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WO2008140989A2 - Dispositifs médicaux et procédures permettant l'évaluation d'un poumon et le traitement de la bronchopeumathie chronique obstructive - Google Patents

Dispositifs médicaux et procédures permettant l'évaluation d'un poumon et le traitement de la bronchopeumathie chronique obstructive Download PDF

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Publication number
WO2008140989A2
WO2008140989A2 PCT/US2008/062680 US2008062680W WO2008140989A2 WO 2008140989 A2 WO2008140989 A2 WO 2008140989A2 US 2008062680 W US2008062680 W US 2008062680W WO 2008140989 A2 WO2008140989 A2 WO 2008140989A2
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WO
WIPO (PCT)
Prior art keywords
pleura
lung
section
conduit
viscera
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/US2008/062680
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English (en)
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WO2008140989A3 (fr
Inventor
Don Tanaka
Scott M. Russell
Alex Nedvetsky
Attila Meretei
Carl J. Evens
Asia Chang
Walter J. Aster
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Portaero Inc
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Portaero Inc
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Priority to EP08747659A priority Critical patent/EP2146653A2/fr
Publication of WO2008140989A2 publication Critical patent/WO2008140989A2/fr
Publication of WO2008140989A3 publication Critical patent/WO2008140989A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Definitions

  • the present invention relates to medical devices and methods for accessing and treating diseased lungs.
  • Chronic obstructive pulmonary disease is a persistent obstruction of the airways caused by chronic bronchitis and pulmonary emphysema. In the United States alone, approximately fourteen million people suffer from some form of chronic obstructive pulmonary disease and it is in the top ten leading causes of death.
  • the epiglottis automatically closes off the larynx during swallowing so that solids and/or liquids enter the esophagus rather than the lower air passageways or airways.
  • the air passes into the trachea, which divides into two branches, referred to as the bronchi.
  • the bronchi are connected to the lungs.
  • the lungs are large, paired r spongy, elastic organs, which are positioned in the thoracic cavity. The lungs are in contact with the walls of the thoracic cavity. In humans, the right lung comprises three lobes and the left lung comprises two lobes. Lungs are paired in all mammals, but the number of lobes or sections of lungs varies from mammal to mammal. Healthy lungs, as discussed below, have a tremendous surface area for gas/air exchange. Both the left and right lung is covered with a pleura! membrane. Essentially, the pleural membrane around each lung forms a continuous sac that encloses the lung. A pleura! membrane aiso forms a lining for the ⁇ hora ⁇ c cavity.
  • the space between the pleura! membrane forming the lining of the thoracic cavity and the pleural membranes enclosing the lungs is referred to as the pleura! cavity.
  • the pleural cavity comprises a film of fiuid that serves as a lubricant between the lungs and the chest wall.
  • the bronchi branch into a multiplicity of smaller vessels referred to as bronchioles.
  • bronchioles typically, there are more than one million bronchioles in each lung.
  • Each bronchiole ends in a cluster of extremely small air sacs referred to as alveoli.
  • An extremely thin, single layer of epithelial cells lining each alveolus wall and an extremely thin, single layer of epithelial cells lining the capillary wails separate the air/gas in the alveolus from the blood.
  • Oxygen molecules in higher concentration pass by simple diffusion through the two thin layers from the alveoli into the blood in the pulmonary capillaries.
  • carbon dioxide molecules in higher concentration pass by simple diffusion through the two thin layers from the blood in the pulmonary capillaries into the aiveoii.
  • Breathing is a mechanical process involving inspiration and expiration.
  • the thoracic cavity is normally a closed system and air cannot enter or leave the lungs except through the trachea. If the chest wall is somehow compromised and air/gas enters the pleura! cavity, the !ungs wil! typically collapse.
  • the volume of the thoracic cavity is increased by the contraction of the diaphragm , the volume of the lungs is also increased.
  • the pressure of the air in the lungs falls slightly below the pressure of the air external to the body (ambient air pressure) Accordingly, as a result of this slight pressure differential, externa! or ambient air flows through the respiratory passageways described above and fiils the lungs until the pressure equalizes. This process is inspiration.
  • Chronic obstructive pulmonary disease is a persistent obstruction of the airways caused by chronic bronchitis and pulmonary emphysema. Chronic bronchitis and acute bronchitis share certain similar characteristics; however, they are distinct diseases.
  • Both chronic and acute bronchitis involve inflammation and constriction of the bronchia! tubes and the bronchioles; however, acute bronchitis is g ⁇ n ⁇ raily associated with a viral and/or bacterial infection and its duration is typically much shorter than chronic bronchitis.
  • chronic bronchitis the bronchial tubes secrete too much mucus as part of the body's defensive mechanisms to inhaled foreign substances. Mucus membranes comprising ciliated cells (hair like structures) line the trachea and bronchi.
  • the ciliated cells or ciiia continuously push or sweep the mucus secreted from the mucus membranes in a direction away from the lungs and into the pharynx, where it is periodically swallowed.
  • This sweeping action of the cilia functions to keep foreign matter from reaching the lungs.
  • the ciiiated cells may become damaged, leading to a decrease in the efficiency of the cilia to sweep the bronchial tubes and trachea of the mucus containing the foreign matter.
  • Pulmonary emphysema may be caused by a number of factors, including chronic bronchitis, long term exposure to inhaled irritants, e.g. air pollution, which damage the cilia, enzyme deficiencies and other pathological conditions. Pulmonary emphysema is a disease in which the alveoli walls, which are normally fairly rigid structures, are destroyed.
  • the destruction of the alveoli wails is irreversible, in pulmonary emphysema, the alveoli of the lungs lose their elasticity, and eventually the walls between adjacent alveoli are destroyed. Accordingly, as more and more alveoli walls are lost, the air exchange (oxygen and carbon dioxide) surface area of the lungs is reduced until air exchange becomes seriously impaired.
  • Mucus hyper-secretion and dynamic airway compression are mechanisms of airflow limitation in chronic obstructive pulmonary disease. Mucus hyper-secretion is described above with respect to bronchitis. Dynamic airway compression results from the loss of tethering forces exerted on the airway due to the reduction in lung tissue elasticity, in other words, the breakdown of Sung tissue leads to the reduced ability of the lungs to recoil and the loss of radial support of the airways. Consequently, the loss of elastic recoil of the lung tissue contributes to the inability of individuals to exhale completely. The loss of radial support of the airways also allows a collapsing phenomenon to occur during the expiratory phase of breathing.
  • This collapsing phenomenon also intensifies the inability for individuals to exhale completely. As the inability to exhale compieteiy increases, residual volume in the lungs also increases. This then causes the lung to establish in a hyperinfiated state. The individual develops dyspnea in which the individual can only take short shallow breaths. Essentially, air is not effectively expelled and stale air accumulates in the lungs. Once the stale air accumulates in the lungs, the individual is deprived of oxygen.
  • Another aspect of an emphysematous Sung is that the communicating flow of air between neighboring air sacs is much more prevalent as compared to healthy lungs. This phenomenon is known as collateral ventilation.
  • collateral ventilation since air cannot be expelled from the native airways due to the Soss of tissue eSastic recoil and radia! support of the airways (dynamic collapse during exhalation), the increase in collateral ventilation does not significantly assist an individual in breathing.
  • drug therapy such as bronchodilating agents
  • lung volume reduction surgery and long term oxygen therapy.
  • Long term oxygen therapy is widely accepted as the standard treatment for hypoxia caused by chronic obstructive pulmonary disease.
  • Transtracheal oxygen therapy is prescribed using a nasal cannula.
  • Transtracheal oxygen therapy has become a viable alternative to long term oxygen therapy.
  • Transtracheal oxygen therapy delivers oxygen directly to the lungs using a catheter that is placed through and down the trachea.
  • Bronchodilating drugs only work on a percentage of patients with chronic obstructive pulmonary disease and generally only provide short- term relief.
  • Oxygen therapy is impractical for the reasons described above, and lung volume reduction surgery is an extremely traumatic procedure that involves removing part of the lung.
