Patent Grant
9498338
This disclosure generally relates to systems and methods for performing spinal and other surgical procedures. More specifically, embodiments of the present disclosure relate to threaded surgical implants, such as interbody spacers, for interbody fusion of the spine or other bony structures.
The degeneration of the intervertebral disk, such as the degeneration of the nucleus pulpous of the disk, results in a loss of height in the affected disk space which is associated with a weakening of the annulus fibrous and of the ligaments. As a consequence, the spinal column may become instable and more susceptible to horizontal displacement of the vertebral bodies with respect to one another. Such movement may result in impairments of the nerve roots in this region and/or of the spinal marrow with pain resulting therefrom.
The principle treatment of these symptoms consists of the surgical removal of the nucleus pulpous and the insertion of support bodies in order to restore the normal height of the disk space. While there are a number of traditional systems and methods for inserting support bodies, there are a variety of demands on both the surgeon performing an intervertebral disk procedure, the tools used to secure and insert the interbody spacers, and on the spinal spacers themselves.
In many cases, a surgeon inserts an interbody spacer within a spinal column using an insertion tool configured to threadably secure an interbody spacer. Many insertion tools include a male-threaded tip configured to mate with a corresponding female-threaded component formed in or on an interbody spacer. Alternatively, an insertion tool may be configured to grasp the perimeter of an interbody spacer during insertion.
Traditional interbody spacers, such as fusion cages, may comprise bodies manufactured from PEEK (polyehteretherketone). PEEK is commonly used because it does not distort MRI and CT images of the vertebrae. However, because new bone growth does not adhere well to PEEK, bone fusion with a PEEK cage typically relies on bridging bone growth through holes in the cage to provide stabilization.
The reliance on bridged bone growth through holes in the cage leads to interbody spacers with a large percentage of open space relative to the supporting PEEK structure. The more open space an interbody spacer has, the higher the load on each portion of the interbody spacer will be. In order to increase the strength of the interbody spacer, increase the stiffness of the interbody spacer, and/or to foster bone growth, various alternative materials have been developed for use in interbody spacers.
Interbody spacers made of PEEK can be readily threaded in order to accommodate insertion tools with male-threaded members. However, some materials that are suitable for interbody spacers, such as silicon nitride (Si3N4) and various other ceramics that are otherwise viable materials for use as spinal implants, are either not threadable, not easily threaded, or result in threads that break under a load.
The present disclosure provides apparatus, systems, and methods for forming an insert or another similar connection feature into a spacer or other implant that is made up of a material having different characteristics from the primary material of the implant. For example, the implant may be not threadable, not easily threaded, or may result in weak or otherwise undesirable threads or other connection features, and a female-threaded or threadable insert may be secured within the implant to improve the ability of the implant to provide a suitably strong set of threads, such as for engagement with an installation instrument.
According to some implementations, a cavity may be drilled or otherwise formed in a non-threadable interbody spacer. The cavity may then be filled, or otherwise receive, a threadable material, such as PEEK, polypropylene, titanium, or another metal. The threadable material may then be threaded in order to form a female-threaded member within the non-threadable interbody spacer.
According to one implementation, a silicon nitride interbody spacer may have a cavity formed in a proximal end. The cavity may be round, oval, rectangular, polygonal, or another shape. The cavity may be tapered and may include one or more vents, retention features, or anti-rotational features. A threadable material, such as PEEK, polypropylene, polyethylene, polymethylene, or another plastic, acrylate, acrylics, titanium, or another metal, may be press-fit, injection molded, extruded, adhered, or melted into the cavity. The threadable material may then be threaded using a threading tool to create a female-threaded insert within the interbody spacer. A male-threaded insertion tool may threadably secure the non-threadable interbody spacer via the female-threaded insert during surgical insertion.
