Barrier device, method of forming same, method of operating intraoral scanner

Abstract

A barrier device, a method of forming the same, a method of operating an intraoral scanner wherein the barrier device comprises: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the scanner, the cover comprising a window allowing transmission of an optical signal between the scanner and an external environment; a scanner includes a cover adapted to cover a handle of the scanner, and a flexible sleeve adapted to cover the handle of the scanner, the flexible sleeve coupled to the cover at an interface region configured to prevent fluid from passing through a barrier device between the cover and the sleeve, where the flexible sleeve is more flexible than the cover. The barrier device according to the present application can reduce the opportunity of cross contamination between patients and / or protect the scanning device from physical damage.

Description

[0001] This application is a divisional application of an application whose applicant is "Allain Technologies Co., Ltd.", whose application date is July 29, 2020, whose application number is 202080054458.9, and whose invention name is "Full Scanner Barrier for Intraoral Devices".

[0002] Incorporation by reference

[0003] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0004] A bio-barrier covering for a medical device having an optical component, such as an intra-oral dental scanning device, is described. Background Art

[0005] The surfaces of medical devices can serve as reservoirs for microorganisms that can cause infection to patients and healthcare workers through cross contamination. Pathogen transmission can occur directly when a patient or healthcare worker comes into direct contact with a contaminated object, or indirectly when a healthcare worker's hands or gloves become contaminated by contact with a contaminated object and the healthcare worker then touches the patient with those contaminated hands or gloves. In the case of medical devices, care must be taken to prevent such direct or indirect cross contamination, as these devices are often handled by healthcare workers and are close to or in contact with patients.

[0006] One way to prevent cross contamination is to sterilize the entire medical device between patient use. However, care must be taken to ensure that the sterilization process fully disinfects the medical device between patient use, especially when the medical device surface has cracks and cavities where contaminants may be trapped. Another way to reduce cross contamination is to cover the entire surface of the medical device with a flexible sheet of polymer material (such as a plastic bag or liner), which can be discarded after use by one patient and replaced with a new bag or liner when used by another patient. For example, camera probes and ultrasonic scanning devices are usually covered by disposable plastic bags. However, for some types of scanner devices, simple plastic sheets may not be applicable. For example, some optical scanners can be configured to transmit and / or receive optical signals (such as light) with high precision in order to form images with appropriate resolution. In this case, a flexible plastic material placed on such an optical scanner may interfere with correct imaging. For example, the plastic may not have sufficient transmittance and / or the material may move (such as displacement and sliding) during the scanning operation, thereby interfering with reliable transmission of optical signals to and / or from the device.

[0007] Therefore, what is needed is an improved bio-barrier covering for medical devices. Summary of the invention

[0008] A barrier device for an intraoral scanner can prevent contamination of the intraoral scanner without interfering with the operation of the scanner. The barrier device described herein can be used to cover a medical device to provide a biological barrier between the medical device and the external environment. The barrier device can reduce the chance of direct and indirect cross-contamination and in some cases protect the medical device from damage. As described herein, the barrier device or a portion of the barrier device can be referred to as a cover, a covering, a protector, a sleeve, a sheath, or simply a barrier.

[0009] According to one aspect, a removable barrier device for covering a handheld intraoral scanner is provided, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner located at a distal end of the scanner, the cover comprising a window allowing transmission of optical signals between the scanner and an external environment; and a flexible sleeve adapted to cover a handle of the scanner, the flexible sleeve being coupled to the cover at an interface region configured to prevent fluid from passing through the barrier device between the cover and the sleeve, wherein the flexible sleeve is more flexible than the cover.

[0010] According to some embodiments, the interface region comprises a tape and / or a gasket.

[0011] According to some embodiments, the gasket comprises one or more of the following forms: an O-ring, an elastic material.

[0012] According to some embodiments, the gasket is integral with the proximal cap or the gasket is integral with the flexible sleeve or the gasket is arranged on the proximal cap and the flexible sleeve to provide a press fit.

[0013] According to some embodiments, the interface region includes a clip configured to releasably couple the cover and the sleeve, or the interface region includes a weld region that couples the cover and the sleeve as one.

[0014] According to some embodiments, the barrier device further comprises a gasket sealing the cover and the sleeve together.

[0015] According to some embodiments, the cover is adapted to hold the window in a fixed position relative to optical components of the scanner.

[0016] According to some embodiments, the cover is adapted to cover the one or more actuators of the handle, the cover being thin and flexible enough for a user to actuate the one or more actuators from an outer surface of the cover.

[0017] According to some embodiments, the sleeve is more flexible than the cover.

[0018] According to some embodiments, the barrier device has a length ranging from about 6 inches to about 20 inches from the distal end of the barrier device to the proximal end of the barrier device.

[0019] According to some embodiments, the barrier device further comprises an airflow guide configured to guide airflow into and out of the scanner, wherein the cover is configured to cover at least a portion of the airflow guide.

[0020] According to some embodiments, the cover and the sleeve are made of one or more materials that are substantially impermeable to contaminants.

[0021] According to some embodiments, one or both of the cover and the sleeve are made of an autoclavable material.

[0022] According to some embodiments, the proximal cover includes two or more components configured to be mechanically connected together around the scanning portion of the intraoral scanner.

[0023] According to some embodiments, the two or more components are configured to snap fit together.

[0024] According to another aspect, a removable barrier device for covering a handheld intraoral scanner is provided, the barrier device comprising: a cover portion adapted to be mounted on a distal end of the intraoral scanner, the cover portion comprising at least one rigid window allowing transmission of optical signals between the scanner and an external environment; an engagement area within the cover portion configured to removably engage with the distal end of the scanner and to secure a fixed relationship of the window relative to the scanner; and a flexible sleeve portion extending proximally from the cover portion and adapted to cover a handle and a cable of the intraoral scanner, wherein the flexible sleeve and the cover are configured to prevent fluid from flowing into the intraoral scanner, and wherein the flexible sleeve portion and the cover portion are formed of the same flexible material.

[0025] According to another aspect, a removable barrier device for covering a handheld intraoral scanner is provided, the removable barrier device comprising: a cover adapted to be mounted on a probe of the scanner, the cover comprising: a distal portion having a plurality of walls and formed of a first material, the plurality of walls defining an inner cavity for accommodating a distal end of the probe, wherein at least one of the plurality of walls comprises at least one window allowing transmission of an optical signal between the probe and an external environment; and a proximal portion molded to the distal portion and formed of a second material different from the first material; and a flexible sleeve adapted to cover a handle of the scanner, the flexible sleeve being connected to the proximal portion of the cover at an interface region configured to prevent fluid from passing through the barrier device between the cover and the sleeve.

[0026] According to another aspect of the present application, a method for forming a removable barrier device for covering a handheld intraoral scanner is also provided, the method comprising: forming a cover suitable for being mounted on a probe of the scanner by: forming a distal portion of the cover by injection molding a first material, wherein the distal portion includes a plurality of walls defining an inner cavity, wherein one of the plurality of walls includes at least one window opening or at least one window formed by the first material; forming a proximal portion of the cover by overmolding a second material on the first material so that the second material is combined with the first material, the first material being different from the second material, wherein the proximal portion is combined to edges of the plurality of walls of the distal portion to form an extension of the plurality of walls of the distal portion; and combining a flexible sleeve to the proximal portion of the cover so that an interface area between the flexible sleeve and the proximal portion of the cover is capable of preventing fluid from passing through, wherein the sleeve is suitable for covering the handle of the scanner and is more flexible than the distal portion of the cover.

[0027] According to another embodiment, a method for operating an intraoral scanner is provided, the method comprising: scanning an identifier of a sleeve using the intraoral scanner, wherein the identifier is located on the sleeve; identifying one or more features specific to the sleeve from a database based on the identifier; and adjusting the operation of the intraoral scanner based on the identified one or more features.

[0028] According to yet another embodiment, a removable barrier device for covering a handheld intraoral scanner is provided, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner located at a distal end of the intraoral scanner, the cover comprising a window allowing transmission of optical signals between the intraoral scanner and an external environment; wherein the cover has a wall sufficiently rigid to maintain the window in a fixed position relative to an optical window of the intraoral scanner, wherein the wall comprises one or more protrusions, one or more recesses, or one or more protrusions and recesses configured to removably secure the cover to the scanning portion of the intraoral scanner; and a flexible sleeve extending proximally from the cover and adapted to cover a handle of the intraoral scanner, wherein the flexible sleeve is more flexible than the cover.

[0029] In addition, the present application also provides a removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover suitable for being mounted on a scanning portion of the intraoral scanner located at a distal end of the intraoral scanner, the cover comprising a window allowing transmission of optical signals between the intraoral scanner and the external environment; wherein a wall of the cover comprises one or more protrusions, one or more recesses, or one or more protrusions and recesses, configured to removably fix the cover to the scanning portion of the intraoral scanner; and a flexible sleeve suitable for covering the handle of the intraoral scanner, the flexible sleeve being connected to the cover at an interface area, the interface area being configured to prevent fluid from passing through the barrier device between the cover and the sleeve, wherein the flexible sleeve is more flexible than the cover.

[0030] According to another aspect, a removable barrier device for covering a handheld intraoral scanner is provided, the barrier device comprising: a cover portion adapted to be mounted on a distal end of the intraoral scanner, the cover portion comprising at least one rigid window allowing transmission of optical signals between the intraoral scanner and an external environment; a coupling area within the cover portion configured to removably couple with the distal end of the intraoral scanner and secure a fixed relationship of the at least one rigid window relative to the intraoral scanner, wherein the coupling area comprises one or more protrusions, one or more recesses, or one or more protrusions and recesses; and a flexible sleeve portion extending proximally from the cover portion and adapted to cover a handle and a cable of the intraoral scanner, wherein the flexible sleeve portion and the cover portion are configured to prevent fluid from flowing into the intraoral scanner, and wherein the flexible sleeve portion is more flexible than the cover portion.

[0031] According to yet another aspect, a method is provided, the method comprising: coupling a flexible sleeve to a removable protective end member, the protective end member being attached to a distal end of a probe of an intraoral scanner to allow transmission of optical signals between the probe and an external environment, such that the flexible sleeve at least partially surrounds a handle of the intraoral scanner, wherein the removable protective end member is formed from a first material; and sealing a distal region of the flexible sleeve to a joining region on an outer surface of the removable protective end member to form an airtight seal between the removable protective end member and the flexible sleeve.

[0032] According to another aspect, a device is provided, comprising: a removable protective end member configured to be removably connected to a distal end of a probe of an intraoral scanner configured to collect optical data of a subject's dentition; and a flexible sleeve having a distal opening configured to be inserted over the removable protective end member and to engage with an outer surface of the removable protective end member to form an airtight seal therewith.

[0033] Also provided is a device comprising: a removable protective end member configured to be removably connected to a distal end of a probe of an intraoral scanner configured to collect optical data of a subject's dentition, the removable protective end member comprising a window allowing transmission of optical signals between the probe and an external environment; and a flexible sleeve having a distal opening configured to be inserted over the removable protective end member and engage with an outer surface of the removable protective end member to form an airtight seal therewith.

[0034] According to another aspect of the present application, a removable barrier device for covering a handheld intraoral scanner is provided, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner located at a distal end of the intraoral scanner, the cover comprising a window allowing transmission of optical signals between the intraoral scanner and an external environment; wherein the cover has walls sufficiently rigid to maintain the window in a fixed position relative to an optical window of the intraoral scanner; and a flexible sleeve extending proximally from the cover and adapted to cover a handle of the intraoral scanner, wherein the flexible sleeve is connected to the cover at an interface region configured to prevent fluid from passing through the barrier device between the cover and the sleeve.