  • the long term benefits of lung volume reduction surgery are not fully known. Accordingly, there exists a need for removing trapped gases from a diseased Sung or iungs. Accordingly there aSso exists a need for safely and effectively accessing a diseased Sung or lungs for the treatment of a variety of chronic lung diseases.
  • a collateral ventilation bypass trap system may be utilized to take advantage of the above-described collateral ventilation phenomenon to increase the expiratory flow from a diseased iung or lungs ; thereby treating chronic obstructive pulmonary- disease.
  • Various methods may be utilized to determine the location or locations of the diseased tissue, for example, computerized axial tomography or CAT scans, magnetic resonance imaging or MRL positron emission tomograph or PET : and/or standard X-ray imaging. Essentialiy, the most collaterally ventilated area of the lung or lungs is determined utilizing the scanning techniques described above.
  • a conduit or conduits are positioned m a passage or passages that access the outer pleural layer of the diseased lung or lungs.
  • the conduit or conduits utilize the collateral ventilation of the Sung or lungs and allow the entrapped air to bypass the native airways and be expeiled to a containment system outside of the body.
  • a long term oxygen therapy system may also be utilized to effectively treat hypoxia caused by chronic obstructive pulmonary disease.
  • the components of the system are preferably sealed to the lung. Accordingly, methods and devices to create a chemically and/or mechanically localized pleurodesis of the present invention may be utilized to provide the seals required for effective sealing of the components of the Song term oxygen therapy system and the collateral ventilation bypass trap system as well as other devices requiring pleurodesis.
  • the present invention therefore relates to medical devices and methods for accessing and treating diseased lungs as disclosed herein.
  • the disclosed medicaS devices and methods include variable parietal/visceral pleural coupiings that allow for an air tight seal between the parietal and viscera! pie ⁇ ra without the need for a pleurodesis.
  • the pleural coupling includes at least one moveable member having a first section connected to the visceral pleura and a second section connected to the parietal pleura for establishing a pleurodesis free connection to allow trapped gases to flow from the i ⁇ ngs.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include a viscera! pleura ring connector that may be utilized to anchor and seal the viscera! pleura to a conduit or other device entering the lung from a non-native airway. The viscera!
  • a collateral ventilation bypass system may- include at least one device connected to at least one !ung for removing trapped gases in the lung and a removable ring assembly positionable around the at least one device for securing the at ieast one device to the viscera! pleura.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include a pulmonary pleura! stabilizer may be utilized to hold the visceral pleura of the lung during surgical procedures involving accessing the lung or lungs of a patient directly through the lung and not the native airways.
  • the pulmonary pleural stabilizer allows components of systems for treating lung diseases as described herein to be surgically implanted directly though the !ung or iungs of a patient.
  • the promismonary viscera! pleura! stabilizing system includes a device for creating a controllable negative pressure and a removable holding device connected to the device for creating a controllable, negative pressure thereby creating a suction force, the holding device being operable to secure the pulmonary viscera! pleura for creating an opening therethrough.
  • the device utilizes a slight negative pressure or vacuum to draw in and hold the viscera! pleura during the procedure.
  • the device allows the lung to be opened while another device is inserted and sealed to the lung. Once the device is inserted, a viscera!
  • pleura ring connector may be positioned around the pleura and the device to receive and secure the device in piace.
  • a pulmonary visceral pieura anastomosis reinforcement device may be positioned in a proximity to the device or conduit to be inserted so that when the pleura is secured to the conduit, the reinforcement device provides structural reinforcement and aids in preventing damage to the pleura.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include a pulmonary viscera! pleura anastomosis reinforcement device.
  • the device maintains the integrity of an opening in the viscera!
  • the device includes a buttress attachable to the conduit and the visceral pleura of the lung.
  • the reinforcement device comprises a structure, material and/or mesh that facilitates making the seal of the viscera! pleura around the anastomosis device.
  • the anastomosis device may be a conduit or any other device that enters the lung not through a native airway.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include methods and devices for creating a localized area where the visceral and parietal pleura of the lung are fused together rather than a much larger area than is done now.
  • the present invention includes devices for creating a localized pleurodesis for lung devices utilizing a combination of a mechanical component and a chemical component.
  • the chemical component is utilized to create an acute adhesion whiie the mechanica! compound is utilized to create a chronic adhesion.
  • the present invention utilizes a chemical component to create adhesion between the visceral pleura and the parietal pleura and a mechanical component to create a chronic adhesion.
  • the chemical component provides stability for the mechanica! component to be implemented.
  • the localized pleurodesis device can include an implantable structure positionable proximate to at least one of the visceral or parietal pleura and a radiopaque marker affixed to the implantable structure.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include a device and method for maintaining luminal patency proximate openings in parenchymal tissue. Some embodiments include methods and devices for maintaining patency in parenchymal tissue. In any of the implantable devices described herein, the luminal patency of the device is preferably maintained to allow for airflow. Embodiments include both mechanical and chemical means for maintaining implant patency.
  • One aspect includes a system for maintaining luminal patency proximate openings in parenchymal tissue including a device for substantially interfering with tissue and secretionai buildup on or around the opening.
  • One aspect includes a mechanical device or chemical process which is utilized to maintain lumina! patency in conduits or other devices implanted in the lung or lungs of a patient. The mechanical device or chemical process ensures that air flows freely through the implanted conduit or device.
  • the disclosed medical devices and methods for accessing and treating diseased lungs include an implantable medical device comprising a bridging element configured for attachment between one or more adjacent ribs in a patient and one or more fittings operatively associated with the bridging element.
  • the bridging element is an implantable device for holding an ⁇ securing a conduit or other medical device implanted in a patient's lung.
  • the bridging element includes a hole or other fitting to secure the device positioned in the lung.
  • the bridging element spans the intercostal space through which the devices described herein pass.
  • the one or more fittings are configured to receive and secure devices connected to a lung of a patient.
  • the bridging element alleviates some of the potential discomfort associated with the chronic placement of a device in the intercostal space.
  • FIG. 1 is a diagrammatic representation of a first exemplary embodiment of the long term oxygen therapy system.
  • FiG. 2 is a diagrammatic representation of a first exemplary embodiment of a sealing device utilized in conjunction with the long term oxygen therapy system.
  • FIG. 3 is a diagrammatic representation of a second exemplary embodiment of a sealing device utilized in conjunction with the long term oxygen therapy system
  • FIG. 4 is a diagrammatic representation of a third exemplary embodiment of a sealing device utilized in conjunction with the long term oxygen therapy system.
  • FIG. 5 is a diagrammatic representation of a fourth exemplary embodiment of a sealing device utilized in conjunction with the long term oxygen therapy system.
  • FIG. 6 is a diagrammatic representation of a second exemplary embodiment of the long term oxygen therapy system,
  • FIG. 7 is a diagrammatic representation of a first exemplary embodiment of a collateral ventilation bypass trap system
  • FIG. 8 is a diagrammatic representation of a first exemplary embodiment of a localized pieurodesis chemical delivery system.
  • FfG. 9 is a diagrammatic representation of a second exemplary embodiment of a localized pieurodesis chemica! delivery system
  • FIGS. 10A-10G are diagrammatic representations of an exemplary mechanical device for producing a chronic local adhesion.
  • FIGS. 1 1A and 11 B are diagrammatic representations of an exemplary pulmonary pleura! stabilizer.
  • FIGS. 12A, 12B r 12C and 12D are diagrammatic representations of two exemplary holding devices.
  • FIGS. 13A and 13B are diagrammatic representations of an exemplary viscera! pleura ring connector.
  • FSG. 14 is a diagrammatic representation of an exemplary pulmonary viscera! pleura anastomotic reinforcement device.
  • FIG. 15 is a diagrammatic representation of an exemplary modified tip of an implantable medica! device.
  • FfG. 16 is a diagrammatic representation of a first exemplary mechanical cleaning device.
  • FIG. 17 is a diagrammatic representation of a second exemplary mechanica! clearing device.
