CN101491115B - Method and apparatus for transmitting vibrations - Google Patents

Abstract

Disclosed herein are methods and apparatus for transmitting vibrations through teeth via electronics and/or transducer assemblies. The assembly may be mounted, bonded, or otherwise embedded in or on a removable oral device to form a hearing aid assembly. Such an oral device may be a custom made device. The electronic and transducer assembly may receive input sounds directly or through a receiver to process and amplify these signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as a maxillary, mandibular, or palatine bone structure.

Description

Method and apparatus for transmitting vibrations

Cross References to Related Applications

This application claims the benefit of priority to U.S. Provisional Application No. 60/809,244, filed May 30, 2006, and U.S. Provisional Application No. 60/820,223, filed July 24, 2006, each of which is incorporated by reference Form is incorporated herein in its entirety.

field of invention

The present invention relates to methods and apparatus for transmitting vibrations through dental or bony structures in and/or around the mouth. More specifically, the present invention relates to methods and apparatus for conducting sound through dental or bony structures in and/or around the mouth by transmitting vibrations associated with auditory signals received by the user.

Background of the invention

Hearing loss affects more than 31 million people in the United States (approximately 13 percent of the population). As a chronic disease, the incidence of hearing loss is comparable to that of heart disease and similar heart diseases, and the incidence of hearing loss increases dramatically with age.

Although the majority of people with hearing loss can be helped through the use of well-fitted and high-quality hearing devices, only 22% of the total number of people with hearing loss own hearing devices. Current products and distribution methods do not satisfy or reach the more than 20 million people with hearing loss in the United States alone.

Hearing loss adversely affects people's quality of life and mental health. People with hearing loss often stay away from social activities to avoid the frustration of not being able to understand conversation. Recent studies have shown that hearing loss can lead to increased nervousness, lower self-confidence, reduced social skills, and reduced productivity.

The human ear generally consists of three regions: the outer ear, middle ear, and inner ear. The outer ear usually includes the pinna and the ear canal, the tube-like passage through which sound travels to the middle ear. The outer ear is separated from the middle ear by the eardrum (tympanic membrane). The middle ear usually includes three small bones, called ossicles, that form the mechanical conductor from the eardrum to the inner ear. Finally, the inner ear includes the cochlea, which is a fluid-filled structure that includes a large number of fine sensory hair cells connected to the auditory nerve.

Hearing loss can also be classified as conductive, sensorineural, or a combination of both. Conductive hearing loss is usually caused by a disease or disorder that limits the transmission of sound through the middle ear. Most conductivity losses are treatable with drugs or surgery. Complete conductive hearing loss accounts for a relatively small fraction of the total hearing loss population (estimated to be less than 5% of the total hearing loss population).

Sensorineural hearing loss occurs primarily in the inner ear and accounts for a large proportion of hearing loss (estimated at 90-95% of the total number of people with hearing loss). Sensorineural hearing loss (sometimes called "nerve loss") is primarily caused by damage to the sensory hair cells in the cochlea. Sensorineural hearing loss occurs naturally with aging or with long-term exposure to loud music and noise. This type of hearing loss cannot be reversed and cannot be treated with medication or surgery, however, people's quality of life can be improved through the use of properly fitted hearing devices.

Conventional hearing devices are the most commonly used devices for the treatment of mild to severe sensorineural hearing loss. These devices are acoustic devices that amplify the sound to the eardrum. After 4 to 6 individual visits to an audiologist or hearing instrument specialist, the devices can be customized to the patient's physical and acoustic characteristics, respectively. These devices typically include amplifiers, amplifiers, batteries and speakers. Currently, hearing device manufacturers increase the complexity of sound processing, often by using digital techniques to provide features such as programmability and multi-band compression. Although these devices have been miniaturized and less conspicuous, they can still be seen and have a greater sound limitation.

Industry research has shown that the main barriers to not purchasing a hearing device often include: a) feelings of stigma (stigma) associated with carrying a hearing device; b) opposing attitudes from the medical community, especially on the part of ENT physicians; c) performance issues related to perceived Associated product value issues; d) a general lack of information and education at the consumer and physician level; and e) negative word of mouth from dissatisfied users.

Other devices, such as cochlear implants, have been developed for people with severe to profound hearing loss who are essentially deaf (approximately 2% of the total hearing loss population). The electrodes of a cochlear implant are inserted into the inner ear during an invasive and irreversible procedure. The electrodes electrically stimulate the auditory nerve through an electrode array that provides the user with auditory cues that are not normally interpreted by the brain as normal sounds. Following surgery, users typically require intensive and long-term counseling and training to achieve the desired results.

Other devices, such as electronic middle ear implants, are often surgically placed in the middle ear for hearing loss. They are surgically implanted devices with externally worn components.

The manufacture, assembly and distribution of hearing devices remains an arcane and inefficient process. Most hearing devices are custom produced by the manufacturer, fabricated to fit the ear of each intended purchaser. Impressions of the ear canal can be obtained by the assignee (audiologist or licensed hearing instrumentation specialist) and mailed to the manufacturer for analysis and fabrication of a custom molded rigid plastic housing. The hand-wired electronics and transducers (amplifier and speakers) are then placed inside the enclosure and after a period of time, usually 1 to 2 hours, the final product is Send back to professional assignee.

