WO2015029023A1

WO2015029023A1 - Lockable device, system and method for in-situ drill guide sleeve orientation

Info

Publication number: WO2015029023A1
Application number: PCT/IL2014/050761
Authority: WO
Inventors: Roni Shabat
Original assignee: Navident Medical Device Ltd
Priority date: 2013-08-26
Filing date: 2014-08-25
Publication date: 2015-03-05

Abstract

The present invention relates to a device, system and method for producing a dental implant drill guide and in particular to such a device system and method for a drill guide sleeve within a drill guide configured to determine the drill path for positioning a dental implant at an implantation site over an edentulous site.

Description

LOCKABLE DEVICE, SYSTEM AND METHOD FOR IN-SITU DRILL GUIDE SLEEVE ORIENTATION

FIELD OF THE INVENTION

The present invention relates to a device, system and method for producing a dental implant drill guide and in particular to such a device system and method for positioning a drill guide sleeve within a drill guide to determine the drill path for positioning a dental implant at an implantation site over an edentulous site. BACKGROUND OF THE INVENTION

Dental implants are well known in the art and typically include a dental anchor securely inserted into the patient's jawbone, and an abutment member mountable to the dental anchor, the abutment utilized for coupling a restoration .

One of the initial steps in the implantation process and perhaps the most crucial step is determining where to place the implant anchor within the jawbone over the edentulous area. This first initial step is crucial in that it determines the quality of the implantation process and the likelihood of its success. Therefore the initial determination of where to drill, at what angle, depth and size, greatly impacts the success of the implantation process. It is extremely important that the hole drilled in the bone tissue has a correct location and inclination with respect to the thickness and morphology of the bone. Care is to be taken to avoid any imperfect fit of the implant, and, most critically, to avoid any perforation or damage to nearby anatomical structures .

In order to facilitate the proper placement, direction, and depth of the drilling process practitioners plan the procedure. In so doing practitioners rely on medical imagery such as X-rays, and computer tomography scans (CT scans) to carefully planned the procedure. The planned procedure generally includes determining the drill sequence, drill location, size and depth. In order to facilitate this process and in order to ensure that the procedure is carried out according to plan, a drill guide has been developed that provides a practitioner with the tool to minimize errors .

A dental drill guide is an acrylic resin mask obtained from a model of the patient's dental arch, adapted to exactly fit over the patient's teeth and/or edentulous areas of the jaw (or just "over the patient's jaw"). The guide mask is provided with one or more guiding holes that are placed in the exact position of the holes to be made or, more preferably, it is provided with one or more metallic hollow cylinders plunged in the resin in the desired locations .

Determining the position of the metallic hollow cylinder, also referred to as a stent or a tubular sleeve, is a central and key factor in determining the quality of the drill guide. In planning the implantation procedure, particularly with the aid of modern medical imagery prior to the CAD/CAM production of the drill guide, a clinician can plan the best suited position of the sleeve relative to the medical imagery available .

While this determination is done on the basis of the clinician's knowledge and practice and aided with medical imagery, however, the drill guide itself is generally prepared by a technician and not by the implanting practitioner, therefore lending itself to human error.

More over inherent errors in the medical imagery devices, giving an error of about 10%, leads to further error in determining the location of the sleeve within the drill guide. However such errors are usually not identified until the onset of the implant procedure itself, where a mismatch between the drill guide and the clinical situation before an implanting practitioner is realized .

Most drill guides are limited in that once the template is made its configuration cannot be further adjusted .

Some drill guides provide the option of correcting the sleeve location within the drill guide, as for example the drill guides taught by US Patent No. 7,905,726 to Stumpel, and Canadian Patent Publication No. 2,484,475 to Csillag. However both Stumpel and Csillag are limited in the range of motion they offer over the edentulous area, specifically they do not provide a full range of motion over the edentulous area. Stumpel and Csillag only provide the opportunity to make incremental changes to the drill guide sleeve rather than allowing a full range and changes to be made to the guide.

SUMMARY OF THE INVENTION

The present invention overcomes the deficiencies of the background by providing a device, system and method for facilitating the determination of a drill path over the entire edentulous area where an implant procedure is to take place. Embodiments of the present invention overcome the deficiencies of the prior art by allowing a practitioner to controllably determine the orientation and position of a drill guide sleeve over the entire edentulous area with a device that provides full range and continuous motion in both the Buccal-Lingual axis, the Mesio-Distal axis, so as to allow the practitioner to identify the optimal location and/or orientation for the drill path according to the clinical situation at hand.

Embodiments of the present invention provide for controllably locking and unlocking the drill guide sleeve as necessary until the optimal sleeve orientation is identified.

Embodiments of the present invention further provide for determining the optimal orientation in- situ in a chair side manner.

Embodiments of the present invention further provide for determining the optimal orientation in- situ in a chair side manner with the option of utilizing medical imagery.

