Stable anchoring system for guided implantology and method of using the anchoring system

Abstract

A stable fixation system for guided implant dentistry and method of using the fixation system is disclosed. The fixation system includes a fixation tray having a shell for quick placement of the fixation tray, the shell defining a cavity, an inner surface of the cavity configured to hold a flowable or malleable material and placed on one or more teeth during a guided implant dentistry procedure. The shell sidewalls are joined to a cross member having a curved region on each side of the shell, each sidewall having an upper side portion and a lower side portion. Without a lock, a squeezing force on the upper side portion causes the lower side portion to bend outward. The lock pushes the upper side portion outward to cause the lower side portion to bend inward, thereby holding the material against the teeth once the material hardens. The lock reduces or eliminates the freedom of movement of the tray. The system allows for quick disassembly and is strong enough to withstand forces from various angles and leverage.

Description

TECHNICAL FIELD

[0001] The present invention relates to a fixation system, more particularly to a fixation system for guided dental implant surgery, the fixation system comprising a fixation tray configured to accommodate a hardening material and a locking piece. BACKGROUND

[0002] Dental implants can be used in cases where natural teeth are missing or have to be extracted. Implant surgery involves drilling a hole in the maxilla or mandible (upper or lower jaw) and enlarging it to a certain size, then screwing an implant, a screw-like object, into the jaw. After implant surgery, an abutment and a crown are placed.

[0003] Correct and precise placement of implants is important for various reasons. There are anatomical structures that one does not want to drill into, such as the inferior alveolar and mental nerves, the maxillary sinus or perforation of the bone. In addition, one does not want to drill into a tooth root or another implant. It is not easy to accurately position an implant "blindly" (only seeing the original entry opening) about 8-13 mm deep in the bone. Ideally, the implant should be placed in a certain position and orientation so as to have occlusal forces on the long axis of the tooth. Improper placement can hinder achieving these. At least 2 mm of bone should be left for the implant to prevent bone resorption. There are also aesthetic components for the placement of implants, especially in the front part of the mouth, where the final aesthetic result is affected by the precise placement of the implant.

[0004] Initially, the only way to perform any surgical procedure was usually by hand, without any guidance about the anatomical structures that can be encountered during the surgery. To compensate for this, the surgical access opening had to be large enough to allow visual verification. Endoscopy and other guides have helped in this regard in many types of surgery.

[0005] In dentistry, guided dental surgery helps the surgeon to follow a pre-planned treatment plan. It makes the surgical procedure minimally invasive, reduces the risk of tissue damage and facilitates achieving the required precision. Therefore, guided surgery is the preferred method for dental implant surgery.

[0006] During dental and certain other types of guided surgery, real-time computerized measurements of the spatial position and orientation of specially marked objects, such as surgical instruments and implants to be implanted into predetermined positions, are required. The orientation and position of the surgical instruments are monitored by position sensors, and the real-time position of the instruments can be displayed on previously acquired patient picture data. The patient's orientation and position are also usually tracked separately to allow sensing of anatomical motion relative to the tracking instruments during the surgery. In dental surgery and certain other surgeries, the various orientations and positions of the tracked objects need to be determined very accurately - in the case of dental surgery, usually to less than a quarter of a millimeter. SUMMARY

[0007] One aspect is a stable fixation system for guided implantology, comprising a fixation tray customizable to a patient, the fixation tray comprising a shell defining a chamber configured to contain a flowable or malleable material and to be placed over one or more teeth of a human being during guided implantology, a lock configured to reduce or eliminate degrees of freedom of movement of the fixation tray when positioned thereon, the shell having a plurality of side walls, the side walls engaging a transverse member on each side of the shell, each side wall having an upper side portion and a lower side portion, the transverse member comprising a curved region on each side of the shell, wherein a pressing force on the upper side portion causes the lower side portion to bend outward when the lock is not positioned on the fixation tray, the lower side portion being configured to press the hardened flowable or malleable material against the teeth.

[0008] In some embodiments, the lock is configured to push the upper side portion outward to cause the lower side portion to bend inward, thereby pressing the flowable or malleable material against the teeth once hardened.

[0009] In some embodiments, the lock comprises a plurality of protruding members, the outer side walls of the protruding members being tapered, the protruding members being configured to fit into a correspondingly shaped plurality of recesses of the fixation tray, each of the recesses being partially defined by the upper side portion and the curved region.

[0010] In some embodiments, the fixation tray is configured to be placed over a plurality of back teeth, and wherein the chamber comprises a channel that is substantially straight along a longitudinal direction of the side walls.

[0011] In some embodiments, the side walls of the shell are curved along a longitudinal direction of the side walls, and wherein the fixation tray is configured to be placed over one or more front teeth of a human being.

[0012] In some embodiments, the lock comprises a protruding member, the outer side wall of the protruding member being tapered, the protruding member being configured to fit into a correspondingly shaped recess of the fixation tray, the recess being defined by the upper side portion and the transverse member.

[0013] In some embodiments, the fixation system further comprises a holder configured to define a cavity for containing a tracking element, the holder protruding from one of the side walls of the shell of the fixation tray.

[0014] In some embodiments, the lock has a single protruding member configured to be positioned proximate each of the upper portions to bend the upper portions outwardly to push the lower portions inwardly.

[0015] In some embodiments, the lock has a first protruding member and a second protruding member positioned on the lateral members of the retention tray and configured to bend the upper portions outwardly to bend the lower portions inwardly.

[0016] In some embodiments, the lock is configured to bend the upper portions of the housing outwardly to bend the lower portions inwardly when the lock is positioned on the retention tray.

[0017] In some embodiments, the housing includes a structure configured to bond the flowable or malleable material to the housing once the flowable or malleable material hardens such that a greater separation force is required to separate the flowable or malleable material once the flowable or malleable material hardens than a separation force required to separate the flowable or malleable material from the one or more teeth.

[0018] In some embodiments, the lock is configured to reduce the degree of freedom of movement of each of the upper portions of the sidewalls of the retention tray.

[0019] In some embodiments, the lock has a first protruding member configured to be positioned proximate one of the upper portions and a second protruding member configured to be positioned proximate another of the upper portions to bend the upper portions outwardly to push the lower portions inwardly.

[0020] In some embodiments, the lateral members of the retention tray have a holder configured to define a cavity for receiving a tracking element. In some embodiments, the lock has a first protruding member configured to be positioned proximate one of the upper portions and the holder and a second protruding member configured to be positioned proximate another of the upper portions and the holder.

[0021] In some embodiments, the lock has a substantially U-shaped end view.

[0022] In some embodiments, at least one of the lower portions of the sidewalls of the housing has a plurality of spaces configured to allow the flowable or malleable material to flow into and lock once hardened.

[0023] Another aspect is a method of using a stable fixation system during dental implantation, comprising configuring a fixation tray over one or more teeth, the fixation tray holding a flowable or malleable material, the fixation tray having a shell defining a cavity configured to contain the flowable or malleable material, and the shell having a plurality of sidewalls coupled to a cross member, each of the sidewalls having an upper portion and a lower portion, the cross member including a curved region on each side of the shell such that a squeezing force on the upper portion causes the lower portion in an unlocked position to bend outward, the sidewalls being configured to hold the flowable or malleable material against the one or more teeth; allowing the flowable or malleable material to harden to a rigid but brittle state; configuring a lock over the fixation tray by positioning a first sidewall and a second sidewall of the lock to push the upper portion of the shell outward, thereby causing the lower portion to bend inward, the lock being configured to reduce or eliminate the freedom of movement of the fixation tray; removing the lock by squeezing the upper portion such that the lower portion bends outward.

[0024] In some embodiments, the method further comprises reconfiguring the fixation tray over the one or more teeth, the fixation tray holding new flowable or malleable material, such that the fixation tray retains a same spatial position relative to the one or more teeth. In some embodiments, further comprising allowing the new flowable or malleable material to harden and repositioning the lock over the reconfigured fixation tray to retain the same spatial position. In some embodiments, further comprising performing guided dental implant surgery while the fixation tray and the lock are maintained in position in a firm and stable positioning.

[0025] In some embodiments, further comprising rigidly attaching a connector to the fixation tray, and not

[0026] (a) before configuring the fixation tray and configuring the lock, performing a computer tomography scan of the one or more teeth, and then after configuring the fixation tray and the lock, moving a tracking device along the one or more teeth to register the one or more teeth, and

[0027] (b) after configuring the fixation tray and the lock and rigidly attaching a connector to the fixation tray, performing a computer tomography scan of the one or more teeth, and then not (i) moving a tracking device along the connector to register the connector, or (ii) rigidly attaching the tracking device to the connector to register the connector based on a physical relationship between the tracking device and the connector.

[0028] Another aspect is a stable fixation system for guided implant dentistry, comprising a fixation tray having a shell defining a cavity configured to receive a flowable or malleable material and to be placed over one or more teeth of a human during guided implant dentistry, the flowable or malleable material being configured to harden into a brittle or fragile material so as to conform to a contour of the one or more teeth, the shell comprising a first side wall and a second side wall respectively engaging a cross member, each of the side walls having an upper side portion and a lower side portion, the cross member comprising a curved region on each side of the shell; and a lock positioned over the fixation tray so as to urge each upper side portion to bend outwardly and reduce or eliminate a degree of freedom of movement of the fixation tray.

[0029] In some embodiments, without the lock positioned over the fixation tray, a compressive force on the upper side portion causes the lower side portion to bend outwardly.

[0030] In some embodiments, the lock, when positioned, is configured to urge each upper side portion outwardly, thereby urging each lower side portion inwardly.

[0031] In some embodiments, the lock has a tapered first side wall and a tapered second side wall configured to fit into recesses adjacent the upper side portions, such that the upper side portions bend outwardly, thereby urging the lower side portions inwardly.

[0032] In some embodiments, the shell has a retainer defining a recess configured to receive and retain at least a portion of a tracking element.

[0033] In some embodiments, once the flowable or malleable material hardens, more force is required to separate the flowable or malleable material than was required to separate the flowable or malleable material from the one or more teeth.

[0034] Yet another aspect is a stable fixation system for guided implant dentistry, comprising a fixation tray customizable to a patient, the fixation tray comprising a shell defining a cavity configured to receive a flowable or malleable material and to be placed over one or more teeth of a human during guided implant dentistry, the shell having a plurality of sides, at least a portion of the sides being configured to bend under stress, the sides being configured to urge the flowable or malleable material against the teeth; and a lock positioned over the fixation tray to reduce or eliminate a degree of freedom of movement of the fixation tray.

[0035] In certain embodiments, the lock is a locking wedge positioned above the securing tray. In certain embodiments, the locking wedge has an inner surface configured to define a cavity, the securing tray being configured to fit tightly into the cavity or into the cavity using a friction fit.