The time period for distributing hearing devices, ie from the initial diagnosis period to the final fine-tuning period, typically spans a period of several weeks, eg 6 to 8 weeks, and involves multiple distributors.

Therefore, a need exists for methods and devices that are effective and safe for treating hearing loss in patients.

Contents of the invention

The electronics and transducer device may be attached, bonded or otherwise embedded in or on a removable dental or oral appliance to form a hearing aid assembly. Such a removable oral appliance may be a custom-made device manufactured by a thermoforming process using a replica model of the tooth structure obtained by conventional dental impression methods. The electronics and transducer assembly can receive incoming sound, either directly or through a receiver, to process and amplify these signals, and transmit the processed sound via a vibrating transducer element coupled to a tooth or other bone structure, other bone The structure is, for example, a maxillary, mandibular or palatine structure.

The assembly for transmitting vibrations via the at least one tooth may generally include a housing having a shape conforming to at least a portion of the at least one tooth, and a housing that may be placed in or on the housing and in vibrational communication with a surface of the at least one tooth. Actuated transducer (actuatabletransducer). Furthermore, the transducer itself may be a separate component from the electronics, and may be placed along another surface of the tooth, such as the occlusal surface, or even attached to an implanted post or screw embedded in the underlying bone. In addition, the transducers can also be placed directly on the surface of the gum tissue close to the teeth to enable transmission of vibrations through the tissue and into the underlying bone.

An embodiment of a method for transmitting vibrations via at least one tooth may generally include positioning a housing of a removable oral device onto the at least one tooth such that the housing has a shape that conforms to at least a portion of the tooth, and Contact is maintained between the surface of the tooth and the actuatable transducer such that the surface and transducer are in vibratory communication.

Description of drawings

Figure 1 shows the dentition of a patient's teeth and a variation of a hearing aid removably placed on or attached to the patient's teeth as a removable oral appliance.

Figure 2A shows a perspective view of the lower teeth showing an exemplary location for placing a removable oral device hearing aid.

Figure 2B shows another variation of a removable oral device in the form of a mouthguard placed over a row of teeth.

Figure 2C shows another variation of a removable oral appliance supported by arches.

Figure 2D shows another variation of an oral device configured as a mouthguard.

Figure 3 shows a detailed perspective view of an oral appliance in another variation of the apparatus, which sits on the patient's teeth, is usable in conjunction with a transmitting assembly outside the oral cavity, and is wearable by the patient.

Figure 4 shows an exemplary structure of the various components in a variation of an oral device having an external delivery assembly and an intraoral receiving assembly and transducer assembly.

Figure 5 shows an exemplary structure of another variation of the device in which the entire assembly is contained by an oral appliance in the user's mouth.

Figure 6A shows a partial cross-sectional view of an oral device placed on a tooth with the electronics/transducer assembly bonded to the surface of the tooth via an adhesive.

Figure 6B shows a partial cross-sectional view of a removable backing bonded to an adhesive surface.

Figure 7 shows a partial cross-sectional view of another variation of an oral device placed on a tooth with the electronics/transducer assembly snugly attached to the tooth surface via an osmotic pouch.

Figure 8 shows a partial cross-sectional view of another variation of an oral appliance placed on a tooth, the device having the electronics/transducer assembly resting against the surface of the tooth via one or more biasing elements.

Figure 9 shows another variation of an oral device having the electronics assembly and transducer assembly spaced apart within the electronics and transducer housing of the oral device.

Figures 10 and 11 illustrate additional variations of oral appliances in which the electronics and transducer assembly can be maintained on the tooth surface via ramps and biasing elements.

Figure 12 shows yet another variation of an oral appliance having an interfacing member between the electronics and/or transducer assembly and the surface of the tooth.

Figure 13 shows yet another variation of an oral appliance having an actuatable mechanism for pressing the electronics and/or transducer assembly against the tooth surface.

Figure 14 shows yet another variation of an oral appliance having a cam mechanism for engaging the electronics and/or transducer assembly against the tooth surface.

Figure 15 shows yet another variation of an oral device with a separate transducer mechanism that can be positioned on the occlusal surface of the teeth to transmit vibrations.

Figure 16 shows yet another variation of an oral appliance having a mechanism for affixing the electronics and/or transducer assembly to the tooth surface through the use of a bite-actuated mechanism.

Figure 17 shows yet another variation of an oral appliance having a composite dental anchor for coupling the transducer to the tooth.

18A and 18B show side and top views, respectively, of variations of an oral device having one or more transducers that may be positioned on the occlusal surfaces of teeth.

Figures 19A and 19B illustrate yet another variation of an oral device made from a shape memory material, and show the device in its preformed relaxed configuration and its position, respectively, as it is placed on a patient's teeth. A structure that deforms when an interference fit is formed.

Fig. 20 shows yet another variation of an oral device, the device being made from a pre-formed material, wherein the transducer may be positioned between the bias side of the oral device and the tooth surface.

Figure 21 shows a variation in which the oral appliance can be omitted and the electronics and/or transducer assembly can be fitted to a composite dental fixture fitted directly to the tooth surface.

22A and 22B show partial cross-sectional side and perspective views, respectively, of another variation of an oral device assembly with occlusal surfaces removed or omitted for patient comfort.

23A and 23B show perspective and side views, respectively, of an oral device that may be coupled to a screw or post implanted directly into underlying bone, such as a maxilla or mandible.

