Dental implants using porous implant materials

Abstract

To provide a dental implant incorporating features to encourage stable fixation following implantation.SOLUTION: A dental implant 100 includes: a base 110 having a plurality of exterior surfaces and a plug opening 111 formed therein; a plug assembly 120 inserted into the plug opening; and at least one region 131, 132, 133, and 134 of porous ingrowth material associated with at least one of exterior surfaces 112A, 112B, and 112C of the base.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This is a non-provisional application based on U.S. Provisional Patent Application No. 62,950,396, filed December 19, 2019, entitled "Dental Implant Using Porous Implant Material," which is incorporated herein by reference.

[0002] 2. Background of the Invention 1. Field of the invention The present disclosure relates to dental implants, and more particularly, to dental implants incorporating features that promote stable fixation after implantation.

[0003] 2. Description of Related Technology It is known that dental implants can be used to treat defective areas in a patient's mouth. Known dental implants have a base portion that is fixed in the mouth before a replacement tooth is attached to the base portion. Before a replacement tooth can be attached to the base portion, the base portion must be immovably and stably fixed in the mouth. In many cases, the base portion is fixed in the mouth using a fixation screw that is screwed into solid tissue, such as the tissue of the jawbone. Not only is this fixation painful for the patient, but such fixation is not always sufficient to hold the dental implant in place, requiring revision surgery and additional pain and recovery time for the patient.

[0004] What is needed in the art is a reliable method for treating defective areas within a patient's mouth.

[0005] Summary of the Invention Exemplary embodiments disclosed herein provide dental implants having a porous ingrowth material on one or more surfaces of the implant to promote tissue ingrowth into the material and fixation of the dental implant.

[0006] In some exemplary embodiments provided according to the present disclosure, a dental implant has a base having a plurality of outer surfaces and plug openings formed therein, a plug assembly inserted into the plug openings, and at least one region of porous ingrowth material associated with at least one of the outer surfaces of the base.

[0007] In some exemplary embodiments provided according to the present disclosure, a method of treating a defect area in a mouth includes positioning an implantation hole in the defect area and implanting a dental implant in the implantation hole. The dental implant has a base having a plurality of outer surfaces and plug openings formed therein, a plug assembly inserted into the plug openings, and at least one region of porous ingrowth material associated with at least one of the outer surfaces of the base and in contact with tissue of the defect area.

[0008] One advantage that may be realized by exemplary embodiments provided in accordance with the present disclosure is that the region of endogenous material may allow for rapid fixation and stabilization of the implant in the tissue of the defect area.

[0009] Another advantage that may be realized by the exemplary embodiments provided in accordance with the present disclosure is that the implants may be easily tailored to treat both mild and severe defect areas.

[0010] Yet another advantage that may be realized by exemplary embodiments provided in accordance with the present disclosure is that the base may have reservoirs for eluting one or more therapeutic agents into the defect area to further increase the rate of healing. [Brief description of the drawings]

[0011] The above and other features and advantages of the present invention, and the manner in which they are accomplished, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is an exploded perspective view of one exemplary embodiment of a dental implant provided by the present disclosure. [Diagram 2] FIG. 2 illustrates the dental implant shown in FIG. 1 implanted into a defect area in a patient's mouth. [Diagram 3] 1 is an exploded perspective view of another exemplary embodiment of a dental implant provided by the present disclosure; [Figure 4] FIG. 4 is a perspective view of the dental implant shown in FIG. 3. [Diagram 5] FIG. 5 shows the dental implant shown in FIGS. 3 and 4 implanted in a defect area in a patient's mouth.

[0012] Corresponding reference characters indicate corresponding parts throughout the several views. The examples described herein illustrate embodiments of the present invention, and such examples are not to be construed as limiting the scope of the invention in any way.