[0036] In certain embodiments, the lock includes a mechanism for rigidly securing at least multiple sides of the housing in place.

[0037] In certain embodiments, the housing includes a structure configured to engage the flowable or malleable material to the housing once the flowable or malleable material hardens, such that a greater separation force is required to separate the flowable or malleable material once the flowable or malleable material hardens than a separation force required to separate the flowable or malleable material from the one or more teeth.

[0038] In certain embodiments, the lock is configured to reduce the freedom of movement of each of a first sidewall and a second sidewall of the securing tray.

[0039] In certain embodiments, the housing includes a pair of inwardly angled arm extensions extending from an inner surface of the cavity. In certain embodiments, the housing is made of a first material and the arm extensions are made of a flexible second material.

[0040] In certain embodiments, the lock includes a first locking wedge sidewall that is thicker than a flexible first sidewall of the housing, and a second locking wedge sidewall that is thicker than a flexible second sidewall of the housing.

[0041] In certain embodiments, the securing tray has a plurality of recesses and the lock has corresponding protruding members. In certain embodiments, the protruding members protrude from a bottom side of a locking wedge top of the lock. In certain embodiments, the recesses are planar recesses, the recesses being positioned such that when the protruding members are mated with the planar recesses, a first planar protruding member is adjacent to and within a first sidewall of the securing tray, and a second planar protruding member is adjacent to and within a second sidewall of the securing tray.

[0042] In certain embodiments, the housing has an elongated recess configured to accommodate a tracking element.

[0043] In certain embodiments, an end view of at least one of (i) the securing tray or (ii) the lock is substantially U-shaped.

[0044] In certain embodiments, the housing includes a plurality of arm extensions, each configured to cause the flowable or malleable material to harden in an undercut of the one or more teeth to stabilize the system.

[0045] In certain embodiments, the retention tray includes a plurality of sidewalls, and each of the arm extensions is more flexible than each of the sidewalls.

[0046] In certain embodiments, the housing has a plurality of spaces configured to allow the flowable or malleable material to flow into and lock into once the flowable or malleable material hardens.

[0047] Another aspect is a method of using a stabilized retention system during dental implantation, including configuring a retention tray over one or more teeth, the retention tray holding a flowable or malleable material, the retention tray having a housing defining a chamber for containing the material, and having a plurality of sides, at least a portion of the sides configured to bend under stress, the sides configured to press the flowable or malleable material against the one or more teeth; configuring a lock over the retention tray, the lock configured to reduce or eliminate degrees of freedom of movement of the retention tray; allowing the flowable or malleable material to harden into a rigid but brittle state; removing the lock, and then removing the retention tray by exerting a force on the retention tray to create a stress that causes at least a portion of the hardened material to break.

[0048] In certain embodiments, exerting the force includes rotating an element in a recess of the housing, thereby breaking at least a portion of the previously hardened flowable or malleable material, and allowing a portion of the sides of the housing to bend.

[0049] In certain embodiments, the method further includes performing guided dental surgery while the tray and lock are held in a firm and stable position.

[0050] In certain embodiments, the method further comprises rigidly attaching a connector to the securing tray and not (a) before configuring the securing tray and configuring the lock, performing a computerized tomography scan of the one or more teeth, and then after configuring the securing tray and the lock, moving a tracking device along the one or more teeth to register the one or more teeth, or (b) after configuring the securing tray and the lock and rigidly attaching a connector to the securing tray, performing a computerized tomography scan of the one or more teeth, and then not (i) moving a tracking device along the connector to register the connector, or (ii) rigidly attaching the tracking device to the connector to register the connector based on a physical relationship between a tracking device and a connector.

[0051] Yet another aspect of the present application is a stable securing system for guided dental implantation, comprising a securing tray comprising a shell defining a chamber configured to hold a flowable or malleable material and to be placed over one or more teeth of a human during a guided dental implantation procedure, the flowable or malleable material being configured to harden into a friable or brittle material to conform to a contour of the one or more teeth, the shell having a mechanism configured to push the flowable or malleable material toward the one or more teeth; and a locking wedge positioned over the securing tray to reduce or eliminate a degree of freedom of movement of the securing tray.

[0052] In certain embodiments, the shell comprises a structure configured to engage the flowable or malleable material to the shell once the flowable or malleable material hardens such that a greater separation force is required to separate the flowable or malleable material once it hardens than a separation force required to separate the flowable or malleable material from the one or more teeth.

[0053] In certain embodiments, the shell has a mechanism configured to hold at least a portion of a tracking element and a mechanism configured to exert a stress on the shell and / or the friable or brittle material to break at least a portion of the friable or brittle material and remove the securing tray from the one or more teeth.

[0054] Yet another aspect is a stable fixation system for guided implantation of teeth, comprising a fixation tray customizable to a patient, the fixation tray comprising a shell defining a chamber configured to hold a flowable or malleable material and to be placed over one or more teeth of a human during guided implantation of teeth, the shell having a plurality of sides, at least a portion of the sides being configured to bend under stress, the sides being configured to press the flowable or malleable material against the teeth, wherein the shell comprises a locking mechanism configured to reduce or eliminate degrees of freedom of motion of the fixation tray by reducing or eliminating the ability of at least a portion of the sides of the shell to bend under pressure.

[0055] In certain embodiments, at least a portion of the sides of the shell are configured to bend such that another portion of the sides is from a top of the shell, the portion of the sides expanding outward more under stress.

[0056] In certain embodiments, the system further comprises a registration element configured to rigidly attach to the tray.

[0057] These and other features, aspects, and advantages of the present application will become better understood with reference to the following drawings, descriptions, and claims. BRIEF DESCRIPTION OF DRAWINGS

[0058] Various embodiments are described herein, by way of example only, with reference to the accompanying drawings, in which:

[0059] Figure 1 is an exploded view of a stable fixation system for implantation of teeth with a rod with a connector to a patient tracking device according to an embodiment of the present application.

[0060] Figure 2 is a stable fixation system of Figure 1 with a tracking device according to an embodiment of the present application.

[0061] Figure 3A is a first arm extension of a fixation tray of a stable fixation system according to an embodiment of the present application from a side and end view.

[0062] Figure 3B is a second arm extension of a fixation tray of a stable fixation system according to an embodiment of the present application from a side view.

[0063] Figure 4 is an end view of a fixation tray of a stable fixation system according to an embodiment of the present application.

[0064] Figure 5 is a top view of a fixation tray of a stable fixation system according to an embodiment of the present application.

[0065] Figure 6 is a side view of a fixation tray of a stabilized fixation system according to an embodiment of the application.

[0066] Figure 7 is a bottom view of a fixation tray of a stabilized fixation system according to an embodiment of the application.

[0067] Figure 8 is an end view of a locking wedge of a stabilized fixation system according to an embodiment of the application.

[0068] Figure 9 is a top view of a locking wedge of a stabilized fixation system according to an embodiment of the application.

[0069] Figure 10 is a side view of a locking wedge of a stabilized fixation system according to an embodiment of the application.

[0070] Figure 11 is a bottom view of a locking wedge of a stabilized fixation system according to an embodiment of the application

[0071] Figure 12 is a side view of a rod of a stabilized fixation system or a rod for use with a stabilized fixation system according to an embodiment of the application.

[0072] Figure 13 is a cross-sectional view of a rod of a stabilized fixation system or a rod for use with a stabilized fixation system according to an embodiment of the application. Figure 12

[0073] Figure 14A is a side view of a tracking device and handle for a stabilized fixation system according to an embodiment of the application.

[0074] Figure 14B is a front view of a tracking device and handle for a stabilized fixation system according to an embodiment of the application.

[0075] Figure 14C is another view of a tracking device and handle Figures 14A-14B

[0076] Figure 15 is an end view of a version of a fixation tray of a stabilized fixation system according to an embodiment of the application.

[0077] Figure 16 is a flowchart of a method according to an embodiment of the application.

[0078] Figure 17 is a flowchart of a method according to an embodiment of the application.

[0079] Figure 18 is a flowchart of a method according to an embodiment of the application.​​

[0080] Figure 19 is a schematic view of another locking mechanism according to an embodiment of the application applied to Figure 4 .

[0081] Figure 20 is a schematic view of another locking mechanism according to an embodiment of the application applied to Figure 4 .

[0082] Figure 21 is a flowchart of a method according to an embodiment of the application.

[0083] Figure 22 is a flowchart of a registration method according to an embodiment of the application.

[0084] Figure 23 is a flowchart of another registration method according to an embodiment of the application.

[0085] Figure 24 is a perspective view from the end and front of a fixed tray mainly for back teeth according to an embodiment.

[0086] Figure 25 is a perspective view of a lock piece for a fixed tray according to an embodiment of Figure 24 .

[0087] Figure 26A is an exploded view of a fixed tray and a lock piece according to an embodiment of Figure 25 and 25 .

[0088] Figure 26B is a perspective view of a fixed tray and a lock piece assembled together according to an embodiment of Figure 26A .

[0089] Figure 27A is an exploded view of a fixed tray and a lock piece according to an embodiment of Figure 26A except taken from the front and opposite end of Figure 26A .

[0090] Figure 27B is a perspective view of a fixed tray and a lock piece assembled together according to an embodiment of Figure 27A .

[0091] Figure 28A is a front view of a fixed tray mainly for back teeth according to an embodiment.

[0092] Figure 28B is a side view of a fixed tray mainly for back teeth according to an embodiment.

[0093] Figure 28Cis a rear view of a fixed tray primarily for back teeth according to one embodiment.

[0094] Figure 28D is a top view of a fixed tray primarily for back teeth according to one embodiment.

[0095] Figure 28E is a perspective view of a fixed tray primarily for back teeth according to one embodiment.

[0096] Figure 29A is an end view from the side of a lock piece according to one embodiment.

[0097] Figure 29B is a bottom view of a lock piece according to one embodiment.

[0098] Figure 29C is a front view of a lock piece according to one embodiment.

[0099] Figure 29D is a perspective view of a lock piece according to one embodiment.

[0100] Figure 30 is a bottom view of a fixed tray primarily for front teeth according to one embodiment.

[0101] Figure 31 is a top view of a fixed tray according to one embodiment. Figure 30

[0102] is a front exploded view of a fixed tray according to one embodiment. Figure 32A Figures 30-31 is a perspective view of a fixed tray assembled together with a lock piece according to one embodiment.

[0103] Figure 32B Figure 32A is a rear exploded view of a fixed tray according to one embodiment.

[0104] Figure 33A is a perspective view of a fixed tray assembled together with a lock piece according to one embodiment. Figures 30-31

[0105] is a front view of a fixed tray primarily for front teeth according to one embodiment. Figure 33B Figure 33A is an end view from the side of a fixed tray primarily for front teeth according to one embodiment.

[0106] Figure 34A is a perspective view of a fixed tray primarily for front teeth according to one embodiment.

