US20060095002A1 - Methods and devices for obstructing and aspirating lung tissue segments - Google Patents
Methods and devices for obstructing and aspirating lung tissue segments Download PDFInfo
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- US20060095002A1 US20060095002A1 US11/271,211 US27121105A US2006095002A1 US 20060095002 A1 US20060095002 A1 US 20060095002A1 US 27121105 A US27121105 A US 27121105A US 2006095002 A1 US2006095002 A1 US 2006095002A1
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- 0 C1C*C*C1 Chemical compound C1C*C*C1 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12159—Solid plugs; being solid before insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
- A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22067—Blocking; Occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22068—Centering
Definitions
- the present invention relates generally to medical methods, systems, and kits. More particularly, the present invention relates to methods and apparatus for effecting lung volume reduction by aspirating isolated segments of lung tissue.
- Chronic obstructive pulmonary disease is a significant medical problem affecting 16 million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and chronic obstructive pulmonary disease remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit.
- lung function in patients suffering from some forms of chronic obstructive pulmonary disease can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung.
- Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood.
- Lung reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades.
- WO 99/01076 and corresponding U.S. Pat. No. 5,957,919 describes devices and methods for reducing the size of lung tissue by applying heat energy to shrink collagen in the tissue.
- air may be removed from a bleb in the lung to reduce its size. Air passages to the bleb may then be sealed, e.g., by heating, to fix the size of the bleb.
- WO 98/48706 describes a plug-like device for placement in a lung air passage to isolate a region of lung tissue, where air is not removed from the tissue prior to plugging.
- WO 98/49191 describes the use of surfactants in lung lavage for treating respiratory distress syndrome.
- U.S. Pat. No. 5,925,060 may also be of interest.
- Patents and applications relating to lung access, diagnosis, and treatment include U.S. Pat. Nos. 5,957,949; 5,840,064; 5,830,222; 5,752,921; 5,707,352; 5,682,880; 5,660,175; 5,653,231; 5,645,519; 5,642,730; 5,598,840; 5,499,625; 5,477,851; 5,361,753; 5,331,947; 5,309,903; 5,285,778; 5,146,916; 5,143,062; 5,056,529; 4,976,710; 4,955,375; 4,961,738; 4,958,932; 4,949,716; 4,896,941; 4,862,874; 4,850,371; 4,846,153; 4,819,664; 4,784,133; 4,742,819; 4,716,896; 4,567,882; 4,453,545; 4,468,216; 4,327,721; 4,327,
- mucolytic agents for clearing lung obstructions is described in Sclafani (1999) AARC Times, January, 69-97.
- Use of a balloon-cuffed bronchofiberscope to reinflate a lung segment suffering from refractory atelectasis is described in Harada et al. (1983) Chest 84:725-728.
- the present invention provides improved methods, systems, devices and kits for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired.
- the present invention is likewise suitable for the treatment of bronchopleural fistula.
- the methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung. Isolation is achieved by deploying an obstructive device in a lung passageway leading to the target lung tissue segment. Once the obstructive device is anchored in place, the segment can be aspirated through the device.
- This may be achieved by a number of methods, including coupling an aspiration catheter to an inlet port on the obstruction device and aspirating through the port. Or, providing the port with a valve which allows outflow of gas from the isolated lung tissue segment during expiration of the respiratory cycle but prevents inflow of air during inspiration. In addition, a number of other methods may be used.
- the obstructive device may remain as an implant, to maintain isolation and optionally allow subsequent aspiration, or the device may be removed at any time. Likewise, the device may biodegrade over a period of time.
- the obstruction device may take a variety of forms to allow delivery, deployment and anchoring in a lung passageway. Delivery is commonly performed with the use of a minimally invasive device, such as a flexible bronchoscope or an access catheter.
- the flexible bronchoscope may be utilized with a sheath having an inflatable cuff disposed near its distal end, a full description of which is provided in co-pending application [Attorney Docket No. 017534-001300], assigned to the assignee of the present invention and incorporated by reference for all purposes.
- the scope When using such a sheath, the scope is introduced into a lumen in the sheath to form an assembly which is then introduced to the lung passageway.
- the cuff may then be inflated to occlude the passageway.
- an access catheter may be used which may be steerable or articulating, may include an inflatable balloon cuff near its distal end and may include a number of lumens for balloon inflation, tracking over a guidewire, and optical imaging, to name a few.
- the obstruction device is typically housed within a lumen of the access catheter, bronchoscope, sheath or suitable device, mounted near the distal tip of the catheter or carried by any method to the desired lung passageway leading to the target lung tissue segment. Therefore, the obstruction device must be sized appropriately for such delivery and is typically designed to expand upon deployment to anchor within the lung passageway.
- the present invention is depicted in relation to use with an access catheter, however it may be appreciated that any suitable device may be used.
- the obstruction device comprises a structural support which expands and thereby anchors the device in the lung passageway.
- Such supports may comprise a number of configurations for a variety of expansion techniques.
- the structural supports may allow the obstruction device to coil, roll, bend, straighten or fold in a cone, rod, cylinder or other shape for delivery. Then, once positioned in a desired location, the obstruction device may be released and expanded to anchor the device in the passageway.
- Such expansion may be unaided, such as in the release of a compressed structure to a pre-formed expanded position.
- such expansion may be aided, such as with the use of an inflatable balloon or cuff.
- a balloon or inflatable member may be incorporated into the obstruction device and may remain inflated to occlude the passageway. This may be provided in combination with structural supports or an inflatable balloon or similar device may be used without such support.
- the structural supports may be comprised of any type of wire, particularly superelastic, shape-memory or spring tempered wire, or any type of polymer or a suitable material.
- the balloon or inflatable member may be comprised of any flexible, polymeric material suitable for such a purpose.
- the member may be inflated with gas or liquid as desired, or it may be inflated with an expanding foam or similar material. Likewise, it may be inflated or injected with an adhesive.
- an adhesive may expand the member and/or rigidify the member to reduce the likelihood of collapse. Further, the adhesive may additionally serve to bond the device to the walls of the lung passageway to increase anchorage.
- the device may be impregnated or coated with an antibiotic agent, such as silver nitrate, or similar agent for delivery of the agent to the lung passageway. Such delivery may occur by any applicable means.
- the structural supports may comprise a variety of designs.
- the structural supports comprise radial segments which expand to fill the passageway and longitudinal segments which rest against the walls of the passageway to help anchor the device.
- the structural supports comprise a mesh which expands to fill the passageway.
- the structural supports comprise a helically or spirally wound wire which also expands to contact the walls of the passageway and anchor the device.
- the structural support may be connected with or encapsulated in a sack comprised of a thin polymeric film, open or closed cell foam or other suitable material to provide a seal against walls of the lung passageway and obstruct airflow through the device.
- the sack material may also be infused with an adhesive, sealant or other material to improve obstruction of the airway and possibly improve adhesion to the airway walls.
- the obstruction device may further comprise ports for aspiration through the device. This may allow access to the collapsed lung segment at a later time, for example, in the case of an infection.
- the obstruction device will have an inlet port located near the proximal end of the device, away from the isolated lung tissue segment. Such a port is thus accessible by minimally invasive devices, such as an aspiration catheter, which may be advanced through the bronchial passageways.
- an outlet port may be located near the distal end of the obstruction device.
- the ports may comprise a variety of designs for a number of purposes.
- the port comprises a self-sealing septum.
- a septum may comprise a solid membrane or a pre-cut membrane.
- Aspiration through the port may be achieved with the use of an aspiration catheter having an access tube or penetrating element at its distal end.
- Such a catheter may be advanced to the site of the obstruction device itself or with the use of an access catheter.
- the septum may be penetrated, either pierced through a solid membrane or passed through the cuts of a pre-cut membrane, by the access tube.
- the inlet port and optionally the outlet port may be penetrated in this fashion.
