802 facilitates insertion of the intervertebral cage device 500 and / or intervertebral cages 100, 300 and controls the deployment of the intervertebral cage device 500 and / or intervertebral cages 100, 300. Can be configured.

  The deployment tool 802 can include a variety of shapes and sizes and can include a variety of features. In some embodiments, for example, the deployment tool 802 can be a mechanical device, an electromechanical device, and / or an electrical device. In some embodiments, for example, the deployment tool 802 can be manually operated, electrically controlled, and / or controlled using any other desired control technique. it can. As depicted in FIG. 8, the deployment tool 802 includes a control interface 804. The control interface 804 can be configured to allow a user to control the deployment tool 802 and the insertion and / or deployment of the intervertebral cage device 500 and / or the intervertebral cages 100,300. In some embodiments, for example, the control interface is configured to receive and use user input to cause deployment of the intervertebral cage device 500 and / or intervertebral cage 100, 300. Can include any feature, system, and / or module As depicted in FIG. 8, the control interface 804 can include a simple manual control configured to apply a force to one end of the deployment cable 806.

  In some implementations, the deployment tool 802 can be used in conjunction with other features to insert the intervertebral cages 100,300. In such an embodiment, the deployment tool 802 can be used with a rigid shaft. In one embodiment, the rigid shaft can include a proximal end secured to the deployment tool 802 and a distal end configured to engage the intervertebral cage 100, 300. In some embodiments, these features configured to engage the intervertebral cages 100, 300 and located at the distal end of the rigid shaft engage the portions of the intervertebral cages 100, 300. One or more protrusions (not shown) configured as described above may be included. In some embodiments, the features configured to selectively secure the intervertebral cages 100, 300 to the deployment tool 802 are along any of the axes 104, 106, 108 of the intervertebral cages 100, 300. And / or manipulation of the intervertebral cages 100, 300 about either of them.

  In some embodiments, the rigid shaft can be configured to allow passage of the deployment cable 806 from the deployment tool 802 to the intervertebral cage 100, 300. In some embodiments, the deployment cable 806 can pass along and / or through the rigid shaft from the deployment tool 802 to the intervertebral cage 100, 300. Passing the deployment cable 806 from the deployment tool 802 to the intervertebral cage 100, 300 can be facilitated by one or more passages located within the rigid shaft. In some embodiments, these rigid passages can be located on the outer surface of the rigid shaft and / or can be located within the rigid shaft. In some embodiments, the passageway can extend the entire length of the rigid shaft and / or along a portion of the rigid shaft.

  In some embodiments where the deployment tool 802 is used only for deployment of the intervertebral cages 100, 300, a separate inserter and / or instrument can be used for insertion of the intervertebral cages 100, 300. Some embodiments of such inserts and / or implants can be found in US 2012/0083887 published April 5, 2012, which is hereby incorporated by reference. The entirety is incorporated herein.

  The deployment cable 806 can be configured to transmit force from the deployment tool 802 to the intervertebral cage device 500 and / or the intervertebral cages 100, 300. In some embodiments, deployment cable 806 facilitates deployment of intervertebral cage device 500 and / or intervertebral cages 100, 300 and / or intervertebral cage device 500 and / or intervertebral cage 100. , 300 can be configured to facilitate maintaining the expanded configuration. In some embodiments, the deployment cable 806 can be configured to be used as a marker, specifically to represent the position of the intervertebral cage 100, 300 and / or the intervertebral cage 100. , 300 and / or as a marker for determining how much the intervertebral cage 100, 300 is expanded. In some embodiments, for example, whether the deployment cable 806 expands the intervertebral cage 100, 300 by allowing the length of the deployment cable 806 within the intervertebral cage 100, 300 to be determined and / or Or it may include regularly spaced features that allow a determination of how much the intervertebral cage 100, 300 is expanded. Because deployment of the intervertebral cages 100, 300 may change the dimensions of the intervertebral cages 100, 300 in some embodiments, by determining the length of the portion of the deployment cable 806 located within the intervertebral cage, It can be facilitated to determine whether and / or to what extent the intervertebral cages 100, 300 are expanded.

  Deployment cable 806 can include a variety of shapes and sizes and can be made from a variety of materials. All or part of the deployment tool may be manufactured by 3D printing. In some embodiments, the deployment cable 806 can include any shape and size, and can apply the force required to deploy the intervertebral cage device 500 and / or the intervertebral cages 100,300 and It can be made from any material capable of withstanding that force.

  As depicted in FIG. 8, the deployment cable 806 includes a first end 808 and a second end 810. In some embodiments, the first end 808 can include an attachment feature 812. The attachment feature 812 enables the attachment of the deployment cable 806 to a portion of the intervertebral cage 100, 300 and / or deployment cable 806 in one or more specified directions relative to the intervertebral cage 100, 300. It can be any feature configured to prevent movement.

  The attachment feature 812 can include a variety of shapes and sizes and can be made from a variety of materials. In one embodiment, for example, the attachment feature 812 allows the attachment feature 812 to engage a portion of the intervertebral cage 100, 300, thereby limiting movement of the deployment cable 806 relative to the intervertebral cage 100, 300. The shape and / or size that allows it can be included. Specifically, as seen in FIG. 8, in some embodiments, the attachment feature can include a spherical feature located at the first end 808 of the deployment cable 806.

  In some embodiments, the deployment cable 806 can include a break (not shown). In some embodiments, the break point can be a portion of the deployment cable 806 that is configured to split, break and / or separate when a force threshold is exceeded. In some embodiments, the force threshold at break is less than a force threshold that breaks or breaks other portions and / or features such as, for example, attachment feature 812 and / or locking feature 814 of deployment cable 806. It can be. In some embodiments, the break point can be positioned, for example, between the locking feature 814 and the second end 810 of the deployment cable 806. Advantageously, applying a force that exceeds the force threshold results in the breakage of the deployment cable 806 at the break point, such positioning of the break point results in the deployment cable 806 when the intervertebral cage 100, 300 is expanded. The need to cut off can be eliminated.

  Also, as seen in FIG. 8, the second end 810 of the deployment cable 806 can be connected to a portion of the deployment tool 802. As further seen in FIG. 8, in some embodiments, deployment cable 806 can be located, for example, at any location along the deployment cable, and in some embodiments, with attachment features 812 and It further includes a locking feature 814 that can be positioned between the second end 810 of the deployment cable 806. The locking feature 814 can be configured to allow a user to lock and / or securely secure the intervertebral cage 100, 300 in an expanded configuration. In some embodiments, the locking feature 814 can include a size and / or shape configured to interact with a portion of the intervertebral cage 100, 300, such that the intervertebral cage 100, Intervertebral cages 100, 300 are prevented from returning to an unexpanded configuration after 300 is expanded.

  In some embodiments, for example, the distance between the attachment feature 812 and the locking feature 814 can be different distances. Specifically, for example, the distance between the attachment feature 812 and the locking feature 814 is the size of the intervertebral cage 100, 300 and the deployment cable 806 moved before the intervertebral cage 100, 300 is deployed. The distances that must be made and / or different distances based on any other desired parameters.

