Apparatus for treating body tissues with electricity or medicaments

APPARATUS AND METHOD FOR TREATING BODY TISSUES BY ELECTRICITY OR MEDICINES

Technical field

The present invention relates generally to devices that are implanted into the body of a living animal or human to exert a therapeutic effect on the target tissue. More particularly, the present invention relates to an apparatus and method for the selective electrical stimulation of body tissues or organs as well as for the selective distribution of a drug to a target tissue or target organ. It is also an object of the invention to provide improved treatment by reducing the time interval between the measurement of specific activity in the tissue or organ being treated and the activity measured therein at the onset of electrical stimulation or drug delivery.

State of the art

Many lesions, such as brain lesions and certain par120 ki palsy, are treated with electrical stimulation or a topical drug that is distributed to specific locations within the brain or body. One disadvantage of conventional medical devices and treatment procedures is that conventional medical devices are large and their installation may cause injury to the patient. Another disadvantage of conventional medical devices and treatment procedures is that these devices are often implanted and need to remain connected to the outside world to receive control signals or power supplies. A further disadvantage of conventional medical devices and treatment procedures is that drug delivery to the target tissue can cause trauma to the patient and drug delivery to the target tissue may be inaccurate. Another disadvantage of conventional procedures is that physical contact with the outside world and repeated patient injury due to the required recurrent invasion and insertion of foreign bodies increases the likelihood of infection. A further disadvantage of conventional devices and procedures is that they do not allow accurate timing of electrical stimulation or drug delivery in response to events that may occur and irritation caused by the tissue or organ being treated, thereby demonstrating the need for such electrical stimulation or drug.

Nature of the Invention

It is an object of the present invention to provide a device and method for selectively applying electrical stimulation over a period of time to target tissue of the body, such as the brain, without causing major injury in the target area and unnecessarily connecting to the outside world, i.e. outside the patient's body. Selective stimulation means that stimulation is temporally and geometrically determined and can be triggered by a tissue operation at a specified location.

Another object of the invention is to provide a device and method for selectively distributing a drug over a period of time to a target tissue such as the brain without the need for contact with the outside world, i.e. outside the patient's body.

It is another object of the present invention to provide a method of treating body tissue comprising the steps of providing a device for generating therapeutic voltage and current in response to ultrasound oscillations, positioning the device in the vicinity of the tissue being treated and subjecting the device to ultrasonic oscillations to enable the device to generate an electric current of therapeutic voltage and current.

It is a further object of the invention to provide a device for treating body tissue having a housing provided with a medicated storage compartment.

Attached to the housing is an oscillating member which communicates with the medicament tray and is adapted to oscillate in response to a utraEE 200000366 A sound stimulation. The housing is provided with a drug fill valve, which is in fluid communication with the drug tray and is adapted to allow the drug to be guided and contained in the tray. The drug fill valve is further adapted to selectively release drug from the drug reservoir in response to oscillations of the oscillating element, which causes pumping to pump the drug out of the receptacle in response to external high frequency stimulation.

Another object of the present invention is to provide a method of treating body tissue comprising the steps of preparing a device having a body provided with a medicament storage tray. The oscillating element is secured to the housing and is electrically connected to the medicament tray and adapted to oscillate in response to ultrasonic stimulation. The drug fill valve is located in the housing and communicates with the drug tray and is adapted to allow the drug to be guided and contained in the tray. The drug fill valve is further adapted to selectively release drug from the drug reservoir in response to oscillations of the oscillating member. In use, the drug is passed through the drug fill valve into the drug delivery tray. The device is positioned near the tissue to be treated and is subjected to ultrasonic vibrations to such an extent and for a period of time sufficient for the oscillating element to oscillate to such an extent and for such time as to cause the desired amount of drug to be delivered to the treated tissue.

It is another object of the invention to provide a sensor or plurality of sensors that are coupled to a tissue or organ being treated, such as the brain. The sensors are muffled by one or more actuators adapted to selectively distribute a predetermined electrical impulse or amount of medicament to the tissue or organ being treated in response to stimuli produced by the tissue or organ being treated and indicating the need for such electrical impulse or drug delivery. In a particularly preferred embodiment, irritation is measured in one tissue, such as the brain or nerve, and stimulation occurs in a different tissue, such as paralyzed leg muscle.

Brief description of the drawings

In FIG. 1 shows a piglet designed for electrical stimulation of target tissue according to the invention;

FIG. 2 shows a device for delivering a drug to a target tissue according to the invention;

<td>10. alternative</td><td>3 is an illustration implementation;</td><td>Figure</td><td>FIG.</td><td> 1</td><td>given</td><td>device</td>

<td>FIG. alternative 15th</td><td>4 implementation;</td><td>Figure</td><td>FIG.</td><td> 2</td><td>given</td><td>device</td>

<td>FIG. alternative</td><td>5 is a view implementation;</td><td>Figure</td><td>FIG.</td><td> 1</td><td>given</td><td>device</td>

<td>FIG.</td><td>6</td><td>Figure</td><td>FIG.</td><td> 2</td><td>given</td><td>device</td>

an alternative embodiment;

FIG. Fig. 7 is an alternative embodiment of the device according to the invention for dispensing a drug to a target tissue.

