Facial alignment tool

Abstract

The present disclosure provides a facial alignment tool to project a laser line or multiple lines onto a patient's face to assess symmetry and / or alignment during facial and / or nasal plastic surgery procedures such as rhinoplasty, nasal reconstruction, facial reconstruction, among other cosmetic or functional facial plastic surgery procedures. The facial alignment tool includes a moldable mouth guard specifically fabricated to be received in a patient's mouth, a support plate configured to receive the moldable mouth guard, a flange rigidly attached at its proximal edge to a front of the support plate, a positioning component attached to the distal edge of the flange, a rigid beam rigidly attached at its proximal end to the positioning component such that actuating the positioning component laterally translates the rigid beam, and a light source mounted to a distal end to the rigid beam by an adjustable laser mount configured to allow translation and rotation of the laser light source in the adjustable laser mount. The laser source is mounted such that when a patient has the support plate with the moldable mouth guard in their mouth the light source emits visible light projected onto the patient's face, and adjusting the positioning components moves the rigid beam and the light source attached thereto with respect to the patient's face.

Description

[0001] FACIAL ALIGNMENT TOOL

[0002] FIELD

[0003] The present disclosure relates to a facial alignment tool for projecting a laser line or other patterns onto a patient’s face to assess symmetry and / or alignment during facial and / or nasal plastic surgery procedures.

[0004] BACKGROUND

[0005] In rhinoplasty and nasal reconstruction, achieving symmetry is critical for optimal patient outcomes and reducing re-operation rates. Assessing nasal asymmetry is challenging, both pre- and intra-operatively, due to the limits of a surgeons’ visual perception to judge and manipulate the small distances on the patient’s nose important to cosmesis (<2 mm). Evaluating symmetry throughout a procedure is additionally challenging due to the surgeon’s proximity and position relative to the patient on the operating table, his / her loss of initial reference (e.g., from degloving or swelling), and objectivity due to prolonged focus on the nose during surgery.

[0006] WO 2017 / 058710 discloses a process and apparatus for intraoperative viewing of patient 3D surface images useful in imaging of a patient in aesthetic and reconstructive surgery. This is accomplished through image acquisition of 3D images by any available method (e.g., laser surface scanning, stereoscopy, among others), processing the images to provide relevant data in the form of surgical map(s) or models, and projecting the images, map(s) and / or models onto the patient for guidance during surgery and / or displaying the images, map(s) or models to simulate the surgeon's point of view or another vantage point of interest.

[0007] The process disclosed in WO 2017 / 058710 describes laser surface scanning as a method for acquiring 3D depth data where structured light is interpreted by a computational imaging system. Laser lines or patterns in this disclosure are instead used for visualization and display interpreted by a clinician. The WO 2017 / 058710 disclosure projects an image or model onto the patient for topographical mapping and assessing surface contours. The laser light projections from this device disclosure are simpler lines and / or grid patterns for measuring, compared to a pixel-based image or model. The WO 2017 / 058710 disclosure also claims that the projection unit comprises a headmounted device to display the images or model. In this context, head mounting refers to the surgeon’s head, rather than on the patient; for example, by using a virtual or an augmented reality glasses product. The device claimed here is for mounting to the patient’s head to maintain alignment between the laser projection and the patient’s face.

[0008] United States Patent No. 5,280,342 discloses a profilometry system that can be used by surgeons dealing with malformation of body portions of patients. A collimated light beam is projected through one of a selected number of customized grid patterns which are projected upon the select body portion of the patient. The surgeon then determines from this projected grid the presence of any deviations from certain "standard" orientation goals and thus what reconstruction is needed to correct for the malformation.

[0009] The system disclosed in Patent No. 5,280,342 displays lines and grids from a projector onto the patient but it is not mounted to the patient and would not be intended for use in an operating room. The device in this disclosure is designed specifically for intra-operative assessment, as well as when the patient is awake in an upright position for pre-operative assessment. By registering the device to the patient’s occlusion, pre-operative and intraoperative measurements can be compared relative to each other as the alignment remains constant (as occlusion does not change).