  • FSG. 18 is a diagrammatic representation of a first chemical clearing device.
  • FfG. 19 is a diagrammatic representation of a second chemical clearing device.
  • FIG. 20 is a diagrammatic representation of a first exemplary variable parietal/visceral pleural coupling.
  • FfG. 21 is a diagrammatic representation of a second exemplary variable parietai/viscerai pleural coupling.
  • FIG. 22 is a diagrammatic representation of a third exemplary variable parietai/viscerai pleural coupling.
  • FIG. 23 is a diagrammatic representation of a fourth exemplary variable parietal/viscera! pleural coupling.
  • FfG. 24 is a diagrammatic representation of a conduit positioned through a hole in a rib of a patient.
  • FIG. 25 is a diagrammatic representation of a first exemplary bridging element.
  • FIG. 26 is a diagrammatic representation of a second exemplary bridging element.
  • a Song term oxygen therapy system and method may be utilized to deliver oxygen directly into the lung tissue in order to optimize oxygen transfer efficiency in the lungs.
  • improved efficiency may be achieved if oxygen were to be delivered directly into the aiveoiar tissue in the iungs.
  • alveoli walls are destroyed, thereby causing a decrease in air exchange surface area.
  • coliateral ventilation resistance is towered. Accordingly, if it can be determined where collateral ventilation is occurring, then the diseased lung tissue may be isolated and the oxygen delivered to this precise location or locations.
  • Various methods may be utilized to determine the diseased tissue locations, for example, computerized axial tomography or CAT scans, magnetic resonance imaging or MRi, positron emission tomograph or PET 1 and/or standard X-ray imaging.
  • pressurized oxygen may be directly delivered to these diseased areas and more effectively and efficiently forced into the Sung tissue for air exchange.
  • anastomotic openings are made in the thoracic cavity and Sung or lungs and one or more oxygen carrying conduits are positioned and sealed therein.
  • the one or more oxygen carrying conduits are connected to an oxygen source which supplies oxygen under elevated pressure directly to the diseased portion or portions of the lung or lungs.
  • the pressurized oxygen essentially displaces the accumulated air and is thus more easily absorbed by the alveoli tissue, in addition, the long term oxygen therapy system may be configured in such a way as to provide collateral ventilation bypass in addition to direct oxygen therapy.
  • FIG. 1 ilSustrates a first exemplary long term oxygen therapy system 100.
  • the system 100 comprises an oxygen source 102, an oxygen carrying conduit 104 and a one-way vaSve 106.
  • the oxygen source 102 may comprise any suitable device for supplying filtered oxygen under adjustably regulated pressures and flow rates , including pressurized oxygen tanks, liquid oxygen reservoirs, oxygen concentrators and the associated devices for controSling pressure and flow rate e.g. regulators.
  • the oxygen carrying conduit 104 may comprise any suitable biocompatible tubing having a high resistance to damage caused by continuous oxygen exposure.
  • the oxygen carrying conduit 104 comprises tubing having an inside diameter in the range from about 1/16 inch to about 1/2 inch and more preferably from about 1/8 inch to about 1/4 inch.
  • the one-way valve 106 may comprise any suitable, in-line mechanical valve which allows oxygen to flow into the lungs 108 through the oxygen carrying conduit 104, but not from the lungs 108 back into the oxygen source 102. For example, a simple check valve may be utilized. As illustrated in FIG. 1 , the oxygen carrying conduit 104 passes through the lung 108 at the site determined to have the highest degree of collateral ventilation.
  • the exemplary system 100 described above may be modified in a number of ways, including the use of an in-line filter.
  • both oxygen and air may flow through the system. Sn other words, during inhalation, oxygen is delivered to the lungs through the oxygen carrying conduit 104 and during exhalation, air from the lungs flow through the oxygen carrying conduit 104.
  • the inline filter would trap mucus and other contaminants, thereby preventing a blockage in the oxygen source 102
  • no valve 106 would be utilized
  • the flow of oxygen into the lungs and the flow of air from the lungs is based on pressure differentials.
  • an air-tight sea! is preferably maintained where the oxygen carrying conduit 104 passes through the thoracic cavity and lung. This sea! is maintained in order to sustain the inflation/functionality of the i ⁇ gs. If the seal is breached, air can enter the cavity and cause the lungs to collapse as described above.
  • a method to create this seal comprises forming adhesions between the viscera! pleura of the lung and the inner wall of the thoracic cavity. This may be achieved using either chemical methods, including irritants such as Doxycycline and/or Bleomycin, surgical methods, including pleurectomy or horoscope talc pleurodesis, or radiotherapy methods, including radioactive gold or externa! radiation. Al! of these methods are known in the relevant art for creating pleurodesis. With a sea! created at the site for the ventilation bypass, an intervention may be safely performed without the danger of creating a pneumothorax of the lung.
  • the oxygen carrying conduit 104 may be sealed to the skin at the site of the ventilation bypass, in one exemplary embodiment, illustrated in FtG. 2, the oxygen carrying conduit 104 may be sealed to the skin of the thoracic wall 202 utilizing an adhesive 204.
  • the oxygen carrying conduit 104 comprises a flange 200 having a biocompatible adhesive coating 204 on the skin contacting surface.
  • the biocompatible adhesive 204 would provide a fluid tight sea! between the flange 200 and the skin or epidermis of the thoracic wall 202.
  • the biocompatibte adhesive 204 provides a temporary fluid tight seal such that the oxygen carrying conduit 104 may be disconnected from the ventilation bypass site. This would allow for the site to be cleaned and for the long term oxygen therapy system 100 to undergo periodic maintenance,
  • FIG. 3 iilustrates another exemplary embodiment for sealing the oxygen carrying conduit 104 to the skin of the thoracic wall 202 at the site of the ventilation bypass.
  • a coupling plate 300 is sealed to the skin at the site of the ventilation bypass by a biocompatible adhesive coating 204 or any other suitable means.
  • the oxygen carrying conduit 104 is then connected to the coupling plate 300 by any suitable means, including threaded couplings and locking rings.
  • the exemplary embodiment also allows for clearing of the site and maintenance of the system 100.
  • FfG. 4 illustrates yet another exemplary embodiment for sealing the oxygen carrying conduit 104 to the skin of the thoracic wall 202 at the site of the ventilation bypass.
  • balloon flanges 400 may be utilized to create the seal.
  • the balloon flanges 400 may be attached to the oxygen carrying conduit 104 such that in the deflated stale, the oxygen carrying conduit 104 and one of the balloon flanges passes through the ventilation bypass anastomosis.
  • the balloon flanges 400 are spaced apart a sufficient distance such that the balloon flanges remain on opposite sides of the thoracic wall 202, When inflated, the balloons expand and form a fluid tight seal by sandwiching the thoracic wail.
  • this exemplary embodiment allows for easy removal of the oxygen carrying conduit 104.
  • FIG. 5 illustrates yet another exemplary embodiment for sealing the oxygen carrying conduit 104 to the skin of the thoracic wall 202 at the site of the ventilation bypass
  • a single balioon flange 500 is utilized in combination with a fixed flange 502.
  • the balloon flange 500 is connected to the oxygen carrying conduit 104 in the same manner as described above.
  • the balloon flange 500 when inflated, forms the fluid tight seal.
  • the fixed flange 502 which is maintained against the skin of the thoracic wall 202, provides the structurai support against which the balloon exerts pressure to form the seal.
  • a collateral ventilation bypass trap system utilizes the above-described collateral ventilation phenomenon to increase the expiratory flow from a diseased lung or lungs, thereby treating another aspect of chronic obstructive pulmonary disease.
  • the most collaterally ventilated area of the lung or lungs is determined utilizing the scanning techniques described above. Once this area or areas are located, a conduit or conduits are positioned in a passage or passages that access the outer pleura! layer of the diseased lung or lungs.
  • FIG. 6 illustrates an exemplary embodiment of a collateral ventilation bypass/direct oxygen therapy system 600.