DETAILED DESCRIPTION OF THE INVENTION

Miniature Oscillating Ceramic Motors, or Oscillating Ceramic Motors (OCM), are well known in the art and are disclosed in U.S. Patent No. 5,453,653 (Zumeris), which is incorporated herein by reference. Such motors can be very small and of any shape, and operate on sufficient contact with the surface to generate sufficient friction to allow the motor to crawl along the contact surface and to change its position relative to the contact surface when power is supplied to the motor. Such motors can be adequately insulated for operation in a liquid environment. Its small size and low power consumption make it particularly suitable for use inside living organisms.

In FIG. 1 shows an embodiment of a ceramic motor used in accordance with the invention to provide electrical stimulation of the target tissue. The electrical stimulation device 1 is provided with electrodes 2. In normal use, the electrodes 2 are provided with electrical energy which causes the electrical stimulation device 1 to generate oscillations in the ultrasonic region. It is well known that turning a conventional electric motor 10 produces electricity. Similarly, when the ceramic motor is oscillated by ultrasound, an electric current is generated which is discharged from the electrodes 2. The ceramic motor operates according to a second piezoelectric effect, and vice versa, generating a current by oscillating the ceramic corresponds to the first piezoelectric effect. The frequencies used in different embodiments of the invention may be varied as required by specific applications. Depending on the type and location of the tissue being treated, as well as the type and amount of tissue through which the HF oscillations must pass, a wide frequency range, such as radio frequency or ultrasound, may be used.

Stimulation of nerve cells in the brain and everywhere else in the body is recommended for the treatment of various disorders, such as activation of muscles with reduced biological activation. In practice, the device is introduced into the target area being treated, such as the brain, using conventional procedures such as catheter insertion or surgical implantation. Because the electrical stimulation device 1 is small, the patient's injuries are minimal. In addition, because the electrical stimulation device 1 is left in place, it reduces the likelihood of complications or tissue damage due to repeated invasion, such as needles that are repeatedly inserted and removed. Moreover, since there is no need for the electrical stimulation device 1 to remain connected to the outside world after implantation, it reduces the likelihood of complications such as infection that may occur as a result of being connected to the outside world.

When the electrical stimulation device 1 is present, it is subjected to ultrasonic energy 8 from the means 10 to selectively generate ultrasonic vibrations 8 which cause the electrical stimulation device 1 to oscillate and generate electricity from the electrodes 2. The electrodes 2 may be dimensioned and mounted on the device as required by specific applications to maximize treatment efficiency. The electrical stimulation device 1 and treatment time may be modified to generate electrical energy of the desired voltage and current for a desired period of time, as required by specific applications.

In FIG. 2 shows a drug delivery device 3 according to the invention. 2 shows that the drug delivery device 3 is provided with a housing 4 having a tray 5 for holding the drug 6. The housing 4 is also provided with an oscillating member 7 made of a material adapted to oscillate in response to ultrasonic stimulation 8. The oscillating member 7 that the oscillating member 7 contacts the medicament 6 stored in the treatment water 5. The housing 4 is also provided with a medicament filler valve 9 which is in fluid communication with the medicament drawer 5. The medicament filler valve is adapted to allow the medicament to be fed into the medicament drawer 5 and is further adapted to allow the medicament 6 to be dispensed from the medicament drawer 5. A wide variety of filler caps or valves, well known to those skilled in the art, may be used for this purpose; 2, a flexible non-return valve.

In use, the physician guides drug 6 through the fill valve 9 into the drug tray

5. The drug delivery device 3 is then introduced into the target area using the conventional procedures mentioned above. As shown in FIG. 2, the medicament delivery device 3 may be actuated by the physician 10 for selectively generating and transmitting ultrasound oscillations 8 to the oscillating element 7 using ultrasonic energy 8 generated. The ultrasonic energy 8 which strongly influences the oscillating element 7 causes the oscillating element 7 to oscillate as shown in FIG. 2. This causes the desired amount of drug 6 to be dispensed from the drug tray 5 via the drug fill valve 9 to the target area. The time period during which the device 3 is subjected to ultrasonic oscillations 8 may be varied as required by specific applications and will depend upon factors such as the target area to be treated, the amount of drug 6 delivered, and the composition of drug 6, e.g. or what is its viscosity.

Using both the electrical stimulation device 1 and the drug delivery device 3, the device 10 for generating ultrasonic oscillations may be manually controlled, programmed to generate ultrasonic oscillations for a predetermined time, e.g., 10 seconds, at predetermined intervals, such as every full hour, or may be automatically triggered .