According to various alternative embodiments and implementations, an insert may be formed in any interbody spacer made from any of a variety of materials. Moreover, such an insert may be formed in other biomedical implants, medical devices, support members, and/or structures that are otherwise non-threadable or not capable of forming a similar connection feature of suitable strength. For example, a female-threaded insert or another insert having distinct physical properties from one or more other materials making up the device may be formed in intervertebral spacers, spinal plates, bridge members, bone screws, facet clamps, and/or other medical support or fastening members.
Some embodiments of biomedical implants according to the present disclosure may comprise a body comprising a first material and an insert coupled with the body. The biomedical implant may comprise, for example, a spinal interbody spacer. The insert may comprise a second material distinct from the first material, and the second material may have physical properties distinct from the first material. For example, the second material may be threadable and the first material may be non-threadable. In some embodiments, the second material may comprise, for example, PEEK, polypropylene, polyethylene, polymethylene, acrylate, acrylic, and titanium. The first material may comprise, for example, a silicon nitride ceramic or another sinterable material.
A connectable feature may be formed within the insert such that the insert is capable of being connected with a device, such as a surgical instrument. The connectable feature may comprise a female thread formed within the insert. In such embodiments, the female thread may be configured to be connected with an insertion tool for installing the interbody spacer during surgery. The insert may be positioned within a cavity of the implant. In some embodiments, the cavity may comprise a thru-bore. The cavity may comprise a wide-base cavity configured to prevent the insert from being removed from the cavity. The insert may comprise an anti-rotation feature and/or a retention feature. In some embodiments, the anti-rotation feature may also comprise a retention feature.
In one more specific embodiment according to the present disclosure, a spinal interbody spacer system may comprise an interbody spacer comprising a silicon nitride ceramic material. A cavity may be formed within the interbody spacer with a threaded insert positioned within the cavity. The threaded insert may comprise a threadable material distinct from the silicon nitride ceramic material. The threaded insert may also comprise a retention feature configured to prevent the threaded insert from being removed from the cavity. An insertion tool comprising a male thread configured to engage the threaded insert may also be provided. In some embodiments the interbody spacer may comprise a STALIF implant.
In some implementations of methods for forming a connectable insert within a biomedical implant, the method may comprise providing an implant body comprising a first material, wherein the first material is non-threadable, forming a cavity in the implant body, and positioning an insert within the cavity. The insert may comprise a second material distinct from the first material, and the second material may have physical properties distinct from the first material. A female thread may be formed within the insert.
In some embodiments, the spinal spacer may comprise a concave face and an opposite convex face. A first end wall may connect the concave face with the convex face and an opposite second end wall may connect the concave face with the convex face. The cavity may be positioned within at least one of the first and second end walls.
In some implementations, the step of positioning an insert within the cavity may comprise at least one of press-fitting, injection molding, extruding, and melting the second material into the cavity. In some implementations, the step of forming a cavity in the implant body may comprise forming a wide-base cavity configured to prevent the insert from being removed from the cavity. An anti-rotation feature may also be formed on the insert. In some implementations, the step of forming an anti-rotation feature on the insert may comprise forming an anti-rotation cavity that is coupled with the cavity.
In some implementations, the step of positioning an insert within the cavity may comprise providing a block of threadable material having a V-shaped nose and forcing the block of threadable material into the cavity such that the V-shaped nose enters the cavity first. The step of positioning an insert within the cavity may also comprise heating the second material in order to increase the malleability of the second material. The step of positioning an insert within the cavity may also comprise providing a guide structure comprising a center hole and an engagement surface configured with a shape corresponding to a surface of the implant body surrounding the cavity and pressing the second material into the cavity through the guide structure.
Additional aspects of the various apparatus, systems, and methods will be apparent from the following detailed description, which proceeds with reference to the accompanying drawings.
Non-limiting and non-exhaustive embodiments of the disclosure are described, including various embodiments of the disclosure with reference to the figures, in which:
In the following description, numerous specific details are provided for a thorough understanding of the various embodiments disclosed herein. The systems and methods disclosed herein can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In addition, in some cases, well-known structures, materials, or operations may not be shown or described in detail in order to avoid obscuring aspects of the disclosure. Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more alternative embodiments.