  9, 10A and 10B depict perspective views of one embodiment of an intervertebral cage device 900. FIG. Specifically, FIG. 9 depicts one embodiment of an intervertebral cage device 900 in an unexpanded configuration, and FIGS. 10A and 10B illustrate one embodiment of an intervertebral cage device 900 in an expanded configuration. A perspective view is drawn. As seen in FIGS. 9, 10A and 10B, the intervertebral cage 100 can be configured to be used with a deployment cable 806. In some embodiments, for example, the intervertebral cage 100 has one or more openings and / or one or more passages configured to receive, guide, and / or hold a portion of the deployment cable. Can be included. These openings can include a variety of shapes and sizes and can be located in any desired portion of the intervertebral cage. In some embodiments, the size and shape of the opening is the size and shape of the feature housed in the opening, such as, for example, the deployment cable 806, the attachment feature 812, and / or the locking feature 814. Can be determined. Specifically, for example, the intervertebral cage 100 includes one or more distal openings 902 positioned proximate to the distal end 112 of the body 102 of the intervertebral cage 100 and the intervertebral cage 100 in proximity. First and / or second proximal openings 906, 908 located proximate to the distal end 110 may be included.

  Distal opening 902, first proximal opening 906, and second proximal opening 908 can be configured to receive a portion of deployment cable 806. In some embodiments, for example, all or some of the distal opening 902, the first proximal opening 906 and / or the second proximal opening 908 can connect the deployment cable 806 to a portion of the intervertebral cage 100. You can guide inside and outside. In some embodiments, these openings 902, 906, 908 can be connected to one or more passages through all or part of the intervertebral cage 100. Thus, in some embodiments, the deployment cable enters the intervertebral cage 100 from the first proximal opening 906, and then the deployment cable 806 passes through all or a portion of the intervertebral cage 100, for example, May exit the passageway within the intervertebral cage 100 via another opening, such as the distal opening 902 and / or the second proximal opening 908.

  As further seen in FIG. 9, in some embodiments, the deployment cable 806 can pass through the interior volume 126 of the body 102 of the intervertebral cage 100. Specifically, in some embodiments, the entire or portion of deployment cable 806 extends along the inner surface of cage 100 from first proximal opening 906 to distal opening 902 and / or distal opening 902. To a second proximal opening 908.

  In some embodiments, multiple deployment cables 806 can be used in connection with a single intervertebral cage 100, 300. In some embodiments, the number of deployment cables 806 can be determined by the desired type of deployment. Thus, in some embodiments, more deployment cables 806 can be used to achieve more complex deployment operations.

  FIG. 11 depicts one embodiment using multiple deployment cables. Specifically, FIG. 11 depicts a further embodiment of the intervertebral cage device 1100. As seen in FIG. 11, the intervertebral cage device 1100 includes an intervertebral cage 300 that includes a body 102 having a proximal end 110 and a distal end 112. The body 102 defines a longitudinal axis 104 that extends between the proximal end 110 and the distal end 112 along the center of the body 102. The body 102 of the intervertebral cage 300 further includes a plurality of segments 116 joined by a living hinge 118, defining an interior volume 126 of the body, a top 120 and a bottom 122, and between the top 120 and the bottom 122. And defines a vertical axis 108 extending perpendicular to the longitudinal axis 104. The body 102 of the intervertebral cage 300 further defines a transverse axis 106 that extends perpendicular to both the longitudinal axis 104 and the vertical axis 108.

  Also, as seen in FIG. 11, the body 102 of the intervertebral cage 300 includes a side split 302. Side crevice 302 can be configured to allow expansion of body 102 of intervertebral cage 300. In some embodiments, for example, the side split 302 can be configured to allow expansion of all or a portion of the body 102 of the intervertebral cage 300 in a direction orthogonal to the side split 302. The side crack 302 includes a first end 304 and a second end 306. The first end 304 of the side split 302 is positioned proximate to the distal end 112 of the body 102 and the second end 306 of the side split 302 is positioned approximately in the center of the body 102. The side split 302 divides the body 102 at least partially into a top portion 308 and a bottom portion 310. Advantageously, the main body 102 of the intervertebral cage 300 can be expanded by splitting the main body 102 into a top portion 308 and a bottom portion 310 by a side split 302. In some embodiments, for example, this extension of the body 102 of the intervertebral cage 300 can be orthogonal to the side crevice 302, and in some embodiments, this extension of the body 102 can be lateral. It may not be orthogonal to the partial crack 302. The upper portion 308 and the bottom portion 310 of the body 102 allow the body 102 to expand in a direction parallel to the transverse axis 106 by extension of the side splits 302.

  As further seen in FIG. 11, the intervertebral cage 300 includes a lower first proximal opening 1102, a lower second proximal opening 1104, an upper first proximal opening 1106, and an upper second A proximal opening 1108, a lower distal opening 1110 and an upper distal opening 1112 are included.

  Also, as seen in FIG. 11, the intervertebral cage device 1100 includes two deployment cables 806. One of the deployment cables 806 depicted in FIG. 11 is inserted through the lower first proximal opening 1102 and then passes through the variable volume pouch 400, where one of the deployment cables 806 passes the variable volume pouch. Exit from one of the at least one lower distal opening 1110 before passing again to the lower second proximal opening 1104. This path of the deployment cable 806 ensures that a portion of the variable volume pouch 400 is secured to the intervertebral cage 300, specifically to the bottom portion 310 of the intervertebral cage 300.

  Also, as seen in FIG. 11, the other deployment cable 806 passes through the upper first proximal opening 1106 and then again through the variable volume pouch to the upper second proximal opening 1108. It passes through the variable volume pouch to at least one of the upper distal openings 1112. Similar to deployment cable 806 passing through lower openings 1102, 1104, 1110, deployment cable 806 passing through upper openings 1106, 1108, 1112, a portion of variable volume pouch 400 is specifically connected to intervertebral cage 300. In this case, the intervertebral cage 300 is securely fixed to the upper portion 308. Advantageously, the intervertebral cage 300 is at least partially relative to the vertical axis 108 by filling the internal portion of the variable volume pouch 400 by securely securing the variable volume pouch 400 to the top portion 308 and the bottom portion 310. Allows the use of a variable volume pouch 400 that is deployed vertically.

  FIG. 11 depicts an embodiment in which two deployment cables 806 are used and show specific locations of openings 1102, 1104, 1106, 1108, 1110, 1112; It will be appreciated that the deployment cable 806 can be used in the context of the intervertebral cage 300 and that a wide range of positions can be used for the opening.

Method of Using Intervertebral Cage Device FIG. 12 is a flowchart illustrating one embodiment of a process 1200 for using intervertebral cages 100, 300 and / or intervertebral cage devices 500, 1100. The process begins at block 1210 where the disc space is prepared, for example, by removing a portion of the annulus fibrosus, removing the nucleus, and then removing the cartilage endplate.