Embodiment of the present invention further allow for corrective measures to be applied, by providing a replaceable orientation device that may be associated and/or disassociated with a guide mold.

Preferably the drill guide sleeve orientation device of the present invention provides a practitioner with at least five (5) degrees of freedom in orienting and/or maneuvering a sleeve within the device's housing and over the edentulous area.

Embodiments of the present invention provide a drill guide sleeve orientation device for setting the drill path over an edentulous area, the device including:

a housing configured to fit over the entire edentulous area, the housing having a substantially cylindrical body, having an upper surface, lower surface and a perimeter external surface, the housing provided for housing a drill guide sleeve and a sleeve locking assembly; wherein the drill guide sleeve may be maneuvered substantially freely within the housing and locked and unlocked into position within the housing with the locking assembly; the drill guide sleeve having a substantially tubular body including a distal end, a proximal end, and a medial portion, wherein the medial portion may be disposed within the housing; the sleeve locking assembly disposed internally within the housing along the inner perimeter, the locking assembly configured to associate with the drill guide sleeve along the sleeve medial portion. Optionally the locking assembly may comprise: at least two guiding members associated along the sleeve medial portion, including a proximal guiding member and a distal guiding member, provided for facilitating maneuvering the sleeve within the housing; wherein the proximal guiding members may be disposed between the housing upper surface and a proximal surface of a bobbin guiding member, the distal guiding members may be disposed between a locking ring and a distal surface of the bobbin guiding member; wherein a central opening about the bobbin guiding member houses at least a portion of the sleeve medial portion; the locking ring associated with a press switch along its upper surface and with wave spring along its lower surface, the wave spring having two states, a first locked state, wherein the spring may be decompressed and a second released state wherein the spring may be compressed; wherein switching between the two states may be facilitated with the press switch; and wherein the press switch provided to control the wave spring via the locking ring member associated over the wave spring; wherein the locking ring may be configured to compressed the wave spring against the lower surface of the housing.

Preferably embodiments of the present invention may be performed in- situ in a chair-side manner to provide for setting a drill path over an edentulous area where the drill path is configured by determining the orientation of a drill guide sleeve.

Optionally the maneuverable guiding members may be provided in a ring shaped form.

Optionally the maneuverable guiding members may be associated with inner surface of the perimeter surface of the housing.

Optionally the guiding member may be provided from flexible material having a high coefficient of friction.

Optionally the shape of the guiding member may be configured relative to their coefficient of friction. Optionally the locking assembly members may be configured relative to the coefficient of friction of the guiding members.

Optionally the sleeve orientation device about its housing may be configured to securely fit within a guide mold along its outer perimeter surface. Optionally sleeve orientation device about its housing may be removed from a guide mold.

Optionally the dimensions of the sleeve orientation device about its housing may be configured to fit over an edentulous area, according to the size of the edentulous area. Optionally the locking assembly members may be ring shaped having a central opening characterized in that the size and shape of the central opening may be configured to fit over the edentulous area.

Optionally the dimensions of the housing may be configured to fit over an edentulous area corresponding to one or more teeth.

Optionally the device housing may be customized to fit over any portions of an edentulous area of a jaw.

Optionally the drill guide sleeve may be associated with a dedicated sleeve manipulating tool provided for manipulating the sleeve within the device housing. Optionally the manipulating tool may be linked and/or associated with a computational module. Optionally the sleeve manipulating tool further provides for introducing an inner tube member within the lumen of the sleeve.

Optionally the sleeve manipulating tool further facilitates associating or disassociating the device with the guide mold.

Optionally the outer surface of drill guide device may be configured to facilitate coupling with at least one more drill guide orientation device, to form an arrangement of at least two or more adjacent drill guide devices.

Embodiments of the present invention provides a system for orientating a drill guide sleeve within a drill guide mold, the system comprising: the drill guide sleeve orientation device, as previously described, that may be associated with a computational module provided for facilitating orienting the drill guide sleeve within the housing while utilizing medical imagery displayed by the computational module.

Optionally the system may further comprise a dedicated sleeve manipulating tool provided to interface between the computational module and the drill guide sleeve orientation device and wherein the dedicated tool provides for manipulating the sleeve within the device housing.

Optionally the dedicated tool may be adapted to provide for manually orienting the sleeve within the housing. Optionally the dedicated tool may be an automated robotic device adapted to provide for automated orientation of the sleeve. Optionally the automated orientation of the sleeve may be provided relative to reference points disposed about the guide mold.

Optionally the system may further comprise a computation module stage for associating the guide mold with the computational module. Optionally the computation module stage comprises a plurality of reference point connectors for coupling with corresponding reference point recess disposed about the guide mold.