[0010] United States Patent No. 7,436,988 discloses a method of human face authentication which uses a 3D triangular facial mesh input to extract the bilateral symmetry plane of the surface of the face which is used to compute the symmetry profile based on the intersection between the symmetry plane and the facial surface. The method disclosed in Patent No. 7,436,988 displays lines and grids digitally for assessing symmetry using a computer system based on a 3D scan of the patient. The device in this disclosure projects lines and grids physically for assessing symmetry directly on the patient’s face without any additional computational system.

[0011] SUMMARY

[0012] The development of a tool for pre-operative and on-table assessments aims to optimize patient outcomes, reduce surgery time, and decrease reoperation rates in nasal surgery, which would be very beneficial. The present disclosure provides a device used to project a laser line(s) and or grids onto a patient’s face to assess symmetry and / or alignment during facial and / or nasal plastic surgery procedures.

[0013] The present disclosure provides a facial alignment tool, comprising a moldable mouth guard custom fitted to the patients’ dental occlusion to be attached to a support plate in the patient’s mouth. A flange is rigidly attached at its proximal edge to the front of the support plate and extends past the lips to magnetically attach to a lateral positioning component integrated with a rigid beam that is rigidly attached at its proximal end to the lateral positioning component. A light source mounted to a distal end to the rigid beam by an adjustable laser mount configured to allow rotation and superior-inferior translation of the laser light source in the adjustable laser mount. The laser source mounted such that when a patient has the occlusal plate in their mouth the light source emits visible light projected onto the patient’s face, and adjusting the positioning devices moves the rigid beam and the light source attached thereto with respect to the patient’s face.

[0014] The light source is a focused light source emitting in the visible portion of the spectrum. The focused light source may be any one of a laser or a light emitting diode emitting in the visible portion of the spectrum.

[0015] The light source is a laser emitting in the visible portion of the spectrum and may be a laser pointer that emits a laser line beam.

[0016] The lateral positioning component may be a milli- or micro-positioner with at least 8 mm of lateral translation to allow alignment across a wide range of nasal deviation and with anatomic landmarks.

[0017] The positioning component may be any one of a screw-based adjustment mechanism, gear-based adjustment mechanism, calipers, micrometers, or moveable measurement rulers with at least 8 mm of lateral translation to allow alignment with anatomic landmarks. The positioning component mechanisms may be integrated into the designed parts or a commercially available product integrated and attached to adjacent components. The anatomic landmarks may be any one or combination of the patient’s facial midline, medial canthi, lateral canthi, pupillary lines, dental midline, frontal midline, maxillary midline and across the maximum nasal deviation.

[0018] The light source is configured to emit a light pattern having a preselected geometrical shape which may be a light pattern of any one or combination of one or more vertical lines, one or more horizontal lines, one or more of both vertical lines and horizontal lines and a preselected grid pattern.

[0019] The rigid beam may include two (2) or more telescoping beam members that can be telescoped with respect to each other to adjust the distance the light source is located with respect to the patient’s face, and including a locking mechanism to lock the two or more telescoping beam members to give a preselected length of the rigid beam. Telescoping could also be actuated with a rack and pinion gear mechanism.

[0020] The rigid beam may have a length selected so that the light source is at least 5 centimeters from the patient’s mouth for positioning in front of the nose.

[0021] The light source may include a focusable optical lens for focusing the light projected onto the patient’s face depending on the distance between the light source and the patient’s face.

[0022] A further understanding of the functional and advantageous aspects of the disclosure can be realized by reference to the following detailed description and drawings.

[0023] BRIEF DESCRIPTION OF THE DRAWINGS The disclosure will be more fully understood from the following detailed description thereof taken in connection with the accompanying drawings, which form part of this application, and in which:

[0024] Figure 1 is a perspective view of the facial alignment tool disclosed herein showing a light source 28 connected to a mouth guard 14 by a rigid beam 26.

[0025] Figure 2 is a top view of the facial alignment tool of Figure 1.

[0026] Figure 3a is a side view of the facial alignment tool of Figure 1.

[0027] Figure 3b is a perspective view of the facial alignment tool shown in Figure 1 but viewed from the other direction compared to the view in Figure 1.