  After the disc space is prepared, the process 1200 proceeds to block 1212 where the intervertebral cages 100, 300 are placed in the disc space. In one embodiment, the intervertebral cages 100, 300 are centered about the longitudinal axis 104 of the intervertebral cages 100, 300 such that the vertical axis 108 of the body 102 of the intervertebral cages 100, 300 is parallel to the vertebral endplate. Rotate and place in disc space.

  Process 1200 proceeds to block 1214 where the intervertebral cages 100, 300 are rotated 90 degrees about the longitudinal axis 104 of the intervertebral cages 100, 300. After rotation of the intervertebral cage 100, 300, the top 120 and bottom 122 contact the vertebral endplate. The distance between the top portion 120 and the bottom portion 122 of the body 102 of the intervertebral cage 100, 300 is greater than the width of the body 102 of the intervertebral cage 100, 300 measured parallel to the transversal axis 106. In this embodiment, a 90 degree rotation of the body 102 along the longitudinal axis 104 of the body 102 increases the height of the disc space.

  After rotating the intervertebral cages 100, 300 90 degrees about the longitudinal axis 104 of the intervertebral cages 100, 300, the process 1200 includes the interbody cages 100, 300 by the body 102, in some embodiments. Proceed to block 1216 which is expanded to increase the internal volume 126 defined by the segment 116 and the living hinge 118 forming the body 102. In some embodiments, the expansion of the intervertebral cage 100, 300 can proceed as outlined in step 1406 depicted in FIG.

  In some embodiments, the body 102 is expanded until the body 102 is in an expanded configuration. For example, in some embodiments where the intervertebral cages 100, 300 are used in the context of the deployment tool 802, actuation of the deployment tool 802 causes the deployment of the intervertebral cages 100, 300, thereby causing the intervertebral cage 100. 300 expansion and expansion of the internal volume 126 of the intervertebral cage 100, 300 can occur. In some embodiments, the intervertebral cage 100, 300 includes a body 102 made of a memory material, such as PEEK Altera ™, for example, the intervertebral cage 100, 300 is non-expanded. Expansion can be achieved by inducing actuation of the memory material to deform from a position (second position) to an expanded position (first position). In some embodiments, the trigger can be temperature induced, stress induced, electrically and / or mechanically induced, chemically induced, and / or triggered by other trigger mechanisms. In some specific embodiments, a trigger can be triggered when the threshold temperature of the intervertebral cage 100, 300 is exceeded or when the stress threshold of the intervertebral cage 100, 300 is exceeded.

  After dilating the intervertebral device to increase the internal volume 126 defined by the body 102, the process 1200 may be performed by a locking mechanism, such as, for example, a deployment cable 806, in some embodiments. Proceed to block 1218, which is locked in the expanded configuration. In some embodiments, process 1200 can include block 1218, but the steps in this block can be omitted and process 1200 can proceed to block 1220.

  The process 1200 can then proceed to block 1220 where the internal volume 126 of the body 102 of the intervertebral cage 100, 300 is filled with bone graft material to allow bone fusion between adjacent vertebrae. In some embodiments, the internal volume 126 of the body 102 of the intervertebral cage 100, 300 can be filled via a proximal opening 124 located at the proximal end 110 of the body 102 of the intervertebral cage 100, 300. it can.

  One skilled in the art will recognize that the steps of the foregoing process can be performed in the same or different orders. One skilled in the art will further recognize that process 1200 may include more or fewer steps than outlined above.

  FIG. 13 is a flowchart illustrating one embodiment of a process 1300 for using the intervertebral cage device 500. In some embodiments, portions of step 1300 can be performed prior to insertion of intervertebral cage device 500 into the intervertebral space, and in some embodiments, insertion of intervertebral cage device into the intervertebral space. Later, the portion of step 1300 may be performed.

  Process 1300 begins at block 1302 where the variable volume pouch 400 is inserted into the intervertebral cage 100,300. In some embodiments, for example, insertion of the variable volume pouch 400 into the intervertebral cage 100, 300 can be performed using a variety of instruments and techniques. In some embodiments, for example, the variable volume pouch can be inserted into the intervertebral cage 100, 300 via the proximal opening 124 at the proximal end 110 of the body 102 of the intervertebral cage 100, 300. In some embodiments, the variable volume pouch 400 can be inserted into the internal volume 126 of the intervertebral cage 100, 300 via the proximal opening 124 located at the proximal end 110 of the intervertebral cage 100, 300. it can. In some embodiments, the variable volume pouch 400 can be pre-inserted into the intervertebral cage 100, 300 and the process 1300 can begin with a block other than the block 1302.

  After the variable volume pouch 400 is inserted into the intervertebral cage 100, 300, the process 1300 includes a block 1304 where the opening 406 of the variable volume pouch 400 is positioned proximate to the proximal opening 124 of the intervertebral cage 100, 300. Proceed to In some embodiments, positioning the opening 406 of the variable volume pouch 400 proximate to the proximal opening 124 of the intervertebral cage 100, 300 can, for example, cause the first end 402 of the variable volume pouch 400 to be near. This can be accomplished by inserting the second end 404 of the variable volume pouch 400 through the proximal opening 124 before passing through the lateral opening 124. According to this insertion procedure, the opening of the variable volume pouch 400 located at the first end 402 of the variable volume pouch 400 by first inserting the second end 404 of the variable volume pouch 400 through the proximal opening 124. 406 can be easily positioned proximate to the proximal opening 124 of the intervertebral cage 100, 300. In some embodiments in which the variable volume pouch 400 is pre-inserted into the intervertebral cage 100, 300, the process 1300 can begin at block 1304. In some embodiments, the opening 406 of the variable volume pouch 400 can be pre-positioned proximate to the proximal end 124 of the intervertebral cage 100, 300, and step 1300 can be a block other than block 1304. Can start from.

  After the opening 406 of the variable volume pouch 400 is positioned proximate to the proximal opening 124 of the intervertebral cage 100, 300, the process 1300 includes a block 1306 where the variable volume pouch 400 is secured to the intervertebral cage 100, 300. Proceed to In some embodiments, for example, the variable volume pouch 400 may be secured to all or a portion of the intervertebral cage 100,300, specifically, to all or a portion of the body 102 of the intervertebral cage 100,300. it can. In some embodiments, for example, the variable volume pouch 400 can be secured to the body 102 of the intervertebral cage 100, 300 along the portion of the body 102 that defines the internal volume 126. Specifically, the portion of the variable volume pouch 400 can be fixed to the segment 116 and the living hinge 118 that constitute the main body 102.

  In some embodiments, the variable volume pouch 400 includes, for example, one or more fasteners, one or more hooks, one or more snaps, one or more adhesive areas, and / or variable volume. Intervertebral features with features located on the body 102 of the intervertebral cage 100, 300, such as any other desired feature located on one or both of the pouch 400 and the body 102 of the intervertebral cage 100, 300 It can be fixed to the main body 102 of the cage 100, 300. In some embodiments, for example, the variable volume pouch 400 is attached to the intervertebral cage 100, 300 by an additional feature that is not an integral part of either the variable volume pouch 400 or the body 102 of the intervertebral cage 100, 300. Can be fixed. In some embodiments, these features can include, for example, one or more deployment cables 806. In some embodiments, for example, the deployment cable 806 can be fused to secure the variable volume pouch 400 to the intervertebral cage 100, 300. In some particular embodiments, deployment cable 806 is inserted through a portion of intervertebral cage 100, 300, such as body 102, through a portion of variable volume pouch 400, and then a portion of intervertebral cage 100, 300. Can be inserted again. In some embodiments, passage of deployment cable 806 through portions of intervertebral cages 100, 300 and variable volume pouch 400 may ensure that variable volume pouch 400 is secured to intervertebral cages 100, 300. .

