Patent Application
20160331489
The present invention relates generally to dental implants and more particularly to an improved means and method for the preparation and insertion of dental implants.
A dental implant is an artificial prosthesis normally comprised of a single cylindrical component to replace the missing root structure of a natural tooth that has been lost. This standard implant is typically inserted into the jawbone by threading or screwing it into a prepared hollowed out bony site in the jawbone called in the field an osteotomy. The prepared osteotomy typically has a diameter that corresponds to the body dimensions of the implant without its threads and the threads of the implant engage (self-tap) the vertical inner walls of the osteotomy as it is screwed into place. The implant typically remains buried in the bone (endosseous) for a period of time to allow for “osseo-integration” or the growth and adhesion of natural bone around all the external surfaces of the implant, securing and stabilizing it in place so that it can withstand load forces. This cylindrical implant typically contains down its internal center a machined threaded internal hollow sleeve or bore that allows the dental practitioner upon later surgical exposure of the head or top (coronal) section of the cylindrical implant to screw into place a machined screw-in abutment (either with an integral screw on its inferior aspect or a separate connector screw which threads through a center hollow sleeve or bore of the abutment). The abutment, which extends into the oral cavity, is then utilized by the dentist to fabricate a single fixed prosthesis (crown), a multiple fixed prosthesis (dental bridges-multiple crowns connected to each other) in the case of adjacent multiple implants, or can take the form of a fixed prosthesis (over-denture bar prosthesis) to anchor a removable prosthesis such as a permanent denture, using techniques that are widely known in the dental field.
The upper and lower jaws are made up of a narrow strip of softer, spongy, alveolar bone sandwiched between two thin outer hard cortical plates of bone. In the posterior regions the entire width (cheek to tongue or buccal-lingual) of the jawbones is typically only 5 to 7 millimeters thick. The average interdental (anterior-posterior length between the teeth) space remaining when a molar tooth is lost (missing tooth space) is typically 10 to 12 millimeters long. The vertical depth of alveolar bone present where the tooth was lost can be as little as 5 to 10 millimeters before one encounters either the maxillary sinus space (in the upper jaw) and the inferior alveolar nerve (in the lower jaw).
To allow for a proper volume or thickness of jaw bone between the implant and the adjacent teeth so as to allow for a proper blood supply and health of the bone between the implant and the adjacent teeth, it has been accepted in the dental field to maintain a minimum distance of 1.5 to 2 millimeters between the implant and the adjacent teeth on either side of the implant and 1.5 to 3 millimeters between adjacent multiple implants.
This means that the target bone site for the proper placement of a dental implant is very limited and requires the practitioner who wishes to place dental implants safely to exercise considerable care performing the implant procedure after first having acquired a high degree of skill level and clinical experience. This becomes even more difficult for the practitioner when attempting to place multiple dental implants in the same jawbone.
Dental implants are typically placed using the following two surgical techniques: 1. Delayed technique: the unsalvageable tooth is extracted and the entire root socket(s) are allowed to heal with bone filling the void(s) over several months. Once this healing process has been completed, the practitioner opens the gum and drills into the bone to create the osteotomy (bone preparation) to allow for the insertion of the dental implant. 2. Immediate Extraction-Immediate Implant technique: At the same visit, the practitioner extracts the unsalvageable tooth and immediately inserts the dental implant into the fresh root socket voids or using a drill modifies this root socket or drills a new hole and places the implant into it. In the case of a molar tooth extraction the practitioner is left with multiple proximal root socket voids in the jawbone (where the multiple natural roots used to be) and an oval or rhomboid distal void (where the root trunk used to be).
Both surgical techniques require the sequential use of a series of increasing diameter and or length bone drills to properly prepare the osteotomy and so allow for the insertion of the dental implant. This is required in order to safely remove bone tissue in a gradient manner so as not to overheat the surrounding bone as would invariably occur if the largest diameter and length bone drill was used initially instead of the above described drilling protocol.
It is well established medical fact that overheating bone tissue is highly destructive to surrounding bone tissue and leads invariably to necrosis of bone tissue, a highly undesirable outcome.
The vast majority of dental implants are surgically inserted by the dental practitioner into the jawbones of the patient using the above two described surgical techniques in a free-hand manner (i.e. without the aid of any guidance system). As described above, this means that the dental practitioner in order to safely place dental implants relies solely on his/her skill level acquired through his experience, his latent natural talent, and his diligent exercise of care throughout the procedure. This required exercise of care and surgical skill level defined above applies both to both phases of the implantation procedure; namely: the bone preparation (osteotomy) and the subsequent insertion (implantation) of the dental implant into said bone preparation.