Embodiment of the present invention provides a method for orienting a drill guide sleeve within a guide mold, in situ, the method comprising: coupling a drill guide sleeve orientation device, as previously described, with a guide mold over the edentulous area; placing the guide mold over the dental arch of a patient; associating an orientation tool within the lumen of the sleeve, the orientation tool associated with a computational module comprising a display, displaying a stored medical image of the patient's dental arch and edentulous area; wherein the orientation tool provides a projection of the sleeve on the stored medical image; while viewing the medical image and the projection of the sleeve, manually maneuvering the sleeve within the housing with the orientation tool over the edentulous area until an optimal orientation of the sleeve may be determined; and locking the position and orientation of the sleeve within the housing with the locking apparatus.

Optionally the method may further comprise the stage of associating an inner tube within the drill guide sleeve's lumen. Unless otherwise defined the various embodiment of the present invention may be provided to an end user in a plurality of formats/platforms, and may be outputted to at least one of a computer readable memory, computer readable media, a computer display device, a printout, a computer on a network or a user.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

The materials, methods, and examples provided herein are illustrative only and not intended to be limiting.

Implementation of the method and system of the present invention involves performing or completing certain selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.

Within the context of this application the term "in-situ" and "chair side" interchangeably refers to performing a dental procedure substantially in real time where a practitioner performs a procedure while the patient is in the chair.

Within the context of this application the term processor, processing module, microprocessor or the like may be used to refer to any device featuring a data processor and/or the like computational properties and/or the ability to execute one or more instructions for example including but not limited to a computer, computer network, PC (personal computer), a server, a minicomputer, a cellular telephone, a smart phone, a PDA (personal data assistant), mobile communication device, mobile processing device, any two or more of such devices in

communication with each other, and/or any computer in communication with any other computer, may optionally comprise a "computer network".

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

FIG. 1 is a schematic block diagram of an exemplary drill guide assembly according to optional embodiments of the present invention; FIG. 2 is a schematic block diagram of an exemplary system according to optional embodiments of the present invention;

FIG. 3A-C are schematic illustrations of an exemplary drill guide assembly according to optional embodiments of the present invention;

FIG. 4 is a schematic illustration of an exemplary drill guide sleeve according to optional embodiments of the present invention;

FIG. 5A-C are schematic illustrations of an exemplary drill guide sleeve locator assembly according to optional embodiments of the present invention;

FIG. 6A-B are cross sectional views of a schematic illustration of an exemplary sleeve locator assembly according to optional embodiments of the present invention;

FIG. 7 is a partial exploded view of an exemplary sleeve locator assembly according to optional embodiments of the present invention;

FIG. 8A-C are schematic illustrations of exemplary drill guide assembly systems according to optional embodiments of the present invention; and

FIG. 9 is a flowchart of an exemplary method according to optional embodiments of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description. The following figure reference labels are used throughout the description to refer to similarly functioning components throughout the specification herein below.

5 edentulous area;

10 computational module;

12 processor ;

14 display;

20 drill guide coupling stage;

24 reference point connectors;

40 dedicated orientation tool ;

42 manual orientation tool;

45 automated orientation tool/robotic arm;

50 drill guide system;

200 drill guide; 102 impression mold guide;

104 reference point connectors;

210 sleeve orientation device;

212 housing ;

212a housing upper surface;

212b housing lower surface;

212r central recess;

212L housing lumen;

212p outer perimeter surface;

216 sleeve;

216d sleeve distal end;

216p sleeve proximal end;

216m sleeve medial portion ;

216L sleeve lumen;

220 sleeve locking apparatus

222 wave spring;

224 press switch member;

225 locking ring member;

226 bobbin guiding member;

226a upper and/or proximal surface;

226b distal surface;

228 guiding member;

228a proximal guiding member;

228b distal guiding member;

FIG. 1 shows a schematic block diagram of drill guide 200 including an impression guide mold 102 and a sleeve orientation device 210 utilized for orienting sleeve 216 within guide mold 102.

Preferably impression guide mold 102 includes at a plurality of reference point connectors 104. Optionally and preferably reference point connectors 104 may be utilized as markers which provide for defining a reference coordinate system. Optionally reference point connectors may facilitate the orientation of sleeve 216 with orientation device 210, for example by triangulation of sleeve 216 relative to connectors 104. Optionally guide mold 102 comprises at least two connectors 104 and more preferably at least three connectors 104.

Optionally connectors 104 may be coupled with or otherwise associated with a proximity location based sensor, for example a RFID tag, optical sensor or the like.

Most preferably drill guide sleeve orientation device 210 provides for setting the drill path over the entire edentulous area where an implantation is to be performed.

Drill guide 210 comprises housing 212, sleeve 216 and a locking assembly 220 for locking sleeve 216 in position. Preferably, housing 212 configured to fit over the entire edentulous area, allowing sleeve 216 to be oriented and placed anywhere over the entire edentulous area.

Optionally housing 212 may be reversibly associated with guide mold 102, for example associated and/or disassociated with guide mold 102.

Optionally housing 212 may be integrated and/or fixed and/or irreversibly fixed with guide mold 102 over the edentulous area.

