Patent Description:
The present invention relates generally to novel surgical implant devices incorporating porous surfaces. More specifically, the present invention relates to novel surgical implant devices incorporating porous surfaces for enhancing bony fixation and purchase when implanted. These porous surfaces are formed via novel additive manufacturing techniques and, optionally, novel post-processing manufacturing techniques. They include novel needle-like protrusions and/or lattice structures.

When various surgical implant devices, well known to those of ordinary skill in the art, are placed adjacent to or between bony surfaces, it is desirable that adequate friction is present to hold them in place and that surfaces are available for bony fixation and purchase over time. Accordingly, these surgical implant devices often incorporate mechanically-manufactured friction surfaces or utilize friction coatings or bondings for such purposes. <CIT> discloses a method for manufacturing a surgical implant device and the corresponding surgical implant device, whereby one or more of its surfaces comprise a plurality of protruding structures that are integrally formed with its body. Furthermore, a rough exterior may be applied to its constituting lattice by applying a plasma spray coating to the injection mold tool or sand blasting the injection mold tool to give the lattice and hence the final cast implant a rough outer surface. However, these mechanically-manufactured friction surfaces, typically consisting of teeth, grooves, striations, or the like, are often not adequate and do little to promote bony purchase. Similarly, these friction coatings or bondings may delaminate and fail.

Thus, what are still needed in the art are improved surgical implant devices that incorporate essentially-integral friction surfaces that are strong and durable, and that provide adequate surface area for bony fixation and purchase, while still being economical to manufacture. Improved additive and post-processing manufacturing techniques now make this possible.

The present invention relates to a method for manufacturing a surgical implant device according to claim <NUM> and surgical implant device device according to claim <NUM>. Preferred embodiments of the invention are set forth in the respective dependent claims.

In one exemplary embodiment, a surgical implant device, comprising: a body portion defining a plurality of ports; a plurality of bone screws disposed partially through the plurality of ports defined by the body portion; a locking plate disposed over a head portion of at least one of the plurality of bone screws and engaging a plurality of recesses manufactured into a side of the body portion; and a screw operable for compressing the locking plate against the side of the body portion. Optionally, the surgical implant device further comprising: one or more surfaces comprising a plurality of protruding structures; wherein the body portion and the one or more surfaces comprising the plurality of protruding structures are integrally formed. The one or more surfaces comprising the plurality of protruding structures are formed by an additive manufacturing process. The plurality of protruding structures comprise a plurality of needles. Optionally, the plurality of protruding structures comprise a plurality of needles that are disposed substantially perpendicular to the body portion. Alternatively, the plurality of protruding structures comprise a plurality of needles that are disposed at an angle to the body portion. Preferably, the plurality of protruding structures comprise a plurality of needles that comprise titanium. The body portion defines a hollow interior cavity. Optionally, the body portion defines one or more ports that are configured to receive a bone screw. The body portion defines one or more ports that are configured to allow bony ingrowth. The surgical implant device comprises one of an anterior lumbar interbody fusion cage and a cervical cage.

In another exemplary embodiment, the present invention provides a method for manufacturing a surgical implant device, comprising: providing a body portion; and forming one or more surfaces comprising a plurality of protruding structures on an exterior portion of the body portion; wherein the body portion and the one or more surfaces comprising the plurality of protruding structures are integrally formed. The one or more surfaces comprising the plurality of pro truding structures are formed by an additive manufacturing process. The plurality of protruding structures comprise a plurality of needles. Optionally, the plurality of protruding structures comprise a plurality of needles that are disposed substantially perpendicular to the body portion. Alternatively, the plurality of protruding structures comprise a plurality of needles that are disposed at an angle to the body portion. Preferably, the plurality of protruding structures comprise a plurality of needles that comprise titanium. The body portion defines a hollow interior cavity. Optionally, the body portion defines one or more ports that are configured to receive a bone screw. The body portion defines one or more ports that are configured to allow bony ingrowth.

The present invention is illustrated and described herein with reference to the various drawings, in which like reference numbers are used to denote like device components/method steps, as appropriate, and in which:.