- Aspiration may be achieved through the access tube and aspiration catheter to withdraw gases and/or liquids from the isolated lung tissue segment and passageway.
- a 100% oxygen, Helium-Oxygen mixture or low molecular weight gas washout of the lung segment may be performed by introducing such gas through the access tube, such as by a high frequency jet ventilation process.
- aspiration would remove both the introduced gas and any remaining gas.
- liquid perfluorocarbon or certain drugs, such as antibiotics, retinoic acid and hyaluronic acid may be introduced prior to aspiration. In most cases, aspiration will at least partially collapse the lung segment.
- the septum may self-seal or it may be further sealed with a sealant or other sealing means for later access or permanent closure.
- aspiration through the port may alternatively be achieved by coupling an aspiration catheter to the obstructive device. Coupling may comprise engaging the aspiration catheter to the port or sliding a coupling member or the aspiration catheter over the port to form a seal. In either case, suction through the aspiration catheter may allow gases and/or liquids to pass through the cuts in the membrane to be withdrawn from the isolated lung tissue segment and passageway. Again, this will at least partially collapse the lung segment. Likewise, upon removal of the aspiration catheter from the port, the septum may self-seal or it may be further sealed with a sealant or other sealing means for later access or permanent closure.
- the port comprises a unidirectional valve.
- a valve may comprise a port covered by a flexible layer which is attached to the port by at least one point of connection. Movement of the layer away from the port opens the valve and movement against the port closes the valve.
- the flexible layer is solid, movement of the layer away from the port allows gas to flow between the points of connection and around the edges of the flexible layer.
- the flexible layer may have holes therethrough.
- the port may also comprise a partition having holes which are not aligned with the holes in the flexible layer. Movement of the layer away from the port allows gas to flow through the holes in the partition and out through the holes in the flexible layer. When the layer moves against the partition, the holes will be covered closing the valve.
- Other valve designs include a spring-loaded ball valve or a biased pre-loaded diaphragm valve.
- Aspiration through a unidirectional valve may be achieved by a number of methods.
- the port may be accessed by advancing an aspiration catheter or similar device through the bronchial passageways to the site of the obstruction device. This may optionally be achieved with the use of an access catheter.
- the aspiration catheter may be placed near the valve or engaged to the valve, wherein suction or vacuum applied through the catheter opens the valve. If the aspiration catheter is not engaged to the valve, adequate suction to open the valve may be achieved by occluding the passageway proximal to the point of suction which is typically the distal end of the aspiration catheter.
- Such occlusion may be achieved by inflating a balloon or occlusion device mounted on the distal end of the aspiration catheter or mounted on an access catheter. In either case, the vacuum may draw the flexible layer away from the port, allowing gases and/or liquids to flow out from the isolated lung segment, through the valve and into the aspiration catheter.
- aspiration through a unidirectional valve may be achieved naturally during respiration. Pressure changes may open the valve during expiration as gases flow out from the isolated lung segment. Reverse pressure changes, during inspiration, may close the valve preventing gases from flowing into the isolated segment. This may reduce the amount of gas trapped in the terminal segment over time and thus at least partially collapse the lung segment.
- aspiration through the unidirectional valve may be achieved by external mechanical pressure on the lung to force out of the lung segment and through the valve. Again, reverse pressure changes upon recoil of the lung would close the valve preventing gases from flowing into the isolated segment.
- the obstruction device may comprise a blockage device which is deployed in a lung passageway to close the airway.
- a blockage device may be of similar design as previously described obstruction devices as it may be similarly delivered, deployed and anchored within a lung passageway.
- embodiments of the blockage device typically comprise expandable support structures.
- the support structure comprises a coil.
- the support structure comprises a mesh.
- the support structures may be connected to or encased in a polymer film or sack to provide a seal against the walls of the lung passageway and obstruct airflow through the device.
- the blockage device will be placed in the passageway after the terminal lung segment has been aspirated by other methods.
- the blockage device may be placed in the passageway before the terminal lung segment has been aspirated. In this case, air trapped in the lung segment may be absorbed over time and would eventually collapse, a process known as absorption atelectasis. This process may be enhanced by insufflating the lung segment with 100% oxygen, a Helium-Oxygen mixture or low molecular weight gas prior to placing the blockage device. Such enhancement may promote complete collapse of the lung segment.
- the blockage device may optionally be later removed if it is so desired.
- Methods of the present invention include the utilization of an obstruction device to achieve lung volume reduction.
- methods include delivery, deployment and anchoring of an obstruction device in a lung passageway leading to a target lung tissue segment. At least partial collapse of the terminal lung tissue segment may be achieved by aspirating the segment through the obstruction device deployed in the passageway. Aspiration may be accomplished with the use of an aspiration catheter or similar device through a port on the obstruction device. Also described above, when the port comprises a unidirectional valve, aspiration and eventual lung volume reduction may be accomplished by the opening and closing of the valve in response the respiratory cycle.
- methods of the present invention include deployment of a blockage device in a lung passageway leading to a terminal lung tissue segment, as previously described.
- Systems of the present invention may include any of the components described in relation to the present invention.
- a particular embodiment of a system of the present invention comprises an access catheter and an obstruction device, as described above, wherein the obstruction device is introduceable by the access catheter.
- the obstruction device may be houseable within a lumen of the access catheter for deployment out the distal end of the catheter, or the obstruction device may be mountable on the access catheter near its distal end. In either case, the obstruction device may be deployed and anchored within a lung passageway.
- kits for such use.
- the kits may comprise an obstruction device deployable within a lung passageway and instructions for use.
- such kits may further include any of the other system components described in relation to the present invention and any other materials or items relevant to the present invention.
- FIG. 1 is a perspective illustration of an access catheter useful in the methods, systems, and kits of the present invention.
- FIG. 2 is a cross-sectional view taken along line 2 to a FIG. 1 .
- FIGS. 3A-3F illustrate alternative cross-sectional views of the access catheter of FIG. 1 .
- FIGS. 4A-4C illustrate a steerable imaging guidewire which may be used to facilitate positioning of the access catheter used in the methods of the present invention.
- FIG. 5A illustrates use of the access catheter of FIG. 1 for accessing a target lung tissue segment according the to the methods of the present invention.
- FIG. 5B illustrates use of a visualizing tracheal tube with the access catheter of FIG. 1 for accessing a target tissue segment according the to the methods of the present invention.
- FIG. 6 illustrates a method of deployment or delivery of an obstructive device.
- FIGS. 7A-7B are perspective views of embodiments of obstructive devices having, among other features, radial and longitudinal structural supports.
- FIG. 8 is a perspective view of an embodiment of an obstructive device in a rolled configuration prior to release in a lung passageway.
- FIG. 9 is a perspective view of an embodiment of a rolled, cylindrical shaped obstructive device in an expanded state within a flexible sack.
- FIG. 10 illustrates an embodiment of a double conical shaped obstructive device.
- FIG. 11 is a perspective view of an embodiment of an obstructive device having, among other features, a mesh structural support encased by a polymer film.
- FIG. 12 is a perspective view of an embodiment of an obstructive device having, among other features, a spiral structural support.
- FIG. 13 is a perspective view of an embodiment of an obstructive device having a cone shape with an inlet port at the apex of the cone.
- FIGS. 14A-14C illustrate embodiments of self-sealing septums of the present invention.
- FIG. 15 illustrates a method of aspirating through an obstructive device by inserting an access tube through a septum of an inlet port.
- FIG. 16 illustrates a method of aspirating through an obstructive device by contacting an aspiration catheter to an inlet port.
- FIG. 17 illustrates a method of aspirating through an obstructive device by sliding the distal end of an aspiration catheter over an inlet port.
- FIGS. 18A-18C illustrate a method of deploying, anchoring and aspirating through an obstruction device while such a device is connected to an aspiration catheter.
- FIG. 19A is a front view of an embodiment of a unidirectional valve of the present invention.
