WO2007138578A2

WO2007138578A2 - Implantable dynamic pump device

Info

Publication number: WO2007138578A2
Application number: PCT/IL2007/000638
Authority: WO
Inventors: Daniel Ruben; Nissim Darvish; Eli Bar
Original assignee: Interventional Lung Therapeutics, Llc.
Priority date: 2006-05-25
Filing date: 2007-05-27
Publication date: 2007-12-06
Also published as: WO2007138578A3

Abstract

An implantable dynamic pump device for fluid control inside body passage is disclosed. The device comprises a one-way valve, the valve sealably deployable within the body passage and provided with a deployable structure comprising at least one deployable stent coupled to the one way valve; an electrically activated pump for pumping fluids; and a power source for powering the pump.

Description

IMPLANTABLE DYNAMIC PUMP DEVICE

FIELD OF THE INVENTION

[0001] The present invention relates generally to methods and devices for use in fluid control inside a body passage, for example for performing pulmonary procedures and, procedures for treating lung diseases. More specifically the present invention relates to an implantable dynamic pump device.

BACKGROUND OF THE INVENTION

[0002] Pulmonary diseases, such as chronic obstructive pulmonary disease, (COPD), reduce the ability of one or both lungs to fully expel air during the exhalation phase of the breathing cycle. The term "Chronic Obstructive Pulmonary Disease" (COPD) refers to a group of diseases that share a major symptom - dyspnea. Such diseases are accompanied by chronic or recurrent obstruction to air flow within the lung. Because of the increase in environmental pollutants, cigarette smoking, and other noxious exposures and some genetic factors, the incidence of COPD has increased dramatically in the last few decades and now ranks as a major cause of activity-restricting or bed- confining disability in the United States, Europe and other parts of the western world. COPD can include such disorders as chronic bronchitis, bronchiectasis, asthma, and emphysema. While each has distinct anatomic and clinical considerations, many patients may have overlapping characteristics of damage at both the acinar (as seen in emphysema) and the bronchial (as seen in bronchitis) levels.

[0003] Emphysema is a condition of the lung characterized by the abnormal permanent enlargement of the airspaces distal to the terminal bronchiole, accompanied by the destruction of their walls, and without obvious fibrosis.

[0004] It is known that emphysema and other pulmonary diseases reduce the ability of one or both lungs to fully expel air during the exhalation phase of the breathing cycle. One of the effects of such diseases is that the diseased lung tissue is less elastic than healthy lung tissue, which is one factor that prevents full exhalation of air. During breathing, the diseased portion of the lung does not fully recoil due to the diseased (e.g., emphysematic) lung tissue being less elastic than healthy tissue. Consequently, the diseased lung tissue exerts a relatively low driving force, which results in the diseased lung expelling less air volume than a healthy lung. The reduced air volume exerts less force on the airway, which allows the airway to close before all air has been expelled, another factor that prevents full exhalation.

[0005] The problem is further compounded by the diseased, less elastic tissue that surrounds the very narrow airways leading to the alveoli, which are the air sacs where oxygen-carbon dioxide exchange occurs. The diseased tissue has less tone than healthy tissue and is typically unable to maintain the narrow airways open until the end of the exhalation cycle. This traps air in the lungs and exacerbates the already-inefficient breathing cycle. The trapped air causes the tissue to become hyper-expanded, no longer capable of effecting efficient oxygen-carbon dioxide exchange.

[0006] In addition, hyper-expanded, diseased lung tissue occupies more of the pleural space than healthy lung tissue. In most cases, a portion of the lung is diseased while the remaining part is relatively healthy and, therefore, still able to efficiently carry out oxygen exchange. By taking up more of the pleural space, the hyper-expanded lung tissue reduces the amount of space available for accommodating the healthy, functioning lung tissue. As a result, the hyper-expanded lung tissue causes inefficient breathing due to its own reduced functionality and because it adversely affects the functionality of adjacent healthy tissue.

[0007] Lung reduction surgery is a conventional method of treating emphysema. According to the lung reduction procedure, a diseased portion of the lung is surgically removed, which makes more of the pleural space available to accommodate the functioning, healthy portions of the lung. The lung is typically accessed through a median sternotomy or small lateral thoracotomy. A portion of the lung, typically the periphery of the upper lobe, is freed from the chest wall and then resected, e.g., by a stapler lined with bovine pericardium to reinforce the lung tissue adjacent the cut line and also to prevent air or blood leakage. The chest is then closed and tubes are inserted to remove air and fluid from the pleural cavity. The conventional surgical approach is relatively traumatic and invasive, and, like most surgical procedures, is not a viable option for all patients. [0008] Some recently proposed treatments include the use of devices that isolate a diseased region of the lung in order to reduce the volume of the diseased region, for example, by collapsing the diseased lung region. According to such treatments, isolation devices are implanted in airways feeding the targeted region of the lung to regulate fluid flow to the diseased lung region in order to fluidly isolate the region of the lung. These implanted isolation devices can be, for example, one-way valves that allow flow in the exhalation direction only, occluders or plugs that prevent flow in either direction, or two-way valves that control flow in both directions. However, such devices are still in the development stages. Thus, there is much need for improvement in the design and functionality of such isolation devices, as well as in the methods of deploying and using such devices.