It will be appreciated that if the practitioner errs to even a relatively slight degree of 1-2 mm in any straight or angled direction (depth or position) while preparing the osteotomy and while inserting the implant into said bone preparation, s/he risks damaging sensitive anatomical structures as well as ending up with an implant placed in a non-optimal position in relation to the adjacent and opposing teeth and the final dental prosthesis placed onto the implant which will be used for functional biting and chewing and which relies on the implant for structural load support. The dental prosthesis will be secured to the implant once the implant has osseo-integrated (bone having grown in intimate contact around the exterior surface of the implant so that it is now stable). As mentioned above, it will be further appreciated that the required accuracy and precision described above is compounded when multiple implants are placed in the same patient.
In order to reduce the above skill requirements of the dental practitioner, surgical guided stents have in recent years begun to be used in the field in a limited fashion. Such stents are custom-made for each patient (discarded after a single use) and are fabricated using elaborate imaging equipment that has been wedded to sophisticated three dimensional software computer programs and which requires additional specialized dental laboratory fabrication to produce said stent.
This process is both time-consuming and expensive for the dental practitioner in terms of delay of delivery of treatment to the patient, fees to the laboratory, and the costs of the imaging and software licenses. As the stent is custom made for each patient these costs must be repeated for each patient.
The stent is usually made of acrylic materials and is custom shaped to closely conform to the alveolar ridges of the particular patient for whom they are to be placed in, in order to assure an intimate and accurate fit of the stent to the patient's mouth. Single or multiple hollow metal drill guide tubes are incorporated into the body of the stent at the location(s) of the intended implant target bone site(s).
It will be appreciated that these drill guide tubes only provide a location and angle for the practitioner. In order to limit or control the vertical drilling depth, they must be used in conjunction with multiple hand-held instruments that have hollow rings of varying diameters at their working ends and whose rings have circumferential limiting flanges that act as a stop limit in regards to the vertical depth of the bone drill when said bone drill is inserted into it.
The varying diameters of the hollow rings of the hand-held instruments, described above, correspond to varying diameters (of the previously described) sequentially used bone drills that are used to prepare the osteotomy at the target bone site.
In order to secure a surgical stent to the patient's jawbone, multiple pre-drilled holes are incorporated into the stent on the buccal (cheek-side) side wall of the alveolar ridge in a plane that is perpendicular to the crest of the alveolar ridge. Multiple holes are then drilled into the side wall of the buccal surfaces of the jawbone of the patient by the practitioner through said pre-drilled stent holes and metal securing pins are screwed or tapped into these holes to secure the stent to the jawbone. It can be appreciated that this required method for surgically securing the stent is quite invasive to the patient and results in significant post-operative pain and healing.
The above stents are normally placed onto the jawbone after surgical incisions are made to the gum tissue and reflection of the gum tissue has been performed, though some now advocate their use without prior reflecting of the gum tissue.
There is varying thickness of the gum tissue overlying the alveolar ridges in different patients so that reflecting the gum tissue prior to placing the stent onto the alveolar ridge is desirable as this allows for more accurate positioning of the stent directly onto the coronal bone surface of the alveolar ridge.
The circumferential outer lip of the embedded ring tubes of the stents can also be used as a limiting flange to control the vertical depth to which the implant is screwed/threaded into the osteotomy.
It will be obvious that a guidance system that does not require a custom-made surgical stent for each patient yet allows for similar or improved guided drilling and insertion of dental implants would be most advantageous.
In accordance with some embodiments, a one time or reusable universal implanting apparatus is provided which comprises a compact surgical clamp apparatus that contains an outer frame, inner frame, swivel platform and guide ring, with individually adjustable positioning elements to clamp and secure itself directly onto the bone or onto the gums and bone of a unilateral section of the jawbone, at an optimal position and angle. According to some embodiments, an apparatus is provided that comprises: a platform suitable for being positioned over a bone and maintained in position for a procedure including preparing a bone for an implant and/or implanting an implant into a bone, said platform having a guide bore therethrough; one or more frames connected to the platform, wherein the one or more frames includes clamp arms that extend to opposing sides of the bone; one or more fixation cleats on each arm, wherein each fixation cleat has a tip suitable for penetrating into a bone and/or gum tissue on the opposing sides of the bone so that the frame is secured to the bone during the procedure; one or more means for adjusting the relative position of the each fixation cleats in relation to the clamp arm retaining it for securing the clamp arms to the bone prior to and during the procedure and for removing the clamp arms from the bone after the procedure; wherein the apparatus includes one or more features for positioning the platform, for changing a position of the platform, for changing an angle of a component attached to the platform or any combination thereof and locking this position of the platform, following the securing of the clamp arms to the bone and prior to the procedure.