Generally speaking, and without intending to be limiting, one aspect of the invention relates to improved medical implants that include, for example, at least the following: a primary structure formed from metal; and at least one needle-populated, metallic surface portion formed on at least one exterior portion of the primary structure, the at least one surface portion located such that it engages with a patient's bone when the implant is implanted in the patient. Such needle-populated, metallic surface portions may contain, for example, a collection of at least fifty, a hundred, two hundred, five-hundred or more needles, and may be further characterized by at least one, two, three, four, five or more of the following characteristics: (a) the needles in the collection are all oriented substantially normal to the surface portion; (b) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion; (c) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion, but within <NUM> degrees from the normal direction; (d) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion, and more than <NUM> degrees from the normal direction; (e) the collection includes needles oriented in at least three different directions relative to the surface portion; (f) the collection includes needles oriented in at least five different directions relative to the surface portion, with all of the needles oriented within <NUM> degrees from the surface portion normal direction; (g) all of the needles in the collection have substantially the same height; (h) the collection includes needles of at least three different heights; (i) all of the needles in the collection have substantially the same shape; (j) the collection includes needles of at least two different shapes; (k) the needles are distributed substantially uniformly over the surface portion; (<NUM>) the needles are distributed non-uniformly over the surface portion; (m) all of the needles in the collection are anchored to the primary structure; (n) most of the needles in the collection are anchored to the primary structure; (o) most of the needles in the collection are anchored to structural elements contained within an osteo-porous, osteo-derived or trabecular coating on the at least one exterior portion of the primary structure; and/or (p) all of the needles in the collection are anchored to structural elements contained within an osteo-porous, osteo-derived or trabecular coating on the at least one exterior portion of the primary structure. The at least one exterior portion preferably includes at least one osteo-porous surface, which may comprise at least one osteo-derived surface. The at least one osteo-porous surface and the needles may be simultaneously formed by an additive manufacturing process, such as, but not limited to, EBM or DMSLS. The primary structure may comprise, for example, a dental implant, a foot-and-ankle or long-bone osteotomy wedge, an intervertebral fusion device, a tibial/femoral augment or spacer, a tibial tray portion of a knee implant, a femoral component portion of a knee implant, a primary hip implant, a revision hip implant, a hip trauma component, an acetabular cup, a hip acetabular augment, or other appropriate structure.

Again, generally speaking, and without intending to be limiting, another aspect of the invention relates to method(s) for making a medical implants with at least one osteo-porous surface by, for example: forming at least a portion of a primary structure of the implant; and forming at least one needle-populated, metallic surface portion on at least one exterior portion of the primary structure using an additive manufacturing technique, the at least one needle-populated surface portion located such that it engages with a patient's bone when the implant is implanted in the patient.

Other aspects of the invention relate to additional features, structures, processes and materials depicted in the figures and/or described herein.

Referring to <FIG>, the exemplary flow starts with a spongy bone sample, which is micro CT scanned to obtain 3D scan data, which is then processed into solid model data representing an osteo-porous or osteo-derived texture. This texture data is then combined with data representing the overall implant geometry to create a fabrication file for use by either of the manufacturing steps that follow.

The fabrication file may utilize any recognizable solid model specification, such as ". amf" format [see <NPL>)] or ". stl" format [see <NPL>)], and may be embodied on any sort of permanent storage medium (e.g., CD, CD-ROM, flash), semi-permanent (e.g., SRAM) or transitory (e.g., DRAM) storage medium, or embodied in a coded data signal.

Additional background details concerning the fabrication of medical devices using additive techniques can be found in: <NPL>)).

Referring to <FIG>, an additional step can be inserted that adds outwardly-protruding "needles" on the outer surface(s) of the osteo-porous and/or osteo-derived coating(s). Such needles substantially increase the coefficient of friction of the coating. Having a high coefficient of friction is clinically advantageous because it provides stronger initial fixation, which is important before bone is able to grow onto/into the porous structure. Such needles can be uniformly or non-uniformly (as shown in <FIG>) distributed along the porous surface. Likewise, various shapes for the needles are possible, including rectangular (as depicted in <FIG>), pyramidal, conical, tube-shaped, etc. Also, the needles need not be oriented exactly normal to the exterior surface, but are preferably oriented in a substantially normal (e.g., within +/-<NUM> degrees from normal) orientation. Furthermore, the orientation and/or shape of all needles need not be the same, and the needles may be rendered on selected portions, or the entirety, of the exterior coated surface(s).

Utilizing these or similar techniques, one can efficiently and advantageously form (and/or finish) implants of the sort depicted herein.

Referring to <FIG>, two preferred process flows for fabricating and finishing implants using an abrasive blast are shown. <FIG> shows two alternative flows that employ the blasting technique as well. <FIG> and <FIG> contrastingly depict SEM images of porous implant sections that have and have not undergone an abrasive blasting step. As can be seen from the images, the non-blasted samples are mostly smooth if viewed on the <NUM> or <NUM>µrn scale, whereas the blasted samples are almost entirely rough, when viewed at similar magnification. This blast process creates a texture approximately l-<NUM> in scale. This is an ideal scale for microtexture because it helps osteoblasts adhere to the titanium struts. The blast material is not deposited on the strut (as an HA coating would be). It simply textures the titanium surface by erosion.

