IMPLANTABLE RESPIRATION THERAPY DEVICE

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims the benefit of US Provisional Application 60/799,951, filed May 11, 2006, entitled, "Implantable respiration therapy device," which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to implantable medical devices, and specifically to implantable medical devices for providing respiration therapy.

BACKGROUND OF THE INVENTION

Mechanical ventilation assists or replaces spontaneous breathing. Positive pressure ventilation is the provision of air under pressure into the lungs, either invasively or non-invasively. Invasive positive-pressure ventilation is the delivery of positive pressure via an invasive artificial airway, such as an endotracheal tube or tracheostomy tube, while noninvasive positive-pressure ventilation (NPPV) is the delivery of positive pressure without such an invasive artificial airway, instead using a nasal or face mask.

Ventilation modes include volume ventilation, pressure-controlled ventilation, bi-level positive airway pressure (BIPAP) ventilation, inspiratory positive airway pressure (IPAP) ventilation, continuous positive airway pressure (CPAP) ventilation, and pressure-controlled ventilation (PCV) . CPAP ventilation delivers a constant pressure, which assists inspiration and resists

expiration. BIPAP ventilation delivers a higher pressure during inspiration, and a lower pressure during expiration.

SUMMARY OP THE INVENTION

In some embodiments of the present invention, apparatus for providing invasive positive-pressure ventilation comprises a tracheal implant comprising a propeller. One or more blades of the propeller rotate to deliver positive pressure to the trachea. The implant can be used with or without supplemental oxygen.

For some applications, the implant is used to treat a patient suffering from emphysema. The implant delivers a low level of positive pressure that provides a constant state of expansion of alveoli. Patients suffering from emphysema generally must first inhale in order to expand the alveoli, which are able to effectively exchange oxygen only upon expansion. The constant state of expansion provided by the implant enables the alveoli to exchange oxygen during a greater portion of inhalation than is achievable in the absence of the applied constant state of expansion. In addition, such constant expansion typically reduces friction/shear injury to alveoli associated with the continuous inflation and deflation of the alveoli. Alternatively, the implant is used to treat ^' other conditions, such as congestive heart failure, a pulmonary condition (e.g., pulmonary edema or chronic obstructive pulmonary disease (COPD) ) , or sleep apnea (e.g., obstructive sleep apnea).

There is therefore provided, in accordance with an embodiment of the present invention, apparatus including: a housing configured to be implanted in a trachea of a patient; and a propeller, coupled to the housing, and configured to generate a positive pressure in the trachea while the propeller is in the trachea.

In an embodiment, the apparatus includes circuitry configured to: drive . the, propeller, .to generate the positive pressure, and regulate the positive pressure generated by the propeller by setting a rate of rotation of the propeller.

In an embodiment, the propeller includes one or more blades, and the apparatus includes circuitry configured to: drive the propeller to generate the positive pressure, and regulate the positive pressure generated by the propeller by setting an angle of inclination of the blades . In an embodiment, the propeller includes one or more blades, and the apparatus includes a tube that surrounds at least one element of the apparatus selected from the group consisting of: the housing, and the blades.

In an embodiment, the propeller includes one or more blades, the housing is shaped so as to define, an inlet and outlet that together define a flow path, and the blades are positioned within the housing in the flow path.

In an embodiment, the apparatus is configured to treat a condition of the patient selected from the group consisting of: congestive heart failure, a pulmonary condition, pulmonary edema, chronic obstructive pulmonary disease (COPD) , sleep apnea, obstructive sleep apnea, and emphysema.

In an embodiment, the apparatus includes circuitry configured to drive the propeller to generate the positive pressure. in accordance .with a .schedule.

In an embodiment, the apparatus includes circuitry configured to: drive the propeller to generate the positive pressure, and drive the propeller to reduce a level of operation when the patient is sleeping. In an embodiment, the housing includes an anchoring mechanism, which is configured to couple the housing to an inner surface of the trachea.

In an embodiment, the housing is releasably coupled to the anchoring mechanism. In an embodiment, the anchoring mechanism includes a stent, which is sized to adhere to the inner surface of the trachea.

In an embodiment, the anchoring mechanism includes a plurality of wire springs, which are configured, upon expansion, to come in contact with the inner surface of the trachea.

In an embodiment, the springs are generally spiral-shaped.

In an embodiment, the propeller is configured to generate the positive pressure at a low level that provides a constant state of expansion of alveoli of the patient.

In an embodiment, the apparatus is configured to treat emphysema of the patient.