[0028] Figure 4a shows the facial alignment tool coupled to a patient’s mouth / head looking at the patient’s face.

[0029] Figure 4b shows a perspective view of the facial alignment tool coupled to a patient’s mouth / head.

[0030] DETAILED DESCRIPTION

[0031] The details of the facial alignment tool are described below. Although embodiments of the present invention are disclosed herein, the disclosed embodiments are merely exemplary and it should be understood that the invention may include many alternative forms. Furthermore, the Figures are not drawn to scale and some features may be exaggerated or minimized to show details of particular features while related elements may have been eliminated to prevent obscuring novel aspects. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for enabling someone skilled in the art to employ the present invention in a variety of manners.

[0032] As used herein, the terms “comprises”, “comprising”, “includes” and “including” are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in this specification including claims, the terms “comprises”, “comprising”, “includes” and “including” and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components.

[0033] As used herein, the terms “about” and “approximately”, when used in conjunction with ranges of dimensions, compositions of mixtures or other physical properties or characteristics, is meant to cover slight variations that may exist in the upper and lower limits of the ranges of dimensions so as to not exclude embodiments where on average most of the dimensions are satisfied but where statistically dimensions may exist outside this region. It is not the intention to exclude embodiments such as these from the present invention.

[0034] As used herein, the coordinating conjunction “and / or” is meant to be a selection between a logical disjunction and a logical conjunction of the adjacent words, phrases, or clauses. Specifically, the phrase “X and / or Y” is meant to be interpreted as “one or both of X and Y” wherein X and Y are any word, phrase, or clause.

[0035] Referring to Figures 1 to 3b inclusive, a facial alignment tool shown generally at 10 which during use is anchored to the patient’s upper teeth with a commercially available moldable mouth guard 14 to which a support plate 12 is attached as shown in Figure 2. The mouth guard 14 may be for example a Safe Jawz® but the present device is not restricted to this particular mouth guard. The mouth guard 14 is custom molded for the patient and is shaped ahead of the clinical assessment and / or surgery procedure(s). In use, the mouth guard 14 is then affixed to the support plate 12 by, but not limited to, gluing, snap / press fit, magnetic attachment and screw fixation to mention just a few methods. The mouth guard 14 may be based on commercially available products used to prevent teeth grinding or protective sports equipment. Anchoring the device 10 to the teeth via mouth guard 14 and support plate 12 allows for visual comparisons to the midline of the maxilla and the middle of the central incisor teeth.

[0036] The support plate 12 connects from the teeth anchoring to a lateral translation component using a flange 16 that may include embedded magnets. In use, the flange 16 connects to a lateral translation component 20 by, but not limited to, magnetic attachment, gluing, snap / press fit, and screw fixation to mention just a few methods. The proximal end of a rigid beam 26 is coupled to the lateral translation component 20 in such a way that by adjusting a screwbased adjustment mechanism 22 integrated into designed flange 16 and rigid beam components 26, the rigid beam 26 is laterally displaced.

[0037] In an alternative embodiment, the lateral translation component 20 may for example be a commercially available micro-positioner component that is integrated and attached to the adjacent components. While Figures 1 and 2 show a screw-based adjustment mechanism, it will be appreciated that an embodiment of the facial alignment device may use custom integrated milli- or micro-positioning with at least 8 mm of lateral translation. A small lateral translation ruler 18 (Figure 1) may be attached to the lateral translation component 20 to quantify the lateral translation. In another alternative embodiment, the lateral translation ruler could be replaced with a digital readout of translation (i.e., similar to a caliper or micrometer device). It will be appreciated that other types of positioners may be used, including, but not limited to calipers, micrometers, or a measurement ruler on a sliding track or with a gear mechanism. As seen in the perspective view of Figure 1 , a distal end of rigid beam 26 is rigidly connected to one end of a rigid beam 27 perpendicular to and in the same plane as rigid beam 26 and the other end of beam 27 is connected to a rigid beam 29 extending upwards and perpendicular beam 27.