According to some embodiments of the present invention, an apparatus is provided, that includes:
In some embodiments, the apparatus further comprising a plurality of individually engageable fixation cleats connectable to each arm, wherein at least one of the fixation cleats has a swivel tip suitable for self-aligning and penetrating into a bone and/or gum tissue on the opposing sides of the bone so that the outer frame is secured to the bone during the procedure.
In some embodiments, the inner frame has at least two articulating arms being connectable to the platform.
In some embodiments, the two or more clamp arms are connected by one or more guide pins and a right or left threaded bolt to enable the two clamp arms to be adjusted simultaneously.
In some embodiments, the platform comprises a single platform connectable to the inner frame at opposing end walls of the platform, said opposing end walls of the platform being curved to allow swiveling of the platform within the inner frame thereby enabling changing of the direction of an angle of the platform relative to the bone, so that the apparatus can be used for preparing dental osteotomies having bores with different angles and different directions of the respective angles.
In some embodiments, the guide bore is provided through a top surface of the platform and receives a guide member for receiving a surgical component, the position of the guide member within the guide bore of the platform being adjustable to change the effective height of the guide member relative to the bone.
In some embodiments, the platform guide bore is adapted to receive an orientation member to aid in the orientation of the platform.
In some embodiments, the platform further includes a locking mechanism for locking the guide member at a selected position relative to the platform.
In some embodiments, the guide member is in the form of a hollow cylinder, the outer wall of the cylinder having a series of fixed projections or teeth for mating with a corresponding projection or tooth that is moveable into and out of the bore thereby enabling engagement with and disengagement from a projection or tooth of the guide member with respect to the platform.
In some embodiments, the clamp arms of the outer frame have an upper region that extend above the crestal height and the occlusal plane of the teeth, wherein the upper region of the clamp arms have a plurality of bore holes and are connected by one or more clamp arm connection screws extending through a bore hole of each clamp arm and by one or more clamp arm guide pins extending through a bore hole of each arm, wherein the bore holes are aligned so that the clamp arms are maintained in a generally parallel relationship.
In some embodiments, each clamp arm of the outer frame has internally threaded bore holes for each of the cleats so that the each of the cleats can be screwed individually against the gum, and the clamp arm connection screw has a knob for screwing the arms together so that the cleats can evenly penetrate the gum tissue and/or the bone independent of the curvature of the gum tissue and/or bone.
In some embodiments, one or more of the cleat tips is a self-adjusting rotatable tip with a separate self-adjusting rotatable limiting face.
In some embodiments, the inner frame includes a guide assembly main frame attachment section inner surface for engaging over the guide pins and the right or left threaded bolt of the outer frame, and an element bore for insertion of a guide assembly attachment screw to secure the inner frame to the clamped outer frame.
In some embodiments, the inner frame slideably engages the guide pins and the right or left threaded bolt of the outer frame.
In some embodiments, each of the articulating arms has a curved inner surface for receiving the platform with a curved inner surface, thereby enabling the connected platform to swivel in all directions.
In some embodiments, the apparatus includes one or more features for positioning the platform, swiveling the platform, changing a position of the platform, changing an angle component of the platform relative to the bone, locking the platform at a selected position relative to the support arms or any combination thereof, following the securement of the clamp arms of the outer frame to the bone and prior to the procedure.
In some embodiments, the apparatus may be used for preparing a dental osteotomy and/or implanting a dental implant into a jaw bone.
According to further embodiments of the present invention, a kit is provided that includes any combination of a clamping apparatus and at least one of, an implant driver tool, a drill guide gauge, an extraction socket gauge, an orientation member or a calibration device.
According to further embodiments of the present invention, a process is provided that may include one or more steps, including:
In some embodiments, the step of adjusting the platform may include a step of adjusting one or any combinations of the following:
In still further embodiments, the implanting apparatus may include at least one of the following:
In further embodiments, the bone is a jaw bone, and the procedure includes preparing a dental osteotomy and/or implanting a dental implant into a jaw bone.
In further embodiments, at least a portion of the platform includes one or more features for changing an angle of the platform relative to the bone, so that the apparatus can be used for preparing one or more dental osteotomies optionally having bores with different angles.
In further embodiments, at least a portion of the platform includes one or more features for changing the direction of an angle of the platform relative to the bone, so that the apparatus can be used for preparing one or more dental osteotomies having bores with different angles and different directions of each of these angles.