The present disclosure describes examples of apparatus, systems, and methods for forming an insert within a cavity in an implant formed from one or more materials having distinct physical properties from the insert. For example, an insert made from a material that is easily threadable may be positioned on, or within, an implant formed from a generally non-threadable material. More generally, an insert comprising a material that is desirable or suitable for forming a particular connection feature may be positioned on, or within, an implant made from a material that is generally unsuitable for forming a particular desired connection feature.
According to various embodiments, an interbody spacer may include a proximal end and a distal end. The interbody spacer may be manufactured using a non-threadable material, such as a silicon nitride ceramic, another ceramic material, a glass material, or a highly porous material. A cavity may be formed in the interbody spacer, such as in the proximal end for example. A threadable material may be inserted into the cavity. The threadable material may then be threaded in order to form a female-threaded insert within the non-threadable interbody spacer. An insertion tool configured with a male-threaded tip may then be used to threadably secure the interbody spacer via the female-threaded insert during surgery. In other embodiments, the insert(s) may be configured with larger threads to receive, for example, a bone screw, such as in a standalone anterior lumbar interbody fusion (“STALIF”) implant.
In some embodiments of a spacer comprising a silicon nitride ceramic, the silicon nitride ceramic may comprise a doped silicon nitride ceramic. Examples of suitable silicon nitride materials are described in, for example, U.S. Pat. No. 6,881,229, titled “Metal-Ceramic Composite Articulation,” which is incorporated by reference herein. In some embodiments, dopants such as alumina (Al2O3), yttria (Y2O3), magnesium oxide, and/or strontium oxide, can be processed to form a doped composition of silicon nitride. In embodiments comprising a doped silicon nitride or another similar ceramic material, the dopant amount may be optimized to achieve the highest density, mechanical, and/or antibacterial properties. In further embodiments, the biocompatible ceramic may have a flexural strength greater than about 900 MPa, and a toughness greater than about 9 MPa·m1/2. Flexural strength can be measured on standard 3-point bend specimens per American Society for Testing of Metals (ASTM) protocol method C-1161, and fracture toughness can be measured using single edge notched beam specimens per ASTM protocol method E399. In some embodiments, powders of silicon nitride may be used to form the ceramic implants, either alone or in combination with one or more of the dopants referenced above.
Other examples of suitable silicon nitride materials are described in U.S. Pat. No. 7,666,229 titled “Ceramic-Ceramic Articulation Surface Implants,” which is also hereby incorporated by reference. Still other examples of suitable silicon nitride materials are described in U.S. Pat. No. 7,695,521 titled “Hip Prosthesis with Monoblock Ceramic Acetabular Cup,” which is also hereby incorporated by reference.
According to various embodiments, the cavity may be shaped to reduce or prevent the rotation or separation of the threadable material from the non-threadable interbody spacer. For example, the cavity may be rectangular, oval, hexagonal, octagonal, polygonal, and/or other non-circular shape. Additionally, the cavity may be tapered, may include an anti-rotation forming feature, and/or may include a vent. The cavity may be formed during the initial manufacturing process, or may be formed later in a post-processing phase, such as through the use of mechanical drilling, chemical etching, laser etching, particle blasting, and/or other cavity-forming process.
The material inserted into the cavity may comprise PEEK (polyehteretherketone), a polypropylene, titanium, metals, alloys, and/or other materials having desirable characteristics not present in the material within which it is placed. For example, the material may be capable of being threaded or may be capable of forming more rigid or otherwise more desirable threads than the primary material or materials of the spacer. The threadable material may be inserted within the cavity using any of a wide variety of insertion processes, including, but not limited to press-fitting, injection molding, extrusion, adhesives, or melting. According to some embodiments, a combination of insertion processes may be utilized. For example, a PEEK material may be injected into the cavity and then further pressed to finalize the insertion.
