CA2470023A1 - Intra-thoracic collateral ventilation bypass system - Google Patents

Abstract

A long term oxygen therapy system having an oxygen supply directly linked with a patient's lung or lungs may be utilized to more efficiently treat hypoxia caused by chronic obstructive pulmonary disease such as emphysema and chronic bronchitis. The system includes an oxygen source, one or more valves and fluid carrying conduits. The fluid carrying conduits link the oxygen source to diseased sites within the patient's lungs. A collateral ventilation bypass trap system directly linked with a patient's lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating another aspect of chronic obstructive pulmonary disease. The system includes a trap, a fitter/one-way valve and an air carrying conduit. In various embodiments, the system may be intrathoracic, extrathoracic or a combination thereof. A pulmonary decompression device may also be utilized to remove trapped air in the lung or lungs, thereby reducing the volume of diseased lung tissue. A lung reduction device may passively decompress the lung or lungs.
In order for the system to be effective, an airtight seal between the parietal and visceral pleurae is required. Chemical pleurodesis is utilized for creating the seal.

Description

INTRA~THOACIC C LLATEAL ~IENTILAT10N YpASS SYSTEIUi CROSS REFERENCE TO RELATED APPLICATIONS
T his application claims the benefit of Provisional Application Number 60/x.75,990 filed June 5, 2~3.
Background of the Invention 1. Field of the Invention The present invention relates to systems and methods for removing trapped air in emphysematous lungs, and more particularly, to systems arid methods for removing trapped air in emphysematous hyperinflated lungs by bypassing rson-patent airways via a conduit through tl7e outer pleural layer of the lung to a containment/trap device. The present invention also relates to a collateral vewtilation bypass system that utilizes the trachea for expelling 2~ trapped air rather than a containment/trap device. The present invention also relates to a device and methodology to assist in pulmonary decompression and non-surgical/resection lung volume reduction. The present invention also relates to systems and met~°ods for chemical pleurodesis.
2. Discussion of the Related Art As a result of studies that date back to the ~ 9~~'s and particularly studies conducted in the 19~a(3's and early 1370's, it has been determined that tong-term continuous oxygeF~ therapy is beneficial in tl ~e treatment of hypoxemic patients with chronic obstructive pulmonary disease. tn other words, a patient's life and quality of life carp be unproved lby providing a constant supplemental supply of oxygen to the patient's lungs.

However, with the desire to contain medical costs, thorn is a growing concern that the additional cost of providing continuous oxygen therapy for chronic lung disease will create an excessive increa:>e in the annual cost of oxygen therapy. Thus, it is desirable that oxygen th~;rapy, when provided, be as cost effective as possible.
t~ Various devices and methods have been devised fo;° performing emergency cricothyroidotornies and for providing a trache~torrsy tube so that a patient whose airway is oth~:rwise blocked may continue to breath. Such devices are generally intended only for use with a patient wwho is not breathing spontaneously and are not :~G~itable for the long term t~ eafrr~ent of chronic lung 20 disease. Typically, such devices are installed by pur,nturinc~ the skin to create Other devices which have been found satisfactory fc~r err~ergency or ventilator use are described in E~.S. I~aten~ IVos. 958,822 to I~ogers;
2,8'78,742 3C~ to Shelden; 3,384,087 to rur~nmelkamp; 8,511,243 to T oy; 8,556,108 to Calhoun; 2,991, i 87 to Shelden, et al; 8,688,78 to eiss; 8,81 x,250 to ~lleiss, et al.; and 8,916,903 to F'c~~~i.

Although tracheotorr3y tubes are satisfactory for their intended purpose, they are not intended for chronic usage by outpatients as a rr~eans for delivering supplemental oxygen to spo~taneousfy breathing patients with chronic obstructive pulmon;~ry disease. Such trache~c~tomy tubes are generally designed so as to provide the total air supply to the patient for a relatively short period of titres. The tracheotomy tubes are generally of rigid or semi-rigid construction and of caliber ranging from 2.5 mm outside diameter in infants to mm outside diameter ire adults. They are normally inserted in an operating room as a surgical procedure or during emergency situations, through the 1~ crico-thyroid membrane where the tissue is less vascular and the possibility of bleeding is reduced. These devices are intended to permits passage of air in both directions until normal breathing has been restored by other means.
Another type of tracheotomy tube is disclosed in Jacobs, tJ.S. J'at. Nos.
1:5 3,682,166 and 3,788,326. Tl~e catheter described therein is placed over 14. or 16 gauge needle and inserted through the crico-thyroid membrane for supplying air or oxygen arid vacuum on an emergency basis to restore the breathing of a non-breathing patient. The air or oxygen is supplied at 30 to 1 J~
psi for inflation and deflation of the patient's lungs. TJ~e Jacobs catheter, Jike 2a the other tracheotomy tubes previously used, is not ;suitable for long term outpatient use, and coultt riot easily be adapted to such use.
Due to the limited fulctionaGty of tracheotomy tubes, transtracheaJ
catheters have been propo:5ed arid used for long term supplemental oxygen 2~ therapy. For example the small diameter transtracheal catheter (16 gauge) developed by Dr. Henry J. I-leimlich ddescribed in TF-IF ANNALS OF
OTOLOGY, RHINOLOGY LARYNGOLOGY, November-December 1982;
Respiratory Rehabilitation with Transtracheal Oxygen ;ystem) has been used by the insertion of a relativE9ly large cutting needle (1 ~ gauge} into the trachea 30 at the mid-point between the cricothyroid membrane and the eternal notch.
This catheter size can supply oxygen up to about 3 liters per minute at low pressures, such as 2 psi which may be insufficient for patients who reguire higher flow rates. It does not, however, lend itself to outpatient use and s maintenance, such as periodic removal and cleaning, primarily because the connector between the catheter and the oxygen supply ho:je is adjacent and against the anterior portion of the trachea and cannot be easily seen and manipulated by the patient, f=urthermore, the catheter ise not provided with positive means to protect against kinking or collapsing whicah would prevent its effective use on an outpatient basis. such a feature is not only desirable but necessary for long temp outpatient and home care use. Also, because of its structure, i.e. only one exit opening, the oxygen from the catheter is directed straight down the trachea toward the bifurcation between the bronchi. Because of the normal anatomy of the bronchi wherein the left bronchus is at a more acute angle to the trachea than the right bronchus, more of the oxygen from that catheter tends to be directed into the right bronchus rather than being directed or rr~ixed for mor;: equal utifizatior: by both bronchi. Also, as structured, the oxygen can .strike the carina, resulting in an undesirable tickling sensation and cough. fn addition, in such devices, if a substantial portion of the oxygen is directed against the back wall of the trachea causing erosion of the mucosa in this area which rr~ay cause chapping and bleeding. Overall, because of the limited output from the device, it may not operate to supply sufficient supplemental oxygen when the patient is exercising or otherwirise quite active or has severe disease.
Diseases associated with chronic obstructive pulmonary disease include chronic bronchitis and emphyserr~a. One aspect of an emphysematous lung is that the communicating flow of air between neighboring air sacs is much more ~5 prevalent as compared to healthy lungs. ~Chis phenomenon is known as collateral ventilation. Another aspect of an emphysematous lung is that air cannot be expelled from the native airways due to the loss of tissue elastic recoil and radial support of the airways. ~ssentiaify, 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 completely increases, residual volume in the lungs also increases.

