This invention relates to prostheses, and in particular to a vestibular prostheses.
The ability of human beings to maintain stability and balance is controlled by the vestibular system. This system provides the central nervous system with the information needed to maintain balance and stability.
The other endorgans in the vestibular system are the otolith organs, the utricle and the saccule. These endorgans act as linear accelerometers and respond to both linear acceleration and gravity.
In response to the vestibular nerve impulses, the central nervous system experiences motion perception and controls the movement of various muscles, thereby enabling the body to maintain its balance.
One affliction that affects the vestibular system is Meniere's disease. Meniere's disease is a condition in which the vestibular system, for unknown reasons, suddenly begins varying the pulse-repetition frequency in a manner inconsistent with the patient's motion. This results in severe dizziness. Subsequently, and again for no known reason, the vestibular system begins generating a vestibular signal consistent with the person's spatial orientation, thereby ending the person's symptoms.
To alleviate symptoms of Meniere's disease, electrical prostheses can be used to provide a stationary signal to the brain. This can be achieved by producing a jamming signal, through electrical stimulation, that applies a high-amplitude stationary signal to the vestibular nerve, thereby preventing disorienting variations from being sent to the brain by the vestibular periphery. A description of the use of electrical stimulation of the vestibular system to alleviate Meniere's disease symptoms is provided in U.S. patent application Ser. No. 10/738,920, entitled “Vestibular Stimulator”, filed Dec. 16, 2003, the contents of which are hereby incorporated by reference in their entirety.
In one aspect, the invention includes an apparatus to stimulate a vestibular system. The apparatus comprises an actuator configured to mechanically stimulate the vestibular system, and a control module coupled to the actuator, the control module being configured to provide a control signal that causes the actuator to stimulate the generation of a stationary nerve signal by the vestibular system.
In some embodiments the actuator comprises a balloon attached to a catheter, the balloon having a volume that varies in response to the control signal.
In some embodiments the actuator comprises a piezoelectric device, the piezoelectric device being configured to be displaced in response to the control signal.
In some embodiments the actuator comprises a piston, the piston being configured to be displaced in response to the control signal.
In some embodiments the actuator comprises an elastic membrane, the elastic membrane being configured to expand in response to the control signal.
In some embodiments the control signal includes data to control an adjustable frequency, an adjustable amplitude, and/or an adjustable duration of the stationary nerve signal.
In some embodiments the apparatus further comprises a power source electrically coupled to the actuator, and/or the control module.
In some embodiments the control module is configured to generate the control signal in response to a non-stationary signal detected by a sensor positioned proximate to the vestibular system.
In some embodiments the stationary signal includes a pulse train characterized by a constant pulse repetition rate, and/or a sinusoidal signal.
In another aspect, the invention includes a method for stimulating a vestibular system. The method comprises inserting an actuator in mechanical communication with the vestibular system, and causing the actuator to stimulate the generation of a stationary nerve signal by the vestibular system.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Like reference symbols in the various drawings indicate like elements.
The actuator 210 receives control signals transmitted from the control module 220. Transmission of control signals from the control module 220 to the actuator 210 can be done using wireless transmission. Alternatively, the control signals can be sent from an electrical wire connecting the control module 220 to the actuator 210. The wire can be placed inside a catheter that runs subcutaneously from the control module 220 to the control mechanism of the actuator 210.
Displacement of the piston depends on the nature of the stimulated signal that is required to mask the symptoms of Meniere's disease. Thus, if a pulse train signal is required, the piston 312 is displaced in the cylinder 316 at a constant frequency and amplitude, thereby causing the vestibular system to generate a stationary signal to be provided to the central nervous system. That stationary signal drowns out, or masks, any time-varying signals produced due to the onset of Meniere's disease, thereby enabling the central nervous system to block out the non-stationary signals produced as a result of Meniere's disease.
As the piston 312 is displaced, it presses against the endosteum 302. This causes the endosteum 302 to be displaced inwardly. The displacement of the endosteum 302 displaces the endolymph in a semicircular canal, thereby causing the hair cells in the cupula to be deflected.
To minimize damage to the endosteum 302 due to the piston's motion, the piston head is covered with a soft biocompatible material 314. A suitable biocompatible material is Silastic.
Since the actuator 310 is implanted, it should be constructed using biocompatible materials. Thus, in some embodiments the piston-based actuator 310 is made of suitable metallic materials such as stainless steel or titanium. Other suitable materials include various types of ceramics that are approved for medical applications.
