The present disclosure relates to dental implants, specifically to a dental implant for inserting into the lower mandible.
A dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
Dental implants rely on osseointegration, a biological process in which the material of the implant, such as titanium, forms an intimate bond to bone. The implant fixture is first placed so that it is likely to osseointegrate, and then a dental prosthesis is added. A variable amount of healing time is required for osseointegration before either the dental prosthesis is attached to the implant or an abutment for holding a dental prosthesis is connected to the implant.
There are numerous risks and complications relating to current procedure, relating to pre-surgery, during surgery and post-surgery. For example, pre-surgery conditions affecting the success or failure of implants include the health of the person receiving the treatment, medication which affects the chances of osseointegration, and the health of the bone and tissues in the mouth. The prerequisites for long-term success of osseointegrated dental implants are healthy bone and gingiva. Since either bone or gingiva can atrophy or degenerate after tooth extraction, pre-prosthetic procedures such as bone grafts, sinus lifts or gingival grafts are sometimes required to recreate ideal bone and gingiva.
Where there is significant bone loss, it is very difficult to place a conventional implant as a tooth replacement method. To replace the bone alternative methods are available such as autogenous bone graft from the ramous of the mandible or chin. These procedures have only a 60% success rate and in addition can be uncomfortable for the patient. Factors such as increased risk of post-operative infection and the difficulty of the procedure itself, which is highly demanding for the dentist, mean failure of bone grafting or integration is common.
Placement of dental implants is a surgical procedure and carries the risks of surgery including infection, excessive bleeding and necrosis of the flap of tissue around the implant. Nearby anatomic structures, such as the inferior alveolar nerve, the maxillary sinus and blood vessels can also be injured when the osteotomy is created or the implant placed. An inability to place the implant in bone to provide stability of the implant (referred to as primary stability of the implant) increases the risk of failure to osseointegrate and further damage to the surrounding tissue.
Current procedures also carry risks related to biomechanical factors, where the geometry of the implant does not support the teeth in the same way the natural teeth did such as when there are cantilevered extensions (fewer implants than roots or teeth that are longer than the implants that support them or a poor crown-to-root ratio). Similarly, grinding teeth alongside a lack of bone or low diameter implants increase the biomechanical risk. Finally, there are technological issues, where the implants themselves can fail due to fracture or a loss of retention to the teeth they are intended to support.
An aspect of the present disclosure relates to a dental implant, comprising an implant platform and a strap, wherein the strap is suitable for encircling the lower mandible so as to affix the implant to the lower mandible.
The term “dental implant” is intended to mean an assembly, for example an implant platform, strap and abutment. The implant platform may be capable of receiving an abutment. The abutment may be suitable for securing a dental prosthesis e.g. a crown, bridge or denture, or any other suitable means for securing a crown, bridge or denture, or other prosthesis. In one embodiment, the implant also includes the dental prosthesis.
The strap may be a flexible sheet. The strap may have a plurality of apertures forming a mesh. The apertures may be circular or hexagonal in shape. The apertures may have a diameter of 0.7 mm, or when hexagonal, a widest dimension of 0.7 mm. The apertures provide “breathing space” for the bone of the lower mandible, thereby mitigating the natural tendency of the bone to resorb in response to an implant and also providing apertures to encourage the bone to osseointegrate.
The strap is configured to entirely encircle the lower mandible. The tissue around the lower mandible may be dis-engaged from the mandible (also known as “elevated”) by the dentist so that the strap sits against the bone, the tissue may then be re-fixated. This arrangement works uniquely on the lower mandible because of its shape and because the blood supply and cranial nerve are in a channel (a foramen) which goes through the centre of the lower mandible. Therefore, a dentist can displace the tissue surrounding the lower mandible without damaging the nerve or blood supply. As such, the mechanism of wrapping the strap around the bone is possible for this specific anatomy, without damaging the anatomy. This arrangement avoids the need to drill into the bone.