  In some embodiments, the variable volume pouch 400 can be connected to the intervertebral cages 100, 300 along the entire periphery of the internal volume 126, and in some embodiments, the variable volume pouch 400 can be connected to the intervertebral cage 100. , 300 can be connected at discontinuous points. In some embodiments, the variable volume pouch 400 is 1 point, 2 points, 3 points, 4 points, 5 points, 6 points, 8 points, 10 points, 20 points, 50 points, or any other or intermediate It can be connected to the intervertebral cage 100 at several points. Some embodiments in which the variable volume pouch 400 is pre-inserted into the intervertebral cage 100, 300 and the opening 406 of the variable volume pouch 400 is pre-positioned proximate to the proximal opening 124 of the intervertebral cage 100, 300. The process 1300 may begin at block 1306. In some embodiments, the variable volume pouch 400 can be pre-fixed to the intervertebral cage 100, 300, and the process 1300 can begin with a block other than the block 1306. In some embodiments where the assembly of the intervertebral cage device 500 is temporally decoupled from use of the intervertebral cage device 500, the process 1300 may end at block 1306.

  In some embodiments of the process 1300 where assembly of the intervertebral cage device 500 is in time proximity to use of the intervertebral cage device 500, after the variable volume pouch 400 is secured to the intervertebral cages 100, 300, the process 1300 is performed. Can proceed to block 1308 where the intervertebral cages 100, 300 are expanded. In some embodiments, the block 1308 can be preceded by a step for preparing the intervertebral space and inserting the intervertebral cage device 500. In some embodiments, these processes can include, for example, some or all of the steps of process 1200 depicted in FIG.

  In some embodiments, the intervertebral cages 100, 300 can be expanded using any desired deployment technique and / or deployment device. In some specific embodiments, for example, the intervertebral cage can be expanded using a deployment system 800 that includes a deployment tool 802 and a deployment cable 806. In some embodiments, the deployment of the intervertebral cages 100, 300 is measured along one or more of the longitudinal axis 104, the transverse axis 106, and / or the vertical axis 108. Changes can be made to the dimensions.

  After the intervertebral cages 100, 300 are expanded, the process 1300 proceeds to block 1310 where the variable volume pouch 400 is filled. In some embodiments, for example, the variable volume pouch 400 can be filled through the opening 406 in the variable volume pouch 400. In some embodiments, the variable volume pouch 400 can be filled via the variable volume pouch opening 406 and the proximal opening 126 located at the proximal end 110 of the intervertebral cage 100, 300. In some embodiments, the variable volume pouch can be filled with, for example, a gas material, a liquid material, and / or a solid material. In some embodiments, the variable volume pouch 400 can be filled with, for example, a solid material, specifically a graph material that can include multiple pieces of solid material. In some embodiments, these materials can include bone fragments and / or bone fragments, and / or any biocompatible material.

  In some embodiments, the variable volume pouch 400 can be filled with a desired amount of membrane material. In some embodiments, the desired amount of membrane material can be based on the desired size of the variable volume pouch 400 in the expanded state. Thus, in some embodiments, the desired size of the expanded volume variable pouch 400 can determine the amount of membrane material. After the variable volume pouch 400 is filled, a step of maintaining the fill material in the variable volume pouch 400 can be performed. In some embodiments, these steps include, for example, sealing the opening 406, closing the opening 406, closing the opening 406, or evacuating the variable volume pouch 400 by evacuating the membrane material. Any other action that prevents becoming can be included.

  FIG. 14 is a flow chart illustrating one embodiment of a process 1400 for preparing and / or using an intervertebral cage device 900, 1100 that may or may not have a variable volume pouch 400. In some embodiments, step 1400 can be performed prior to insertion of intervertebral cage devices 900, 1100 into the intervertebral space, and in some embodiments, insertion of the intervertebral cage device into the intervertebral space. Later, step 1400 may be performed.

  Process 1400 begins at block 1402 where deployment cable 806 is threaded through proximal end 110 of intervertebral cage 100, 300. In some embodiments, for example, deployment cable 806 is inserted through proximal end 110 of intervertebral cage 100, 300 by inserting deployment cable 806 through first proximal openings 906, 1104, 1108. . In some embodiments, the deployment cable 806 inserted through the first proximal openings 906, 1104, 1108 passes through the proximal end 110 of the intervertebral cage 100, 300 and the intervertebral cage 100, 300. Enters internal volume 126. In some embodiments, a deployment cable 806 inserted into the first proximal openings 906, 1104, 1108 enters the passage and passes through all or a portion of the intervertebral cage 100, 300. In some embodiments, the deployment cable 806 can be pre-inserted into the proximal end 110 of the intervertebral cage 100, 300 and the process 1400 can begin with a block other than the block 1402. In some embodiments, the deployment cable 806 need not be inserted through the proximal end 110 of the intervertebral cage 100, 300, but rather at or near the proximal end 110 of the intervertebral cage 100, 300. Simply attached or fixed.

  After deployment cable 806 is inserted or secured to the proximal end 110 of the intervertebral cage 100, 300, step 1300 moves to block 1304 and deployment cable 806 is inserted through the distal end 112 of the intervertebral cage 100, 300. Is done. In some embodiments, the deployment cable 806 is inserted into the distal end 112 of the intervertebral cage 100, 300 by inserting and / or threading the deployment cable 806 into the distal opening 902, 1110, 1112. Can do. In some embodiments, the deployment cable 806 passes through the proximal end 1110 of the intervertebral cage 100, 300 into the interior volume 126, and the deployment cable 806 extends from the interior volume 126 to the distal openings 902, 1110, It can be inserted into the distal end 112 via 1112. In some embodiments where the deployment cable 806 passes through the passage from the first proximal openings 906, 1104, 1108, the deployment cable 806 passes through the passage through the distal end of the intervertebral cage, thereby providing an intervertebral space. The distal ends 1112 of the cages 100, 300 may be inserted. In some embodiments where the deployment cable 806 has been pre-inserted through the proximal end 110 of the intervertebral cage 100, 300, the process 1400 can begin at block 1404. In some embodiments, the deployment cable 806 can be pre-threaded into the distal end 112 of the intervertebral cage 100, 300 and the process 1400 can begin with a block other than the block 1404. In some embodiments where the assembly of the intervertebral cage device 900, 1100 is temporally disconnected from use of the intervertebral cage device 900, 1100, the process 1400 can end at block 1404.