  • the system 600 comprises an oxygen source 602 (with potential filter), an oxygen carrying conduit 604 having two branches 606 and 608, and a contra! valve 610.
  • the oxygen source 602 and oxygen carrying conduit 604 may comprise components similar to the above-described exemplary embodiment illustrated in FiG. 1.
  • the valve 610 when the individual inhales, the valve 610 is open and oxygen flows into the lung 612 and into the bronchial tube 614.
  • the branch 608 may be connected to the trachea 616. Accordingly, during inhalation oxygen flows to the diseased site in the lung or lungs and to other parts of the lung through the normal bronchial passages.
  • the valve 610 is closed so that no oxygen is delivered and air in the diseased portion of the Sung may flow from the lung 612, through one branch 606 and into the second branch 608 and finally into the bronchia! tube 614. In this manner, stale air is removed and oxygen is directly delivered.
  • FiG. 7 illustrates a first exemplary collateral ventilation bypass trap system
  • the system 700 comprises a trap 702, an air carrying conduit 704 and a filter/one-way valve 706.
  • the air carrying conduit 704 creates a fluid communication between an individual ' s lung 708 and the trap 702 through the filter/one-way valve 706. It is important to note that although a single conduit 704 is illustrated, multiple conduits may be utilized in each lung 708 if it is determined that there are more than one area of high coilatera! ventilation.
  • the trap 702 may comprise any suitable device for collecting discharge from the individual's Sung or lungs 708. EssentiaSly, the trap 702 is simply a containment vessel for temporarily storing discharge from the iu ⁇ gs, for example, mucous and other fluids that may accumulate m the lungs.
  • the trap 702 may comprise any suitable shape and may be formed from any suitable metallic or non-metallic materials.
  • the trap 702 should be formed from a lightweight, non-corrosive material, in addition, the trap 702 should be designed in such a manner as to allow for effective and efficient cleaning.
  • the trap 702 may comprise disposable liners that may be removed when the trap 702 is full.
  • the trap 702 may be formed from a transparent materia! or comprise an indicator window so that it may be easily determined when the trap 702 should be emptied or cleaned.
  • a lightweight trap 702 increases the patient's mobility.
  • the filter/one-way valve 706 may be attached to the trap 702 by any suitable means, including threaded fittings or compression type fittings commonly utilized in compressor connections.
  • the filter/one-way valve 706 serves a number of functions.
  • the filter/one-way valve 706 allows the air from the individual ' s lung or lungs 708 to exit the trap 702 while maintaining the fluid discharge and solid particulate matter in the trap 702
  • This filter/one-way vaive 706 would essentially maintain the pressure in the trap 702 below that of the pressure inside the individual's lung or lungs 708 so that the flow of air from the lungs 708 to the trap 702 is maintained in this one direction.
  • the filter portion of the filter/one-way valve 706 may be designed to capture particulate matter of a particular size which is suspended in the air, but allows the clean air to pass therethrough and be vented to the ambient environment.
  • the filter portion may also be designed in such a manner as to reduce the moisture content of the exhaled air.
  • the air carrying conduit 704 connects the trap 702 to the lung or lungs 708 of the patient through the filter/one-way valve 706
  • the air carrying conduit 704 may comprise any suitable biocompatible tubing having a resistance to the gases contained in air.
  • the air carrying conduit 704 comprises tubing having an inside diameter in the range from about 1/16 inch to about 1/2 inch, and more preferably from about 1/8 inch to about 1/4 inch
  • the filter/one-way valve 706 may comprise any suitable valve which allows air to flow from the lung or lungs 708 through the air carrying conduit 704 : but not from the trap 702 back to the lungs 708.
  • a simple check valve may be utilized.
  • the air carrying conduit 704 may be connected to the filter/one-way vaive 708 by any suitable means.
  • a quick release mechanism is utilized so that the trap may be easily removed for maintenance.
  • the air carrying conduit 704 passes through the lung 708 at the site determined to have the highest degree of collateral ventilation, if more than one site is determined, multiple air carrying conduits 704 may be utilized.
  • the connection of multiple air carrying conduits 704 to the filter/one-way valve 706 may be accomplished by any suitable means, including an octopus device similar to that utilized in scuba diving regulators.
  • the air carrying conduit 704 is preferably able to withstand and resist collapsing once in place. Since air will travel through the conduit 704, if the conduit is crushed and unable to recover, the effectiveness of the system is diminished. Accordingly, a crush recoverable material may be incorporated into the air carrying conduit 704 in order to make it crush recoverable Any number of suitable materials may be utilized. For example, Nitinol incorporated into the conduit 704 will give the conduit collapse resistance and collapse recovery properties.
  • Expandable features at the end of the condurt 704 may be used to aid in maintaining contact and sealing the conduit 704 to the lung pleura. Nitinol incorporated into the conduit 704 will provide the ability to deliver the conduit 704 in a compressed state and then deployed in an expanded state to secure it in place. Shoulders at the end of the conduit may also provide a mechanicai stop for insertion and an area for an adhesive/sealant to join as described in detail subsequently.
  • an air-tight seal is preferably maintained where the air carrying conduit 704 passes through the thoracic cavity and lungs 708.
  • a sealed joint 705 is provided at the end of conduit 704 This seal is maintained in order to sustain the inflation/functionality of the lungs.
  • One exemplary method for creating the seal comprises forming adhesions between the visceral pleura of the lung and the inner wall of the thoracic cavity. This may be achieved using either chemical methods, including irritants such as Doxycyc ⁇ ne and/or Bleomycin, surgical methods, including pleurectomy or thorascopic talc pleurodesis : or radiotherapy methods, including radioactive gold or externa! radiation. Al! of these methods are known m the relevant art for creating pleurodesis.
  • a sealed joint between the air carrying conduit 704 and the outer pleural layer includes using various glues Io help with the adhesion/sealing of the air carrying conduit 704.
  • Focal Inc. markets a sealant available under the trade name FOCAL/SEAL-L which is indicated for use on a Sung for sealing purposes, Focal/Seal- L is activated by light in order to cure the sealant.
  • Another seal available under the trade name THOREX, which is manufactured by Surgical Sealants inc., is currently conducting a clinical trial for lung sealing indications.
  • Thorex is a two-part sealant that has a set curing time after the two parts are mixed.
  • the creation of the opening in the chest cavity may be accomplished in a number of ways.
  • the procedure may be accomplished using an open chest procedure, sternotomy or thoracotomy.
  • the procedure may be accomplished using a laparoscopic technique, which is less invasive.
  • the seal should be established while the lung is at least partially inflated in order to maintain a solid adhesive surface.
  • the opening may then be made after the joint has been adequately created between the conduit component and the lung pleura! surface.
  • the opening should be adequate in cross-sectional area in order to provide sufficient decompression of the hyperinflated Sung.
  • This opening as staled above, may be created using a number of different techniques such as cutting, piercing, dilating, blunt dissection, radio frequency energy, ultrasonic energy , microwave energy, or cryoblative energy.
  • the air carrying conduit 704 may be sealed to the skin at the site by any of the means and methods described above with respect to the oxygen carrying conduit 704 and iliustraied in FiGS. 2 through 5. in operation, when an individual exhales, the pressure in the lungs is greater than the pressure in the trap 702. Accordingly, the air in the highly coilateralized areas of the lung will travel through the air carrying conduit 704 to the trap 702. This operation will allow the individual to more easily and completely exhale.
  • a pneumothorax (collapsed Sung) may occur. Essentially, in any circumstance where the Sung is punctured and a device inserted, an air-tight seal should preferably be maintained.
  • pleur ⁇ desis i.e. an obliteration of the pleura! space.
  • pleurodesis methods including chemical, surgical and radiological, in chemical pleurodesis, an agent such as tetracycline, doxycycline, bleomycin or nitrogen mustard may be utilized, In surgical pleurodesis, a pleurectomy or a thorascopic talc procedure may be performed. In radiological procedures, radioactive gold or external radiation may be utilized.
  • Exemplary methods for creating the sea! comprises forming adhesions between the viscera!