[0009] The abovementioned treatment methods are limited in many ways: one cannot control the rate of reducing the trapped air, there are problems with collateral air escape through other airways connected to the diseased portion of the lung that will cause re- trapping of air, bringing about the need of more than one valve, as well as other problems.

[0010] US 6,941,950 (Wilson et al.) disclosed methods and devices for regulating fluid flow to and from a region of a patient's lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. An identified region of the lung is targeted for treatment, such as to modify the flow to the targeted lung region or to achieve volume reduction or collapse of the targeted lung region. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. The bronchial isolation of the targeted lung region is accomplished by implanting a flow control device into a bronchial passageway that feeds air to a targeted lung region. The device includes a passive pump that is activated by the environmental pressure exerted on the device by the surrounding bronchial airway as it changes during the normal breathing cycle. [0011] US 6,904,909 (Andreas et al.) - and see also US 7,165,548 (Deem et al.), US 6,694,979 (Deem et al.), US 6,679,264 (Deem et al.) - all disclose systems, methods and devices for performing pulmonary procedures, and in particular treating lung disease. A flow control element includes a valve that prevents airflow in the inhalation direction but permits airflow in the exhalation direction. The flow control element is guided to and positioned at the site by a bronchoscope that is introduced into the patient's trachea and used to view the lungs during delivery of the flow control element. The valve may include one, two or more valve elements, and it may be collapsible for easier delivery. A source of vacuum or suction may be used to increase the amount of fluid withdrawn from the lung tissue. A device for measuring hollow structures, such as bronchioles, and a device for removing a previously-placed flow control element are disclosed as well.

[0012] In one embodiment the flow control valve includes a chamber that can be used as a pump. The chamber is influenced by the bronchial passageway it resides in collapsing and expanding while the patient breathes, producing pumping action.

[0013] In view of the foregoing, there is, therefore, a need for improved methods and devices for regulating air-flow to a diseased lung region, and it is an aim of the present invention.

SUMMARY OF THE INVENTION

[0014] There is thus provided, in accordance with some preferred embodiments of the present invention, an implantable dynamic pump device for fluid control inside body passage, the device comprising:

[0015] a one-way valve, the valve sealably deployable within the body passage and provided with a deployable structure comprising at least one deployable stent coupled to the one way valve;

[0016] an electrically activated pump for pumping fluids ;

[0017] a power source for powering the pump.

[0018] Furthermore, in accordance with some preferred embodiments of the present invention, the one-way valve comprises a membrane cap mounted over a support structure provided with separable leaves which initially engulf a core and when a threshold pressure difference between distal and proximal ends of the device are reached the leaves detach from the core allowing flow of fluid through. [0019] Furthermore, in accordance with some preferred embodiments of the present invention, the membrane cap includes a skirt for enhanced sealing.

[0020] Furthermore, in accordance with some preferred embodiments of the present invention, the support structure comprises deployable supporting ribs connected to the core.

[0021] Furthermore, in accordance with some preferred embodiments of the present invention, the supporting ribs for deploying the supporting ribs are coupled to said at least one stent.

[0022] Furthermore, in accordance with some preferred embodiments of the present invention, the pump comprises a slanted revolvable disc.

[0023] Furthermore, in accordance with some preferred embodiments of the present invention, the power source comprises a battery.

[0024] Furthermore, in accordance with some preferred embodiments of the present invention, the power source comprises a capacitor.

[0025] Furthermore, in accordance with some preferred embodiments of the present invention, the capacitor is coupled to an antenna for receiving remotely transmitted energy.

[0026] Furthermore, in accordance with some preferred embodiments of the present invention, the antenna comprises a coil.

[0027] Furthermore, in accordance with some preferred embodiments of the present invention, the device is further provided with a remote energizer for remotely energizing the power source.

[0028] Furthermore, in accordance with some preferred embodiments of the present invention, the device incorporates a tube inside which a flow restrictor is present generally blocking passage of fluids in at least one direction which is opposite to the flow direction in the one-way valve, and through which a catheter can be passed to reach a distal end of the device and beyond.

