Ultrasonic dosage device and method

Surgery – Liquid medicament atomizer or sprayer – Ultrasonic

Reexamination Certificate

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Details

C128S200140, C128S200210, C128S202250

Reexamination Certificate

active

06748944

ABSTRACT:

FIELD OF INVENTION
This invention relates generally to a dosage device and method for medicinal purposes, and more particularly, to a portable hand-held dosage device and cartridge which ultrasonically nebulizes a liquid or gel or powder or a combination of such for inhalation by the user.
BACKGROUND ART
Devices in prevalent use today use the standard devices for producing sprays. Either a pump is used or gases are used to create and eject the sprays under pressure. Squeeze containers, also used for sprays, create large droplets for injection into the mouth or nose.
For medicinal purposes, sprays are used which are inhaled either through the nose or the mouth and provide a delivery to the systemic system. The medicaments include water, decongestants, or other drugs for the treatment of colds, bronchitis, asthma, cutaneous diseases and the like. Furthermore, inhalation of medicaments into the lungs provides for a convenient and rapid way to apply treatment to other parts of the body, as well as to the breathing passages and lungs of the user.
With ultrasonic inhalation techniques it is known to get a more usable concentration of droplet size. Ultrasonic techniques can produce a larger percentage of the droplets having a useful size compared with the percentage that is commonly available for other types of pneumatic administration of the medication. The use of screens to control particle size is also known.
Various medicinal and medical devices are presently known which employ ultrasonic transducers. L. E. Dailey, TRANSDUCER DEVICE, U.S. Pat No. 3,102,535; Mettler, METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF LOWER TISSUES SIMULTANEOUS WITH HEATING OF SUBCUTANEOUS, OUTER MUSCLE AND LOWER TISSUES, U.S. Pat No. 3,828,769; and J. M. Richards, et al., REMOTE CONTROL MEDICAL THERAPY INSTRUMENT, U.S. Pat. No. 3,219,029 teach the use of ultrasound for physical therapy of muscles and tissues for various parts of the body.
An ultrasonic dosage device for direct inhalation of medicaments by the user or for application to other internal and external body areas. The device in the preferred embodiment has a rechargeable and/or replaceable storage battery which operates an ultrasonic transducer. A cartridge containing medicament is placed atop the ultrasonic transducer. The cartridge may be disposable and/or sterile or reusable or within itself contain the ultrasonic transducer. The ultrasonic energy created by the transducer converts the liquid, powder or gel medicament into a fine vapor or mist. A spout attached to the (disposable) cartridge may be placed into the mouth or nostrils, or natural, traumatic or surgical air passages of the user for inhalation of the vapor. Alternatively it may be placed against a body part such as the eye, membranes or integument. Alternatively, the spout may be hinged to the device and include a spike which punctures the top of the disposable cartridge to allow vapors to escape for inhalation by the user.
Ultrasound techniques are also used to increase the efficiency of surgical cutting tips in Kriezman, et al., ANGULATED ULTRASONIC SURGICAL HANDPIECES AND METHOD FOR THEIR PRODUCTION, U.S. Pat No. 4,634,419; Dotson, Jr., PNEUMATIC ULTRASONIC SURGICAL HANDPIECE, U.S. Pat. No. 4,609,368; Loschilov, et al., SURGICAL INSTRUMENT FOR ULTRASONIC SEPARATION OF BIOLOGICAL TISSUE, U.S. Pat No. 4,188,952; and Banko, et al., MATERIAL REMOVAL APPARATUS AND METHOD EMPLOYING HIGH FREQUENCY VIBRATIONS, U.S. Pat No. 3,589,363.
Other usage of ultrasonic equipment in medical practice consist of vibration of medicinal fluids as taught by Moulding, Jr., METHOD OF AND INSTRUMENT FOR INJECTING A FLUID INTO A UTERINE CAVITY AND FOR DISPENSING THE FLUID INTO THE FALLOPIAN TUBES, U.S. Pat No. 4,601,698; and Crowson, SONIC TEETH-CLEANING APPARATUS AND METHOD, U.S. Pat. No. 4,760,799.
Still another use of ultrasonic devices in the medical field is to control the delivery of biologically active substances from a polymer matrix as taught by Langer, et al., A ULTRASONICALLY MODULATED POLYMERIC DEVICES FOR DELIVERING COMPOSITIONS, U.S. Pat No. 4,657,543.
Although the above devices and techniques may be suitable for the purpose for which they are intended, none of these devices or techniques use ultrasonic techniques for the purpose of vaporizing a liquid, powder, or gel medicament for direct inhalation by the user. Ultrasonic vaporization of medicaments provide a very fine mist for more efficient and greater absorption by the tissues and lungs of the user.
OBJECTS OF THE INVENTION
It is the general object of the instant invention to provide an ultrasonic dosage device, container and method for the application of medicaments which overcome the shortcomings of existing devices.
It is another object of the instant invention to provide an ultrasonic dosage device, container and method which converts and applies medicaments in liquid gel or powdered form to vapor for application by the user.
It is yet another object of the instant invention to provide an ultrasonic dosage device, container and method for the inhalation of medicaments which is portable and hand-held.
It is still yet another object of the instant invention to provide an ultrasonic dosage device, container and method which uses a transducer powered by a rechargeable or replaceable battery or adaptor to provide ultrasonic energy to convert a (liquid), powder or gel medicament to a vapor.
It is a further object of the instant invention to provide an ultrasonic dosage device and method to be used with a disposable and/or sterile (or reusable) cartridge containing a medicament, which can also be dispersed and delivered in a unit dose.
It is a further object of the instant invention to provide an ultrasonic dosing device and method which can provide a vaporized medicament with a passively or negatively charged particle.
It is a further object to provide electrostatic control of the method of suspension and emission.
It is yet a further object of the instant invention to provide an ultrasonic dosage device with a spout for inhalation attached to a disposable cartridge containing a liquid medicament.
It is still yet a further object of this invention to provide an ultrasonic dosage device, or container and method with a hinged spout for application of medicaments and a spike to pierce a disposable cartridge containing a medicament to be vaporized by the device for application.
SUMMARY OF INVENTION
These and other objects of the instant invention are achieved by providing a device and a method in which a cartridge of a medicament in liquid, gel or powder form is transformed into vapor form for inhalation by the user through the use of an ultrasonic transducer or acoustically transmissible barrier. The device comprises a rechargeable storage battery, a printed circuit board, and a transducer which is powered by a rechargeable battery or adaptor. A disposable cartridge is inserted into the device so that it abuts the transducer. When power from the battery is applied to the transducer, the liquid in the cartridge is ultrasonically vibrated to convert the liquid into a vapor for direct application to the user. The medicament is provided within a sealed assembly placed in vibrational contact with the transducer. The sealed assembly can be sterile. The vapor particles can be electrostatically charged prior to application to the user. A push button, protected by a hinged cover, is used to apply power to the transducer when desired. Alternately the device can be initiated by a change in lung pressure, chest expansion, pneumography and electrocardiography. The printed circuit board provides power connections between the rechargeable battery and the transducer, and a regulator for regulating the power used to recharge the battery. The printed board also contains a female socket for connection to a battery recharger. In one alternate approach, a spout is connected directly to the disposable cartridge. After or during the substance is or has been vaporized, a cover is removed from the end of the spout for direct inhalation by the user.
In an alte

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