In accordance with the invention, the preferred abrasive blast process utilizes an MCD Apatitic Abrasive (Multi-phased Calcium Phosphate containing HA, TCP and other CaP phases) distributed by Hitemco Medical Applications, Inc. , <NUM> Sweet Hollow Rd. , Old Bethpage, NY <NUM>. The blast media has a <NUM> - <NUM> size range. The process utilizes a Comco AccuFlo® standard tank micro-abrasive blaster, equipped with Simoom® Technology and PowderGate® valve. Tank orifice is <NUM> inches (approx. <NUM>); Nozzle is <NUM> inches (approx. <NUM>); Pressure is <NUM> +/-<NUM> psi (approx. <NUM> +/- <NUM> Bar). A satisfactory roughness has been achieved when the blast does not further affect the visual appearance, specifically the color and reflectivity of the device. Machined devices may require a blast touch up.

<FIG> illustratively depict the concept of slightly-irregular lattices that are ideally adapted for additive manufacturing. As shown in these figures, node perturbation refers to the location of intersecting struts. In accordance with this aspect of the invention, such intersection locations are be randomized such that the node deviates from a uniform lattice by a randomized distance. Strut size randomization refers to a deviation in cross-section dimension (e.g., strut diameter). Discrete struts in a lattice could have different cross-sectional sizes, or the struts could have a diameter gradient from one end to the other. These parameters can be randomized for greater diversity in the lattice's geometry. Such slightly-irregular lattices can be used to fabricate any sort of medical implant for which regular lattices are currently used, including, for example, those disclosed in the cited Pressacco et al. and Jones et al. applications.

Another illustrative application of the invention relates to bone fixation/fusion devices of the sort disclosed in <CIT> and/or <CIT> that have been modified to include one or more needle-populated surface(s) in accordance with the teachings of the present invention.

Such fusion/fixation devices are preferably fabricated by additive techniques, may utilize multi-circular cross-sectional profiles (either uniform or tapered), and preferably include exterior needles, preferably oriented in a direction that would resist removal of the implant. Multi-circular cross-sectional profiles have the distinct advantage of not requiring one or more bore broaching steps, thus making insertion quicker and reducing patient infection risk.

Finally, it should be understood that the novel structures disclosed and enabled by the present invention are not limited exclusively to those manufactured using additive manufacturing. Indeed, as persons skilled in the art will appreciate, other known surface modification techniques - such as, for example, Surfi-Sculpt (<CIT>) - may be used to produce the osteoporous, osteo-derived, and/or needle-containing textures of the inventive implants.

Referring now specifically to <FIG>, in one exemplary embodiment, the present invention provides an ALIF cage <NUM> for use in spinal surgical procedures. More specifically, the present invention provides an ALIF cage <NUM> that includes one or more porous surfaces <NUM> that promote bony fixation. Preferably, these porous surfaces <NUM> are formed via an additive manufacturing technique using a titanium alloy powder or the like (as is described in greater detail herein below), thereby providing a unitary structure and eliminating the need to use coatings or bondings for such purpose.

In general, the ALIF cage <NUM> includes a body structure <NUM> that defines a hollow interior portion <NUM> and a plurality of ports <NUM> through which screws <NUM> (<FIG>) or the like are disposed, through the hollow interior portion <NUM> and into adjacent bone. Optionally, the hollow interior portion <NUM> is sized and configured to contain bone graft material or the like, to further enhance bony fixation. The screws <NUM> are shown at a given angle, although any suitable angle(s) for a given application may be utilized, as may any suitable number and size of screws <NUM>.

Advantageously, the ALIF cage <NUM> consists of a unitary structure that is substantially solid in the middle, for example, and graduates to porous at given surfaces, for example. This provides enhanced structural integrity, allows for the porosity to be carefully controlled in a given area, etc. Alternatively, there may be a relatively sharp dividing line between the solid portion and the porous portions, although it is contemplated that they are integrally formed via the additive manufacturing technique.

The following description is partially taken from <CIT> and explains how the porous surfaces <NUM> of the ALIF cage <NUM> are formed.