[0029] Furthermore, in accordance with some preferred embodiments of the present invention, the tube passes through the power source. [0030] Furthermore, in accordance with some preferred embodiments of the present invention, the device is further provided with at least one pressure sensor for sensing local pressure.

[0031] Furthermore, in accordance with some preferred embodiments of the present invention, said at least one pressure sensor comprises two pressure sensors, one of which is positioned at a distal end of the device and the other of which is positioned at a proximal end of the device, so as to allow detecting pressure differences between the distal and proximal ends.

[0032] Furthermore, in accordance with some preferred embodiments of the present invention, said at least one sensor is coupled to a controller for detecting a predetermined pressure difference threshold value and for activating the pump when the predetermined pressure difference threshold value is reached.

[0033] Furthermore, in accordance with some preferred embodiments of the present invention, the device is further provided with a catheter adapted to pass through the device.

[0034] Furthermore, in accordance with some preferred embodiments of the present invention, further provided with a remote controller.

[0035] Furthermore, in accordance with some preferred embodiments of the present invention, there is provided a method for fluid control in a body passage, the method comprising:

[0036] providing an implantable dynamic pump device for fluid control inside body passage, the device comprising a one-way valve, the valve sealably deployable within the body passage and provided with a deployable structure comprising at least one deployable stent coupled to the one way valve; an electrically activated pump for pumping fluids ; a power source for powering the pump;

[0037] deploying the device within a body passage at a desired position;

[0038] activating the pump to pump out fluids from selected portion of the body passage.

[0039] Furthermore, in accordance with some preferred embodiments of the present invention, the method comprises detecting a pressure difference between a proximal end and distal end of the device and upon determining a threshold pressure difference between the distal and proximal ends activating the pump.

[0040] Furthermore, in accordance with some preferred embodiments of the present invention, the body passage is a bronchial airway, and wherein the device is used for reducing the volume of a selected portion of a lung.

[0041] Furthermore, in accordance with some preferred embodiments of the present invention, the method further comprises determining existence of lateral leakage in the selected portion of the lung and sealing the leakage for effective performance of the device.

[0042] Furthermore, in accordance with some preferred embodiments of the present invention, the method further comprises remotely energizing the device using a remote energizer device.

[0043] Furthermore, in accordance with some preferred embodiments of the present invention, the method further comprises remotely setting a performance regime for the device using a remote control device.

[0044] Furthermore, in accordance with some preferred embodiments of the present invention, the method further comprises providing the device with at least one pressure sensor for sensing local pressure.

[0045] Furthermore, in accordance with some preferred embodiments of the present invention, said at least one pressure sensor comprises two pressure sensors, the method further comprising positioning one of at a distal end of the device and positioning the other sensor at a proximal end of the device, and detecting pressure differences between the distal and proximal ends.

[0046] Furthermore, in accordance with some preferred embodiments of the present invention, upon detecting that a predetermined pressure difference threshold value is reached the pump is activated.

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] In order to better understand the present invention, and appreciate its practical applications, the following Figures are provided and referenced hereafter. It should be noted that the Figures are given as examples only and in no way limit the scope of the invention. Like components are denoted by like reference numerals.

[0048] Fig. 1 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, deployed in a bronchial airway.

[0049] Fig. 2 illustrates cross-sections of parts of the dynamic lung pump device, according to a preferred embodiment of the present invention, as shown in Fig. 1.

[0050] Fig. 3 illustrates a cross-sectional view of a deployment catheter used for the deployment of a device according to a preferred embodiment of the present invention.

[0051] Fig. 3a illustrates a deployment tool for deploying a dynamic lung pump, in accordance with a preferred embodiment of the present invention.

[0052] Fig. 4 illustrates a cross sectional view of the dynamic lung pump device, according to a preferred embodiment of the present invention, as shown in Fig. 1, in action, pumping out fluid.

[0053] Fig. 5a and Fig. 5b illustrate the membrane cap of the dynamic lung pump shown in Fig. 1, in closed (Fig. 5a) and open (Fig. 5b) states.

[0054] Fig. 6 illustrates a cross-sectional view of the dynamic lung pump device, according to a preferred embodiment of the present invention, with a catheter passing through the device for treatment of the distal end of the device.

[0055] Fig. 7 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with a remote energizer device.

[0056] Fig. 8 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with an auxiliary catheter with pressure sensors for measuring the local distal and proximal pressures.

[0057] during a final stage of deployment, as it is positioned in the desired location, based on position information provided by two sensors located on the deploying catheter. [0058] Fig. 9 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with incorporated pressure sensors for measuring the local distal and proximal pressures.