This then causes the lung ~~o establish in a hyperinflated si:ate where an individual can only take short shallow breaths. EsSE=r~tially; air is not effectively expelled and stale air accumulates in the lungs. ance the stale air accumulates in the lungs, the individual is deprived o~ oxygen.
currently, treatments ror chronic obstructive ~'ralrr~or~ary disease include bronchodilating drugs, oxygen therapy as described above, and lung volume reduction surgery. ~ronchodilating drugs only work on a percentage of patients with chronic obstructive pulmonary disease and generally only provides short term relief. t~xygen therap&~ is impractical for the reasons described above, and lung volume reduction surgery is an extremely traumatic procedure that involves removing part of tl-~e lung. The long term benefits of lung volume reduction surgery are no~ fully known.
l~ Accordingly, there exists a need for increasing the expiratory flow from an individual suffering from chronic obstructive pulmonarydisease. In addition, there exists a need for a minimally invasive means for removing trapped air from the lung or lungs that ~~ould allow healthy lung i:issue to better ventilate.
There also exists a need for a minimally invasive means for allowing trapped air from the lung or lungs to escape that would allow healthy lung tissue to better ventilate.
summary of the Invention 2~ The present invention overcomes the disadvantages associated with treating chronic obstructive pulmonary disease, as briefly described above, by utilizing the phenomenon of collateral ventilation to increase the expiratory flow from a diseased lung. The ~~resent invention also provides a means for assisting in or facilitating pulmonary decompression to compress the diseased 3G area or area of the lung or lungs to a smaller volume., The intra-thoracic collateral ventilation bypass system of the present invention removes trapped air in an emphysematous hyperinflated lung by s bypassing non-patent airways via a conduit through the outer pleural layer of the lung to a more proximal airway closer to the trachma.
fn accordance with a first aspect, the present inventi~cn is directed to an .5 intra-thoracic collateral ventilation bypass system. The system comprising at least one conduit having first and second ends, a first sealing device and a second sealing device. The first end of the conduit is. in fluid cornmunicaticn with an airway in proximity to a trachea of a patient a'~d the second end is in fluid communication with the inner volume of a lung o~f a pa~:ient at a 1~ predetermined site. The first sealing device is utilizet3 for' establishing an airtight sea! between the conduit and the proxirr~ate air~ray. The second seating device is utilized for establishing an airtight sE=a! between the conduit and the lury.
15 !n accordance with another aspect, the present invention is directed to a method for decornpresslng a hyperinffated portion of a lung of a patient. The method comprising deterr~ireing a site of hyperinflation in a hatfent's lung, and bypassing non-patent airways utilizing a device in cornrn~anication with a hyperinflated portion of a patient's lung and an airway proximate a patient's 2~ trachea.
s Essentially, stale air accumulates in the lungs, thereby depriving the individual of oxygen. ilarious 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 MRI, ~pc~sitron emission tomograph or PET, andfor standard ~C-ray imaging. t~r~ce tire location or locations of the diseased tissue are located, anastomotic openings are made in the thoracic cavity and lung or lungs and one or more' oxygen carrying conduits are positioned and seated therein. The one or more oxygen carrying conduits are connected to an oxygen source which supplies o;~ygen under elevated tf~ pressure directly to the diseased portion or portions of the lung or lungs. The pressurized oxygen essentially displaces tl~e 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 taxygen therapy. In this configuration, an additional I5 conduit may be connected between the main conduit and the individual's trachea with the appropriate valve arrangement. In this configuration, stale air may be removed through the trachea when the individual exhales since the trachea is directly linked with the diseased site or sites in the lung via the conduits.
2~
The long term oxygen' therapy system of fihe present invention improves oxygen transfer efficiency in the lungs thereby reducing oxygen supply requirements, which in turn reduces the patient's medical costs. The system also allows for improved self-image, improved mobility, greeter exercise 2~ capability and is easily maintained.
The above-described song term oxygen therapy system may be utilized to effectively treat hypoxia caused by chronic obstructive pulmonary disease;
however, other means may Ibe desirable to treat other aspects of the disease.
30 As set forth above, emphysema is distinguished as irreversible damage to lung tissue. The breakdown of lung tissue leads to the reduced ability for the lungs to recoil. The tissue breahdo~rvn also leads to the loss of radial support of the airways. Consequently, the loss of elastic recoil of the lung tissue contributes to the inability for individual s trvith emphysema 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 increases, residua! volume in the lungs also increases. This then causes the lung to establish in a hyperinflated state vvherein an individual can only take short shallow brea.tl-~s.
The collateral ventila~:ion bypass trap system ~sf the present invention utilizes the above-described collateral venfiilation phenorr~er~on to increase the expiratory flow from a diseased lung or lungs, thereby treating another aspect of chronic obstructive pulmonary disease. Essentiallt~, the ~~ost collaterally ventilated area of the Fang or lungs is determined utilizincl tf~e scanning techniques described above. once this area or area:3 are located, a conduit or 1~ conduits are positioned in a passage or pe.ssages theft access the outer pleural layer of the diseased lung o:~~ lungs. The conduit or conduits utilize the collateral ventilation of the lung or lungs and allow th~~ entra.pped air to bypass the native airways and be e;~pelied to a containment :>yster~~ outside of the body.
z~
In an alternate embodiment, the trachea, or other prc'ximal airrrvays, including the bronchus, rnay be utilized for expelling trapped air rather than a containmentitrap device.
The lung reduction d~:voce of the present invention allows trapped air from hyperinflated regions of the lung or iur~gs of a patient to vent to the s external environment through a ono-way valve. The valve prevents air from flowing back into the lung or lungs.
In order for the system to be effective, the corr~ponents of the system are preferably sealed to the lung. Rccordingly, the Icnali.~ed pleurodesis chemical delivery system of the present ir~ver~tion is utilized to create a pleurodesis in the area or areas of the lung that are ra~ost collaterally ventilated.
Various chemicals, agents and/or compounds rnay be delivered via catheter based delivmy systems or via implantabfe medical d~:vices,.
~0 brief ~escrintion of the ~ra~~in s The foregoing anc~ other features arid advantages of the invention wil! be apparent from the following, rryore particular description of preferred 15 embodiments ofi the invention, as illustrated in the accor~ipanying drawings.
Figure 1 is a diagrarrrr~atic representation of a virst exemplary embodiment of the long terrn oxygen Therapy system in accordance with the present invention.
Figure ~ is a diagrar~rr~atic representation of a first exemplary embodiment of a sealing device utilized in con~ur~ctior~ with the long term oxygen therapy system of the present invention.
Figure 3 is a diagrat~matic representation of a second exemplary embodiment of a sealing device utilized in con~unctior~ with the long terra~a oxygen therapy system of tl-~e present invention.
Figure 4. is a diagrarr~rnatic representation of a Third E=xemplary 3~ embodiment of a sealing device utilized in con~uractior~ with the long term oxygen therapy system of the present invention.
s Figure 5 is a diagrarxamatic representation of a. fourth exemplary embodiment of a seating device utilized in canjunction with the Gong term oxygen therapy system of the present invention.
Figure 6 is a diagrammatic representation of a second exemplary embodiment of the tong terra oxygen therapy syster~~ in accordance with the present invention.
Figure 7 is a diagrammatic representation of a first exemplary 1~ embodiment of a collateral ventilation bypass trap system in accordance with the present invention.
Figure is is a diagrammatic representation of a second exemplary embodiment of a collateral ventilation bypass systems in accordance with the 1~ present invention.
Figure 9 is a diagram:m~atic representation of a. third exemplary embodiment of a collateral ~sentilation bypass system in accordance with the present invention.
2C~
Figure 10 is a diagrarr~matic representation of a fourth exemplary embodiment of a collateral ventilation bypass system in accordance with the present inVentiOn.
25 Figure 11 is a diagrammatic representation of an exemplary embodiment of an intra-thoracic collateral ventilation bypass system in accordance with the present invention.
Figure 12 is a diagrammatic representation of an exemplary pulmonary 30 decompression device in accaordance with the present invention.
Figures 13a and 13b are diagrammatic representations of the effects on lung volume in accordance with the present invention.
~o Figures 14a and 14b are diagrammatic representations of the effects on lung volume reduction utilizing the lung reduction system in accordance with the present invention.
Figure 15 is a diagrammatic representation of a first/ exemplary embodiment of a localized pig=urodesis chemical delivery system.
Figure 1~ is a diagrammatic representation of a. second exemplary embodiment of a localized pleurodesis chemical delivery system.
~etailed ~escription of the I~referred Embodiments Air typically eaters the mammalian body througf ~ the nostrils and flows into the nasal cavities. As the air passes through the nostrils and nasal I5 cavities, it is filtered, moistened and raised or lowered to approximately body temperature. The back of the nasal cavities is continuous vwith the pharynx (throat region; therefore, air may reach the pharynx from the nasal cavities or from the mouth. Accordlagly, if equipped, the mammal may breath through its nose or mouth. Generally air from the mouth is not as filtered or temperature regulated as air from the nostrils. The air in the phar~rnx flo~rvs from an opening in the floor of the pharynx arid into the larynx (voice box). The epiglottis automatically closes off the larynx during swallov~ing ;~o that solids andlor liquids enter the esophagus rather than the lower air passageways or airways.
From the larynx, 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, spongy, elastic organs, which are positioned in the thoracic cavity. The lungs are in contact e~ith the walls sat the thoracic cavity. In humans, the right lung comprises three lobes and the left lung 3t) comprises two lobes. Lungs are paired in al! mammals, but the number of lobes or sections of lungs varies from mammal to mammal. hlealthy lungs, as discussed below, have a tremendous surface area for gas/air exchange. both the left and right lung is covered with a pleural membrane. Essentially, the pleural membrane around each lung forms a continuous sac that encloses the lung. A pleural membrane also forms a lini~~g for the thoracic; cavity. 'The space between the pleural membrane forming the lining of the thoracic cavity and the pleural membranes enclosing the lungs is referred to as the pleural cavity. The pleural cavity comprises a film of fluid that serves as a lubricant between the lungs and the chest wall.
!n the lungs, the bronchi branch into a multipliciay of smaller vessels referred to as bronchioles. ~'ypically, there are more than one million bronchioles in each lung. each bronchiole ends in a cluste~~ of extremely srnail 1C~ air sacs referred to as alveoli. ~r~ extremely thin, single layer of epithelia8 cells lining each alveolus wall and an extremely thin, single layer of epithelial cells lining the capillary walls separate the air/gas in the alveolus from the blood.
~xygen molecums in higher concentration, pass by simple diffusion through the two thin layers from the alveoli into the blood in the p~slmor~ary capillaries.
I:~ Simultaneously, carbon dioxide molecules in higher r~oncentration pass by simple diffusion through the two thin layers from the blood in the pulmonary capillaries into the alveoli.
breathing is a mechanical process involving inspiration and expiration.
20 The thoracic cavity is normally a closed system and air caenot enter or leave the lungs except through the trachea. If the chest v~rall is somehow compromised and airlgas enters the pleural cavity, the lungs will typically collapse. Ullhen the volume of the thoracic cavity is increased by the contraction of the diaphragm, the volume of the lungs is also increased. ~s the 25 volume of the lungs increase, 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, external or ambient air flows through the respiratory passageways dese~ribed above and fills the lungs until the pressure eguaiizes. This process is inspiration. i~lhen the 3Q diaphragm is relaxed, the volume of the thoracic cavity decreases, which in turn decreases the volume of the lungs. As the volume of the lungs decrease, the pressure of the air in the lungs rises slightly above the pressure of the air exten~al to the body. accordingly, as a resulf of this slight pressure differential, ~2 the air in the alveoli is expelled through the respiratory pass~~geways until the pressure equalizes. This process is expiration.
Continued insult to the respiratory system may resc,~lt in variods diseases, for example, chronic obstructive pulmonary disease. chronic obstructive pulmonary disease is a persistent obstruction of i:he airways caused by chronic bronchitis and pulmonary emphysema. In the United States atone, approximately fourteen million people suffer from some form of chronic obstructive pulmonary disease and it is in the top ten leadincl causes of death.
chronic bronchitis anc acute bronchitis share certain similar characteristics; however, they are distinct diseases. Soth cf~~ronic and acute bronchitis involve infiamrnation and constriction of the broncf~ia! tubes and the bronchioles; however, acute bronchitis is generally associated with a viral tS andlor bacterial infection and its duration is typically much shorter tha-n chr onic bronchitis. In chronic bronchitis, the bronchial tubes secrete too much mucus as part of the body's defensi~re mechanisms to inhaled foreign substances.
tviucus membranes comprising ciliated cells (hair like structures) line the trachea and bronchi. The ciliated cells or cilia continuously push or sweep the 2~ mucus secreted from the mucus membranes in a direction away from the lungs and into the pharynx, where it is periodically swallowed. 'lehis sweeping action of the cilia functions to keep foreign matter from reaching the lungs. Foreign matter that is not filtered by the nose and larynx, as descr~ibE:d above, becomes trapped in the mucus arid is propelled by the cilia into the pharynx. When too 25 much mucus is secreted, thc~ ciliated cells rnay become darr'aged, leading to a decrease in the efficiency of the cilia to sweep the brc~nchiaf tubes and trachea of the mucus containing the voreign matter. This in turn causes the bronchioles to become constricted and inflamed and the individual becomes short of breath. In addition, the individual will develop a chronic cough as a means of 3~ attempting to clear the airways of excess mucus.
Individuals who suffer from chronic bronchitis rr~ay develop pulmonary emphysema. Pulmonary emphysema is a disease in which the alveoli wails, which are normally fairly rigid structures, are destroyed. The destruction of the alveoli waifs is irreversible. 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 pathofogica) conditions. In pulmonary errjphyser~°~a, thf:
alveoli of the lungs lose their elasticity, ar~ci eventually the walls between adjacent alveoii 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. T he combination of mucus hypersecretion and dynamic airway compression are rr~echanisms of airflow limitation in chronic obstructive pulmonary disease, dynamic airway compression results from the loss of tethering forces exerted on the airway due to the reductiorf i~~ lung tissue elasticity. f~lucus hypersecretion is described above with respect to bronchitis. In other words, the breakdown of lung tissue leads to the reduced ability of the lungs to recoil and the loss of radial support of the airways. ~onsequentler, 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 Kal~errornenori to occur during the expiratory phase of breathing. This collapsing phenomenon also 2~ intensifies the ir~abiiity for individuals to exhale completely. As the inability to exhale completely increases, residual volume in the lungs also increases. This then causes the lung to establish in a hyperinfiated state where an individual can only take short shallow breaths. Essentially, air is not ei~fectively expelled and stale air accumulates in the lungs. Once the stale air accumulates in the lungs, the individual is deprived of oxygen. There is no cure for pulmonary emphysema, only various treatments, including exercise, drug therapy, such as bronchodilating agents, lung volume reduction surgery and Kong term oxygen therapy.
3~ As described above, long term oxygen therapy is widely accepted as the standard treatment for hypoxia caused by chronic obst~~uctive pulmonary disease. Typically, oxygen therapy is prescribed using a nasal cannula. There are disadvantages associated with using the nasal canoula. One disadvantage associated with utilizing nasal cannula is the significant loss of oxygen between the cannula and the nose, uv!~ich in turn equates to more frequent changes in the oxygen source, or higher energy requirements to generate more oxygen.
Another disadvantage associated with utilizing nasal c;a~ir,ula is the fact that the cannuias may cause the nasal passages to become dry, cr~ccked and sore.
Transtracheal oxygen therapy has become a viable alternative to long term oxygere therapy. Trans~tracheal oxygen therapy delivers oxygen directly to the lungs using a catheter that is placed through and down the trachea. due to t0 the direct nature of the oxygen delivery, a number of advantages are achieved.
These advantages include lower oxygen requirements due t:o greater efficiency, increased mobility, greater exercise capability and improved self image.
The long term oxyger~n therapy system and method of the present invention may be utilized to deliver oxygen directly into the lung tissue in order to optimize oxygen transfer efficiency in the lungs. In other words, improved efficiency may be achieved if oxygen were to be delivered directly into the alveolar tissue in the lungs. In emphysema, alveoli wills are destroyed, ~0 thereby causing a decrease in air exchange surface area. As more alveoli walls are destroyed, collateral ventilation resistance is lowered. In other words, pulmonary emphysema causes an increase in collateral verytilation and to a certain extent, chronic bron~:hitis also causes an increase ire collateral ventilation. Essentially, in an emphysematous lung, the e;ornmunicating flow of air between neighboring air sacs (alveoli), known as collate~°al ventilation, is much more prevalent as compared to a normal lung. ~ince~ air cannot be expelled from the native airways due to the loss of tissue elastic recoil and radial support of the airways dynamic collapse during exha.lation), the increase in collateral ventilation does not significantly assist are individual in breathing.
The individual develops dsypnea. 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. l9arious methods may be utilized to determine the diseased tissue locations, for example, computerized axis( tomography or ~~T scans, magnetic resonance imaging or !VlRI, positron emission tomograph or ~E'~, and/or standard ~~-ray imaging.
Once the diseased tissue is located, pressurized oxygen rnay be directly delivered to these diseased areas and more effectively and efficiently forced into the lung tissue for air exchange.
Figure 1 illustrates a first exemplary long term oxygen therapy system 100. The system 100 co~apr~ises an oxygen source 102, are oxygen carrying conduit 104 and a one-way valve 108. The oxygen source 102 may comprise fi0 any suitable device for supp(y(ng filtered oxygen under adjustably regulated pressures and flow rates, inc(ud(ng pressurszed oxygen tanks, liquid oxygen reservoirs, oxygen concentrators and the associated devices for controlling pressure and f iavf rafie e.g. r~;gu(ators. The oxygen carry(ng conduit 10~
may comprise any suitable biocornpatib(e tubing having a high resistance to fi5 damage caused by continuous oxygen exposure. The oxygen carrying conduit i04 comprises tubing having arf inside diameter in the range from about 1/16 inch to about 1I2 inch and acre preferably from about 1/8 inch to about 1/4 inch. The one-way valve 106 may comprise ar~y suitable, in-(ire mechanical valve which a((ovvs oxygen to f(:ow into the lungs 10~ through the 20 oxygen carrying conduit 104, but not from the (ur~gs 108 back into the oxygen source 102. For example, a simple check valve may be uti((zed. As illustrated in Figure 1, the oxygen carrying conduit 104 passes thr~ugr~ the lung 108 at the site determined to have fibs highest degree of collateral ventilation.
25 The exemplary system 100 described above rr~a~ be modified in a number of ways, including tt-~e use of an in-line finer. (n this exemplary embodiment, both oxygen acrd air may f(ov~r through the system. Ire other words, during inhalation, oxygen is delivered to the lungs through the oxygen carrying conduit 104 and dug°ing exhalation, air from tf~e (unc~s flow through the 30 oxygen carrying conduit 10~. T he in-line filter would trap mucus and other contaminants, thereby prev~:nting a blockage in the oxygen source i02. In this exemplary embodiment, no valve 106 would be utilized. The flow of oxygen is into the lungs and the flow of air from the lungs is based on pressure differentials.
In order for the exemplary song term oxygen therapy system 100 to S function, an airtight seal is preferably maintained where the oxygen carrying conduit 104 passes through the thoracic cavity and lung. This seas is maintained in order to sustain the inflation/functionality of the lungs. if the seal is breached, air can enter the cavity and cause the lungs to collapse as described above.
~ method to create this seal comprises forming adt~e;~ions between the visceral pleura of the lung and the inner waif of the thoracic cavity. This may be achieved usir~,g either chemical methods, including irritants such as Doxycyciine and/or Sieomycin, surgical methods, including pleurectomy or IS horoscope Laic pleurodesis, or radiotherapy methods, including radioactive gold or external radiation. Ail of ttlese methods are known in the relevant art for creating pleurodesis. With a seal created at the site for the ventilation bypass, an intervention rnay be safely performed without the clanger of creating a pneumothorax of the lung.
Similarly to ostomy pouches or bags, the oxygen carrying conduit 104 may be sealed to the skin at the site of the ventilation bypass. in one exemplary embodiment, illustrated in figure 2, the oxygen carrying conduit 104 may be sealed to the skin of the thoracic wall utilizing an adhesive. As illustrated, the oxygen carrying conduit 104 comprises a flange 200 having a blocompatible adhesive coating on the skin contacting surfsce. The biocompatible adhesive woc~ld provide a fluid tight seal between the flange and the skin or epidermis of the thoracic wall. in a preferred embodiment, the biocompatible adhesive provides a temporary fluid tigi~t seal such that the oxygen carrying conduit 104 may be disconnected from the ventilation bypass site. This would allow for th~~ site to be cleaned and for the long term oxygen therapy system 100 to undergo periodic maintenance.