[0035] According to some embodiments, a barrier device is configured to cover an optical scanning device (also referred to herein as a scanner, scanning device, scanning system, or optical device), such as an intraoral dental scanning device for imaging a patient's dentition. The barrier device may include one or more windows adapted to allow transmission of optical signals to and / or from the scanning device. The window may be made of a material that is at least partially optically transparent. In some cases, the window includes optically transparent glass, quartz, sapphire, and / or an optically transparent polymer material. In some cases, the window is integrally formed in the barrier. The barrier device may be configured to align the window of the barrier device with an optical component of the scanning device (such as an optical device window). The barrier device may be configured to maintain the window in a fixed position relative to the optical component, for example, during a scanning operation. In some variations, the barrier device is integral with the window (e.g., formed as a single, unitary member, formed of the same material in some variations). The window may be connected to the barrier device and may be sealed to the barrier device by, for example, welding, bonding, and the like.

[0036] The barrier device may include different parts having features suitable for covering different corresponding parts of the scanning device. For example, the barrier device may include a cover for covering the scanning portion of the scanner and a cover for covering the handle of the scanner. The cover and the cover may be made of one or more materials that are substantially impermeable to contaminants; the cover and the cover may be made of the same material and may be integrally formed with each other (e.g., formed as a single, integral, continuous part), or may be made of different materials. The cover may be relatively rigid or include rigid portions to keep the window aligned relative to the optical components of the scanner. The cover may be relatively flexible to allow a user to operate buttons, switches, or touch pads on the handle of the scanner.

[0037] The barrier device may include an interface region connecting the cover and the sleeve, which may also be substantially impermeable to contaminants and provide a seal to prevent biological material from passing between the cover and the sleeve. In some cases, the interface region provides a hermetic seal between the cover and the sleeve (and / or between the barrier device and the scanner or a region of the scanner). According to some embodiments, the interface region includes an adhesive tape that may have a specified width to provide an adequate seal. In some cases, the interface region includes a clip that releasably couples the cover and the sleeve. In some cases, the interface region includes a fusion region where the material(s) of the cover and the sleeve are fused (e.g., melted) together.

[0038] The barrier device described herein may include a cover made of two or more materials. A first portion of the cover may be made of a first material that is sufficiently rigid and optically transparent to cover the area of ​​the scanning probe that transmits and receives optical signals. A second portion of the cover may be made of a second material that can be molded and / or welded to the first portion and the sleeve to form a sealed barrier device, effectively serving as a biological barrier for the intraoral scanner probe.

[0039] According to some embodiments, during the molding operation, the window of the barrier device is integrally formed with at least a portion of the cover. For example, the wall and the window can be formed during an injection molding process, wherein both the window and the wall are made of an optically transparent polymer. The thickness of the window and / or the wall and the injection molding process itself can be specified to provide a sufficiently transparent and uniform window.

[0040] According to some embodiments, the window of the barrier device is formed separately from the wall of the cover. In one embodiment, the wall of the cover is formed using an injection molding process, and the window is adhesively coupled to the cover. The window can be positioned relative to the opening of the cover to allow optical signals to be transmitted through the cover.

[0041] The barrier devices described herein are well suited for providing a biological barrier for intraoral optical scanning systems, such as those manufactured by ALIGN TECHNOLOGY, INC., headquartered in San Jose, California, USA. Scanners and other scanning devices and systems. The barrier device described herein may include any features of the optical scanning devices and protective sleeves described in U.S. Patent Application No. 16 / 105,916, entitled “PROTECTIVE SLEEVE FOR INTRAORAL SCANNER” filed on August 20, 2018 and U.S. Patent Application No. 14 / 192,137, entitled “THERMAL DEFOGGING SYSTEM AND METHOD” filed on February 27, 2014 (now Patent No. 10,111,581), which are all incorporated herein by reference in their entirety.

[0042] For example, described herein is a removable barrier device for covering a handheld intraoral scanner. The barrier device may include: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the scanner, the cover including a window to allow transmission of optical signals between the scanner and an external environment; wherein the cover is adapted to hold the window in a fixed position relative to an optical component of the scanner; and a flexible sleeve extending from the cover and adapted to cover a handle of the scanner.

[0043] Typically, the cover and sleeve are made of one or more materials that are substantially impermeable to contaminants.

[0044] In some variations, the cover (or cover region / cover portion) and the flexible sleeve (or sleeve region) are integrally formed into the same structure, which can be bag-like. Thus, both the cover and the sleeve can be formed from a flexible material (e.g., formed into a plastic bag-like structure). The interior of the device can include an engagement region (e.g., within the cover region or cover portion) that is configured to removably engage with the distal end of the scanner and fixedly secure the window relative to the scanner. For example, the engagement region can be a snap or friction fit region that includes a protrusion that can engage with a contact or attachment on the outside of the distal end of the scanner, such as an elastic housing on the distal end of the scanner. Any suitable engagement member can be used (e.g., an attachment, a snap, a friction fit, a magnetic attachment, etc.).

[0045] In some variations, the flexible sleeve may be coupled to the cover at an interface region that is configured to prevent fluid from passing through a barrier device between the cover and the sleeve. For example, the interface region may include adhesive tape. In some variations, the interface region includes a gasket (e.g., an O-ring), which may be an elastomeric material. The gasket may be integral with the proximal cover. The gasket may be integral with the flexible sleeve. The gasket may be arranged on the proximal cover and the flexible sleeve to provide a compression fit.

[0046] In some variations, the interface region includes a clip configured to releasably couple the cover and the sleeve. The device may include a gasket that can seal the cover and the sleeve together. The interface region may include a weld region that integrally couples the cover and the sleeve. The flexible sleeve may be more flexible than the cover.

[0047] Any of the devices described herein may include a nanostructured anti-reflective material located on at least one side (eg, both sides) of the window and configured to reduce internal reflections from the window.

[0048] Any of these devices can be in a pre-deployed configuration. For example, the flexible sleeve can be held in a folded or compressed pre-deployed configuration within the package. The package can hold the flexible sleeve with the sleeve rolled, folded, or otherwise compressed so that a long passage through the sleeve remains open for insertion of the handle of the intraoral scanner so that the sleeve can be unfolded (unrolled, unfolded, etc.) over the handle and / or cable. This can advantageously prevent tangling, contamination, or scaling of the cover.

[0049] The cover may be adapted to cover the one or more actuators of the handle, the cover being thin and flexible enough to facilitate a user to actuate the one or more actuators from an outer surface of the cover.

[0050] Any of these devices may have a length from the distal end of the barrier device to the proximal end of the barrier device that ranges from about 6 inches to about 20 inches.

[0051] Any of these devices may include an airflow guide configured to direct airflow into and out of the scanner, wherein the cover is configured to cover at least a portion of the airflow guide. The airflow direction may include a channel, a duct, or the like.

[0052] The device may be disposable, or the device may be reusable (including sterilizable, such as autoclavable). For example, one or both of the cover and sleeve may be made of a material that can be autoclavable.

[0053] In some variations, the proximal cover may include two or more components that are configured to be mechanically connected together around a scanning portion of the intraoral scanner. For example, the two or more components may be configured to snap fit together.

[0054] The present invention also describes a method of operating an intraoral scanner, the method comprising: scanning an identifier of a sleeve using the intraoral scanner, wherein the identifier is located on the sleeve; based on the identifier, identifying one or more characteristics specific to the sleeve from a database; and adjusting the operation of the intraoral scanner based on the identified one or more characteristics.

[0055] The one or more characteristics may include information related to the optical characteristics of the window(s) of the sleeve (e.g., thickness, transparency, curvature, material properties, etc.). The one or more characteristics may include information about the sleeve (e.g., batch number, recall, regional use approval, etc.).

[0056] Any suitable identifier may be included, such as a barcode, a QR code, an alphanumeric code, a logo or symbol, etc. The identifier may be located on the inside or outside of the sleeve. In some variations, the identifier is located on a window of the sleeve.

[0057] The step of identifying from a database may include accessing a remote database and / or accessing a local database. In some variations, the local database may be part of the device. The remote and / or local databases may be maintained and / or updated to include new information about the set.

[0058] Adjusting the operation of the intraoral scanner may include adjusting one or more of the following: the usage mode and / or calibration parameters (including focal length, scanning rate, scanning intensity, wavelength, etc.) of the intraoral scanner. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The novel features of the embodiments described herein are set forth with particularity in the appended claims.A better understanding of the features and advantages of the embodiments may be obtained by reference to the following detailed description and accompanying drawings which set forth illustrative embodiments.

[0060] Figure 1A A side view of a variation of an intraoral scanning device (intraoral scanner) is shown.

[0061] Figure 1B A perspective view of another variation of an intraoral scanner is shown, wherein there are multiple inputs (eg, touch-sensitive inputs, buttons, etc.) on the body of the wand.

[0062] Figure 1C A view showing another variation of an intraoral scanner in which the vent is located on the proximal end of the scanner rather than on the handle.

[0063] Figure 1D is configured to connect to Figure 1C An example of a cable interface for an intraoral scanner.

[0064] Figure 1E is configured for sealing Figure 1C An example of a protective cover for the aperture of an intraoral scanner.

[0065] Figure 2A-2L Examples of barrier devices (eg, barrier devices configured as protective sleeves) and components of barrier devices are shown.

[0066] Figure 2A is an example of a barrier device (protective cover) for an intraoral scanner, comprising a semi-rigid or rigid distal region and a thin and flexible proximal portion that is sealed to and extends from the distal region.

[0067] Figure 2B and Figure 2C A rigid or semi-rigid distal portion of a protective sheath (eg, a barrier device) is shown.

[0068] Figure 2D1 is an exemplary schematic diagram of a flexible proximal portion of a protective sheath that may extend from a more rigid or semi-rigid distal region, showing exemplary dimensions (may be + / - 5%, 10%, 15%, 10%, etc.).

[0069] Figure 2D2 is an exemplary schematic diagram of another variation of a proximal portion of a protective sheath that may extend from a more rigid or semi-rigid distal region, also showing exemplary dimensions (may be + / - 5%, 10%, 15%, 10%, etc.).

[0070] Figure 2E-2F4 One example of a method of attaching a flexible proximal portion of the protective sheath to a more rigid distal region using, for example, an adhesive such as tape or an elastic gasket such as an O-ring is shown.

[0071] Figure 2G1 One example of an assembled protective sleeve is shown, comprising a more rigid distal region and a more flexible proximal region with an open support (eg, a paper backing) that may be removed or left in place during use.

[0072] Figure 2G2 Another example of an assembled protective cover is shown that includes a rigid distal region and a more flexible proximal region packaged in a pre-expanded form in which the flexible proximal region is rolled or compressed to enable it to be placed over the distal end of an intraoral scanner and unfolded (e.g., by extension) over the intraoral scanner as described herein.

[0073] Figure 2H-2I Shown as Figure 2G1The protective cover shown is applied to an intraoral scanner (such as a wand of an intraoral scanner) as described herein.

[0074] Figure 2J Another example of a protective sheath is shown where a flexible proximal region is coupled to a more rigid distal region (eg, a distal face of the distal end and / or a slightly more distal region on the outside of the more rigid distal region) by, for example, welding.

[0075] Figure 2K-2L Shown are a perspective view and a top view, respectively, of another variation of a protective cover as described herein, in which the protective cover extends only partway along the handle region of the wand.

[0076] Figure 3A-3D An example of an air flow guide is shown that may be used with an intraoral scanner and optionally with a barrier device.

[0077] Figure 4A-4C An example of another variation of a protective cover as described herein is shown, including a removable clip portion of the barrier device.

[0078] Figure 5 Another embodiment is shown in which the cover includes two or more components configured to be mechanically coupled together to provide a seal around the sleeve and scanner.

[0079] Figure 6A-6L Another embodiment of a barrier device is shown in which the cover of the barrier device includes multiple molded portions to provide an enhanced weld with the sleeve.