Figure 24 shows another variation in which the oral appliance may be coupled to screws or posts implanted directly into the palate of the patient.

25A and 25B show perspective and side views, respectively, of an oral device that may have its transducer assembly or coupling assembly fitted to a gum surface to conduct vibrations through gum tissue and underlying bone.

Figure 26 shows an example of how multiple oral device hearing aid components or transducers may be placed on multiple teeth in a patient's mouth.

27A and 27B show a perspective view and a side view, respectively, of an oral device (similar to the variation shown above) that may have a microphone unit positioned close to or on the gingival surface to physically The amplifier is separated from the transducer to attenuate or eliminate feedback.

Figure 28 shows another variation of a removable oral device supported by an arch and having a microphone unit integrated into the arch.

Figure 29 shows yet another variation showing at least one microphone and optional additional microphone units positioned around the user's mouth and in communication with the electronic device and/or the transducer components for wireless communication.

Detailed description of the invention

The electronics and transducer device may be assembled, bonded, or otherwise embedded in or on a removable oral appliance or other oral device to form a hearing aid assembly. Such an oral appliance may be a custom-made device manufactured by a thermoforming process using a replica model of the tooth structure obtained by conventional dental impression methods. The electronic assembly and transducer assembly can receive incoming sound directly or through a receiver to process and amplify these signals and via coupling to teeth or other skeletal structures, for example, to the maxilla, mandible or The vibration transducer of the palatine structure transmits the processed sound.

As shown in FIG. 1 , a patient's oral cavity and dentition 10 are shown, which illustrate the process of removably fitting a hearing aid component 14 to or against at least one tooth, e.g., a molar 12. a possible location. The patient's tongue TG and palatine bone PL are also shown for reference. Electronics and/or transducer assembly 16 may be mounted, bonded, or otherwise embedded in or onto assembly 14, as described in further detail below.

2A shows a perspective view of a patient's lower dentition showing hearing aid assembly 14 including removable oral appliance 18 and electronics and/or transducer assembly 16 positioned along the side of assembly 14 . In this variation, the oral appliance 18 is mounted on both molars 12 within the tooth-engaging channel 20 defined by the oral appliance 18 for stabilization on the patient's teeth, but in other variations a single molar or tooth may be used. Alternatively, oral appliance 18 may fit on more than two molars. In addition, the electronics and/or transducer assembly 16 is shown positioned on the side of the oral appliance 18 such that the assembly 16 is aligned along the buccal surface of the tooth 12, however, other surfaces such as the lingual surface of the tooth 12 and other locations are also possible. can be used. These figures are schematic illustrations of variations and are not intended to be limiting; thus, other structures and shapes of oral device 18 are intended to be included herein.

Figure 2B shows another variation of a removable oral device in the form of a device 15 placed over a row of teeth in the manner of a mouthguard. In this variation, device 15 may be configured to cover the entire lower row of teeth or alternatively the entire upper row of teeth. In an additional variant, the device 15 covers not the entire row of teeth, but most of the teeth in a row. Assembly 16 may be placed along one or more portions of oral device 15 .

Figure 2C shows yet another variation of the oral appliance 17, which has an arcuate configuration. In this device, one or more tooth retaining portions 21, 23 may be supported by arches 19, which in this variation may be placed along the upper row of teeth, arches 19 may be adjacent Placed on or along the user's palate. As shown, the electronics and/or transducer assembly 16 may be placed along one or more portions of the tooth retention portions 21 , 23 . Furthermore, while the illustrated variation shows an arch 19 that may cover only a portion of the user's palate, other variations may be configured with an arch that covers the entire user's palate.

Figure 2D shows yet another variation of an oral device in the form of a mouthguard or retainer 25 that can be easily inserted into or removed from a user's mouth. Such a mouthguard or retainer 25 can be used in sports wearing a conventional mouthguard, however, a mouthguard or retainer 25 with the assembly 16 integrated therein can be used by a hearing impaired person, or by such It is used by people who receive the mouthguard or retainer 25 through the grooves or channels 26 between their teeth to receive instructions remotely and communicate over long distances.

In general, the bulk of the electronics and/or transducer assembly 16 can be minimized so that it is unobtrusive and comfortable to the user when placed in the oral cavity. Although dimensions may vary, assembly 16 may have a volume of less than 800 cubic millimeters. Of course, this volume is exemplary and not limiting, as the size and volume of assembly 16 may vary from user to user.

In addition, the removable oral device 18 can be fabricated from different polymers or combinations of polymers and metal materials using any number of methods, such as by computer-aided machining processes using computer numerical control (CNC) systems or Three-dimensional printing processes, such as stereolithography (stereolithography) apparatus (SLA), selective laser sintering (SLS), and/or other similar processes that utilize the three-dimensional geometry of the patient's dentition, wherein the three-dimensional geometry of the patient's dentition Shapes can be obtained via any number of techniques. These techniques may include the use of scanned dentition through the use of intraoral scanners such as laser scanners, white light scanners, ultrasound scanners, mechanical three-dimensional contact scanners, magnetic resonance imaging (MRI), Computed tomography (CT), other optical methods, etc.

In forming the removable oral device 18, the device 18 can optionally be formed so that it is shaped to fit over the dentition and at least a portion of the adjacent gum tissue to prevent food, fluids and other residues from entering the oral device 18 and the transducer between the component and the tooth surface. Additionally, the greater surface area of oral device 18 may facilitate placement and deployment of components 16 onto device 18 .