Most preferably housing 212 is configured to allow maximal movement and orientation of sleeve 216 over the entire edentulous area 5. Most preferably the orientation of sleeve 216 and may be controlled in a fluid and continuous manner in all directions and axes about the edentulous area, including the Buccal-Lingual axis and the Mesio-Distal axis. Optionally and preferably sleeve 216 may also provide for determining the depth of the drill path .

Preferably sleeve 216 is provided substantially in the form of an open ended tube having a proximal end 216p, a distal end 216d and a medial portion 216m spanning therebetween. Preferably sleeve 216 comprises an open lumen 216L along its length.

Optionally lumen 216L provides for receiving and associating with at least one or more inner tubes. Optionally an inner tube member may be provided in a tubular structure, similar to that of sleeve 216 having an open lumen provided for receiving a drill bit. .

Optionally sleeve 216 may be maneuvered and/or manipulated within housing 212 manually by a practitioner or with the aid of an optional dedicated tool 40. Optionally dedicated tool 40 may be utilized to introduce an inner tube into sleeve lumen 216L.

Optionally the dimensions of housing 212 may configured to fit over an edentulous area corresponding to at least one or more teeth. Optionally housing 212 may be provided from malleable materials and may optionally be customized in its shape and geometry in order to fit over any portions of an edentulous area of a jaw.

Housing 212 includes a locking apparatus 220 provided for controllably locking sleeve 216 into position within housing 212 and over an edentulous area 5. Optionally locking apparatus 220 provides for locking and unlocking sleeve 216 to provide for adjusting the orientation of sleeve 216, as is needed depending on a clinical situation. Preferably locking and/or unlocking apparatus 220 may be provided with a controllable switch that may be controlled manually by a clinician or optionally with an optional dedicated tool 40.

Optionally locking apparatus 220 provides for securely holding the position and orientation of sleeve 216 sufficient to overcome forces produced during drilling procedures such that sleeve 216 remains in the locked position during drilling.

FIG. 2 shows a block diagram of a drill guide system 50 that provides for chair-side, in situ determination of a drill path orientation within an edentulous area with the drill guide 200. System 50 includes drill guide 200 having a sleeve orientation device 210 that is associated with a computational module 10.

Computation module 10 is preferably provided in the form of a computer or the like device having processing, displaying, memory and communication capabilities. Optionally computation module 10 may be realized as a mobile processing device, dedicated device, server, smart phone, PDA or the like.

Preferably computational module 10 comprises processing module 12 and display module 14.

Preferably, computation module 10 provides for displaying medical imagery, for example in the form of a CT scan, utilizing display module 14.

Optionally processing module 12 may provide for actively processing and updating the displayed medical imagery, relative to changes made to the orientation of sleeve 216. For example, module 10 enables visualization of a projection of sleeve 216 onto medical imagery, while sleeve 216 is maneuvered within housing 212 over the edentulous area 5.

Optionally computational module 10 may be linked or associated with optional devices for example including a drill guide stage 20, a dedicate orientation tool 40. Dedicated orientation tool 40 may for example be provided in the form of a manual orientation tool 42 or automated orientation tool 45, a semi-automated orientation tool, or the like, for example as shown in FIG. 8A-C.

Optionally computational module 10 may be linked or associated with additional computers and/or servers, as is known in the art. Optionally remote linkage of computation module 10 may optionally allow a practitioner to seek the advice and/or input for field experts located remotely, based on the clinical situation being faced .

A drill guide stage 20 preferably provides for associating drill guide 200 with computation module 10, allowing a practitioner to amend and/or correct sleeve 216 within drill guide 200 while directly linked to computation module 10, allowing the practitioner to visualize a projection of sleeve 216 onto medical image displayed via display module 14.

Drill guide stage 20 provides for chair- side orientation of sleeve 216 when the drill guide is not associated with the patient, however, enabling a visualization of the patient's oral anatomical structures in relation to sleeve 216, by providing a projection of sleeve 216 onto the given medical image .

Drill guide stage 20 includes reference point connectors 24 that align and couple with reference point connectors 104 provided on drill guide 200. Preferably the association of reference point connectors 104 and 24 allows computation module 10 to project the orientation of sleeve 216 associated with guide 200 onto medical imagery displayed on display module 14.

Optionally drill guide stage 20 may be coupled and/or associated with computation module 10 by wired and/or wireless communication protocols as is known in the art .

Optionally and exemplary orientation tool 40 may be coupled and/or associated with computation module 10 by wired and/or wireless communication protocols as is known in the art. Optionally an orientation tool 40 may be provided in optional forms including a manual orientation tool 42 or an automated orientation tool 45. Most preferably orientation tool 40 facilitates maneuvering sleeve 216 within housing 212 about the edentulous space. Optionally tools 40 may also provide for locking and/or unlocking locking apparatus 220.