Figure 3 illustrates another exemplary embodiment fc~r sealing the oxygen carrying conduit 104 to the skin of the thoracic wall at the site of the ventilation bypass. In this exemplary embodiment, a coupling plate 300 is sealed to the skin at the site of the ventilation bypass by a biocompatible adhesive coating or any other suitable means. the oxygen carrying conduit 104 is then connected to the coupling plate 300 by any suita.bie means, including threaded couplings and locking rings. the exemplary embodiment also allows for cleaning of the site and mai~~tenance of the system 100.
t0 Figure 4 illustrates yet another exemplary embodiment for sealing the oxygen carrying conduit ~ 04 to the skin of the thoracic wail at the site of the ventilation bypass. In this exemplary embodiment, balloon flanges 400 may be utilized to c,reage the seal. 'The balloon flanges 400 may be attached to the oxygen carrying conduit 104 siuch that in the deflated state, the oxygen carrying t5 conduit 104 and one of the balloon flanges passes through the ventilation bypass anastomosis. ~'he balloon flanges 400 are spaced apart a sufficient distance such that the balloon flanges remain on opposite sides of the thoracic wall. l~Ihen inflated, the ballaons expand and form a fluid tight sea! by sandwiching the thoracic wall. ~nce again, this exemplary embodiment allows 20 for easy removal of the oxygen carrying conduit 104.
Figure 5 illustrates yet another exemplary embodiment for sealing the oxygen carrying conduit 104 to the skin of the thoracic wall at the site of the ventilation bypass. In this exemplary embodiment, a single balloon flange 500 25 is utilized in combination inrith a fixed flange 502. 'The balloon flange 500 is connected to the oxygen carr;ring conduit '104 in the same manner as described above. In this exc~rnplary embodiment, the balloon flange 500, when inflated, fom~s the fluid tight seal. 'The fixed flange 50~, which is maintained against the skin of the thoracic wall, provides the structure! support against 30 which the balloon exerts pressure to form the seal.
If an individual has difficulty exhaling and requires additional oxygen, collateral ventilation bypass rr~ay be combined with direct oxygen therapy.