  In some embodiments, the deployment cable 806 can be returned to the proximal end 110 of the intervertebral cage 100, 300 after the deployment cable 806 has been inserted through the distal end 112 of the intervertebral cage 100, 300. . In some embodiments, the deployment cable 806 returns to the proximal end 110 of the intervertebral cage 100, 300 by inserting and / or inserting the deployment cable 806 into the second distal opening 902, 1110, 1112. be able to. After deployment cable 806 is inserted and / or inserted through second distal openings 902, 1110, 1112, deployment cable 806 passes through distal end 112 of intervertebral cage 100, 300 and intervertebral cage 100. , 300 into the internal volume 126. In some embodiments, a deployment cable 806 that is inserted into the distal openings 902, 1110, 1112 enters the passage and passes through all or a portion of the intervertebral cage 100, 300.

  After the deployment cable 806 has returned to the proximal end 110 of the intervertebral cage 100, 300, the deployment cable 806 is inserted into the intervertebral cage 100 by inserting the deployment cable 806 through the second proximal openings 908, 1102, 1106. , 300 can be inserted through the proximal end 110. In some embodiments, the deployment cable 806 inserted through the second proximal openings 908, 1102, 1106 from the internal volume 126 of the intervertebral cage 100, 300 to the proximal end 110 of the intervertebral cage 100, 300. Pass through. In some embodiments, the deployment cable 806 can be pre-inserted through the proximal end 110 of the intervertebral cage 100, 300. In some embodiments, the deployment cable 806 need not be inserted through the proximal end 110 of the intervertebral cage 100, 300, but rather at or near the proximal end 110 of the intervertebral cage 100, 300. It can simply be attached or fixed.

  After the deployment cable 806 has been inserted or secured to the proximal end 110 of the intervertebral cage 100, 300, the deployment cable 806 can be connected to a deployment tool 802 that can be used to deploy the intervertebral cage 100, 300. .

  In some embodiments of step 1400 where the assembly of the intervertebral cage device 900, 1100 is in time proximity to use of the intervertebral cage device 900, 1100, the step 1400 includes the intervertebral cage 100, via the deployment cable 806. Application of force to 300 proceeds to block 1406 where the intervertebral cages 100, 300 are expanded. The force applied to the intervertebral cages 100, 300 via the deployment cable 806 can be generated using a variety of instruments and / or techniques. For example, in some embodiments where deployment cable 806 is part of insertion system 800 including deployment tool 802, via deployment cable 806 by using control interface 804 to tension deployment cable 806. A force can be applied to the intervertebral cages 100,300. In some embodiments, when force is applied to the intervertebral cages 100, 300 via the deployment cable 806, the user can deploy to allow the user to understand the status of the deployment. Feedback is provided via tool 802. Specifically, in some embodiments, the deployment tool 802 provides feedback that further applies force to the intervertebral cages 100, 300 to provide locking of the intervertebral cages 100, 300 in an expanded configuration. Can be provided to the user. In some embodiments, for example, this feedback can include an audible signal, a visual signal, and / or a tactile signal that indicates that the intervertebral cage 100, 300 is about to be in a locked and / or expanded configuration. . In some embodiments, block 1406 can be preceded by a step for preparing the intervertebral space and inserting the intervertebral cage devices 900, 1100. In some embodiments, these processes can include, for example, some or all of the steps of process 1200 depicted in FIG.

  After the intervertebral cage 100, 300 is expanded by applying force to the intervertebral cage 100, 300 via the deployment cable 806, step 1400 is a block 1408 where the intervertebral cage 100, 300 is locked in the expanded configuration. Proceed to In some embodiments where the deployment cable 806 includes a locking feature 814, the locking feature 814 on the deployment cable 806 can be used to lock the intervertebral cage 100, 300 in the expanded configuration. In one particular embodiment of how the locking feature 814 can be used in the context of the intervertebral cage 100, 300 to lock the intervertebral cage 100, 300 in an expanded configuration, The portion can include members having dimensions and / or diameters greater than the diameter of the deployment cable 806. When the deployment cable 806 is retracted from the second proximal opening 908, 1104, 1108 to deploy the intervertebral cage 100, 300, the locking feature 814 is the proximal end of the intervertebral cage 100, 300. 110 can be moved out of the second proximal openings 908, 1104, 1108. In some embodiments where the locking feature 814 is used to securely secure the intervertebral cage 100, 300 in an expanded and / or locked configuration, the second proximal openings 908, 1104, 1108 include: While the locking feature 814 allows the proximal end 110 of the intervertebral cage 100, 300 to exit the second proximal opening 908, 1104, 1108, the locking feature 814 is second. It can be configured to prevent retraction through the proximal openings 908, 1104, 1108 and back into the proximal end 110 of the intervertebral cage 100, 300. Thus, in some embodiments, when the locking feature is pulled from the proximal end 110 of the intervertebral cage 100, 300 via the second proximal openings 908, 1104, 1108, the locking feature is The intervertebral cages 100, 300 can be engaged with portions of the second proximal openings 908, 1104, 1108 to securely fix the intervertebral cages 100, 300 in a locked and / or expanded configuration. In some embodiments, after the intervertebral cages 100, 300 are locked in the expanded configuration, the force threshold can be exceeded and the deployment cable 806 can break at the break point. In some embodiments, after the intervertebral cage 100, 300 is in the locked and / or expanded configuration, the filling material and / or graft material is delivered through the proximal opening 124 to the body 102 of the intervertebral cage 100, 300. Can be inserted into the internal volume 126.

  One skilled in the art will recognize that steps 1300, 1400 may include more or fewer steps than those outlined above. One skilled in the art will further recognize that the steps outlined above for processes 1300, 1400 can be performed in any desired order and that these steps can include sub-steps or sub-processes. Those skilled in the art will not be limited to the specific embodiments listed herein, as the specific method of locking the intervertebral cage 100, 300 in the expanded configuration is not limited to the intervertebral cage 100, 300. It will be further appreciated that a variety of techniques and devices can be used to lock in the expanded and / or locked configuration. Those skilled in the art will be able to combine the steps depicted in FIGS. 12, 13, and 14 and thus use the intervertebral cages 100, 300 with both the variable volume pouch 400 and the deployment cable 806. You will recognize further.

  FIGS. 15A-15C are views of an embodiment of an intervertebral cage device 1500 having a distal opening 1502 located at the distal end of the body 102. In an alternative embodiment, the aperture 1502 may be offset from the axis 104, but referring to FIG. 15A, which is a perspective view of the intervertebral cage device 1500, the distal aperture 1502 is centered about the longitudinal axis 104. In the illustrated embodiment, the distal opening 1502 has a diameter that is smaller than the diameter of the proximal opening 124 and a coupling mechanism is incorporated along the inner surface of the distal opening 1502. In certain embodiments, the coupling mechanism takes the form of a bayonet mount. As shown in FIG. 15B, which is a cross-sectional view of the intervertebral cage device 1500 along section AA (shown in FIG. 15A), the distal opening is configured to receive two or more pins 1618. These slots 1504 may be present at the distal end of the implant 1600 (described further with reference to FIGS. 16A-16C).