In a particularly preferred embodiment, one or more sensors 11 as shown in FIGS. 1 to FIG. 6 to monitor the tissue being treated for various preselected physiological activities and parameters that indicate the need for treatment and the amount of treatment required. These physiological activities and parameters include, but are not limited to, changes in the target region's neurological activity, temperature, pressure, fluid excretion, chemical composition of excretion, and chemical changes in the treated tissue.

The sensor or sensors 11 may be implanted in multiple locations on or within the tissue or organ being treated, as required by specific applications. Alternatively, the sensor 11 may be arranged on the devices 1 and 3 as shown in FIGS. 3 to FIG. 6. The sensor 11 is adapted to be coupled to the device 10 for selectively generating and transmitting ultrasonic oscillations 8 as described above. The communication 13 between the sensor 11 and the means 10 for generating the ultrasonic oscillations 8 may be direct, for example an electrical conductor, however in a preferred embodiment the communication 13 is by radio transmission. The radio communication between the sensor 11 and the ultrasonic oscillation generating means 10 reduces the patient's discomfort and also reduces the likelihood of infection because a wire connection is not required.

In use, the sensor 11 monitors the physiological parameters of the tissue or organ being treated and measures changes in their physiological parameters. After recording the change, the sensor 11 sends a signal to the device 10 to generate ultrasonic oscillations 8. In response to the signal from the sensor 11, the device 10 generates ultrasonic oscillations 8 for a period of time sufficient for the device to provide the tissue or organ to be treated with the desired treatment as explained above. The time period during which the ultrasound signal 8 is generated may be fixed or selectively variable depending on the physiological change measured by the sensor 11, and may vary depending on the type and degree of physiological change measured by the sensor 11. In a particularly preferred embodiment, the means 10 for generating ultrasonic oscillation 8 may be provided with means 12 for calculating the amount of electricity or drug required by the tissue or organ being treated, depending on the type and degree of physiological change measured. By varying the duration of the generated ultrasound oscillation 8, the amount of electricity or drug distributed to the tissue or organ being treated can be varied and controlled. Thus, this embodiment provides a self-tracking and self-dispensing system that quickly calculates the required treatment and allows for rapid delivery of the required amount of treatment to the target area. The means 10 for generating the ultrasonic oscillation 8 may also be arranged on the devices 1 and 3 as shown in FIGS.

and FIG. 6 to create a one-piece monitoring, dose calculating, and dispensing system.

Alternatively, the measurement may be in a single tissue, such as the brain or nerve, and the stimulation may be in a different tissue, such as paralyzed muscle.

The devices and methods of the invention may be modified and adapted to a wide variety of treatments, and in a particularly preferred embodiment, particularly for paralysis, according to the requirements of the particular circumstances. For example, if a person's foot is paralyzed, it is possible to provide a stimulator that is connected to the leg muscles. The stimulator would generate stimulation of the muscles in response to a sensor that could be located in, or associated with, for example, the father. Thus, if a person wants to activate the muscles of his leg, he may do so by deliberately moving his hand for a predetermined distance or in a predetermined direction. The hand sensor senses hand movement and generates a signal that communicates with a person's leg muscular stimulator. This allows the subject to selectively generate muscle stimulation and allows the subject to selectively activate the muscles of his leg.

In FIG. Fig. 7 shows a drug delivery device 3 according to the invention for delivering a drug to a target tissue. In FIG. 7, the drug delivery device 14 is provided with a housing 15 having one or more drug delivery blisters 16 to hold the drug 6. The blisters 16 are made of a material well known to those skilled in the art and selected and adapted to rupture in response to ultrasound stimulation 8. The housing 15 may also be provided with one or more drug filler valves 17 in fluid communication with the medicament tray bubbles 16. The medicament filler valves 17 are adapted to allow the drug 6 to be delivered to the medicament tray bubbles 16. A wide variety of filler caps or fillers well known to those skilled in the art.

In use, the medicament 6 is guided by the physician through the drug filler valve 17 into the medicament tray blisters 16. The drug dispensing device 14 is then guided to the target area using the conventional procedures described above. The physician may selectively actuate the drug delivery device 14 by ultrasound energy in the aforementioned manner. The ultrasonic energy that strongly affects the bubbles 16 causes the bubbles to burst. This causes the desired amount of drug 6 to be dispensed from the drug tray bubbles to 16 target areas. The time period during which the device 14 is subjected to ultrasonic vibration may be varied as specified by the specific applications and will depend upon factors such as the target area to be treated, the amount dispensed, the composition such as solid or liquid 6 and / or the material used to make the bubbles 16. In an alternative embodiment, the drug fill valve is not used. Instead, the drug 6 is placed between the housing 15 and the bubbles 16 before the bubbles 16 are attached to the housing 15.

The devices and methods of the present invention provide minimally invasive electrical and pharmacological stimulation of tissue, reducing the risk of complications such as infection that conventional methods can cause. Although the invention has been described in a limited number of examples of embodiments, it should be understood that many variations, modifications and other applications of the invention are possible.