[0059] Fig. 9a illustrates a sensor with controller and antenna.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0060] The present invention introduces method and device for minimally invasive volume reduction of the lung by way of implanting a device which comprises a dynamic implantable pump incorporating a one-way valve, with an internal or external energy supply, into the bronchial airway, in order to achieve the desired air or/and fluid deflation. The proper deflated (reduced) volume is maintained by the one-way valve that stops air from moving distally into the lungs while permitting air to flow proximally out of the lung. In some preferred embodiments of the present invention, periodic activation of the pump is used to obtain the above mentioned results. A catheter can be attached to the device to enable an external pump to pump out air and/or fluid.

[0061] Reference is now made to Fig. 1, illustrating a cross-sectional view of a dynamic lung pump device 10, in accordance with a preferred embodiment of the present invention, shown in the figure to be located within a bronchial airway 12. The device structure includes two structural supports (a proximal stent 14 and a distal stent 16) on a core tube 18. The stents are cramped during the delivery (through a bronchial airway) and are expanded when deployed, anchoring against the walls of the bronchial airway. The device structure may be constructed from various materials, for example, elastic, plastic, and/or memory shaped material such as stainless steel, gold, titanium, cobalt- chromium alloys, tantalum alloys, nitinol, or various polymers and other metal alloys. The stent may include coating made form materials comprising nickel plating, polymer, chemicals or pharmaceutical material with or without sustained release mechanism that can be active or inactive in order to minimize damage (obstruction, narrowing, inflammation, mucous plugging, ulceration, perforation, bleeding, reorganization) to the bronchial wall and for treating active disease. The device may be permanently placed or it may be temporarily placed and then removed. The core tube 18 is provided with receptacle valve 27, which is designed to prevent fluid from flowing through the tube from the proximal end (the higher end in this figure) through to the distal end (the lower end in the figure). For that aim a one way valve can be used, for example a two or three- cuspid valve (the same structure as in heart valves). The valve is designed to be opened for a catheter to pass through from the proximal end to the distal end in order to perform procedures on the device, on the lung tissue (which faces the precluded zone of the lung), or in order to access and evacuate phlegm.

[0062] Supporting ribs 20, which are rigid, are connected to core tube 18 and capable of being deployed radially to present a splaying profile on either ends of the device (alternatively the supporting ribs can be provided only on the distal end of the device). On the distal end of the device membrane cap 22 is mounted over supporting ribs 20, with a preferable skirt 17 for enhancing the sealing obtained when the device is deployed within the bronchial airway. Slanted revolving disc 25 (mounted on motor 24) is mounted over and aligned with core tube 18 within the volume defined inside membrane cap 22. It is in fact incorporated with a motor that is motivated by capacitor 26, which can be energized externally through coil (or antenna) 28. Energy can be transmitted externally to the device.

[0063] The shape of the device shown in the figures includes a tapered zone in the middle of the device (between the two opposite stents). In this zone the device does not support the walls of the bronchial airway, and it is anticipated that the wall may collapse on the device so as to present better sealing.

[0064] Fig. 2 illustrates cross-sections of parts of the dynamic lung pump device, according to a preferred embodiment of the present invention, as shown in Fig. 1.

[0065] The device is anchored to the walls of a bronchial airway when the stents are deployed, pressing against the bronchial airway wall.

[0066] The narrow portion of membrane 22 acts as a valve. It comprises a number of leaves 21. The leaves open/close due to pressure differences between the pressure inside the volume defined within membrane cap 22 and slanted revolving disc 25 and the pressure outside membrane cap 22 (in the direction of upper respiratory airways). The membrane can be knitted, weaved, braided, or manufactured in dipping technology, or any other technology to create this type of shape. It can be made of metal, polymeric fiber, polymeric solution, biological material such as pericardium or other biological membrane material, or any other suitable flexible material, similarly to materials used for cardiac valves.

[0067] The membrane forms a sheath that is either non-permeable or semi-permeable (allowing some of materials - for example medication - to pass while blocking others) and that covers the device as shown and creates a seal with the wall of the bronchial airway once the device is implanted in the desired position. The wide end is placed distally (deeper into the lung) and the narrow end is placed proximally. The wide end of the cup presses against the walls of the bronchial airways forming a seal that prevents flow of air or fluid in a distal direction toward the periphery of the lung. Alternative anchoring means, such as hooks, which can comprise of glue, radial pressure provider, or other means, can also be used to firmly position the device in the desired location.

[0068] When the pump is not activated the device serves as a one-way flow control element, permitting air/fluid to flow proximally across the valve, while preventing flow distally.