- FIGS. 19B-19C are perspective views of the unidirectional valve of FIG. 19A in various stages of operation.
- FIGS. 20-21 illustrate positioning of embodiments of unidirectional valves of the present invention in a lung passageway.
- FIGS. 22A-22B are front views of an embodiment of a unidirectional valve of the present invention.
- FIGS. 23A-23B are perspective views of the unidirectional valve of FIGS. 21A-21B in various stages of operation.
- FIG. 24 illustrates a method of deployment or delivery of a blockage device.
- FIG. 25 illustrates an embodiment of a blockage device comprising a coil encased in a polymer film.
- FIG. 26 illustrates an embodiment of a blockage device comprising a mesh connected to a polymer film.
- FIG. 27 illustrates an embodiment of a blockage device comprising a barb-shaped structure.
- FIG. 28 illustrates an embodiment of a blockage device having a cylindrical-type balloon with textured friction bands.
- FIG. 29 depicts an embodiment of a blockage device comprising a multi-layer balloon which has an adhesive material between an outer layer and an inner layer of the balloon.
- FIG. 30 illustrates an embodiment of a blockage device which is similar to that of FIG. 29 , including openings in the outer layer through which adhesive may seep.
- FIG. 31 illustrates a kit constructed in accordance with the principles of the present invention.
- Lung volume reduction is performed by collapsing a target lung tissue segment, usually within lobar or sub-lobular regions of the lung which receive air through a single lung passage, i.e., segment of the branching bronchus which deliver to and receive air from the alveolar regions of the lung.
- Such isolated lung tissue segments are first isolated and then collapsed by aspiration of the air (or other gases or liquids which may be present) from the target lung tissue segment.
- Lung tissue has a very high percentage of void volume, so removal of internal gases can reduce the lung tissue to a small percentage of the volume which it has when fully inflated, i.e. inflated at normal inspiratory pressures.
- the exemplary and preferred percentages for the volume reduction are set forth above.
- FIGS. 1 and 2 An exemplary access catheter 10 is illustrated in FIGS. 1 and 2 and comprises a catheter body 12 having a distal end 14 , a proximal end 16 , and at least one lumen therethrough.
- the catheter 10 further comprises an inflatable occlusion balloon 18 near its distal end.
- the catheter will have at least two lumens, a central lumen 20 and a balloon inflation lumen 22 .
- the balloon inflation lumen 22 may be an annular lumen defined by inner body member 24 and outer body member 26 which is coaxially disposed about the inner body member.
- the lumen 22 opens to port 30 on a proximal hub 32 and provides for inflation of balloon 18 .
- the central lumen 20 opens to port 36 on hub 32 and provides for multiple functions, including optional introduction over a guidewire, aspiration, introduction of secondary catheters, and the like.
- the dimensions and materials of access catheter 10 are selected to permit endotracheal introduction and intraluminal advancement through the lung bronchus or passageway, optionally over a guidewire and/or through a primary tracheal tube structure (as illustrated in FIG. 4B below).
- Suitable materials include low and high density polyethylenes, polyamides, nylons, PTFE, PEEK, and the like, particularly for the inner tubular member 24 .
- the outer member, including the occlusion balloon, can be made from elastomeric materials, such as polyurethane, low density polyethylene, polyvinylchloride, silicone rubber, latex, and the like.
- portions of the outer tubular member 26 proximal to the inflatable balloon can be made thicker and/or reinforced so that they do not dilate upon pressurization of the balloon.
- Exemplary dimensions for the access catheter 10 are set forth in the table below.
- ACCESS CATHETER DIMENSIONS Exemplary Preferred Inner Outer Inner Outer Tubular Tubular Tubular Tubular Member Member Member Member Member Outer Diameter (mm) 0.4-4 0.6-4.5 1-1.5 2-4 Wall Thickness (mm) 0.05-0.25 0.5-0.25 0.1-0.2 0.15-0.25 Length (cm) 50-150 same 50-80 same Balloon Length (mm) 5-50 10-20 Balloon Diameter (mm) 2-20 6-15 (inflated)
- the access catheter 10 may be modified in a number of ways, some of which are illustrated in FIGS. 3A-3F .
- the catheter can be a single extrusion having a catheter body 30 with a circular main lumen 32 and a crescent-shaped inflation lumen 34 , as illustrated in FIG. 3A .
- catheter body 40 may be formed as a single extrusion having three lumens, i.e., a primary lumen 42 for receiving a guidewire, applying aspiration, and/or delivering secondary catheters.
- a second lumen 44 can be provided for inflating the occlusion balloon, and a third lumen 46 can be provided as an alternative guidewire or aspiration lumen.
- Catheter body 50 comprising a main tubular body 52 having an outer layer 54 fused thereover to define a lumen 56 suitable for balloon inflation as shown in FIG. 3C .
- a primary lumen 58 is formed within the main tubular member 52 .
- catheter body 60 can be formed from a primary tubular member 62 , and a secondary tubular member 64 , where the tubular members are held together by an outer member 66 , such as a layer which is applied by heat shrinking.
- the primary tubular member 62 provides the main lumen 68 while secondary tube 64 provides a secondary lumen 70 .
- the secondary lumen 70 will typically be used for balloon inflation, while the primary lumen 68 can be used for all other functions of the access catheter.
- catheter body 80 can be formed to include four lumens, typically by conventional extrusion processes.
- Lumen 82 is suitable for passage over a guidewire.
- Lumens 84 and 86 both contain light fibers 88 for illumination.
- Lumen 90 carries an optical wave guide or image fiber 92 .
- Lumen 82 can be used for irrigation and aspiration, typically after the guidewire is withdrawn. Balloon inflation can be effected through the space remaining and lumens 84 and 86 surrounding the light fibers 88 .
- a second catheter body 100 is formed as a coaxial arrangement of a number separate tubes.
- Outer tube 102 contains a separate guidewire tube 104 defining lumen 106 which permits introduction over a guidewire as well as perfusion and aspiration after the guidewire is removed.
- Second inner tubular member 110 will carry an optical image fiber 112 and a plurality of light fibers 112 are passed within the remaining space 114 within the outer tubular member.
- forward imaging can be effected by illuminating through the light fibers and detecting an image through a lens at the distal end of the catheter. The image can be displayed on conventional cathode-ray or other types of imaging screens. In particular, as described below, forward imaging permits a user to selectively place the guidewire for advancing the catheters through a desired route through the branching bronchus.
- a guidewire through the branching bronchus will be manipulated while viewing through the imaging components of the access catheter. In this way, the access catheter can be “inched” along by alternately advancing the guidewire and the access catheter.
- positioning could be done solely by fluoroscopy.
- a steerable, imaging guidewire 300 FIGS. 4A-4C ) could be used.
- the guidewire 300 includes a deflectable tip 302 which can be deflected in a single plane using push/pull ribbon 304 .
- the tip will comprise a spring 306 to facilitate deflection.
- the guidewire 300 will include an optical imaging wave guide 310 and illuminating optical fibers 312 , as best seen in cross-sectional view of FIG. 4C .
- the guidewire 300 can be steered through the branching bronchus to reach the target tissue segment using its own in situ imaging capability.
- an access catheter can be introduced to the target lung tissue segment as well. Since the guidewire has imaging capability, the access catheter need not incorporate such imaging. This can be an advantage since it permits the access lumen to be made larger since the catheter need not carry any optical wave guides.
- a catheter 10 can be advanced to a lung tissue segment, specifically a diseased region DR, within a lung L through a patient's trachea T.
- Advancement through the trachea T is relatively simple and will optionally employ an endotracheal tube and/or a guidewire to select the advancement route through the branching bronchus.
- the endotracheal tube may have a thin-walled design wherein the inner diameter is larger than in standard endotracheal tubes.
- Standard endotracheal tubes have a 7.0 mm ID with a 10 mm OD.