In an embodiment, the apparatus includes circuitry configured to drive the propeller to generate the positive pressure in a ventilation mode.

In an embodiment, the ventilation mode is selected from the group consisting of: volume ventilation, pressure-controlled ventilation, bi-level positive airway pressure (BIPAP) ventilation, inspiratory positive airway pressure (IPAP) ventilation, continuous positive airway pressure (CPAP) ventilation, and pressure-controlled ventilation (PCV) , and the circuitry is configured to drive the propeller to generate the positive pressure in the selected ventilation mode.

In an embodiment, the circuitry is configured to drive the propeller to generate a controllable level of positive end expiratory pressure (PEEP) .

In an embodiment, the apparatus includes a sensor configured to sense at least one parameter of respiration of the patient, the circuitry is configured to drive the propeller responsively to the at least one parameter. In an embodiment, the sensor includes a pressure sensor.

In an embodiment, the pressure sensor is configured to detect pressure fluctuations between 0.05 and 1 Hz.

In an embodiment, the circuitry is configured to detect pressure fluctuations between 0.05 and 1 Hz.

In an embodiment, the apparatus includes: an activity sensor; and circuitry, which is configured to modulate a parameter of operation of the propeller responsively to a sensed level of activity of the patient.

In an embodiment, the activity sensor is selected from the group consisting of: an accelerometer, a respiration rate monitor, and a heart rate monitor.

In an embodiment, the circuitry is configured to increase a speed of the propeller in response to an increase in the sensed level of activity.

In an embodiment, for administering a drug, the housing is shaped so as to define a drug reservoir configured to hold the drug, and the apparatus includes an application mechanism, coupled to the housing, and configured to release the drug from the reservoir into the trachea.

In an embodiment, the application mechanism is configured to spray the drug into the trachea. In an embodiment, the apparatus includes circuitry configured to: actuate the application mechanism, and regulate at least one parameter of administration of the drug selected from the group consisting of: a dosage of the administration, and a timing of the administration.

In an embodiment, the circuitry is configured to receive a signal, and to regulate the administration of the drug responsively to the signal. In an embodiment, the signal is selected from the group consisting of: an acoustic signal indicative of an onset of a transient pathological respiratory condition, and a pressure signal indicative of an onset of a transient pathological respiratory condition, and the circuitry is configured to receive the selected signal, and to regulate the administration responsively thereto.

There is further provided, in accordance with an embodiment of the present invention, apparatus for administering a drug, the apparatus including: a housing configured to be implanted in a trachea of a patient, the housing shaped so as to define a drug reservoir configured to hold the drug/ and an application mechanism, coupled to the housing, and configured to release the drug from the reservoir into the trachea. In an embodiment, the application mechanism is configured to spray the drug into the trachea.

In an embodiment, the apparatus includes circuitry configured to: actuate the application mechanism, and regulate at least one parameter of administration of the drug selected from the group consisting of: a dosage of the administration, and a timing of the administration .

In an embodiment, the circuitry is configured to receive a signal, and to regulate the administration of the drug responsively to the signal.

In an embodiment, the signal is selected from the group consisting of: an acoustic signal indicative of an onset of a transient pathological respiratory condition, and a pressure signal indicative of an onset of a transient pathological respiratory condition, and the circuitry is configured to receive the selected signal, and to regulate the administration responsively thereto.

There is still further provided, in accordance with an embodiment of the present invention, a method including:

implanting a propeller in a trachea of a patient; and rotating the propeller ^' to generate a positive pressure in the trachea. In an embodiment, the method includes providing supplemental oxygen in conjunction with rotating the propeller.

' j

There is yet further provided, in accordance with an embodiment of the present invention, a method for administering a drug, the method including: implanting, in a trachea of a patient, a drug reservoir configured to hold the drug; and releasing the drug from the reservoir into the trachea. The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. IA-C are schematic illustrations of a tracheal implant for providing positive pressure, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Figs. IA-C are schematic illustrations of a tracheal implant 10 for providing positive pressure, in accordance with an embodiment of the present invention. Fig. IA shows implant 10 during insertion into a trachea 20 of a patient, Fig. IB shows the implant after it has been coupled to the trachea, and Fig. 1C shows the implant during operation thereof.