  • a sealed joint between the air carrying conduit 704 and the outer pleura! layer includes using various glues to help with the adhesion/sealing of the air carrying conduit 704.
  • Focal Inc. markets a sealant available under the trade name FOCAL/SEAL-L which is indicated for use on a lung for sealing purposes. Focal/Seai-L is activated by light in order to cure the sealant.
  • Another sea! available under the trade name THOREX which is manufactured by Surgical Sealants inc., is currently conducting a clinica! trial for lung sealing indications.
  • Thorex is a two-part sealant that has a set curing time after the two parts are mixed.
  • Exemplary devices and methods for delivering a chemical(s) or agent(s) in a localized manner for ensuring a proper air-tight seal of the above-described apparatus is described below.
  • the chemical(s), agent(s) and/or compound(s) are used to create a pieurodesis between the parietal and visceral pleura so that a component of the apparatus may penetrate through the particular area and not result in a pneumothorax.
  • the chemicai(s), agent(s) and/or compo ⁇ nd(s) include talc, tetracycline, doxycyciine, bleomycin and minocycline.
  • a modified drug delivery catheter may be utilized to deliver chernical(s), agent(s) and/or cornpound(s) to a localized area for creating a pleurodesis in that area, in this exemplary embodiment, the pleur ⁇ desis is formed and then the conduit 704, as illustrated in FIG, 7, is positioned in the lung 708 through the area of the pleurodesis.
  • the drug delivery catheter provides a minimally invasive means for creating a localized ple ⁇ rodesis. Referring to FiG. 8, there is illustrated an exemplary embodiment of a drug delivery catheter that may be utilized for this purpose. Any number of drug delivery catheters may be utilized, in addition, the distal tip of the catheter may comprise any suitable size, shape or configuration thereby enabling the formation of a pieurodesis having any size, shape or configuration.
  • the catheter 800 is inserted into the patient such that the distal end 802 is positioned in the pleural space 804 between the thoracic wall 808 and the lung 808.
  • the distal end 802 of the catheter 800 comprises a substantially circular shape that would allow the chemicai(s), agent(s) and/or compound(s) to be released towards the inner diameter of the substantially circular shape as indicated by arrows 810.
  • the distal end 802 of the catheter 800 comprising a plurality of holes or openings 812 through which the chemicai(s), agent(s) and/or compound(s) are released.
  • the distal md 802 may comprise any suitable size, shape or configuration.
  • the catheter 800 may be removed to allow for implantation of the conduit 704 (FiG. 7). Alternately, the catheter 800 may be utilized to facilitate delivery of the conduit 704.
  • the distal end or tip 802 of the catheter 800 should preferably maintain its desired size, shape and/or configuration once deployed in the pleural space. This may be accomplished in a number of ways.
  • the material forming the distal end 802 of the catheter 800 may be selected such that it has a certain degree of flexibility for insertion of the catheter 800 and a certain degree of shape memory such that it resumes its original or programmed shape once deployed. Any number of biocompatible polymers with these properties may be utilized, in an alternate embodiment, another material may be utilized.
  • a metallic material having shape memory characteristics may be integrated into the disiai en ⁇ 802 of the catheter 800. This metallic material may inciude Mitino!
  • the metailic material may be radiopaque or comprise radiopaque markers.
  • the catheter 800 may be viewed under x-ray fluoroscopy and aid in determining when the catheter 800 is at the location of the highest collateral ventilation.
  • a local drug delivery device may be utilized to deliver the pleurodesis chemicaS(s), agent(s) and/or compound(s), In this exemplary embodiment, the pleurodesis is formed and then the conduit 704 : as illustrated in FIG.
  • chemicai(s), agent(s) and/or compound(s) may be affixed to an implantable medical device.
  • the medical device is then implanted in the pleura! cavity at a part ⁇ cuiar site and the chemical(s), agent(s) and/or compound(s) are released therefrom to form or create the pleurodesis.
  • Any of the above-described chemical(s ⁇ , agent(s) and/or compound(s) may be affixed to the medical device.
  • the chemica!(s), agent(s) and/or compound(s) may be affixed to the medical device in any suitable manner.
  • the chemicals), agent(s) and/or compound(s) may be coated on the device utilizing any number of well known techniques including, spin coating, spraying or dipping, they may be incorporated into a polymeric matrix that is affixed to the surface of the medicai device, they may be impregnated into the outer surface of the medical device, they may be incorporated into holes or chambers in the medical device, they may be coated onto the surface of the medical device and then coated with a polymeric layer that acts as a diffusion barrier for controlled release of the chemica! ⁇ s), agent(s) and/or compound(s), they may be incorporated directly into the materia! forming the medical device, or any combination of the above-described techniques.
  • the medicai device may be formed from a biodegradable materia! which eiutes the chemical(s), agent ⁇ s) and/or compound(s) as the device degrades.
  • the implantable medica! device may comprise any suitable size, shape and/or configuration, and may be formed using any suitable biocompatible material.
  • FIG. 9 illustrates one exemplary embodiment of an implantable medical device 900.
  • the implantable medica! device 900 comprises a substantialiy cy ⁇ ndricai disk 900.
  • the disk 900 is positioned in the pleura! space 902 between the thoracic wall 904 and the lung 906.
  • the disk 900 elutes or otherwise releases the chemicaS(s), agent(s) and/or compound(s) that form the pleur ⁇ desis.
  • the release rate may be precisely controlled by using any of the various techniques described above, for example, a polymeric diffusion barrier.
  • the disk 900 may be formed from a biodegradable material that eiutes the chernical(s), agent(s) and/or compound ⁇ s) as the disk 900 itself disintegrates or dissolves.
  • a non-biodegradable disk 900 may or may not require removal from the pleura! cavity 902 once the pleurodesis is formed.
  • it may be desirable that the disk 900 is a permanent implant that becomes integral with the pleurodesis
  • the disk 900 may comprise a radiopaque marker or be formed from a radiopaque material.
  • the radiopaque marker or material allows the disk 900 to be seen under fluoroscopy and then positioned accurately.
  • the fluid characteristics of the chemicai(s), agent(s) and/or compound(s) may be altered.
  • the chem ⁇ cal ⁇ s), agent(s) and/or compound(s) may be made more viscous. With a more viscous chemical agent and/or compound, there would be less chance of the chemical, agent and/or compound moving from the desired location in the pleural space.
  • the chemical(s), agent(s) and/or compound(s) may also comprise radiopaque constituents Making the chemical(s), agent(s) and/or compounds radiopaque would allow the confirmation of the location of the chemicaS(s), agent(s) and/or compound(s) with regard to the optimal location of collateral ventilation.
  • the chemical(s), agent(s) and/or compound(s) as modified above may be utilized in conjunction with standard chemical pleurodesis devices and processes or in conjunction with the exemplary embodiments set forth above.
  • an implantable structure in combination with a chemical agent and/or a therapeutic agent may be utilized to create a localized area where the visceral and parietal pleura of the lung are fused together, in this exemplary embodiment, a localized pleurodesis may be created utilizing either or both a mechanical component and a chemical component.
  • the purpose of the chemical component is to provide an acute adhesion between the parietal and viscera! pleura, while the mechanica! component is utilized to provide a chronic adhesion.
  • the acute adhesion provided by the chemical adhesive would provide enough stability at the implant location on the lung to allow for the mechanical component to create a chronic adhesion.
  • the combination of a chemical adhesive with a tissue growth promoting materia! in a specific area of the lung would promote a weli-c ⁇ ntro ⁇ eel localized pleurodesis reaction.
  • FIG. 1 OA, 10B and 10C illustrate a first exemplary mechanical device 1000 for providing a chronic adhesion.
  • FIG, 1 OA shows a close up view of the sectional view of mechanical device 1000 shown in FlG. 10B.
  • FIG. 10C shows a cutaway view of the mechanical device 1000 shown in FIG 10B on the surface of lung 1022
  • the mechanical device 1000 comprises a mesh 1002 that may be formed out of any suitable biocompatible material.