[0080] Fig. 6A A side view of the cap showing the distal and proximal portions molded together is shown.

[0081] Figure 6B An aerial view showing a sleeve molded onto the proximal portion of the cap is shown.

[0082] Figure 6C A top view of the cover is shown; Fig.6D A side view of the cover is shown; Fig. 6E A bottom view of the cover is shown.

[0083] Fig. 6F Another bottom view of the cover is shown; Figure 6G Shows Fig. 6F sectional view of .

[0084] Figure 6H A close-up view showing the molded area of ​​the distal portion of the cap is shown; Fig.6I A close-up view showing the molded area of ​​the proximal portion of the cap is shown; Figure 6J The molded areas of the distal and proximal portions of the cap are shown.

[0085] Figure 6K Another close-up view showing the molded area of ​​the distal portion of the cover is shown.

[0086] Figure 6L The drafting angle of the cover is shown.

[0087] Figure 7 An example image of a window is shown, demonstrating the non-uniformity due to the injection molding manufacturing process.

[0088] Figure 8A-8E Shows Figure 6A-Figure 6I A variation of the embodiment having a separately formed window.

[0089] Fig. 8A A perspective view of the cover is shown, showing the separately formed window and adhesive.

[0090] Figure 8B shows a top view of the cover, Figure 8C A side cross-sectional view of the cover is shown.

[0091] Fig.8D shows a perspective view of the cover, Fig. 8E Another side cross-sectional view of the cover is shown.

[0092] Fig. 9 is a flow chart illustrating an example process of forming a cover using an overmolding process.

[0093] Fig. 10A An example of an intraoral scanner is schematically shown.

[0094] Fig. 10B It passes through Fig. 10A Cross-section of an intraoral scanner showing the internal reflection of the window.

[0095] Fig. 10C It passes through Fig. 10A Cross-section of an intraoral scanner where the window includes anti-reflective material to prevent or reduce internal reflections.

[0096] Fig.11 is a schematic diagram of a sleeve including a window including anti-reflective material on both the inner surface (S1) and the outer surface (S2) of the window. DETAILED DESCRIPTION

[0097] Described herein is a covering that provides a biological barrier for a medical device to prevent cross contamination during use on a patient. The barrier device is very suitable for covering an optical scanner operated by a physician (such as a doctor, dentist, orthodontist, dental technician, etc.) to obtain images of the patient's body. Any barrier device described herein can be removed from the optical device so that the barrier device can be easily replaced and / or cleaned between imaging operations. For example, before imaging the patient's teeth, the physician can install the barrier device on the optical device, and then remove the barrier device from the optical device after the imaging operation is completed. In some cases, the barrier device (or a portion of the barrier device) is disposable, so the physician can discard the barrier device (or a portion of the barrier device) as medical waste after use. Then, a new, clean barrier device can be placed on the optical device for subsequent imaging operations. In some cases, the barrier device (or a portion of the barrier device) is reusable, so the physician can properly clean the barrier device (or a portion of the barrier device) before reusing it.

[0098] Figure 1A An example scanning device 100 is shown in accordance with some embodiments. The housing of the scanner 100 may include internal optical components for capturing images of a patient's dentition. Figure 1A The scanner 100 in the present invention is configured as an intraoral scanner and can be a handheld scanner that a physician can hold and manipulate with his hands. In some embodiments, the scanner 100 is connected to a power source and / or a computer via one or more cables 101 (e.g., wires or cables). In some embodiments, the scanner 100 is configured to send data to a display that displays an image of the patient's dentition collected by the scanner 100. In some cases, the scanner 100 is configured to take a two-dimensional image and / or a three-dimensional image of the dentition. In some embodiments, the scanner 100 has its own power source (e.g., a battery) and / or can wirelessly communicate with a computer.

[0099] The housing of the scanner may include a body 108 and a scanning portion 106, the scanning portion including one or more optical components 104 (e.g., optical windows) that transmit optical signals to and / or from the internal optical components. The shape and size of the scanning portion 106 are suitable for manipulating around the patient's dentition and positioning the optical component 104 relative to the patient's dentition. In some embodiments, the scanning portion 106 is located at the distal end of the scanner 100, and the one or more optical components 104 are located at one side of the scanning portion 106. In some cases, at least a portion of the scanning portion 106 may enter or approach the patient's mouth during the scanning operation. The scanning portion 106 may be connected to the body 108 at a non-parallel angle to provide better access and operability around the patient's dentition. The body 108 may include a handle 110, the size and shape of the handle being suitable for the physician to hold by hand. The body 108 may include one or more actuators 112 (e.g., buttons, switches, touch pads, and / or sliders) for actuating one or more functions of the scanner 100. In some cases, the body includes one or more holes 116 (e.g., openings) that allow airflow into and out of ventilation components in the interior cavity of the scanner 100 to cool the internal components of the scanner 100. In some cases, the proximal end of the body 108 tapers at a cable interface region 114 that couples the cable 101 to the body 108.

[0100] Figure 1B A stereoscopic view of an intraoral scanner 100 is shown, which includes one or more inputs on a handle portion for controlling the actions of the scanner. In this example, the scanner includes a touch-sensitive input (e.g., a touch sensor 130) and one or more buttons 140. The scanner may be a medical scanning device for scanning objects other than the oral cavity. Other types of medical scanning devices 100 to which embodiments of the present invention may be applied include other types of optical scanners, x-ray devices, ultrasonic devices, and the like. Each such medical scanning device may include at least: an image sensor for generating a medical image; a communication module for transmitting the medical image to a computing device; and a touch sensor that can be used to manipulate the medical image on the computing device and / or a representation of the scanned object generated from the medical image. These components may be directly coupled together or coupled together via a bus. The touch sensor may also be used to navigate a user interface of a medical scanning program running on the computing device. The medical scanning device may also include one or more buttons that may be used to initiate the generation of a medical image and to actuate and / or deactivate the touch sensor.

[0101] In one embodiment, the intraoral scanner 100 may include a probe 111 extending from one end of the body of the intraoral scanner 100. The probe 111 may include a scan head 120 that captures optical data and provides the optical data to one or more optical sensors disposed within the intraoral scanner 100.

[0102] In one embodiment, the intraoral scanner 100 includes a semiconductor laser unit that emits a focused beam. The beam may pass through an illumination module disposed within the intraoral scanner 100 that splits the beam into an array of incident beams. For example, the illumination module may be a grating or microlens array that splits the beam into an array of beams. In one embodiment, the array of beams is a telecentric array of beams. Alternatively, the array of beams may not be telecentric.

[0103] The intraoral scanner 100 may also include a unidirectional mirror or a beam splitter (e.g., a polarizing beam splitter) through which the beam array passes. A unidirectional mirror allows light from a semiconductor laser to pass through to downstream optical elements, but reflects light traveling in the opposite direction. A polarizing beam splitter allows a beam with a specific polarization to be transmitted and a beam with a different (e.g., opposite) polarization to be reflected. In one embodiment, due to the structure of the unidirectional mirror or beam splitter, the beam array will produce a ring of light on the illuminated area of ​​the imaging object within the field of view of the scanning head 120 (as long as the area is not in focus). In addition, once in focus, the ring will become a fully illuminated point. This ensures that the difference between the intensity measured outside the focus and in the focus is larger.

[0104] Along the optical path of the beam array, after the one-way mirror or beam splitter, the intraoral scanner 100 can include a confocal focusing optical element and a probe 111 (also referred to as an endoscopic detection member). In addition, a quarter wave plate can be disposed along the optical path after the one-way mirror or beam splitter to introduce a specific polarization into the beam array. In some embodiments, this can ensure that the reflected beam does not pass through the one-way mirror or beam splitter.

[0105] The probe 111 may include a rigid light-transmitting medium inside, which may be a hollow object with a light transmission path defined therein or an object made of a light-transmitting material (e.g., a glass body or a tube). In one embodiment, the probe 111 includes a prism (such as a folding prism). At the end of the probe 111 where the scanning head 120 is located, the probe 111 may include a reflector that ensures total internal reflection. The reflector can thus direct the array of light beams toward a tooth segment or other object. The scanning head 120 thus emits an array of light beams that impinge on the surface of the scanned object (such as a tooth).

[0106] like Figure 1A-1BThe scanner 100 shown also includes one or more holes 116. The holes 116 can be, for example, air inlet / outlet holes configured to allow air to flow into the device to prevent overheating during operation. In these examples, the holes 116 are typically located on the proximal portion of the handle 110 of the scanner. Figure 1C Another embodiment of an intraoral scanner 100 is shown in which an aperture 116 is not disposed on the handle 110, but rather is disposed on a proximal end (e.g., an end face) 111 of the scanner 100 and / or through a cable interface 114. An advantage of moving the aperture 116 to the proximal end (e.g., an end face) of the scanner rather than being located on the handle 110 is that the aperture 116 (providing an opening to the interior of the scanner) is not easily accessible or manipulated by the operator during the scanning process. Since the proximal end of the device is not easily accessible during the procedure, sterilization of the device after the procedure can be simplified. For example, regulations may require that only the portion of the device that contacts the patient or operator be sterilized after use. Thus, in Figure 1C In the embodiment of the present invention, the probe 106 and handle 110 of the scanner can be immersed or wiped with a sterilizing solution without the risk of the sterilizing solution entering the hole 116 (which may permanently damage the scanner). Figure 1C The scanner may also include a number of seams 109 between the various parts of the scanner's housing. To further seal the scanner, these seams 109 may be additionally sealed internally or externally using gaskets, O-rings or silicone.

[0107] It should be noted that Figure 1C The scanner 100 may be powered by a hardwired power cord or may be implemented in a wireless manner including batteries. Figure 1D As shown, the hard-wired type also requires a cable interface 114 in addition. In addition to providing an electrical / data connector 113, the cable interface 114 may also include a cavity 115 and an exhaust hole 117, as shown. The cavity 115 may include a male connector configured to mate / connect with the hole 116 of the scanner 100. During the process, the airflow in and out of the scanner 100 can be directed from the hole 116 to the cavity 115 and into / out of the exhaust hole 117 of the cable interface 114. The exhaust hole may be located more proximally (e.g., along the cable 133). For example, the cable may include one or more channels for exhaust and / or cooling, which extend from the proximal side to the distal side along the cable and may be opened at a certain distance from the handle (e.g., 0.5 meters or more, 0.7 meters or more, 0.8 meters or more, 0.9 meters or more, 1 meter or more, etc.). In some embodiments, the aperture 116, the cavity 115, and / or the cable interface 114 itself may further include a gasket, an O-ring, or other sealing mechanism configured to prevent contaminants and / or liquids from entering the scanner.

[0108] Figure 1EAn embodiment of a protective cover 119 is shown that is configured to be placed over the proximal end of the scanner when the scanner is not in use or is being sterilized. The protective cover 119 may include a sealing plug 121 that is configured to cooperate with the hole 116 to seal the hole and prevent contaminants or fluids from entering the scanner. In some embodiments, the sealing plug 121 may include a soft, flexible material, such as an elastomer or rubber. The protective cover 119 may also include an O-ring or gasket 123 disposed around the periphery of the cover to further seal the hole of the scanner from contaminants or fluids when the cover is inserted onto the scanner. With the protective cover in place, Figure 1C The scanner 100 can be completely immersed in a sterilization tank or wiped with a high-level disinfectant without the risk of contaminants or fluids entering the scanner through the holes 116 or seams of the scanner. In some variations, the wand or a cover used with the wand can include a valve configured to prevent fluids (e.g., sterilizing fluids) from entering the wand device during sterilization. In some variations, the valve can be disabled or otherwise opened during operation, such as by connecting a cable or power supply to the wand.