[0107] Figure 34B is a perspective view of a fixed tray primarily for front teeth according to one embodiment.

[0108] Figure 34C ​​​is a rear view of a retention tray primarily for front teeth according to one embodiment.

[0109] Figure 34D is a top view of a retention tray primarily for front teeth according to one embodiment.

[0110] Figure 34E is a perspective view of a retention tray primarily for front teeth according to one embodiment.

[0111] Figure 35A is a front view of a lock according to one embodiment.

[0112] Figure 35B is an end view from the side of a lock according to one embodiment.

[0113] Figure 35C is a rear view of a lock according to one embodiment.

[0114] Figure 35D is a top view of a lock according to one embodiment.

[0115] Figure 35E is a perspective view of a lock according to one embodiment.

[0116] Figure 36 is a flowchart of a method according to one embodiment. DETAILED DESCRIPTION

[0117] The following detailed description is of the best currently contemplated modes of carrying out the application. The description is not to be taken in a limiting sense, but is merely provided for the purpose of illustrating general principles of the application.

[0118] The present application generally provides a stable retention system for guided implant surgery, in certain embodiments comprising a retention tray and a lock. In certain embodiments, the system is designed to be able to attach a tracking device that interacts with a guided implant surgery system, where such tracking device remains stationary or at least stationary relative to the patient's mouth.

[0119] Certain embodiments of the present invention utilize several principles that reflect the added advantages or requirements of the tracking system used during a dynamic guided implant surgery. The first principle is a system that is quick and easy to place that can be customized for the patient. The system should allow for the attachment of the tracker to the subject's anatomical part so that the tracker moves in precise conjunction with the anatomical part and the surgical site. The second principle is the stability of the system that holds the tracker even in the face of great forces applied from various angles and through leverage (against the tracker or its connectors or directly against the system). The third principle is the quick removal of the system with limited force and without damaging the teeth.

[0120] In certain embodiments, the principle of quick and easy placement is achieved by many things, including a fixed tray shell and a flowable or malleable material placed inside the shell, as the material is flowable or malleable, the material can be effectively customized to the patient's teeth. In certain embodiments, the second principle of stability is achieved by several things, including hardening the flowable or malleable material, a locking mechanism that reduces or eliminates the freedom of movement of the tray (derived from the features of the lock and the features of the tray), and a mechanism that pushes the material against one or more teeth. In certain embodiments, the third principle of quick removal with limited force and without damaging the teeth is achieved by many things, including: a locking mechanism that is easy to remove; and using a flowable or malleable material that hardens into a brittle or fragile material, and providing the material within a tray that is configured to easily break away from forces or stresses, such as shear stress; a mechanism that creates forces or stresses (such as shear stress) on the tray and on the material inside the tray; provided that the separation force required to separate the material from the tray is greater than the separation force required to separate the hardened material from the teeth, so that the material is removed with the tray and does not remain attached to the teeth when the tray is removed; and using a tray whose shell has at least one part or parts or region or regions or points that are configured to bend under stress (in some embodiments, such bending causes the tray to also break under the stress).

[0121] The fixed tray can have a shell that defines a chamber, the inner surface of the chamber is configured to hold a flowable or malleable material, so that the shell effectively becomes customizable to the patient's teeth. The shell is characterized by its part that bends under stress, which facilitates the movement of the fixed tray.

[0122] In one embodiment of the shell that holds the tray, the tray can have a plurality of side walls and a tray top that connects the first side wall to the second side wall of the tray. In certain embodiments, the side walls or portions thereof are configured to bend at least somewhat under stress or pressure. In some cases, the side walls have a plurality of arm extensions that are significantly more flexible than any other portion of the tray, including the first and second side walls. For example, in some embodiments, the arm extensions are made of a different material than the side walls themselves, and in a non-limiting example, are silicone. In some embodiments, the additional flexibility of the arm extensions is a manufacturing consideration, but the arm extensions help to push the flowable or malleable material held by the tray inward toward the teeth, and can make the tray adaptable to fit more jaw and tooth sizes. In certain embodiments, this additional flexibility also makes the tray easier to manufacture. In other cases, the side walls of the tray have a pair of inwardly directed steps at or near the free ends of the side walls or at another location along the side walls.

[0123] The securing system also includes a lock that, in certain embodiments, is implemented as a locking wedge configured to be placed on the tray during guided implant surgery when the tray is placed on the teeth, in order to reduce or eliminate the freedom of movement of the tray that would otherwise result from forces on the tray (or from forces on the connectors of a tracking device (not shown) that in turn apply forces to the tray).

[0124] After the flowable or malleable material has hardened in a brittle form into a rigid state, the securing system can be quickly removed, for example by removing the locking wedge, and then a force is applied in the tray, for example a force on an element located in a cavity of the shell (such as a rod that can be rotated within the cavity). The force can be applied on the element to create a force or pressure or stress, such as a shear stress, to break at least a portion of the hardened material on the occlusal surfaces of the teeth, and cause the entire shell or a portion of the side of the shell (including any arm extensions or steps) to bend so that the tray can be removed or dislodged from the tooth or teeth. If steps are used instead of additional flexible arm extensions, in one example, the entire first and second side walls or the side or side portions of the shell will bend somewhat along with the steps due to the recesses along the side of the side walls or side portions.

[0125] In certain embodiments, the securing system is configured to be quickly placed on the tooth or teeth, to be quickly removed from the tooth or teeth, and / or to remain in place in a stable and reliable manner (partly due to the locking mechanism) under a significant amount of weight or under forces applied at various angles, including forces applied through a lever.

[0126] The principles and operation of a stable fixation system for guided implant dentistry can be better understood with reference to the drawings and accompanying descriptions.

[0127] As Figures 1-15 shown, in particular Figures 1-2 , Figures 4-5 with Figure 8 one embodiment of the present application is a stable fixation system 10 for guided implant dentistry, the fixation system 10 including a fixation tray 20, the fixation tray having a shell 20a in some embodiments, the shell 20a defining a cavity 25 configured to hold a flowable or malleable material (not shown) and to be placed on one or more teeth of a human body during a guided implant dentistry procedure. The use of a hardened flowable or malleable material to conform to the shape of the patient's teeth facilitates a custom system 10 for each patient (in particular the shell 20a of the tray 20). This facilitates the quick positioning of the system 10 on one or more teeth of the patient.

[0128] The fixation tray 20 is configured to be placed on one or two or three or four or five or six teeth, or on a portion of the patient's arch spanning 1-6 teeth. Typically, these will be consecutive adjacent teeth of the arch. In some embodiments, the fixation tray 20 is configured to be placed between 2 and 5 teeth, or on a portion of the arch spanning a row of 2 or 3 or 4 or 5 teeth. In some embodiments, the fixation tray 20 is configured to be placed on 1 to 6 adjacent teeth or 2 to 6 adjacent teeth or 2 to 5 adjacent teeth. In some embodiments, the system 10, in particular the fixation tray 20, is configured to be placed on one or more (e.g. two or three or four or five or six) posterior teeth. Figures 24 to 29D The version shown is primarily for posterior teeth. In other embodiments, the system 10, in particular the fixation tray 20, is configured to be placed on one or more (e.g. two or three or four or five or six) anterior teeth. Figures 30 to 35E The version shown is primarily for anterior teeth.

[0129] The mechanism for quickly positioning the system 10 onto the patient's teeth can also be at least partially achieved by providing the shell 20a with a mechanism for holding the flowable or malleable material against the one or more teeth. Thus, in some embodiments, the shell 20a can have a pair of inwardly directed arm extensions 32, 34 Figures 1-3B or a pair of inwardly directed steps 23a, 23b Figure 15 extending from the inner surface 25a of the cavity 25, each arm extension 32, 34 or step 23a, 23b of the pair being configured to hold the flowable or malleable material against the one or more teeth.

[0130] AlthoughFigure 4 The housing 20a (particularly the inner surface 25a of the chamber 25 defined therein) is depicted to include straight portions of its walls, but this is only one non-limiting embodiment, and in other embodiments, the housing 20a, and particularly the inner surface 25a of the chamber 25, may have circular or curved walls or boundaries. The housing 20a defining the chamber 25 may include sides that can be circular or straight, or a combination of both. In one embodiment, the housing 20a (and the chamber 25) includes a first sidewall 22, a second sidewall 24, and a top 26 of a fixed tray connecting the two sidewalls 22, 24. The sidewalls 22, 24 may be straight, curved, or a combination thereof. Figure 4 In one version shown, housing 20a includes sidewalls 22, 24, which have straight portions and rounded portions, except for any arm extensions 32, 34 or steps 23a, 24b. Top 26 is sometimes referred to as transverse member 26 and is not necessarily located at the top of housing 20a.

[0131] The sidewalls 22 and 24 extend, in a longitudinal direction. This refers to the direction along the rows of teeth (the term "row" is used under the assumption that the system 10 is configured to be placed on multiple teeth), and the fixing tray 20 is configured to be placed on the rows of teeth. In some embodiments, particularly when used with one or more posterior teeth, the chamber 25 defined by the housing 20a forms a substantially straight channel in the longitudinal direction.

[0132] In some embodiments, the purpose of the fixation system 10 is to be able to attach a tracking system that is immobile or at least immobile relative to the patient's mouth during guided implant surgery. For this purpose, in one non-limiting embodiment, the fixation tray 20 may have a portion, such as the top 26 of a housing 20a (e.g., including a retainer 28, which is a region of the top 26), therein (i.e., within the retainer 28) defining a recess, such as an elongated recess 62, configured to receive a tracking device (not shown) or a handle and / or connector 60 connected to such a tracking device. The tracking device can be used during implant surgery. In some embodiments, the connector 60 may be made of titanium and may also be connected to a registration device, or the connector 60 itself may be a registration device or part of it. Figure 1 and Figure 2 In the embodiments shown and in Figures 24 to 28EIn the illustrated embodiment, and in any of the methods (e.g., 500, 600), the connector 60 can be connected to the tray 20 using a stem 65 located at a first end of the connector 60, and can be connected to a tracking device at the other end of the connector. It should be appreciated that the stem 65 is a non-limiting example of how the connector 60 can be connected to the tray 20, and that many other examples of components having other shapes are possible. Additionally, the term "stem" does not imply a cylindrical shape, although it can be.

[0133] When the lock 40 or locking wedge 40 is not configured to the fixed tray 20, at least a portion of the housing 20a, such as the sidewalls 22, 24, is configured to flex under stress. In some embodiments, the housing 20a can also be configured to flex under stress at least to some extent due to the fact that it defines an open chamber (until the flowable or malleable material hardens into a rigid state). Another way to enable portions of the housing 20a, such as the sidewalls 22, 24, to flex under stress is to incorporate at least one recess, such as recesses 27, 29 in the walls of the housing 20a, such as a recess beside the first sidewall 22 and a recess beside the second sidewall 24. In one non-limiting embodiment, the recesses 27, 29 are planar recesses between the respective sidewall and a portion of the top 26, such as the ledge 28. Other configurations of the recesses are possible, and the recesses 27, 29 are not planar. Other ways to configure portions of the housing 20a to flex under stress are also possible, such as depending on the properties of the material from which the housing 20a is made. In certain forms, the housing 20a is cylindrical, so only a single recess is needed.