[0013] Description of the Invention Referring now to the drawings, and more particularly to FIGS. 1-2, one exemplary embodiment of a dental implant 100 for implantation within gingival tissue is shown. The dental implant 100 generally comprises a base 110 having a plug opening 111 formed therein, a plug assembly 120 for insertion into the plug opening 111, and at least one region 131, 132, 133, 134 of ingrowth material, also referred to as an "ingrowth region," associated with one or more respective faces 112A, 112B, 112C of the base 110. In some embodiments, as shown in FIGS. 1-2, the base 110 defines a generally cylindrical shape with a pair of enlarged ends 113A, 113B and a body portion 114 connecting the ends 113A, 113B. In some embodiments, the base 110 comprises a generally non-porous material that may have a porosity of about 0% to about 10%. Foundation 110 may comprise one or more biocompatible materials suitable for short-term or long-term placement within the body of a human or other animal, including, but not limited to, metals such as titanium, stainless steel, cobalt chrome, and / or tantalum; polymers such as ultra-high molecular weight polyethylene (UHMWPE), other forms of polyethylene, polyetheretherketone (PEEK), polylactic acid (PLA), and / or polyglycolic acid (PGA); and / or ceramics such as hydroxyapatite (HA), high density alumina, so-called "bioglass," and graphite. It should be understood that all of the above materials are exemplary only, and that many other types of biomaterials may be incorporated into foundation 110.

[0014] In some embodiments, one or more fluid delivery channels 115A, 115B are formed in the body portion 114 to deliver fluid from a reservoir 116 formed within the base 110 to surrounding tissue, as described further herein. The faces 112A and 112C of the base 110 may also each have one or more fluid delivery channels 115C. In some embodiments, two or more delivery channels, such as channel 115A, extend circumferentially about a longitudinal axis LA defined through the base 110, and one or more delivery channels, such as channel 115B, extend parallel to the longitudinal axis LA and connect each of the circumferentially extending delivery channels 115A. The shapes and dimensions of the delivery channels 115A, 115B may be tailored to provide different fluid delivery characteristics from the reservoir 116 of the implant 100 to the surrounding tissue. Fluid feed channels 115A, 115B may be fluidly connected to a reservoir 116 formed in base 110 via a reservoir opening 117 formed in the reservoir 116 and partially surrounded by feed channel 115B.

[0015] A plug assembly 120 is inserted into the plug opening 111 of the foundation 110 to close the plug opening 111. In some embodiments, the plug assembly 120 has a foundation engagement portion 121 with threads 122 that thread into corresponding threads of the foundation 110 to couple the foundation engagement portion 121 to the foundation 110. The foundation engagement portion 121 may have a through hole 123 extending therethrough and extending from one end 124A to the opposite end 124B of the foundation engagement portion 121. In some embodiments, a stop 125 is formed in the foundation engagement portion 121 between the ends 124A and 124B to prevent the foundation engagement portion 121 from being over-threaded into the foundation 110. Base engagement portion 121 may be unthreaded on one side of stop 125, adjacent end 124A, and may be threaded on the other side of stop 125, adjacent end 124B.

[0016] The plug assembly 120 may further include a plug portion 126 disposed within the through hole 123 of the base engagement portion 121. The plug portion 126 may include, for example, a shaft 127 having a diameter smaller than the diameter of the through hole 123 and a head 128 having a diameter larger than the diameter of the through hole 123 and coupled to the shaft 127. In some embodiments, the plug portion 126 may include a generally inelastic material, such as a thermosetting polymer. Alternatively, the plug portion 126 may include an elastic material, such as rubber. It should be understood that the plug portion 126 should sufficiently occlude the through hole 123 of the base engagement portion 121 to close the through hole 123 so that fluid from the reservoir 116 does not rapidly leak out of the through hole 123 when subjected to increasing fluid pressure.

[0017] In some embodiments, the through hole 123 is formed in a mount 141 of the base engagement portion 121, and the mount 141 is shaped and dimensioned to mount, for example, a replacement tooth to the mount 141. In other words, the plug assembly 120 is configured to mount a replacement tooth to the plug assembly 120. The replacement tooth can be fitted directly onto the mount 141 for fixation in the patient, or alternatively, an adapter may be fitted onto the mount 141 and then the replacement tooth may be attached to the adapter. Many such mounts for replacement teeth are known, and therefore further description of the mount 141 is omitted for the sake of brevity.