In further embodiments, the apparatus comprises an outer frame having at least two clamp arms and an inner frame connectable to the outer frame, the inner frame preferably having at least two support arms being connectable to the platform.
Preferably, the platform comprises a single platform connectable to the inner frame and wherein the opposing ends of the platform that connect to the inner frame are curved to allow swiveling of the platform within the frame. More preferably, the ends of the platform are curved in a convex form to match a concave form provided by the support arms of the inner frame.
In further embodiments, at least a portion of the platform includes one or more features for changing the effective drilling height of the platform relative to the bone, so that the apparatus can be used for preparing two osteotomies having bores of different depths. Preferably this is achieved by the position of a guide member for receiving a drill head, gauge or other tool for preparing an osteotomy and/or for implanting a dental implant in a jawbone, the guide member being adjustable within the bore of the platform. More preferably, the guide member is in the form of a hollow cylinder, the outer wall of which is provided with a series of fixed projections or teeth that can mate with a corresponding projection or tooth that is moveable into and out of the bore. The projection or tooth is moveable into and out of the bore to allow engagement with and disengagement from a projection or tooth of the guide member, respectively enabling locking and unlocking of the guide member with respect to the platform. Movement of the tooth or projection into the bore is preferably by means of a slide mechanism.
In further embodiments, the guide bore may receive an orientation member in place of the guide member for assisting in the positioning of the platform with respect to the frame Preferably, the orientation member comprises a cylindrical head with a cut-out for receipt within the bore, the head having a shaft extending therefrom comprising a handle for orientating the platform with respect to the frame and also providing a visual marker to evaluate the angle and direction (guide path) of proposed drilling, or respectively, the orientation member incorporates a center bore so that a drill bit may be inserted therein and the drill bit's shank utilized as a handle in a similar fashion as the shaft extending from the head of the member as described above.
In further embodiments, the clamp arms of the outer frame have an upper region that extend above the crestal height of the jawbone and the occlusal plane of the teeth, wherein the upper region of the arms have a plurality of bore holes and are connected by one or more arm connection screws extending through a bore hole of each arm and by one or more arm guide pins extending through a bore hole of each arm, wherein the bore holes are aligned so that the arms are maintained in a generally parallel relationship.
In further embodiments, the platform is connected to a detachable inner frame, the inner frame has an upper portion, wherein the upper portion of the inner frame has a connecting arm having a cut out on its undersurface for receiving the clamp arm guide pins and the clamp arm connection screw, wherein the connecting arm of the upper portion of the inner frame has one or more features for securing and detaching the inner frame in a fixed position relative to the clamp arm connection screw and the clamp arm guide pins.
In further embodiments, the inner frame has a lower portion comprising parallel support arms that are connectable to opposing ends of the platform, each support arm being articulated with respect to the platform. Preferably, a locking screw and, optionally, a locking spring, may attach the articulated arm to the platform.
In further embodiments, the clamp arm connection screw is a right/left threaded screw so that both of the clamp arms of the outer frame can be simultaneously and/or equally moved towards or away from the inner frame and platform in a linear manner.
In further embodiments, the apparatus includes one or more screws for positioning and locking the platform in the anterior to posterior axis relative to the inner frame, relative to the outer frame, or both. The platform may be sprung-mounted with respect to the inner frame.
In further embodiments, the apparatus is sufficiently adjustable so that it can be used for implanting implants in a plurality of patients.
In further embodiments, the apparatus is formed of materials capable of being sterilized after use in preparing an osteotomy so that the apparatus can be employed in an osteotomy for a different patient.
In further embodiments, each clamp arm of the outer frame has internally threaded bore holes located at different heights and positions of each of the clamp arms for the insertion of each of the cleats so that the each of the cleats can be screwed individually into its clamp arm threaded bore position such that each of the cleat tips further variably penetrate into the gum depending upon the depth they are screwed in, and the arm connection screw has a knob for screwing the arms together so that the cleats can evenly penetrate the gum tissue and/or the bone independent of the curvature of the gum tissue and/or bone and the location of each cleat in its clamp arm bore. Each cleat may have a cleat tip that is moveable with respect to the main body of the cleat, preferably having a cleat tip that swivels freely in all directions so that when the cleats are individually engaged the coupled limiting face element of each cleat swivels as well so as to align itself parallel to the gum tissue overlying the jawbone plate that it is penetrating at its position in the clamp arms.
In further embodiments, the apparatus is capable of preparing a vertical osteotomy and is also capable of preparing an osteotomy at an angle of about 1° or more from the vertical axis.