Figure 6 illustrates an exemplary embodiment of a collateral ventilation bypass/direct oxygen therap~~ system 600. The system 600 comprises an oxygen source 602, an oxygen carrying conduit 604 having two branches 606 and 606, and a control valve 610. The oxygen source 602 a.nd oxygen carrying conduit 604 may comprise components similar to the above-described exemplary embodiment illustrated in Figure 1. In this exemplary embodiment, when the individual inhales, the valve 610 is open and oxygE:n flows into the lung 612 and into the bronchial tube 614. In an alternate exemplary embodiment, the branch 606 may be connected to the trachea 616.
Accordingly, during inhalation oxygen flows to the diseased site in the iung or lungs and to other parts of the lung through the normal bronchial passages.
During exhalation, the valve 610 is closed so that no oxygen is delivered and air in the dijcas~:d portion of the lung may flow from the lung 612, through one branch 606 and into the second branch 606 and finally into the bronchial tube l~ 616. In this manner, stale air is removed and oxygen is directly delivered.
Cnce again, as described above, the flo~rv of oxygen a.nd air is regulated by simple pressure differentials.
The connection and sealing of the oxygen carr~~ing conduit 604 and branches 606, 606 to the lung 612 and bronchial tube ~i14 may be made in a manner similar to that described above.
The above-described long term oxygen therapy system may be utilized to effectively treat hypoxia caused by chronic obstructive pulmonary disease;
however, other means may be desirable to treat other aspects of the disease.
As set forth above, emphysema is distinguished as irreversible damage to sung tissue. The breakdown of lung tissue leads to the reduced ability for the lungs to recoil. The tissue breakdown also leads to the loss of radial support of the native airways. Consequently, the loss of elastic recoil of the lung tissue contributes to the inability fo~~ individuals with emphysema to exhale completely. The loss of radial support of the native ai~gays also allows a collapsing phenomenon to occur during the expiratory phase of breathing. 'This collapsing phenomenon alsr3 intensifies the Inability for individuals to exhale completely. ~1s the inability to exhale increases, residual volume in the lungs also increases. This then causes the lung to establish it a hyperinflated state wherein an individual can only take short shallow breaths.
The collateral ventiiati$~r~ bypass trap system of the present invention utilizes the above-described collateral ventilation phenomenon to increase the expiratory flow from a diseased lung or fangs, thereby treating another aspect of chronic obstructive pulmonary disease. Essentially, the rr~ost collaterally ventilated area of the lung or lungs is determined utili~.ing 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 pleural layer of the diseased lung or lungs. 'fhe conduit or conduits utilize the collateral ver~ti9aiion of the lu~7g or lungs and allows the entrapped air to bypass the native airways and be expelled to a containment system outside of the body.
Figure 7 illustrates a first exemplary collateral ventilation bypass trap system 700. The system '~00 comprises a trap 702, an air carrying conduit x'04 and a filter/one-way valve ?06. The air carrying conduit X04 creates a fluid communication between an individual's lung ~0~ and the trap 702 through the filterlone-way valve 706. It i s important to note that aithougt~ a single conduit 704 is illustrated, multiple conduits may be utilized in each lung X08 if it is determined that there is more than one area of high collateral ventilation.
'The trap 702 may cor°x~prise any suitable device for collecting discharge from the individual's lung or 'lungs X06. Essentially, tine trap 702 is simply a containment vessel for temporarily storing discharge from the lungs, for example, raucous and other fluids that may accumulate in the lungs. The trap 702 may comprise any suitable shape and may be formed from any suitable metallic ar non-metallic matE;rials. Preferably, the trap X02 :should be formed from a lightweight, non-corrosive material. in additior°~, the trap '702 should be designed in such a manner as to allow for effective and efficient cleaning. in one exemplary embodiment,. 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 material or comprise an indicator window so that it may be easily determined when the trap ~G2 should be emptied or cleaned. A lightweight trap x'02 increases the patient's mobility.
S
The filterlone-way vahre '~06 may be attached to the trap 702 by s.ny suitable means, including threaded fittings or compres;sior~ type fittings commonly utilized in compressor connections. The filter/one-way valve BOG
serves a number of functionv,. The filter/one-way valve 706 allows the air from t0 the individual's lung or lungs 708 to exit the trap '~02 while maintaining the fluid discharge and solid particulate matter in the trap '7~2. This filter/one-way valve 706 would essentially maintain the pressure in the trap 702 below that of the pressure ir~sici:: ape indi°,~ic~ual's lung or lungs X08 so that the flow of air from the lungs 708 to the trap 702 is c~aaintained in this one direction. The filter portion 15 of the filterlone-way valve '~Ga may be designed to capture particulate matter of a particular size which is suspended in the air, but allc~v~s thE: clean air to pass therethrough and be vented ~:o the ambient environment. Tf de filter portion r~nay also be designed in such a ~~anner as to reduce the moisture content of the exhaled air.
The air carrying conduit 70~ connects the trap 7G2 to the lung or lungs 708 of the patient through the filterlone-way valve ~Of. The air carrying conduit 704 may comprise any suitable biocompatibie tubing having a resistance to the gases contained in air. The air carrying conduit 704 comprises tubing having an inside diameter in the range frorra about ~/~ 6 inch to about 1l2 inch, and more preferably frorrr about ~/8 inch to about 1/.4 inch.
The filterlone-way valve X06 may comprise any suitable valve which allows air to flow from the lung or lung48 a 08 through the air carrr~ing conduit 7G4, but not from the trap 7G2 back to th~~ lungs 7G8. For example, a simple check valve may be utilized. The air carrying conduit 704 may be connected to the filterlone-way valve 706 by arty suitable means. l3referably, a quick release mechanism is utilized so that the trap may be easily removed for maintenance.
2~

As illustrated in Figure 7, the air carrying conduit 704 passes through the lung 708 at the site determined to have the highest degree of collateral ventilation.
(f more than one site is determined, multiple air carrying conduits 704 may be utilized. The connection of multiple air carrying condt,cits 704 to the filter/one-way valve 706 may be accomplished by aray suitable mean;>, including ars octopus device similar to that utilized in scuba diving regulators.
The air carrying conduit 704 is preferably able to v~itp~stand and resist collapsing once in place. Since air will travel through the conduit 704, if the la 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 suiac~ie matermals may be utilized. For example, Nitinol incorporated into the conduit 704 gill give the conduit collapse resistance and collapse 1S recovery properties.
Expandable features at the end of the conduit 734 rnay be used to aid in maintaining contact and sealing the conduit 704 to the lung pleura. Nitinol incorporated into the conduit 704 gill provide the ability to deliver the conduit 20 704 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 mechanical stop for insertion and an ar ea for an adhesiveisealant to loin as described in detail subsequently.
~5 In order for the exemplary collateral ventilation bypass trap system 700 to function, an airtight seal is preferably maintained where the air carrying conduit 704 passes through the thoracic cavity and lungs 708. This seal is maintained in order to sustain the inflation/functionality of the lungs. if the seal is breached, air can enter the cavity and cause the lungs 'to collapse. one :30 exemplary method for creating the seal comprises dorming adhesions between the visceral pleura of the lung and the inner wall of the thoracic cavity.
This may be achieved using eii~her chemical methods, including irritants such as ~oxycycline andlor Sleomycin, surgical methods, ir~cludir~g p9eurectomy or 2~