The strap may comprise a means for engaging the implant platform. The implant platform may comprise a mandible facing surface which may be substantially flat and configured to sits on the mandible surface. In another embodiment the mandible facing surface comprises a projection for insertion into a mandible. In an alternative embodiment, where there is a projection, or where the retention is poor, a pilot hole may optionally be created by the dentist at a position where such a hole would be drilled through the cortical bone but would not pierce the cortical plate of the mandible. The projection may be inserted into the pilot hole. It will be appreciated that, for traditional implants that are implanted into the bone mass of the lower mandible, a minimum volume of bone is required to provide sufficient anchoring for the implant and to prevent the implant from approaching the nerve that runs in the lower mandible. Thus, for patients with weakened or thinned lower mandibles it can be necessary to increase the volume of bone available at the implantation site.
As the dental implant of the embodiments is anchored to the lower mandible by the strap and does not need to penetrate the bone structure of the lower mandible, thus the embodiments described herein avoids the need for bone grafts or distraction of the bone. Where a pilot hole is required, the depth required is significantly less than for conventional implants. The dental implant may be used for replacing any tooth on the lower mandible. Preferably, the dental implant is suitable for replacing teeth at the distal portion of the lower mandible.
The strap is configured to be long enough to completely encircle a portion of the lower mandible. Thus, the strap is substantially rectangular in shape having two ends and two long sides. The strap may be thin so that the surrounding tissue can be returned to its position around the strap, thereby minimising trauma to the area. Preferably, the strap is between 0.05 mm and 0.25 mm in thickness.
The strap ends may meet at the top surface of the lower mandible at the position where the original tooth root was. The strap ends comprise a means of attaching to each other or to the implant platform, or both. The strap may be secured such that it cannot move circumferentially or axially relative to the lower mandible. This ensures that the lateral and occlusal forces acting on the lower mandible and on the surrounding teeth are minimised, for example during chewing etc. The strap may be flexible. The strap may be elastically deformable to fit against the lower mandible.
In an embodiment, in place of apertures the strap may be composed of a plurality of loops or rings, such as metal rings, that are interlinked with other rings that neighbour the ring structure in at least two orthogonal directions so as to form a two dimensional sheet structure, similar to the structure of chainmail. The small metal rings may be machined, produced using additive manufacturing, laser cutting or any other suitable technology. If individual loops are formed these loops may subsequently be interlinked with each other in the above described manner. Alternatively, if the rings are created using additive manufacturing, the rings can be created in a fashion so that they are already interlinked as the rings grow and before they are closed. The holes in the metal loops also provide “breathing space” for the bone of the lower mandible, as discussed in relation to the strap apertures.
Alternatively, the strap may be composed of woven threads or comprise a section that is so composed. The woven structure may be woven so that no apertures are left between adjacent threads or more loosely woven, for example to provide apertures of at least one thread with between adjacent threads. Loosely woven threads provide similar benefits to the apertures of the strap, for example “breathing space”. The woven threads may be metal. Alternatively, the woven threads may be a polymer material such as, for example, polypropylene or PTFE. The woven threads may be thin enough to allow flexibility. The structure may resemble a rectangular shaped woven sheet.
Where the strap structure is made from metal threads or chainmail it may comprise laser welded intersection points at the peripheral edges, at the ends and/or the long side edges, to secure the threads in position and increase stability of the strap. Alternatively, some or all of the ends and long side edges of the woven material may be bonded by chemical, mechanical, heat or solvent treatment. The strap may alternatively be composed of a combination of chainmail and woven threads and the peripheral edges may be bonded by any of the methods discussed above.
The strap may comprise a metal material capable of integrating with bone. The metal material may be titanium. Alternatively, the material may be medical grade steel, cobalt chromium, Zirconium, a titanium alloy or a medical grade polymer. Additionally or alternatively, any material comprising mechanical properties suitable for use as a dental implant, i.e. appropriate wear properties, tensile and compressive strength, fracture toughness, could be used.
In one embodiment, the strap is treatable to introduce shape memory properties to a portion of the strap. This could be useful for patients with unusual anatomies, for example while the typical lower mandible cross section is substantially ellipsoidal, a lower mandible could conceivable be fabiform or “bean shaped”. Where a patient has such an anatomy, there would be a gap between the encircling strap and the concave portion of the lower mandible. Therefore in one embodiment, a strap comprising NiTi alloy may be heat treated to form a stiffer and curved portion which may fit such bone shapes. A dentist could use X-rays or CT scans to establish the anatomy of the patient and establish whether this property is necessary.