[0038] A light source 28 (which may be a laser or light emitting diode) emitting in the visible part of the spectrum is contained in a housing 32 mounted to the top of rigid beam 29 using a mount 30 which is configured to provide adjustable rotation and superior-inferior translation of the light source 28. A maintained- type button switch 42 is a component of the housing 32 cap that is electronically connected to activate the light source 28.

[0039] The laser mount 30 rotation and superior-inferior translation may be actuated with a gear or screw-based adjustment mechanism integrated into the component design. A knob 36 is rotated to adjust a worm gear arrangement 34 to provide the adjustable rotation of the light source 28. A knob 40 is rotated to adjust a spur gear arrangement in a gear support plate 38 to adjust the superior-inferior translation of the light source 28. The rotation of laser light source 28 enables the clinician to adjust the laser lines parallel to the facial midline perpendicular to the inter-canthal line. The superior-inferior translation enables the clinician to adjust the laser lines between the inter-canthal line and the alar rims or elsewhere along the nose. The rigid beam 26 extends the light source 28 anteriorly away from the patient’s face and rigid beam 29 extends the light source 28 superiorly from the occlusal plane of the teeth and mouth to enable the light to shine across the whole facial region of the patient.

[0040] With the configuration of rigid beam 26, rigid beam 27 and rigid beam 29, light source 28 is offset from beam 26 by the length of beam 27. Rigid beam 27 connects beam 26 and beam 29 with a chamfered-type transition. In alternative embodiments, the anterior and superior beams could connect with other designed transitions, including fillets, bevels, or be configured to be directly connected. Rigid beams 26, 27, and 29 may include cross-sectional geometries to increase rigidity and beam stiffness, such as I-beam, C-beam, or U-beam cross-sections.

[0041] The rigid beam 26 has a length selected so that the light source 28 is at least 5 centimeters from the patient’s face. The rigid beam 26 can have a longer length depending on how far the clinician wants the light source from the patient’s face. The light source 28 may include a focusable optic lens for focusing the light on the patient’s face depending on how far it is from the face. While device 10 is shown using one (1) light source 28, it will be appreciated that more than one light source 28 can be used and mounted to the distal end of rigid beam 26, depending on the type of data the clinician is looking to obtain.

[0042] In an embodiment the rigid beam 26 may be made of two (2) or more telescoping beam members that can be telescoped with respect to each other to adjust the distance the light source 28 is from the patient’s face, and includes a locking mechanism to lock the telescoping beam members to give a preselected length of the rigid beam 26 or a gear-based mechanism (for example, a rack and pinion) to adjust the telescoping beam length.

[0043] The light source 28 may be a commercially available laser pointer with a laser line beam with focusing optics. The laser 28 could alternatively be cross line beam that illustrates where the facial midline is perpendicular to the eyeline, for example. Alternatively, a variety of other laser patterns, such as various grids, could be used to assess position, shape and symmetry. The laser electronics (for example, the laser diode, batteries, wiring, and switch) may also be a custom component designed as a removable insert that may be placed in the fully sealed housing 32 to facilitate sterilization. As the clinician rotates the adjustment screw 22 the laser 28 undergoes lateral translation.

[0044] Referring to Figures 4a and 4b, the facial alignment tool 10 is shown coupled to a patent’s head. Lateral translation, superior-inferior translation, and rotation allows the surgeon to adjust the laser’s position on the face to assess relative positions. The laser line 50 emitted by laser 28 enables the surgeon to visually assess anatomic deviations from the patient’s facial midline, especially for nasal asymmetries. The lateral translation enables the surgeon to find the facial midline and re-assess after any steps taken in the corrective procedure. A key aspect of the present facial alignment device is the use of the mouth guard 14 which allows us to use the teeth as a registration modality so that alignment of device 10 can be performed pre-operative, intra-operative and post-operative in the same orientation.

[0045] As noted above, alternative embodiments to the laser line may include multiple parallel lines, or a cross or a linear grid pattern. Alternatively, multiple lasers could be added to project different landmark lines across the face, which could also include different colours of light. In the case of a projected grid, or multiple perpendicular and parallel lines, the offset of the nasal midline from the facial midline can be measured and asymmetries within the nose itself (i.e. , the mirror image across the midline) can be assessed and measured.

