Interbody Microstructure Device

Abstract

A medical device such as an interbody cage component, a hip stem component, or an acetabular shell component having a microstructure in at least one direction for osteointegration and boney in-growth. The microstructure is controlled by machine parameters and may be created by an additive manufacturing program. Typically, the microstructure occurs in both the +/−X and the +/−Y directions, and the microstructure can be added in the range of 0.010 to 0.150 mm.

Claims

1. A surgical implant comprising: a base having an interior surface, an exterior surface, a proximal end and a distal end; and a plurality of microstructures formed on a select one of the interior and exterior surfaces, wherein the plurality of microstructures is formed in at least one direction and in at least one area of the select one of the interior and exterior surfaces.

2. The surgical implant of the present invention as recited in claim 1, wherein the surgical implant is selected from a group consisting of an interbody cage component, a hip stem component, an implant or an acetabular shell component.

3. The surgical implant of the present invention as recited in claim 1, wherein the plurality of microstructures is formed by an additive manufacturing process.

4. The surgical implant of the present invention as recited in claim 1, wherein a portion of the plurality of microstructures are formed on the interior surface of the base.

5. The surgical implant of the present invention as recited in claim 4, wherein the portion is formed in a plurality of zones on the interior surface.

6. The surgical implant of the present invention as recited in claim 5, wherein a first zone of the plurality of zones has a first microstructure having at least one different characteristic from a second microstructure in a second zone of the plurality of zones.

7. The surgical implant of the present invention as recited in claim 6, wherein the at least one different characteristics is a height or a width of the microstructure.

8. The surgical implant of the present invention as recited in claim 1, wherein the at least one direction is selected from a +/−X or a +/−Y direction.

9. The surgical implant of the present invention as recited in claim 8, wherein the plurality of microstructures have a height in a range of about 0.010 to 0.150 mm.

10. The surgical implant of the present invention as recited in claim 1, wherein the plurality of microstructures form a surface topography having a plurality of shallow areas and a plurality of raised areas to create a plurality of distinct zones.

11. A method of producing a microstructure device comprising the steps of: contouring a bone area in a patient; providing an implant device for use in a surgical procedure; creating a design for a pattern of microstructures on the implant device based on the step of contouring of the bone area; and forming the pattern on the implant device by a variable manufacturing process.

12. The method as recited in claim 11 further comprising a step of comparing the design and the pattern after the step of forming.

13. The method as recited in claim 12 further comprising a step of modifying the pattern based on the step of comparing the formed pattern with the design after the step of forming.

14. The method as recited in claim 13 further comprising a step of securing the implant device to the contoured bone area of the patient after the step of forming.

15. The method as recited in claim 11, wherein the pattern comprises a plurality of microstructures having a height in a range of about 0.010 to 0.150 mm.

16. The method as recited in claim 11, wherein the microstructure device is selected from a group consisting of an interbody cage component, a hip stem component, an implant and an acetabular shell component.

17. The method as recited in claim 11, wherein the step of forming is performed in at least one direction, and further wherein the at least one direction is selected from a +/−X or a +/−Y direction.

18. The method as recited in claim 11, wherein the pattern of microstructures has at least one zone with a different characteristic from at least one other zone, and further wherein the pattern of microstructures is provided on an interior surface of the microstructure device.

19. The method as recited in claim 11, wherein the step of forming the pattern of microstructures creates a surface topography having a plurality of distinct zones comprised of a plurality of shallow and raised areas.

20. An interbody cage component comprising: a base having an interior surface and an exterior surface; the interior surface having a surface topography having shallow areas and raised areas and surface topography having microstructures having a height or thickness in the range of about 0.010 to 0.150 mm; and. the surface topography formed in at least one direction and the at least one direction is selected from +/−X or +/−Y direction on the interior surface.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The description refers to provided drawings in which similar reference characters refer to similar parts throughout the different views, and in which:

[0016] FIG. 1A illustrates a perspective view of the macro topography of one potential embodiment of an interbody cage component of the present invention in accordance with the disclosed structure;

[0017] FIG. 1B is a cross sectional view of the plate of the present invention which shows the interior surface, exterior surface and the pattern that is built up on the interior surface of the plate;

[0018] FIG. 2 shows a perspective view of the macro topography with added texture of one potential embodiment of an interbody cage component of the present invention in accordance with the disclosed specification;

[0019] FIG. 3 displays a perspective view of one potential embodiment of the added texture of the present invention shown in a close-up view in accordance with the disclosed description;

[0020] FIG. 4 presents a perspective view of one potential alternative embodiment of the added texture to the interbody cage component of the present invention in accordance with the disclosed structure;

[0021] FIG. 5 illustrates a perspective view of one potential embodiment of the hatch lines and contour line created during the additive manufacturing program of the present invention in accordance with the disclosed specification;

[0022] FIG. 6 shows a perspective view of one potential embodiment of the laser pathways created during the additive manufacturing program of the present invention in accordance with the disclosed description; and

[0023] FIG. 7 provides a block diagram showing an exemplary method of making an implant or plate having a microstructure.

DETAILED DESCRIPTION OF THE INVENTION

[0024] The innovation is now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding thereof. It may be evident, however, that the innovation can be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate a description thereof.

