Porous surgical implant and method of making the same

Abstract

A surgical implant and a method for making the surgical implant are provided. The surgical implant comprises various particles incorporated into the upper and lower surfaces of its body portion. The particles can be pressed into the upper and lower surfaces via physical forces using at least one mold portion. The physical forces applied by the at least one mold portion can deform and / or squeeze the upper and lower surfaces so that these surfaces are infiltrated with the particles. The particles can provide bioabsorbable and / or mechanically enhanced properties to the implant.

Description

Technical Field

[0001] The present technology generally relates to a surgical implant and a method of making a surgical implant incorporating bioabsorbable and / or mechanically enhanced properties, wherein particles incorporated into the surgical implant are used to provide the bioabsorbable and / or mechanically enhanced properties. Background Art

[0002] Surgical implants have been used in the human body to help repair anatomical defects such as damaged spine and fractures. When using this type of surgical implant, usually rely on the interaction of fasteners and / or implants themselves and surrounding anatomical structures to maintain the surgical implant in the proper position in the body. For example, spinal implants may include surface structures or surface roughness for interacting with surrounding anatomical structures to maintain the spinal implant in the proper position in the body. For example, this type of surface structure or surface roughness can provide the insertion of spinal implants in the intervertebral space between adjacent vertebral bodies and resist the migration of spinal implants in the intervertebral space between adjacent vertebral bodies. However, considering the need to prevent the migration of surgical implants in the body, it is necessary to prevent migration in a manner that does not interfere with the insertion of this type of implants. Summary of the invention

[0003] The technology of the present disclosure generally relates to a surgical implant and method for making a surgical implant that incorporates particles made of one or more materials different from the material of the surgical implant and method for making the surgical implant.

[0004] In one aspect, the present disclosure provides a method for forming a spinal implant for implantation into a human body, the method comprising: providing a spinal implant workpiece having a first end surface, an opposite second end surface, a first lateral side surface, an opposite second lateral side surface, an upper surface, and a lower surface; providing at least one mold portion, comprising at least one surface configured to contact at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface, the at least one surface of the at least one mold portion comprising a surface structure for correspondingly producing a surface structure on at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface; positioning particles between the at least one surface of the at least one mold portion and the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface. between at least one of the upper surface and the lower surface; heating the at least one mold part and / or the spinal implant workpiece; pressing the particles against at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface and the lower surface via the physical force of the at least one surface of the at least one mold part to bind the particles into the spinal implant workpiece so that the particles extend from the at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface and the lower surface into the spinal implant workpiece; and forming a surface configuration on at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface and the lower surface, the surface configuration corresponding to the surface structure formed on the at least one surface of the at least one mold part.

[0005] In another aspect, the present disclosure provides a method for forming a spinal implant for implantation into a human body, the method comprising: providing a spinal implant workpiece having at least one working surface formed thereon; providing at least one mold portion comprising at least one surface configured to contact the at least one working surface, the at least one surface of the at least one mold portion comprising a surface structure for correspondingly producing a surface structure on the at least one working surface; positioning particles between the at least one surface of the at least one mold portion and the at least one working surface; heating the at least one mold portion and / or the at least one working surface of the spinal implant workpiece; pressing the particles against the at least one working surface via the physical force of the at least one surface of the at least one mold portion to incorporate the particles into the spinal implant workpiece; and forming a surface configuration on the at least one working surface using the at least one mold portion.

[0006] In yet another aspect, the present disclosure provides a spinal implant for insertion into an intervertebral space between adjacent vertebral bodies, the spinal implant comprising: a main body portion having a first end surface, an opposite second end surface, a first lateral side surface, an opposite second lateral side surface, an upper surface, and an opposite lower surface, the first lateral side surface and the second lateral side surface extending between the first end surface and the second end surface, and the upper surface and the lower surface extending between the first end surface and the second end surface; wherein portions of the upper surface and the lower surface each include an end plate for contacting one of the adjacent vertebral bodies to prevent the spinal implant from being inserted into an intervertebral space between adjacent vertebral bodies a surface structure or surface roughness that migrates after being implanted into the intervertebral space; and wherein the main body portion comprises particles that are physically forced into one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface, the particles extending from the one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface into the main body portion, the particles being formed of a bioabsorbable material that provides for absorption of the particles after the spinal implant is implanted into the intervertebral space.