- the thin-walled design would have a 9.0 mm ID with a 10 mm OD; the larger ID allows the insertion of a larger instrument while providing adequate ventilation. Steering can be effected under real time imaging using the imaging access catheters illustrated in FIGS. 3E and 3F .
- the access catheter 10 may be introduced through a visualizing tracheal tube, such as that described in U.S. Pat. No. 5,285,778, licensed to the assignee of the present application.
- the visualizing endotracheal tube 120 includes an occlusion cuff 122 which may be inflated within the trachea just above the branch of the left bronchus and right bronchus LB and RB, respectively.
- the visualizing endotracheal tube 120 includes a forward-viewing optical system, typically including both illumination fibers and an image fiber to permit direct viewing of the main branch between the left bronchus LB and right bronchus RB.
- a forward-viewing optical system typically including both illumination fibers and an image fiber to permit direct viewing of the main branch between the left bronchus LB and right bronchus RB.
- initial placement of the access catheter 10 can be made under visualization of the visualizing endotracheal tube 120 and optionally the access catheter 10 itself.
- the access catheter may be positioned with or without the use of a trachea tube or similar device. When such a device is used, it may take a number of forms and may be positioned in a number of locations. For example, the trachea tube or device may be positioned as shown in FIG.
- the access catheter 10 may be positioned to achieve “one lung ventilation” wherein the side of the lung not involved in the corrective procedure will be properly ventilated.
- the access catheter may be positioned under local anesthesia without intubation.
- the access catheter 10 is advanced until its distal end 14 reaches a region in the bronchus or lung passageway which leads directly into the diseased region DR.
- an obstructive device may be deployed in the passageway.
- the method of deployment or delivery of the obstructive device is dependent on a number of factors, particularly the design of the obstructive device itself.
- the obstructive device is housed within the access catheter 10 or within a catheter that may be passed through the access catheter 10 .
- the obstructive device 150 may be compressed or collapsed within an interior lumen of the access catheter 10 .
- the obstructive device 150 depicted is one of many designs which may be utilized.
- the obstructive device 150 may then be pushed out of the distal end 14 of the catheter 10 , in the direction of the arrow, into the lung passageway 152 . If the device 150 is self-expanding, for example by tension or shape-memory, the device 150 will expand and anchor itself in the passageway 152 . If the device 150 is not self-expanding, it may be expanded with the use of a balloon or other mechanism provided by the access catheter 10 , a catheter or device delivered through the access catheter 10 , or another device. Similarly, the obstructive device 150 may be mounted or crimped over the access catheter 10 (not shown) or a delivery catheter and delivered to the desired location. A sheath may then be placed over the device 150 during insertion. Deployment of the device 150 may be achieved by withdrawing the sheath and allowing the device 150 to self-expand or expanding the device 150 with the use of a balloon or other mechanism.
- obstructive devices 150 are provided.
- a number of embodiments of the obstructive device 150 are comprised of structural supports which expand to anchor the device 150 in the passageway 152 .
- the supports 154 may be comprised of radial segments 160 and longitudinal segments 162 .
- the radial segments 160 allow the device 150 to expand to fill the passageway 152 and the longitudinal segments 162 rest against the walls of the passageway 152 to help anchor the device 150 .
- the supports 154 may be individual, as shown in FIG. 7A , or may be connected to one another, as shown in FIG. 7B , for example.
- the supports 154 may continue along a proximal end 164 and distal end 166 of the device 150 , as shown in FIG. 7A , or the supports 154 may not be present at such ends 164 , 166 , as shown in FIG. 7B .
- the supports 154 may be comprised of a mesh 170 or similar interlocking structure.
- the mesh 170 may be coiled or rolled into a cylindrical shape to fit within an inner lumen of a delivery or access catheter or to be mounted on the end of a such a delivery or access catheter.
- the device 150 may be released within the lung passageway 152 where the mesh 170 expands, uncoils and/or unrolls to fill the passageway 152 . Such release may allow self-expansion or may involve the use of mechanical means to expand the mesh 170 .
- the expanded device 150 may fill the passageway 152 in a generally cylindrical shape, as shown in FIG. 9 , in single or double conical shape, as shown in FIG. 10 , or it may form a variety of other shapes, an example of which is shown in FIG. 11 .
- the supports 154 may be a helix or spiral 171 comprised of helically wound or spiral wound wire.
- the spiral 171 may be compressed in a number of ways to load the spiral 171 within a lumen or on a distal end of a delivery catheter.
- the spiral 171 may be wound tightly, similar to a watch spring, to reduce the cross-section of the spiral and provide spring tension.
- the coils 173 expand to contact the walls of the passageway 152 and anchor the device 150 .
- the supports 154 may be connected to, encapsulated in, coated or impregnated with a material to prevent flow of gases or liquids through the structural supports 154 , thereby providing an obstruction.
- the material may include an antibiotic agent for release into the lung passageway.
- obstructive materials include a thin polymer film 156 , such as webbing between the structural supports 154 , which may be used to seal against the surface of the lung passageway 152 . Such a design is depicted in FIGS. 7A-7B , 10 and 12 .
- the structural supports 154 may be filled with an adhesive or sealant which will adhere the structural support members together and prevent flow or gasses or liquids through the device 150 .
- the supports 154 may be encased in a sack 158 comprised of a thin polymer, foam or other material. Expansion of the supports 154 within the sack 158 presses the sack 158 against the walls of the passageway 152 forming a seal.
- the sack 158 has been extended beyond the ends of the rolled support structure 154 for illustration purposes to differentiate between the sack 158 and support structure 154 . However, typically, the support structure 154 will fill the sack 158 .
- the structural supports may comprise a variety of designs, creating devices 150 of various lengths and shapes.
- the sack 158 may be utilized without structural supports 154 .
- the sack may expand to fill the passageway by a variety of methods and may be held in position by impregnation with an adhesive or other material. Such impregnation may rigidify or support the sack to provide obstruction of the lung passageway.
- a number of embodiments of the obstructive device 150 include an inlet port 172 , located near the proximal end 164 , and an outlet port 174 , located near the distal end 166 .
- Such ports 172 , 174 may be of any size or shape but are typically round or oval and are often located near the center of the passageway 512 lumen for ease of accessibility.
- Some devices 150 may only include an inlet port 172 near the proximal end 164 , as shown in FIG. 13 . In this case, the distal end 166 is expanded to contact the walls of the lung passageway 152 and anchor the device 150 .
- the obstruction device 150 appears to have a cone shape with the inlet port 172 at the apex of the cone. To ensure concentric placement of the obstruction device 150 , the device 150 should contact the walls of the passageway 152 for a length of at least 1.0 to 1.5 times the internal diameter of the passageway that the device 150 occupies.
- the inlet port 172 , outlet port 174 or both may comprise a membrane or septum 176 covering the opening of the port.
- the septum 176 will typically be self-sealing.
- One type of self-sealing septum 176 comprises a solid membrane 178 , illustrated in FIG. 14A .
- Other types comprise pre-cut membranes in which the septum 176 includes cuts 180 or slits, as shown in FIGS. 14B and 14C . Such cuts 180 may allow ease of penetration through the septum 176 by an access tube or penetrating element, as will be later described, while preventing flow through the septum when the penetrating element is removed.
- the device 150 may be left as an implant to obstruct the passageway 152 from subsequent airflow.
- Airflow may include air and/or any other gas or combination of gases, such as carbon dioxide.
- the above described embodiments of the device 150 may be accessed to aspirate the lung tissue segment through the obstructive device 150 . This will cause the segment to at least partially collapse as part of a method for lung volume reduction. Aspirating through the obstructive device 150 may be accomplished by a variety of methods. For example, referring to FIG.
- aspiration may be achieved by first inserting a penetration element, needle or access tube 200 through the septum 176 of the inlet port 172 .