Most preferably orientation tools 40 may be associated with computation module 10 to enable visualization of the orientation of sleeve 216 relative to medical imagery while sleeve 216 is maneuvered. Therein allowing a practitioner to amend and/or correct drill guide 200 while directly linked to computation module 10 allowing the practitioner to visualize a projection of sleeve 216 onto a medical imagery displayed via display module 14.

Optionally an automated orientation tool 45, for example provided in the form of a robotic arm, for example as shown in FIG. 8A, may be associated with stage 20. Optionally automated orientation tool 45 may be directly linked to computation module 10 without stage 20 allowing a practitioner to control the orientation of sleeve 216, in a clinical setting .

Optionally the movements of sleeve 216 by orientation tool 45 may be automated or linked to a man machine interface, for example a joystick, via computational module 10. Optionally control of orientation tool 45 may be controlled remotely, for example with a remotely linked computational module 10 for example by a consulting expert .

Optionally a manual orientation tool 42, for example as shown in FIG. 8B, may be associated with guide 200 about sleeve 216 while guide 200 is within the oral cavity of a patient, therein allowing a practitioner to control the drill path by controlling the orientation of sleeve 216, in situ. Optionally manual orientation tool 42 may be associated with computational module 10 in a wired or wireless manner as is known in the art. Preferably orientation tool 42 may be associated with sleeve 216 through its open lumen 216L allowing tool 42 to control the maneuverability of sleeve 216 within device 210.

FIG. 3 A shows a side view of schematic illustrative diagram of drill guide 200 disposed on an impression cast. Drill guide 200 comprises a guide mold 102 and securely fixed with a sleeve orientation device 210 that provides for determining the orientation of sleeve 216 over the edentulous area 5 corresponding to a single tooth.

FIG. 3B shows a perspective view of drill guide 200 showing a plurality of reference point connectors 104. Optionally and preferably reference point connectors 104 may be utilized as markers which provide for defining a reference coordinate system, when coupling drill guide 200 to stage 20. Optionally reference point connectors 104 may facilitate the orientation of sleeve 216 with orientation device 210, with a dedicated tool 40 and/or computational module 10 and/or stage 20. For example reference point connectors 104 may facilitate orientation of sleeve 216 by triangulation.

Optionally connectors 104 may be coupled with or otherwise associated with a proximity location based sensor, for example a RFID tag, optical sensor or the like .

FIG. 3C shows a planar cross sectional view of drill guide 200 having a plurality of connectors 104 and an integrated sleeve orientation device 210.

Optionally and preferably guide 200 comprises at least two or more connectors 104 and more preferably at least three connectors 104.

FIG. 4 shows a perspective view of sleeve 216 shows as a substantially tubular sleeve 216 comprising a proximal end 216p, distal end 216d, and a medial portion 216m provided to associate within housing 212 and locking apparatus 220. Sleeve 216 comprises an open, hollow lumen 216L spanning its length.

FIG. 5A-B show a perspective view of sleeve orientation device 210, FIG. 5A shows device 210 in the closed, locked, configuration while FIG. 5B shows device 210 in the open, unlocked and/or released configuration. FIG. 5C shows a cross sectional view of device 210 revealing locking apparatus 220.

Sleeve orientation device 210 preferably includes a housing 212, sleeve 216. Housing 212 is optionally and preferably provided in a substantially cylindrical body including an outer perimeter surface 212p, an upper surface 212a and a lower surface 212b.

As shown, sleeve 216 extends through housing 212, wherein sleeve medial portion 216m is preferably disposed internally to housing 212 within its inner lumen 212L, sleeve distal end 216d extends below lower surface 212b, and sleeve proximal portion 216p extends above housing upper surface 212a.

Preferably upper housing surface 212a and lower housing surface 212b comprises a central recess 212r within which sleeve 216 may be maneuvered freely. Optionally and preferably the size of central recess 212r is configured according to the edentulous area 5, preferably central recess 212r is configured to provide maximal area over the edentulous area 5 so as to allow sleeve guide 216 to assume any position and orientation over the edentulous area 5. Although housing 212 is shown in a substantially cylindrical configuration capable of fitting over an edentulous area corresponding to a single tooth, however, housing 212 may be configured to fit over and correspond with an edentulous area of any size corresponding to one or more teeth or a plurality of teeth.

Housing 212 comprises a sleeve locking assembly 220 within its lumen

212L along the inner side of perimeter surface 212p. Locking assembly 220 is provided for locking and/or unlocking the orientation and position of sleeve 216 within housing 212 relative to the edentulous area 5.

Locking assembly 220 is preferably controlled with a press switch 224 that extends from upper surface 212a. Optionally and preferably switch 224 is pressed against surface 212a when locking assembly 220 is in the unlocked position, as shown in FIG. 5B. Optionally and preferably switch 224 is pressed away from surface 212a when locking assembly 220 is in the locked position, as shown in FIG. 5A.