The strap is configured to completely encircle the lower mandible. This makes the implantation procedure safer; since depending on the mandible, in certain circumstances, no drilling may be required, thus risk of fracture of the bone or drilling into the cranial nerve or the blood supply at the centre of the bone is significantly reduced or at least mitigated.
The strap is configured such that it is flexible and may fit closely against lower mandibles of varied geometries and thus be suitable for various patients. The strap may be sized such that it is the width of a single tooth. Alternatively, the strap may be adjustable in size depending on the patient's anatomy. The dentist may have the option to use X-rays or CT scans to establish the anatomy of the patient and the strap may be machined to fit or simply cut to size by the dentist before implantation in response to the patient's anatomy, thereby providing versatility and patient-customisability.
Preferably, the strap is not tight enough to exert pressure on the lower mandible but sits intimately enough to allow the bone to osseointegrate. This provides a way of implanting a tooth implant without drilling into the bone. However, in practice and at the dentist's option, a shallow pilot hole could be created to take a cylindrical mandible project which would be advantageous.
The strap may comprise a means for engaging the implant platform. The means for engaging the implant platform may comprise cantilever arms, or receiving apertures, which engage with complementary features on the implant platform. The strap is configured to attach to the implant platform, holding it in position against the lower mandible. The strap may instead be attached to any type of implant which has suitable fasteners.
The strap may, for example be permanently attached to a first side of implant platform and either or both of the implant platform and the strap may comprise attachment means such that the strap may attach to the implant platform on an opposite side of the implant platform to the first side. For example, the strap may be already affixed to the platform and in use the free end of the strap is wound around the lower mandible and the free end is then connected to the opposite end of the strap or directly to the platform.
Alternatively, the strap comprises cords which may be tied to an eyelet or other hoop structure on the implant platform. The attachment means on the strap may comprise at least one loose end or cord at one of the ends of the strap. Alternatively, the strap may comprise two or four cords at two or four of the corners of the strap. Where the strap comprises one or two cords on just one end, the strap may also comprise an alternative means for attaching to the implant platform at the other end.
The attachment means may be configured to not only attach the strap to the implant platform but to also allow in use tightening, preferably a gradual tightening, of the strap around the lower mandible whilst maintaining or increasing a connection between the strap and the implant platform. In another embodiment, the strap is not permanently attached to the implant platform on one side. Instead, the above described gradually tightenable attachment means may be provided on both sides of the implant platform.
Alternatively, the strap and implant platform may be configured so that the strap can be securely anchored to one side of the implant platform and a gradually tightenable attachment means is provided upon a side opposite to the side to which the strap is anchored. In yet another embodiment a gradual tightening means may be provided that allows relative gradually tightening movement of the two strap ends relative to each other whereby such tightening movement increases tightening engagement with the tightening means. The implant platform may be connected to the tightening means, for example so that it rides on top of the tightening means opposite to the side of the tightening means that is closest to the lower mandible. It is not essential for the strap to be tightened to a degree that friction anchors the implant platform to the lower mandible. Anchoring is preferably instead provided by osseointegration with the strap or with apertures therein.
The implant platform may be generally cuboid in shape. The implant platform may have one surface which, in use, touches the bone surface. The bone touching surface may be the “bottom” face of the implant platform. The implant platform may have a second surface, situated opposite the bone touching surface. The second surface may comprise an area configured to hold an abutment and a dental prosthesis. A dental prosthesis may sit in the centre of the platform, thus the tooth implant holding area may be at the centre of the platform. The platform may provide a securement area for the tooth implant in cases of recessed bone tissue without the need for grafts or distraction of the bone.
The tooth implant holding surface may be the “top” surface of the implant platform. The top surface of the implant platform may additionally have an attachment means for attaching the strap to the implant platform. The strap attachment means may be a protrusion, or a fastener, series of protrusions/fasteners suitable for engaging cantilever arms or receiving openings on the strap. The strap attachment means may be provided at one or both sides of the tooth implant holding area. The strap attachment means may comprise a protrusion/fastener capable of interfacing with an engagement feature on the strap. The terms “engagement means” and “attachment means” are used interchangeably herein. The protrusion/fastener may be integrally formed with the implant platform. The protrusion/fastener may be machined into the implant platform. Alternatively, the protrusion/fastener may be a separate component which has been affixed to the implant platform.