- Positioning of the access tube 200 for such insertion may be achieved by any method, however, the access tube 200 is typically positioned by inserting the access tube 200 , or a catheter carrying the access tube 200 , through a lumen in the access catheter 10 until it passes out of the distal end 14 . Inflating the balloon 18 on the access catheter 10 may center the distal end 14 of the catheter in the lung passageway 152 . If the inlet port 172 is similarly centered, the access tube 200 may be passed directly out of the catheter 10 and through the septum 176 of the inlet port 172 .
- the access tube 200 may be sharp enough to puncture or pierce the membrane 178 . If the septum 176 has cuts 180 or slits, the access tube 200 may be pushed through the cuts 180 . In either case, the membrane or septum 176 will seal around the access tube 200 . If the obstruction device 150 also has an outlet port 174 , the access tube 200 may optionally be passed through both the inlet and outlet ports 172 , 174 . Once the access tube 200 is inserted, gases and/or liquids may be aspirated through the access tube 200 from the lung tissue segment and associated lung passageways.
- a 100% oxygen, Helium-Oxygen mixture or low molecular weight gas washout of the lung segment may be performed by introducing such gas through the access tube 200 .
- aspiration would removed both the introduced gas and any remaining gas.
- liquid perfluorocarbon or certain drugs, such as antibiotics may be introduced prior to aspiration. This may allow access to the collapsed lung segment at a later time, for example, in the case of an infection. In most cases, aspiration will at least partially collapse the lung segment, as previously described.
- the access tube 200 may then be withdrawn.
- the septum 176 of the inlet port 172 and/or outlet port 174 will then automatically seal, either by closing of the puncture site or by closure of the cuts.
- the ports may be additionally sealed with a sealant or by use of a heat source or radiofrequency source.
- aspiration through the obstructive device 150 may be achieved by contacting the obstructive device 150 with a suction tube or aspiration catheter 202 and aspirating gas or liquids through the device 150 .
- the distal end 204 of the aspiration catheter 202 may be held against the inlet port 172 .
- Positioning of the aspiration catheter 202 for such contact may be achieved by any method, however the catheter 202 is typically positioned in a manner similar to the access tube described above.
- a seal may be created and gases and/or liquids may be aspirated from the lung tissue segment through the device 150 .
- the inlet port 172 and the outlet port 174 if present, must not be covered by a solid membrane 178 . If cuts 180 are present, the gas or liquid may flow through the port due to the pressure of the suction. As shown in FIG. 17 , the distal end 204 of the aspiration catheter 202 may be slid over the inlet port 172 to form a seal. Again, gases and/or liquids may then be aspirated through the device 150 in a similar manner. The aspiration catheter 202 may then be withdrawn. The septum 176 of the inlet port 172 and/or outlet port 174 will then automatically seal, typically by closure of the cuts. Optionally, the ports may be additionally sealed with a sealant or by use of a heat source or radiofrequency source.
- the obstruction device 150 may be deployed, anchored and aspirated therethrough while connected to an aspiration catheter 210 .
- the access catheter 10 is positioned within the lung passageway 152 at a desired location. If the catheter 10 has an inflatable occlusion balloon 18 near its distal end 14 , the balloon 18 may be inflated to secure and center the catheter 10 within the passageway 152 ; however, this step is optional.
- an aspiration catheter 210 carrying an obstruction device 150 is then introduced through a lumen in the access catheter 10 . As shown in FIG.
- the aspiration catheter 210 is advanced so that the obstruction device 150 emerges from the distal end 14 of the access catheter 10 and deploys within the lung passageway 152 . Expansion and anchoring of the obstruction device 150 within the passageway 152 may be achieved by self-expansion or by expansion with the aid of a balloon, for example.
- the lung tissue segment isolated by the device 150 is then aspirated through the device 150 and the attached aspiration catheter 210 . Such aspiration may remove air, gases, or liquids from the segment and lung passageway 152 to at least partially collapse the lung segment.
- the obstruction device 150 is then detached from the aspiration catheter 210 and left behind in the passageway 152 .
- the proximal end 164 of the obstruction device 150 may comprise an inlet port 172 which would allow subsequent access to the isolated lung tissue segment at a later time.
- the proximal end 164 may comprise a sealed end, wherein the obstruction device 150 may not be subsequently accessed and may provide long-term isolation of the terminal lung tissue segment.
- the above described method may be similarly achieved without the use of an aspiration catheter 210 .
- the obstruction device 150 may be carried directly by the access catheter 10 and may be deployed while remaining attached to the access catheter 10 .
- Aspiration may be achieved through the obstruction device 150 and the access catheter 10 to remove gases from the isolated lung tissue segment and passageway 152 .
- the obstructive device 150 may then be detached from the access catheter 10 and left behind in the passageway 152 for subsequent access or simple occlusion.
- the obstruction device 150 may remain in its anchored position, as described.
- the obstruction device 150 will essentially occlude the lung passageway 152 and prevent the inflow or outflow of air or gases to the isolated lung tissue segment or diseased region DR. This may be effective in maintaining the desired level of collapse of the lung tissue segment to achieve lung volume reduction.
- the lung tissue segment may be reaccessed and/or reaspirated by repeating the steps described above.
- the obstruction device 150 may be removed from the lung passageway 152 , either by collapse of the expandable structure or by other means.
- Additional embodiments of the obstructive device 150 are comprised of a unidirectional valve.
- the valve may be operated upon access or it may operate in response to respiration.
- the valve may be accessed by engaging an aspiration catheter or a coupling member to the valve. Aspiration through the aspiration catheter or coupling member then opens the valve to remove gases and/or liquids from the isolated lung segment.
- the valve may open automatically in response to respiration.
- the valve may open during expiration to allow outflow of gas from the lung segment and the close during inspiration to prevent inflow of gas to the lung segment.
- the unidirectional valves may take a number of forms.
- the unidirectional valve 230 front-view shown in FIG. 19A , is comprised of a port 232 and a flexible layer 233 which is attached to the port 232 by at least one point of connection 234 .
- the flexible layer 233 may be attached to the front surface of the port 232 at four symmetrical points of connection 234 .
- edges 236 of the layer 233 are positioned outside of the opening of the port 232 (indicated by dashed lines). This provides a desired seal when the valve is in the closed position.
- FIGS. 19B and 19C depict the valve 230 during different stages of the respiratory cycle.
- the valve 230 opens, as depicted in FIG. 19B .
- expiration of gases is illustrated by arrows.
- Gases exiting through the lung passageway, within which the valve 230 is positioned, apply force to the backside of the flexible layer 233 causing the layer 233 to expand outwardly away from the surface of the port 232 as shown. This allows the gases to flow through the spaces between the points of connection 234 .
- inspiration the valve 230 closes, as depicted in FIG. 19C .
- inspiration of air is illustrated by an arrow. Air entering the lung passageway applies force to the front side of the flexible layer 233 causing the layer 233 to seal against the surface of the port 232 as shown. This prevents gases from flowing through the valve 230 .
- Unidirectional valves 230 may be positioned in the lung passageway 152 by methods similar to those previously described for other types of obstruction devices 150 .
- the valve 230 may be positioned in the passageway 152 so that the outside perimeter of the port 232 contacts the walls of the passageway 152 .
- the valve 230 is essentially the size of the passageway lumen and provides the maximum area for potential flow-through of gas.
- the valve 230 is depicted in its open state, with gas flow traveling from an isolated lung tissue segment, through the valve and out of the patient's airways.
- the valve 230 may alternatively be attached to or part of structural supports 154 which expand radially to anchor the device 150 in the passageway 152 . Such supports 154 are similar to those previously described.
- the valve 230 is depicted in its open state. It may be appreciated that the valve 230 may be of any size or shape and may substituted for any of the inlet and/or outlet ports previously described.
- FIGS. 22A-22B Another embodiment of a unidirectional valve is illustrated in FIGS. 22A-22B .
- the valve 230 is comprised of a port 232 and a flexible layer 233 as in the previous embodiment.