thorascopic talc pleurodesis, or radiotherapy methods, in chiding radioactive gold or external radiation. All of these methods are known ire the relevant art for creating pleurodesis. In another alternate exemplary embodiment, a sealed joint between the air carrying conduit 704 and the outer pleural layer includes using various glues to rsefp ~,~~ith the adhesionlseafing of the .air carrying conduit 704. currently, Focal Inc. markets a sealant available unde!~ the tradename FocaI/Seal-I~ which is indicated for ise on a hung for sealing perirposes.
FocalISeah-L is activated by light in order to cure the sealant. Another seal available under the tradename Thorex, which is manufactured by Surgical Seahants Inc., is currently conducting a clinical trial for' ring 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 t5 a number of ways. For exar-nple, the procedure may !k~e acc:omplished using an open chest procedure, aterr~otomy or thoracotomy. Alternately, the procedure may be accomplished ising a laproscopic technique, which is less invasive.
Regardless of the procedure itilized, the seal should be established while the lung is at least partially inflated in order to maintain a solid adhesive surface.
2d The opening may then be made after the joint has been adequately created between the conduit component and the lung pleural surface. The opening should be adequate in cross-sectional area in order to provide sufficient decompression of the hyperinflated hung. This opening, as stated above, may be created using a number of different techniques sich as cutting, piercing, 25 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 3a carrying conduit 704 and ill~rstrated in Figures 2 through ~.
In operation, when a~°~ individual exhales, the pressure in the lungs is greater than the pressure in the trap 702. Accordingly, the air in the highly 2s collaterilized areas of the lung will travel through the air carrying conduit 704 to the trap 702. 'This operation wi!! allow the individual to more easily and completely exhale.
Figure 8 illustrates another exemplary collateral ventilation bypass system 800. In this exemplary embodiment, the trachea is utilized to remove trapped air rather than the native airways. As illustrated, a first conduit extends from the patient's trachea 804, or other proxirna! airways, including the bronchus, to a position externs! of the patient's body. ~ second conduit 80E~
is conrgected to the first conduit 802 via a fitting 808 and passes through the thoracic wall 810 and passes through the Sung 812 at the sil:e determined to have the highest degree of collateral ventilation. If more than one site is determined to nave a high: degree of collateral ventilation, rr~ultipie conduits may be utilized. !n operation, when fhe patient exhales, the pressure in the lungs is greater than the pressure in the trachea 804; accordingly, the air in the highly collaterilized areas of the lung will travel through the first and second conduits 802,806 to the trachea 804 and out of the patient°s nose and mouth with the normally exhaled air.
2~ The first and second conduits 802, 806 may com~arise any suitable biacompatibie tubing havincl a resistance to the various gases and other constituents contained in inhaled and exhaied~air. As in previously described embodiments, the first and second conduits 802, 806 comprise tubing having an inside diameter in the range from about 1116 inch to about 1l2 inch, and more preferably from about 1l8 inch to about 1l4 inchs.
The connection of the first conduit 802 to the trachea 804 may comprise any suitable airtight seal. F°or example, a fluid comrr~unicakion between the trachea 804 and the first conduit 802 may be established in a manner identical 3~a to that established for a tracheotomy. !n addition, as stated above, in order for the collateral ventilation bypass system 800 to functlan, are airtight sea! is preferably maintained where the second conduit 80E~ passes through the thoracic wall 810 and into tire lungs 812. An exemplary method for creatiryg 24.

this airtight sea! comprises farming adhesians between the visceral pleura of fhe lung and the parietal pleura. This may be achieved using either chemical methods, including irritants, surgical methods, inciudir~g p(eurectomy or thorascopic talc pieurodesis, or radiotherapy methods, in~:lu.~ing radioactive gold or external radiation.
The creation of the opening in the thoracic wail may be accomplished in a number of ways. For example, the procedure may be accomplished using an open chest procedure, aternotomy or thoracotomy. Aiterr~ately, the procedure may be accomplished using a laproscopic technique, which is less invasive.
Regardless of the procedure utilized, the seal should Ibe established while the lung is at least partially infiatc~d in order fo maintain a solid adhesive surface.
The opening c ~~ay then be made after the point has bean adequately created between the conduit comporsent and the lung pleural surface. The opening should be adequate in cr~ss~-sectional area in order to provide sufficient decompression of the f-iyperinflated lung. This opening, a.s :Mated 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 cryobfative energ~~.
The conduits X02, ~t~~~ may be sealed to the sl~:in at the sites by any known methods, including those described above with respE:ct to Figures 2 through 5. '~'he connection c~f the extrathoracic component, conduit ~0~, may comprise a drug; chemical, agent, or other means for preve,r~ting or substantially reducing the risk of infection.
The fitting X08 connecting the first and second conduits X02, ~a~ may comprise any suitable de~pice for creating an airtight seal. The fitting ~t3~
may comprise any type of tfnreadc:d or non~threaded union, compression fittings similar to compressor type fittings or any other suitable device far establishing an airtight seal and providinc; for quick release between the two ends of the fitting ~0~. This type of design would allow easy access for periodic maintenance of the system 0~, for example, cleaning the conduits 8~2, 80fi.

Since the fitting 808 is external to the body, access to the inner body component of the system 800 would be easier. Essentially, access ofi the system 800 from outside the body woaaid allow for maintenance and diagnosislobservatiorZ of the system 800 without subjecting the patient to additional stress and risk. It would also be less time consuming fior the doctor.
Figure 9 illustrates an alternate exemplary embodiment of the exemplary collateral ventilation bypass system 800 described above. In this exemp~ary embodiment, the system 900 comprises an externally positioned access porft i~ 908. As illustrated, a conduit 902 extends from the patient's trachea 90~, or other proximal airways, including the bronchus, through a suitable passageway internal to the patient's body arid then passes t#~rough the lung 912 at the site determined to 5 eave the highest degree of collatera~ ventilation. As set forth above, if more than one site is determined to have a high degree of collateral ver~tilatior~, multiple conduits :nay be utilised. At the desired location within the body, the access port 908 may be placed in-line with the conduit 902 such that at least a portion of the access port 90~ is accessible outsidE3 of the body.
Essentially, the access port 908 shoo~d allow the patient or a doctor to open the port and access the system 900 within the patient's body for maintenance and diagnosislobservation ofi the system 900 as described above.
The access port 908 may comprise any suitable device for providing an airtight seal when closed anti easy access to the conduit 90~~ when open. The access port 908 may comprise various valve arrangements and connectors for connecting other components which may be utilised for various functions. For example, oxygen may be supp~ied directly to the patient's lungs 912 if needed.
In this instance, a valve may be needed to prevent the oxygen from bypassing the lungs 912 and go straight to the trachea 904..
All the remaining components may be the same as described above. In addition, ail seals may be accomplished as described above.
2s !n yet another alternate exemplary embodiment, the extrathoracic access port 908, illustrated in P~igure 9, may be positioned just under the skin so that it is accessible percutaneously. Essentially, tt~e access port would riot truly be extratharacic, but rather just located under the skin and accessible extrathoracically. In this exemplary embodiment access would not be as easily accessible; however, the access point would remain r~orb discrete than the previously described exemplary embodiments. Figur~s 10 illustrates this exemplary embodiment.
t6 As illustrated in Figure ~10, the collateral ventilation bypass system 1000 comprises a conduit ~ 002 t~~av extends from the patient's trachea ~ 004, or other proximal airways, including the bronchus, through a suitable passageway internal to a~; paiient's bodyr and then passes througl-r the lung ~ 0~ 2 at the site determined to have the highest degree of collateral ventilation. As set forth t5 above, if more than one site is determined to have a high degree of collateral ventilation, multiple conduits may be utilized. At the desired location within the body, an internal access port ti 008 may be placed in-line with the conduit 1002.
The access port 1008 may c;ompoise any suitable device that allows access via percutaneous means. ill rEmaining components may be thre same as 2G described above. In addition, all seals may be accomplished as described above.
It is important to note that in each of the above;-described exemplary embodiments, additional components may be added t~rat function to prevent 25 flow from the trachea end of the conduit to the lung. For example, one or more valves may be incorporated throughout the systems to prevent mucus and other substances from entering or re-entering the lung. The main function of the system is to allow exhalation. In theory, patients vvitl-r emphysema have increased resistance to expiration and not inhalation. Arry ;suitable valves rnay 30 be utilized, for example, one:-way check valves.
Figure 11 illustrates stet another alternate exemplary collateral ventilation bypass system 1 ~ 00. In this exemplary embodiment, like the exemplary embodiments illustrated in 1=figures 8-10, the trachea or other proximal airvJays, including the bronchus, is utilized to remove air trapped in the lung or lungs.
.~s illustrated, a conduit 1102 extends from the patieni:'s bronchus 1104 and passes directly into the lung '3100 at the site determined to !-lave the highest degree of collateral ventilation. If more than one site is determined to have a high degree of collateral ventilation, multiple conduits r~~ay be utilized. In operation, when the patient exhales, the pressure in the lungs is greater than the pressure in the bronchus 1104; accordingly, the air in the highly collateralized area or areas of the lung will travel through the conduit 1102 to lfi the bronchus 1104, into the trachea 1108 and out of the patient's nose and mouth, not shown, with the normally exhaled air The cor rauit 1 i 02 in this exemplary embodiment doer not leave the patient's body. The conduit '1102 may comprise any suitably: biocompatible tubing having a resistance to the various gases and oi:her cc,nstituents contained in inhaled and exhaled air. As in previously described exemplary embodiments, the conduit 110 comprises tubing having an inside diameter in the range from about 1110 inch to about ~/2 inch, and more preferably in the range from about 1~8 inch to about'/ inch.
The conduit 1102 prei~erably is able to withstand and resist collapsing.
Since air will travel through tl~e conduit 1102, if the conduit J 102 is crushed and is unable to recover, the effectiveness of the pro;:edure may be substantially reduced. Therefore, various materials may be incorporated into the conduit 1102 to make it crush recoverable. for example, materials exhibiting super elastic or shape memory properties or characteristics may be utilized. Nitinol incorporated into the conduit 1102 wili give the component collapse resistance and collapse recovery properties. The conduit 1102 may comprise a polymeric coating over a suitably arranged nitinol base structure.
The polymeric coating or cover layer may be formed from any suitable polymeric materials, including polytetrafluoroethylene, silicone and polyurethanes.