[0134] In certain embodiments, portions of the housing 20a, such as the sidewalls 22, 24, are configured to flex under stress such that the free ends 22b, 24b of the walls 22, 24 extend outward, or at least extend outward closer to the top 26 than the portions of the housing 20a. This can be a result of the pinching motion caused by the lock 40 or locking wedge 40 at the other ends of the sidewalls 22, 24, for example.

[0135] In forms in which the housing 20a includes a fixed tray top 26 configured to connect the first and second sidewalls 22, 24, the interior surface 25a of the chamber 25 can be defined by the interior surface of the tray top 26 together with the interior wall surface 22a, 24a of each of the first and second sidewalls 22, 24. The chamber 25 is configured to hold a flowable or malleable material (not shown) that can be placed on one or more teeth (not shown) of a human body during a guided dental implant procedure as part of the tray 20.

[0136] In one embodiment, both the first side wall 22 and the second side wall 24 are made of the first material, and each side wall 22, 24 has an arm extension 32, 34 that is more flexible than the side wall 22, 24. The arm extensions 32, 34 can be configured to hold the flowable or malleable material against the tooth or teeth.

[0137] In some embodiments, the flowable or malleable material is a type of material used for temporary crowns. In one non-limiting example, the flowable or malleable material is highly viscous, similar to ketchup (5000-20000 mPa-s at 25°C) or peanut butter (104 to 106 mPa-s) or even asphalt (2.3 x 1011), and in another example has a low viscosity, similar to whole milk (2.2 mPa-s at 20°C), even anything with a viscosity higher than water (1 at 20°C) or any viscosity in between the above ranges. In any event, the flowable or malleable material is configured not only to harden, but also to harden into a material that is brittle or fragile, which easily breaks in response to stress, particularly in response to shear stress, as is necessary when the fixed tray 20 is intended to be removed from the tooth or teeth.

[0138] In one embodiment, the arm extensions 32, 34 extend from each side of the housing 20a, for example by extending from each of the side walls 22, 24 of the housing. In one implementation, the arm extensions 32, 34 extend from the free ends of the side walls 22, 24, respectively (i.e., the arm extension 32 extends from the free end of the side wall 22, and the arm extension 34 extends from the free end of the side wall 24). In another embodiment, the arm extensions 32, 34 extend from points adjacent to the free ends of the side walls 22, 24. In other embodiments, the arm extensions 22, 24 extend from points a few millimeters (1 or 2 or 3 mms) above the free ends of the side walls 22, 24. In some embodiments, the arm extensions extend from midpoints or different portions of the side walls. As Figures 1-2 In certain embodiments as shown, the arm extensions 32, 34 point inward. In certain embodiments, the arm extensions 32, 34 are also angled, in one non-limiting example, at an angle of between 30° and 60° (e.g., between 40°-50°) relative to the side walls 22, 24 (or relative to the sides of the housing 20a or the inner surface 25a of the chamber 25). The free ends 22b, 24b of the side walls 22, 24 refer to the ends farthest from the top 26, in some embodiments, the ends connect the side walls 22, 24.

[0139] The arm extensions 32, 34 can be made of a different material than the rest of the fixed tray 20, for example, different than the shell 20a or different than the side portions of the shell 20a or different than the rest of each side wall 22, 32. For example, in one embodiment, the arm extensions 32, 34 are made of silicone and the silicone is flexible (and more flexible than the rest of the fixed tray 20 or the shell 20a). The fact that the arm extensions 32, 34 are inwardly directed and in some cases also angled, helps to push the flowable or malleable material onto or towards the tooth or teeth and helps the fixed tray 20 to fit more jaw and tooth sizes, the arm extensions 32, 34 are each configured to form a juxtaposition with the undercut of the tooth or teeth and to push the flowable or malleable material to closely adhere to the anatomy of the tooth or teeth and into the undercut, such that when the material hardens into a rigid state, the tooth or teeth are effectively clamped in the undercut of the tooth or teeth. This increases the stability of the system 10, as the entire system 10 cannot be moved out as a unit and in fact cannot be substantially moved during the dental procedure.

[0140] As a result, there is no realistic option to pull the tray 20 with the hardened material vertically up and out of the teeth.

[0141] By using a tray 20 having at least a portion or a portion configured to bend under stress, and by using a flowable or malleable material that is brittle or fragile once hardened, the hardened material in the chamber 25 breaks upon application of pressure (for example by a rotating element, such as the rod 65 of the connector 60 in the recess 62 of the top 26 of the tray 20), as the force from the rotating element 65 creates a pressure or stress on the fixed tray 20 that translates into a stress (for example shear stress) or pressure against the hardened material that causes it to break and detach from the teeth (as the hardened material is firmly attached to the tray 20). Thus, when the fixed tray 20 is removed, the hardened material comes off with the tray 20. If the tray were rigid and not configured to bend under stress, the stress applied on the tray would not cause the hardened material to break, and the force applied on the tray 20 would press the teeth or the teeth themselves and can simply break or extract the tooth or teeth in their entirety.

[0142] In some embodiments, the shell includes a mechanism or structure configured to bind the flowable or malleable material to the shell once the flowable or malleable material hardens, such that a greater separation force is required to separate the flowable or malleable material from the shell once the flowable or malleable material hardens, than the separation force required to separate the flowable or malleable material from the tooth or teeth. In one non-limiting implementation of such a mechanism or structure, the fixed tray 20, and in particular the shell 20a, can have holes 21 (Figure 1 (or other shaped spaces, such as elongated or other shapes), configured to allow the flowable or malleable material to flow into, and lock upon hardening. In this way, when the securing tray 20 is removed, the hardened material (previously flowable or malleable material) breaks away and is removed from the teeth. This helps to quickly remove the system with limited force, without damaging the teeth. Although Figure 1 A non-limiting embodiment is depicted in which one or more holes 21 are located in the sidewalls 22, 24 of the housing 20a of the securing tray 20, it is contemplated that in other embodiments, one or more holes 21 or other shaped spaces can be located in other portions of the securing tray 20, such as the top 26 of the securing tray. In another non-limiting embodiment of this mechanism, the flowable or malleable material is configured to adhere to the material the housing of the tray 20 is made of to a greater extent than the extent to which the flowable or malleable material adheres to the tooth or teeth (once hardened), by the type and nature of the material itself.

[0143] Note that as Figure 1 shown, the tray 20 is upside down relative to the manner in which it is placed on the patient's lower jaw or teeth, and right side up relative to the manner in which it is placed on the patient's upper jaw or teeth. Thus, for the sake of convenience, the phrase "placed over" or "configured over" one or more teeth, or "positioned over" or "positioned on" one or more teeth, as used throughout this patent application, should be broadly construed to broadly describe placing, configuring or positioning the tray 20 over the lower teeth (or teeth) of the patient, as well as placing, configuring or positioning or securing the tray 20 under the upper teeth of the patient. Likewise, in this patent application, when it is stated that the lock 40 or locking wedge 40 is placed or configured over or on the tray 20, the words "over" and "on" in this context should be broadly construed to also include the situation in which the system is applied to the upper teeth and the lock 40 or locking wedge 40 is secured to the tray 20 by placing the lock 40 or locking wedge 40 under the tray 20 when the tray 20 is held in position secured to (or positioned to) the upper teeth.

[0144] As shown in Figures 1-2As seen in 8-11, the securing system 10 can also include a lock 40 (which in one embodiment can be implemented as a locking wedge 40 positioned on or above the securing tray 20) positioned on the tray 20 so as to reduce or eliminate the freedom of movement or mobility of the housing 20a or all or a portion of the sides of the housing 20a or the plurality of side walls of the housing 20a or the first and second side walls 22, 24 of the securing tray 20. The lock 40 or locking wedge 40 is configured with some mechanism designed to securely hold the housing 20a or at least the sides of the housing 20a in place. In one implementation, the lock 40 or locking wedge 40 is configured to securely hold the side walls 22, 24 in place. In any embodiment, the phrase "locking wedge" refers to positioning the lock 40 on the securing tray 20 by a friction fit or a tight fit on the securing tray 20. It can or can not include a tapered wall of the lock 40, even though it refers to a tapered wall, such a tapered wall of the lock 40 does not necessarily have to taper down to a thin edge.

[0145] In certain embodiments of the locking wedge 40, the locking wedge 40 has an inner surface 40a Figure 8 configured to define a cavity 45 in which the securing tray 20 is configured to fit or nest. For example, the inner surface 40a can be configured so that the tray 20 fits tightly into the cavity 45 or, for example, fits into the cavity 45 with a friction fit or under pressure.

[0146] In one non-limiting implementation of a flexible mechanism for securing or removing the housing 20a or at least a portion of the housing 20a, the locking wedge 40 can include a first locking wedge side wall 42 that is thicker than the first side wall 22, a second locking wedge side wall 44 that is thicker than the second side wall 24, and possibly a locking wedge top 46 configured to connect the first locking wedge side wall 42 and the second locking wedge side wall 44. Figure 9 is a top view that depicts the sides 44, 46 of the locking wedge 40 as if they are flaring outward, but this view is not intended to be a realistic depiction.

[0147] As Figure 4 shown, in certain embodiments, the securing tray 20 or its top 26 can have a recess 27 and a recess 29. The recess 27 is positioned alongside the side wall 22, for example alongside the protruding top of the first side wall 22, and the recess 29 is positioned alongside the side wall 24, for example alongside the protruding top of the second side wall 24. Figure 4 Any arm extensions 32, 34 or any steps 23a, 23b that the housing 20a can have are not shown and are not intended to be depicted.

[0148] As Figure 8As shown, in certain embodiments, the locking wedge top portion 46 has protruding members 47, 49 configured to mate or fit within at least a portion of the recesses 27, 29, respectively, such as Figure 1 As shown, for example, in certain embodiments, the locking wedge top portion 46 can have planar protruding members 47, 49 that correspond to planar recesses 27, 29. In other embodiments, the recesses 27, 29 and the protruding members 47, 49 fit together without either of them being planar. The protruding members 47, 49 that can be planar can protrude from the underside of the locking wedge top portion 46.

[0149] As shown. Referring to Figures 1-2 , Figure 4 and Figure 8 In one embodiment, the placement of the substantially planar recesses 27, 29 is such that when the substantially planar protruding members 47, 49 mate with the substantially planar recesses 27, 29, the first substantially planar protruding member 47 is inwardly adjacent to and within the first sidewall 22 of the fixed tray 20, and the second substantially planar protruding member 49 is inwardly adjacent to and within the second sidewall 24 of the fixed tray 20.