- the flexible layer 233 has a series of holes 250 through the layer.
- the valve 230 is comprised of a partition 252 which also has holes 250 .
- the holes 250 may be of any size, shape or arrangement throughout the entire or a portion of the layer 233 and partition 252 .
- the partition 252 covers the port 232 and the layer 233 is positioned over the partition 252 , as illustrated in FIG. 22A and depicted by arrows, so that the holes 250 are substantially misaligned and therefore blocked.
- the layer 233 is attached to the partition 252 and/or port 232 along its perimeter; it may be a continuous attachment or may have discrete points of connection with spaces therebetween.
- FIGS. 23B and 23C depict the valve 230 during different stages of the respiratory cycle.
- the valve 230 opens, as depicted in FIG. 23B .
- expiration of gases is illustrated by arrows.
- Gases exiting through the lung passageway, within which the valve 230 is positioned pass through the holes 250 in the partition 252 and apply force to the backside of the flexible layer 233 .
- the valve 230 closes, as depicted in FIG. 23C .
- inspiration of air is illustrated by an arrow.
- Air entering the lung passageway applies force to the front side of the flexible layer 233 causing the layer 233 to seal against the surface of the partition 252 as shown. This prevents gases from flowing through the valve 230 .
- This embodiment of a unidirectional valve 230 may be positioned in a lung passageway 152 by methods similar to those previously described for other types of obstruction devices 150 , particularly as shown in FIGS. 20 and 21 .
- valves may additionally or alternatively be operated manually.
- Valves positioned in a lung passageway may be accessed by coupling an aspiration catheter to the valve. Coupling may comprise engaging the aspiration catheter, a suitable catheter or a coupling member to the valve.
- the valve 230 comprises a port 232 which is smaller in diameter than the lumen of the lung passageway, as depicted in FIG. 21
- the distal end of the aspiration catheter or coupling member may be slid over the port to form a seal. This was previously depicted in FIG.
- FIGS. 24 and 25 Further embodiments of the obstructive device 150 are comprised of a blockage device 280 having no ports through which aspiration of the isolated lung tissue segment may be achieved. After the blockage device 280 is deployed and anchored within a lung passageway 152 leading to a lung tissue segment, the device 280 is to be left as an implant to obstruct the passageway 152 from subsequent airflow. Although the previously described embodiments of obstructive devices 150 having inlet and/or outlet ports 172 , 174 may be utilized in a similar manner, the blockage device 280 may not be later accessed to aspirate the lung tissue segment through the device. An example of such a blockage device 280 is illustrated in FIGS. 24 and 25 .
- the blockage device 280 may be housed within the access catheter 10 or within a catheter that may be passed through the access catheter 10 . As depicted in FIG. 24 , the obstructive device 150 may be compressed or collapsed within an interior lumen of the access catheter 10 .
- the blockage device 280 depicted is one of many designs which may be utilized. The blockage device 280 may then be pushed out of the distal end 14 of the catheter 10 , in the direction of the arrow, into the lung passageway 152 .
- the device 280 is to be self-expanding by tension or shape-memory so that it will expand and anchor itself in the passageway 152 .
- one embodiment of the blockage device 280 comprises a coil 282 .
- the coil 282 may be comprised of any type of wire, particularly superelastic or shape-memory wire, polymer or suitable material.
- the tension in the coil 282 allows the device 280 to expand to fill the passageway 152 and rest against the walls of the passageway 152 to anchor the device 280 .
- the coil 282 may be connected to a thin polymer film 284 , such as webbing between the coils, to seal against the surface of the lung passageway 152 .
- a film 284 prevents flow of gases or liquids through the coils, thereby providing an obstruction.
- the coil 282 may be encased in a sack 286 . Expansion of the coil 282 within the sack 286 presses the sack 286 against the walls of the passageway 152 forming a seal. Again, this prevents flow of gases or liquids, depicted by arrows, through the coil 282 , thereby providing an obstruction.
- another embodiment of the blockage device 280 comprises a mesh 283 .
- the mesh 283 may be comprised of any type of wire, particularly superelastic or shape-memory wire, polymer or suitable material.
- the tension in the mesh 283 allows the device 280 to expand to fill the passageway 152 and rest against the walls of the passageway 152 to anchor the device 280 .
- the mesh 283 may be connected to a thin polymer film 284 , such as webbing between the lattice of the mesh, to seal against the surface of the lung passageway 152 .
- a film 284 prevents flow of gases or liquids through the mesh, thereby providing an obstruction.
- FIG. 27 another embodiment of the blockage device 280 comprises a barb-shaped structure 304 designed to be wedged into a lung passageway 152 as shown.
- a structure 304 may be comprised of a solid material, an inflatable balloon material, or any material suitable to provide a blockage function.
- the structure 304 may be inflated before, during or after wedging to provide sufficient anchoring in the lung passageway.
- the structure 304 may be impregnated or infused with an adhesive or sealant before, during or after wedging to also improve anchoring or resistance to flow of liquids or gasses through the passageway 152 .
- FIG. 28 another embodiment of the blockage device 280 comprises an inflated balloon.
- a balloon may take a number of forms.
- the balloon may have take a variety of shapes, such as round, cylindrical, conical, dogboned, or multi-sectional, to name a few.
- a series of distinct or interconnected balloons may be utilized.
- the surface of the balloon may be enhanced by, for example, corrugation or texturing to improve anchoring of the balloon within the lung passageway.
- FIG. 28 illustrates a cylindrical-type balloon 300 with textured friction bands 302 which contact the walls of the lung passageway 152 when the balloon 300 is inflated as shown.
- balloons may be inflated with an number of materials, including saline, gas, suitable liquids, expanding foam, and adhesive, to name a few.
- a multi-layer balloon 310 may be utilized, as shown in FIG. 29 , which allows the injection of adhesive 312 or suitable material between an outer layer 314 and an inner layer 316 of the balloon 310 .
- adhesive 312 may provide a hardened shell on the obstruction device 280 to improve its obstruction abilities.
- the balloon 310 may be inflated within the inner layer 316 with a foam 318 or other material.
- FIG. 29 shows that provides a hardened shell on the obstruction device 280 to improve its obstruction abilities.
- the outer layer 314 of the blockage device 280 may contain holes, pores, slits or openings 320 which allow the adhesive 312 to emerge through the outer layer 314 to the outside surface of the multi-layer balloon 310 .
- the outer layer 314 of the balloon 310 will press against the walls of the passageway 152 and the adhesive 312 will bond with the walls in which it contacts.
- adhesion is designed to improve anchorage and obstructive abilities of the blockage device 280 .
- the above described blockage devices may be impregnated, coated or otherwise deliver an antibiotic agent, such as silver nitrate. Such incorporation may be by any means appropriate for delivery of the agent to the lung passageway.
- a multi-layer balloon may be provided which allows the injection of an antibiotic agent between an outer layer and an inner layer of the balloon 310 .
- the outer layer 314 of the blockage device 280 may contain holes, pores, slits or openings 320 which allow the agent to emerge through the outer layer 314 to the outside surface of the multi-layer balloon 310 .
- the agent may be delivered to the walls and/or the lung passageway.
- blockage device 280 may comprise a variety of designs having various lengths and shapes.
- many of the designs illustrated for use as a blockage device 280 may also be adapted with an aspiration port for use as described in relation to the previously illustrated embodiments of obstruction devices 150 .
- a port 172 having a septum 176 is shown in FIG. 30 . If the port is not accessed, the device simply serves as a blockage device 280 .
- blockage devices 280 and obstructive devices 150 are synonymous.
- kits 400 comprise at least an obstruction or blockage device 500 and instructions for use IFU.
- the kits may further include any of the other system components described above, such as an access catheter 10 , guidewire 402 , access tube 200 , aspiration catheter 202 or other components.