In addition, the removable oral appliance 18 is optionally manufactured with shrinkage so that when the oral appliance 18 is placed on the dentition, it can be configured to clamp securely to the teeth, thus, the appliance 18 The resulting size of the tooth may be slightly smaller than the size of the scanned tooth on which the device 18 is formed. This fit results in a secure interference fit between the device 18 and the underlying dentition.

In a variation, as shown in FIG. 3 , where the assembly 14 is located on the tooth, an extraoral transmitter assembly 22 located outside the patient's mouth may be used to receive the auditory signal for processing and transmission via a wireless signal 24. Transmitted to the electronic device and/or transducer assembly 16 located in the patient's oral cavity, the electronic device and/or transducer assembly 16 can then process the signal and transmit the processed auditory signal via a vibration conductor (vibratory conductance) to the following teeth, and thereby transmitted to the inner ear of the patient.

As described in further detail below, transmitter assembly 22 may include a speaker assembly as well as a transmitter assembly, and may be configured in any number of shapes and forms worn by a user, for example, a watch, necklace, lapel, telephone, Equipment on belts, etc.

4 shows a schematic diagram of a variation of a hearing aid assembly 14 using an extraoral transmitter assembly 22, which may generally include a microphone 30 for receiving sound, and the microphone 30 is electrically powered. Connected to a processor 32 for processing auditory signals. Processor 32 may be electrically connected to transmitter 34 to transmit the processed signal to electronics and/or transducer assembly 16 placed on or near the user's teeth. Microphone 30 and processor 32 may be configured to detect and process audible signals in any feasible range, but in one variation they may be configured to detect audible signals in the range from, for example, 250 Hz to 20,000 Hz.

With regard to the loudspeaker 30, a variety of different loudspeaker systems may be used. For example, microphone 30 may be a digital, analog, and/or directional type microphone. These different types of microphones may alternatively be configured for use with the assembly, if desired.

(BLUETOOTH SIG，公司，Bellevue，WA)等的任何无线形式传送给组件16。组件22还可选择地包括一个或多个输入控制28，用户可操作这些输入控制28以调节电子设备和/或变换器组件16的各种声学参数，如声学聚焦(acoustic focusing)、音量控制、滤波、静音、频率优化、声音调节和音调调节，等。A power source 36 may be connected to each component in the transmitter assembly 22 to provide power thereto. Transmitter signal 24 can use such as radio frequency, ultrasonic, microwave, bluetooth

(BLUETOOTH SIG, Inc., Bellevue, WA) etc. to component 16 over the air. Assembly 22 may also optionally include one or more input controls 28 that a user may operate to adjust various acoustic parameters of the electronics and/or transducer assembly 16, such as acoustic focusing, volume control, Filtering, muting, frequency optimization, sound adjustment and tone adjustment, etc.

The signal 24 transmitted by the transmitter 34 may be received by the electronics and/or the transducer assembly 16 via a receiver 38, which may be connected to an internal processor for additional processing of the received signal. The received signal may be transmitted to the transducer 40 which in turn may vibrate on the tooth surface to conduct the vibration signal through the tooth and bone and thereby reach the middle ear to facilitate hearing of the user. Transducer 40 may be configured as any number of different vibration devices. For example, in one variation, transducer 40 may be an electromagnetically driven transducer. In other variations, the transducer 40 may be in the form of a piezoelectric crystal having a vibrational frequency range of, for example, 250 Hz to 4000 Hz.

A power supply 42 may also be included in the assembly 16 to power the receiver, the transducer, and/or the processor, if included. While the power source 42 may be a simple replaceable or permanent battery, other variations may include an inductively charged power source 42 via an external charger. Furthermore, the power supply 42 may alternatively be charged by directly coupling to an alternating current (AC) source or a direct current (DC) source. Other variations may include charging the power source 42 via mechanical means, such as internal pendulums or slidable electric inductive chargers known to those skilled in the art, which are actuated by, for example, jaw movement and/or displacement. to convert the mechanical motion into stored electrical energy to charge the power source 42.

As shown in FIG. 5, in another variation of assembly 16, instead of using an extra-oral transmitter, hearing aid assembly 50 is configured as a self-contained assembly entirely contained within the user's mouth. Accordingly, assembly 50 may include an internal microphone 52 in communication with on-board processor 54 . As noted above, the internal loudspeaker 52 may include any number of different types of loudspeakers. Processor 54 may be used to process any received auditory signals to filter and/or amplify them and transmit them to transducer 56, which is in vibratory contact with the tooth surface. As noted above, a power supply 58 may also be included within the assembly 50 to provide power to each of the components of the assembly 50 as necessary.

In order to transmit vibrations corresponding to received auditory signals to the tooth efficiently and with minimal loss, it is desirable to maintain a firm mechanical contact between the transducer and the tooth to ensure effective vibration communication. Thus, any number of devices may be used to maintain the vibratory communication.

In a variation as shown in Fig. 6A, a partial cross-sectional view of a removable oral device 60 on a tooth TH is shown. It can be seen that the electronics and/or transducer housing 62 is bounded along the oral device 60 such that the housing 62 is aligned along or adjacent to the lateral, buccal and/or lingual surfaces of the teeth TH. Housing 62 may provide protection for the electronics and/or transducer assembly from the oral environment.