  In the illustrated embodiment, the slot 1504 is such that the first portion of the slot extends distally from the proximal end of the distal opening 1502 to a position between the proximal and distal ends of the opening 1502. An “L-shaped” slot formed along the inner surface of the distal opening. As more clearly shown in FIG. 15C, which is a cross-sectional view of the intervertebral cage device 1500 along section BB (shown in FIG. 15B), the second portion of the slot 1504 is along the inner circumference of the inner surface of the distal opening. Extending in the radial direction. The radial extension can be about 45 degrees to about 135 degrees about the longitudinal axis 104. In the illustrated embodiment, the circumferential extension is about 90 degrees. In some embodiments, fewer or more slots 1504 may be used. Additionally, in some embodiments, the slot 1504 may be positioned such that the first portion of the slot 1504 is centered in the plane formed by the axes 104, 108. This can advantageously allow larger pins 1618 to be used, thereby reducing local stresses and strains when the device is deployed.

  In other embodiments, the slot 1504 of the distal opening 1502 does not have a second portion such that the first portion extends completely from the proximal end of the opening 1502 to the distal end of the opening 1502; Pin 1618 allows it to pass entirely through opening 1502. In such embodiments, the implant pin 1618 can be used instead to engage and abut the distal surface 1505 of the intervertebral cage device 1500. In still other embodiments, the distal opening 1502 has a diameter that is equal to or greater than the diameter of the proximal opening 124. Still further, in other embodiments, other types of coupling mechanisms, such as, but not limited to, press fits, interference fits, friction fits, threads, and other coupling mechanisms known in the art, may be implanted. It is contemplated that the device can be used to couple with the body 102.

  Referring to FIG. 15B, the proximal end 110 of the body 102 has a notch 1506 configured to receive the mating portion 1608 of the implant 1600 shown in FIGS. 16A-16C. In the illustrated embodiment, the two notches 1506 are located along the outer periphery of the proximal end 110. In other embodiments, a different number of notches 1506 can be used, and these notches are not limited to placement along the outer periphery of the proximal end 110 of the body 102.

  16A-16C are views of an embodiment of an implant 1600 that can be used to convert an intervertebral cage device 1500 or other cage device described herein from an unexpanded position to an expanded position. Referring to FIG. 16A, which is a partial cross-sectional view of an embodiment of an implant 1600, the implant 1600 extends between the proximal and distal ends of the instrument 1600 and is an outer cannula about the optical axis 1604. 1602. At the distal end of the outer cannula 1602 is a connector 1606 configured to contact the proximal end 110 of the body 102. As more clearly shown in FIG. 16C, which is a view of the distal end of the implant 1600, in one embodiment, the connector 1606 advantageously distributes any contact pressure over the entire surface area of the proximal end 110. As such, it has a dimension that is equal to or greater than the dimension of the proximal end 110 of the body 102. In some embodiments, the connector 1606 is inserted into a notch 1506 in the proximal end 110 of the body 102 and is configured to engage with it, such as a tooth projecting distally from the connector 1606. Two fitting portions 1608 are provided. In other embodiments, the connector 1606 may have fewer or more mating portions 1608 depending on the amount of notches 1506 in the proximal end 110 of the body 102. The mating portion 1608 is configured to engage the rotation of the body 102 directly with the rotation of the outer cannula 1602 when engaged, thereby providing direct control of the rotation of the body 102 to the user of the implant 1600 during the implantation procedure. Let it be done.

  At the proximal end of the outer cannula 1602 is a handle 1610 that is configured to be held by a user of the implant 1600. The handle 1610 is attached directly to the outer cannula 1602 such that rotation of the handle 1610 also causes rotation of the outer cannula 1602. As such, the user of the implant 1600 can advantageously control the rotation of the body 102 through the handle 1610. The implant 1600 also has an internal shaft 1612 about the lumen axis 1604 that is slidably translatable and slidably rotatable within the outer cannula 1602. In the illustrated embodiment, the inner shaft 1612 is directly attached to the control member 1614 such that rotation and translation of the control member 1614 causes the inner shaft 1612 to rotate and translate. In this embodiment, the control member 1614 is generally received within an opening 1616 in the handle. In other embodiments, the aperture is sized only to receive the inner shaft 1612 such that the control member 1614 remains outside the handle. The control member 1614 may have raised ridges, protrusions, textured portions, gripping portions, or other mechanisms to assist the user of the device to rotate and translate the control member 1614.

  In some embodiments, there is a pin 1618 at the distal end of the shaft that corresponds to a coupling mechanism in the form of a slot 1504 located in the distal opening 1502 of the intervertebral cage device 1500. The shaft 1612 is slidably translatable and slidably rotatable within the outer cannula 1602, so that the engagement of the mating portion 1608 with the notch 1506 is against the body 102 via the outer cannula 1602. The shaft 1612 can be rotated as well as translated to engage the “L-shaped” slot 1504 of the distal opening 1502 while force is applied.

  FIG. 17 illustrates one way in which the implant 1600 can be used to convert the intervertebral cage device 1500 or any other such device described herein from an unexpanded position to an expanded position. In the illustrated embodiment, a shaft 1612 with a pin 1618 and an intervertebral cage device 1500 with a distal opening 1502 that includes a slot 1504 is used. During the first step, the implant 1600 is directed toward the proximal end 110 of the intervertebral cage device 1500 in an unexpanded configuration such that the connector 1606 is positioned adjacent and in contact with the proximal end 110 of the body 102. Move forward. During this advancement process, the mating portion 1608 is simultaneously inserted into and engaged with the notch 1506, thereby interlocking the rotation of the body 102 with the rotation of the outer cannula 1602.

  Next, during the second step, the shaft 1612 is slidably advanced distally through the outer cannula 1602 and into the intervertebral cage device 1500. The shaft is initially advanced through the proximal opening 124 and then through the interior volume 126 and is ultimately disposed adjacent and in contact with the trailing edge of the distal opening 1502. In this embodiment, the distal opening 1502 has a slot 1504 corresponding to the pin 1618 at the distal end of the shaft 1612 so that the shaft 1612 is further advanced into the distal opening 1502 by following the profile of the slot 1504. Can be made. The shaft 1612 can then be rotated so that the shaft 1612 is engaged with the distal opening 1502. In this engaged position, shaft 1612 and body 102 are coupled such that translation of shaft 1612 results in translation of body 1502. The notation of the above steps such as “first” and “second” is used only to illustrate one method of deploying the intervertebral cage device 1500 and other cage devices described herein. Please note that. In other embodiments, this order can be reversed so that the second step is completed before the first step.

  In an embodiment of an intervertebral cage device 1500 having a slot 1504 that extends the entire length of the distal opening 1502, the shaft is advanced generally through the distal opening 1502. When the pin 1618 is located on the distal side of the distal surface 1505 of the body 102, the shaft 1612 is rotated and retracted so that the pin 1618 contacts the distal surface 1505.