In further embodiments, the apparatus is capable of preparing an osteotomy at an angle of about 1° or more from the vertical axis and in a full 360° directional arc of the horizontal axis.
According to some embodiments, a process is provided that comprises the steps of: clamping a dental implantation apparatus to a jawbone, preferably being a dental implantation apparatus as hereinbefore described, wherein the dental implantation apparatus includes an outer frame having two clamp arms each having a lower portion that extends along opposing sides of a jawbone, and the apparatus includes a plurality of cleats protruding from each clamp arm of the frame, and the step of clamping the apparatus includes inserting and engaging the each one of the cleats individually into gum tissue and/or into the bone; after clamping, attaching to the frame a platform for guiding one or more tools for preparing an osteotomy and/or for implanting a dental implant into a jawbone; adjusting the position of the platform relative to the jawbone after the apparatus has been attached to the jawbone; and maintaining the position of the platform while performing one or more steps of preparing an osteotomy and/or implanting a dental implant.
More preferably, after clamping, an inner frame is attached to the outer frame and the inner frame is secured to the platform.
According to some embodiments, the step of adjusting includes a step of adjusting one or any combinations of the following: a) adjusting the buccal to lingual position of the platform; b) adjusting the tilt angle of at least a portion of the platform relative to the vertical axis; c) adjusting the anterior to posterior position of the platform; or d) adjusting the direction of the projection of the tilt angle of the at least a portion of the platform onto the plane perpendicular to the vertical axis in a full 360° range of motion of the horizontal axis.
According to some embodiments, the process includes a step of measuring a distance between a portion of the platform and the crestal region of the jawbone for calibrating the depth for a step of preparing an osteotomy, wherein the step of measuring occurs after a step of adjusting the position of the platform.
According to some embodiments, the process includes a step of measuring the depth of an osteotomy (e.g., relative to a portion of the platform) for calibrating an insertion depth for inserting an implant, wherein the step of measuring a depth occurs after a step of adjusting the position of the platform.
According to some embodiments, the process comprises implanting an implant immediately following the extraction of a tooth, wherein the process includes one or any combination of the following steps: a) inserting an adjustable extraction socket gauge into a fresh extraction socket and measuring the depth of the socket; b) calibrating a calibration device utilizing a drill bit whose depth has been chosen based on a measured depth of the extraction socket; c) calibrating an implant driver and an adjustable drill guide gauge by inserting them into their appropriate slots in in the calibration device; d) clamping the outer frame over the extraction socket; e) adjusting the position and locking the inner frame and attached platform to the desired anterior/posterior and buccal/lingual position relative to the outer frame and the extraction socket; f) adjusting the platform of the dental implantation apparatus to a desired angular position using an orientation member as hereinbefore described inserted into the bore of the platform to determine a desired angle and/or a desired direction and locking the platform in this position; g) replacing the orientation member with a guide member attached to the calibrated drill guide gauge and pushing these down into the guide bore of the platform to determine a desired depth and locking the guide member at this depth within the bore by engagement of complementary teeth on the bore and guide member; h) removing the drill guide gauge and inserting the previously chosen drill bit length and/or bushing that was used to calibrate the calibration device into the locked guide member to prepare an osteotomy having or including a desired angle, a desired direction, a desired depth or any combination thereof; and/or i) inserting thereafter the calibrated implant driver into the guide member (e.g., a drill guide ring) and installing an implant into the now prepared osteotomy at a desired angle, a desired direction, a desired depth, or any combination thereof.
According to some embodiments, the process may be carried out for delayed placement of an implant and may further include one of the following steps: a) waiting for some or all of the socket to fill with bone following extraction of the tooth; b) calibrating a calibration device utilizing a drill bit whose drilling depth has been chosen based on diagnostic imaging of the target bone site; c) calibrating an implant driver and an adjustable drill guide gauge by inserting them into their appropriate slots in the calibration device; d) clamping the outer frame over the target bone site; e) adjusting the position and locking the inner frame and platform to the desired anterior/posterior and buccal/lingual position relative to the outer frame and the target bone site; f) adjusting the platform of the dental implantation apparatus to a desired angular position using an orientation member as hereinbefore described that has been inserted into the guide bore of the platform to determine a desired angle and/or a desired direction and locking the platform in this position; g) replacing the orientation member with a guide member attached to the calibrated drill guide gauge and pushing these down into the guide bore of the platform to determine a desired depth and locking the guide member at this depth within the bore by engagement of complementary teeth of the guide bore and member; h) inserting the calibrated drill guide gauge into the guide member, pushing down the drill guide gauge until its tip penetrates the gum and rests on the bone of the target implant site and locking the position of the guide member so that the guide member is locked and calibrated to drill to a desired depth, and removing the drill guide gauge from the guide member, so that the guide member is calibrated to drill to a desired drill depth independent of the thickness of the gum tissue overlying the bone of the target bone site; i) inserting one or more drill bits and/or bushings with a desired drill depth into the guide member for completing an osteotomy, wherein each provides a limiting flange when inserted into the guide member; and/or j) inserting a calibrated implant driver connected to an implant into the guide member, and screwing down the implant with an implant driver into the osteotomy, wherein the implant driver has a limiting flange for lying flush with a top surface of the guide member.