The actuators shown in
The balloon catheter is inserted into the perilymph space by cutting a small opening through the bony labyrinth 304 and the endosteum 302. The balloon catheter may subsequently be inserted into the perilymph space using a micromanipulator. After insertion of the balloon catheter, the openings in the bony labyrinth and endosteum are sealed and allowed to heal.
The actuator 340 also includes a larger diameter catheter (also not shown) located outside the bony labyrinth. This larger diameter catheter is coupled to the smaller catheter that was inserted into the perilymph space. The larger catheter runs subcutaneously to a closed container in which a pump mechanism, a fluid reservoir for inflating the balloon, and a control mechanism to control the actuation of the balloon 342 are all located. The pump mechanism, fluid reservoir, and the control mechanism are of conventional design and are therefore omitted from
The control mechanism for the balloon actuator shown in
Thus, with reference to
The fluid reservoir used to inflate the balloon should have enough fluid to ensure that the balloon-based actuator 340 would continue operating notwithstanding any fluid leakage. In some embodiments the reservoir has enough fluid to fill a volume 10,000 times that occupied by the inflated balloon 342. The fluid reservoir is preferably equipped with a recharging mechanism so that when the fluid level in the reservoir dips below a certain threshold level, the reservoir can be recharged to ensure continued operation of the actuator 340.
The use of the pump mechanism together with the fluid reservoir described in relation to the actuator 340 can also be used to actuate the balloon-based actuators shown in
Yet another embodiment shown in
Yet another embodiment uses a magnetic field created by a coil of wire to move a piston electromagnetically, which, in turn, pushes fluid to activate any of the balloon-like actuators 322332, 342 discussed previously. Alternatively, the piston moved by the magnetic coil could push directly on the endosteum 302.
Other types of actuators for actuating the semicircular canal to cause the generation of stationary signals that are sent to the central nervous system are also possible.
As noted above, and as can be seen from
As further shown in
The control module 220 includes a computing device 224 configured to generate control signals to control the actuator 210 to produce a jamming signal for symptomatic relief of Meniere's disease.
The jamming signal characteristics are selected to cause the vestibular system to generate a stationary signal which in effect drowns out the time-varying signals produced by the malfunctioning vestibular system of the patient suffering from Meniere's disease. One such jamming signal is a high-frequency sinusoid signal having a frequency greater than around 350 Hz. Another jamming signal is a pulse train having controllable pulse amplitude and a pulse repetition frequency. The jamming signal causes the mechanical actuator 210 to displace the endosteum 302 in a controlled pattern, thereby stimulating the nerves of the vestibular system. This mechanical stimulation causes the nerves to generate a nerve signal having a constant pulse-repetition frequency. Such a signal has a substantially constant spectrum. In one embodiment, the pulse-repetition frequency is approximately equal to the maximum neuron firing rate, which is typically on the order of 450 Hz. This pulse-repetition frequency is likely to result in the firing of neurons at or near their maximum firing rate. However, it may be useful in some cases to have a much higher pulse-repetition frequency, for example in the 1-10 kilohertz range, so that neurons fire more asynchronously.
The control signals may be used to cause the actuator 210 to produce other oscillatory jamming signals to stimulate the vestibular system nerves.
The jamming signal need only be present during an attack of Meniere's disease. When the attack subsides, the jamming signal is removed and the patient regains normal vestibular function. The computing device 224 thus includes a signal-suspension mechanism for applying and suspending the generation of the jamming signal.
In one example, the computing device 224 has a patient-accessible switch located on a user interface (not shown) connected to the control module 220. When the patient feels the onset of a Meniere's disease attack, he uses the switch to apply the jamming signal. A disadvantage of this type of control unit is that because the jamming signal masks the symptoms of the attack, the patient is unable to tell whether the attack is over. Consequently, in this embodiment the patient uses the switch to turn off the jamming signal after a reasonable time has elapsed. The resulting change in the pulse-repetition frequency of the signal received by the brain may result in some dizziness. However, if the attack of Meniere's disease is in fact over, this dizziness should abate shortly. If the dizziness does not abate, the patient uses the switch to turn the jamming signal on again.
Alternatively, the signal-suspension mechanism of the computing device 224 can include a timer that automatically turns the jamming signal off after the lapse of a pre-determined jamming interval. In some embodiments, the length of the jamming interval is user-controlled and can be entered through the user interface, whereas in others, the length of the jamming interval is hard-wired into the control unit. If the dizziness does not fade after the jamming signal has been turned off, the patient uses the switch on the user interface to turn the jamming signal on again.