[0007] The details of one or more aspects of the disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 To illustrate a top perspective view of a spinal implant containing particles incorporated therein;

[0009] Figure 2 To illustrate the method for combining particles in Figure 1 A representative side elevation view of a first portion of a procedure in which portions of a spinal implant are inserted;

[0010] Figure 3 To illustrate the method for combining particles in Figure 1 A representative side elevation view of a second portion of a procedure of a portion of a spinal implant;

[0011] Figure 4 To illustrate the method for combining particles in Figure 1 A representative side elevation view of a third portion of a process of a portion of a spinal implant;

[0012] Figure 5 To show Figure 1 A lateral elevational view of a spinal implant partially inserted into the intervertebral space;

[0013] Figure 6 To illustrate the implant after the particles have been absorbed to form voids in the implant, similar to Figure 5 a side elevation view of

[0014] Figure 7 To show the implant after the particles have been absorbed and bone has formed in the implant, similar to Figure 5 Side elevation view of . DETAILED DESCRIPTION

[0015] The implant according to the preferred embodiment of the present disclosure is Figure 1 and 4 -7 is indicated as a whole by the number 10. Figure 1 and 4 -7, implant 10 may be an intervertebral spinal fusion implant, but the present disclosure is not limited to such applications. Implants according to the present disclosure may be used throughout the body where an implant having properties such as bioabsorbable and / or mechanically enhanced is desired. As discussed below, implant 10 may incorporate particles to provide bioabsorbable and / or mechanically enhanced properties.

[0016] like Figure 1 As depicted in FIG. 1 , the implant 10 is configured to be inserted into the intervertebral space between adjacent vertebral bodies. The implant 10 includes a body portion 11 having a first end surface 12 and a second end surface 14, and a first central axis A extending through the first end surface 12 and the second end surface 14. 1The length between the first end surface 12 and the second end surface 14. In addition, the main body portion 11 of the implant 10 includes a first lateral side surface 16 and a second lateral side surface 18, and a second central axis A extending through the first lateral side surface 16 and the second lateral side surface 18. 2 The length between the first lateral side surface 16 and the second lateral side surface 18 is .

[0017] In addition, if Figure 1 , the body portion 11 of the implant 10 includes an upper surface 20 and a lower surface 22, and an aperture 24 extending through the body portion 11 between the upper surface 20 and the lower surface 22. The aperture 24 can receive bone ingrowth and can be filled with a bone growth promoting substance to promote such bone ingrowth.

[0018] The first end surface 12, the second end surface 14, the first lateral side surface 16, the second lateral side surface 18, the upper surface 20, and the lower surface 22 may include portions that are flattened and / or smoothly or significantly contoured to have various protrusions, recesses, and / or other surface structures or surface roughness. In addition, the first end surface 12, the second end surface 14, the first lateral side surface 16, the second lateral side surface 18, the upper surface 20, and the lower surface 22 may be arranged at various angles relative to each other. The flat portions, contours, surface structures, and / or angles of these surfaces may be configured to complementarily interface with anatomical structures.

[0019] like Figure 1 As depicted in , for example, the first end surface 12, the first lateral side surface 16, and the second lateral side surface 18 have a flattened surface; the second end surface 14 has a smoothly contoured convex surface; and the upper surface 20 and the lower surface 22 have various protrusions (or surface roughness) 30. The protrusions 30 formed on the upper surface 20 and the lower surface 22 provide insertion of the implant 10 in the intervertebral space and resist migration of the implant in the intervertebral space. Thus, considering the orientation of the protrusions 30, the protrusions are oriented so that during insertion into the intervertebral space, the first end surface 12 is the front end and the second end surface 14 is the rear end. However, the upper surface 20 and the lower surface 22 may include protrusions oriented opposite to the protrusions 30, so that the front end and the rear end are reversed.

[0020] As discussed above, the implant 10 includes an aperture 24. The aperture 24 may be sized to receive a bone growth promoting material therein, thereby promoting bone growth through the implant 10 between adjacent vertebral bodies. The implant 10 may include additional apertures formed through the first end surface 12, the second end surface 14, the first lateral side surface 16, and the second lateral side surface 18, and these apertures may be used, for example, to promote the attachment of instruments and / or promote bone growth through the apertures. For example, the first lateral side surface 16 may include an aperture 32 that may be repeated on the second lateral side surface 18, and the second end surface 14 may include an aperture 34 that may also be repeated on the first end surface 12.

[0021] Implant 10 can be formed of a variety of materials including metals, polymers, ceramics, biologics, and / or other bioabsorbable or non-bioabsorbable materials. These materials can be porous, and their porosity can promote bone ingrowth. For example, body portion 11 can be formed of one or more of these materials, and different materials of these materials, such as Figure 1 The particles 40 depicted in the figure can be incorporated into the main body 11. For example, the size of the particles 40 can be 100 to 1000 microns, and the particles have a uniform or irregular shape. In a preferred embodiment of the present disclosure, for example, the main body 11 of the implant 10 can be formed by polyetheretherketone (PEEK), and for example, the particles 40 incorporated in the main body 11 can be formed by organic and / or inorganic minerals found in bones. The particles 40 can provide the main body 11 with bioabsorbable and / or mechanically enhanced properties.