[0069] When the pump is activated a pressure gradient is formed across the motor/blade such that air/fluid is pumped from the airway and lung distal to the device proximally.

[0070] Slanted revolving disc 24 (motor operated) is mounted aligned with the tube and within the volume defined inside the membrane 22. When the motor is activated the slanted disc revolves creating a differential pressure between the proximal and distal ends of the motor, consequently creating pressure differences between the distal and proximal ends of the device, forcing a flow from the distal end towards the proximal end through spaces between leaves 21 and the outer surface of core tube 18, when the leaves are forced open by the pressure difference.

[0071] The motor can be of brush or brushless type, the core either on blade or manifold, thus enabling unidirectional pumping of air (proximally) so as to achieve volume reduction. The blade can be a single blade or multiple blade form or any other shape that creates a differential pressure between the proximal and distal ends of the blade/motor structure.

[0072] The device is powered by a local power supply 26 (typically a battery or capacitor), acting as an energy source for the motor. The power supply preferably has a tubular cavity within in order to provide a channel for air or fluid to pass through, or may have multiple channels. Alternatively it may have no such channels (such that air or fluid passes around it).

[0073] Fig. 3 illustrates a cross-sectional view of a deployment catheter used for the deployment of a device according to a preferred embodiment of the present invention.

[0074] Catheter 30 with grasping end 32 is used to deliver the device within the respiratory system to its target position in the desired bronchial airway. During delivery the grasping end holds the proximal end of the device, and upon reaching its destination it is unhooked leaving the device in position. The delivery catheter is then retracted. IF necessary the delivery catheter can be used for removing the device from its position in the bronchial airway.

[0075] Fig. 3a illustrates a deployment tool for deploying a dynamic lung pump, in accordance with a preferred embodiment of the present invention. The deployment method in this embodiment involves placing the dynamic lung pump device 10 (shown schematically and undetailed) inside catheter 30 near the distal end of the catheter, and pushing it out using a balloon catheter, a stylet or similar device (not shown in this figure) In another embodiment the device is self deployed, for example a device made of shape-memory alloys.

[0076] Fig. 4 illustrates a cross sectional view of the dynamic lung pump device, according to a preferred embodiment of the present invention, as shown in Fig. 1, in action, pumping out fluid. When a pressure build-up within membrane cap 22 exceeds a threshold level, leaves 21 open up allowing fluid to pass upstream (towards the upper respiratory system).

[0077] Fig. 5a and Fig. 5b illustrate the membrane cap of the dynamic lung pump shown in Fig. 1, in closed state (Fig. 5a), before the pressure within the membrane cap reaches the threshold level and in open (Fig. 5b) state, when the threshold pressure level is exceeded.

[0078] Fig. 6 illustrates a cross-sectional view of the dynamic lung pump device, according to a preferred embodiment of the present invention, with a catheter 30 passing through the device for treatment of the distal end of the device. It may be used to suck away phlegm 33, or flush the distal end of the device with flushing liquid or provide medication. The receptacle valve 27 forms a seal with the catheter and permits manipulation from the external environment in order to maintain pulmonary hygiene and patency of the airway and the device. The catheter can be pushed through the receptacle valve distally, beyond the position of the device, and can thus serve as a conduit between the airways and the lung, and the external environment. The catheter can be delivered to the device through the working channel of a bronchoscope and pushed beyond the limit of the bronchoscope to the device under bronchoscopic visualization by the physician.

[0079] The catheter can be used for suction, irrigation, intrapulmonary delivery of medications and radioisotope therapeutic materials, delivery of contrast material for enhanced imaging of the airways (bronchography) by X-ray, Tomography, CT, MRI and other imaging techniques, delivery of radioisotope material that enables imaging of airways by SPECT, gamma camera, and other radio-isotope imaging methods, fluid, and energy transfer. The catheter also enables the clearance of phlegm, plugging and other problems of the device and the airway that need maintaining. It also allows for controlled suction of air on a periodic basis if needed as a supplement to the internal pump mechanism. Also the catheter may include a balloon for better sealing while performing suction procedure. The catheter may also include a sensor, for example, pressure senor, oxygen sensor, nitrite sensor - for better monitoring of the suction procedure. The catheter may also serve as a conduit to introduce imaging devices such as UltraSound , MRI, or infrared probes for diagnostic or treatment of the distal area.