[0018] At least one region of ingrowth material, shown as four regions 131, 132, 133, 134, is associated with one or more respective sides 112A, 112B, 112C of base 110. As used herein, each of ingrowth regions 131, 132, 133, 134 is "associated" with a respective side of base 110 in the sense that each of ingrowth regions 131, 132, 133, 134 is directly or indirectly attached to a respective side 112A, 112B, 112C of base 110. To promote tissue ingrowth, each of ingrowth regions 131, 132, 133, 134 of ingrowth material is porous and includes a biocompatible material. Each region 131, 132, 133, 134 may have the same implant material, or alternatively, one or more of the regions 131, 132, 133, 134 may have a different implant material than one or more of the other regions 131, 132, 133, 134. In some embodiments, the implant material comprises titanium or polyetheretherketone (PEEK) having a porosity of about 50% to 70%, an average pore size of about 500 μm to about 550 μm, a pore continuity of about 210 μm to about 250 μm, and a nominal thickness of about 0.25 mm to 1.25 mm. One exemplary implant material that may be used in one or more of the regions 131, 132, 133, 134 is commercially available under the trade name OSTEOSYNC® from SITES MEDICAL®, Inc., Columbia City, Indiana. It should be understood that the above characteristics of the implant material are merely exemplary. In some embodiments, one region, such as region 131, is associated with the top surface 112A of the base 110, one region, such as region 132, is associated with the periphery 112B of the base 110 between the end regions 113A, 113B of the base 110 that are not covered by any inplant material, and two regions, such as regions 133 and 134, are associated with the bottom surface 112C of the base 110. Each of the surfaces 112A, 112B, 112C may have through holes formed therethrough to the reservoir 116 to allow fluid to pass from the reservoir 116 through the holes in the inplant regions 131, 132, 133, 134 to the surrounding tissue.

[0019] In some embodiments, two inplant regions associated with the same surface, such as inplant regions 133 and 134 associated with bottom surface 112C of foundation 110, are different from one another. For example, inplant region 133, which may be referred to as a "first region of inplant material" and is sandwiched between inplant region 134 and bottom surface 112C of foundation 110, may have a first inplant material having a lower porosity compared to the second inplant material of inplant region 134, which may be referred to as a "second region of inplant material." In other words, the first inplant material of the first region of inplant material 133 may have a first porosity and the second inplant material of the second region of inplant material 134 may have a second porosity that differs from the first porosity, for example, in that it is higher than the first porosity. By providing the in-plant region 133 with a lower porosity than the in-plant region 134, the rate of fluid transfer from the reservoir 116 to the surrounding tissue may be limited based on the porosity of the in-plant region 133, while the porosity of the in-plant region 134 may be higher to promote tissue ingrowth into the pores of the in-plant region 134. Such a configuration may allow fluid to be transferred from the reservoir 116 to the surrounding tissue for an extended period of time based on the relatively low porosity of the in-plant region 133, while providing larger pores in the in-plant region 134 to promote tissue ingrowth and stabilize the implant 100. Alternatively or additionally, the two in-plant regions 133, 134 may differ from one another, for example, by having different compositions and / or shapes. It should be understood that in-plant regions associated with the same surface may differ from one another in other respects, and the above examples are merely representative of some possible ways in which the regions may differ from one another.

[0020] In some embodiments, a perforated sleeve 142 is disposed between the periphery 112B of the base 110 and the in-plant region 132 to provide a uniform surface relating the in-plant region 132 to the periphery 112B. As shown in FIG. 1, the periphery 112B may be relatively non-uniform due to the fluid feed grooves 115A, 115B formed therein, which makes it difficult to secure the in-plant region 132 to the surface 112B. Thus, the perforated sleeve 142 is fitted, such as by press fitting, over the periphery 112B between the end regions 113A, 113B of the base 110 to provide a uniformly sized surface for securing the in-plant region 132. Additionally, the size of the openings 143 formed in the perforated sleeve 142 may be adjusted to control the flow rate from the reservoir 116 through the reservoir openings 117 to the in-plant region 132, thereby controlling the fluid feed through the pores of the in-plant region 132. In this regard, the perforated sleeve 142 assists in the association of the implanted region 132 with the periphery 112B of the base 110 as well as controlling fluid delivery from the reservoir 116 to the surrounding tissue after implantation.