[0109] Described herein is a barrier device (e.g., a protective cover) that typically includes a rigid or semi-rigid distal portion that covers and / or forms the probe 111 portion of the scanner, and a more flexible and typically thinner proximal region that covers the handle portion of the scanner including any inputs (e.g., a touch sensor 130 and / or buttons 140) and typically does not interfere with the action of those inputs.

[0110] The barrier devices described herein may include aspects adapted to substantially cover a surface of an optical device while allowing normal function of various features of the optical device.The barrier devices described herein may be adapted to cover some or all of an outer surface of a scanning device. Figure 2A-2I Various components of an exemplary barrier device 200 are shown in accordance with some embodiments. Figure 2AThe barrier device 200 is shown fully assembled when covering a scanning device (e.g., 100 of FIG. 1 ). The barrier device 200 in this example includes: a rigid or semi-rigid distal portion (cover 202) adapted to cover at least a portion of a scanning portion / probe (e.g., 106 of FIG. 1 ) of a scanner; a more flexible sleeve portion 204 (extending proximally from the more rigid portion) adapted to cover at least a portion of a handle (e.g., 110 of FIG. 1 ); and an interface region 206 that connects and seals the more rigid distal portion (cover 202) to the more flexible sleeve 204 at the proximal end. The dimensions of the barrier device 200 and any barrier device described herein may vary depending on the size of the scanner. The barrier device 200 is generally adapted to cover surfaces of the scanner that come in contact with a patient, a physician, and any fluids from the patient and the physician. For example, the barrier 200 may cover substantially all of the surfaces of a scanning portion (e.g., 106 of FIG. 1 ) of a scanner that may otherwise come in contact with a patient and / or a patient's bodily fluids. The barrier 200 should cover at least a portion of the handle of the scanner (e.g., 110 of FIG. 1 ), which may otherwise come into contact with the physician's hand or glove. In some embodiments, the length of the barrier 200 may extend proximally at least to the cable interface area of ​​the scanner (e.g., 114 of FIG. 1 ). In some embodiments, the length of the barrier 200 from the distal end 203 to the proximal end 201 ranges from about 6 inches to about 20 inches (e.g., 6 inches, 7.5 inches, 9 inches, 10.5 inches, 13.75 inches, or 19.5 inches). In some cases, the cover 202 may be reusable. For example, the cover 202 may be configured to allow it to be sterilized between uses, such as by autoclaving or any other suitable method.

[0111] refer to Figure 2B and Figure 2C , the rigid or semi-rigid distal cap region 202 may include a body 212 that is shaped according to a scanning portion of the scanner (e.g., 106 of FIG. 1 ). As described above, the scanning portion of the scanner typically operates around the patient's dentition. Therefore, the body 212 should be light and not bulky so as not to interfere with the operability of the scanner. The walls of the body 212 may be made of a relatively rigid material so that the body 212 can maintain its shape. In some embodiments, the body 212 is made of a rigid polymer material (such as a polycarbonate material). In some examples, the body 212 and thus the distal cap region 202 may have an angular shape, such as a shape having a square, triangular, or rectangular cross-section. In other examples, the body 212 and the distal cap region 202 may be cylindrical or have an elliptical cylindrical shape.

[0112] Window 214 may be located within the aperture of body 212 to cover the optical components of the scanner (e.g., 104 of FIG. 1 ). Window 214 may provide a protective barrier for the window of the scanner to prevent severe contamination and physical damage. Window 214 may be made of an optically transparent material to allow transmission of optical signals to and / or from the scanner (e.g., light). In some embodiments, window 214 is made of glass, quartz, sapphire, and / or an optically transparent polymer material. In some embodiments, window 214 provides a calibration surface for the scanner. For example, the presence of window 214 may be considered to calibrate the optical components of the scanner. For example, during scanning, body 212 may be adapted to maintain the position and orientation of window 214 relative to the optical components of the scanner. For example, one or more surfaces (e.g., walls, edges, and / or retaining features) of body 212 may engage with the scanner to keep window 214 aligned relative to the optical components (e.g., 104 of FIG. 1 ). In addition, body 212 may position window 214 at a specified distance from the optical components of the scanner. The rigidity of the body 212 provides physical protection for the scanning portion of the scanner and prevents severe contamination, as well as ensuring repeatable and accurate placement of the windows 214. Figure 2B and Figure 2C The body 212 shown includes one window 214, but the barrier device described herein may include any number of windows. For example, the barrier device may include multiple windows according to the corresponding multiple optical components of the scanning device.

[0113] In variations where the window 214 is formed and attached separately from the body 212, the window 214 may be coupled to the body 212 in any suitable manner, including using one or more of the following: adhesives, welding, flexible gaskets, and mechanical fastening.

[0114] It should be noted that in some variations, the sleeve may not include a separate, more rigid body portion 212, and may be formed entirely as a flexible sleeve (e.g., sleeve 204). Thus, in some variations, the window may be directly attached to the flexible sleeve 204, for example, by any suitable means (such as by welding, bonding, or other methods, etc.). In this configuration, the window 214 may be aligned with the scanner based on one or more elements on and / or in the scanner itself, and the sleeve or body portion may not be required to achieve the alignment. For example, attaching the sleeve directly to the window to form full rod coverage (without the need for a rigid sleeve) may be accomplished, for example, using a custom molded silicone cover for the scanner (into which the window may fit), but may also be accomplished using a variety of soft materials and attachment methods.

[0115] Figure 2D1 and Figure 2D2An example of a flexible proximal sleeve 204 of a barrier device 200 is shown. The sleeve 204 can be disposed on a backing 228 (e.g., a paper backing) and in some cases enclosed in a bag 230 that is removed before the sleeve 204 is coupled to the cover 202. The sleeve 204 can be made of a thin sheet of a flexible material (such as a flexible polymer). When the sleeve 204 covers the scanner, the material can be sufficiently flexible and / or thin enough to enable a user to actuate one or more actuators on the scanner. The thickness of the sleeve 204 can vary, for example, depending on the type of material. In some cases, the sleeve 204 is made of a polyethylene material (e.g., PEF) having a thickness between about .001 inches and about .01 inches (e.g., .001 inches, .002 inches, .004 inches, .005 inches, .007 inches, or .01 inches). The sleeve 204 can be more flexible than the cover 202. In some embodiments, the sleeve 204 is made of a different material (e.g., a different polymer type) than the cover 202. In some embodiments, sleeve 204 is made of the same material (e.g., the same polymer type) as cover 202, but is thinner than cover 202. In some embodiments, sleeve 204 substantially conforms to the shape of the body of the scanner (e.g., 108 of FIG. 1). Sleeve 204 can be tubular in shape with an internal opening for accommodating the body of the scanner. Sleeve 204 can include a narrow section 226 and a wide section 224. Wide section 224 can have a width large enough to accommodate the width of the body of the scanner. Narrow section 226 can be configured to engage with cover 202 and can include an open end 222 through which cover 202 can be positioned.

[0116] exist Figure 2D1-Figure 2D2 In the figure, the flexible proximal portion is configured as two flat material members that are attached together along the edges to form a mitten or glove-like structure (e.g., by welding, bonding, etc.); as shown, one side can remain attached to the support backing.

[0117] In any of the variations described herein, the proximal end of the flexible proximal portion may be configured to be supported by a support member (e.g., paper or a secondary material that is more rigid than the material forming the main part of the flexible proximal portion). Figure 2H and 2I As described, the proximal end of the flexible proximal portion may be attached to a more rigid material (e.g., paper (such as adhesive-backed paper, etc.), a polymer material, etc.), which may help keep the mouth of the protective sleeve open to allow easy insertion / removal of the intraoral scanner wand in the protective sleeve. In some variations, the proximal port may be configured to allow airflow into the intraoral scanner. Non-limiting examples of such configurations may include a channel or passage through or along the protective sleeve to the hole, limiting the length of the protective sleeve in the proximal direction to prevent covering or otherwise blocking the hole, etc.

[0118] Figure 2E-2F4An example of how the proximal flexible portion of the sleeve 204 according to some embodiments may be coupled to the more distal, more rigid cover 202. The distal more rigid cover 202 may be positioned partially through the opening of the narrow section 226 such that the narrow section 226 overlaps the more flexible cover 202. The wide section 224 of the sleeve 204 may be free to subsequently cover the scanning device.

[0119] Figure 2F1 How to use interface area 206 to securely couple sleeve 204 to cover 202 is shown. Interface area 206 can be in the form of a tape that bonds sleeve 204 to cover 202. In some embodiments, about half of the width W of the tape covers the cover 202, and about half of the width W of the tape covers the narrow section 226 of the sleeve 204. In some embodiments, the tape is made of a polyethylene film with an acrylate adhesive. In some embodiments, the tape has a minimum width W to provide a suitable seal (e.g., an airtight seal) between cover 202 and sleeve 204. In some embodiments, the minimum width W is about 20 mm.

[0120] In another embodiment, Figure 2F2 As shown, interface area 206 can be in the form of an elastic gasket, which compresses and seals sleeve 204 and lid 202 to the scanner. Elastic gaskets can include, for example, O-rings, particularly in embodiments where lid 202 and body 212 are cylindrical or elliptical cylindrical. In other embodiments, when lid and body are in an angled shape, customized angular gaskets can be used to compress and seal the sleeve 204 against lid 202. Lid 202 can be placed on sleeve 204 and compressed by elastic gaskets or sleeve 204 can be placed on lid 202 and compressed by elastic gaskets. In certain embodiments, elastic gaskets are separated from lid and sleeve. Elastic gaskets can be configured to only contact lid 202, only contact sleeve 204, or can have suitable width to allow elastic gaskets to contact two parts across the interface between lid and sleeve.

[0121] In other embodiments, Figure 2F3 and Figure 2F4 As shown, the resilient gasket may be integrally formed with the cover 202 or the sleeve 204 . Figure 2F3 An embodiment is shown in which the gasket is integrally formed with the sleeve 204. In this example, the cover 202 may be placed on the scanner first, and then the sleeve 204 with the integrally formed interface area 206 may be placed on the cover to compress and seal the cover and sleeve against the scanner. Alternatively, Figure 2F4 An embodiment is shown in which an interface region 206 in the form of a resilient gasket is integrally formed with the cover 202. In this example, the sleeve 204 may be placed on the scanner first, and then the cover 202 with the integrally formed gasket may be placed on the sleeve 204 to seal and compress the cover and sleeve against the scanner.

[0122] In some embodiments, the barrier device 200 is provided to a user (eg, a dentist) in a pre-assembled form so that the user only needs to plug the barrier device 200 onto the scanner. Figure 2G1 The barrier device 200 is shown as it would appear to a user. The barrier device 200 may be provided preassembled in a package. For example, the cover 202 (e.g., a rigid portion) may be covered in a bag 240 (e.g., a polymer bag), and the sleeve 204 (e.g., a flexible portion) may be disposed on a backing 228 (e.g., a paper backing). The sleeve 204 may be bonded (e.g., welded or coupled using an adhesive) to the backing 228 so that the sleeve 204 is substantially flat and extends along its entire width.

[0123] Alternatively, in some variations, the sleeve assembly may be held in a pre-deployed form, wherein the more flexible sleeve portion 204 is rolled, compressed, folded, etc. within a package 234 (which may be held in the pre-deployed form and / or may be held in the pre-deployed form by a removable restraining member (e.g., a tie, a wrap, etc.). Figure 2G2 As shown, the assembly including the more rigid cover portion 202 and the flexible sleeve 204 (which is "squeezed") is held in a pocket 234. The user can place the cover portion 202 over the scanner and pull the flexible sleeve portion 204 over the more proximal portion of the scanner to enclose the scanner and the scanner's cable within the sleeve.