[0080] Fig. 7 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with a remote energizer device. The remote energizer device 50 comprises, for example, RF generator which generates RF radiation that is emitted via antenna 52, and is picked up by coil 28 of the implanted dynamic lung pump device 10. Other radiation ranges, such as Ultrasound and others, can be transmitted, and is picked up by coil 28 and stored in capacitor 26 and may be using transdermal energy transfer. The power supply preferably has a tubular cavity within in order to provide a channel for air or fluid to pass through, or may have multiple channels. The power supply can be AC or DC source. In a preferred embodiment of the present invention the device includes an antenna that transmits energy to the receiving antenna 6 of the endobrochially placed device. There are typically two types of energy transmitter devices. One is in the clinic which is a bedside device which can be operated by the medical staff attending the patient, and another that is a portable device and can be mobile, or worn by the patient in the form of a vest and can be activated manually (or at pre-programmed dose and frequency per the instructions/prescription of the attending physician). For example, the physician may prescribe activation for 30 minutes (dose), daily (frequency). The portable device contains a battery that can be charged by plugging into electric outlet in the patients home when it is not worn

[0081] Once the device is positioned and deployed the physician can evaluate its potential effectiveness in achieving volume reduction, and thus clinical efficacy. This can be achieved by introducing a catheter across the catheter receptacle on the device and measuring pressures in the airways distal and proximal to the device. The catheter has two pressure sensors, one of which will be deployed in the airway distal to the device, and the other in the airway proximal to the device (the distance between the pressure sensors on the catheter would be 5-10 mm more than the length of the device). The application of suction should create a pressure gradient across the device such that the pressure distal to the device would be less than the pressure proximal to it. The lack of such pressure gradient could mean an inadequate seal or airflow through collateral airways.

[0082] Alternatively, pressure sensors on the proximal and distal ends of the device can and serve to check pressure gradient across the device with or without deployment of a catheter. A pressure difference between the distal pressure sensor and the proximal pressure sensor on the device indicates proper function of the device and greater likelihood of successful volume reduction. The physician can perform such an examination of pressures at the time of placement and periodically thereafter.

[0083] In some preferred embodiments of the present invention detected increase in the pressure at the distal end of the device triggers activation of the pump until the desired pressure is achieved. That can be achieved either by increasing the length of treatment time (one time or at different time interval) by increasing the speed of motor rotation or by other work parameter changes. [0084] In some preferred embodiments of the present invention the power source can be recharged while the patient is sleeping.

[0085] Fig. 8 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with an auxiliary catheter 64 with pressure sensors 60, 62 for measuring the local distal and proximal pressures. The auxiliary catheter with the pressure sensors can be used to monitor the activity of the dynamic lung pump device, as well as the condition of the precluded zone of the lung. The distance between the pressure sensors corresponds the distance between the distal and proximal ends of the device (or is greater).

[0086] Fig. 9 illustrates a cross-sectional view of a dynamic lung pump device, according to a preferred embodiment of the present invention, with incorporated pressure sensors 60, 62 for measuring the local distal and proximal pressures.

[0087] The pressure sensors are used to obtain pressure readings from the distal and proximal ends of the device, and can be used to regulate the activation of the dynamic lung pump device.

[0088] Fig 9a shows schematically a controller 70 that is connected to the pressure sensor (or sensors), which upon reaching a threshold pressure difference level activates the motor on which the slanted revolving disc is mounted. The controller can be programmed and adjusted at any time following the implantation using RF or any other telemetry methods, using coil 28 of the device as antenna.

[0089] Other types of sensors can be incorporated to in the device, or on an auxiliary catheter (for example position sensors).

[0090] An operating procedure demonstrating the use of the device is described hereinafter:

[0091] The device 10 is positioned in the bronchial airway such that the large end of the cup faces distally and the smaller end faces proximally towards the main bronchus. The Device is anchored against the walls of the bronchial airway by deploying the stents. [0092] During inspiration the activated pump creates an increase of pressure inside the volume entrapped between the pump blade and the proximal end of the cap, trapping air inside, where Pi denotes the pressure inside the entrapped volume (hereinafter - the intermediate chamber), while Pii is the pressure in bronchial airway proximal to device; If Pi>Pii air flows towards the main bronchus regardless of the breathing cycle,

[0093] If Pi = Pii or Pi < Pii air will not flow proximally towards the main bronchus regardless of the breathing cycle.

[0094] However, air cannot flow peripherally into the lung past the device where the cup forms a seal with walls of the bronchial airway and diverts the flow back proximally.

[0095] When the pump is active during the exhalation part of the breathing cycle, where Pi = Pressure inside the intermediate chamber, while Pii = Pressure in bronchial airway proximal to device. During expiration when the pump is active pressure inside the intermediate chamber increases while intra-bronchially proximal to the device the pressure decreases such that Pi>Pii, causing outflow of air thought the valve leaflets 5 resulting in release of trapped air volume peripherally.