The conduit 1102 may also comprise modified ends. For example, expandable features at each end may be utilized to maintain contact and sealing between the conduit 1102 and/or the bronchus 1104, the trachea 1106, and the lung 1106 pleura. Once again, nitinol or other similar property materials may be incorporated into the conduit 1102 and thus provide the conduit 1102 to be delivered in a smaller diameter compressed state and then deployed in a larger diameter expanded state to help secure it in piece.
Alternately, shoulders at each end of the conduit 1102 may also provide a mechanical stop for insertion and an area for an adhesive/:~ealant to join.
lU
The conduit 1102 m~ly be introduced into the body of the patient ire a number of ways. In one exemplary embodiment, the conduit 1102 may be introduced utilizing an openuchest procedure, for example, a sternotomy or thoracotomy. in al alternate= exemplary embodiment, the conduit 1102 may be 1~ introduced utilizing a lapros~~opic technique to make ilhe procedure less invasive. It is important to r~o~te that the conduit 110'. rrray be incorporated into the opening creating device. If the conduit 1102 is incorporated with the opening creating device, the conduit 1102 may be inserted and established in the same step as the opening creation.

As stated in the above-described exemplary embodiments, in order for the collateral ventilation by~~ass system 1100 to function, are airtight seal is preferably made between the conduit 1102 and the outer pleural layer of the lung 1106. This seal is maintained in order to sustain the inflation/functionality 2'~ of the lungs. If the seal is breached, air can enter the pleural space and cause the lungs to collapse. one method for creating the sE;al involves pleuroderi~, or forming adhesions betweer°: the visceral pleura of thE; lung and the inner wall of the thoracic cavity as briefly described above and in more detail subsequently.
In another alternate exemplary embodiment, a sealed joint between the conduit 30 1102 and the outer pleural layer includes using various glues to help with the adhesionlsealing of the conduit 1102 as described above. Regardless of the procedure utilized, the seal should be established while thE: lung is at least partially inflated in order to r~naintain a solid adhesives surfac>e. The opening ~9 may then be made after the;pint has been adequately created between the conduit 1102 and the lung pleural surface. The opening should be adequate in cross-sectional area in arder to provide sufficient decamprEassion of the hyperinflated lung.
The connection of the conduit 1102 to the tracf~ea or bronchus 1104 should also be an airtight seal. For example, fBuid communication between the bronchus 1104 and the conduit 110 may be established in a manner identical to that established for a tracheotomy.
1~
The conduit 110 may be positioned at any suitable location within the patient's body. Preferably, the conduit 1102 is positioned such that it will not affect the patient's ability to function normally.
15 It is important to note that in the above-described exemplary embodiment, additional cc~r~rponenfs may be added that ~fur~ction to prevent flow from the bronchus to the lung. For example, one or mere valves or filters may be incorporated into the conduit to prevent mucus and other substances from entering or re-entering the lung. The main function of the collateral 2C9 ventilation bypass system is to allow exhalation. In theory, patients with emphysema have increased resistance to expiration and not inspiration. Any suitable valves may be utilised, for example, one-way checi~ valves.
As described above, pulmonary emphysema leads to the breakdown of 25 lung tissue, which in turn leads to the reduced ability of the lungs to recoil and the loss of radial support of the airways. consequently, the Boss of elastic recoil of the lung tissue con~:ributes 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 3C~ phenomenon also intensifies the inability for individuals 'to exhale completely.
As the inability to exhale completely increases, residual volume in the lungs also increases. This then causes the lung or lungs to establish in a hyperinflated state where an individual can only take short :shallow breaths.
so 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.
Lung volume reduction surgery is an extremely traumatic procedure that involves removing part or paints of the lung or lungs. fly removing the portion of the lung or lungs which is hyperinflated, pulmonary function may improve due to a number of mechanisms, including enhanced elastic recoil, correction of Venttlation/perfusion mismatch and improved efficiency of respiratory work.
Essentiaily, as the emphysematous tissue volume is reduced, the healthier tissue is better ventilated. I-~~~wever, lung volume reduction :surgery possesses a number of potential risks as described in more detail subsequently.
The collateral ventilation bypass trap system 700, illustrated in I=figure 7, and the collateral ventilation bypass system 800, illustrated in Figure ~, ut'li~e the collateral ventilation phenomenon to allow the air entrapped in the lung or lungs to bypass the native airways and be expelled either to a containment vessel or to the ambient environment. I~iowever, in an alternate exemplary embodiment, a device, which works similarly to collateral ventilation bypass and provides results comrne~lsurate with lung volume reduction surgery, is disclosed herein. Essentially, in this exemplary embodimen~k, the invention is directed to a device and ass~~ciated method for assisting pulmonary decompression. In other words, the present invention is directed to pulmonary decompression assist device and method that would provide a means for the removal of trapped air in the emphysematous lung and the maintenance of the emphysematous area compressed to a smaller volume, with the result being that healthier lung tissue will have more volume in the thoracric cavity to ventilate. The effects of this device may be similar to that of lung volume reduction surgery.
~0 The exemplary pulrr~onary decompression assist device of the present invention may be strategically positioned in the body of a patient such that it is in fluid communication with tile patient's lung or lungs and t~~e external environment. The device would allow air to be exhaled out from the lung or lungs through the native airways while assisting in removing trapped air in the hyperinflated portion of the lur;g or lungs. l..ung volume reduction surgery is an extremely invasive and traurraatic procedure that in a substantially high number of cases causes the patients ~,qndergoing the procedure to become excluded from being a candidate for lung transplantation. The device of the present invention provides for a minimally invasive procedure for causing the lung volume to reduce similarly to lung volume reduction surgery while allowing the patient to remain a viable candidate for lung transplaroation.
The exemplary pulmonary decompression device may utilize any number of known technique: far creating a sufficient prevsa~re differential between the inside of the lung or lungs and an area external of the lung or lungs to allow the trapped air to exit the lung or lungs. The device may comprise arty suitable device such as pumps or fans or any other means to create the pressure differential. If the collateral airflow and areas of emphysema are situated so that air may reinflate that area, the device may be configured to continuously draw air from the lung or lungs tc> maintain a smaller lung volume of the emphysematous tissue. The device may be left in the patient's body indefinitely ire order to maintain the compression of the emphysematous tissue in the lung or lungs. In addition, in order to maintain the cleanliness of the device and the safety of the patient, the device may be constructed as a disposable device and be replaced at various intervals. In addition, portions of the device that are easily accessible may be made disposable. Alternately, the device may be constructed for easy removal, easy cleaning and easy replacement.
deferring to Figure t~~., there is illustrated an e;~eernplary pulmonary decompression device 12~~~ ire accordance with the present invention. As 3~ described herein, there is generally an optimal location to penetrate the eater pleura of the lung to access tt-~e mast callateraliy ventilated area or areas of the lung and a variety of techniques to locate the area or areas. (7nce the desired location is determined, the de; ampression device 1 ~~G may be inserted into 3~