[0022] Preferably, a physical process may be used to press particles 40 into various surfaces of body portion 11, and such infiltration of particles 40 into body portion 11 may occur during and / or after the molding process that forms most, if not all, of the final shape of the body portion. Figure 2-4 , a mold portion 42 is used to press particles 40 into a workpiece 44 that ultimately forms the body portion 11 of the implant 10 via physical force. The workpiece 44 is the body portion 11 in an unfinished form, and the mold portion 42 used to physically force the particles 40 into the workpiece 44 can also be used to form the final form of the body portion 11. In doing so, the mold portion 42 acts on the upper surface 46 of the workpiece 44 to deform and / or press the upper surface 46 by infiltrating the particles 40 into and through the upper surface 46, and deforming and / or pressing the upper surface 46 into a shape dictated by the shape of the mold 42. In a preferred embodiment, the mold portion 42 is heated via an internal or external heat source to facilitate this process, but the mold portion 42 may not be heated during this process.

[0023] like Figure 2-4As depicted in , mold portion 42 includes at least one working surface including surface structures 48 for correspondingly producing protrusions 30 formed in upper surface 20 of body portion 11. The working surface of mold portion 42 may also be provided with surface structures for correspondingly producing surface configurations / structures on upper surface 20, including portions that are flattened and / or smoothly or significantly contoured to have various protrusions, recesses, and / or other surface structures or surface roughnesses. Although Figure 2-4 The mold portion 42 depicted in FIG. 1 is used to form the final form of the upper surface 20 ( Figure 4 ), but mold portion 42 or other molds may be used in a similar manner to form the final form of the various surfaces of body portion 11.

[0024] During use of mold portion 42, for example, particles 40 may be positioned adjacent to upper surface 46 of workpiece 44, and mold portion 42 contacts particles 40 and upper surface 46 of workpiece 44. Upper surface 46 is thus formed according to the shape of surface structure 48 of mold portion 42, and particles are pressed into and through upper surface 46 to form upper surface 20 of body portion 11.

[0025] The workpiece 44 may include one or more additional surfaces that may be impregnated with particles. For example, the workpiece 44 may include a lower surface (not shown) for receiving particles 40 therein to form the lower surface 22 of the body portion 11. In addition, a second portion (not shown) of the mold portion 42 or one or more additional molds (not shown) may be used to physically force the particles 40 into the lower surface of the workpiece 44. Thus, the particles 40 may be positioned adjacent to the lower surface of the workpiece 44, and the second portion of the mold portion 42 or another mold is in contact with the particles 40 and the lower surface of the workpiece 44. The lower surface of the workpiece 44 is thus formed according to the shape of the surface structure (not shown) of the second portion of the mold portion 42 or another mold, and the particles are pressed into and through the lower surface of the workpiece 44 to form the lower surface 22 of the body portion 11.

[0026] In another preferred embodiment, mold portion 42 may be used after workpiece 44 is preformed to form the shape of body portion 11. For example, workpiece 44 may be machined and / or molded to form the shape of body portion 11, and thereafter, mold portion 42 may be used to facilitate infiltration of particles 40 into preformed workpiece 44. A second portion (not shown) of mold portion 42 or additional one or more molds (not shown) may similarly be used to infiltrate particles 40 into another surface of preformed workpiece 44. And in yet another preferred embodiment, workpiece 44 may be infiltrated with particles 40 before being machined and / or molded to form a shape or body portion 11.

[0027] If the material forming workpiece 44 is a thermoplastic polymer such as PEEK, mold portion 42 or other molds described above are preferably heated, and the material or materials used for particles 40 are selected to withstand the heat of mold portion 42. Mold portion 42 can be heated via application of an external heat source or an internal heat source thereto, and the temperature of mold portion 42 should be such that the PEEK of workpiece 44 is somewhat ductile without melting workpiece 44. That is, mold portion 42 can be heated to above the glass transition temperature of the thermoplastic polymer forming workpiece 44. Increasing the ductility of workpiece 44 can make it easier to deform and / or press upper surface 46 by infiltrating particles 40 into and through the upper surface, and easier to deform and / or press upper surface 46 into a shape dictated by the shape of mold 42 to form upper surface 20. Additionally, workpiece 44 and / or particles 40 may be preheated prior to use of mold portion 42 or other such molds to facilitate infiltration, and preheated workpiece 44 and / or preheated particles 40 may be used with heated or unheated mold portion 42. Furthermore, after such infiltration, workpiece 44 (or body portion 11) may be treated via heat treatment to restore mechanical properties that may have been lost during infiltration.