  Additionally, the steps described above can be performed before or after insertion of the intervertebral cage device 1500 into the intervertebral space. In embodiments where the steps described above are performed before being inserted into the intervertebral space, an implant 1600 is used to deliver the device into the space. In embodiments where the steps described above are performed after insertion into the intervertebral space, a separate instrument may be used to deliver the device into the space.

  During the third step, after the shaft 1612 is engaged with the distal opening 1502, force is applied distally to the proximal end 110 of the body 102 while the shaft 1612 is held in place. The force applied to the proximal end 110 transforms the body 102 from an unexpanded position to an expanded position by deformation along the living hinge 118. In an alternative embodiment, distal opening 1502 is proximal to the distal end of body 102 while outer cannula 1602 is held in place to convert body 102 from an unexpanded position to an expanded position. Power is applied to.

  During the final step, the shaft 1612 is rotated to disengage the pin 1618 from the “L-shaped” slot of the distal opening 1502. The shaft 1612 may then be slidably retracted from the intervertebral cage device 1500 such that the shaft 1612 is removed from the body 102. The connector 1606 may then be retracted so that the mating portion 1608 is removed from the notch 1506. The instrument may then be removed from the intervertebral space and the patient's body.

Vertically Expandable Intervertebral Cage FIG. 18 is an illustration of an embodiment of an intervertebral cage 1800 in an expanded configuration. The intervertebral cage 1800 has both a front panel 1802 and an annular body 1805. In the expanded configuration, the front panel 1802 is configured to provide structural support in the form of struts to the cage 1800. In one embodiment, the front panel 1802 includes a living hinge 1810 positioned equidistant from the top edge 1812 and the bottom edge 1814 that subdivides the front panel 1802 into both a top 1816a and a bottom 1816b. In other embodiments, the living hinge 1810 may be positioned closer to the top edge 1812 or the bottom edge 1814 depending on the geometric shape desired for the unexpanded and expanded configurations. Still further, in yet other embodiments, more than one living hinge can be included in the front panel 1802.

  In some embodiments, the top 1816a and bottom 1816b are separate units that are rotatably mounted on the hinge 110 to form the front panel 102. In these embodiments, the rotatable attachment of top 1816a and bottom 1816b was formed with a reduced thickness along living hinge 1810 configured to allow deformation along living hinge 1810. It can be achieved by a material that allows elastic deformation, such as a hinge or living hinge of the front panel 1802.

  In one embodiment, such as the embodiment illustrated in FIG. 18, the front panel 1802 has an opening 1818 that is substantially centered on the front panel 1802. In other embodiments, the front panel 1802 has a plurality of openings located on both the top 1816a and the bottom 1816b. Opening 1818 allows the distal portion of the implantation device to enter from the rear end 1808 of intervertebral cage 1800 and pass through opening 1818 such that the distal portion of the implantation device is located distal to front panel 1802. Can be configured. In embodiments with multiple openings in the top 1816a and bottom 1816b, the openings are inserted through the first opening into the posterior end 1808 of the intervertebral cage 1800 through the first opening and returned to the posterior end 1808 through the second opening. Can be configured to allow The implantation device or guidewire can be used to apply force to convert the intervertebral cage 1800 from an unexpanded configuration to an expanded configuration.

  As another example, an inflatable device, such as an inflatable bladder, can be placed in the interior volume. The inflatable device can be inflated such that the inflatable device increases the volume in the internal volume. The inflatable device can contact a portion of the intervertebral cage 1800 such that a force is applied to the intervertebral cage to deploy the intervertebral cage 1800. Such a method and apparatus is described in detail in US patent application Ser. No. 14 / 422,750, the entire contents of which are hereby incorporated by reference.

  In the illustrated embodiment, the top 1816a and bottom 1816b have a generally rectangular shape regardless of the opening 1818. In such a configuration, the top edge 1812 and the bottom edge 1814 remain substantially parallel. In other embodiments, the top and bottom are not rectangular, but rather wedge shaped such that the top edge 1812 and bottom edge 1814 are not parallel. These embodiments can be used when the two surfaces requiring support are inclined and different heights are required. Other shapes may include squares such as, but not limited to, squares, rectangles, parallelograms, and trapezoids. Shapes can also include polygons with five or more sides, partial ellipses such as semi-circles, and any other shape that can be selected by one skilled in the art.

  The panels of the intervertebral cage 1800 can use living hinges to form an integral unit with adjacent panels, or can be separate from adjacent units, and are described above. It should be apparent to those skilled in the art that it can be rotatably mounted via a mechanism. In some embodiments of the device, both the living hinge and other attachment features are used simultaneously. This allows the device to be assembled after manufacture and can potentially lead to cost savings. In other embodiments, living hinges are used throughout the apparatus.

Operation As described above, the panels and portions of the intervertebral cage 1800 are rotatably attached to adjacent panels and portions via living hinges. As such, a separate panel of the intervertebral cage 1800 can be rotated from an unexpanded configuration to an expanded configuration. 19A-19C are views from the left side of the intervertebral cage 1800 illustrating one non-limiting method of converting the intervertebral cage 1800 from an unexpanded configuration to an expanded configuration. Three distinct configurations are shown: an unexpanded configuration (shown in FIG. 19A), an intermediate configuration (shown in FIG. 19B), and an expanded configuration (shown in FIG. 19C).

  Referring to FIG. 19A, while in the unexpanded configuration, top 1816a and bottom 1816b are folded to form the sides of the wedge by front panel 1802, living hinge 1810 forming the tip of the wedge. In other embodiments, the side panels are folded inward. In the illustrated embodiment, the living hinge 1810 extends distally outward, thereby providing a wedge-shaped or tapered tip 1806 to the intervertebral cage 1800. Because the front panel 1802 is the first portion of the intervertebral cage 1800 that enters the surgical site and intravertebral space during the implantation procedure, this wedged or tapered configuration is the intervertebral cage 1800 to the patient during the implantation procedure. To facilitate the insertion. First, because of the wedge shape, the user is assisted in placing the cage 1800 in the center of this space when the cage 1800 is advanced into the space formed by the two vertebral endplates. Second, because the intervertebral cage 1800 is low in the unexpanded configuration, portions of the cage 1800, such as the top panel 1850 and / or the bottom panel 1860, contact the endplate, thereby advancing the cage 1800 during the procedure. Is less likely to interfere.

  In some embodiments, conversion of the device from an unexpanded configuration to an expanded configuration can be performed by applying a force in the direction of the rear end 1808 to the front panel 1802. This conversion can be accomplished by pulling the front panel 1802 while preventing translation of the device in a plane parallel to the vertebral endplate (eg, by applying a reaction force to the top plate 1850 and bottom plate 1860). . The living hinge 1810 is pulled toward the rear end 1808 by both the force on the front panel 1802 and the rotatable attachment of the top 1816a and bottom 1816b. This action increases the angle formed between top 1816a and bottom 1816b, thereby causing vertical expansion of cage 1800.