[0025] A medical or surgical device such as an interbody cage component, hip stem component, implant or an acetabular shell component is presented and comprises a microstructure in at least one direction and on at least one surface for osteointegration and boney in-growth. The microstructure is controlled by machine parameters or the additive manufacturing program and may be varied as needed to fit a particular patient's requirement or bone surface as developed as part of the surgical procedure. Typically, the microstructure occurs in both the +/−X and the +/−Y directions, and the microstructure can be added in the range of a height or thickness of about 0.010 to 0.150 mm. The microstructure is provided in a predetermined pattern having first and second zones of structures. The first zone has more structures than the second zone. The first and second zones can be created by alternating the energy or duration of the additive manufacturing or coating processes in order to create distinct regions. By creating a distinct pattern of structures or regions on one or more surfaces of the implant, the manufacturing process can be adapted to different types of surgical procedures so as to be able to optimize a configuration that may speed the on growth of bone material.

[0026] Referring initially to the drawings, FIGS. 1A, 1B and 2 illustrate an interbody cage component, implant or base component 100 comprising a microstructure 102 in at least one direction for osteointegration and boney in-growth. The interbody cage component 100 is typically manufactured using additive manufacturing (AM) techniques and grown as one part on the surface of the plate or implant and is completely integrated with the plate surface so that it does not become dislodged or break apart.

[0027] Additionally, the interbody cage component, implant or base component 100 and its components can be any suitable size, shape, and configuration as is known in the art without affecting the overall concept of the invention. One of ordinary skill in the art will appreciate that the shape and size of the interbody cage component 100 as shown in the FIG. 1A is for illustrative purposes only and many other shapes and sizes of the interbody cage component 100 are well within the scope of the present disclosure. Although dimensions of the interbody cage component 100 (i.e., length, width, and height) are important design parameters for good performance, the interbody cage component 100 may be any shape, size or configuration that ensures optimal performance during use.

[0028] As shown in FIG. 1A, the interbody cage component, implement or base component 100 comprises a proximal end, a distal end, an interior surface and an exterior surface. Further, the surface of the interbody cage component 100 would include a microstructure 102 in at least one direction and in at least one area. The microstructure 102 is controlled by machine parameters or the additive manufacturing program. Thus, FIG. 1A discloses the surface macro topography 104 of the interbody cage component 100. Typically, macro topography 104 can be controlled with unique lattice structures and CAD designs. The microstructure 102 is then controlled by our equipment (machine) parameters. FIG. 1B shows a cross sectional view of the implant or plate of the present invention showing the interior 103 and exterior 105 of the plate 100. On the interior surface 103, a first layer 107 is applied on the surface and through additive manufacturing a further layer 109 is built up to create different regions or zones on the interior surface of the plate.

[0029] As shown in FIG. 2, the interbody cage component, implant or base component 100 comprises a microstructure 102 in both the +/−X and the +/−Y directions. The texture can be added in the range of about 0.010 to 0.150 mm and the height and thickness of the texturing of the surface topography can be varied depending on the requirements of the surgical procedure and or contouring that was done to the bone prior to placement of the plate or implant.

[0030] FIG. 3 discloses an enlarged or expanded view of the microstructure 102 in both the +/−X and the +/−Y directions of the interbody cage component 100. More specifically, FIG. 3 depicts both shallow areas 107 or areas where less build up has occurred, and raised areas 109 where more build up has occurred and is raised a further elevation over the height of the base of the plate or cage component 100.

[0031] In another embodiment shown in FIG. 4, the microstructure 400 of the present invention is controlled by machine parameters and provides the ability to vary the amount, height, width and other features of the coating or structures to be formed. The parameters are set to extend alternating hatch lines and/or to add a secondary alternating contour line, out past the original contour line, to give the surface additional controllable macro texture and other raised features. One way this is done is disclosed in FIG. 5. More specifically, the hatch lines 500 extend past the contour line 502, as shown in FIG. 5, giving the surface the micro texture 400 shown in FIG. 4.

[0032] In another embodiment shown in FIG. 6, the machine parameters are set to delay when the laser turns off or has the laser start early, by microseconds. This keeps the laser on while the focus of the laser moves from one hatch line to the next, creating curved extensions similar to those found with hook and loop fasteners, such as those marketed under the brand Velcro®. Thus, the delay of turning the laser off develops an area 600 and starting the laser early develops an area 602, as shown in FIG. 6. The two pathways can also work in concert with each other while allowing other alternatives and other complex geometries to be created in order to accommodate different bone configurations or surgical procedures. For example, turning the laser on or off can create a J-Hook shape extending out past the surface of the structure, or any other suitable shape as is known in the art can be created by adjusting the laser as well. In another embodiment of the present invention, the medical device can be a hip stem component or acetabular shell component that has a micro surface in both the +/−X and the +/−Y directions. The texture can be added in the range of about 0.010 to 0.150 mm.

[0033] FIG. 7 shows an exemplary block diagram which provides steps in connection with forming a surface topography. The method includes the steps of initially contouring a bone area at step 700 in a patient, then providing a plate or other implant device for using in a surgical procedure at step 710. Next, at step 720 a design for a pattern is created on the implant or plate, based on the step of contouring of the bone area. At step 730, the pattern is formed on the implant or plate by a variable manufacturing process. The formed pattern is compared with the design at step 740 and the pattern may be modified at step 750 based on the step of comparing the formed pattern with the design. Finally, the implant or plate is secured to the contoured bone of a patient at step 760.

[0034] What has been described above includes examples of the claimed subject matter. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the claimed subject matter, but one of ordinary skill in the art may recognize that many further combinations and permutations of the claimed subject matter are possible. Accordingly, the claimed subject matter is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term “includes” is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term “comprising” as “comprising” is interpreted when employed as a transitional word in a claim.