[0021] With specific reference to FIG. 2, the implant 100 is shown after being implanted into the gingival tissue T of the mouth of a patient, which may be a human or other animal. As shown in FIG. 2, the patient has a defect area 200 between two adjacent teeth 201, 202. The defect area 200 previously held a tooth that was lost or otherwise removed, for example, due to disease or trauma. To replace the tooth, the defect area 200 is cleaned to remove any remaining debris of the removed tooth, other debris, and pathogens. In the case shown in FIG. 2, the defect area 200 is a minor defect that has a sufficient amount of localized gingival and bone tissue to support and secure the implant 100, for example, without the need for one or more screws to secure the implant 100.

[0022] An implantation hole 203 is formed in tissue at the defect area 200, and the implant 100 is positioned within the implantation hole 203. In some embodiments, the implantation hole 203 is formed by removing a tooth (or tooth fragment) present in the defect area 200 that is to be replaced by the implant 100. As shown, the mount 141 protrudes from the implantation hole 203 after placement of the implant 100, for example to receive a replacement tooth after the implant 100 is sufficiently secured in the tissue. However, initially, the mount 141 may remain uncovered, exposing the mount 141 and the head 128 of the plug portion 126 at the defect area 200. Before, during, or after implantation, the plug portion 126 may be removed from the through hole 123 in the mount 141, and one or more therapeutic agents may be loaded into the reservoir 116 in the base 110 via the through hole 123. The therapeutic agent may be, but is not limited to, an antibiotic or other antimicrobial agent, an anti-inflammatory agent, an analgesic agent, a growth factor, a solution containing regenerative cells such as stem cells, or any other substance that provides a therapeutic effect to the tissue surrounding the implant 100 after implantation. Alternatively, the therapeutic agent may be loaded into the reservoir 116 through the reservoir opening 117, for example, before the reservoir opening 117 is covered by the perforated sleeve 142 and the implanted region 132. Thus, it should be understood that the reservoir 116 may be initially loaded with one or more therapeutic agents in different manners.

[0023] In some embodiments, the reservoir 116 is initially filled with a first therapeutic agent, which may be one or more antimicrobial agents, to reduce the risk of infection, and then refilled with either the first therapeutic agent, a second therapeutic agent different from the first therapeutic agent, or both the first and second therapeutic agents while the implant 100 is implanted in the patient. For example, the reservoir 116 may be partially refilled with a first therapeutic agent (an antimicrobial agent) to continue to deliver the antimicrobial agent to the surrounding tissue to reduce the risk of infection, but may also be filled with a second therapeutic agent, such as a growth factor, to promote tissue infiltration and ingrowth into the ingrowth regions 131, 132, 133, 134 and promote faster and more stable fixation of the implant 100 in the defect region 200. To refill the reservoir 116, the plug portion 126 is withdrawn from the through hole 123 and the tip of a syringe containing a therapeutic agent is placed into the through hole 123 such that the therapeutic agent may be injected from the syringe into the through hole 123 and into the interior of the fluidically connected reservoir 116. Alternatively, the syringe may be used to remove fluid, which may be a therapeutic agent or a bodily fluid, from the reservoir 116 .

[0024] After the reservoir 116 is partially or completely filled, the plug portion 126 is replaced within the through hole 123. In some embodiments, the plug portion 126 is shaped and dimensioned such that the replacement of the plug portion 126 within the through hole 123 pressurizes the fluid within the reservoir 116 and displaces the fluid from within the reservoir 116, for example, through the reservoir opening 117 formed in the base 110 and into the implanted regions 131, 132, 133, 134. In this regard, the plug portion 126 not only seals the through hole 123, but also provides an initial pressurization of the reservoir 116 to deliver a mass of therapeutic agent to the surrounding tissue while the implant 100 is implanted in the patient. The therapeutic agent remaining within the reservoir 116 after the initial mass of therapeutic agent has been delivered may then migrate from the reservoir 116 into the surrounding tissue due to the compressive forces applied to the implant 100, which "squeeze" the therapeutic agent, and the natural diffusion of the therapeutic agent into the tissue. It should be appreciated that the plug portion 126 may be removed from and replaced into the through hole 123 multiple times during implantation to refill the reservoir 116. Because of the ease of removing and replacing the plug portion 126 to refill the reservoir 116, a patient in whom the implant 100 is implanted may refill the reservoir 116 at home or in other non-clinical settings.