[0150] In certain embodiments of the system 10, there are structural means to snap or lock or fit or otherwise fixedly connect the locking wedge 40 to the fixed tray 20 by friction fit. In Figure 1 , Figure 5 and Figure 11 In one non-limiting implementation of the connection, both the fixed tray 20 and the locking wedge 40 have a plurality of ridges 99 on portions of their sidewalls. For example, as shown in Figure 5 and Figure 11 the outer surfaces of the sidewalls 22, 24 of the fixed tray 20 and the inner surfaces of the sidewalls 42, 46 of the locking wedge 40 have corresponding or matching ridges 99.

[0151] When the locking wedge 40 is placed on the fixed tray 20, the locking wedge 40 is configured to reduce or eliminate the freedom of movement of each of the first sidewall 22 and the second sidewall 24 of the fixed tray 20. In one non-limiting example, the locking wedge 40 is configured to reduce the freedom of movement of each of the first sidewall 22 and the second sidewall 24 by 40% (or at least 40%), or in other embodiments by 50% (or at least 50%), or in other embodiments by 70% (or at least 70%), or in other embodiments by 90% (or at least 90%), or in other embodiments by a particular percentage between 40% and 95%.

[0152] From Figure 4 and Figure 8It can be seen that an end view of at least one of (i) the fixed tray 20 or (ii) the locking wedge 40 is substantially U-shaped. Although Figure 4 The tray 20 can be considered substantially U-shaped even without the arm extensions 32, 34 (see Figure 2 ), but even with the arm extensions 32, 34.

[0153] In Figure 19 and Figure 20 another embodiment of the locking piece 40 shown in FIG. 1 1, the housing 20a includes a locking mechanism 40 configured to reduce or eliminate the freedom of movement of the fixed tray 20 by reducing or eliminating the ability of at least a portion of the side of the housing to bend under stress. In one non-limiting example, the locking piece 40 includes a clamp 41 a and / or a fastener 41 b (i.e., a screw 41 b or a pair of screws 41 b) integral with the tray 20 (or in other versions not integral with the tray 20) such that adjustment of the clamp 41 a and / or the screw 41 b is configured to reduce or eliminate the ability of the housing 20a to bend under stress. In one embodiment of the example, the clamp 41 a and / or the screw 41 b is configured to do so by locking the side walls 22, 24 of the housing 20a, e.g., by traversing the recesses 27, 29 in the tray 20. Another embodiment of the locking piece 40 is similar to Figure 20 that shown in FIG. 1 1, except that there are no recesses 27, 29 in the tray 20 and the clamp 41 a is positioned to clamp the tray 20 further downward, i.e., further away from the top 26 and closer to the free ends of the side walls 22, 24 (or at least closer to the free ends of the side walls 22, 24 than shown in FIG. 1 1 ). In that case, the locking piece 40 can also include a screw 41 a (although in other versions the clamp 41 a operates without the screw 41 b). Figure 20

[0154] ​Thus, one particular embodiment of the present invention is a stable fixation system 10 for guided implant dentistry, comprising a patient-customizable fixation tray 20, the fixation tray 20 comprising a shell 20a defining a cavity 25 configured to hold a flowable or malleable material and to be placed over one or more teeth of a human body during a guided implant dentistry procedure, the shell 20a having a plurality of sides, wherein at least a portion of the sides are configured to flex under pressure, the sides being configured to press the flowable or malleable material against the teeth, and wherein the shell 20a comprises a locking mechanism 40 configured to reduce or eliminate a degree of freedom of motion of the fixation tray by reducing or eliminating the ability of at least a portion of the sides of the shell 20a to flex under pressure. In some versions, at least a portion of the sides of the shell are configured to flex such that the further the portion of the side is from the top of the shell, the more the portion of the side expands outward under stress. In some versions, the system 10 further comprises a registration element 60 configured to be connected to the tray 20. In that case, the system 10 comprises the registration element required to register the tray 20 and the lock 40 for the purposes of the guided procedure. The registration element is configured to align the precise CT coordinates to the real-world coordinates of the registration body rigidly attached to the system 10 (or forming part of the system) for the computer navigation system used during the procedure.

[0155] As shown in FIG. 1, one embodiment of the fixation system 10, referred to herein as the "flex" embodiment, is a stable fixation system for guided implant dentistry, comprising a patient-customizable fixation tray 20, the fixation tray 20 comprising a shell 20a defining a cavity 25 configured to hold a flowable or malleable material and to be placed over one or more teeth of a human body during a guided implant dentistry procedure. As in other embodiments, the fixation tray 20 comprising the shell 20a is configured to be placed over one or more teeth by being placed in front of, on top of, and behind the one or more teeth. Figures 24 to 35E

[0156] The fixation tray 20 is configured to be placed over one or two or three or four or five or six teeth, or over a portion of the patient's arch spanning 1-6 teeth. Typically, these will be consecutive adjacent teeth of the arch. In some embodiments, the fixation tray 20 is configured to be placed over between 2 and 5 teeth, or over a portion of the arch spanning a row of 2 or 3 or 4 or 5 teeth. In some embodiments, the fixation tray 20 is configured to be placed over 1 to 6 adjacent teeth or 2 to 6 adjacent teeth or 2 to 5 adjacent teeth. In some embodiments, the system 10, and in particular the fixation tray 20, is configured to be placed over one or more (e.g., two or three or four or five) posterior teeth (or five posterior teeth plus one adjacent tooth). In these embodiments, the fixation tray 20 is configured to be placed over the posterior teeth by being placed in front of, on top of, and behind the one or more posterior teeth.​Figures 24 to 29D The version shown. In other embodiments, the system 10, and in particular the securing tray 20, is configured to be placed on one or more (e.g., two or three or four or five or six) anterior teeth. Included in these embodiments are Figures 30 to 33B The version shown. The housing 20a can have a plurality of side walls or side walls 22, 24 connected to a cross member 26 on each side of the housing 20a. The housing 20a can include a curved region on each side thereof. For example, the cross member 26 can include a curved region FR on each side of the housing 20a. Each of the side walls 22, 24 can include an upper side portion 22U and a lower side portion 22L of the first side wall 22 and an upper side portion 24U and a lower side portion 24L of the second side wall 24, such that in the unlocked position, a squeezing force on the upper side portions 22U, 24U causes the lower side portions 22L, 24L to bend outward. The cross member 26 can connect the side walls 22, 24 to each other.

[0157] As Figure 25 , Figure 26A , Figure 27A , Figure 29A As shown in FIG. 40-D, the “bent” embodiment of the system 10 can also include a lock 40 positioned on the securing tray 20 so as to reduce or eliminate the freedom of movement of the securing tray 20. According to some implementations, the lock 40 is configured to directly reduce or eliminate the freedom of movement of the upper side portions 22U, 24U of the side walls 22, 24 of the securing tray 20, thereby also indirectly reducing or eliminating the freedom of movement of the lower side portions 22L, 24L of the side walls 22, 24. The side walls 22, 24, and in particular the lower side portions 22L, 24L of the side walls 22, 24 in general, are configured in the locked position (when the lock 40 is positioned on the securing tray 20) to hold the hardened flowable or malleable material against the teeth.

[0158] The "curved" embodiments have two versions (at least). In one of these two versions, the retainer 28 is positioned to project from the transverse member 26 on top of the fixed tray 20. In the second version, the retainer 28 is positioned on a side of the fixed tray 20. One version can be used for posterior teeth and one version for anterior teeth. Generally, the version with the retainer 28 projecting from the transverse member 26 is primarily used for posterior teeth, and the version with the retainer 28 projecting from the side of the fixed tray 20 is primarily suitable for anterior teeth, but this is not required. In fact, the version with the retainer 28 projecting from the side of the tray 20 can also be used for posterior teeth. In addition, the version for one type of tooth, e.g., the version for posterior teeth, can include a front tooth at the end of a plurality of teeth. Another difference between the two versions is the degree of curvature (i.e., along the longitudinal direction of the row of teeth), as greater curvature is required to accommodate the greater curvature of the arch at the anterior teeth. Another difference that can occur is that, in the version for anterior teeth, the non-labial side of the tray 20 can include a shortened lower side portion 22L of the wall 22 of the tray 20.

[0159] Thus, Figures 24-29D One version is shown in FIGS. 30-33B, in which the retainer 28 is positioned to project from the transverse member 26 on top of the fixed tray 20. This version is configured primarily for use with a person's posterior teeth. Another version is shown in FIGS. 30-33B, in which the retainer 28 is positioned on a side of the fixed tray 20. This version is primarily for use with a person's anterior teeth, at least in part due to its greater longitudinal curvature (along the row of teeth). A third version is suitable for posterior teeth (similar to that shown in FIGS. 30-33B, but including a retainer 28 projecting from one of the side walls 22, 24 of the tray 20 (as shown in FIGS. 30-33A). Figures 24-29D A fourth version is suitable for anterior teeth (similar to that shown in FIGS. 30-33B, but including a retainer 28 projecting from one of the side walls 22, 24 of the tray 20 (as shown in FIGS. 30-33A). Figure 32A A fifth version is suitable for posterior teeth (similar to that shown in FIGS. 30-33B, but including a retainer 28 projecting from one of the side walls 22, 24 of the tray 20 (as shown in FIGS. 30-33A).

[0160] In either case, the lock 40 includes at least one projecting member 47A or 147 that fits into a recess on the fixed tray 20. In the version in which the retainer 28 projects from the transverse member 26, the lock 40 includes projecting members 47, 49, the outer side walls 47a, 49a of which are tapered. The projecting members 47, 49 are configured to fit into or mate with (e.g., closely or using a friction fit) corresponding shaped recesses 27, 29 of the fixed tray 20, each of which is defined in part by the upper side portions 22U, 24U of the side walls 22, 24 and by the curved region FR (as shown in FIGS. 30-33B). Figure 24 The projecting member 47 can also be defined by another wall 28a that projects further from the transverse member 26 than the side wall 22, and likewise, the projecting member 49 can also be defined by another wall 28b that projects further from the transverse member 26 than the side wall 24.

[0161] For example, additional walls 28a, 28b may form part of a retainer 28 projecting from the transverse member 26. The retainer 28 is configured to define a recess 62, which is configured to receive a tracking element (as part of a tracking system) used during dynamic guided implant surgery. The first protruding member 47 of the locking member 40 may be configured to bend outward or push the upper portion 22U of the sidewall 22 of the housing 20a outward, thereby bending the lower portion 22L of the sidewall 22 of the housing 20a inward. Similarly, the second protruding member 49 of the locking member 40 may be configured to bend outward or push the upper portion 24U of the sidewall 24 of the housing 20a outward, thereby bending or pushing the lower portion 24L of the sidewall 24 of the housing 20a inward, thereby facilitating the abutment of a flowable or malleable material against the patient's teeth.