[0028] like Figure 1 As depicted in FIG. 1 , many particles 40 incorporated into the main body portion 11 are incorporated into and / or communicate with the upper surface 20. As discussed above, various surfaces of the main body portion 11 may also include similarly placed particles 40. Figure 5-7 As depicted in , when the implant 10 is inserted into the intervertebral space between adjacent vertebral bodies, the upper surface 20 contacts the upper vertebral body 50 of the adjacent vertebral body. Specifically, as shown in FIG. Figure 6 As depicted in FIG. 1 , the upper surface 20 and the particles 40 incorporated into and / or in communication with the upper surface 20 are in contact with the lower surface 52 of the upper vertebral body 50. If the particles 40 are selected to be bioabsorbable, the particles 40 are absorbed by the body. The gaps 60 previously filled by the particles 40 and left behind by their absorption may be voids 62 ( Figure 6 ) or filled with bone 64( Figure 7 ). In any case, the void 62 or the bone 64 can be used to prevent the spinal implant 10 from migrating in the intervertebral space. For example, the void 62 allows the bone of the lower surface (or end plate) 52 to settle therein to prevent the spinal implant 10 from moving, and the bone 64 is used to physically join the implant 10 to the lower surface 52 to prevent the spinal implant 10 from moving. Alternatively, a dissolution process can be used to remove at least some of the particles 44 from the implant 10 before implantation, and the resulting at least partially porous implant 10 can then be implanted. Such a dissolution process may include soaking the workpiece 44 in an acid or base to remove at least some of the particles 44.

[0029] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the instance, certain actions or events in any of the processes of the methods described herein may be performed in different sequences, added, merged, or completely ignored (e.g., not all described actions or events are necessary to implement the technology). In addition, for the purpose of clarity, although an aspect of the present disclosure is described as being performed by a single module or unit, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. A method of forming a spinal implant for implantation in a human body, the method include: providing a spinal implant workpiece having a first end surface, an opposing second end surface, a first lateral side surface, an opposing second lateral side surface, an upper surface, and a lower surface; providing at least one mold portion comprising at least one surface configured for contacting at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface, the at least one surface of the at least one mold portion comprising a surface structure for correspondingly producing a surface structure on the at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface; positioning particles between the at least one surface of the at least one mold portion and the at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface; heating the at least one mold portion and / or the spinal implant workpiece; applying a physical force to the particle via the at least one surface of the at least one mold portion to press the particle against and into the at least one working surface of the spinal implant workpiece such that the particle extends from the at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface into the spinal implant workpiece; as well as When the particles are pressed into the spinal implant workpiece, a surface configuration is formed on at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface and the lower surface, the surface configuration corresponding to the surface structure formed on the at least one surface of the at least one mold part via a physical force applied thereto by at least one surface of the at least one mold part.

2. The method of claim 1, wherein the particles are formed of a bioabsorbable material that provides for absorption of the particles after the spinal implant is implanted in the human body.

3. The method according to claim 1, in, After implantation and resorption of the particles, the interstices in the spinal implant workpiece previously occupied by the particles are voids or bone fillers.

4. The method of claim 1 , wherein the surface configuration on at least one of the first end surface, the second end surface, the first lateral side surface, the second lateral side surface, the upper surface, and the lower surface is formed by deforming and / or compressing the spinal implant workpiece using the at least one mold portion.

5. The method of claim 1, wherein the particles of the spinal implant are formed from at least one of organic and inorganic minerals found in bone.

6. The method of claim 5, wherein the size of the particles is 100 to 1000 microns. The method according to claim 6 , wherein the particles have a uniform or irregular shape.

8. The method of claim 7, wherein the spinal implant workpiece of the spinal implant is formed of at least one of a metal, a polymer, a ceramic, a biologic, and / or other bioabsorbable or non-bioabsorbable material.

9. A method of forming a spinal implant for implantation in a human body, the method include: providing a spinal implant workpiece having at least one working surface formed thereon; providing at least one mold part comprising at least one surface configured for contacting the at least one working surface, the at least one surface of the at least one mold part comprising a surface structure for correspondingly generating a surface structure on the at least one working surface; positioning particles between the at least one surface of the at least one mold portion and the at least one working surface; heating the at least one mold portion and / or the at least one working surface of the spinal implant workpiece; applying a physical force to the particles via the at least one surface of the at least one mold portion to press the particles against and into the at least one working surface to bond the particles into the spinal implant workpiece; as well as When the particles are pressed into the spinal implant workpiece, surface structures are formed on the at least one working surface of the implant workpiece via physical force of at least one surface of the at least one mold portion against the at least one working surface.

10. The method of claim 9, wherein the particles are formed of a bioabsorbable material that provides for absorption of the particles after implantation of the spinal implant in the human body.

11. The method of claim 10, wherein the particles have a size of 100 to 1000 microns.

12. The method of claim 11, wherein the particles have a uniform or irregular shape.

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