[0025] While the implant 100 is implanted, natural tissues, such as gingival and bone tissues, adjacent the defect area 200 may infiltrate and grow into the in-growth areas 131, 132, 133, 134 of the implant 100. As the natural tissues grow into the in-growth areas 131, 132, 133, 134, the implant 100 becomes stably fixed in the tissue. After the implant 100 is stably fixed in the tissue, a replacement tooth may be attached to the mount 141 to complete the replacement of the removed tooth. In some embodiments, the replacement tooth may be attached directly to the mount 141 with a plug portion 126 disposed in the through hole 123 of the base engagement portion 121. In some embodiments, the plug portion 126 may be replaced with another plug in the through hole 123, for example shaped to fill the through hole 123 and engage a socket of the replacement tooth for mounting the replacement tooth on the mount 141. In another embodiment, the base engagement portion 121 may be replaced with another base engagement portion having a mount for mounting the replacement tooth. Thus, it should be understood that many different methods of attaching a replacement tooth to the implant 100 may be used to secure the replacement tooth to the implant 100.

[0026] It has been found that certain ingrowth materials, such as OSTEOSYNC®, as described above, provide surprisingly good tissue ingrowth and fixation characteristics for the implant 100. When OSTEOSYNC® is used to form the ingrowth regions 131, 132, 133, 134, the pull-out strength of the implant 100 can nearly equal that of natural bone after only five weeks of implantation. This result was unexpected because such implants provide a significant improvement over known dental implants. Without being bound to any particular theory as to why such results were observed, it is theorized that the in-growth regions 131, 132, 133, 134, when containing OSTEOSYNC® or a similar material, provide an excellent substrate for cortical bone tissue ingrowth. Given the high concentration of cortical bone tissue adjacent to the jawbone, it is theorized that the stable fixation of the implant 100 at five weeks is at least partially attributable to the rapid ingrowth and proliferation of cortical bone tissue in the ingrowth regions 131, 132, 133, 134. Thus, it is theorized that the implants provided in accordance with the present disclosure are suitable as dental implants because they replicate the natural fixation of teeth in the gum and bone tissue present in a patient's mouth, i.e., primarily the ingrowth of and integration with the adjacent cortical bone tissue.

[0027] It has also been found that rapid and stable fixation of the implant 100 can be promoted by providing one or more therapeutic agents in the reservoir 116 for delivery of the therapeutic agent during implantation. As described above, the reservoir 116 can be initially loaded with one or more antimicrobial agents to reduce the risk of pathogens infecting the defect region 200 and preventing tissue growth to secure the implant 100. To promote tissue ingrowth into the ingrowth regions 131, 132, 133, 134 and stable fixation of the implant 100, the reservoir 116 can be refilled with antimicrobial agents, or other therapeutic agents, one or more times during implantation, as described above. Thus, implants provided in accordance with the present disclosure also promote rapid and stable fixation in the surrounding native tissue by delivering one or more therapeutic agents from the reservoir 116 into the surrounding tissue to provide a suitable environment for tissue ingrowth into the ingrowth regions 131, 132, 133, 134.

[0028] 3-5, another exemplary embodiment of a dental implant 300 for implantation in severely deficient gingival tissue is shown. Similar to the implant 100 described above, the implant 300 also includes a base 310 having a plug opening 311 formed therein, a plug assembly 320 inserted into the plug opening 311, and at least one region 331, 332, 333, 334, 335 of in-growth material associated with one or more respective surfaces 312A, 312B, 312C of the base 310. As shown in FIG. 3, for example, the in-growth regions 331 and 332 may be associated with the top surface 312A of the base 310, the in-growth region 333 may be associated with the peripheral surface 312B of the base 310, and the in-growth regions 334 and 335 may be associated with the bottom surface 312C of the base 310. In comparison to implant 100 which typically has a cylindrical base 110 with a circular cross-section, implant 300 shown in FIG. 5 and further described herein has a relatively large base 310 with an elliptical cross-section to stabilize implant 300 in the severe defect area 510.