  • the mesh 1002 may comprise a metallic material, a polymeric materia! and/or a ceramic material. Primary variations of this materia! may be bi ⁇ -res ⁇ rbable or n ⁇ n-resorbable materials that promote tissue growth.
  • the mesh 1002 may be inserted between the parieta! 1005 and viscera! 1007 p!eura at the desired location by any suitable means as set forth below.
  • the mesh 1002 may be simply positioned or secured in place by any number of suitable means.
  • the mechanical device is secured in such a manner than ensures the apposition of the device to either and/or both the visceral pleura 1007 and parieta! pleura 1005.
  • this may be accomplished by a percutaneous application of a chemical adhesive 1010 after the lung is inflated to allow for a chemical agent to form an acute adhesion between the viscera! pleura 1007 and parieta! pleura 1005.
  • the chemical adhesive 1010 may include fibrin backed adhesive, cyanoacrylate bond adhesive or aldehyde bond adhesive.
  • a suture 1004 may be threaded into the device and pulled along with the visceral pleura 1007 against the parietal pleura 1005 of the thoracic wall 1020. Radiological markers may be incorporated into the device 1000 thereby increasing its radiopacity under fluoroscopy.
  • markers may be incorporated into the device 1000 in any number of suiiabie ways.
  • a wire ring 1006 may be woven into the spot of the tissue growth promoting materia! of the mesh.
  • radiological fibers 1008 may be incorporated into the tissue promoting fibers of the mesh 1002.
  • a radiological chemica! adhesive may be utilized as shown in FiG 10G.
  • the delivery of the device 1000 may be approached utilizing any number of acceptable procedures.
  • a thoracotomy procedure to open the thoracic cavity may be performed, and the device 1000 placed directly in the location.
  • a minimally invasive approach using a cannula or such like device may be utilized to percutaneousiy access the thoracic cavity.
  • the device 1000 could then be entirely delivered via a delivery system through the cannula or sheath.
  • the visceral pleura must be properly attached to the conduit in order to properly seal around the conduit.
  • a technique that may be utilized is to gather and attach the visceral pleura around the conduit using a purse-string suture or similar technique. This technique, however, requires the handling of the pleura in order to provide a counterforce on the pleura as the conduit is being positioned in the lung. In addition, what makes this technique more difficult is as soon as an access is made through the pleura for the conduit, the lung will immediately leak air and collapse to a smaller size. Therefore, providing a counierforce to insert a conduit or other device described herein through the access in the lung becomes even more vital.
  • the visceral pieura of the lung are thin and somewhat fragile. Manipulation of the pieura using surgical instruments such as forceps or hemostats may create a break in the pieura. It is often difficult to seal the leak that wil! foilow and the leak wil! typicaily result in a pneumothorax or a collapsed iung. In an emphysematous lung where the patient is already compromised with the inability to breath, a pneumothorax may potentially lead to serious complications, including death.
  • the present application describes a device that would provide the ability to insert a conduit or other device in the lung with a significantly decreased chance of injuring the Sung if conventional surgical tools are utilized. Essentially, if a device could stabilize the visceral pleura and provide the counterforce without damaging the pleura, the procedure of inserting the device in the iung could become easier, faster and less conducive to injuring the pleura.
  • a vacuum assist device 1102 may be utilized to hold the pleura while a conduit or other device is being positioned in the lung.
  • 11A 1 there is illustrated an inflated lung 1100A and a deflated lung 1100B and an access point 1100C. Illustrated in FIG. 11B is a vacuum assist device 1102 which comprises a substantially disc-like structure or removable holding device 1104 illustrated in FIGS. 12A.12B 1 12C and 12D, that exerts a vacuum force 1200 on the visceral pleura 1101 in contact therewith and an insertion envelope 1106 through which a conduit or other device may be inserted.
  • any shape device may be utilized, for ease of explanation a substantially disc like structure is illustrated.
  • the disc-like structure 1104 preferably has one substantially flat surface 1202 that makes contact with the viscera! pieura 1101.
  • This flat surface has one or more openings through which a vacuum force that is created by an external source (not illustrated) is transmitted to the viscera! pieura.
  • This gentle vacuum force in the range from about 10mm Hg to about 450mm Hg is preferably evenly distributed over the substantially flat surface and gently pulis the viscera! pleura 1101 into contact with the substantialiy flat surface 1202.
  • the disc like structure 1104 comprises a slit like opening 1108 that forms the envelope 1106. in an alternate exemplary embodiment, illustrated m FIG.
  • the disc like structure 1104 comprises a two piece structure that when connected together forms the envelope 1106,
  • the disc like structure 1104 may be formed from any suitable biocompatible materia! that will not damage the visceral pleura and is easily removed from the pleura! space when the vacuum is cut off.
  • the vacuum assist device 1102 Once the vacuum assist device 1102 is inserted and placed into contact with the viscera! pleura 1101 the vacuum is started and draws and holds the viscera! pleura 1101 in place while the conduit 1204 or other device is inserted through the envelope 1106.
  • the vacuum assist device 1102 maintains the counter-pressure for insertion and sealing without damaging the lung tissue. When the seal is created, the vacuum is cut off and the device 1102 is removed.
  • the vacuum pressure or negative pressure may be created in a variety of ways. For example, surgical sites are typically equipped with vacuum devices that may be regulated to draw a negative pressure in the desired range. A simple pressure regulator or vacuum regulator may be connected between two vacuum sources and the device 1102 by any suitable means.
  • the device 1102 may comprise a vacuum pump and regulator.
  • the vacuum pump may use hospital power or be a self-contained battery power unit.
  • the device As described above, once a device such as a conduit 1204 is inserted into the lung, the device must be sealed to the lung tissue. Also as described above is the purse-string suture that may be utilized to gather and attach the visceral pleura 1101 around the conduit 1204 or other device to create the seal. While this technique and other similar techniques may be utilized to create a seal, when the suture is pushed through the visceral pleura 1101 and around the conduit 1204, ⁇ will inevitably leave small ho!es or tears through the pleura which may eventually lead to teaks. Accordingly, it would be advantageous to sea! the viscera! pleura 1101 around the conduit 1204 without having to make any holes or tears through or in the viscera! pleura 1101.
  • FIGS. 13A and 13B 1 there is illustrated an exemplary viscera! pleura! ring connector 1300.
  • the viscera! pieural ring connector 1300 is simply placed around the gathered pleura 1302 which is gathered around the conduit 1304. Any suitable biocompatible material may be utilized in constructing the viscera! pleura! ring connector 1300.
  • pleural ring connector 1300 may be constructed from any number of suitable materials, including supereiastic materials such as nickei titanium a ⁇ oys and bioa ⁇ sorbabte materials such as polyglycolic acid. If a supereiastic material, such as a nickel titanium alloy, is utilized, the materia! may be programmed to be delivered at a first expanded diameter and, when released from a delivery device, allowed to contract to a second smaller diameter that snuggly holds the gathered viscera! pleura 1302 to the conduit 1304. it is important that the ring 1300 not fit too tight so as to avoid potential damage to the viscera! pleura 1302.
  • the ring 1300 may be delivered in its contracted form, expanded and positioned over the gathered viscera! pieura 1302 and then allowed to contract to its programmed size
  • various means may be incorporated into the ring structure 1300 for delivery and securing.
  • the ring 1300 may comprise a split ring design wherein the ring 1300 may be opened like a chain link, placed around the gathered viscera! pleura and then manually closed to create a snug fit.
  • various serf-iocking structures may be incorporated into the ring structure 1300.
  • a ratchet mechanism may be utilized to tighten the ring 1300 around the gathered viscera! pleura 1302. It is important to note that any type of locking or tightening mechanisms may be utilized.
  • one or more agents may be affixed to the ring 1300. The one or more agents may be directly affixed to the surface of the ring 1300, incorporated into a polymeric vehicle and then affixed to the surface of the ring 1300, incorporated into channels or holes in the ring 1300 or incorporated into the bulk material forming the ring 1300.