Most preferably press switch 224 is provided for controlling the position of a wave spring 222, allowing a user to toggle between its compressed state, wherein locking assembly is released FIG. 5B, and decompressed state, wherein locking assembly is in locked formation FIG. 5A.

Locking assembly 220 is disposed within housing 212 about its inner lumen 212L as shown in FIG. 5C. Most preferably locking assembly 220 is configured to associate with drill guide sleeve 216 along said sleeve medial portion 216m. Most preferably sleeve 216 is associated with at least two guiding members 228 associated along medial portion 216m. Most preferably guiding members 228, 228a, 228b are provided for facilitating maneuvering and supporting sleeve 216 within housing 212. Guiding members 228 include a proximal guiding member

228a and a distal guiding member 228b. Most preferably guiding members 228 are supported within housing 212 with a bobbin guiding member 226.

Optionally and preferably bobbin guiding member 226 may be shaped and configured according to the housing 212 in order to fit along the inner portion of its perimeter 212p. Preferably bobbin 226 comprises a central recess that is in line with the central recess 212r, an upper and/or proximal surface 226a, and a lower and/or distal surface 226b.

Most preferably proximal guiding member 228a may be disposed between housing upper surface 212a and bobbin proximal surface 226a. Most preferably, distal guiding member 228b may be disposed between locking ring 225 and bobbin distal surface 226b.

Most preferably when sleeve 216 is in the locked position, upper guiding member 228a is sandwiched between upper surface 212a and bobbin proximal surface 226a, such that guiding member 228a is locked into position and not allowed to move, that in turn provides for locking sleeve 216 in its position.

Similarly, lower guiding member 228b is sandwiched between bobbin distal surface 226b and locking ring 225, such that guiding member 228b is locked into position and not allowed to move, that in turn provides for locking sleeve 216 in its position.

Locking ring 225 is associated with press switch 224 along its upper surface and wave spring 222 along its lower surface, such that switch 224 controls the state of wave spring 222 by applying or relieving pressure with locking ring 225, allowing wave spring 222 to assume a compressed state or a decompressed state. Most preferably the state of wave spring 222 determines the lock state of device 210.

Wave spring 222 has two states, a first locked state, wherein spring 222 is decompressed and a second released state wherein spring 222 is compressed, wherein switching between the two states is dependent on applying a force through ring 225 via switch 224.

Preferably locking ring 225 is configured to compress wave spring 222 against the inner side of housing lower surface 212b, where device 210 is in the unlocked position.

Optionally and preferably maneuverable guiding members 228a,b may be provided in a ring shaped form.

Optionally maneuverable guiding members 228a,b may be associated with inner surface of housing perimeter surface 212p.

Optionally guiding members 228a,b may be provided from flexible material having a high coefficient of friction.

Optionally the shape of guiding members 228a,b may be configured relative to their coefficient of friction.

Optionally locking assembly members, as previously described may be configured relative to the coefficient of friction guiding members 228a,b. Optionally the locking assembly members may be provided in a ring shape, having a central opening characterized in that the size and shape of the central opening may be configured to fit over an edentulous area.

Optionally, the drill guide sleeve 216 may be associated with a dedicated sleeve manipulating tool 40, 42, 45 provided for manipulating sleeve 216 within housing 212.

Optionally the manipulating tool 40, 42, 45 may be linked and/or associated with a computational module 10.

Optionally the manipulating tool 40, 42, 45 may further provide for introducing an inner tube member (not shown) within the sleeve lumen 216L.

Optionally the manipulating tool 40, 42, 45 may further facilitate associating or disassociating device 210 with said guide mold 102.

Most preferably device 210 provides for setting the drill path over an edentulous area 5 that is performed in-situ in a chair-side manner .

FIG.6A shows locking assembly where housing 212 has been partially removed to reveal locking assembly 220, showing the functional parts as previously described. FIG. 6B shows a cross section of FIG 6A again showing member of locking assembly 220, with its constituting parts as previously described.

FIG. 7 shows a partial exploded view of FIG. 6B, with switch 224 and locking ring 225 removed to show wave spring 222, bobbin 226 and guiding members 228a,b.

FIG. 8A-C show optional embodiments of system 50 utilizing an orientation tool 40 for maneuvering sleeve 216 within guide 200 .

FIG. 8A shows utilization of an automated orientation tool 45, in the form of a robotic arm. Optionally and preferably robotic arm 45 may be utilized to manipulate sleeve 216 in order to assume the best suited position relative to the clinical situation at hand. Most preferably robotic arm 45 is associated with computation module 10 (not shown) and drill guide 200 via drill guide stage 20. Preferably drill guide stage 20 is associated with drill guide 200 about at least three reference point connectors 104, 24 disposed thereon.

Optionally drill guide stage 20 may be associated with computational module 10 directly or via robotic arm 45. Optionally robotic arm 45 may be used to maneuver sleeve 216 by a clinician in a clinical setting while visualizing the orientation of sleeve 216 relative to medical imagery, as previously described, while allowing a user and/or tool 45 to lock sleeve 216 into position using locking apparatus 210 and thereafter unlock sleeve 216 as is necessary.