Generally speaking, and without intending to be limiting, one aspect of the present invention relates to improved medical implants that include, for example, at least the following: a primary structure formed from metal; and at least one needle-populated, metallic surface portion formed on at least one exterior portion of the primary structure, the at least one surface portion located such that it engages with a patient's bone when the implant is implanted in the patient. Such needle-populated, metallic surface portions may contain, for example, a collection of at least fifty, a hundred, two hundred, five-hundred or more needles, and may be further characterized by at least one, two, three, four, five or more of the following characteristics: (a) the needles in the collection are all oriented substantially normal to the surface portion; (b) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion; (c) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion, but within <NUM> degrees from the normal direction; (d) the needles in the collection are all oriented in substantially the same direction, with the direction being other than normal to the surface portion, and more than <NUM> degrees from the normal direction; (e) the collection includes needles oriented in at least three different directions relative to the surface portion; (f) the collection includes needles oriented in at least five different directions relative to the surface portion, with all of the needles oriented within <NUM> degrees from the surface portion normal direction; (g) all of the needles in the collection have substantially the same height; (h) the collection includes needles of at least three different heights; (i) all of the needles in the collection have substantially the same shape; (j) the collection includes needles of at least two different shapes; (k) the needles are distributed substantially uniformly over the surface portion; (l) the needles are distributed non-uniformly over the surface portion; (m) all of the needles in the collection are anchored to the primary structure; (n) most of the needles in the collection are anchored to the primary structure; (o) most of the needles in the collection are anchored to structural elements contained within an osteo-porous, osteo-derived or trabecular coating on the at least one exterior portion of the primary structure; and/or (p) all of the needles in the collection are anchored to structural elements contained within an osteo-porous, osteo-derived or trabecular coating on the at least one exterior portion of the primary structure. The at least one exterior portion preferably includes at least one osteo-porous surface, which may comprise at least one osteo-derived surface. The at least one osteo-porous surface and the needles may be simultaneously formed by an additive manufacturing process, such as, but not limited to, EBM or DMSLS. The primary structure may comprise, for example, the ALIF cage <NUM> of the present invention, a dental implant, a foot-and-ankle or long-bone osteotomy wedge, an intervertebral fusion device, a tibial/femoral augment or spacer, a tibial tray portion of a knee implant, a femoral component portion of a knee implant, a primary hip implant, a revision hip implant, a hip trauma component, an acetabular cup, a hip acetabular augment, or other appropriate structure.

Again, generally speaking, and without intending to be limiting, another aspect of the present invention relates to method(s) for making a medical implants with at least one osteo-porous surface by, for example: forming at least a portion of a primary structure of the implant; and forming at least one needle-populated, metallic surface portion on at least one exterior portion of the primary structure using an additive manufacturing technique, the at least one needle-populated surface portion located such that it engages with a patient's bone when the implant is implanted in the patient.

The exemplary flow starts with a spongy bone sample, which is micro CT scanned to obtain 3D scan data, which is then processed into solid model data representing an osteo-porous or osteo-derived texture. This texture data is then combined with data representing the overall implant geometry to create a fabrication file for use by either of the manufacturing steps that follow. The fabrication file may utilize any recognizable solid model specification, such as ". amf" format [see <NPL>)] or ". stl" format [see <NPL>)], and may be embodied on any sort of permanent storage medium (e.g., CD, CD-ROM, flash), semi-permanent (e.g., SRAM) or transitory (e.g., DRAM) storage medium, or embodied in a coded data signal.

An additional step can be inserted that adds outwardly-protruding "needles" on the outer surface(s) of the osteo-porous and/or osteo-derived coating(s). Such needles substantially increase the coefficient of friction of the coating. Having a high coefficient of friction is clinically advantageous because it provides stronger initial fixation, which is important before bone is able to grow onto/into the porous structure. Such needles can be uniformly or non-uniformly distributed along the porous surface. Likewise, various shapes for the needles are possible, including rectangular, pyramidal, conical, tube-shaped, etc. Also, the needles need not be oriented exactly normal to the exterior surface, but are preferably oriented in a substantially normal (e.g., within +/-<NUM> degrees from normal) orientation. Furthermore, the orientation and/or shape of all needles need not be the same, and the needles may be rendered on selected portions, or the entirety, of the exterior coated surface(s).

Utilizing these or similar techniques, one can efficiently and advantageously form (and/or finish) implants. Finally, it should be understood that the novel structures disclosed and enabled by the present invention are not limited exclusively to those manufactured using additive manufacturing. Indeed, as persons skilled in the art will appreciate, other known surface modification techniques -- such as, for example, Surfi-Sculpt (<CIT>) -- may be used to produce the osteoporous, osteo-derived, and/or needle-containing textures of the inventive implants.