  • the one or more agents may include chemicals to promote the pleurodesis reaction between the parietal pleura (inner thoracic wali) and the visceral pleura (lung).
  • the pieurodesis is a key component to the chronic success of the procedure.
  • the pleurodesis reaction will allow for the anastomosis to chronically exist without the danger of pneumothorax.
  • a pulmonary viscera! pleura anastomosis reinforcement device may be utiiized to create a strong and asr light seal around a conduit of other device positioned in the iung through a non-native airway. As described above, when a suture is passed through the viscera!
  • the advantage of the purse-string suture is the ability for the conduit or other device to be removed from the anastomosis even after the suture has been secured.
  • the pulmonary viscera! pleura anastomosis reinforcement device may be positioned around the conduit or other device prior to making the purse-string suture thereby reducing the likeiihood of a suture hole or tear leading to leaks and potentially a pneumothorax.
  • FIG. 14 there is illustrated an exemplary pulmonary viscera! pleura anastomosis device 1400.
  • the pulmonary visceral pleura anastomosis reinforcement device 1400 fits around the conduit 1402 or other medical device.
  • the visceral pleura 1404 and the pleura anastomosis reinforcement device 1400 are gathered and sutured or secured with the ring described above.
  • the reinforcement device 1400 may comprise any suitable shape or configuration that lends itself to the process described herein.
  • the pulmonary visceral pieura anastomosis reinforcement device 1400 may be a removable device or a permanent implant.
  • the reinforcement device 1400 may be sutured in place : stapled into piace : affixed in place with a tissue adhesive or any other suitable means.
  • the reinforcement device may be combined with a tissue growth factor to promote endotheliaiization.
  • the pulmonary visceral pleura anastomosis reinforcement device 1400 may be fabricated from any number of biocompatible materials, including metals , metai alioys and polymers.
  • the material may be biodegradable, for example, polyglycoiic acid or non-biodegradable, for example Teflon®, in addition, the material may comprise ansmal tissue.
  • the material is formed into a structure for the acute reinforcement around a bypass anastomosis to prevent any leakage.
  • One or more agents may be affixed to the reinforcement device 1400.
  • the one or more agents may be directly affixed to the surface of the reinforcement device 1400, incorporated into a polymeric vehicle and then affixed to the surface of the reinforcement device 1400 : incorporated into channels or holes in the reinforcement device 1400.
  • the one or more agents may include chemicals to promote the pleurodesis reaction between the parietal pleura (inner thoracic wall) and the viscera! pleura (lung).
  • the pleurodesis is a key component to the chronic success of the procedure.
  • the pleurodesis reaction will aliow for the anastomosis to chronically exist without the danger of pneumothorax.
  • the above-described devices are utilized to treat the symptoms of chronic obstructive pulmonary disease by applying the theory of collateral ventilation.
  • the devices would provide trapped air in the iung to escape through an alternate pathway- through the pleura of the lung, in order for these devices to be effective, the conduits should preferably remain patent throughout the lifetime of the implant. Because the body reacts to implants by building tissue barriers around the device, the patency of the implant may come into question. Accordingly, this application discloses a device that allows ail previously described devices to remain patent once implanted into the lung parenchyma.
  • Tissue growth at the tip of the conduit or other device is hindered or inhibited mechanically or chemically. By doing this, one could ensure that the lumen of the impiant remains patent thereby allowing air from the lung to move freely through the device.
  • Exemplary mechanical embodiments include features attached to or part of the implanted device or independent devices used as accompaniments to the implant, for example, introduced periodically utilizing interventional techniques.
  • a serrated tip 1502 may be formed at or attached to the conduit or implant 1504.
  • FlG. 15 shows conduit or implant 1504 passing through thoracic wall 1500 between two ribs 1501 into parenchymal tissue 1506.
  • the serrated tip 1502 could hinder the growth of tissue by constantly creating new injury due to implant device 1504 movement relative to the surrounding lung parenchyma! tissue 1506.
  • trocar 1602 may be inserted through the lumen of the implant 1604 to inhibit tissue growth at the tip of the implant 1604.
  • trocar 1602 is a sharp pointed or sharp tipped surgical instrument used with a cannula to puncture a body cavity. In this case, however, the trocar is adopted to create an opening in tissue ingrowth.
  • a modified balloon catheter 1702 as illustrated in FiG. 17, may be utilized within the Surnen of the impiant 1704.
  • the balloon 1706 may be repeatedly inflated and deflated just beyond the tip of the impiant to inhibit tissue growth.
  • Each of these independent devices may be used periodically on a consistent basis for as long as the implant remains in the body.
  • Tissue growth hindrance or inhibition may also be achieved through the application of certain drugs.
  • the implanted device 1802 may be coated at or near the tip with a drug or agent 1804 that inhibits ceil growth.
  • the drug or agent 1804 may be affixed to the implant 1802, incorporated directly into the implant 1802 or incorporated into a polymeric matrix and then affixed to the implant 1802, Alternatively, a cuff or other similar device may be utilized to incorporate the drug or agent.
  • the drug or agent 1804 should be configured for sustained release over a given time period.
  • the drug delivery vehicle may be configured to be refilled periodically through any number of known means, for example, via an injection catheter.
  • a drug or agent may be injected iocaily through the Surnen of the device as illustrated in FlG. 19.
  • a device such as an injection catheter 1906 or infusion balloon may be guided through the lumen of the implant 1902 and deliver the agent or drug 1904 directly to the site.
  • agents or drugs may be utilized, for example, a rapaymcin or elastic may be utilized.
  • shunts for hydrocephalus dialysis grafts, colostomy bag attachment devices, ear drainage tubes, ieads for pace makers and implantable defibrillators can also benefit from the device-drug combination approach.
  • Devices which serve to improve the structure and function of tissue or organ may also show benefits when combined with the appropriate agent or agents. For example, improved osteo-integration of orthopedic devices to enhance stabilization of the impianted device could potentially be achieved by combining it with agents such as bone-morphogenic protein.
  • Perivascular wraps may be particularly advantageous, aione or in combination with other medical devices.
  • the perivascular wraps may supply additional drugs to a treatment site.
  • any type of medical device may be coated in some fashion with a drug or drug combination which enhances treatment over use of the singular use of the device or pharmaceutical agent.
  • the coatings on these devices may be used to deliver therapeutic and pharmaceutical agents including; anti- proiiferative/anti-mitotic agents including naturai products such as vinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine), pacSitaxel, epidipodophyllotoxins (i.e.
  • antibiotics dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin
  • anthracyclines mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin
  • enzymes L-asparaginase which systemicaily metabolizes L ⁇ asparagine and deprives cells which do not have the capacity to synthesize their own asparagine
  • antiplatelet agents such as G(GP) lib/Ilia inhibitors and vitronectin receptor antagonists
  • anti-pro ⁇ ferative/antimit ⁇ tic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methySmelamines (h ⁇ xamethylmelamine and thiotepa), alky I sulfonates-
  • anti-coagulants heparin, synthetic heparin salts and other inhibitors of thrombin
  • fibrinolytic agents such as tissue plasminogen activator, streptokinase and urokinase
  • aspirin dipyridamole
  • ticlopidine adrenocortical steroids
  • cortisone adrenocortical steroids
  • fludrocortisone prednisone, prednisolone, ⁇ methylprednisolone, triamcinolone, betamethasone, and dexamethasone
  • nonsteroidal agents salicylic acid derivatives i.e. aspirin; para-am inophenol derivatives i.e. acetaminophen; indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroary!
  • acetic acids tolmeti ⁇ diclofenac, and ketorolac
  • arylpropionic acids ibuprofen and derivatives
  • anthranilic acids mefenamic acid, and meclofenamic acid
  • enolic acids piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone
  • nabumetone gold compounds (auranofin, aurothioglucose, gold sodium thiomaiate); immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; antisense oligonucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, and growth factor receptor signal transduction kinas
  • variable parietai/visceral pleura! couplings may be utilized for the placement of conduits or other implantable devices into the lung through non-native airways without the need for the creation of a pleurodesis or iocalized pleurodesis.