The electronics and/or transducer assembly 64 may simply be placed, embedded or packaged within the housing 62 for contact with the tooth surface. In this variation, component 64 may be adhered to the surface of the tooth via an adhesive surface or membrane 66 so that contact may be maintained therebetween. As shown in Figure 6B, a removable liner 68 is adhered to the adhesive surface 66 and may be removed prior to placement on the tooth surface. In this way, assembly 64 can be replaced on the tooth with additional electronics and/or transducer assemblies, if necessary.

Next to the adhesive film 66, another option is to use an expandable or inflatable member to ensure firm mechanical contact of the transducer with the tooth. As shown in FIG. 7 , a permeable sheet or expandable hydrogel 74 may be placed between housing 62 and electronics and/or transducer assembly 72 . After the oral device 60 is placed, the hydrogel 74 may absorb some fluid from any surrounding fluid or from fluid introduced into the hydrogel, so that the size of the hydrogel 74 expands, causing the component 72 to squeeze against the teeth surface contact. Assembly 72 may be configured to define a contact surface 70 that has a relatively small contact area to promote uniform contact of surface 70 to the teeth. Such an interface 70 may be included in any of the variations described herein. Additionally, a thin encapsulating layer or surface 76 may be placed on the shell 62 between the contact surface 70 and the underlying tooth to prevent any residue or other fluids from entering the shell 62 .

Another variation is shown in FIG. 8 , which shows electronics and/or transducer assembly 80 contained within housing 62 . In this variation, one or more biasing elements 82, such as springs, preformed shape memory elements, etc., may be placed between assembly 80 and housing 62 to pressurize assembly 80 such that the The device rests against the tooth surface, thereby ensuring mechanical contact.

In yet another variation, the electronics may be contained as a separate component 90 enclosed within housing 62 , and transducer 92 may be kept separate from component 90 but also within housing 62 . As shown in Figure 9, the transducer 92 may be held against the tooth surface by a spring or other biasing element 94 and driven by any of the mechanical means described above.

In another variation as shown in FIG. 10, the electronics and/or transducer assembly 100 may be configured to have a ramp 102 that interfaces with the surface of the tooth. Surface 102 may be angularly offset from the occlusal surface of the teeth. The assembly 100 may be urged by a biasing element or spring 106 which rotates the ramp 102 about position 104 into contact with the tooth to ensure transducer to tooth surface contact.

FIG. 11 shows another similar variation of an electronics and/or transducer assembly 110 that also has a ramp 112 that interfaces with the tooth surface. In this variation, the chamfer 112 may approach angularly towards the occlusal surface of the teeth. Likewise, assembly 110 may be urged by biasing member or spring 116 , which rotates assembly 110 about its lower end to bring assembly 110 into contact with the tooth surface at region 114 .

In yet another variation shown in FIG. 12, the electronics and/or transducer assembly 120 is located within the housing 62 and an interface layer 122 is located between the assembly 120 and the tooth surface. The interface layer 122 can be configured to conform to the surface of the tooth and conform to the component 120 so that vibrations can be transmitted through the layer 122 and reach the tooth in a consistent fashion. Accordingly, interface layer 122 may be made of a material that will minimize vibration dampening. The interface layer 122 can be made in different forms, e.g., simple inserts, O-ring configurations, etc., or even in the form of a gel or paste, e.g., dental paste or oral paste, etc. . Furthermore, layer 122 may be made of different materials, such as hard plastic or polymer materials, metals, and the like.

Figure 13 shows yet another variation in which the electronics and/or transducer assembly 130 may be advanced relative to the tooth surface by a mechanical mechanism. As shown, the assembly 130 may be mounted to a structural member 132 , such as a threaded member or a simple shaft, which passes through the housing 62 and connects to an engaging member 134 located outside the housing 62 . A user may rotate engagement member 134 (as indicated by rotational arrow 136) or simply push member 134 (as indicated by linear arrow 138) to advance assembly 130 into contact with the teeth. Furthermore, actuation of the engagement member 134 may be accomplished manually in the oral cavity, or by the user's cheek, or even by manipulation of the engagement member 134 by the user's tongue.

Figure 14 shows another variant of the mechanical mechanism. In this variation, electronics and/or transducer assembly 140 may define a portion as engagement surface 142 for contacting cam or lever mechanism 144 . The cam or lever mechanism 144 can be configured as a pivot 146 so that actuation of a lever 148 extending through the housing 62 can cause the cam or lever mechanism 144 to push the engagement surface 142 so that the assembly 140 rests on the underlying tooth surface .

In yet another variation, the electronics 150 and transducer 152 may be separated from each other so that the electronics 150 remains within the housing 62, while the transducer 152, connected via wires 154, is located in the oral cavity of the tooth along the occlusal surface of the tooth. The device 60 is below, as shown in FIG. 15 . In this configuration, vibrations are transmitted through the occlusal surfaces of the teeth via the transducer 152 . Additionally, the user can bite down on the oral appliance 60 and transducer 152 to mechanically press the transducer 152 against the occlusal surface to further enhance the mechanical contact between the transducer 152 and the underlying teeth, thereby further facilitating passage. their transmission.