[0029] Similar to the base 110, the base 310 may also have fluid delivery channels 315A, 315B, 315C formed therein that communicate fluid from a reservoir 316 formed therein to the in-plant regions 331, 332, 333, 334, 335 through openings, such as reservoir opening 317 formed in the base 310 to the reservoir 316. The reservoir 316 may be refilled by removing the plug portion 326 from the plug assembly 320 and delivering fluid to the reservoir 316 through the through hole 323 of the plug assembly 320, for example, with a syringe or other fluid delivery device. Similar to the implant 100, the implant 300 may have a perforated sleeve 342 between the in-plant region 333 and the periphery 312B and a mount 341 for mounting a replacement tooth.

[0030] The implant 300 is configured to be implanted in severe defects, i.e. defects in which the adjacent tissue is diseased, destroyed, and / or otherwise not suitable for fixation of the implant 300 without additional fixation means. To provide additional fixation means required for stable fixation of the implant 300, one or more fixation openings 351, 352 for receiving respective fixation means, such as one or more orthopedic screws 501 (shown in FIG. 5), may be formed in the peripheral surface 312B of the base 310. Corresponding openings 353, 354 may also be formed in the perforated sleeve 342 and the implanted region 333, such that the fixation openings 351, 352 are not covered for receiving the screws 501. For example, the fixation openings 351, 352 may be provided with threads for threadingly engaging the screws 501 to fix the implant 300 in the patient's mouth. In this respect, implantation and use of implant 300 is similar to that of implant 100, but includes the additional step of fastening means 501 in a defect area, such as defect area 500 shown in Figure 5, and coupling the fastening means 501 to implant 300, for example by threading fastening means 501 into fastening openings 351, 352. In all other respects, implantation and use of implant 300 may be similar to that of implant 100 described above.

[0031] While the present invention has been described with respect to at least one embodiment, the present invention may be further modified within the spirit and scope of the disclosure. This application is thus intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains and fall within the scope of the appended claims.

Claims

1. 1. A dental implant comprising: a foundation having a plurality of exterior and interior plug openings; a plug assembly inserted into the plug opening; at least one region of porous ingrowth material associated with at least one of said exterior surfaces of said foundation; a perforated sleeve disposed between a periphery of the foundation and an area of ​​the porous ingrowth material corresponding to the periphery; A dental implant comprising:

2. The dental implant of claim 1 , wherein the plug assembly is configured to have a replacement tooth attached thereto.

3. 3. The dental implant according to claim 1 or 2, wherein the drilling sleeve is press-fitted onto the base.

4. The dental implant of claim 1 , wherein the base has a reservoir formed therein, the reservoir being configured to hold a fluid therein.

5. The dental implant of claim 4 , wherein the base has at least one fluid feed channel formed therein, the fluid feed channel being in fluid communication with the reservoir.

6. 5. The dental implant of claim 4, wherein at least one of the exterior surfaces associated with at least one region of the implant material has a through hole formed therein extending into the reservoir.

7. The dental implant of claim 1 , wherein the base comprises a non-porous material.

8. 10. The dental implant of claim 1, wherein at least one region of said implant comprises an implant having a porosity of between 50% and 70%.

9. The dental implant of claim 8 , wherein the implant material comprises titanium or polyetheretherketone.

10. The dental implant of claim 1, wherein the first region of implant material and the second region of implant material are associated with the same outer surface, the first region of implant material having a first implant material, and the second region of implant material having a second implant material different from the first implant material.

11. The dental implant of claim 10, wherein the first implant material has a first porosity and the second implant material has a second porosity different from the first porosity.

12. The dental implant of claim 11 , wherein the first region of implant material is sandwiched between the base and the second region of implant material, and the first porosity is less than the second porosity.

13. The dental implant of claim 1 , wherein the base has a circular cross-section.

14. The dental implant of claim 1 , wherein the base has an elliptical cross-section.

15. 2. The dental implant of claim 1, wherein the base has at least one anchoring opening configured to receive an anchoring means for anchoring the dental implant in gingival tissue.

16. The dental implant of claim 15, wherein the at least one anchoring aperture is uncovered.

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