[0162] like Figure 25 , Figure 26A , Figure 27A , Figure 29A and Figure 29D As shown, the first protruding member 47 and the second protruding member 49 can also represent the outer wall of the locking member 40.

[0163] exist Figures 30-33B In the version of the "bent" embodiment shown, from Figure 30 It can be best seen that the sidewalls 22, 24 of the housing 20a can be bent along the longitudinal direction of the sidewall (the longitudinal direction of the sidewall refers to the longitudinal direction along the row of teeth or a series of teeth (moving from one tooth to the next). In this case, the locking member 40 may include a protruding member 147, which may be a single (unitary) protruding member 147, whose outer sidewalls 147a, 147b are tapered, such as... Figure 31 As shown, the protruding member 147 is configured to fit (e.g., tightly or through frictional engagement) into a correspondingly shaped recess 127 of the fixed tray 20, the recess 127 being defined by upper portions 22U, 24U and a transverse member 26. Figure 32A (and similar) Figure 25 As can be seen, the locking member 40 may have a top 150, from which protruding members 147 (and similar 47, 49) may protrude, and the top 150 may be wider than the protruding members 147 in order to grip the locking member 40.

[0164] like Figures 30 to 34EAs shown, in the version with retainers 28 on the sides, the retainers 28 do not generally protrude from the cross members 26 (e.g., from the top of the cross members 26), but rather protrude from one of the side walls 22, 24 of the housing 20a of the fixed tray 20. The retainers 28 are configured to define a recess 62 configured to accommodate a tracking element (as part of a tracking system) used during a dynamic guided implant surgery. The protruding members 147 can be configured to be positioned closely adjacent to each of the upper side portions 22U, 24U to cause the upper side portions 22U, 24U to flex outwardly, thereby pushing the lower side portions 22L, 24L inwardly.

[0165] In addition, as shown in FIG. 28 and Figure 29A As can be seen, the lower side portions 22L of the walls 22 of the tray 20, which are on the side of the tray 20 that is not the labial side, are generally shorter than the lower side portions 24L of the walls 24 of the tray 20 on the labial side of the tray 20. This is for practical reasons.

[0166] Taking into account the thickness of the protruding members 47, 49 and the protruding member 147 that taper toward the bottom of the lock 40 (the bottom being the portion closer to the gum line, and in some embodiments, the portion or edge configured to contact the cross members of the tray (not including any retainers 28)), in Figure 25 In one particular non-limiting embodiment shown, the tapering is such that the thickness is reduced by about 50% or at least 50%. In some embodiments, the respective cross sections of the first protruding member 47 and the second protruding member 49 are substantially triangular or substantially trapezoidal or substantially wedge-shaped, although the respective bottom edges 47b, 49b of these protruding members 47, 49 do not necessarily have to be sharp (e.g., to increase the surface area of the lock 40 that mates with the tray 20), as Figure 25 shown.

[0167] In addition, in some embodiments, there are holes 21 in the side walls 22, 24 of the fixed tray 20, and the holes 21 are configured to accommodate a flowable or malleable material. Although Figure 24 Nine holes 21 are shown engraved in each of the lower side portions 22L, 24L in a particular pattern and particular size, it should be readily understood that the number, size, and location of these holes 21 can vary.

[0168] At the unlocking position (after removing the locking member 40 from the retaining tray 20 or before positioning the locking member 40 on the retaining tray 20), the first sidewall 22 and the second sidewall 24 of the retaining tray 20 are pressed against each other, configured to release the tray 20 from one or more teeth (due to the effect of the bending area) by bending the lower portions 22L, 24L outward and away from the hardened material (resulting in material breakage). Therefore, the bending embodiment of system 10 enables rapid positioning of the tray 20 and locking member 40 on the patient's teeth, and easy and quick removal of system 10 with limited force and without damaging the teeth. Furthermore, in the bending embodiment, in order to generate stress on the housing 20a, the force of pressing the sidewalls disengages the lower portions 22L, 24L from the hard material without inserting the element into a recess (e.g., the recess of the retainer 28), allowing for easy and quick removal of system 10 with limited force and without damaging the teeth.

[0169] It can be said that the sidewalls 22, 24 extend in the longitudinal direction, which refers to the direction along which the fixed tray 20 is configured to be placed on the row of teeth (the term "row" is used under the assumption that the system 10 is configured to be placed on multiple teeth, but the directional meaning of "longitudinal" also applies to a single tooth).

[0170] like Figure 24 , Figure 26A -B、 Figure 27A -B and Figure 28B and Figure 28E As shown, the chamber 25 can be defined by the lower portions 22L, 24L of the housing 20a and the transverse member 26 or the top 26. The chamber 25 can be shaped as a channel, the length of which is in the direction of the tooth row. In some embodiments, the chamber 25 is shaped as a substantially straight channel in the longitudinal direction (in the direction of the tooth row or in the direction of consecutive teeth among the multiple teeth of the placement tray 20). In versions with retainers 28 on the sides, for the front teeth, the chamber 25 can be shaped as a curved channel, such as... Figure 30 , Figure 33B and Figure 34D As shown. The fixed tray 20 configured to be placed on multiple rear teeth can also have a certain degree of curvature, but less than the curvature of the tray 20 configured to be placed on the front teeth.

[0171] from Figure 16As can be seen from the flowchart, one embodiment of the present application is a method 100 of using a stable and secure system during implantation. The method 100 can include a step 110 of configuring a secure tray 20 holding flowable or malleable material onto one or more teeth, the secure tray having a shell 20a, wherein at least a portion, such as a side of the shell 20a, is configured to bend under stress. The shell 20a can include a secure tray top 26 or a transverse member 26 that can be configured to connect the first and second side walls. The shell 20a defines a cavity 25 and can have any of the structures described with respect to any of the embodiments of the secure tray 20 or system 10 including the bending embodiments. For example, the shell 20a can have an element such as a plurality of additional flexible arm extensions, such as inwardly facing (and can be angled) arm extensions to seat the flowable or malleable material against the one or more teeth. For example, the arm extensions 32, 34 can extend from a free end or a point adjacent to a free end of each of the first and second side walls (or sides of the shell 20a) or can extend from different portions of the first and second side walls (or sides of the shell 20a) when angled inwardly facing arm extensions are configured to seat the flowable or malleable material against the one or more teeth. In some embodiments, the step 110 of configuring can be accomplished quickly and easily.

[0172] The method 100 can also include a step 120 of locking the secure tray, such as by a lock 40 or by configuring a locking wedge on the secure tray, such as a locking wedge 40 configured to secure the tray 20 in place or to grip the secure tray 20 and / or reduce or eliminate its freedom of movement. The mechanism for reducing or eliminating the freedom of movement of the tray 20 or securing the tray 20 in place can be any suitable mechanism, such as any of the mechanisms described with respect to the system 10 or tray 20. In some embodiments, the step 120 of locking achieves a stable and secure system to which a tracking device can be attached and which is stable when faced with large forces applied from various angles and using leverage. The step 120 can also include locking an element bar 65, such as by using a fastener or screw that passes through a hole in the lock 40 and a hole in the tray 20 (see Figure 1 、 Figure 5 、 Figure 9 ).

[0173] Step 130 of method 100 can include allowing the flowable or malleable material to harden, for example, to a rigid but crisp or brittle state, for example, a crisp or brittle state that is prone to breaking when a force or stress, such as a shear stress, is applied. In some cases, the flowable or malleable material flows into the space 21 in the housing 20a of the tray 20 such that when it hardens it is locked in the tray 20. In some embodiments, step 130 of allowing the flowable or malleable material to harden is performed prior to step 120 of configuring the lock 40 or locking wedge 40 on the fixed tray 20.

[0174] Method 100 can include additional steps of reconfiguring the fixed tray to secure the new flowable or malleable material on the one or more teeth such that the fixed tray (and lock) retains the same spatial position relative to the one or more teeth (or jaw bone). Further steps can include allowing the new flowable or malleable material to harden and repositioning the lock on the tray so as to retain the same spatial position of the tray (and lock) relative to the one or more teeth (or jaw bone). Thus, method 100 can achieve the feature of precise repeatability of the configuration of system 10.

[0175] Method 100 can include additional steps of performing guided dental procedures while system 10, including tray 20 and lock 40, remains in a solid and stable position regardless of the forces applied on system 10.

[0176] Step 140 can include unlocking the lock 40 or removing the locking wedge 40 easily and quickly, for example, with limited force without damaging the teeth, and then removing the securing tray 20. For example, in certain embodiments, the locking wedge 40 is removed quickly by applying a force thereon, for example, by using an instrument operably connected to the element in the recess 62 of the securing tray 20. In certain embodiments, the removal of the tray is accomplished by applying a force on the shell 20a that creates a stress, such as a shear stress, which can be translated into a stress, such as a shear stress, on the hardened material (previously flowable or malleable material) that is brittle or fragile. In one non-limiting implementation, this can be accomplished by applying a force (e.g., a rotational force) on an element of the tray 20, such as a rod 65. For example, the force can be applied to an internal element of the tray 20. In one implementation, the force can be applied to an element located in the recess 62 of the securing tray 20, for example, in the top 26 of the tray 20 (in some embodiments, the recess 62 in the retainer 28 of the top 26), to create a pressure on a portion of the tray 20 and on the hardened material that causes a stress, such as a shear stress, to break at least a portion of the hardened material (e.g., on the occlusal surface of the plurality of teeth), thereby allowing the sides or side portions of the shell 20a (including the arm extensions 32, 34 or including the steps 23a, 23b) to flex and the tray 20 to be removed from the teeth. Figure 1 is an exploded view of the tracking device connector or handle 60 that allows visualization of the element in the recess 62, according to one embodiment. The tracking device connector or handle 60 includes a rod 65 configured to fit within the recess 62. To begin the process of removing the securing tray 20, a rotational force can be applied on the rod 65. This has the effect of pressing on the entire securing tray 20, but particularly on the sides of the tray 20, such as the arm extensions 22, 24 of the tray 20. It can have the effect of pressing on the retainer 28, the top 26, the side walls 22, 24, and the arm extensions 32, 34. It can have the additional effect of applying a stress, such as a shear stress, and breaking at least a portion of the hardened material, for example, on the occlusal surface of the plurality of teeth, thereby causing the sides of the shell 20a to flex so as to remove the securing tray 20 from the tooth or teeth and remove the securing tray 20.

[0177] In the method 100 (or the methods 200, 300, 400), if an element, such as the rod 65, is placed in the tray 20, step 140 can also include removing the fastener or screw that locks the rod 65.