In a variation of FIG. 16 , another embodiment of a coupling mechanism for enhanced snapping is shown in which the electronics and/or transducer assembly 160 defines an angled interface that interfaces with a corresponding angled engagement member 164 162. The proximal end of the engagement member 164 may extend through the housing 62 and terminate in a pusher member 166 on the occlusal surface of the tooth TH. Once the oral device 60 is initially placed on the teeth TH, the user can bite down or otherwise press down on the top of the oral device 60, thereby pressing down on the pusher member 166, which in turn pushes down on the engagement member 164. , as indicated by the arrow. As engagement member 164 is advanced down the gum, its sloped face may press against the corresponding and opposing sloped face 162 to press assembly 160 against the tooth surface, thereby forming a secure mechanical contact.

In yet another variation, the electronics and/or transducer assembly 170 may define a channel or groove 172 along the surface for engaging a corresponding dental retainer 174, as shown in FIG. 17 . Dental retainer 174 may comprise a light curable acrylate-based composite material that is adhered directly to the tooth surface. In addition, the dental retainer 174 can be configured to conform to the shape of the channel or groove 172 so that the two can be properly mated with each other. In this way, the transducers in the assembly 170 can vibrate directly against the tooth holder 174, which can then transmit these signals directly into the tooth TH.

18A and 18B show a partial cross-sectional side view and top view, respectively, of another variation in which an oral device 180 may define a plurality of channels or grooves 184 along the top of the oral device 180. . In these channels or recesses 184, one or more transducers 182, 186, 188, and 190 can be placed so that they contact the occlusal surfaces of the teeth, and each of these transducers can be adjusted to deliver consistently frequency. Optionally, each of these transducers can be tuned to transmit only within a specified frequency range. Accordingly, each transducer may be programmed or preset for a different frequency response such that each transducer may be optimized for a different frequency response and/or transmission to deliver relatively high fidelity sound to the user.

In another variation, Figures 19A and 19B illustrate an oral device 200 that may be preformed with a shape memory polymer or alloy or a superelastic material such as Nitinol, eg, Nitinol. FIG. 19A shows oral device 200 in a first configuration in which members 202 and 204 are in an unbiased memory configuration. When the members 202 and 204 are placed on the tooth TH, they can be deflected into a second configuration in which the members 202' and 204' are deformed to engage the tooth TH with a secure interference fit, as shown in Figure 19B. The biased member 204' may be used to press the electronics and/or transducer assembly contained therein against the surface of the tooth, as well as maintain the firmness of the oral appliance 200 on the tooth TH.

Similarly, as shown in FIG. 20, a removable oral device 210 may have a biased member to securely engage a tooth TH, as described above. In this variation, the ends of members 212 and 214 may be configured as curved portions under which transducer element 218 coupled to electronics assembly 216 may be snapped or otherwise secured, To ensure mechanical contact with the tooth surface.

Figure 21 shows yet another variation in which the oral appliance can be omitted entirely. Here, a composite dental retainer or bracket 226 as described above may be affixed directly to the tooth surface. Alternatively, bracket 226 may be made of a biocompatible material, such as stainless steel, nickel titanium, nickel, ceramic, composite materials, etc., that is formed into a bracket and secured to the tooth surface. Bracket 226 may be configured to have a shape 228 over which electronics and/or transducer assembly 220 may slide via channel 222 having a corresponding receiving structure 224 for engaging bracket 226 . In this way, the assembly 220 can be engaged directly to the bracket 226 through which the transducer can vibrate directly to the underlying tooth TH. Furthermore, in the event that the assembly 220 needs to be removed from the tooth TH, the assembly 220 can simply be slid or rotated to disengage the bracket 226 and a replacement assembly can be placed in place on the bracket 226 .

22A and 22B show partial cross-sectional side and perspective views, respectively, of yet another variation of an oral device 230 . In this variation, the oral device 230 may be configured to omit the occlusal portion of the oral device 230 and instead engage the sides of the teeth TH, eg, only the lingual and buccal surfaces. As above, electronics and/or transducer assembly 234 may be contained within housing 232 to contact the tooth surface. Additionally, as shown in FIG. 22B, one or more optional cross-members 236 may be attached to the side portions of the oral device 230 to provide some structural stability as they are placed on teeth. This variation can define the occlusal opening 238 so that when the oral device is placed on the teeth, the user is free to bite down directly on the natural occlusal surface of the teeth without being obstructed by the oral device, thereby providing the user with enhanced comfort.

In yet another variation, the vibrations may be transmitted directly to the underlying bone or tissue structure rather than directly through the user's teeth. As shown in FIG. 23A, an oral appliance 240 is shown positioned on a user's teeth, in this embodiment on molars positioned in the upper row of teeth. The electronics and/or transducer assembly 242 is shown positioned on the buccal surface of the tooth. Rather than having the transducer contact the tooth surface, a conduction transmission member 244, such as a rigid or solid metal member, is coupled to the transducer in assembly 242 and extends from the oral appliance 240 to the post. or screws 246, while posts or screws 246 are implanted directly into the underlying bone 248, such as the maxilla, as shown in the partial cross-sectional view of FIG. 23B. Since the end of the transmission member 244 is directly coupled to the post or screw 246, vibrations generated by the transducer can be transmitted through the transmission member 244 and directly into the post or screw 246, which in turn transmits the vibration directly to the post or screw 246. bone 248 and is transmitted through bone 248 to the user's inner ear.