[0124] Figure 2H and Fig.2I A view of the barrier device 200 mounted on the scanner 100 is shown. The scanner 100 can be positioned through the sleeve 204 of the barrier device while still being coupled to the backing 228. This can provide some rigidity to the sleeve 204, allowing a user to easily position the scanner 100 through the sleeve 204 so that the scanning portion of the scanner 100 can fully enter the cover 202 of the barrier device. After the barrier device is placed on the scanner 100 (or when the barrier device is placed on the scanner 100), the user can peel the backing 228 from the sleeve 204. When installed, the sleeve 204 of the barrier device can loosely cover the first hole 116-A (e.g., the air inlet hole). At the top of the proximal end of the sleeve 204, it can end at the second hole 116-B (e.g., the air outlet hole) just before reaching the scanner 100. This can allow air to flow into and out of the holes 116-A and 116-B of the scanner when the scanner is covered.

[0125] In some variations, the protective cover may be formed of a more rigid distal region 252 to which a more flexible proximal portion 254 is attached, for example, by adhesive and / or welding. As described above, the proximal portion 254 may be connected to a backing (not shown) and / or the proximal end may be supported to be easily opened and / or held open to insert / remove the intraoral scanner and / or to allow operation of the scanner without blocking the aperture or preventing operation of input controls (e.g., touch pad, buttons, etc.).

[0126] Figure 2K-2L Another example of a protective cover is shown that extends only partially along the length of the handheld portion of the scanner. Figure 2K and Figure 2L , the protective cover 260 partially extends along the handle portion 265 without covering the hole 262.

[0127] refer to Figure 3A-3C In some embodiments, a barrier device may be used with an airflow guide 300 that is configured to direct airflow into and / or out of a scanner as part of a ventilation system for the scanner. The airflow guide 300 may include a first opening 320 at a distal end and a second opening 322 at a proximal end. The second opening 322 may be in the form of a cutout for access to the top and / or bottom of the scanner. An inner surface 326 of the airflow guide 300 may include one or more engagement features 324-A to 324-D that are configured to engage with one or more surfaces of the scanner to, for example, keep the airflow guide 300 coupled to the scanner during a scanning operation. A barrier device (e.g., 200 of FIG. 2 ) may be configured to be placed on an outer surface 328 of the airflow guide 300.

[0128] Figure 3DThe airflow guide 300 assembled on the body 108 of the scanner 100 is shown. The first opening 320 of the airflow guide 300 can accommodate the body 108 passing therethrough so that the airflow guide 300 can surround the body 108. In some embodiments, one or more engagement features 324-A to 324-D can engage with one or more surfaces of the body 108 to keep the airflow guide 300 coupled to the scanner 100. In some cases, one or more engagement features 324-A to 324-D snap the airflow guide 300 onto the scanner 100. In some embodiments, the engagement features 324-B and 324-C engage with one of the plurality of holes (e.g., 116-A) of the scanner 100. For example, the engagement features 324-B and 324-C can include protrusions that enter the opening of the hole. The second opening 322 can provide access to the holes 116-A and 116-B of the scanner. For example, the scanner 100 may include a first hole 116-A (e.g., an air inlet hole) and a second hole 116-B (e.g., an air outlet hole) for cooling the scanner 100. The air flow guide 300 may rest above the first hole 116-A to provide a space between the air flow guide 300 and the first hole 116-A where air can enter (if the hole 116-A is an air inlet hole) or leave (if the hole 116-A is an air outlet hole) the scanner 100. The second opening 322 of the air flow guide 300 may leave the second hole 116-B uncovered so that air can enter (if the hole 116-B is an air inlet hole) the scanner 100 or leave (if the hole 116-B is an air outlet hole) the scanner 100. Thus, the air flow guide 300 directs the air flow in and out of the scanner toward the proximal end 120 of the scanner 100. Thus, when the sleeve of the barrier device (e.g., Figure 2A 204) is placed on the airflow guide 300, which allows air to effectively flow through the proximal opening of the barrier device (e.g. Figure 2A 201).

[0129] Figure 4A-4C An alternative embodiment of a barrier device is shown. In this embodiment, a cover 402 (e.g., a rigid portion) of the barrier device is configured to be removably coupled with a retaining clip 406. The retaining clip 406 can be coupled to a flexible sleeve (e.g., Figure 2A-2I Thus, the retaining clip 406 may replace the above reference Figure 2A-2I In some embodiments, a simple flexible bag is used instead of a sleeve of a specific size (e.g. Figure 2A-2I204). The retaining clip 406 may include an engagement feature 446 configured to removably engage with the proximal end of the cover 402. In some embodiments, the engagement feature 446 includes a row of lugs positioned around the peripheral edge of the retaining clip 406, which engages with, for example, the edge of the cover 402 to form a snap fit between the two. In some cases, the retaining clip 406 includes multiple rows of lugs to provide a safer and tighter seal between the parts. In some embodiments, the cover 402 and the retaining clip 406 are made of the same material (e.g., polycarbonate). In some embodiments, the polycarbonate is a polycarbonate / acrylonitrile-butadiene-styrene (PC / ABS) material. In some embodiments, the cover 402 and the retaining clip 406 are injection molded from optical grade polycarbonate. In some variations, the device may also include a gasket in the interface between the cover 402 and the retaining clip 406 to ensure a seal between the rigid portion 402 and the flexible sleeve 404.

[0130] When the cover 402 is reusable (e.g., autoclavable) and the sleeve is disposable, the removable configuration of the retaining clip 406 (e.g., as opposed to tape) can be useful. Specifically, the retaining clip 406 can allow the user to quickly couple and detach the cover 402 from the sleeve between scanning operations. In some cases, the retaining clip 406 can also be reused by removing the retaining clip 406 from the disposable sleeve. Figure 4B and Figure 4C A cover 402 is shown that is engaged with a retaining clip 406, wherein the retaining clip 406 is attached to a sleeve 404, in which case the sleeve 404 is a simple flexible bag. In some cases, the sleeve 404 is inserted between the retaining clip 406 and the cover 402 so that when the retaining clip 406 is clamped to the cover 402, the sleeve 404 becomes coupled to the device. In this way, the sleeve 404 can help provide a tight seal (e.g., effectively acting as an O-ring) between the retaining clip 406 and the cover 402. In other embodiments, the retaining clip 406 is securely coupled (e.g., by an adhesive or molding) to the sleeve. In some embodiments, the sleeve 404 is a simple flexible bag with a closed end that the user pierces with the retaining clip 406 when attached to the cover 402. In some cases, the retaining clip 406 includes a prying feature that can help the user separate the retaining clip 406 from the cover 402.

[0131] Figure 5Another embodiment is shown, wherein cover 502 comprises two or more members 502a and 502b, and they are configured to be mechanically connected together around cover 205 and scanner to provide sealing.In one embodiment, as shown in the figure, cover members 502a and 502b may include interlocking parts 505 on one or more surfaces of the cover member to allow the members to be mechanically connected together in a snap-fit ​​manner.Interlocking parts may include, for example, annular snaps, cantilever snaps or torsional snaps.In one example, as described above, cover 504 may be placed on the scanner.Then, cover 502 may be mechanically connected (e.g., snap fit) on the scanner and cover 504 to seal the scanner to prevent contaminants from entering.In some examples, as described above, additional interface areas (e.g., tape or elastic gaskets) may be provided between the cover and the cover to provide additional sealing layers.

[0132] In some embodiments, the interface region connecting the cover and the sleeve is a weld region, wherein the material of the cover is welded together with the material of the sleeve. For example, heat treatment can be used for local heating of the material around the cover and / or the sleeve until the two parts form an integral interface. In some cases, an ultrasonic welding process is used. In some cases, preferably, the cover and the sleeve include the same type of material (e.g., the same polymer) so that the weld region has good integrity. For example, both the cover and the sleeve can be made of polyethylene material (e.g., the sleeve is thinner). In some cases, due to the advantages of different material properties, the cover and the sleeve preferably include different types of materials (e.g., different polymers). For example, some polymers are more rigid, therefore can be used to form a cover, and other polymers are more flexible, therefore can be used to form a sleeve. However, it may be difficult to weld different types of materials together to form a sufficiently strong bond.

[0133] The barrier devices described herein can be completely disposable, or completely reusable. In some cases, the barrier devices are partially disposable and / or partially reusable. For example, in some cases, the barrier device is designed to be completely disposable, so the user can discard the barrier device after use (e.g., as medical waste). In other cases, the entire barrier device is designed to be sterilizable (e.g., autoclavable), so the barrier device can be reused. In some cases, parts of the barrier device are disposable, while other parts of the barrier device are designed to be reusable. For example, in some cases, the cover can be made of an autoclavable material (e.g., can withstand the heat of an autoclave process), while the cover is made of a substantially non-autoclavable material. In other cases, the cover is reusable and the cover is disposable.

[0134] In some variations, the barrier device described herein is configured to be sterilized and reused. For example, in some variations, the barrier device is configured or adapted to be sterilized by using a liquid disinfectant. The barrier device may be configured to be sterilized (or degermed) after being removed from the rod and then replaced on the same or different rod. Alternatively or additionally, in some variations, the barrier is configured to be sterilized when on the rod (or forming a part of the rod). Therefore, the barrier described herein can be a durable barrier that is configured to form a part of a reusable rod and can be sterilized without damaging the rod including internal electronic devices and / or optical devices. In some variations, the barrier is configured to be worn on the rod (or connected to the rod, formed integrally with the rod, or become a part of the rod) and sterilized by immersion in a disinfecting solution. Therefore, the device described herein can be configured to restrict entry / exit of the rod, for example, by one or more valves or covers, to prevent fluids (including contaminants and / or disinfectant) from entering the holes or other possible openings of the rod.

[0135] Any barrier device described herein can be tested for effectiveness as a biological barrier (e.g., a bacterial and / or viral barrier). The test can comply with the Good Laboratory Practice (GLP) and / or Good Manufacturing Practice (GMP) regulations of various government agencies (such as the FDA). In some examples, the test process includes an immersion test in which the covered scanner is immersed in a culture medium with pathogens. The covered scanner is then removed from the culture medium and the barrier assembly is removed from the scanner. The scanner is then tested to check for pathogens or for passing through the barrier through the material of the cover and / or sleeve or through the interface between the cover and sleeve.

[0136] In some examples, the test is performed on the barrier device without a scanner. Such a test process may involve exposing the barrier device to a test solution and inspecting the barrier device to check whether there is evidence of the test solution passing through the barrier device. In some cases, a portion of the barrier device that is most likely to allow biomaterials to enter (such as (one or more) interfaces between the cover and the sleeve and / or other interfaces or sealing areas of the sleeve) is detected. A test process involves exposing the outer surface of the barrier device to a solution containing biomaterials (e.g., bacteria) and extracting a sample from the relative inner surface of the barrier device. The sample is then analyzed to analyze whether there are signs of biomaterials. Another test process involves exposing the barrier device to a non-biological solution (as a substitute for a biomaterial solution). In one embodiment, synthetic blood is used. For example, the outer surface of the barrier device is exposed to synthetic blood, and then a sample is extracted from the inner surface and analyzed for signs of synthetic blood. In some cases, the barrier device should be tested for water leakage resistance. In a test process, the interior of the barrier device is filled with water. Then after a predetermined time (e.g., between about 5 minutes and 20 minutes), check the outer surface of the barrier device for signs of water leakage. The results of both the non-biological solution test and the biological material solution test showed excellent results.

[0137] Also described herein is a sterilization / disinfection kit that can be used with any device described herein (e.g., a barrier, a rod including a barrier, etc.). For example, a rod including a barrier can be sterilized by immersion sterilization in a groove or chamber, and the groove or chamber includes a bracket configured to fix the rod at the proximal end to the outside of the immersion fluid to prevent fluid from entering the hole or other opening. In some variations, the sterilization groove or sterilization chamber can be configured to keep the rod on the sterilization fluid for a long enough time to ensure sterilization, and the holes of other entry areas will not be exposed to the sterilization fluid. In some variations, the (one or more) holes on the rod are configured to be sealed or at least covered when located in the sterilization groove, even if the portion of the rod (or the rod barrier) is not immersed in the sterilization groove or sterilization chamber.