  Note that the cage 1800 can be opened using other methods. For example, a force can be applied to the annular body 1805 toward the tip 1806 while preventing the front panel 1802 or more specifically the living hinge 1810 from translating in the same direction. In other examples, the force may be applied to the side panel in a direction opposite to the direction in which the side panel is bent instead. Thus, when the side panels are bent inward toward the internal volume 1890, separate forces can be applied to each side panel in a direction away from the internal volume 1890. If the side panels are bent outward in a direction away from the internal volume 1890, a separate force can be applied to each side panel in the direction toward the internal volume 1890. In another example, an upward normal force may be applied to the bottom surface of the top panel and a downward normal force may be applied to the top surface of the bottom panel to initiate the conversion process. Some or all of the methods described above can be combined together in the process of converting the cage 100 from an unexpanded configuration to an expanded configuration.

Variations, Modifications, and Combinations Various modifications to the implementations described in this disclosure can be readily apparent to those skilled in the art, and the general principles defined herein are within the spirit or scope of this disclosure. Other implementations can be applied without departing. Moreover, any of the steps described herein can be performed simultaneously or in a different order than the steps ordered herein. Moreover, it will be appreciated that the features and attributes of the specific embodiments disclosed herein may be combined in different ways to form additional embodiments, all of which are disclosed herein. Included in range. Accordingly, this disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the principles and features disclosed herein.

  In particular, conditional languages used herein, such as “can be”, “can be”, “can be”, “may”, “for example” and others, Unless otherwise specified or otherwise understood within the context in which it is used, other embodiments are not included, but generally to convey that an embodiment includes certain features, elements, and / or conditions. Is intended. Thus, such conditional languages are those features, elements and / or states that may require some form of one or more embodiments, or with or without author input or input requests. And / or implying that one or more embodiments necessarily include logic to determine whether a state is or should be implemented in any particular embodiment. Generally not intended.

Claims (20)

A method for making an expandable intervertebral cage with a living hinge using a 3D printable material for placement between adjacent vertebrae, comprising:
Providing 3D data of the expandable intervertebral cage to a 3D printer, wherein the expandable intervertebral cage is an annular body and during the transition of the annular body from an unexpanded configuration to an expanded configuration Providing an annular body having a plurality of side segments rotatably mounted by an integral living hinge configured to bend or deform to
Printing the plurality of side segments and the integral living hinge of the annular body using one or more 3D printable materials.   The method of claim 1, wherein the one or more 3D materials are selected from the group consisting of thermoplastics, photopolymers, metal powders, eutectic metals, titanium alloys, and combinations thereof.   The one or more 3D materials are selected from the group consisting of natural biocompatible materials, synthetic biocompatible materials, metal biocompatible materials, adaptive materials, 4D printing, and combinations thereof. The method described.   The one or more 3D materials comprise polyetheretherketone (PEK), polyetherimide (PEI) such as Ultem, ultrahigh molecular weight polyethylene (UHMPE), polyphenylene, eg, memory PEEK material such as PEEK Altera 2. The method of claim 1 selected from the group consisting of (PEEK) and combinations thereof.   The intervertebral cage comprises an outer coating selected from the group consisting of plasma spraying, hydroxyapatite coating, biologics, antibiotics, drugs or gene therapy, nanotechnology platforms, and combinations thereof. Method.   The method of claim 1, wherein the integral living hinge comprises a relatively soft 3D printable material and the side segment comprises a relatively rigid 3D printable material.   The method of claim 1, wherein the relatively soft 3D printable material comprises a non-metallic material and the relatively rigid 3D printable material comprises a metallic material.   The method of claim 1, wherein the 3D data is standard cage size predefined data.   The method of claim 1, wherein the 3D data is 3D imaging data, and the method further comprises pre-imaging a patient's adjacent vertebra to generate 3D imaging data.   The method of claim 5, wherein the outer coating is a 3D printable material.   The method of claim 1, wherein the living hinge includes a narrowed portion of the annular body and / or a notch to the annular portion configured to allow local bending or deformation of the annular body. .   The annular body includes a proximal end and a distal end opposed to each other along a lateral axis, and in the unexpanded configuration, the proximal end and the distal end are maximized. Spaced apart and in the expanded configuration, the proximal end and the distal end are closer together, and the expandable intervertebral cage is moved from the unexpanded configuration between adjacent vertebrae. The method of claim 1, wherein the method is configured to expand horizontally in the expanded configuration.   Printing the top and bottom panels, each top and bottom panel being rotatably attached to one or more side segments by an integral living hinge, wherein the expandable intervertebral cage is adjacent The method of claim 1, wherein the method is configured to expand vertically from the unexpanded configuration to the expanded configuration between vertebrae.   The method of claim 1, wherein the expandable intervertebral cage further comprises a variable volume pouch that is positionable within an internal volume of the intervertebral cage.   The expandable intervertebral cage further includes a deployment cable coupled to the annular body and configured to apply a force to the annular body to transition the annular body from the unexpanded configuration to the expanded configuration. The method of claim 1, wherein:   The expandable intervertebral cage further includes a deployer coupled to the annular body and configured to apply a force to the annular body to transition the annular body from the unexpanded configuration to the expanded configuration. The method of claim 1, wherein:   The expandable intervertebral cage is configured to be positioned between the endplates of two vertebrae and results in a change in the size and shape of the expandable intervertebral cage from an unexpanded configuration, and the expansion The method of claim 1, further configured to transition to an expanded configuration that increases the changeable internal volume of the possible intervertebral cage. A method for making and using a patient-specific expandable intervertebral cage with a living hinge that uses a 3D printable material for placement between adjacent vertebrae, comprising:
Imaging the patient's adjacent vertebrae preoperatively to generate 3D imaging data;
Providing the 3D data to a 3D printer;
Printing an expandable intervertebral cage using one or more 3D printable materials, wherein the expandable intervertebral cage is an annular body, from the unexpanded configuration to the expanded configuration Printing comprising an annular body having a plurality of side segments rotatably attached by an integral living hinge configured to bend or deform during transition of the annular body;
Surgically positioning the expandable intervertebral cage between the adjacent vertebrae;
Expanding the expandable intervertebral cage from the unexpanded configuration to the expanded configuration between the adjacent vertebrae.   The one or more 3D materials are thermoplastic, photopolymer, metal powder, eutectic metal, titanium alloy, natural biocompatible material, synthetic biocompatible material, metal biocompatible material, polyether ketone (PEK) , Polyetherimide (PEI) such as Ultem, ultra high molecular weight polyethylene (UHMPE), polyphenylene, polyetheretherketone (PEEK) including a memory PEEK material such as PEEK Altera, and combinations thereof. The method of claim 1. A system for deploying an expandable intervertebral cage with a living hinge using a 3D printable material for placement between adjacent vertebrae, comprising:
An expandable intervertebral cage made of one or more 3D printable materials configured to transition from a non-expanded configuration to an expanded configuration, having a proximal end and a distal end And a plurality of side segments rotatably attached by an integral living hinge configured to bend or deform during transition of the annular body from the non-expanded configuration to the expanded configuration An expandable intervertebral cage comprising an annular body having
A variable volume pouch positionable within the intervertebral cage, wherein the variable volume pouch is configured to move the expandable intervertebral cage from the unexpanded configuration to the expanded configuration.

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