FIG. 8B shows an alternative depiction so system 50 similar to that depicted in FIG. 8A, however utilizing a manual orientation tool 42, with drill guide stage 20.

FIG. 8C shows an alternative depiction so system 50, utilizing a manual orientation tool 42, in-situ, as previously described with respect to FIG. 2.

Optionally manual orientation tool 42, shown in the form of a stylet, may be associated with guide 200, while guide 200 is within the oral cavity of a patient, therein allowing a practitioner to control the drill path by controlling the orientation of sleeve 216, in situ. Optionally and preferably orientation tool 42 may be associated with sleeve 216 through its open lumen 216L allowing tool 42 to control the maneuverability of sleeve 216 within device 210. Optionally manual orientation tool 42 may further associated with computational module 10, in a wired or wireless manner, to allow visualization of sleeve 216 relative to medical imagery, for example in the form of a CT scan, displayed with computational module 10 .

Optionally dedicated sleeve manipulating tool 40, 42, 45 may further provide for introducing an inner tube member concentrically within the sleeve lumen 216L .

Optionally inner tube member may be provided in a tubular structure, similar to that of sleeve 216 having an open lumen provided for receiving a drill bit. Optionally inner tube may be readily associated within sleeve lumen 216L.

Optionally tool 42 may configured to provide for associating and/or introduce device 210 within a guide mold 102. Optionally tool 42 may be configured to provide for removing and/or disassociating and/or releasing device 210 from guide mold 102. For example if a mistake was make in the orientation of sleeve 216 an erroneous sleeve orientation device 210 may be wholly removed from mold 102 and replace with a new one so as to allow for re-determination, correction and re-orientation of a new sleeve member 216 within the oral cavity, optionally such removal and introduction may be facilitated with a dedicated manipulating tool 42 . FIG. 9 shows a flowchart of a method utilizing drill guide 200 having a sleeve orientation device 210, in a chair-side manner in a clinical setting. In stage 900, a prefabricated drill guide 200 comprising orientation device 210 is associated with a patient's dental arch over an edentulous area. Most preferably the orientation and drill path of sleeve 216 has not yet been fixed within housing 212 of device 210. Next in stage 901, both the location and orientation of sleeve 216 is adjusted by a clinician to assume the clinically optimal location and/or orientation over the entire edentulous site 5 so as to ensuring optimal results for the overall implant procedure. Optionally stage 901 may be performed with the assistance of an orientation tool 42 as previously described, with or without medical imagery visualization.

Next in stage 902 a clinician may lock the location and orientation and sleeve 216 over the edentulous area by locking apparatus 220 via switch 224 to compress wave spring 222 within housing 212.

Next in optional stage 903, a clinician may choose to validate the selected locked location and orientation of sleeve 216, defined in stage 902, with reference to available medical imagery. This may optionally be accomplished within the oral cavity with the aid of a manual orientation tool 42, associated with a computational module as previously described, as shown in FIG.8C.

Optionally, in stage 903, the orientation of sleeve 216 may be validated utilizing drill guide stage 20 in conjunction with an automated orienting tool 40,45, as previously described FIG. 8A-B. Optionally, guide 200 is associated with stage 20 and computational module 10 to visualize sleeve 216 relative to the available medical imagery on display 14.

Next, in stage 904 the location and orientation of sleeve 216 is adjusted if and/or as necessary relative to the medical imagery, wherein further fine tuning adjustments may be made by unlocking device 210 with locking apparatus 220 via switch 224 where wave spring 222 assumes the decompressed configuration allowing sleeve 216 to be maneuverable within housing 212.

Next in stage 905 sleeve 216 is locked into position with locking apparatus

220, as previously described.

Optionally, next in stage 906 an inner tube is introduced within sleeve lumen 216L, optionally with the aid of tools 40,42, allowing a clinician to initiate the implantation procedure. While the invention has been described with respect to a limited number of embodiment, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.

Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not described to limit the invention to the exact construction and operation shown and described and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.

Claims

What is claimed is:

1. A drill guide sleeve orientation device (210) for setting the drill path over an edentulous area, the device including:

a. a housing (212) configured to fit over an edentulous area (5), said housing having a substantially cylindrical body, having an upper surface (212a), lower surface (212b) and a perimeter surface (212p), said housing provided for housing a drill guide sleeve (216) and a sleeve locking assembly (220); wherein said drill guide sleeve may be maneuvered substantially freely within said housing and locked and unlocked into position within said housing with said locking assembly; b. said drill guide sleeve(216) having a substantially tubular body

including a distal end (216d), a proximal end (216p), and a medial portion (216m), wherein said medial portion is disposed within said housing (212);

c. said sleeve locking assembly (220) disposed internally within said housing along the inner perimeter, said locking assembly configured to associate with said drill guide sleeve (216) along said sleeve medial portion (216m);

d. said locking assembly comprising :

i. at least two guiding members (228, 228a, 228b) associated along said sleeve medial portion (216m), including a proximal guiding member (228a) and a distal guiding member (228b), provided for facilitating maneuvering said sleeve within said housing;

ii. said proximal guiding members is disposed between said

housing upper surface and a proximal surface (226a) of a bobbin guiding member (226), said distal guiding members (228b) is disposed between a locking ring (225) and a distal surface (226b) of said bobbin guiding member (226); wherein a central opening about said bobbin guiding member houses at least a portion of said sleeve medial portion;