Figure 24 shows a partial cross-sectional view of an oral appliance 250 placed on a user's teeth TH, with electronics and/or transducer assembly 252 located on the lingual surface of the teeth. Likewise, vibrations may be transmitted through the conductive transmission member 244 and directly into the post or screw 246, which in this embodiment is implanted in the palatine bone PL. Other variations may use this structure located in the lower row of teeth for delivery to a post or screw 246 drilled into the mandible.

In yet another variation, rather than using posts or screws drilled into the underlying bone itself, the transducers are mounted, coupled or otherwise secured directly to the surface of the gum tissue proximate the teeth. As shown in Figures 25A and 25B, an oral device 260 may have an electronics assembly 262 with wires 264 on one side thereof and from there extending to a transducer assembly 266 that is mounted to the gum tissue next to the tooth TH. Surface 268. Transducer assembly 266 may be mounted to tissue surface 268 by adhesive, structural support arms extending from oral appliance 260, dental screws or posts, or any other structural means. In use, the transducer vibrates and transmits it directly to the underlying gum tissue, which in turn conducts the signal to the underlying bone.

As with any of the variations described above, they may be used as a single device or, to the extent practicable, in combination with any of the other variations herein to achieve the desired hearing level of the user. In addition, more than one oral device device and electronics and/or transducer assembly may be in use at any one time. For example, Figure 26 shows an embodiment in which multiple transducer assemblies 270, 272, 274, and 276 may be placed on multiple teeth. Although several components are shown on the lower row of teeth, they could alternatively be placed on the upper row of teeth or could be placed on both rows of teeth. Additionally, each component can be configured to transmit vibrations within a consistent frequency range. Alternatively, in other variations, different components may be configured to vibrate in non-overlapping frequency ranges between each component. As noted above, each transducer 270, 272, 274, and 276 may be programmed or preset for a different frequency response such that each transducer is optimized for a different frequency response and/or transmission to the user Relatively high-fidelity sound.

In addition, each of the different transducers 270, 272, 274, and 276 may also be programmed to vibrate in a manner indicative of the directionality of sound received by a microphone worn by the user. For example, different transducers located at different locations in the user's mouth may vibrate in a prescribed manner by providing a queue of sounds or vibrations to inform the user which sensor is detected relative to the user's orientation. direction sound. For example, a first transducer, such as located on the user's left tooth, may be programmed to vibrate in response to detected sounds emanating from the user's left side. Likewise, a second transducer, located eg on the user's right tooth, may be programmed to vibrate in response to a detected signal originating from the user's right side. Since these embodiments are intended to be exemplary of possible variations, other variations and alignments may be used.

In variations where one or more microphones are located in the cheek, the microphones may be integrated directly into the electronics and/or transducer assembly, as described above. However, in other variations, the microphone unit may be located at a distance from the transducer assembly to minimize feedback. In one embodiment, similar to the variation shown above, the microphone unit 282 may be separate from the electronics and/or transducer assembly 280, as shown in Figures 27A and 27B. In such a variation, the microphone unit 282 located on or near the gum surface 268 may be electrically connected via the wire 264 .

Although this variation shows the microphone unit 282 positioned near the gum tissue 268, the unit 282 could be located on another tooth or another location in the oral cavity. For example, Fig. 28 shows another variation 290 which uses arches 19 connecting one or more tooth retention portions 21 and 23, as described above. In this variation, however, the loudspeaker unit 294 may be integrated into or onto the arch 19 , thereby being separate from the transducer assembly 292 . One or more wires 296 routed through arch 19 may electrically connect microphone unit 294 to assembly 292 . Alternatively, rather than using wires 296, microphone unit 294 and assembly 292 are coupled to each other wirelessly, as described above.

In yet another variation that separates the loudspeaker from the transducer assembly, FIG. 29 shows another variation in which at least one loudspeaker 302 (or optionally any number of additional loudspeakers 304 and 306 ) may be located in the user's oral cavity while being separated from the electronic device and/or the transducer assembly 300. In this manner, one or an optional plurality of microphones 302, 304, and 306 may be wirelessly coupled to the electronics and/or transducer assembly 300 in a manner that attenuates or eliminates feedback from the transducer , if feedback exists.

Applications of the devices and methods discussed above are not limited to treating hearing deficits, but may include any number of further therapeutic applications. Additionally, these devices and methods can be applied to other treatment sites within the body. Modifications of the above-mentioned components and methods for implementing the present invention, combinations between different variations within the feasible range, and variations of various aspects of the present invention that are obvious to those skilled in the art are expected to be included in the claims In the range.

Claims (46)