[0178] Figure 17Another method 200 shown in the middle can include a step 210 of configuring a holding tray holding a flowable or malleable material onto one or more teeth, the holding tray having at least a portion, such as a plurality of side walls, configured to bend under stress, and a top connecting them, and having inwardly extending additional flexible arm extensions to hold the flowable or malleable material against the one or more teeth. For example, arm extensions 32, 34 can extend from a portion of the side walls 22, 24 (or a plurality of sides of the housing 20a), and in some cases, from a free end or a point adjacent to a free end of each side wall of the tray 20, and the arm extensions 32, 34 can point inwardly (and can be angled) to hold the flowable or malleable material against the one or more teeth.

[0179] A step 220 of the method 200 can include locking the holding tray, for example by configuring a locking wedge 40 on the holding tray 20, for example to grip the holding tray 20, for example to limit movement of the side walls of the holding tray. A step 230 can include allowing the flowable or malleable material to harden into a brittle or fragile rigid state. In some cases, the flowable or malleable material flows into the space 21 in the housing 20a of the tray 20, so that when it hardens, it locks in the tray 20. The method 200 can include additional steps of performing the procedure without considering the forces exerted on the system 10, the system including the tray 20 and the lock 40, remaining in a solid and stable position.

[0180] A step 240 can include unlocking the lock or removing the locking wedge, and then removing the holding tray by exerting a force on an element of the holding tray, for example by rotating a rod or other element in a recess in the top of the holding tray, thereby creating pressure on the housing 20a, causing at least a portion of the housing 20a to bend (the portion can be the side including the arm extensions 32, 34), and possibly causing the material to break, which removes the holding tray from the plurality of teeth.

[0181] The method 200 can include further steps of reconfiguring a holding tray holding a new flowable or malleable material onto the one or more teeth, so that the holding tray retains the same spatial position relative to the one or more teeth (or jaw bone). The method 200 can include further steps of allowing the new flowable or malleable material to harden, and then reconfiguring a lock on the reconfigured holding tray, so that the holding tray (and the lock) retains its same spatial position relative to the one or more teeth (or jaw bone).

[0182] In Figure 18A flowchart of another method 300 is shown. It includes a step 310 of configuring a securing tray holding a flowable or malleable material onto one or more teeth, the securing tray having some sidewalls configured to hold the flowable or malleable material against the teeth. For example using any of the mechanisms described above with respect to system 10, including for example the additional flexible inward facing arm extensions 32, 34, or using the inward facing steps 23a, 23b. Locking the securing tray using a lock on the tray or by configuring a locking wedge on the securing tray can include a step 320 of method 300. Hardening the flowable or malleable material in step 330. In some cases, the flowable or malleable material flows into the space 21 in the housing 20a of the tray 20 so that it is locked in the tray 20 when it hardens. Method 300 can include additional steps of performing a procedure while system 10 including the tray 20 and the lock 40 remains in a solid and stable position regardless of forces applied on system 10. Step 340 can include unlocking the lock, for example by removing the locking wedge, and then removing the securing tray by applying a force on one of the elements in the recess of the securing tray so as to break the hardened material.

[0183] Method 400 can include a step 410 of configuring a securing tray holding a flowable or malleable material onto one or more teeth, the securing tray 20 having a housing 20a defining a chamber 25 and having a mechanism to hold the material against the one or more teeth. Step 420 can include locking the securing tray 20 to reduce or eliminate its freedom of movement. Step 430 can include allowing the material to harden while the tray 20 and the lock 40 remain in a solid and stable position and performing a guided procedure. Step 440 can include removing or unlocking the lock 40 and then removing the securing tray 20. Any suitable version of any of the elements described herein with respect to system 10 can be used for the elements in method 400.

[0184] By using a tray 20 having at least one portion configured to bend under pressure in any of methods 100, 200, 300, 400 or system 10, system 10 is designed to break the hardened material when pressure is applied, for example by rotating an element such as a rod 65 in a recess 62 of the top 26 of the tray 20. Since the tray 20 has one or more portions configured to bend under stress applied on the securing tray 20, this causes the pressure applied to be against the hardened (previously flowable or malleable) material. This causes the hardened material to break and fall off the teeth when the securing tray 20 is removed. If the tray 20 is rigid, it is possible to simply pull out the entire tooth. For stability reasons, system 10 fills the undercut of multiple teeth, so there is effectively no choice but to pull the system directly vertically upwards.

[0185] As noted, the connector 60 can be connected to a registration body or can itself be the registration body, the registration body used to pair CT coordinates and real world coordinates for use in guided dental surgery. Thus, in embodiments of the invention, the registration method 500 includes a step of performing a computer tomography (CT) scan of the patient's teeth without attaching the system 10 to the teeth. Step 520 includes configuring any version of the system 10 on one or more teeth (including the tray 20 holding the flowable or malleable material and including the lock 40) so that the system 10 is securely attached to the one or more teeth, and so that the connector 60 is also rigidly attached to the system 10, e.g., by being rigidly attached to the tray 20 of the system 10 (the connector 60 is typically outside or mostly outside the patient's mouth). Step 530 includes performing the registration by employing a tracking device (used in conjunction with guided dental surgery) and touching it along the one or more teeth.

[0186] In another embodiment of the invention, the method of registration 600 includes a step 610 of configuring any version of the system 10 on one or more teeth (including the tray 20 holding the flowable or malleable material and including the lock 40) so that the system 10 is securely attached to the one or more teeth, and so that the connector 60 is also securely connected to the system 10, e.g., by being rigidly attached to the tray 20 of the system 10 (the connector 60 is typically outside or mostly outside the patient's mouth). Step 620 includes, after the tray 20 and lock 40 and connector 60 are configured, performing a computer tomography (CT) scan of the patient's one or more teeth. Step 630 includes registering by employing a tracking device (used in conjunction with guided surgery) and either (i) touching it along the connector 60 to register the connector 60 or (ii) simply securely attaching it (the tracking device) to the connector 60 to register the connector 60, as the software of the dental surgery navigation system derives the coordinates of the connector 60 from the coordinates of the tracking device rigidly connected to it.

[0187] Both versions of the registration process (500, 600) can also be used in conjunction with any or all of the steps of the methods 100, 200, 300, 400, 700. Thus, the step of removing the lock and tray (and / or allowing the material to harden) can be omitted from the list of steps of the registration method in certain versions.

[0188] In one embodiment of the invention, a stable fixation system for guided implant surgery includes a fixation tray 20 having a housing 20a defining a cavity 25 configured to receive a flowable or malleable material and to be placed over one or more teeth of a human during a guided implant surgery, the flowable or malleable material being configured to harden into a friable or brittle material to conform to the contour of the one or more teeth, the housing having a mechanism configured to urge the flowable or malleable material (and / or when it has hardened) toward the one or more teeth. The system 10 also includes a lock 40 or locking wedge 40 configured to lock the tray 20 or be positioned on or over the fixation tray 20 to reduce or eliminate the freedom of movement of the housing 20a. The housing 20a can include a mechanism configured to bond the flowable or malleable material to the housing 20a once the material has hardened, such that a greater separation force is required to separate the flowable or malleable material from the housing once the material has hardened than is required to separate the flowable or malleable material from the one or more teeth.

[0189] The housing 20a can include portions configured to flex under stress. For example, the housing 20a can have one or more recesses (as described above), and in some versions the locking wedge can include one or more corresponding protruding members. In some versions, the locking wedge 40 includes a first locking wedge sidewall 42 that is thicker than the first sidewall 22 of the housing 20a and a second locking wedge sidewall 44 that is thicker than the second sidewall 24 of the housing 20a.

[0190] The housing can have a plurality of sides, at least a portion of the sides being configured to flex outward under stress. For example, the sidewalls 22, 24 can flex outward under stress. For example, the free ends of the sidewalls 22, 24 can expand outward under stress. In some cases, the further a portion of the sidewalls 22, 24 is from the top 26 of the housing 20a, the more the portion of the sides expands outward under stress (e.g., due to clamping or retaining forces at or near the top).

[0191] In some embodiments, the housing 20a has a mechanism configured to retain at least a portion of a tracking element and a mechanism configured to exert a force or stress, such as a shear stress mechanism, on the housing and / or the friable or brittle material to facilitate breaking at least a portion of the friable or brittle material and removing the fixation tray from the one or more teeth. When the force is applied, one or more portions of the housing 20a configured to flex then flex such that it is easier to induce stress on the hardened material and easy to remove the tray 20.

[0192] For example, the force can be applied from the interior of the tray 20. In one embodiment, the shell 20a has a recess 62 configured to receive a tracking element or a handle of a tracking element. The recess 62 can also be configured to receive an element (e.g., a stem 65 of a connector 60 of a tracking device) configured to apply a force or stress, e.g., a shear stress, on the shell 20a (or a portion or side of the shell 20a) and / or on the hardened material in order to break at least a portion of the brittle material, thereby causing the securing tray 20 to move away from the tooth or teeth.

[0193] As shown in FIG. 1, in certain embodiments, in order to facilitate the rapid placement system 10, the mechanism of customizing the system 10 to an individual patient's teeth can be achieved by customizing the shell to the individual patient's teeth. In certain cases, this is achieved by a flowable or malleable material and by providing the shell 20a of the securing tray 20 with a pair of inwardly directed arm extensions 22, 24 or inwardly directed steps 23a, 23b configured to hold the flowable or malleable material against the tooth or teeth (including after the material has hardened to a rigid state). Figure 15 As shown in FIG. 1, in certain embodiments, in order to facilitate the rapid placement system 10, the mechanism of customizing the system 10 to an individual patient's teeth can be achieved by customizing the shell to the individual patient's teeth. In certain cases, this is achieved by a flowable or malleable material and by providing the shell 20a of the securing tray 20 with a pair of inwardly directed arm extensions 22, 24 or inwardly directed steps 23a, 23b configured to hold the flowable or malleable material against the tooth or teeth (including after the material has hardened to a rigid state).

[0194] As shown in FIG. 1, in certain embodiments, in order to facilitate the rapid placement system 10, the mechanism of customizing the system 10 to an individual patient's teeth can be achieved by customizing the shell to the individual patient's teeth. In certain cases, this is achieved by a flowable or malleable material and by providing the shell 20a of the securing tray 20 with a pair of inwardly directed arm extensions 22, 24 or inwardly directed steps 23a, 23b configured to hold the flowable or malleable material against the tooth or teeth (including after the material has hardened to a rigid state). Figure 36 As shown in FIG. 1, in certain embodiments, in order to facilitate the rapid placement system 10, the mechanism of customizing the system 10 to an individual patient's teeth can be achieved by customizing the shell to the individual patient's teeth. In certain cases, this is achieved by a flowable or malleable material and by providing the shell 20a of the securing tray 20 with a pair of inwardly directed arm extensions 22, 24 or inwardly directed steps 23a, 23b configured to hold the flowable or malleable material against the tooth or teeth (including after the material has hardened to a rigid state).