In some embodiments, the control module 220 includes a sensing unit having one or more sensors (not shown) that are implanted proximate to the vestibular system to measure the vestibular signal. Upon detection of time-varying changes in the pulse-repetition frequency of the vestibular signal indicative of the onset of an episode of Meniere's disease, the sensing unit causes the computing device 224 to generate the jamming control signal. This jamming control signal is transmitted to the mechanical actuator 210 to actuate the mechanical displacement of the actuator 210, which in turn stimulates the vestibular system. In this case, the jamming signal characteristics can be made to vary in response to the characteristics of the measured vestibular signal.
The computing device 224 can transmit a one-time signal that causes the actuator 210 to mechanically actuate at a constant repetition rate, thereby stimulating the vestibular nerves to produce nerve signals at a constant pulse repetition frequency. When the symptoms of Meniere's disease subside, the computing device 224 can generate a signal that causes the actuator 210 to suspend its mechanical actuation.
Alternatively, the control signals sent to the actuator 210 can be sent as short bursts separated by pre-determined intervals (e.g., every 10 ms). Control signals sent as short bursts can carry information regarding the level, duration and/or frequency of the mechanical actuation. For example, based on fluctuating signal levels provided at set intervals by the sensors used to detect the onset of an episode of Meniere's disease, the computing device 224 determines corresponding control signals representing an adjustable amplitude value, frequency value, and/or time duration to be sent to the actuator 210. The signals sent at set intervals thus enable the actuator 210 to vary the stimulation of the vestibular system in response to changing characteristics of the detected non-stationary signals produced as a result of Meniere's disease.
The computing device 224 may include a computer and/or other types of processor-based devices suitable for multiple applications. Such devices can include volatile and non-volatile memory elements, and peripheral devices to enable input/output functionality. Such peripheral devices include, for example, a CD-ROM drive and/or floppy drive, or a network connection, for downloading software containing computer instructions. Such software can include instructions to enable general operation of the processor-based device. Such software can also include implementation programs to generate control information for controlling the mechanical actuation of the actuator 210. The computing device 224 may include a digital signal processor (DSP) to perform the various processing functions described above. A suitable DSP is the Analog Devices ADSP 2183 processor.
In many implementations the computing device 224 is placed on the person's head. However, the location of the computing device 224 is not critical. The device 224 can thus be placed anywhere on or off the person's body.
As noted above, the control device 220 also includes a user interface (not shown) to enable a user (such as the person wearing the actuator 210, a physician, or a technician) to directly control the actuator 210. Input entered through the user interface is processed by the computing device 224 to generate corresponding control signals for the actuator 210. Typical user interfaces include a small key pad to enable the user to enter data, and/or a switch for activating or suspending the generation of a jamming signal. Such a key pad, and/or switch, could be attached to a housing in which the computing device 224 is held. However, the user interface need not be located proximate to the computing device 224. For example, a computer console can be remotely linked to the computing device 224, either using wireless or wired transmission. Executing on such a computer console would be, for example, a graphical user interface to enable the user to enter the data for controlling the actuator 210.
Typically, the prosthesis 200 has to be calibrated. Calibration of the prosthesis 200 includes calibrating the level of mechanical actuation that would result in a stationary signal suitable for masking the time-varying signals produced as a result of Meniere's disease. One way to calibrate the prosthesis is to wait for an episode of Meniere's disease. During such an episode, one then manually varies the level of actuation of the actuator 210 (e.g., the amplitude and frequency at which the piston 312 is displaced in cylinder 316) until the actuation is such that symptoms disappear. The actuator 210 may also be calibrated to produce levels of actuations that depend on the level and nature of the non-stationary vestibular signals detected by the sensors configured to detect the onset of an episode of Meniere's disease.
In operation, the computing device 224 generates signals to control the level of mechanical actuation. The mechanical actuations produced by actuator 210 stimulate the nerves of the vestibular system, thereby causing the vestibular system to generate stationary nerve signals that drown out, or mask, the non-stationary signals produced as a result of Meniere's disease. Generation of control signals by the computing device 224 can be triggered either automatically, when a sensing device senses the onset of an attack of Meniere's disease, or manually when the patient, or some other individual, operates a switch that causes the computing device 224 to generate and transmit the control signals to control the operation of actuator 210.
Although
Further, although
A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.
Number | Date | Country | |
---|---|---|---|
Parent | 11261394 | Oct 2005 | US |
Child | 13487854 | US |