the lung 1202. ~n insertion and placement of the decompression device 1200 into the lung 1202, it is particularly advantageous to establish an airtight seal of the parietal and visceral pleurae. !f a proper airtight seal is not created between the decompression device, parietal and visceral pleurae, then a pneumothorax may occur.
!t is important to note that one or more devices may be utilized in each lung to remove trapped air from highly coilateralized areas. Alternately, a single device with multiple conduits may be utilized. ~4s illustrated in Figure 12, the decompression device 1200 is placed in the lung 1202 in the area of highest collateral ventilation 1204.. In one exemplary er~bodimeni, only a first section 1208 of the decompression device 1200 is positionE:d within the lung 1202 while a second section 1208 of the decompression device 1200 is secured external to the lung 1202. The sealing of the device 1200 may be t5 made in accordance with any of tl~ce devices and methodologies described herein.
At least a portion of tl~e second section 1208 is external to the patient's body. The portion of the second section 1208 that is external to the patient's body may exit the body at any suitable location. In one exemplary embodiment, the portion of the second section 1208 exists the body through the chest and thus may be sealed in accordance with any of the devices and methodologies descrihed h~;rein.
The first section 1208 may comprise any suitable biocompatible material configured to facilitate the flow of air from the lung 1202. For example, the first section 1206 may comprise a conduit similar in size, material and construction as the other conduits described herein. The second section 1208 may be connected to the first section 1206 by any suitable means, including threaded 3Q unions or compression type fittings. The second section 1 a?08 comprises a housing far an apparatus that draws air from the hyperiwflated portion of the lung 1204 through the first section 120fi and directs it out of the patient's body.
The apparatus may include any suitable device for creating a pressure ss differential between the inside and outside of the lung 12(32 such that air will easily flow from the lung i 20'?. The apparatus may include a miniature pump or fan. The miniature pump or fan may be powered by any :suitable means, including batteries or rechargeable batteries. In the al~ove~c~escribed exemplary embodiment, the miniature pump or fan and its power supply may be housed completely in the housing. In other alternate exemplary embodiments, one or more of ~t#~e pumplfar' or power supply may be located remotely from the second section 1208. For example, the second section 1208 may simply comprise a second conduit removably corrnected on one end to the t0 first conduit and on a second end to the apparatus that draws air from the diseased section of the lung 1204.
In the exemplary embodiment illustrated in Figure 12~ the apparatus that draws air from the diseased section of the lung 1204. and its associated power 15 supply are housed within the second section 1208. This design provides the most freedom for the patient. ~larious known miniature vacuum pumps or fans may be used to cflntinuously draw air from the diseased ser;tion of the lung 1204, thereby reducing the emphysematous tissue volume and allowing the healthier tissue to ventilate better. The miniature fanfpump and associated 20 power supply may be separate components or a single corr~ponent. '~ hese miniature devices may comprise microelectromechanical systems or E11~~, or any other suitable device for drawing air from one location and venting it to a second location. The decompression device 1200 should be designed to be easily maintained. For exa~~~ple, the second section 1208 nnay be made such 25 that it can be removed, the power supply recharged and the other compon~;nts cleaned and then replaced. Alternately, the second section 1208 may simply be disposable.
The power supply may comprise any suitable means for supplying 3G power continuously for extended periods of time. The power supply may comprise batteries, rechargeable batteries, piezoelectr is devices that generate electrical power from mechanical strain or any other suitable device. In addition, other than a fan or pump for creating a vacuum, soma type of switching elements may be utilized for creating a slight pressure differential.
Accordingly, rather than a resection of the lung tissuE:, the decompression device removes trapped air from the emphysematous section of the lung and maintains th~a emphysemai:ous section in a =:~ornpressed state or smaller volume, thereby ~~llo~ving the healthier lung tissue more volume in the thoracic cavity to ventilate. Figure 13a illustrates the decompression device 1200 removing air from the llyperinflated portion 1302 of the lung 1300. As IO illustrated, in this lung, the hyperinflated or emphysematou~> portion 1302 of the lung 1300 is larger than the healthy section or portior~i 1304. of the lung 1300.
As the devise 1300 continues to remove the accumulated or trapped air, the volume of the hyperinflated portion 1302 of the lung 1300 shrinks, thereby allowing the healthier portion 130. more room to fully ventilate, thereby I~ increasing in volume as illustrated in 1~'igure 13b.
In an alternate exemplary embodiment, a more passive device may be utilized for reducing the size of the lung. A lung reduction device may be strategically positioned alcout the body of a patient arid access the patient's 2~0 lung or lungs. The device ~~~ould allow air to be expelled from the lung or lungs while preventing air from re-entering therethrough. essentially, the device would comprise at least one component that accesses the outer pleural layer of the emphysematous portion or portions of the patient's lung or lungs. This at least one component will utilize the collateral ventilation of the lung or 6ur'gs 2~ and allow the entrapped air in the emphysematous portion or portions of the lung or lungs to bypass the native airways and expel thrauc)h to the outside of the body through a second r~omponent. The second component includes a feature that allows air'to tlo~~ from the lung or lungs to the ambient environment, but not from tl~e ambient environment back into the lung or lungs.
3C3 If the collateral airflow and areas of emphysema are situatEid so that air cannot reinfiate these portions of the lung or lungs, then a size reduction of that area of the lung should occur.
ss Referring to Figures 1 ~4a and 14b, there is illustrated an exemplary lung reduction device 1400 in accordance with the present i~ svention. As described herein, there is generally an optimal Bocation to penetrate the outer pleura of the lung to access the most e;oiiaterally ventilated area or arcras of the lung or S lungs and a variety of techniques to locate these areas. C3nce the desired location or locations are determined, the lu~,g reductior& device 1400 may be inserted into the lung 1402. °The insertion or introducti~an of the device 14DD
may be accomplished utilizing a number of minimally invasive techniques, for example, percutaneousfy or endoscopicaliy, thereby substantially reducing the risk to the patient and trauma to the lung ~r lungs. It is important to note that all of the systems and devices described herein are preferably implanted utilizing minimally invasive techniques. (Jn insertion and placement of the ic.mg reduction device 1400 into the lung 1402, it is particularly advantageous to establish an airtight seal of tl~'e parietal and viscera! pleurae utilizing any of the 1S techniques, devices and processes described herein. if an airtight seas is raot established between the lung reduction device 1400, parleta.l and visceral pleurae, then a pneurnothorax may occur.
It is ir~aportant to note that one or more lung rediuction devices may be utilized in each lung to remove trapped air from highly coilat~~raiized areas.
Alternately, a single lung reduction device in fluid communication, through conduits or ofher similar me2us, with multiple locations ray be utilized. For case of explanation, a single device and single diseased portion is described and illustrated. ~nce again, r°eferring to Figures 14a and 14k~9 the lung reduction device 1400 is implanted in the lung 1402 ir!~ the sires of highest collateral ventilation 1404. in the exemplary embodiment illustrated, a first section 1406 of the lung reduction device 1400 is posiitioned within the inner volume of the lung 1402 while a second section 3403 of the lung reduction device 1400 is secured to thf: patient's body external f:o the lung 1402. The first section 1406 of the device 1400 accesses the parenchyma of the lung 1402. The parenchyma are 'the cells in tissues that are concerned with function rather than structure. in other words, the first: section 1406 accesses the alveoli of the lung 14D2. The attainmer't of an airtight seal of the lung ss reduction device 1400 may be made in accordance with any of the devices and methodologies described herein.
>~t least a portion of tf~e second section 1408 is external to the patient's body. The portion of tree second section 1408 that is external to the patient's body may exit or extend from the body at any suitably; location. Preferably, the portion of the second section 1408 exits at a location that proves to be of minimum burden to the patient and allows for easy access for maintenance, repair or replacement. In ore exemplary embodiment, the portion of the second section 1408 exits t~~e body through the chess: and thus may be sealed in accordance with any of th~~ devices and methodologies d4dscribed herein.
The first section 140~~ may comprise any suitable device for facilitating the flow of air from the lung 1402. For example, the fig°st section 1406 may t5 comprise a conduit similar ire size, material and construction or any of the other conduits described herein. -~ he second section 1408 may be connected to the first section 1406 by any suitable means, including threaded connectors, unions or compression type fittings.
The second section 1408 may comprise any suitable means for allowing one-way airflow. In one exemplary embodiment, the second section 1408 comprises a housing 1410 and a one-way valve 141 ~. The housing 1410 may be formed from any suitable biocompatible material. portion of the housing 1410 houses the one-way valve 14.12 while another portion of the housing ~5 1410 forms the portion that is external to the body. The one:-way valve141 ~
may comprise any suitable pressure actuated valve, which allows air to flew from one lung 1402 to the ambient environment. The onL-way valve 141 ~ may comprise a check valve, a reed valve, needle valves, flappE:r check valves or any other suitable device. Ire preferred embodiments, the ore-way valve ~ 412 requires only a slight pressure differential to open and allo~nr air flow from the lung 1402 to the ambient or external environment, bct does not allow air flow back into the lung 1402 eves under substantial rever:~e pressure.
sz in operation, when thf~ person inhales, the volume of the Thoracic caFvity increases by the contraction of the diaphragm and thus the volume of the lClrlgS
also increases. As the volume of the lungs increase, the pressure of the air in the lungs falls slightly below t~se pressure of the air e~;iernal to the body and thus air flows through the re:~piratory passageways into the lungs until the pressure edualizes. UVhen the person exhales, the diaphragm is relaxed, the volume of the thoracic cavit~~ decreases, which in turn decreases The volume of the lungs. As the volume of the lungs decrease, the pressure of the air in the lungs rises slightly above the pressure of the air external to the body.
t0 Accordingly, as a result of this slight pressure differential, the air in the alveoli is expelled through the respiraTory passageways until the pressure egualizes.
I-lowever, in the diseased ar~:ea 1404 of the lung 1402, normal exhalation does not work for the reasons described herein and thus thm increased pressure in the fang 1402 opens the one-way valve 1412 and air flows from the diseased t5 portion 1404 through the first section 1406, through the one-way valve 1412 and out of the body.
The lung reduction device 1400 may be left in the lung indefinitely to maintain the compression of the emphysematous tiss~~e Bung 1400 as 20 described above with resperat to the decompression dfevice. In order to maintain cleanliness and safety, the lung reduction device 1400 or at feast portions thereof may be made disposable and thus bE~ repia.ced at regular intervals or when needed. has the lung reduction device 1400 continues to allow the trapped air to exit the lung 1402, the volume of the hyperinflated or 2S diseased portion 1404 of the lung 1400 shrinks, thereby allowing the healthier portion of the lung 1400 moe°e room to fully ventilate, thereby increasing in volume as illustrated in I~igure 14b.
The lung reduction device 1400 may be left in the body until the area of 30 the compressed emphysematous tissue has permanently compressed, atelectasis. At this point, th~r Fang reduction device 1400 m,~y potentially be removed safely. If healing of The insertion site of the reduction device 1400.
has occurred, the fistula created may be permanently sealed.