[0138] According to some embodiments, the cover of the barrier device comprises multiple materials with different material properties for achieving different functions. Figure 6A-6L Exemplary barrier devices made of different materials are shown. Fig. 6AA cover 602 of a barrier device is shown, which includes a distal portion 604 made of a first material and a proximal portion 606 made of a second material different from the first material. In this example, the distal portion 604 of the cover may include an optically transparent window 610 to allow transmission of optical signals to and / or from the probe of a scanning device. In this example, the window is made of the same material as the wall of the distal portion. Therefore, the first material of the distal portion may be an optically transparent material. The wall of the distal portion may have sufficient rigidity to provide an inner cavity in which the probe of the scanner will be disposed. Therefore, the first material may have sufficient rigidity to maintain the shape of the wall. According to some embodiments, the first material of the distal portion 604 may be a moldable polymer material (e.g., a thermoplastic) that is transparent enough to allow the scanner to transmit and / or receive optical signals. In some embodiments, the first material is polycarbonate, polymethyl methacrylate, polyamide, polymethylpentene, and / or other materials. The proximal portion 606 of the cover can be configured to be combined with the distal portion 602 to form a seal (e.g., an airtight seal) between the distal portion and the proximal portion. The bonding process can include forming a mechanical bond and / or a chemical bond between the distal portion and the proximal portion. In some embodiments, the proximal portion and the distal portion are molded together by an injection molding overmolding process. In some cases, the second material may not have optical transparency and / or rigidity like the first material of the distal portion of the cover. In some embodiments, the second material is a thermoplastic elastomer (TPE) material, such as polyurethane, polypropylene, polyamide and / or other materials. According to some embodiments, the first material and / or the second material are non-toxic (e.g., food grade or higher) and have a flammability standard of UL 94V2 or higher.

[0139] Figure 6B A sleeve 608 is shown, which is bonded to the proximal portion 606 of the cover 602 at a bonding area 609 to form a seal (e.g., an airtight seal) between the sleeve and the cover. For example, the sleeve can be bonded to the cover using a molding process or a welding process. In some embodiments, a heating process is used to heat the proximal portion of the sleeve and / or the cover to weld the components together. The bonding process can include forming a mechanical bond and / or a chemical bond between the distal portion and the proximal portion. Therefore, the second material of the proximal portion 606 can be a material that can be bonded (e.g., moldable or weldable) to the sleeve 608 and can be bonded (e.g., moldable or weldable) to the distal portion 604. According to some embodiments, the material of the sleeve is a medical grade plastic.

[0140] Figure 6C-6E They are shown respectively Fig. 6A and Figure 6B602 of the scanner. The cover can be shaped to be mounted on the probe of the scanner. For example, the cover can have an elongated shape corresponding to the probe and include an opening 605 that provides a passage into the inner cavity where the probe is located. In some embodiments, the proximal portion 606 can be flared (flared, in a trumpet shape) to cooperate with the corresponding flared portion of the probe. The proximal portion can include a lip 607 for engaging with the probe or other parts of the scanner. In some cases, the cover can be slightly tapered toward the far end of the distal portion 604. The shape and size of the window 610 of the distal portion 604 are formulated to allow the optical components of the probe / scanner to transmit light between the probe and the external environment.

[0141] Fig. 6F and Figure 6GA bottom view and a cross-sectional view DD of the cover 602 are shown. The length L and width W of the window 610 may vary depending on the optical design of the scanning probe. In some embodiments, the length L of the window ranges from about 20 millimeters (mm) to 60 mm, and the width W ranges from about 10 mm to 20 mm. The cover 602 may have a small profile (e.g., thickness) so that the cover does not interfere with the scanning of the patient's dentition. In some embodiments, the thickness T of the window 610 (and / or one or more walls 609 of the cover) ranges from about 0.5 mm to 3 mm (e.g., 0.5 mm, 1 mm, 1.25 mm, 1.5 mm, 2 mm, 2.25 mm, 2.5 mm, or 3 mm). The window may have a uniform thickness to provide consistent transmission of the optical signal. In some embodiments, the thickness T of the window does not vary by more than 0.5% to 3% (e.g., 0.5%, 1%, 1.5%, 2%, 2.5%, or 3%). The material of the window (e.g., the first material) may be configured to provide optimal light transmission while still providing an effective pathogen barrier. In some embodiments, the refractive index of the window ranges from 1.4 to 1.8 (e.g., 1.4, 1.45, 1.48, 1.5, 1.52, 1.55, 1.58, 1.6, 1.7, or 1.8). In one embodiment, the material of the window (e.g., the first material) may be configured to transmit light having a wavelength range of about 410 nanometers to 890 nanometers (nm). In some cases, the haze measurement of the window material (e.g., the first material) is 6% or less (e.g., 6%, 5%, 4%, 3%, 2%, or 1%). In some embodiments, the distal portion (e.g., at least one or more windows) has a polished surface (e.g., an outer surface and / or an inner surface) that is free of marks (e.g., gates, burrs, mold release marks, dent marks, weld marks, pores, scratches, and stains). In some cases, the inner and / or outer surfaces of the window are polished to have a scratch specification of 40-20. In some embodiments, the inner surface of the proximal portion 606 and / or the distal portion 604 includes one or more securing features 624, which may include one or more recessed features or raised features configured to engage with corresponding recessed features / raised features of the probe to secure the cover to the probe.

[0142] In some embodiments, the proximal and distal portions of the cap can be formed using an injection molding process. In some cases, an overmolding process is used to create a mechanical bond and / or chemical bond between the proximal and distal portions. Figure 6HAn exploded view of the cap 602 is shown, wherein the distal portion 604 and the proximal portion 606 are separated from each other. During the molding process, the distal portion and the proximal portion can be molded together to form a mechanical bond and / or chemical bond between the two. The molding process can include injecting a first material into a mold to form the distal portion, and then injecting a second material (into a different mold or a different part of the mold) onto an edge 619 of the wall of the distal portion to form an extension of the wall of the distal portion. In some embodiments, the proximal portion and the distal portion include corresponding interlocking features 620 and 622 to strengthen the mechanical bond between the proximal portion and the distal portion. Fig.6I and Figure 6J A close-up view of the interlocking features of the proximal and distal portions is shown. In this example, the interlocking features of the distal portion include tongues and / or grooves that engage with corresponding grooves and / or tongues of the proximal portion. In some cases, the interlocking features of the distal portion are manufactured using a first mold during a first molding process. The distal portion can then be removed from the mold, or the end region of the distal portion can be exposed in other ways. Then, a second material is overmolded over the interlocking features of the distal portion to form corresponding interlocking features of the proximal portion. In other cases, the proximal portion is first formed and then the distal portion is overmolded over the proximal portion. Figure 6K A cross-sectional view and another close-up view (inset) of the connection area 650 between the distal portion 604 and the proximal portion 606 are shown, where corresponding interlocking features are molded together.

[0143] The cover may include one or more draft angles to facilitate removal of the cover from a corresponding one or more molds. Figure 6L It is shown how the inner surface of one wall of the cover 602 includes a draft angle 660 relative to an ejection vector 655 that extends parallel to the inner surface of another wall (e.g., an opposing wall) of the cover. In some embodiments, the draft angle can range from about 0.5 degrees to 5 degrees (e.g., 0.5 degrees, 0.75 degrees, 1 degree, 1.5 degrees, 2 degrees, 2.5 degrees, 2.75 degrees, 3 degrees, 3.5 degrees, 4 degrees, or 5 degrees). In some embodiments, instead of or in addition to the draft angle, the inner surface of the proximal portion 606 has a rough (e.g., non-smooth) surface to facilitate removal of the cover from the mold. For example, a mold used to make the proximal portion may have a non-smooth (e.g., rough / non-smooth) surface to form a corresponding non-smooth surface on the proximal portion to facilitate removal. Figure 6L Also shown is how the proximal end 640 of the proximal portion 606 of the cap has a specified angle 665 relative to the demolding vector. In some embodiments, the proximal end 640 is angled at approximately 95 to 120 degrees relative to the demolding vector.

[0144] In some cases, the injection molding process may affect the size and / or material properties of the sleeve, thereby affecting the performance of the intraoral scanner. For example, the first material and / or the second material may have flow characteristics in the molten state, which may cause the material to deform once it hardens to a solid state. This deformation may not be significant in some applications, but may have a negative impact on, for example, the light transmission characteristics of the window. Figure 7 An example image of a window 700 analyzed using an optical analysis instrument is shown. As shown, the window includes deformation 703 (e.g., wave aberration) from the injection molding process, indicating that the material properties of the entire window are not uniform. In this case, the window has an unacceptable amount of deformation (out of specification) and may cause an unacceptable amount of error in the intraoral scan. In a manufacturing setting, the optical properties of one or more windows (e.g., one or more per batch) can be tested to identify and eliminate windows that are determined to be non-compliant with the specifications. Even if the window has an acceptable amount of deformation (within the specification), there may be differences between different windows even if the same manufacturing process is used. For example, the windows of a batch of barrier devices may have different optical properties from the windows of another batch of barrier devices. In some cases, barrier devices formed using different molds will have windows with different optical properties. In order to compensate for these differences, the intraoral scanner can be calibrated based on the characteristics of a specific window / barrier device or based on the characteristics of a specific batch of windows / barrier devices. Example calibration parameters may include focal length, scan rate, scan intensity, wavelength, etc.

[0145] In some embodiments, the barrier device includes an identifier, which may include information related to the manufacturing process. The identifier may include information related to the optical properties of the window. This information can be used to determine which barrier devices are within the specification, and when within the specification, what the optical properties are. The optical properties can be used to set the use mode or calibration parameters of the scanner. The identifier can be computer-readable (e.g., readable by scanning). Such identifiers may include bar codes, QR codes, alphanumeric codes, logos, symbols, and / or other computer-readable identifiers. In some embodiments, the identifier can be read by the intraoral scanning device itself. The identifier can be bonded to the barrier device (e.g., by adhesive stickers) and / or embossed on the barrier device (e.g., by molding processes). In some embodiments, the adhesive stickers are affixed to the outer surface of the window or other outer surfaces of the barrier device. Examples of suitable identifiers and related methods, devices, and systems are described in U.S. Provisional Patent Applications Nos. 62 / 830,336 and 62 / 955,662, each of which is incorporated herein by reference in its entirety. During the manufacturing process, the measurement and assessment of the barrier device can be performed in any of a variety of methods. In one example, a grid target of predetermined dimensions may be added to each barrier device (e.g., as a part sticker). The grid target may be measured (e.g., using a dedicated grid) and its parameters (e.g., dimensions) recorded in a database and matched to a corresponding identifier. Alternatively, each barrier device may be measured and any deviations from nominal values ​​recorded in a database and matched to a corresponding identifier. In some cases, barrier devices having windows that meet specifications may be marked with a certified identifier, while those having windows that do not meet specifications will not be marked with the identifier (or will be marked with a different identifier), thereby preventing the non-compliant barrier devices from being used with an intraoral scanner.