- the instructions for use IFU will set forth any of the methods as described above, and all kit components will usually be packaged together in a pouch 450 or other conventional medical device packaging.
- those kit components which will be used in performing the procedure on the patient will be sterilized and maintained sterilely within the kit.
- separate pouches, bags, trays, or other packaging may be provided within a larger package, where the smaller packs may be opened separately and separately maintain the components in a sterile fashion.
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Abstract
The present invention provides improved methods, systems, devices and kits for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung. Isolation is achieved by deploying an obstructive device in a lung passageway leading to the target lung tissue segment. Once the obstructive device is anchored in place, the segment can be aspirated through the device. This may be achieved by a number of methods, including coupling an aspiration catheter to an inlet port on the obstruction device and aspirating through the port. Or, providing the port with a valve which allows outflow of gas from the isolated lung tissue segment during expiration of the respiratory cycle but prevents inflow of air during inspiration. In addition, a number of other methods may be used. The obstructive device may remain as an implant, to maintain isolation and optionally allow subsequent aspiration, or the device may be removed at any time.
Description
- The present application is a continuation of U.S. patent application Ser. No. 10/382,131 (Attorney Docket No. 017534-001210US), filed Mar. 4, 2003, which was a continuation of U.S. patent application Ser. No. 09/699,302 (Attorney Docket No. 017534-001200), filed Oct. 27, 2000, which is related to co-pending U.S. patent application Ser. No. 09/699,313 (Attorney Docket No. 017534-001300), also filed Oct. 27, 2000, the full disclosures of which are incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates generally to medical methods, systems, and kits. More particularly, the present invention relates to methods and apparatus for effecting lung volume reduction by aspirating isolated segments of lung tissue.
- Chronic obstructive pulmonary disease is a significant medical problem affecting 16 million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and chronic obstructive pulmonary disease remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit.
- Of particular interest to the present invention, lung function in patients suffering from some forms of chronic obstructive pulmonary disease can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung. Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood. Lung reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades.
- While effective in many cases, conventional lung reduction surgery is significantly traumatic to the patient, even when thoracoscopic procedures are employed. Such procedures often result in the unintentional removal of healthy lung tissue, and frequently leave perforations or other discontinuities in the lung which result in air leakage from the remaining lung. Even technically successful procedures can cause respiratory failure, pneumonia, and death. In addition, many older or compromised patients are not able to be candidates for these procedures. For these reasons, it would be desirable to provide improved methods, systems, and kits for performing lung volume reduction which overcome at least some of the shortcomings noted above.
- 2. Description of the Background Art
- WO 99/01076 and corresponding U.S. Pat. No. 5,957,919 describes devices and methods for reducing the size of lung tissue by applying heat energy to shrink collagen in the tissue. In one embodiment, air may be removed from a bleb in the lung to reduce its size. Air passages to the bleb may then be sealed, e.g., by heating, to fix the size of the bleb. WO 98/48706 describes a plug-like device for placement in a lung air passage to isolate a region of lung tissue, where air is not removed from the tissue prior to plugging. WO 98/49191 describes the use of surfactants in lung lavage for treating respiratory distress syndrome. U.S. Pat. No. 5,925,060 may also be of interest.
- Patents and applications relating to lung access, diagnosis, and treatment include U.S. Pat. Nos. 5,957,949; 5,840,064; 5,830,222; 5,752,921; 5,707,352; 5,682,880; 5,660,175; 5,653,231; 5,645,519; 5,642,730; 5,598,840; 5,499,625; 5,477,851; 5,361,753; 5,331,947; 5,309,903; 5,285,778; 5,146,916; 5,143,062; 5,056,529; 4,976,710; 4,955,375; 4,961,738; 4,958,932; 4,949,716; 4,896,941; 4,862,874; 4,850,371; 4,846,153; 4,819,664; 4,784,133; 4,742,819; 4,716,896; 4,567,882; 4,453,545; 4,468,216; 4,327,721; 4,327,720; 4,041,936; 3,913,568 3,866,599; 3,776,222; 3,677,262; 3,669,098; 3,542,026; 3,498,286; 3,322,126; WO 95/33506, and WO 92/10971.
- Lung volume reduction surgery is described in many publications, including Becker et al. (1998) Am. J. Respir. Crit. Care Med. 157:1593-1599; Criner et al. (1998) Am. J. Respir. Crit. Care Med. 157:1578-1585; Kotloffet al. (1998) Chest 113:890-895; and Ojo et al. (1997) Chest 112:1494-1500.
- The use of mucolytic agents for clearing lung obstructions is described in Sclafani (1999) AARC Times, January, 69-97. Use of a balloon-cuffed bronchofiberscope to reinflate a lung segment suffering from refractory atelectasis is described in Harada et al. (1983) Chest 84:725-728.
- The present invention provides improved methods, systems, devices and kits for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The present invention is likewise suitable for the treatment of bronchopleural fistula. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung. Isolation is achieved by deploying an obstructive device in a lung passageway leading to the target lung tissue segment. Once the obstructive device is anchored in place, the segment can be aspirated through the device. This may be achieved by a number of methods, including coupling an aspiration catheter to an inlet port on the obstruction device and aspirating through the port. Or, providing the port with a valve which allows outflow of gas from the isolated lung tissue segment during expiration of the respiratory cycle but prevents inflow of air during inspiration. In addition, a number of other methods may be used. The obstructive device may remain as an implant, to maintain isolation and optionally allow subsequent aspiration, or the device may be removed at any time. Likewise, the device may biodegrade over a period of time.
- The obstruction device may take a variety of forms to allow delivery, deployment and anchoring in a lung passageway. Delivery is commonly performed with the use of a minimally invasive device, such as a flexible bronchoscope or an access catheter. The flexible bronchoscope may be utilized with a sheath having an inflatable cuff disposed near its distal end, a full description of which is provided in co-pending application [Attorney Docket No. 017534-001300], assigned to the assignee of the present invention and incorporated by reference for all purposes. When using such a sheath, the scope is introduced into a lumen in the sheath to form an assembly which is then introduced to the lung passageway. The cuff may then be inflated to occlude the passageway. Similarly, an access catheter may be used which may be steerable or articulating, may include an inflatable balloon cuff near its distal end and may include a number of lumens for balloon inflation, tracking over a guidewire, and optical imaging, to name a few. The obstruction device is typically housed within a lumen of the access catheter, bronchoscope, sheath or suitable device, mounted near the distal tip of the catheter or carried by any method to the desired lung passageway leading to the target lung tissue segment. Therefore, the obstruction device must be sized appropriately for such delivery and is typically designed to expand upon deployment to anchor within the lung passageway. Hereinafter the present invention is depicted in relation to use with an access catheter, however it may be appreciated that any suitable device may be used.
- In a first aspect of the present invention, the obstruction device comprises a structural support which expands and thereby anchors the device in the lung passageway. Such supports may comprise a number of configurations for a variety of expansion techniques. For example, the structural supports may allow the obstruction device to coil, roll, bend, straighten or fold in a cone, rod, cylinder or other shape for delivery. Then, once positioned in a desired location, the obstruction device may be released and expanded to anchor the device in the passageway. Such expansion may be unaided, such as in the release of a compressed structure to a pre-formed expanded position. Or, such expansion may be aided, such as with the use of an inflatable balloon or cuff. In some cases, a balloon or inflatable member may be incorporated into the obstruction device and may remain inflated to occlude the passageway. This may be provided in combination with structural supports or an inflatable balloon or similar device may be used without such support.
- The structural supports may be comprised of any type of wire, particularly superelastic, shape-memory or spring tempered wire, or any type of polymer or a suitable material. The balloon or inflatable member may be comprised of any flexible, polymeric material suitable for such a purpose. The member may be inflated with gas or liquid as desired, or it may be inflated with an expanding foam or similar material. Likewise, it may be inflated or injected with an adhesive. Such an adhesive may expand the member and/or rigidify the member to reduce the likelihood of collapse. Further, the adhesive may additionally serve to bond the device to the walls of the lung passageway to increase anchorage. In addition, the device may be impregnated or coated with an antibiotic agent, such as silver nitrate, or similar agent for delivery of the agent to the lung passageway. Such delivery may occur by any applicable means.