[0096] When the pump is not activated during the inhalation part of the breathing cycle, air flow distally towards the periphery of the lung is prevented where the cup forms a seal with walls of the bronchial airway and diverts the flow back proximally.

[0097] When the pump is not activated during the exhalation part of the breathing cycle, during normal expiration as the intra thoracic cavity pressure increases such that Pi>Pii, there will be outflow of air thought the valve leaflet resulting in decrease in the trapped air volume. Pi = pressure in the airway distal to the device, while Pii = Pressure in bronchial airway proximal to device.

[0098] The doctor treating a patient with an implanted device can tailor the therapy for that particular patient, for example, number of hours that the device be activated and the interval time between each activation (if working in prescribed periods of time), the pump rotor speed, the desired pressure - all depending on the desired clinical effect.

[0099] A dynamic lung pump, according to a preferred embodiment of the present invention, is introduced endo-bronchially using a standard bronchoscope and/or the use of other intra-pulmonary navigation devices such as the superDimension™/Bronchus, Stereotaxis ™ navigation device, and others. The device is collapsible and fits into a catheter (see for example Fig. 3a). It is delivered and placed by way of a delivery system that include a guide, a guiding catheter, lead by a wire and a disengagement device which allows the device to be deployed and mounted in place and anchored in the airway. A Balloon type catheter can be used to press the stents against the wall of the bronchial pathway so as to better anchor the device in position. In a preferred embodiment of the present invention parts of the device are made of radio-opaque material such that it can be visible in x-ray imaging to assist the delivery and placement of the device.

[00100] According to a preferred embodiment of the present invention a unique disposable catheter introduced endo-bronchially is attached to the catheter valve at the proximal end of the device. This catheter enables the device to be connected to an external environment (for suction, irrigation, intrapulmonary delivery of medications, delivery of contrast material for enhanced imaging of the airways (bronchography) by X-ray, Tomography, CT₅ MRI and other imaging techniques, delivery of radioisotope material that enables imaging of airways by SPECT, gamma camera, and other radioisotope imaging methods, fluid, and energy transfer). This enables the clearance of mucous, plugging and other such maintenance of the device. It also allows for controlled suction of air on a periodic basis if needed as a supplement to the internal pump mechanism.

[00101] The catheter system can be used in conjunction with other implanted endobronchial one-way valve systems. It can thus enable the clearing and maintenance of other devices (of other companies or inventions) by clearing them from mucous, plugging or other debris that may interfere with their proper intended function.

[00102] Furthermore, such a catheter system can enable such other devices to employ active, controlled deflation of the lung at the time of placement of the device or periodically thereafter.

[00103] The device may used in conjunction with passive one-way endobronchial valves, chemical and biological volume reduction materials and methods, biological glues, other active endo-bronchial devices, endobrochial stent devices. The combination of multiple devices and methods in order to achieve greater efficacy in sustained volume reduction, in overcoming collateral airways, and in maximizing safety

[00104] The dynamic lung pump of the present invention can come in various sizes, aimed for use in airways of different diameters and lengths. [00105] The device can also work in conjunction with other treatments like gluing other bronchi (in case of lateral leakage), like stenting other branches and also with passive devices like one way valves.

[00106] The device may be used in conjunction with other flow control devices, passive and active. Multiple devices may be implanted in a lung in order to achieve maximum clinical effect. One or more active devices (the device) may be implanted in different airways of the lung, in combination with one or more passive flow control devices that are placed in different airways within the lung. The device may be placed in with such other flow control devices concomitantly, some time (minutes to months or years) after other flow control device(s) have been placed, or prior to the placement of such other flow control devices.

[00107] The device may be used in conjunction with plugs that are place in the airway in order to substantially block flow in that airway. The device or several of our devices are placed in the airways, in combination with such plugs that will block collateral airways from re-filling the distal area of title lung that is targeted for volume reduction. Such plugs can consist of gels, foams, polymers, metals, stents, biological membranes, and other materials that physically block the airway. Or functional, physiologic plugs such as sutures (close airway), staples, clamps; and by hyfercation, burning by laser, heat, RF or other forms of energy; and other noxious substances that plug by forming scar tissue such as acids, alkaline fluids, steam, nitrous oxide, liquid nitrogen, and other applicators of scaring by freezing.

[00108] The device may be used in conjunction and methods that create new conduits that allow for fluid to flow. Such conduits function as additional airways that enable the outflow of fluid in a proximal direction (towards the trachea) and thus contribute to the volume reduction process of the lung. Such conduits may be formed by needle, knife, laser, or other cutting devices. Such conduits may be kept in on open, patent condition with the use of stents or stent-like devices, that are bare, coated, and/or drug eluting.