According to some embodiments, the process includes unclamping or otherwise removing the apparatus from the jawbone.
According to some embodiments, the process includes a step of sterilizing some or all of the apparatus and a step of using the sterilized components for implanting an implant in a different patient.
According to some embodiments, the process includes a step of preparing a second osteotomy at a different angle, a different direction, a different depth or any combination thereof from the first osteotomy in either the same patient or in a different patient, using the same apparatus (e.g., using the same platform).
According to some embodiments, a calibration device is provided that be used both for drilling an osteotomy having a predetermined depth, and or for inserting an implant into an osteotomy to a predetermined depth, the device comprising: an upper portion having at least one cut out extending from a top surface to a bottom surface of the upper portion for receiving one or more gauges or drill bits; a lower portion that is separate and spaced apart from the upper portion; each of the upper and lower portions having a bore, the bores being aligned between the upper and lower portions to receive a threaded shaft therethrough wherein the spacing between the top and bottom portion is adjustable by rotation of the shaft. Preferably, the threaded shaft is attached to a knob to impart rotation thereto. More preferably, at least one second bore is provided in each of the upper and lower portions spaced apart from the first for receiving a second non-threaded shaft that is freely slideable within this bore. The cutout of the upper portion may have a limiting step that acts as a limiting flange on either side of the cut out for inserting an adjustable drill guide gauge through the cut out and resting a limiting flange of the gauge on the limiting flange on either side of the cut out, wherein the spacing between the upper and lower portions is capable of being set by adjusting the spacing so that the adjustable lower tip of the gauge when inserted into the inner segment of the cut-out (for delayed implanting techniques) just touches the top surface of the lower portion and may be locked in this position. Alternatively, a drill bit of desired length is inserted into the front outer segment of the limiting flanges on either side of the cut out of the upper portion the calibration device, upper portion's position may be adjusted relative to the lower portion so that when the terminal cutting tip of the drill bit aligns with the calibration markings on the face of the lower portion the (pre-) calibration device is now calibrated to the desired drill depth. An adjustable drilling guide gauge or an adjustable and lockable implant driver may then be inserted into the front outer segment of the limiting flanges on either side of the cut out of the upper portion so as to align the gauge lower tip or drill bit lower tip against the face of the lower portion wherein the lower portion has calibration markings for calibrating the adjustable and lockable tip of the gauge or the adjustable and lockable implant driver; thereby enabling the calibration apparatus to be used for drilling an osteotomy (for the immediate implant technique) having a predetermined depth, and/or for inserting an implant into an osteotomy to a predetermined depth.
According to some embodiments, the device includes a cut out segment for receiving an adjustable inner element from a drill guide gauge, a cut out segment for receiving a series of drill bits with or without an attached bushing or an adjustable drill guide an adjustable shaft element of an implant driver.
According to some embodiments, a kit is provided that includes any combination of two or more of a clamping apparatus as hereinbefore described, an implant driver tool, a drill guide gauge, an extraction socket gauge, an orientation member or a calibration device as hereinbefore described.
The principles and operation of the system, apparatus, and method according to the present invention may be better understood with reference to the drawings, and the following description, it being understood that these drawings are given for illustrative purposes only and are not meant to be limiting, wherein:
It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements throughout the serial views.
The following description is presented to enable one of ordinary skill in the art to make and use the invention as provided in the context of a particular application and its requirements. Various modifications to the described embodiments will be apparent to those with skill in the art, and the general principles defined herein may be applied to other embodiments. Therefore, the present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
Embodiments of the present invention enable dental implant treatments using one time or reusable compact surgical clamp apparatus and guidance system. In accordance with a preferred embodiment of the present invention, the implanting apparatus is designed to be compact enough to be placed on one side of the patient's jaw, and can guide the bone preparation and implanting of a single implant into the missing space of a single tooth, even where there are adjacent teeth both anterior and posterior to the missing tooth space.