The threadable material may then be threaded, thereby forming a female-threaded insert within the cavity. Alternatively, a material may be inserted into the cavity that is configured to provide some other type of support. For example, a material may be inserted within one or more cavities formed in an interbody spacer in order to provide structural support for supporting, for example, bone screws in a STALIF implant, interact with various medical support and manipulation devices, interact with insertion tools, and/or to provide a contact point. For instance, certain ceramic interbody spacers may be prone to fracturing under a point load. Accordingly, a cavity may be formed at an anticipated location of a point load and the cavity may be filled with a second material capable of supporting the point load. The second material need not necessarily be threadable.
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this disclosure are not necessarily all referring to the same embodiment. In particular, an “embodiment” may be a system, an article of manufacture, a method, or a product of a process.
The phrases “non-threadable” and similar terms used herein need not encompass only materials that are impossible or impractical to thread. Rather, “non-threadable” is intended to encompass materials that are not readily threadable, not easily threadable, and/or materials which when threaded result in weak or otherwise unsuitable threads. Accordingly, a “non-threadable material,” as used herein, may in fact be threadable through difficult, expensive, or cumbersome processes. Moreover, a “non-threadable material,” as used herein may in fact be threadable, but the threads may be unsuitable for a particular purpose (e.g., the threads may easily strip, break, bend, and/or otherwise fail to support an adequate load). Examples of “non-threadable” materials include, but are not limited to, ceramics, such as silicon nitride ceramics, and glass materials.
Some of the infrastructure and manufacturing tools and/or machinery that can be used with embodiments disclosed herein are already available, such as extruders, presses, injectors, interbody spacers, interbody spacers, threading tools, and threading machines. The interbody spacers of some embodiments may be used as intervertebral spacers or interspinous spacers, and may also be used with a posterior stabilization system, and dynamic rod stabilization system. Any variety of insertion tools and insertion techniques may be utilized in conjunction with various embodiments, including, but not limited to, STALIF, PLIF, and TLIF approaches.
The components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. In other instances, well-known structures associated with interbody fusion have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the present exemplary embodiments. In addition, the steps of the described methods do not necessarily need to be executed in any specific order, or even sequentially, nor need the steps be executed only once, unless otherwise specified. For example, some of the steps in exemplary methods disclosed herein may, in some implementations, be performed simultaneously.
The embodiments of the disclosure are best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. In the following description, numerous details are provided to give a thorough understanding of various embodiments. However, the embodiments disclosed herein can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of this disclosure.
Insert 265 therefore comprises an anti-rotation feature, in that the shape of insert 265 prevents the insert from being rotated within its corresponding cavity. However, insert 265 does not necessarily also comprise a retention feature (although a separate retention feature may be provided if desired), since the octagonal shape itself need not necessarily prevent insert 265 from being removed from its cavity. However, as will be apparent after reviewing this disclosure as a whole, some anti-rotation features may also comprise retention features if such features both inhibit rotation and help prevent the insert from being removed from a cavity.
Cavity 360 may be formed having any shape, width, length, depth, and/or a tapered configuration. Moreover, any of a wide variety of retention features and/or anti-rotational features may be formed by extending portions of cavity 360. Additionally, any number of cavities may be formed in interbody spacer 300 and may be positioned in various locations in addition to, or as an alternative to, proximal end 310. Cavity 360 may be formed by drilling, chemical etching, laser etching, particle blasting, and/or though other material-removing processes.
Alternatively, a cavity may be formed in interbody spacer 300 during the manufacturing stage, such as through the use of molds configured to provide a cavity. In other words, a cavity may be formed in a silicon nitride ceramic or other material for sintering during a green state, instead of machining the cavity after firing. Such embodiments may eliminate the need to remove material and/or reduce the amount of material that needs to be removed in order to form an adequate cavity.