[0195] In a more detailed implementation of the method 700, according to certain embodiments, the method 700 can include the step of configuring a holding tray 20 holding a flowable or malleable material onto one or more teeth, the holding tray 20 having a shell defining a chamber 25 configured to contain the material and having a plurality of side walls connected to a cross member 26, wherein each side wall includes an upper side portion 22U, 24U and a lower side portion 22L, 24L. The cross member 26 can include a curved region on each side of the shell. In an unlocked position (when the lock 40 is not positioned on the holding tray 20), a squeezing force on the upper side portions 22U, 24U (so as to urge them (22U, 24U) toward each other) causes the lower side portions 22L, 24L to bend outward (away from each other).

[0196] Another step of the method 700 can include allowing the flowable or malleable material to harden into a rigid but brittle state.

[0197] The method 700 can include the further step of configuring the lock 40 on the holding tray 20 by positioning a first side wall and a second side wall of the lock 40 to cause the upper side portions 22U, 24U of the shell to bend outward, thereby causing the lower side portions 22L, 24L to bend inward, the lock 40 configured to reduce or eliminate the freedom of movement of the holding tray 20. In the locked position, the side walls 22, 24 of the holding tray 20 are configured to hold the already hardened flowable or malleable material against the one or more teeth.

[0198] Another step of the method 700 can include removing the lock 40 and then removing the tray 20 by squeezing the upper side portions 22U, 24U to cause the lower side portions 22L, 24L to bend outward.

[0199] The method 700 can include the further step of reconfiguring a holding tray holding a new flowable or malleable material onto the one or more teeth such that the holding tray retains the same spatial position relative to the one or more teeth (or jaw bone). The method 700 can include the further step of allowing the flowable or malleable material to harden and then reconfiguring the lock on the reconfigured holding tray such that the holding tray retains its same spatial position relative to the one or more teeth (or jaw bone).

[0200] Thus, the method 700 can achieve the feature of precise repeatability of the configuration of the system 10.

[0201] While this application has been described in connection with limited number of embodiments, it will be understood that many modifications, variations and other applications of the application can be made. Therefore, the claimed application should not be limited to the embodiments described herein but should be limited only by the claims that follow.

Claims

1. A stable fixation system for guided dental implants, characterized in that, The fixed system includes: A fixed tray, customizable for the patient, includes a housing defining a chamber configured to accommodate a flowable or expandable material and placed over one or more teeth during guided implantation. A locking element is configured to reduce or eliminate the degree of freedom of movement of the fixed tray when positioned on the fixed tray. The housing has multiple sidewalls that engage with a transverse member on each side of the housing. Each sidewall has an upper portion and a lower portion. The transverse member includes a curved region on each side of the housing, wherein when the locking member is not positioned on the fixed tray, a compressive force on the upper portion causes the lower portion to bend outward. The lower portion is configured to abut the hardened flowable or stretchable material against the teeth.

2. The fixing system as described in claim 1, characterized in that: The locking element is configured to push the upper portion outward to cause the lower portion to bend inward, thereby abutting the flowable or stretchable material against the teeth once the material hardens.

3. The fixing system as described in claim 1, characterized in that: The lateral member of the fixed tray has a retainer configured to define an opening for receiving a tracking element.

4. The fixing system as described in claim 1, characterized in that: The locking member includes a plurality of protruding members, the outer sidewalls of which are tapered, and the protruding members are configured to fit into a plurality of correspondingly formed recesses of the fixing tray, each of which is partially defined by the upper portion and the curved region.

5. The fixing system as described in claim 1, characterized in that: The fixed tray is configured to be placed above multiple rear teeth, and the chamber includes a channel that is substantially straight along the length of the sidewall.

6. The fixing system as described in claim 1, characterized in that: The sidewall of the housing is curved along the length of the sidewall, and the fixed tray is configured to be placed above one or more front teeth of the human body.

7. The fixing system as described in claim 1, characterized in that: The locking member includes a protruding member with a tapered outer wall, the protruding member being configured to fit into a corresponding shaped recess in the fixing tray, the recess being defined by the upper portion and the transverse member.

8. The fixing system as described in claim 1, characterized in that: It also includes a retainer configured to define an opening for receiving a tracking element, the retainer protruding from one of the side walls of the housing of the fixed tray.

9. The fixing system as described in claim 8, characterized in that: The locking member has a first protruding member and a second protruding member, the first protruding member being configured to be tightly positioned between one of the upper portions and the retainer, and the second protruding member being configured to be tightly positioned between the other of the upper portions and the retainer.

10. The fixing system as claimed in claim 1, characterized in that: The locking member has a single protruding member configured to be closely positioned near each of the upper portions so that the upper portions bend outward, thereby pushing the lower portions inward.

11. The fixing system as claimed in claim 1, characterized in that: The locking member has a first protruding member and a second protruding member, positioned on the transverse member of the fixed tray, and configured to bend the upper portion outward and the lower portion inward.

12. The fixing system as claimed in claim 1, characterized in that: When the locking member is positioned on the fixed tray, the locking member is configured to bend the upper portion of the housing outward, thereby bending the lower portion inward.

13. The fixing system as claimed in claim 1, characterized in that: The housing includes a structure configured to bond the flowable or stretchable material to the housing once the flowable or stretchable material hardens, such that once the flowable or stretchable material hardens, a greater separation force is required to separate the flowable or stretchable material from the one or more teeth compared to the separation force required to separate the flowable or stretchable material from the teeth.

14. The fixing system as claimed in claim 1, characterized in that: The locking member has a first protruding member and a second protruding member, the first protruding member being configured to be closely positioned near one of the upper portions, and the second protruding member being configured to be positioned near the other of the upper portions, so that the upper portions bend outward to push the lower portions inward.

15. The fixing system as claimed in claim 1, characterized in that: At least one of the lower portions of the sidewall of the housing has a plurality of spaces configured to allow the flow of the flowable or extensible material to flow in and to lock in once hardened.

16. A fixation system used during dental implantation, characterized in that, The fixing system includes a fixing tray and a locking device; The fixed tray is configured to hold a flowable or stretchable material on one or more teeth. The fixed tray has a housing that defines a chamber configured to receive the flowable or stretchable material. The housing has a plurality of sidewalls engaging with a transverse member, each sidewall having an upper portion and a lower portion. The transverse member includes a curved region on each side of the housing such that compressive force on the upper portion causes the lower portion to bend outward in the unlocked position. The sidewalls are configured to abut the flowable or stretchable material against the one or more teeth. The flowable or stretchable material is allowed to harden into a rigid but brittle state; The locking member is configured above the fixed tray by positioning a first sidewall and a second sidewall of the locking member to push the upper portion of the housing outward, thereby causing the lower portion to bend inward. The locking member is configured to reduce or eliminate the degree of freedom of movement of the fixed tray. The lower portion bends outward by squeezing the upper portion to remove the lock.

17. The fixing system as claimed in claim 16, characterized in that: The fixation system is configured to reposition the fixation tray onto one or more teeth, the fixation tray being made of a new, flowable or stretchable material such that the fixation tray maintains the same spatial position relative to the one or more teeth.

18. The fixing system as claimed in claim 17, characterized in that: The fixing system is configured to allow the new flowable or stretchable material to harden and reposition the lock on the reconfigured fixing tray to retain the same spatial position.

19. The fixing system as claimed in claim 18, characterized in that: The fixation system is configured to perform guided dental implant surgery when the fixation tray and the locking device are held in position with a firm and stable orientation.

20. The fixing system as claimed in claim 17, characterized in that: The fixing system also includes a connector configured to rigidly attach to the fixing tray, and is not (a) Before configuring the fixed tray and the locking device, a computed tomography scan is performed on one or more teeth. Then, after configuring the fixed tray and the locking device, a tracking device is moved along one or more teeth to align the one or more teeth. (b) After configuring the fixed tray and the locking member and rigidly attaching the connector to the fixed tray, perform a computed tomography scan on the one or more teeth, and then either (i) move a tracking device along the connector to calibrate the connector, or (ii) rigidly attach the tracking device to the connector to calibrate the connector based on the physical relationship between the tracking device and the connector.

21. A stable fixation system for guided dental implants, characterized in that, The stable fixed system includes: A fixed tray, customizable for a patient, includes a housing defining a chamber configured to receive a flowable or stretchable material and placed on top, in front of, and behind one or more teeth in a human body, the teeth occupying a portion of the dentition of the human body. During the guided implantation, the housing has multiple sidewalls, at least a portion of which is configured to bend under stress, the sidewalls being configured to abut the flowable or stretchable material against the teeth. as well as A locking element is located on the fixed tray to reduce or eliminate the degree of freedom of movement of the fixed tray. Each of the sidewalls of the housing has a free end configured to be closer to the gingival line of each jaw than an opposing end; wherein, in at least one location of the system, the free end is configured to bend outward when subjected to compressive force at the opposing end.

22. The fixing system as claimed in claim 21, characterized in that: The fixed tray is configured to be placed above the plurality of teeth, and the chamber defined by the housing includes a channel that is substantially straight along the direction of the tooth row.

23. The fixing system as described in claim 22, characterized in that: The locking element has an inner surface configured to define a cavity, and at least a portion of the fixing tray is configured to be fitted into the cavity either tightly or using a friction fit.

24. The fixing system as claimed in claim 21, characterized in that: The locking element includes a mechanism for rigidly securing at least a plurality of sides of the housing in position.

25. The fixing system as claimed in claim 21, characterized in that: The housing includes a structure configured to bond the flowable or stretchable material to the housing once the flowable or stretchable material hardens, such that once the flowable or stretchable material hardens, a greater separation force is required to separate the flowable or stretchable material from the one or more teeth compared to the separation force required to separate the flowable or stretchable material from the teeth.

26. The fixing system as claimed in claim 21, characterized in that: The locking mechanism is configured to reduce the degree of freedom of movement of each of a first sidewall and a second sidewall of the fixed tray.

27. The fixing system as claimed in claim 21, characterized in that: The locking member has a first wall or protruding member and a second wall or protruding member, the first wall or protruding member being configured to extend along one of the side walls of the housing, and the second wall or protruding member being configured to extend along the second of the side walls of the housing.

28. The fixing system as claimed in claim 21, characterized in that: The fixed tray has multiple recesses, and the locking member has corresponding protruding members.

29. The fixing system as described in claim 28, characterized in that: The protruding member protrudes from the inner surface of the top of the lock.

30. The fixing system as described in claim 28, characterized in that: The recess is a substantially flat recess, and the recess is positioned such that when the protruding member engages with the substantially flat recess, a first substantially flat protruding member is adjacent to and inside a first sidewall of the fixed tray, and a second substantially flat protruding member is adjacent to and inside a first sidewall of the fixed tray.

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