  • variable parietal/viscera! pleural coupling would allow independent motion of the visceral and parietal pleura without compromising pressures in the thoracic cavity.
  • FIG. 2O 1 there is illustrated a first exemplary embodiment of a variable parietal/viscera! pleura coupling.
  • the device comprises a rolling membrane coupling 2002
  • the rolling membrane coupling 2002 comprises a toroidal shape and is positioned in the pleura! cavity 2004 and affixed to both the visceral pleura 2006 and the parietal pleura 2008.
  • the rolling membrane coupling 2002 may be attached to both the viscera! pleura 2006 an ⁇ the parietal pleura 2008 by any suitable means, including sutures and adhesives.
  • the toroidal shape allows for flexible movement between the two pleurae.
  • a conduit or other device as described herein may be implanted.
  • FIG. 21 illustrates a second exemplary embodiment of a variable parietal/viscera! pleura coupling.
  • a magnetic coupling device 2102 is utilized to create the seal.
  • one magnet 2104 is attached to the parietal pleura 2108 and a second magnet 2106 is attached to the visceral pleura 2110
  • the magnets 2104 and 2106 may comprise any suitable size and shape defining an opening 2112 for the placement of the conduit or other medical device.
  • the magnets 2104 and 2106 may comprise any suitable magnetic material that is biocompatible.
  • the magnets 2104 and 2106 may be attached to the pleura 2108, 2110 utilizing any suitable techniques such as adhesives. A sea! is maintained using the magnets 2104 and 2106 to maintain surface contact during independent movement of the coupling 2102 and pleura 2108, 2110.
  • At least one magnet 2106 may comprise a lip or ledge 2114 to prevent the magnets from 2104, 2106 sliding too far and moving out of alignment. As illustrated, the opening 2107 in the magnet 2106 attached to the visceral pleura 2110 is larger than the other opening 2105 to account for relative movement.
  • FfG. 22 illustrates a third exemplary embodiment of a variable parietal/viscera! pleura coupling, in this exemplary embodiment a compression seal coupling 2202 is utilized to maintain the sea!.
  • a first coupling component 2204 is attached to the parietal pieura 2206 using any suitable means and a second coupling component 2208 is attached to the viscera! pleura 2210 using any suitable means.
  • a seal 2212 such as an o-ring may be incorporated to ensure the integrity of the sea! between the first and second components 2204, 2208.
  • FiG, 23 ⁇ lustrates a fourth exemplary embodiment of a variable parietai/viscerai pleura coupling, fn this exemplary embodiment a tube coupling 2302 is utilized to create the seal.
  • One m ⁇ 2304 of the tube 2302 is attached to the viscera! pleura 2306 of the !ung white the other end 2308 of the tube 2302 is attached to the skin 2310 of the patient.
  • a conduit is passed through the patient ' s skin, between the patient ' s ribs and into the patient's lung or lungs.
  • conduit or other implantable device Positioning of a conduit or other implantable device between the ribs or the intercostal space may potentially lead to discomfort. Specifically, in a patient that is mobile or becomes mobile because of the devices described herein, certain movements by the patient may cause the patient a certain degree of discomfort because of the relative movement of the ribs. Accordingly, in order to eliminate the potential discomfort, the conduit or other implantable medical device may be positioned through a rib or a bridge between the ribs that restricts relative movement there between. While exemplary embodiments will be described with respect to conduits, it is important to note that the bridging device may be utilized with any implantable medical device that is to be positioned in the lung from a location accessible through the ribs,
  • FIG. 24 illustrates the placement or positioning of a conduit 2402 through a hole 2404 in a rib 2406
  • a bridge with an opening may be affixed to two ribs.
  • the bridge element 2502 may be surgically positioned or depending upon the type of bridging element, endoscopicaliy positioned and attached.
  • the bridge element 2052 comprises a hole or opening 2506 through which a conduit 2402 may be affixed.
  • the bridge element 2502 may comprise any suitable configuration and may be formed from any number of biocompatible materials, including melais. metal alloys, polymers and ceramics.
  • a bridging element configured for attachment between one or more adjacent ribs in a patient may have one or more fittings operativeiy associated with the bridging element.
  • the one or more fittings may be configured to receive and secure devices connected to a lung of a patient.
  • the bridging element includes a hoie or other fitting to secure the device positioned in the Sung.
  • a bridging element may be configured for holding and securing a conduit or other medicai device implanted in a patient's Sung.
  • the bridging element may be utilized to hoid an ⁇ secure a device passing between the ribs of a patient and into their lung.
  • the bridging element spans the intercostal space through which the devices described herein pass. Accordingly, the bridging eiement alleviates some of the potential discomfort associated with the chronic pSacement of a device in the intercostal space.
  • the bridge element 2502 is preferably constructed so as to minimize movement around the conduit 2402 and to secure the conduit 2402 into position without unduly restricting movement of the ribs. It is important that the ribs and ⁇ b cage remain flexible for ease of breathing.
  • the bridge element 2502 may aiso be formed from a flexible material or be constructed to allow for partial movement. Micro-motion is important so as not to create localized loads on the ribs that are too high or too Sow because stress has a definite physiological effect on bone.
  • bones are dynamic elements and they respond to loading or stress.
  • the stress on that bone has to be maintained within a Sower and upper limit. If the stress on a bone is too low, osteopenia results. If the stress on a bone is too high, osteopenia results. Accordingly, any design would preferably account for loading conditions and maintain the stress on the ribs within the healthy window or range.
  • the bridge element 2502 may be affixed to the ribs 2504 utilizing any number of suitable devices.
  • the bridge eiement 2502 may be glued or cemented to the ribs 2504 utilizing any suitable biocompatible adhesive.
  • the bridge element 2502 may be pinned or attached to the ribs 2504 utilizing surgical screws.
  • the bridge element 2502 may be permanently affixed to or temporarily affixed to the ribs.
  • the bridge element 2502 may be clamped between the ribs 2504 or may comprise the clamp itself.
  • the ribs 2504 may be joined utilizing a biological material.
  • a bone cement may be utilized to fill the space between adjacent ribs.
  • the bone cement may be utilized with other materials to insure that the ribs are not loaded so that osteopenia occurs. Bone cements and artificial tissues are known in the art.
  • the bridge element may be clamped between the ribs or may comprise the clamp itself.
  • two plates 2602 and 2604 may be positioned on either side of the ribs 2606 and secured via a mechanism that causes them to come together, for example, a threaded device

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Abstract

La présente invention concerne un stabilisateur de la plèvre viscérale permettant de maintenir la plèvre viscérale lors d'interventions chirurgicales d'accès au poumon d'un patient directement via la paroi de la cage thoracique. Le stabilisateur permet l'ouverture du poumon tandis qu'un autre dispositif est introduit et fixé au poumon. Une pleurodèse localisée peut être créée au moyen d'un composé chimique pour produire une adhérence aiguë et un composant mécanique pour produire une adhérence chronique. Une fois le dispositif introduit dans le poumon, un dispositif de renfort d'anastomose de la plèvre peut être positionné adjacent au dispositif pour assurer un renfort structurel et empêcher l'endommagement de la plèvre. Un raccord d'anneau de plèvre viscérale peut également être positionné autour de la plèvre et le dispositif pour recevoir et fixer le dispositif. Un dispositif mécanique ou un procédé chimique assure la libre circulation de l'air via le dispositif implanté. Les dispositifs médicaux et les interventions fournissent des traitements pour la bronchopeumathie chronique obstructive et l'emphysème.
PCT/US2008/062680 2007-05-11 2008-05-05 Dispositifs médicaux et procédures permettant l'évaluation d'un poumon et le traitement de la bronchopeumathie chronique obstructive Ceased WO2008140989A2 (fr)

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US60/999,759 2007-05-11
US60/999,758 2007-05-11
US93806307P 2007-05-15 2007-05-15
US92149107P 2007-05-15 2007-05-15
US60/921,491 2007-05-15
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