As illustrated in
In the illustrated embodiment, tapered cavity 460 is wider near proximal end 410 of interbody spacer 400 and is narrower towards distal end 420 of interbody spacer 400. In alternative embodiments, tapered cavity 460 may be wider near distal end 420 of interbody spacer 400 and narrower near proximal end 410 of interbody spacer 400.
As illustrated in
As illustrated in the figure, wide-base cavity 560 may include extended cavity regions 561 and 562 towards the distal end 520 of interbody spacer 500. Accordingly, the opening of wide-base cavity 560 near proximal end 510 of interbody spacer 500 may be substantially narrower than the base of wide-base cavity 560. Wide-base cavity 560 may provide an advantage in that threadable material 565 cannot be easily removed from cavity 560 once threadable material 565 has solidified or otherwise become secured within wide-base cavity 560.
Threadable material 565 may be melted, press-fit, or injected within wide-base cavity 560. Once fully cured, solidified, and/or otherwise secured within wide-base cavity 560, extended cavities 561 and 562 may prevent the removal of threadable material 565. Moreover, depending on the shape of extended cavity regions 561 and 562, they may additionally serve as anti-rotational features preventing or reducing the likelihood of threadable material 565 rotating within wide-base cavity 560.
Threadable material 565 may be threaded in order to form a female-threaded insert 570 within wide-base cavity 560, as illustrated in
As previously described, aperture 530 may serve as a delivery mechanism for BMP and/or provide a location for additional bone growth. Interbody spacer 500 may comprise, for example, a non-threadable silicon nitride or other ceramic, glass, and/or other non-threadable material. Threadable material 565 may comprise, for example, PEEK, a polypropylene, titanium, aluminum, other metal, an alloy, an epoxy, and/or other material capable of being threaded, or at least more suitable for desirable thread formation than the material(s) making up spacer 500.
Again, aperture 630 may serve as a delivery mechanism for BMP and/or provide a location for additional bone growth. Interbody spacer 600 may comprise a non-threadable silicon nitride or other ceramic, glass, and/or other material. Threadable material 665 may comprise PEEK, polypropylene, titanium, aluminum, other metal, an alloy, an epoxy, and/or other material capable of being threaded.
According to various embodiments, threadable material 685 may be melted, press-fit, or injected within tapered cavity 687. Threadable material 685 may comprise PEEK, polypropylene, titanium, aluminum, other metal, an alloy, an epoxy, and/or other material capable of being threaded. The wider distal end of tapered cavity 687 may prevent the removal of threadable material 685. In some embodiments, one or more anti-rotational features may also be provided to prevent or at least reduce the likelihood that the insert 685 will rotate within tapered cavity 687.
According to one embodiment, to reduce the mushrooming and deformation effects of press-fitting a malleable threadable material, a guide structure may be used to guide the malleable threadable material as it is press-fit within a cavity.
As illustrated, malleable threadable material 765 may be press-fit into cavity 760 using guide structure 780 to prevent or reduce deformation and/or mushrooming of the top surface. Moreover, the diameter of center hole 783 may be configured so as to maximize the flow of threadable material 765 based on the type of material used and its characteristics, such as malleability, temperature, viscosity, etc.
According to various embodiments, interbody spacer 800 may include any number of female-threaded inserts in order to provide sufficient support via a corresponding number of bone screws for a STALIF configuration. For example, in one embodiment, interbody spacer 800 may include two female-threaded inserts angled in an upward direction and two female-threaded inserts angled in a downward direction. A STALIF configuration utilizing such an interbody spacer may include four bone screws, two entering the upper vertebrae 840 and two entering the lower vertebrae 845.
Similar to previous embodiments, threadable material 865 may comprise PEEK or other threadable material, and interbody spacer may be manufactured using a non-threadable material, such as silicon nitride or another ceramic material.