[0046] In an embodiment the present disclosure provides a facial alignment tool, comprising a moldable mouth guard specifically fabricated to be received in a patient’s mouth, a support plate configured to receive the moldable mouth guard, a flange rigidly attached at its proximal edge to a front of the support plate, a positioning component attached to the distal edge of the flange, a rigid beam rigidly attached at its proximal end to the positioning component such that actuating the positioning component laterally translates the rigid beam, and a light source mounted to a distal end to the rigid beam by an adjustable laser mount configured to allow translation and rotation of said laser light source in said adjustable laser mount, said laser source mounted such that when a patient has the support plate with the moldable mouth guard in their mouth the light source emits visible light projected onto the patient’s face, and adjusting the positioning components moves the rigid beam and the light source attached thereto with respect to the patient’s face.

[0047] In an embodiment the light source is a focused light source emitting in the visible portion of the spectrum.

[0048] In an embodiment the focused light source is any one of a laser or a light emitting diode emitting in the visible portion of the spectrum.

[0049] In an embodiment the light source is a laser emitting in the visible portion of the spectrum. In an embodiment the laser is a laser pointer that emits a laser line beam.

[0050] In an embodiment the positioning component is a milli- or micropositioner with at least 8 mm of lateral translation to allow alignment with anatomic landmarks.

[0051] In an embodiment the positioning component is actuated with a screw or gear-based mechanism or is any one of calipers, micrometers, or moveable measurement rulers with at least 8 mm of lateral translation to allow alignment with anatomic landmarks.

[0052] In an embodiment the anatomic landmarks are any one or combination of the patient’s facial midline, medial canthi, lateral canthi, pupillary lines, dental midline, frontal midline, maxillary midline and across the maximum nasal deviation.

[0053] In an embodiment the source is configured to emit a light pattern having a pre-selected geometrical shape.

[0054] In an embodiment the preselected geometric shape is a light pattern of any one or combination of one or more vertical lines, one or more horizontal lines, one or more of both vertical lines and horizontal lines and a preselected grid pattern.

[0055] In an embodiment the rigid beam includes two or more telescoping beam members that can be telescoped with respect to each other to adjust the distance the light source is located with respect to the patient’s face, and including a locking mechanism to lock the telescoping beam members to give a preselected length of the rigid beam. In an embodiment the rigid beam has a length selected so that the light source is at least 5 centimeters from the patient’s face.

[0056] In an embodiment the light source includes a focusable optical lens for focusing the light projected onto the patient’s face depending on the distance between the light source and the patient’s face.

[0057] In an embodiment the support plate, said flange, said positioning component and said rigid beam are substantially coplanar.

[0058] In an embodiment the distal end of said rigid beam has a vertically raised section so that the light source is raised relative to the support plate.

[0059] In an embodiment the facial alignment tool further comprises an adjustable rotation mechanism coupled to the light source to provide the adjustable rotation of the light source.

[0060] In an embodiment the adjustable rotation mechanism includes a worm gear with a manually operated knob coupled to the worm gear.

[0061] In an embodiment the facial alignment tool further comprises an adjustable superior-inferior translation mechanism coupled to the light source to adjust the superior-inferior translation of the light source.

[0062] In an embodiment the adjustable superior-inferior translation mechanism includes a spur gear in a gear support plate with a manually operated knob coupled to said spur gear.

[0063] In an embodiment the facial alignment tool further comprises a lateral translation ruler attached to the lateral translation component for quantifying an amount of lateral translation during actuation of the lateral translation component. In an embodiment the source is configurable to emit any one of a single beam of light, a grid of light beams having preselected grid patterns to assess symmetry or deviations at one or multiple regions of the face at the same time.