21 iii. said locking ring (225) associated with a press switch (224) along its upper surface and with a wave spring (222) along its lower surface, said wave spring having two states, a first locked state, wherein said spring is decompressed and a second released state wherein said spring is compressed; wherein switching between said two states is facilitated with said press switch;

iv. and wherein said press switch (224) provided to control said wave spring (222) via said locking ring member (225) associated over said wave spring; wherein said locking ring is configured to compressed said wave spring against the lower surface of said housing.

The device of claim 1 wherein said at least two maneuverable guiding members are provided in a ring shaped form.

The device of claim 1 wherein said at least two maneuverable guiding members are associated with inner surface of said perimeter surface of said housing.

The device of claim 1 wherein said guiding member are provided from flexible material having a high coefficient of friction.

The device of claim 1 wherein the shape of said guiding member are configured relative to their coefficient of friction.

The device of claim 1 wherein said locking assembly members are configured relative to the coefficient of friction of said guiding members.

The device of claims 1 wherein said housing is configured to securely fit within a guide mold (102) along its outer perimeter surface (212p).

The device of claims 1 wherein said housing may be removed from a guide mold.

The device of claim 1 wherein the dimensions of said housing may be configured to fit over an edentulous area.

The device of claim 1 wherein said locking assembly members are ring shaped having a central opening characterized in that the size and shape of said central opening is configured to fit over an edentulous area.

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11. The device of claim 1 wherein the dimensions of said housing may be configured to fit over an edentulous area corresponding to one or more teeth .

12. The device of claim 1 wherein said housing may be customized to fit over any portions of an edentulous area of a jaw.

13. The device of claim 1 wherein said drill guide sleeve may be associated with a dedicated sleeve manipulating tool provided for manipulating said sleeve within said device housing.

14. The device of claim 13 wherein said manipulating tool may be linked and/or associated with a computational module .

15. The device of claim 13 wherein said sleeve manipulating tool further provides for introducing an inner tube member within the lumen of said sleeve.

16. The device of claim 13 wherein said sleeve manipulating tool further

facilitates associating or disassociating said device with said guide mold .

17. The device of claim 1 wherein setting the drill path over an edentulous area is performed in-situ in a chair-side manner .

18. A system for orientating a drill guide sleeve within a drill guide mold, the system comprising: the drill guide sleeve orientation device according to claim 1 that is associated with a computational module provided for facilitating orienting said drill guide sleeve within said housing while utilizing medical imagery displayed by said computational module.

19. The system of claim 18 further comprising a dedicated sleeve manipulating tool provided to interface between said computational module and said drill guide sleeve orientation device and wherein said dedicated tool provides for manipulating said sleeve within said device housing.

20. The system of claim 19 wherein said dedicated tool is adapted to provide for manually orienting said sleeve within said housing.

21. The system of claim 19 wherein said dedicated tool is an automated robotic device adapted to provide for automated orientation of said sleeve.

22. The system of claim 19 wherein said automated orientation of said sleeve is provided relative to reference points disposed about said guide mold.

23. The system of claim 18 further comprising a computation module stage for associating said guide mold with said computational module.

24. The system of claim 23 wherein said stage (20) comprises a plurality of reference point connectors for coupling with corresponding reference point recess (104) disposed about said guide mold (102).

25. A method for orienting a drill guide sleeve within a guide mold, in situ, the method comprising :

a. coupling a drill guide sleeve orientation device according to claim 1 with a guide mold over said edentulous area;

b. placing said guide mold over the dental arch of a patient ;

c. associating an orientation tool within the lumen of said sleeve, said orientation tool associated with a computational module comprising a display, displaying a stored medical image of the patient's dental arch and edentulous area; wherein said orientation tool provides a projection of said sleeve on said stored medical image;

d. while viewing said medical image and the projection of said sleeve, manually maneuvering said sleeve within said housing with said orientation tool over said edentulous area until an optimal orientation of said sleeve is determined;

e. locking the position and orientation of said sleeve within said housing with said locking apparatus;

26. The method of claim 25 further comprising: f) associating an inner tube within said sleeve.

27. The device of claim 1 wherein outer surface (212p) may be configured to facilitate coupling with at least one more drill guide orientation device (210).

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