The fastener may be a wire lock pin type fastener, cable clamp with push mount, nail cable clip, a buckle type clip or any other fastening means suitable for attaching a loose end to a surface. Alternatively or in addition, the dentist could tie the fastening means on the strap in a surgeon's knot or constrictor knot around a loop fixture. There may be a plurality of fasteners.
The implant platform may comprise a metal material capable of integrating with bone. The metal material may be titanium. Alternatively, the material may be medical grade steel, cobalt chromium, Zirconium, a titanium alloy or a medical grade polymer. Additionally or alternatively, any material comprising mechanical properties suitable for use as a dental implant, i.e. appropriate wear properties, tensile and compressive strength, fracture toughness, could be used.
The bone touching surface may be curved to fit the contours of the top surface of the lower mandible. The bone touching surface may be coated. The coating may be hydroxyapatite, fluoride or calcium-based material. The coating may be any other material for increasing surface area or promoting bone attachment or ingrowth. The bone touching surface may also or instead be roughened, for example using a sand blasting technique, to increase surface area for attachment to the bone or ingrowth.
In an embodiment, the mandible facing surface may comprise a means for stabilising the platform relative to the mandible. The means for stabilising the implant platform may comprise spikes for engaging the mandible and preventing rotation. The spikes may be provided in a circular array, positioned concentrically about a mandible facing projection. However, it will be understood that the spikes may be in other configurations. The spikes may be pyramidical, terahedrical, conical protrusions. Other suitable geometries for engaging the bone surface are envisaged.
The centre of the platform may have a recess which is suitable for an abutment. Alternatively, the implant platform comprises a projection for receiving an abutment. The projection or recess geometry may be complimentary to the abutment so that the two components may fit together. The abutment receiving projection may comprise a means of anchoring the abutment to the projection once connected. This anchoring means may be mechanical, a coating or any other suitable means. The means of anchoring the abutment may be a threading on the engaging surfaces of the abutment and the projection. In one embodiment the threading on the outer surface of the projection may be complimentary to a thread on an inner surface of an abutment. The abutment receiving projection may comprise a guide for positioning a dental prosthesis.
A benefit of the described arrangement is that the abutment and dental prosthesis may be replaceable. During the current procedures, when an implant is inserted directly into the bone it fuses with the surrounding bone, therefore, where replacement of the implant is necessary, there is a high risk of fracture of the bone during the removal procedure. In the arrangement of the present invention, the implant platform can stay in position and an abutment and crown can be replaced as many times as necessary. For example, younger generations with implants are more likely to need a replacement implant in their lifetime, because bone naturally resorbs over time and with age. The resorbed bone provides less material to attach to and thus, where further drilling is required for the replacement implant, the implant gradually gets closer to the cranial nerve and blood supply.
In an embodiment, in place of a mandible facing projection the implant platform may comprise a small hole in the bottom, or bone surface facing side. A pilot screw may be inserted through the hole and screwed into the bone underneath. The head of the screw will be bigger than the hole, so that only the threaded part of the screw may fit through the hole. Thus, when the pilot screw has been screwed into the bone beneath the implant platform the implant platform is pinched between the bone and the head of the screw.
Alternatively, there is an additional anchoring means on the pilot screw or mandible facing projection to increase the surface area of the contact between it and the surrounding bone. These configurations provide further stability to the implant and prevent any unnecessary and potentially harmful movement of the implant platform. This is particularly important soon after implantation, before the bone has had time to osseointegrate with the implant and or strap.
In embodiments where a pilot screw is required, the pilot screw may be small relative to the lower mandible. The pilot screw may be 1-4 mm in length. Therefore, it does not pose any risk of damaging the centrally positioned cranial nerve or blood supply.
According to an embodiment there is a method of training comprising the following steps; instructing a dentist to: (i) make a crestal incision on the top side of the mandible; (ii) reflect a flap of the gum/gingiva circumferentially around the mandible to create some space between gum and bone; (iii) fit the implant platform on the top surface of the mandible so as to be in contact with the upper surface of the lower mandible; (iv) wrapping the strap around the lower mandible; and (v) securing strap ends to the implant platform thereby securing the implant platform to the mandible.
In
As shown in
Depicted in
As
As will be shown in subsequent figures, an abutment 30 is affixed to the implant platform 14 and/or threaded ferule 78. Subsequently, a crown or replacement tooth is fitted on the abutment 30 such that the tooth sits above the implant and at the same level as the surrounding teeth.