Means and methods are herein provided for the preparation and insertion into bony tissue of standard implants, and for positioning the apparatus, for changing a position of the apparatus, for changing an angle of a component of the apparatus or any combination thereof, following the securing of the clamp apparatus to the bone and prior to the procedure, such that the bone/gum preparation and implant insertion may be conducted by a practitioner with precise guidance tools to enable enhanced accuracy and safety. According to some embodiments, the adjusting of the apparatus to a patient's jawbone may include adjusting the buccal to lingual position of a portion of the apparatus, adjusting the tilt angle of at least a portion of the apparatus relative to the vertical axis, adjusting the anterior to posterior position of a portion of the apparatus; and/or adjusting the direction of the projection of the tilt angle and the degree of tilt angle from the vertical axis of the at least a portion of the platform onto the plane perpendicular to the vertical axis. In such dental implant treatments, whether for immediate or delayed surgical implantation treatments, the precision positioned and secured guidance system is able to provide the practitioner with the necessary depth, angle and direction of angle measurement to enable optimized and safe preparation and insertion of implants. Additional advantages provided by embodiments of the invention include easier installation and handling of the apparatus.
The clamp apparatus may come in several standard sizes so as to allow for matching a particular size clamp apparatus to better fit inside a particular patient's mouth and clamp properly to different sized jawbones.
The surgical clamp apparatus described herein includes a number of improvements and/or modifications to the apparatus described in the Applicant's co-pending unpublished Application No. GB 1304950.7.
As can be seen in
As can be further seen in the figures, Right/Left threaded bolt 6 includes Right section of Right/Left bolt 6a, Left section of Right/Left bolt 6b, Right/Left unthreaded bolt center section 6c, and Right/Left threaded bolt oval terminal end 6d. Guide pins 7 include guide pin head 7a, and guide pin notch 7b, to allow for linear smooth opening and closing movement of the two clamp arms and simultaneous clamping and de-clamping of both the buccal and lingual bony jaw plates. The Right/Left bolt 6, as can be seen in
Such an assembly of the above parts allows for the two clamp arms 2 to be linearly closed and opened simultaneously (brought closer to or further from each other) in a substantially symmetrically even manner when the knurled knob 8 (with its two locking nuts 8a) is turned either clockwise or counter-clockwise. To further enhance this symmetrically even opening/closing mechanism the two outer guide pins 7 have limiting heads 7a which face and engage a circumferential groove 8d on the knurled knob 8 attached to the center right/left threaded bolt 6.
The relatively vertical segment of each clamp arm 2 may contain an internally threaded bore hole 2f for the insertion of a set screw with a knob (not illustrated) that allows for the fine adjustment along the buccal to lingual axis (cheek to tongue) of the inner frame 12 when the inner frame 12 is attached to the outer frame 1a. The lower horizontal segment 2e of each clamp arm 2 may contain multiple internally threaded bore holes 2c which may be positioned in various positions relative to each other in this clamp arm segment.
Each clamp arm 2 may include one or more fixation swivel cleats 11 with tips and coupled limiting faces that self-adjust to align to and penetrate into a bone and/or gum tissue on the opposing sides of the extraction socket or target bone site, so that the frame is firmly secured to the varying gum/bone morphology of different patients during each individual patient's procedure (see
In some embodiments, guide assembly main frame 12 may have a horizontal and vertical segment in the shape of a “t” bar emerging from its upper horizontal segment which extends to the inner borders of both the right and left clamp arms 2. In some embodiments, the guide assembly main frame 12 when coupled with the two adjustable guide assembly articulating arms 13 serve as an outer frame for the insertion and securing of the swivel guide platform 3 and guidance position locking mechanisms so as to comprise the inner frame guide assembly 5. In some embodiments, the center right/left threaded bolt 6 may contain two spring coils (not shown) around its respective right and left threaded segments 6a and 6b (between either side of the inner frame 5 and the right or left clamp arms 2) to create a spring-loaded action to the movement of the inner frame 5 along the guide pins 7 and threaded bolt 6.
As can further be seen, a pre-calibrating device adjustable threaded guide bolt 29 may be provided, which may include pre-calibrating device adjustable threaded guide bolt threaded shaft 29a and a pre-calibrating device adjustable threaded guide bolt spring 29b, where the spring acts to hold the adjusted position of the upper element 33 in respect to the lower element 34 of the pre-calibrating device 30.