Tracheal implant 10 comprises a housing 26 and at least one propeller 22 coupled thereto. The propeller comprises one or more blades 24. Housing 26 comprises an anchoring mechanism 28, which is adapted to couple implant 10 to an inner surface of trachea 20. For some applications, anchoring mechanism 28 comprises a plurality of wire springs 30, which are configured, upon expansion, to come in contact with the inner surface of the trachea. For example, the springs may be generally spiral-shaped as shown in the figures. The springs typically are appropriately configured and/or coated to reduce the likelihood of damage to the inner surface of the trachea. For some applications, the anchoring mechanism comprises a stent (not shown) sized to adhere to the inner surface of the trachea. Alternative anchoring mechanisms will be evident to those skilled in the art who have read the present application, and are within the scope of the present invention.

For some applications, housing 26 is releasably coupled to anchoring mechanism 28, in order to facilitate replacement of the propeller, a power supply, a drug reservoir, circuitry, or other portions of implant 10, while the anchoring mechanism remains coupled to the trachea, should such replacement be necessary. This replacement technique may be particular useful if fibrous tissue grows on anchoring mechanism 28. The scope of the present invention includes using such a technique to replace electrical or electromechanical apparatus implanted in other parts of the body (e.g., coupled to the heart or to an abdominal organ) , while maintaining an anchoring mechanism of the apparatus in place.

As shown in Fig. 1C, after implant 10 has been coupled to trachea 20, the propeller is activated to deliver positive pressure to the trachea. For some applications, implant 10 comprises a power source, such as a rechargeable battery, while for other applications, the implant is powered wirelessly or via wires by an external power source or by a subcutaneously implanted power source. For some applications in which the implant comprises a rechargeable battery, the battery is wirelessly recharged, such as by using induction, RF energy, or ultrasound energy. Alternatively, the battery is recharged using a wire, which passes, for example, through the nose or mouth, or through the wall of the trachea. For some applications, the wire is coupled to a bite plate, which is adapted to be placed in the mouth.

Implant 10 typically comprises circuitry that drives the propeller to rotate. For some applications, the circuitry is configured to drive the propeller to apply positive pressure in one or more conventional ventilation

modes, such as volume ventilation, pressure-controlled ventilation, bi-level positive airway pressure (BIPAP) ventilation, inspiratory positive airway pressure (IPAP) ventilation, continuous positive airway pressure (CPAP) ventilation, or pressure-controlled ventilation (PCV) , or other ventilation modes currently known in the art or developed in the future. In an embodiment, implant 10 provides a controllable level of positive end expiratory pressure (PEEP) . For ventilation modes that require monitoring of respiration, such as BIPAP ventilation, implant 10 comprises a sensor that detects the patient's respiration, and the circuitry drives the propeller responsively to at least one parameter of the respiration. For example, the sensor may comprise a pressure sensor coupled to housing 26 (e.g., above or below propeller 22) , and the pressure sensor and/or the circuitry may be configured to detect pressure fluctuations between about 0.05 and 1 Hz.

For some applications, the circuitry regulates the pressure applied by the propeller by setting the rate of rotation of the propeller, and/or by setting an angle of inclination of the blades.

For some applications, implant 10 comprises a cylindrical tube (e.g., a tracheal stent) that surrounds housing 26 and blades 24, to reduce the likelihood that the blades may come in contact with the wall of the trachea during operation of the implant. Alternatively, the housing is shaped so as to define an inlet and outlet that together define a flow path, and the blades are positioned within the housing in the flow path.

In an embodiment, implant 10 comprises an activity sensor, e.g., an accelerometer, or a respiration rate or

heart rate monitor, and increases the propeller speed or otherwise modulates the operation of the implant in response to. an .increase in. the .patient's level of activity. Alternatively or additionally, implant 10 operates in accordance with a schedule, and/or reduces

^■ its level of operation when the patient is sleeping. For example, the implant may comprise a clock for determining when the patient is generally sleeping, or another i physiological sensor that generates a signal ! indicative of sleeping by the patient.

In an embodiment of the present invention, a drug-release tracheal implant comprises a drug reservoir for holding a drug, and an application mechanism, that releases the drug from the reservoir into the trachea. For example, the mechanism may be adapted to spray the drug into the trachea. For some applications, the implant comprises circuitry adapted to actuate the application mechanism. For example, the circuitry may be configured to regulate a dosage or timing of administration of the drug. For some applications, the circuitry is adapted to receive a signal, either wirelessly or over wires, and to regulate the administration of the drug responsively to the signal. For example, the signal may be an acoustic signal indicative of the onset of a transient pathological respiratory condition, or a pressure signal indicative of the onset of a transient pathological respiratory condition. For some applications, implant 10 comprises the drug reservoir and the application mechanism. "Propeller," as used in the present application, ^•• "including in the claims, is to be 'understood as including

any mechanical device that rotates to push air, including fans and turbines.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.