<FIG> are side and top planar views of one exemplary embodiment of the posterior lumbar interbody fusion (PLIF) cage <NUM> of the present invention. The PLIF cage <NUM> includes a body structure <NUM> that defines a substantially hollow interior portion <NUM> and incorporates one or more windows <NUM>, such that graft material or the like may be disposed within the PLIF cage <NUM> to promote bony purchase. The PLIF cage <NUM> also includes a leading edge <NUM> that is substantially tapered, such that the PLIF cage <NUM> may be easily disposed in an intervertebral space, and a trailing edge that includes a tool receiving recess <NUM> or the like. As with all devices of the present invention, the PLIF cage <NUM> may be manufactured from PEEK or a metallic material with the porous surface(s) described in detail herein.

<FIG> are top planar, side planar, and bullet views of one exemplary embodiment of the transforaminal lumbar interbody fusion (TLIF) cage <NUM> of the present invention. The TLIF cage <NUM> includes a substantially-curved body structure <NUM> that defines a substantially hollow interior portion <NUM> and incorporates one or more windows <NUM>, such that graft material or the like may be disposed within the TLIF cage <NUM> to promote bony purchase. The TLIF cage <NUM> also includes a leading edge <NUM> that is substantially tapered, such that the TLIF cage <NUM> may be easily disposed in an intervertebral space, and a trailing edge that includes a tool receiving recess <NUM> or the like. As with all devices of the present invention, the TLIF cage <NUM> may be manufactured from PEEK or a metallic material with the porous surface(s) described in detail herein.

<FIG> is perspective, side planar, and top planar views of one exemplary embodiment of the oblique lumbar interbody fusion (OLIF) cage <NUM> of the present invention. The OLIF cage <NUM> includes a body structure <NUM> that defines a substantially hollow interior portion <NUM> and incorporates one or more windows <NUM>, such that graft material or the like may be disposed within the OLIF cage <NUM> to promote bony purchase. The OLIF cage <NUM> also includes a leading edge <NUM> that is substantially tapered, such that the OLIF cage <NUM> may be easily disposed in an intervertebral space, and a trailing edge that includes a tool receiving recess <NUM> or the like. As with all devices of the present invention, the OLIF cage <NUM> may be manufactured from PEEK or a metallic material with the porous surface(s) described in detail herein.

<FIG> is perspective views of the cervical cages <NUM> of the present invention, both in PEEK and titanium embodiments, and incorporating a novel locking mechanism <NUM>. These cervical cages <NUM> are similar to the ALIF cage described in detail herein above, further including the novel locking mechanism <NUM>. The novel locking mechanism <NUM> includes a cover plate <NUM> that is held in place over one of the primary cage screws using a plate screw <NUM>. When actuated, the plate screw <NUM> compresses the cover plate <NUM> against the body structure of the cervical cage <NUM>, driving locking tabs <NUM> in the corners of the cover plate <NUM> into corresponding recesses manufactured into the body structure. This locks the primary cage screws into the body structure and prevents them from backing out. Advantageously, at least three points of contact are provided between the cover plate <NUM> and the body structure to provide the required stability.

<FIG> is top and side planar views of the cervical cage of the present invention, in the titanium embodiment and including at least one porous surface <NUM> formed by the process of <FIG>. In this exemplary embodiment, the porous surface <NUM> does not cover the insertion edge and is thinner at the anterior edge to allow support material for the cover plate <NUM> and plate screw <NUM>.

<FIG> is a series of perspective views illustrating the operation of the locking mechanism of <FIG>.

<FIG> is a perspective view of the ALIF cage of the present invention, in a PEEK embodiment and including a novel locking mechanism. <FIG> is a perspective view of the ALIF cage of the present invention, in a PEEK embodiment and including a novel locking mechanism. These ALIF cages operates in a manner similar to the cervical cages described herein above.

<FIG> is a perspective view of the surgical screw <NUM> of the present invention, incorporating both porous regions <NUM> and non-porous regions <NUM>. Specifically, in this exemplary embodiment, the porous regions are disposed at the threads to promote bony purchase.

Claim 1:
A method for manufacturing a surgical implant device, comprising:
providing a body portion; and
forming one or more surfaces comprising a plurality of needles,
wherein the body portion and the one or more surfaces comprising the plurality of needles are integrally formed, and
wherein an exterior surface of each of the plurality of needles is roughened by abrasive blast of surgical implant device.