In operation, when the person inhales, the volume of the thoracic cavity increases by the contraction of the diaphragm and thus the volume of the fangs also increases. As the volume of the lungs increase, the pressure of the air in the lungs falls slightly below the pressure of the air external to the body and S thus air flows through the respiratory passageways into tl'~e lungs until the pressure equalizes. When the person exhales, the diaphragm is relaxed, the volume of the thoracic cavity decreases, which in turn decrE:ases the volume of the lungs. As the volume of the lungs decrease, the pressure of the air in the lungs rises slightly above the pressure of the air external to the body.
Accordingly, as a result of this slight pressure differential, the air in the alveoli is expelled through the respiratory passageways until the pressure equalises.
However, in the diseased area 14x4 of the lung 1402, nomnal exhalation does not work for the reasons described herein and thus the incrE=used pressure in the fang 1402 opens the one-way valve 1412 and air flows from the diseased portion 1404 through the tirst section 1406, through the one-way valve 1412 and out of the body.
T'he fang reduction device 1400 may be left in the lung indefinitely to maintain the compression ct the emphysematous tissue lung 1400 as described above with respect to the decompression device. In order to maintain cleanliness and sar~ety, the lung reduction dE=vice 1440 or at least portions thereof may be made disposable and thus be replaced at regular intervals or when needed. ass the lung reduction device 14C)0 continues to allow the trapped air to exit the lung 1402, the volume of the hyperinflated or diseased portion 1404 of the lung 1400 shrinks, thereby allowing the healthier portion of the lung 1400 more room to fully ventilate, thereby increasing in volume as illustrated in Figure 14b.
The lung reduction d~=.vice 1400 may be left in 'the body until the area of 3~ the compressed emphysematous tissue has permanently compressed, atelectasis. At this point, the lung reduction device 14tJ0 may potentially be removed safely. If heating of the insertion site of the reduction device 1400 has occurred, the fistula created rr~ay be permanently seated.
3~

fn the above-described exemplary apparatus ,~r~d procedure for increasing expiratory flow from a diseased lung using the phenomenon of collateral ventilation, there will be an optimal location to penetrate the outer pleura of the lung to access the most collaterally ventilated area or areas of the lung. In addition, in the above-described exemplary pulrr~onary decompre~=sion assist device, there is an optimal location for decompressing the hyperinflated lung or lungs. As described above, there are a variet~~ oil tE:chniques to locate the most collaterally ventilated area or areas of the lungs. Since a device or component of the apparatue> functions to allow the air entrapped in the lung to bypass the native airways and be expelled outside of the body, it is particularly advantageous to provide arc airtight seal of the pariet:ai (thoracic wail; and visceral (lung) pleurae. if a proper airtight seal is not created between the device, parietal and visceral pleurae, then a pneumothorax (collapsed fang) I5 may occur. essentially, in any circumstance where tll~e lung is punctured and a device inserted, an airtight seal should preferably be maintained.
Cane way to achieve an airtight seal is through pleurc>desis, i,e. an obliteration of the pleural space. Where are a number of pleurodesis methods, including chemical, surgical and radiologicaB. In chemical pleurodesis, an agent such as tetracycline, doxycycline, bieomycin oir nitrogen mustard may be utilized. In surgical pieurodesis, a pleurectomy or a thorascopic talc procedure may be performed. 1n radiological procedures, radioactiore gold or external radiation may be utilized. Ire the present invention, chemical pleurodesis is utilized.
exemplary devices and methods for delivering a chemicals) or agents) in a localized manner for ensuring a proper airtight seal of t;he above-described apparatus is described below. The chemical(s), ager~t(s) and/or compounds) are used to create a pleurodesis 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. There are a numk>er of c;hemical(s), agents) and/or compounds) that may be utilized to create a pleurodesis in the pleural space. The chemicals}, agent{s} and/or compounds) include talc, tetr acycline, doxycyclirce, ble,omycin and rr~inocycline.
In one exemplary embodiment, a modified drug delivery catheter may be utilized to deliver chemicals}, agent(s} and/or compounds) to a localized area for creating a pleurodesis in that area. In this exempllary ennbodiment, the pleurodesis is formed and then the conduit 704, as illustrated in Figure 7, is positioned in the lung 708 through the area of the pleurodesis. l°he drug delivery catheter provides a minimally invasive means for creating a localized pleurodesis. Referring to Figure '15, there is illustrated an exemplary embodiment of a drug delivery catheter that may be utilized in accordance with the present invention. Any number of drug delivery catheters may be utilized.
In addition. the distal tip of tl°re catheter may comprisE: any ~>uitable size, shape or configuration thereby enabling the for oration of a pleurodesis having any size, shape or configuration.
As illustrated in Figure ~ 5, tile catheter 1500 i~> inserted into the patiE:nt such that the distal end 1502 is positioned in the pleural space 1504 between the thoracic wall ~ 508 and tile lung 1505. In the illustrated exemplary 2C> embodiment, the distal end 1502 of the catheter 150t) comprises a substantially circular shape that would allow the chemical(s), agents} andlor compounds} to be released towards the inner diameter of ~:he substantially circular shape as indicated by arrows 1510. The distal end 1502 of the catheter 1500 comprising a plurality of holes or openings 1512 through which 2~ the chemical{s), agent{s) and/or compounds) are released. As stated above, the distal end 1502 may cornprise any suitable size, :shape or configuration.
once the chemical(s), agents) and/or compounds) e~.re delivered, the catheter 1500 may be removed to allow for implantation of the conduit '~04 (Figure 7).
Alfernately, the catheter 1500 may be utilized to facilitate delivery of the co~lduit 30 704.
The distal end or tip ~3 502 of the catheter 1500 should preferably maintain its desired size, shape andlor configuration once deployed in the ao pleural space. This may be accomplished in a number o~f ways. For example, the material forming the distal end 1502 of the catheter ~5Q0 may be selected such that it has a certain degree of flexibility for insertion of the catheter and a certain degree of shape memory such that it resume: its original or programmed shape once ds~pioyed. Any number of biocompatible polymers with these properties may be utilized. In an alternate embodiment, another material may be utilized. For example, a metallic material having shape memory characteristics may be integrated into the distal end 1502 of the catheter 1500. This metallic material may include nitir aol or stainless steel. In addition, the metallic material may be radiopaque or comprise radiopaque markers. ~y having a radiopaque material or radiopapue rrnarkers, the catheter 1500 may be viewed under ;~c-ray fluoroscopy and aid in determining when the catheter 1500 is at the location of the highest collateral ventilation.
In another alterrvate exemplary embadiment, a local drug delivery device may be utilized to deliver thE; pleurodesis chemical{s), agents) and/or compound{s}. In this exemplary embodiment, the pleurodesis is formed and then the conduit 704, as illustrated in Figure 7, is positioned in the lung 70~
through the pieurodesis, in this exemplary embodiment, chemical(s), agents) 20~ andfor compounds) may be affixed to an impiantable medical device. The medical device is then implm~ted in the pleural cavity at a particular site and the chemical(s), agents) andlor~ compound{s) are released therefrom to forr~~ or create the pleurodesis.
Any of the above-described chemical(s), agen~t(s) andlor compound{s) may be affixed to the medical device. The chem'scal(s), agents} andlor compounds) may be affixed to the medical device in any suitable manner. For example, the chemical{s}, awgent(s) and/or compound{s) rns.y 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 medics! device, they may be irrppregnated into the outer surface of the medical device, they may be incorporai:ed into holes or' chambers in the medical device, they may be coated onto the surface of the medical device and then coG~ted ~rith a polymeric layer that acts as a diffusion barrier for controlled release of the chemical(s), agents) and/or compound(s), they may be incorporated directly into the material forming the medical device, or any combination of the above-described techniques. In another alternate embodiment, the medical device may be formed from a biodegradable material which elutes the chemica!(s), agents) and/or cor~pour~d(s) as the device degrades.
The implantable medical device may comprise any suitable size, shape and/or configuration, and may be formed using any suitable biocompatible material. Figure 16 illustrates one exemplary embodiment of an implantable medical device 1600. In this embodiment, the impiantabie medical device 1600 comprises a substantially cylindrical disk 1600. ~'he disk 1600 is positioned in the pleural space 1602 between the thoiracic gall 1604 and ths~
lung 1606. C)nce in positior°~, the disk 1600 elutes or catherwise releases the chemical(s), agents) andlc~r compounds) that form the plecarodesis. The release rate may be precisely controlled by using any of the various techniques described above, for example, a polymeric diffusion barrier. Also, as stated above, the disk 1600 may be formed from a biodegradable material that elutes the chemical(s), agents) an:~/or compounds) as the disk-1 ~a00 itself disintegrates or dissolves. C)epending upon the material utilized in the construction of the disk 16f~~), a non-biodegradable disk 1 X00 may or may not require removal from the pleural cavity 1602 once the iJleurodesis is formed.
For example, it may be desirable that the disk 1600 is a permanent implant that becomes integral with the pleurodesis.
As described in the previous exemplary embodiment, the disk 1600 may comprise a radiopaque marker or be formed from a radiopaque material. The radiopaque marker or material allows the disk 1600 to be seen under fluoroscopy and then positioned accurately.
in yet another altQrnate exemplary embodiment, the fluid characteristics of the chemical(s), agents) andlor compounds) may be altered. For example, the chemical(s), agents) andior compounds) may be made more viscous.
V'ilith 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) andlor compounds) may also comprise radiopague constituents. IVfaking 'the =;hemical(s), agents) and/or compounds radiopaque would allow the confirmation of the location of the chemical(s), agents) and; or compounds) with regard to the optimal location of collateral ventilation.
t0 The chemical(s), agents) and/or compounds) as modified above may be utilized in conjunction witi~ standard chemical pieurodesis devices and processes or in conjunction ~ruith the exemplary embociiments set forth above.
ilithough shown and described is what is believed to be the most tS practical and preferred er~°3bodirnents, it is apparent that departures from specific designs and methods described and shown ~riil suggest themselves to those skilled in the art and rnay be used without departinci from the spirit and scope of the invention. 'The present invention is not restricted to the particular constructions described and illustrated, but should be constructed to cohere 20 with all modifications that may fall within the scope of the appended clairrss.

4~

Claims (2)

1. An intra-thoracic collateral ventilation bypass system comprising:
at least one conduit having first and second ends, the first end being in fluid communication s with an airway in proximity to a trachea of a patient and the second end being in fluid communication with the inner volume of a lung of a patient at a predetermined site;
a first sealing device for establishing an airtight seal between the conduit and the airway; and a second sealing device for establishing an airtight seal between the conduit and the lung.

2. A method for decompressing a hyperinflated portion of a lung of a patient comprising:
determining a site of hyperinflation in a patient's lung; and bypassing non-patent airways utilizing a device in communication with a hyperinflated portion of a patient's lung and an airway proximate a patient's trachea.