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In accordance with some embodiments, an apparatus and methods are herein provided to enable calibration of implant instruments outside the mouth of a patient, prior to the invasive treatment. For example, if a practitioner determines to use a drill bit set to 10 mm implant, calibration apparatus knob 31 may be turned to set the upper and lower apparatus elements to be set at the appropriate distance in accordance with the desired drill bit length when the drill bit with attached bushing is inserted into the pre-calibration device 30 and the tip of the drill bit aligns with the desired calibration marking (see
In turn, other necessary tools, such as the adjustable implant driver 19 and adjustable drilling guide gauge 25 may be calibrated in accordance with the drill bit settings of the now calibrated pre-calibration device as described above. All such tools may be set at a desired length and locked by rotation of a locking nut, locking collet and shaft. For example in the delayed implantation surgical technique, the unlocked drilling guide gauge inner shaft 26 of the adjustable drilling guide gauge 25 may be inserted into the inner segment of the cut out slot 33a of the upper element 33 so that the drilling guide gauge's limiting flange 28e rests on the limiting shelf 33b and is oriented so that its right and left flat side walls 28f are positioned to be aligned with the side walls of the limiting shelf 33b. The unlocked drilling guide gauge inner shaft is then pushed down so that its tip rests in the shallow limiting bore 34c of the lower element 34 and the locking knob 27 is turned clockwise to engage the collet 28 of the drilling guide gauge 25 and so lock this position of the inner shaft 26 within the drill guide gauge 25 that rests within the calibrating device 30 based on the drill bit length that was previously used to set or calibrate the pre-calibration device for the preparation of the osteotomy to said desired drilling depth. The configured drilling guide gauge 25 may then be removed from the calibration tool, and the appropriate sized drilling guide ring 15 may be snapped onto it. The practitioner inserts the above configuration into the center bore 3e of the swivel guide platform 3 of the clamped surgical guide apparatus 1 which previously had been positioned over the target bone site using the orientation element 37. The practitioner then generally needs to push the locked center shaft probe 26 of the calibrated drilling guide gauge 25 down until s/he feels the point at which the shaft probe end penetrates through the gum and engages the bone so as to set the correct vertical position of the drill guide ring in relation to the alveolar crest of the target bone site while compensating for the varying thickness of the gum tissue in different patients and in different locations in the jaws of the same patient that overlies said alveolar crest. This new vertical position of the drilling guide ring 15 within the center bore 3e of the platform 3 can now be locked by the practitioner when s/he then inserts the hand tool locking cylinder handle end 36c of the double ended hand tool 36 into the upper slot 10c of the locking cylinder handle 10 and slides the guide ring locking cylinder 4 through the locking cylinder bore 3h of the swivel guide platform 3 until the vertical engagement tooth 4d of the locking cylinder 4 has fully engaged the corresponding notch 15f of the drill guide ring 15. The drill guide ring 15 is now locked and set to the depth for bone drilling to the predetermined depth desired (based on the previously chosen drill bit length) exclusive of the gum thickness depth overlying the bone. This method of calibrating the drill guide ring 15 allows for the practitioner to compensate for the variable gum thickness in each patient and to enable the drilling to a depth of 10 mm in jaw bone regardless of the thickness of the gum tissue overlying the bone at the specific chosen target implant site.
Alternatively, in the immediate implantation surgical technique, where the depth of the fresh extraction socket which has previously been measured utilizing the extraction socket gauge 35 and its attached holder 44, the drilling guide gauge 25 can be calibrated on the pre-calibration device 30 to a desired clinical implant depth value determined by the practitioner based on the previously measured depth of the fresh extraction socket with a chosen drill bit of a desired drilling length used in the same manner as described above for the delayed technique in order to calibrate the pre-calibration device 30; and then by placing the unlocked drilling guide gauge 25 into the outer segment of the upper element cut out 33a of the pre-calibration device 30 and orienting the drilling guide gauge 25 in the limiting shelf 33b as described above and then pushing the unlocked inner shaft element 26 down until its tip aligns with the previously determined marking length 34c and then locking this position of the inner shaft 26 of the drilling guide gauge 25 by tightening the knob 27. The drilling guide ring 15 is then snapped securely onto the now calibrated and locked drilling guide gauge 25 and the two assembled components are then inserted into the pre-positioned swivel guide platform center bore 3e (as described above) and pushed down to this pre-determined depth. The locking cylinder 4 is then engaged by the practitioner to the drill guide ring as previously described above and the drill guide ring 15 is now locked to the desired drilling depth.
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According to some embodiments, a kit is provided that includes any combination of two or more of an implant driver tool, a drill guide gauge, an extraction socket gauge, an orientation element or a calibration device.
The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be appreciated by persons skilled in the art that many modifications, variations, substitutions, changes, and equivalents are possible in light of the above teaching. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1322962.0 | Dec 2013 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2014/067281 | 12/23/2014 | WO | 00 |