Female-threaded insert 872 may be configured to threadably receive bone screw 885 at an upward angle, such that bone screw 885 enters an upper vertebra after passing through interbody spacer 800. Plate 890 may serve as an intermediary between the heads of bone screws 885-889 and the surface of interbody spacer 800. As illustrated, bone screws 885, 887, and 889 may pass through apertures 891, 892, and 893 in bone screw plate 890, through female-threaded inserts 871, 872, and 873, and into the adjacent vertebrae. According to some embodiments, apertures 891-893 may be threaded. Alternatively, apertures 891-893 may not be threaded, allowing the shafts of bone screws 885-889 to slidably pass therethrough while retaining the heads of bone screws 885-889.
As previously described, some material types used to manufacture non-threadable interbody spacers, such as interbody spacer 800, may not support point loads without the risk of fracturing. Thus, without plate 890, the heads of bone screws 885-889 may exert a point load on the surface of interbody spacer 800 sufficient to fracture, or otherwise damage, interbody spacer 800. Accordingly, bone screw plate 890 may serve as an intermediary between the heads of bone screws 885-889 and the surface of interbody spacer 800. Plate 890 may distribute the force from the heads of bone screws 885-889 across the face of interbody spacer 800.
According to various embodiments, plate 890 may comprise a metal, such as titanium or aluminum. Alternatively, plate 890 may comprise PEEK, a ceramic capable of distributing the point loads from the heads of bone screws 885-889, an alloy, a plastic, and/or any other suitable material.
A threadable material, or a material having desired properties that may be lacking in the spacer itself, may then be inserted into the cavity at 1120. The threadable material inserted into the cavity may comprise PEEK (polyehteretherketone), polypropylene, titanium, a metal, an alloy, and/or other material capable of being threaded. The threadable material may be inserted within the cavity using any of a wide variety of insertion processes, including, but not limited to, press-fitting, injection molding, extrusion, adhesives, or melting. According to some embodiments, a combination of insertion processes may be utilized. For example, a PEEK material may be injected into the cavity and then pressed within the cavity to finalize the insertion.
The threadable material may then be threaded at 1130. Threading the threadable material forms a female-threaded insert within the cavity of the interbody spacer. A male-threaded tip of an insertion tool may then be threadably attached to the female-threaded insert within the cavity at 1140. The insertion tool may then securely manipulate the interbody spacer via the female-threaded insert during a surgical procedure at 1150.
Of course, the steps in the 1100 need not be performed in the order depicted in
The foregoing specification has been described with reference to various embodiments. However, one of ordinary skill in the art will appreciate that various modifications and changes can be made without departing from the scope of the present disclosure. For example, various operational steps, as well as components for carrying out operational steps, may be implemented in alternate ways depending upon the particular application or in consideration of any number of cost functions associated with the operation of the system. Accordingly, any one or more of the steps may be deleted, modified, or combined with other steps. Further, this disclosure is to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope thereof. Likewise, benefits, other advantages, and solutions to problems have been described above with regard to various embodiments. However, benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced, are not to be construed as a critical, a required, or an essential feature or element.
Those having skill in the art will appreciate that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. The scope of the present invention should, therefore, be determined only by the following claims.
This is a divisional application of U.S. patent application Ser. No. 13/666,685 filed on Nov. 1, 2012 and titled “IMPLANTS WITH A CONNECTABLE INSERT AND RELATED SYSTEMS AND METHODS,” which claims the benefit of priority of U.S. Provisional Patent Application No. 61/554,366 filed Nov. 1, 2011 and titled “IMPLANTS WITH A CONNECTABLE INSERT AND RELATED SYSTEMS AND METHODS.” Both of the aforementioned patent applications are incorporated herein by specific reference in their entireties.
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| Number | Date | Country | |
|---|---|---|---|
| 20150026958 A1 | Jan 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61554366 | Nov 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13666685 | Nov 2012 | US |
| Child | 14515377 | US |