CLAIMS 1. An apparatus for transmitting vibrations via at least one tooth to facilitate hearing in a patient comprising: a housing configured to engage the at least one tooth; an actuatable transducer located within or on said housing and configured to transmit vibrations to a surface of said at least one tooth, wherein said instrument is on at least two surfaces of said instrument and said at least one tooth interference fit between them. 2. The apparatus of claim 1, wherein the housing includes an oral appliance having a shape that conforms to the at least one tooth. 3. The apparatus of claim 2, wherein the oral device is manufactured by a three-dimensional printing process. 4. The apparatus of claim 2, wherein the oral device is manufactured by a mechanical process. 5. The apparatus of claim 1, further comprising an electronic component located in or on the housing, and the electronic component is in communication with the transducer. 6. The apparatus of claim 5, wherein the electronic components are enclosed within the housing. 7. The apparatus of claim 5, wherein the electronics assembly further comprises a power supply in electrical communication with the transducer. 8. The apparatus of claim 7, wherein the power source comprises a battery. 9. The apparatus of claim 7, wherein the power source is rechargeable. 10. The apparatus of claim 5, wherein the electronics assembly further comprises a processor in electrical communication with the transducer. 11. The apparatus of claim 10, wherein the electronics assembly further comprises a microphone for receiving an audible signal, and the microphone is in electrical communication with the processor. 12. The apparatus of claim 5, wherein the electronics assembly further comprises a receiver in wireless communication with an externally located transmitter assembly. 13. The apparatus of claim 1, wherein the transducer is in vibratory communication with the surface via an adhesive layer for maintaining the transducer in contact with the surface. 14. The apparatus of claim 1, further comprising an expandable osmotic bladder positioned adjacent the transducer such that expansion of the osmotic bladder propels the transducer against the surface. 15. The device of claim 14, wherein the osmotic capsule comprises an expandable hydrogel. 16. The apparatus of claim 1, further comprising at least one biasing element positioned adjacent the transducer such that the at least one biasing element maintains the transducer on the surface by a biasing force . 17. The apparatus of claim 16, wherein the at least one biasing element comprises a spring. 18. The apparatus of claim 1, wherein the transducer defines a ramp that interfaces with the surface. 19. The apparatus of claim 1, further comprising an interface layer between the transducer and the surface through which vibrational communication is maintained. 20. The device of claim 19, wherein the interface layer comprises a plastic material or a paste material. 21. The instrument of claim 1, further comprising an elongated support for advancing the transducer crown when actuated via an engagement located on the exterior of the housing on the surface. 22. The instrument of claim 1, further comprising an actuatable cam member configured to, when urged via a mechanism located external to the housing, urge the transducer against the surface. 23. The apparatus of claim 1, wherein the transducer is positioned along a portion of the housing that contacts an occlusal surface of the at least one tooth. 24. The apparatus of claim 1, further comprising an engagement member having an angled interface adapted to The pressure pushes the transducer against the surface when pushed linearly. 25. The apparatus of claim 1, further comprising a holder adhered to the surface, wherein the holder has a structure shaped to receive at least a corresponding portion defined by the transducer. 26. The apparatus of claim 1, wherein the transducer is positioned within the housing along a channel adjacent to an occlusal surface of the at least one tooth. 27. The apparatus of claim 1, wherein said housing comprises a shape memory material having a pre-formed unbiased configuration and a deformed configuration, whereby said housing is secured to said deformed configuration in said deformed configuration. on at least one tooth. 28. The apparatus of claim 1, wherein the housing is conformed to a side of the at least one tooth such that the occlusal surface of the at least one tooth remains uncovered. 29. The apparatus of claim 1, further comprising at least one additional actuatable transducer in vibratory communication with the surface. 30. The apparatus of claim 29, wherein the at least one additional actuatable transducer is located in or on the housing. 31. The apparatus of claim 29, wherein the at least one additional actuatable transducer is located in or on at least one additional housing that also has a tooth conforming to at least a portion of the tooth. shape. 32. The apparatus of claim 29, wherein the transducer and the at least one additional transducer are each configured to have a different frequency response and/or transmission from each other. 33. The apparatus of claim 29, wherein each transducer is adapted to provide a sound or vibration train indicating the direction of the detected sound relative to the user's position. 34. The apparatus of claim 1, wherein the housing is configured as a mouthguard or retainer. 35. The apparatus of claim 1, further comprising: a conductive transmission member coupled to the transducer; and A post or screw that is mounted to the maxilla or mandible and the conductive transmission member. 36. A method of transmitting vibrations via at least one tooth, comprising: An instrument is provided, the instrument comprising a housing and an actuatable transducer located in or on the housing, wherein the instrument produces interference between the instrument and at least two surfaces of the at least one tooth Cooperate; positioning the housing over the at least one tooth; and Contact is maintained between the surface of the at least one tooth and the actuatable transducer such that the transducer transmits vibrations to the surface of the at least one tooth. 37. The method of claim 36, further comprising: receive audible signals via a loudspeaker; and The transducers on the surface are actuated in a corresponding manner. 38. The method of claim 36, wherein the step of positioning the housing comprises securing the housing against or on the at least one tooth. 39. The method of claim 36, wherein the step of maintaining contact comprises securing the transducer against the surface via an adhesive layer. 40. The method of claim 36, wherein the step of maintaining contact comprises advancing the transducer against the surface through an expandable permeable bladder positioned adjacent the transducer. 41. The method of claim 36, wherein the step of maintaining contact comprises urging the transducer against the surface by at least one biasing element located adjacent the transducer. 42. The method of claim 36, wherein said step of maintaining contact comprises providing an interface between said transducer and said surface through which vibrational communication is maintained. 43. The method of claim 36, wherein the step of maintaining contact comprises advancing the transducer against the surface by an engagement located on the exterior of the housing. 44. The method of claim 36, wherein the transducer is in contact with an occlusal surface of the at least one tooth. 45. The method of claim 36, wherein the step of maintaining contact comprises affixing a holder to the surface, and fixedly mounting the transducer to the holder. 46. The method of claim 36, wherein the step of positioning includes securing the housing to the side of the at least one tooth such that the occlusal surface of the at least one tooth remains uncovered.

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