[0146] Figure 8A-8E The barrier device 600 ( Figure 6A-Figure 6I ) is another exemplary barrier device of a variation of ), wherein the window is formed independently of the cover. Fig. 8AA cover 802 of a barrier device is shown, which includes a distal portion 804, a proximal portion 806, a window 810, and a coupling member 813. The cover 802 can be coupled to a sleeve (e.g., sleeve 608) as described herein. The distal portion and proximal portion of the cover 802 can be formed using a molding process / overmolding process as described herein. The window 810 can be formed in a separate process and can be coupled to the cover via a coupling member 813. In some embodiments, the coupling member includes an adhesive, such as a pressure-sensitive adhesive, a dry adhesive, and / or a contact adhesive. In some embodiments, the coupling member includes a spacer or backing, such as a foam spacer or backing (e.g., a double-sided adhesive spacer or backing and / or can also be a gasket, a weld, or a liquid adhesive). The coupling member may have an opening 805 or a space corresponding to the opening of the cover 802 to allow light to pass through the window. The window 810 may have optical properties as described herein. The window 810 may be made of any material that is sufficiently transparent to transmit signals to and / or transmit signals from the probe of the intraoral scanner. In some embodiments, window 810 is made of a transparent polymer material (e.g., polycarbonate and / or polymethyl methacrylate). In some cases, window 810 is made of a material different from distal portion 804 and / or proximal portion 806. In some embodiments, window 810 is made of glass and / or quartz material. In some embodiments, the thickness of window 810 ranges from about 0.5 to about 2 mm (e.g., about 0.75 mm, about 1 mm, about 1.25 mm, about 1.5 mm, etc.). In any device described herein, the window may also have an AR (anti-reflective) coating or treatment applied on one or both sides of the material. This can be achieved by material deposition, application of a specialized optical adhesive or film, and other methods.

[0147] Figure 8B and Figure 8C A top view and a side AA cross-sectional view of the cover 802 are shown, respectively, showing a window 810 assembled therein. In this example, the window 810 can be positioned in the inner cavity of the cover and bonded to the inner surface of the cover. The distal portion 804 can include a window opening 815, wherein the window is aligned and fixed by a coupling member 813. The coupling member 813 can be configured to provide an adhesive barrier between the window and the cover 802. In some cases, the coupling member includes one or more sealants. In some embodiments, the cover includes a plurality of engagement features 820, 824 and 825, configured to engage with corresponding engagement features of the probe of the scanner. The engagement feature can include one or more protruding features (e.g., 820 and 825) and / or recessed features (e.g., 824). The engagement feature can include one or more clips, hooks, buckles and / or fasteners, which are configured to removably engage the barrier device to the probe of the scanner. Fig.8DA bottom perspective view of the cover 802 is shown with the window 810 and coupling member 813 removed from the cover. Fig. 8E A cross-sectional view of the cover taken along plane 830 is shown.

[0148] In some embodiments, cover 802 may include one or more draft angles (e.g., 0.5 and 5 degrees from the demolding vector) to facilitate removal of the cover from the corresponding one or more molds, as described above with reference to cover 602 ( Figure 6A-6L ). In some embodiments, instead of or in addition to the draft angle, the inner surface of the proximal portion 806 and / or the distal portion 804 can have a rough (e.g., non-smooth) surface to facilitate removal of the cover from the mold. Since the window 810 is manufactured independently of the wall of the distal portion 804, the inner surface of the wall of the distal portion 804 can be less smooth (more rough) than the inner and / or outer surface of the window 810.

[0149] Fig. 9 A flow chart 900 is shown, which represents a process for forming a removable barrier device covering a probe of an intraoral scanner according to some embodiments. Referring to 901, a first portion of the cover (e.g., a distal portion) is formed by injection molding a first material. The first material can be injected into a mold having a shape consistent with the first portion of the cover. The first portion of the cover can have an elongated shape, including a plurality of walls defining an inner cavity and a closed end covering the distal end of the probe. In some cases, at least one wall of the first portion of the cover may include at least one window opening for a corresponding window. In some cases, at least one wall of the first portion of the cover may include at least one window formed of the first material, thereby forming a window formed integrally with at least one wall.

[0150] With reference to 904, the second part of the cover is formed by overmolding a second material on the first part. The second material may be the same as the first material or different from the first material. In some embodiments, the first material may be optically transparent and / or rigider than the second material. The molding process may form a seal (e.g., an airtight seal) between the first part and the second part. In some cases, the first part and the second part are chemically bonded to each other. In some embodiments, the second material is overmolded on the edge of the wall of the first part to form an extension of the wall of the first part. In some cases, the first part has an interlocking feature (e.g., a ridge, groove, tongue, depression, and / or protrusion), and the second material matches the interlocking feature (e.g., in a molten state) to form a corresponding interlocking feature (e.g., a ridge, groove, tongue, depression, and / or protrusion), which mechanically strengthens the combination between the first part and the second part. In some cases, the inner surface of one wall of the cover has a draft angle or surface texture (roughness) so as to remove the cover from the corresponding (one or more) molds.

[0151] Referring to 906, the sleeve is positioned over the second portion of the cover. The sleeve can be a flexible polymer sheet or tube (e.g., medical grade). At 908, the sleeve is welded to the second portion of the sleeve, for example, by heating the sleeve and / or the second portion of the cover. The welding process can form a seal (e.g., an airtight seal) between the sleeve and the second portion. After forming the barrier device, one or more testing processes can be implemented to test the efficacy of the barrier device as a biological barrier, as described herein.

[0152] Anti-reflective materials

[0153] Any of the devices described herein may include one or more anti-reflective materials, particularly anti-reflective materials suitable for use in the near infrared frequency range. For example, any of these devices may include an anti-reflective material on a window of a removable barrier device. The anti-reflective material may be formed from a nanostructured material (e.g., a "moth eye" material). The material may be applied to the device (e.g., to the window) as a laminate layer. The material may be a hydrophobic material applied to the sleeve / removable protective cover of the device, or, particularly for a removable window, a hydrophobic material applied to the barrier over the entire intraoral scanner.

[0154] Reflections (such as specular reflections) are particularly problematic in intraoral scanners where there is a large amount of back reflection from the window to a camera within the intraoral scanner, for example when the window for the intraoral scanner is positioned close to the focal point of the sensor (e.g., within a few centimeters) and / or in situations where an internal polarizer may not be used, for example because of insufficient polarization depth.

[0155] Thus, methods and apparatus (e.g., devices) are described herein that include an anti-reflective layer (e.g., on a window of an intraoral scanner and / or on a window of a removable barrier for an intraoral scanner). The anti-reflective layer can be a structure (e.g., a coating, a film, or a laminate) applied to the window of the intraoral scanner and / or the window of the removable barrier. In some variations, the anti-reflective structure is a nanostructure configured as an anti-reflective material that is configured to reduce or eliminate reflections, particularly reflections in the near-infrared range. The anti-reflective material can be a nanostructure array (NSAs); these materials can include silicon and non-silicon materials (e.g., nanoporous SiO2), and can have a structure configured to function as an anti-reflective material in the nanostructure range.

[0156] The anti-reflective structure can be a hydrophobic structure that forms a nanostructured film that reduces or eliminates reflections. A typical "moth eye" anti-reflective structure can have a hexagonal pattern of nanoscale protrusions that are smaller than the wavelength of the applied light (e.g., in this case, near infrared light). In some examples, the anti-reflective structure that can be used includes a material sticker that can be laminated to the window to prevent or reduce reflections.

[0157] An intraoral 3D scanner may include a window having an anti-reflective coating laminated layer by layer in a vacuum chamber. In particular, a removable protective cover / sleeve for an intraoral scanner is described herein, which has a window having a hydrophobic (moth-eye) anti-reflective structure. These devices (e.g., apparatus) and methods (e.g., methods of implementing the anti-reflective structure described herein) may include laminating a material (e.g., as a "sticker") directly onto a molded cover / removable barrier for an intraoral scanner. The anti-reflective material ("sticker") may be laminated onto a glass window / polymer window, for example by applying a sticker having a formed nanoscale structure that forms a moth-eye anti-reflective coating, and the window assembly including the laminated anti-reflective sticker may be combined with the body of the cover / protective cover, as described above. Typically, the moth-eye structure may be added to the window as part of an injection molding process for the window or the entire cover / protective cover.

[0158] In general, the nanostructured (e.g., "moth eye") anti-reflective structures described herein can be formed and applied to a window as a sticker or laminate; alternatively or additionally, the anti-reflective surface of these nanostructures can be formed directly as a coating or layer on the window (e.g., without using a "sticker" configuration that may include additional adhesive material). In some variations, the anti-reflective structures described herein can be formed directly on the window.

[0159] The anti-reflective laminate "stickers" described herein can be particularly advantageous. For example, these structures can be formed at a relatively low cost (e.g., compared to similar anti-reflective coatings) and can be added to a glass or polymer window of a removable protective cover / sleeve for an intraoral scanner. These structures can achieve similar anti-reflective properties on glass or polymer windows. The laminated (e.g., sticky) configuration described herein can allow the anti-reflective material to be manufactured separately from the window, which can allow the formation of even complex anti-reflective designs (e.g., nanostructures), which can include multiple layers laid on a substrate, even if the formation of the multiple layers on the substrate requires higher temperatures. By manufacturing an anti-reflective sticker with an anti-reflective coating separate from the window, damage to the window can be avoided, and in particular, thermal damage to the polymer window can be avoided. In general, these methods and devices can have very high performance anti-reflective coatings.

[0160] The antireflective materials described herein can have very high antireflective performance over an ultra-wide spectral range and a wide range of incident angles, especially compared to other antireflective coating methods (eg, layer laying).

[0161] The anti-reflective material may be located on the outside of the window (e.g., facing the patient). In some variations, the anti-reflective material may be located on the inside of the window (e.g., facing the intraoral scanner); in some variations, the anti-reflective material may be located on both the inside and outside of the window. Including an anti-reflective (e.g., "moth eye") material on the outside of the window may be particularly advantageous because it may also be hydrophobic, which may help prevent saliva from spreading on the window.

[0162] Fig. 10A An example of a schematic diagram of an example of an intra-oral scanner described herein is shown. In this example, the intra-oral scanner includes five light projectors 1003 and six cameras 1005 arranged as shown. Fig. 10B Shown through the Fig. 10A The dotted line in the figure shows a cross section of the intraoral scanner. Fig. 10B In FIG. 1 , two cameras 1005 are arranged at an angle to the light projector 1003 and point outward through a window 1007. The arrangement of the cameras 1005, the light projector 1003, and the disposable window 1007 (which may be located on a sleeve / removable barrier for an intraoral scanner) may result in some of the light generated by the light projector being reflected by the window 1007 and reaching the entrance pupil of the camera 1005. Fig. 10B In the figure, the dashed arrows 1, 4 reach the camera's entrance pupil and then reach the camera sensor surface (although other internally reflected light 5, 2, 3, 6 is not transmitted to the camera). The internally reflected signals that reach the camera sensor are internal reflections and can significantly reduce the signal-to-noise ratio (SNR) of the system; internal reflections may darken the image at the reflection location, thereby limiting or preventing data collection at this location.

[0163] The anti-reflective material (anti-reflective structure) 1009, 1009' described herein can be applied to the window 1007 and can reduce / eliminate internal reflections. The anti-reflective material can include nanostructures (forming a moth-eye structure) that are oriented to prevent internal reflections from within the window while allowing light to return from the tooth. In some variations, as described above, both sides of the window can include anti-reflective material, such as Fig. 10C shown.

[0164] In some variations, the device may include a window (e.g., on a sleeve / removable barrier for an intraoral scanner) to which an anti-reflective material (e.g., a moth-eye nanostructured material) is attached. The nanostructured anti-reflective material (which may be configured to pass visible light and / or near infrared light) may be laminated to the window. For example, the moth-eye (nanostructured anti-reflective material) may be configured as an adhesive sticker; Fig.11As shown, the adhesive sticker can be laminated to the inner surface (S1) and the outer surface (S2) of the molded sleeve 1105. Thus, during the manufacturing process, the adhesive sticker including the nanostructured surface forming the anti-reflective (moth-eye) material can be attached to the inner surface and the outer surface. Then, as described herein, the window can be assembled to the sleeve / removable barrier for the intraoral scanner.