Specific features of the implant are discussed below.
In the embodiment shown in
The implant platform 14 comprises a mandible facing surface 16 at the underside of the implant platform 14. The mandible facing surface 16 is also referred to herein as the base surface 16. The implant platform 14 has a projection 18, or spigot, on the mandible facing surface 16. Protrusion 18 is for insertion into a hole, usually drilled, in the mandible 10. Projection 18 is cylindrical with a frusto-conical termination. In use, the projection 18 extends into the mandible restricting lateral movement of the implant platform 14 relative to the mandible 10.
In an embodiment, the mandible facing surface 16 of the implant platform 14 comprises a plurality of spikes 22 for engaging the bone of the mandible at the site 12. The spikes 22 further stabilise the implant platform 14, preventing lateral movement and rotation of the implant platform 14 relative to the mandible 10. The increased surface area provided by the spikes 22, as well as the close contact with the bone, encourage osseointegration between mandible facing surface 16 and the bone at the site 12. As shown, in an embodiment the spikes 22 are in a circular array, and are positioned concentrically about the base projection 18. However it will be understood that the spikes may be in other configurations. The spikes 22 are pyramidical, tetrahedrical, conical protrusions. Other suitable geometries for engaging the bone surface are envisaged.
The implant shown in
The straps 40 shown comprise a plurality of apertures 42. The apertures 42 are machined into the strap 40 forming a mesh-like geometry. In an embodiment, the apertures are etched into the strap 40. This can, for example, be done using a laser texturing or ablation process or chemical etching process. In an embodiment in place of apertures the strap is formed form a three-dimensional chain mail structure. Minimising the thickness of the strap and adding the apertures make the strap 40 flexible and able to conform to the contours of the mandible 10. The strap 40 is elongate comprising two end portions, the section having apertures extends therebetween.
As depicted in
The strap 40 comprises scalloped edges 56, as shown in for example
Particular embodiments of the strap 40 will now be discussed. The strap 401, 402 and 403 comprises an opening 48 through which the projection 20 of the implant platform 14 protrudes when in situ. In this way, the strap 401, 402 or 403 can engage the implant platform 14 and affix it to the lower mandible 12. As shown in
The strap 40 comprises an engaging and receiving mechanism. As shown in
In the embodiment shown in
In some embodiments, as shown in
In
Therefore, the strap 404, 405 and 406 firmly engages the buckle 54 at a plurality of points, thereby increasing stability and spreading the loading over a plurality of points. The buckle 54 is particularly useful for mandibles of smaller geometries where the cantilever locking arms 80 could distend and slip through an aperture 50.
A strap 407 according to another embodiment is shown in
In an alternative embodiment, shown in
As illustrated in
In embodiments, the assembly further comprises a retaining washer 70. The retaining washer 70 provides a further securing means. In an embodiment, the retaining washer 70 comprises a flat plate as shown in
The flat plate retaining washer 70 of
Alternatively, as illustrated in
In some embodiments, the thread does not extend to the top of the projection 20 to allow the threaded ferule 78 to cover sharp edges of the threads, protecting surrounding soft tissue. As shown in
In the embodiments described, hole 48 is placed over the implant projection 20, the strap 40 is then wrapped around the mandible 12 and the elongated hole 62 slipped over the projection 20. In some embodiments, the ends of the strap 40 are rounded, for example strap 401, 402 and 403 as shown in
Alternative embodiments of the implant platform 14 are shown in
In a further embodiment shown in
In any of the embodiments described the surface of the implant platform 14 and or strap 40 is a smooth and/or polished surface to allow the soft tissue to smooth over. In an embodiment the surface is coated with Titanium Nitride which provides a low friction surface. Alternatively, the surface of the implant platform 14 or strap 40 in any of the embodiments is roughened. A roughened surface enhances osseointegration. In any of the embodiments described the some or all surfaces are coated in Hydroxyapatite, which provides a surface structure which is known to enhance osseointegration.
Whilst certain embodiments have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of the inventions. Indeed, the novel devices, and methods described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions and changes in the form of the devices, methods and products described herein may be made without departing from the spirit of the inventions. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the inventions.
Filing Document | Filing Date | Country | Kind |
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PCT/GB2021/053124 | 11/30/2021 | WO |