[00109] The device may be used in conjunction with other procedures that achieve lung volume reductions including open surgical procedures or thoracoscopic procedures that excise, tie-off, band, constrict, or otherwise collapse a portion of the lung.

[00110] While the device shown in the drawings and discussed herein pertains to lung treatment it is understood that same device can be used for fluid removal or fluid control in other body passages and cavities - all of which are covered by the scope of the present invention.

[00111] It should be clear that the description of the embodiments and attached

Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope.

[00112] It should also be clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the present invention.

Claims

1. An implantable dynamic pump device for fluid control inside body passage, the device comprising: a one-way valve, the valve sealably deployable within the body passage and provided with a deployable structure comprising at least one deployable stent coupled to the one way valve; an electrically activated pump for pumping fluids ; a power source for powering the pump.

2. The device as claimed in claim 1, wherein the one-way valve comprises a membrane cap mounted over a support structure provided with separable leaves which initially engulf a core and when a threshold pressure difference between distal and proximal ends of the device are reached the leaves detach from the core allowing flow of fluid through.

3. The device as claimed in claim 2, wherein the membrane cap includes a skirt for enhanced sealing.

4. The device as claimed in claim 2, wherein the support structure comprises deployable supporting ribs connected to the core.

5. The device as claimed in claim 4, wherein the supporting ribs for deploying the supporting ribs are coupled to said at least one stent.

6. The device as claimed in claim 1, wherein the pump comprises a slanted revolvable disc.

7. The device as claimed in claim 1, wherein the power source comprises a battery.

8. The device as claimed in claim 1, wherein the power source comprises a capacitor.

9. The device as claimed in claim 8, wherein the capacitor is coupled to an antenna for receiving remotely transmitted energy.

10. The device as claimed in claim 9, wherein the antenna comprises a coil.

11. The device as claimed in claim 1, further provided with a remote energizer for remotely energizing the power source.

12. The device as claimed in claim 1, incorporating a tube inside which a flow restrictor is present generally blocking passage of fluids in at least one direction which is opposite to the flow direction in the one-way valve, and through which a catheter can be passed to reach a distal end of the device and beyond.

13. The device as claimed in claim 12, wherein the tube passes through the power source.

14. The device as claimed in claim 1, further provided with at least one pressure sensor for sensing local pressure.

15. The device as claimed in claim 14, wherein said at least one pressure sensor comprises two pressure sensors, one of which is positioned at a distal end of the device and the other of which is positioned at a proximal end of the device, so as to allow detecting pressure differences between the distal and proximal ends.

16. The device as claimed in claim 15, wherein said at least one sensor is coupled to a controller for detecting a predetermined pressure difference threshold value and for activating the pump when the predetermined pressure difference threshold value is reached.

17. The device as claimed in claim 1, further provided with a catheter adapted to pass through the device.

18. The device as claimed in claim 1 , further provided with a remote controller.

19. A method for fluid control in a body passage, the method comprising: providing an implantable dynamic pump device for fluid control inside body passage, the device comprising a one-way valve, the valve sealably deployable within the body passage and provided with a deployable structure comprising at least one deployable stent coupled to the one way valve; an electrically activated pump for pumping fluids ; a power source for powering the pump; deploying the device within a body passage at a desired position; activating the pump to pump out fluids from selected portion of the body passage.

20. The method as claimed in claim 19, comprising detecting a pressure difference between a proximal end and distal end of the device and upon determining a threshold pressure difference between the distal and proximal ends activating the pump.

21. The method as claimed in claim 19, wherein the body passage is a bronchial airway, and wherein the device is used for reducing the volume of a selected portion of a lung.

22. The method as claimed in claim 20, further comprising determining existence of lateral leakage in the selected portion of the lung and sealing the leakage for effective performance of the device.

23. The method as claimed in claim 19, further comprising remotely energizing the device using a remote energizer device.

24. The method as claimed in claim 19, further comprising remotely setting a performance regime for the device using a remote control device.

25. The method as claimed in claim 19, further comprising providing the device with at least one pressure sensor for sensing local pressure.

26. The method as claimed in claim 25, wherein said at least one pressure sensor comprises two pressure sensors, the method further comprising positioning one of at a distal end of the device and positioning the other sensor at a proximal end of the device, and detecting pressure differences between the distal and proximal ends.

27. The method as claimed in claim 26, wherein upon detecting that a predetermined pressure difference threshold value is reached the pump is activated.