[0165] Alternatively, in some variations, a method of forming a window of a cover may include forming a nanostructured anti-reflective material on the optical window. For example, in some variations, the window may be formed by an injection molding process, wherein the mold for injection molding the window includes a nanostructure (e.g., a pattern of hexagonal nanoscale projections). For example, the moth-eye anti-reflective nanostructure may be implemented during the injection molding process of the cover optical window, and then the window is assembled to the cover body. In some variations, the moth-eye anti-reflective nanostructure may be implemented during the injection molding process of the entire cover body.

[0166] In addition to the intraoral scanners described herein, these methods and materials (eg, patches of nanostructured antireflective material) may be used as part of any optical system having a similar geometric arrangement as described herein.

[0167] The nanostructure may be, for example, a hexagonal and / or hexagonally arranged pattern of protrusions with a height between 100 nm and 900 nm (e.g., between 200 nm and 800 nm, between 250 nm and 700 nm), a spacing between about 20 nm and 1000 nm (e.g., between 30 nm and 900 nm, etc.), and a gap between about 100 nm and 600 nm (e.g., between about 200 nm and 500 nm, etc.). In some variations, multiple layers of (protruding) nanoscale patterns may be stacked on top of each other (e.g., two layers, three layers, etc.); the material of each layer may be different (e.g., SiO2, Al2O3, MgF2, TiO2, InSb, ZnO, ZrO2, HgCdTe, Ge, etc.). The nanostructure may be formed on a substrate containing the same or different materials (e.g., Si, etc.).

[0168] When a feature or element is referred to as being "on" another feature or element in this article, it can be directly located on the other feature or element, and / or there can also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly" located on another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. It will also be understood by those skilled in the art that the structure or feature mentioned to be "adjacent" to another feature may have a part overlapping with an adjacent feature or being located under an adjacent feature.

[0169] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "one", "an" and "the" are intended to also include plural forms. It should be further understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of the features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more related listed items and can be abbreviated as " / ".

[0170] Spatial relative terms, such as "below", "below", "lower", "above", "on", etc., may be used herein for ease of description, to describe the relationship between an element or feature as shown in the figure and another one or more elements or features. It should be understood that spatial relative terms are intended to include the same orientation of the device in use or operation in addition to the orientation shown in the figure. For example, if the device in the figure is reversed, the element described as "below" or "below" other elements or features will be "oriented" to be located "above" other elements or features. Therefore, the exemplary term "below" can include the direction of above and below. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative narration used herein is interpreted accordingly. Similarly, unless otherwise expressly stated, the terms "upward", "downward", "vertical", "horizontal", etc. used herein are only for the purpose of explanation.

[0171] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0172] Throughout the specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "including" and "comprising" mean that various components can be used together in methods and articles (e.g., including components of apparatus and methods and devices). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0173] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" the various components, steps, sub-components or sub-steps.

[0174] As used in this specification and claims, including as used in the examples, unless otherwise expressly stated, all numbers can be read as if preceded by "about" or "approximately", even if the word does not appear explicitly. The phrase "about" or "approximately" can be used when describing magnitude and / or position to indicate that the value and / or position described are within the range of reasonable expected values ​​and / or positions. For example, a numerical value may have a value of + / -0.1% of the value (or range of values), + / -1% of the value (or range of values), + / -2% of the value (or range of values), + / -5% of the value (or range of values), + / -10% of the value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include about or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range cited herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed as "less than or equal to" the value, then "greater than or equal to the value" and possible ranges between values ​​are also disclosed, as will be appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that each single digit between two specific single digits is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0175] Although various illustrative embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be viewed as limiting the scope of the invention as described in the claims.

[0176] The examples and illustrations included herein show specific embodiments of the subject matter that can be practiced by way of illustration and not limitation. As described above, other embodiments can be utilized and derived therefrom, so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. These embodiments of the subject matter of the present invention may be referred to herein individually or collectively by the term "invention", only for convenience and not intended to voluntarily limit the scope of the present application to any single invention or inventive concept, if more than one is in fact disclosed. Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all changes or variations of various embodiments. After reading the above description, the combination of the above-mentioned embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the scanner, the cover including a window allowing transmission of optical signals between the scanner and an external environment; as well as A flexible sleeve adapted to cover a handle of the scanner, the flexible sleeve coupled to the cover at an interface region configured to prevent fluid from passing through a barrier arrangement between the cover and the sleeve, wherein the flexible sleeve is more flexible than the cover.

2. The device of claim 1, wherein the interface region comprises tape and / or a gasket.

3. The device according to claim 2, wherein the gasket comprises one or more of the following forms: an O-ring, an elastic material.

4. The device according to claim 3, wherein the gasket is integral with the proximal cover or the gasket is integral with the flexible sleeve or the gasket is arranged on the proximal cover and the flexible sleeve to provide a press fit.

5. The device of claim 1, wherein the interface region comprises a clip configured to releasably couple the cover and the sleeve, or the interface region comprises a weld region coupling the cover and the sleeve as a whole.

6. The device of claim 5, further comprising a gasket sealing the cover and the sleeve together.

7. The apparatus of claim 1, wherein the cover is adapted to hold the window in a fixed position relative to optical components of the scanner.

8. The device of claim 1, wherein the cover is adapted to cover one or more actuators of the handle, the cover being thin and flexible enough for a user to actuate the one or more actuators from an outer surface of the cover.

9. The device of claim 1, wherein the sleeve is more flexible than the cover.

10. The device of claim 1, wherein the barrier device has a length ranging from about 6 inches to about 20 inches from a distal end of the barrier device to a proximal end of the barrier device.

11. The apparatus of claim 1, further comprising an airflow guide configured to direct airflow into and out of the scanner, wherein the cover is configured to cover at least a portion of the airflow guide.

12. The device of claim 1, wherein the cover and the sleeve are made of one or more materials that are substantially impermeable to contaminants.

13. The device of claim 1, wherein one or both of the cover and the sleeve are made of an autoclavable material.

14. The device of claim 1, wherein the proximal cover comprises two or more components configured to be mechanically connected together around the scanning portion of the intraoral scanner.

15. The device of claim 14, wherein the two or more components are configured to snap fit together.

16. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover portion adapted to be mounted on a distal end of the intraoral scanner, the cover portion comprising at least one rigid window allowing transmission of optical signals between the scanner and an external environment; an engagement region within the cover portion configured to removably engage a distal end of the scanner and secure the window in a fixed relationship relative to the scanner; and a flexible sleeve portion extending proximally from the cover portion and adapted to cover a handle and a cable of the intraoral scanner, Wherein the flexible sleeve and the cover are configured to prevent fluid from flowing into the intra-oral scanner, and wherein the flexible sleeve portion and the cover portion are formed of the same flexible material.

17. A removable barrier device for covering a handheld intraoral scanner, the removable barrier device comprising: A cover, adapted to be mounted on a probe of the scanner, the cover comprising: a distal portion having a plurality of walls and formed of a first material, the plurality of walls defining an inner cavity for receiving the distal end of the probe, wherein at least one of the plurality of walls includes at least one window for allowing transmission of optical signals between the probe and an external environment; and a proximal portion molded to the distal portion and formed of a second material different from the first material; and A flexible sleeve is adapted to cover a handle of the scanner, the flexible sleeve being coupled to the proximal portion of the cover at an interface region configured to prevent fluid from passing through the barrier arrangement between the cover and the sleeve.

18. A method of forming a removable barrier device for covering a handheld intraoral scanner, the method comprising: A cover adapted to be mounted on a probe of the scanner is formed by: forming a distal portion of the cap by injection molding a first material, wherein the distal portion includes a plurality of walls defining an interior cavity, wherein one of the plurality of walls includes at least one window opening or at least one window formed of the first material; forming a proximal portion of the cap by overmolding a second material onto the first material such that the second material is bonded to the first material, the first material being different from the second material, wherein the proximal portion is bonded to edges of the plurality of walls of the distal portion to form an extension of the plurality of walls of the distal portion; as well as A flexible sleeve is coupled to the proximal portion of the cover such that an interface region between the flexible sleeve and the proximal portion of the cover is fluid-resistant, wherein the sleeve is adapted to cover a handle of the scanner and is more flexible than the distal portion of the cover.

19. A method of operating an intraoral scanner, the method comprising: scanning an identifier of the sleeve using the intraoral scanner, wherein the identifier is located on the sleeve; identifying from a database one or more characteristics specific to the kit based on the identifier; as well as Operation of the intraoral scanner is adjusted based on the identified one or more features.

20. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the intraoral scanner, the cover including a window allowing transmission of optical signals between the intraoral scanner and an external environment; wherein the cover has a wall sufficiently rigid to hold the window in a fixed position relative to an optical window of the intraoral scanner, wherein the wall includes one or more protrusions, one or more depressions, or one or more protrusions and depressions configured to removably secure the cover to a scanning portion of the intraoral scanner; as well as A flexible sleeve extends proximally from the cover and is adapted to cover a handle of the intraoral scanner, wherein the flexible sleeve is more flexible than the cover.

21. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the intraoral scanner, the cover including a window allowing transmission of optical signals between the intraoral scanner and an external environment; wherein the wall of the cover includes one or more protrusions, one or more depressions, or one or more protrusions and depressions configured to removably secure the cover to a scanning portion of the intraoral scanner; as well as A flexible sleeve adapted to cover a handle of the intraoral scanner, the flexible sleeve coupled to the cover at an interface region configured to prevent fluid from passing through the barrier device between the cover and the sleeve, wherein the flexible sleeve is more flexible than the cover.

22. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover portion adapted to be mounted on a distal end of the intraoral scanner, the cover portion including at least one rigid window allowing transmission of optical signals between the intraoral scanner and an external environment; an engagement region within the cover portion configured to removably engage the distal end of the intraoral scanner and secure the at least one rigid window in a fixed relationship relative to the intraoral scanner, wherein the engagement region comprises one or more protrusions, one or more recesses, or one or more protrusions and recesses; and a flexible sleeve portion extending proximally from the cover portion and adapted to cover a handle and a cable of the intraoral scanner, Wherein the flexible sleeve portion and the cover portion are configured to prevent fluid from flowing into the intra-oral scanner, and wherein the flexible sleeve portion is more flexible than the cover portion.

23. A method comprising: coupling a flexible sleeve to a removable protective end member attached to a distal end of a probe of an intraoral scanner to allow transmission of optical signals between the probe and an external environment such that the flexible sleeve at least partially surrounds a handle of the intraoral scanner, wherein the removable protective end member is formed of a first material; and A distal region of the flexible sleeve is sealed to a bonding area on an outer surface of the removable protective end member to form an airtight seal between the removable protective end member and the flexible sleeve.

24. An apparatus comprising: a removable protective end member configured to be removably coupled to a distal end of a probe of an intraoral scanner configured to collect optical data of a subject's dentition; and A flexible sleeve has a distal opening configured to be inserted over the removable protective end member and to engage an outer surface of the removable protective end member to form an airtight seal therewith.

25. An apparatus comprising: a removable protective end member configured to be removably coupled to a distal end of a probe of an intraoral scanner configured to collect optical data of a subject's dentition, the removable protective end member including a window allowing transmission of optical signals between the probe and an external environment; and A flexible sleeve has a distal opening configured to be inserted over the removable protective end member and to engage an outer surface of the removable protective end member to form an airtight seal therewith.

26. A removable barrier device for covering a handheld intraoral scanner, the barrier device comprising: a cover adapted to be mounted on a scanning portion of the intraoral scanner at a distal end of the intraoral scanner, the cover including a window allowing transmission of optical signals between the intraoral scanner and an external environment; wherein the cover has walls sufficiently rigid to hold the window in a fixed position relative to an optical window of the intraoral scanner; and A flexible sleeve extends proximally from the cover and is adapted to cover a handle of the intraoral scanner, wherein the flexible sleeve is coupled to the cover at an interface region configured to prevent fluid from passing through the barrier device between the cover and the sleeve.

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