Claims

THEREFORE WHAT IS CLAIMED IS:1 . A facial alignment tool, comprising: a moldable mouth guard specifically fabricated to be received in a patient’s mouth; a support plate configured to receive said moldable mouth guard; a flange rigidly attached at its proximal edge to a front of said support plate; a positioning component attached to the distal edge of said flange; a rigid beam rigidly attached at its proximal end to said positioning component such that actuating the positioning component laterally translates the rigid beam; and a light source mounted to a distal end to said rigid beam by an adjustable laser mount configured to allow translation and rotation of said laser light source in said adjustable laser mount, said laser source mounted such that when a patient has said support plate with said moldable mouth guard in their mouth the light source emits visible light projected onto the patient’s face, and adjusting the positioning components moves the rigid beam and the light source attached thereto with respect to the patient’s face.

2. The facial alignment tool according to claim 1 , wherein the light source is a focused light source emitting in the visible portion of the spectrum.

3. The facial alignment tool according to claim 2, wherein the focused light source is any one of a laser or a light emitting diode emitting in the visible portion of the spectrum.

4. The facial alignment tool according to claim 1 , wherein the light source is a laser emitting in the visible portion of the spectrum.

5. The facial alignment tool according to claim 4, wherein the laser is a laser pointer that emits a laser line beam.

6. The facial alignment tool according to any one of claims 1 to 4, wherein the positioning component is a milli- or micro-positioner with at least 8 mm of lateral translation to allow alignment with anatomic landmarks.

7. The facial alignment tool according to any one of claims 1 to 4, wherein the positioning component is actuated with a screw or gear-based mechanism or is any one of calipers, micrometers, or moveable measurement rulers with at least 8 mm of lateral translation to allow alignment with anatomic landmarks.

8. The facial alignment tool according to claims 6 or 7, wherein the anatomic landmarks are any one or combination of the patient’s facial midline, medial canthi, lateral canthi, pupillary lines, dental midline, frontal midline, maxillary midline and across the maximum nasal deviation.

9. The facial alignment tool according to any one of claims 1 to 8, wherein the source is configured to emit a light pattern having a pre-selected geometrical shape.

10. The facial alignment tool according to claim 9, wherein the preselected geometric shape is a light pattern of any one or combination of one or more vertical lines, one or more horizontal lines, one or more of both vertical lines and horizontal lines and a preselected grid pattern.11 . The facial alignment tool according to any one of claims 1 to 10, wherein said rigid beam includes two or more telescoping beam members that can be telescoped with respect to each other to adjust the distance the light source is located with respect to the patient’s face, and including a locking mechanism to lock the telescoping beam members to give a preselected length of the rigid beam.

12. The facial alignment tool according to any one of claims 1 to 11 , wherein said rigid beam has a length selected so that the light source is at least 5 centimeters from the patient’s face.

13. The facial alignment tool according to any one of claims 1 to 12, wherein said light source includes a focusable optical lens for focusing the light projected onto the patient’s face depending on the distance between the light source and the patient’s face.

14. The facial alignment tool according to any one of claims 1 to 13, wherein said support plate, said flange, said positioning component and said rigid beam are substantially coplanar.

15. The facial alignment tool according to any one of claims 1 to 13, wherein the distal end of said rigid beam has a vertically raised section so that the light source is raised relative to the support plate.

16. The facial alignment tool according to any one of claims 1 to 15, further comprising an adjustable rotation mechanism coupled to the light source to provide the adjustable rotation of the light source.

17. The facial alignment tool according to claim 16, wherein the adjustable rotation mechanism includes a worm gear with a manually operated knob coupled to said worm gear.

18. The facial alignment tool according to any one of claims 1 to 17, further comprising an adjustable superior-inferior translation mechanism coupled to the light source to adjust the superior-inferior translation of the light source.

19. The facial alignment tool according to claim 18, wherein the adjustable superior-inferior translation mechanism includes a spur gear in a gear support plate with a manually operated knob coupled to said spur gear.

20. The facial alignment tool according to any one of claims 1 to 19, further comprising a lateral translation ruler attached to the lateral translation component for quantifying an amount of lateral translation during actuation of the lateral translation component.21 . The facial alignment tool according to any one of claims 1 to 20, wherein the light source is configurable to emit any one of a single beam of light, a grid of light beams having preselected grid patterns to assess symmetry or deviations at one or multiple regions of the face at the same time.

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