- When structural supports are present, such supports may comprise a variety of designs. In a first embodiment, the structural supports comprise radial segments which expand to fill the passageway and longitudinal segments which rest against the walls of the passageway to help anchor the device. In a second embodiment, the structural supports comprise a mesh which expands to fill the passageway. In a third embodiment, the structural supports comprise a helically or spirally wound wire which also expands to contact the walls of the passageway and anchor the device. In each of these embodiments, the structural support may be connected with or encapsulated in a sack comprised of a thin polymeric film, open or closed cell foam or other suitable material to provide a seal against walls of the lung passageway and obstruct airflow through the device. The sack material may also be infused with an adhesive, sealant or other material to improve obstruction of the airway and possibly improve adhesion to the airway walls.
- In a second aspect of the present invention, the obstruction device may further comprise ports for aspiration through the device. This may allow access to the collapsed lung segment at a later time, for example, in the case of an infection. Typically, the obstruction device will have an inlet port located near the proximal end of the device, away from the isolated lung tissue segment. Such a port is thus accessible by minimally invasive devices, such as an aspiration catheter, which may be advanced through the bronchial passageways. Optionally, an outlet port may be located near the distal end of the obstruction device. The ports may comprise a variety of designs for a number of purposes.
- In a first embodiment, the port comprises a self-sealing septum. Such a septum may comprise a solid membrane or a pre-cut membrane. Aspiration through the port may be achieved with the use of an aspiration catheter having an access tube or penetrating element at its distal end. Such a catheter may be advanced to the site of the obstruction device itself or with the use of an access catheter. The septum may be penetrated, either pierced through a solid membrane or passed through the cuts of a pre-cut membrane, by the access tube. Depending on the design of the obstruction device, the inlet port and optionally the outlet port may be penetrated in this fashion. Aspiration may be achieved through the access tube and aspiration catheter to withdraw gases and/or liquids from the isolated lung tissue segment and passageway. Optionally, prior to aspiration, a 100% oxygen, Helium-Oxygen mixture or low molecular weight gas washout of the lung segment may be performed by introducing such gas through the access tube, such as by a high frequency jet ventilation process. In this case, aspiration would remove both the introduced gas and any remaining gas. Similarly, liquid perfluorocarbon or certain drugs, such as antibiotics, retinoic acid and hyaluronic acid, may be introduced prior to aspiration. In most cases, aspiration will at least partially collapse the lung segment. Upon removal of the aspiration catheter from the port, the septum may self-seal or it may be further sealed with a sealant or other sealing means for later access or permanent closure.
- When the self-sealing septum comprises a pre-cut membrane, aspiration through the port may alternatively be achieved by coupling an aspiration catheter to the obstructive device. Coupling may comprise engaging the aspiration catheter to the port or sliding a coupling member or the aspiration catheter over the port to form a seal. In either case, suction through the aspiration catheter may allow gases and/or liquids to pass through the cuts in the membrane to be withdrawn from the isolated lung tissue segment and passageway. Again, this will at least partially collapse the lung segment. Likewise, upon removal of the aspiration catheter from the port, the septum may self-seal or it may be further sealed with a sealant or other sealing means for later access or permanent closure.
- In a second embodiment, the port comprises a unidirectional valve. Such a valve may comprise a port covered by a flexible layer which is attached to the port by at least one point of connection. Movement of the layer away from the port opens the valve and movement against the port closes the valve. Wherein the flexible layer is solid, movement of the layer away from the port allows gas to flow between the points of connection and around the edges of the flexible layer. Alternatively, the flexible layer may have holes therethrough. In this case, the port may also comprise a partition having holes which are not aligned with the holes in the flexible layer. Movement of the layer away from the port allows gas to flow through the holes in the partition and out through the holes in the flexible layer. When the layer moves against the partition, the holes will be covered closing the valve. Other valve designs include a spring-loaded ball valve or a biased pre-loaded diaphragm valve.
- Aspiration through a unidirectional valve may be achieved by a number of methods. Again, the port may be accessed by advancing an aspiration catheter or similar device through the bronchial passageways to the site of the obstruction device. This may optionally be achieved with the use of an access catheter. The aspiration catheter may be placed near the valve or engaged to the valve, wherein suction or vacuum applied through the catheter opens the valve. If the aspiration catheter is not engaged to the valve, adequate suction to open the valve may be achieved by occluding the passageway proximal to the point of suction which is typically the distal end of the aspiration catheter. Such occlusion may be achieved by inflating a balloon or occlusion device mounted on the distal end of the aspiration catheter or mounted on an access catheter. In either case, the vacuum may draw the flexible layer away from the port, allowing gases and/or liquids to flow out from the isolated lung segment, through the valve and into the aspiration catheter. Alternatively, aspiration through a unidirectional valve may be achieved naturally during respiration. Pressure changes may open the valve during expiration as gases flow out from the isolated lung segment. Reverse pressure changes, during inspiration, may close the valve preventing gases from flowing into the isolated segment. This may reduce the amount of gas trapped in the terminal segment over time and thus at least partially collapse the lung segment. Similarly, aspiration through the unidirectional valve may be achieved by external mechanical pressure on the lung to force out of the lung segment and through the valve. Again, reverse pressure changes upon recoil of the lung would close the valve preventing gases from flowing into the isolated segment.
- In a third aspect of the present invention, the obstruction device may comprise a blockage device which is deployed in a lung passageway to close the airway. Such a blockage device may be of similar design as previously described obstruction devices as it may be similarly delivered, deployed and anchored within a lung passageway. Thus, embodiments of the blockage device typically comprise expandable support structures. For example, in one embodiment the support structure comprises a coil. And, in a second embodiment, the support structure comprises a mesh. Again, the support structures may be connected to or encased in a polymer film or sack to provide a seal against the walls of the lung passageway and obstruct airflow through the device. Typically the blockage device will be placed in the passageway after the terminal lung segment has been aspirated by other methods. This will seal off the lung segment and maintain lung volume reduction. Alternatively, the blockage device may be placed in the passageway before the terminal lung segment has been aspirated. In this case, air trapped in the lung segment may be absorbed over time and would eventually collapse, a process known as absorption atelectasis. This process may be enhanced by insufflating the lung segment with 100% oxygen, a Helium-Oxygen mixture or low molecular weight gas prior to placing the blockage device. Such enhancement may promote complete collapse of the lung segment. In any case, the blockage device may optionally be later removed if it is so desired.
- Methods of the present invention include the utilization of an obstruction device to achieve lung volume reduction. As described above, methods include delivery, deployment and anchoring of an obstruction device in a lung passageway leading to a target lung tissue segment. At least partial collapse of the terminal lung tissue segment may be achieved by aspirating the segment through the obstruction device deployed in the passageway. Aspiration may be accomplished with the use of an aspiration catheter or similar device through a port on the obstruction device. Also described above, when the port comprises a unidirectional valve, aspiration and eventual lung volume reduction may be accomplished by the opening and closing of the valve in response the respiratory cycle. In addition, methods of the present invention include deployment of a blockage device in a lung passageway leading to a terminal lung tissue segment, as previously described.
- Systems of the present invention may include any of the components described in relation to the present invention. A particular embodiment of a system of the present invention comprises an access catheter and an obstruction device, as described above, wherein the obstruction device is introduceable by the access catheter. For example, the obstruction device may be houseable within a lumen of the access catheter for deployment out the distal end of the catheter, or the obstruction device may be mountable on the access catheter near its distal end. In either case, the obstruction device may be deployed and anchored within a lung passageway.
- The methods and apparatuses of the present invention may be provided in one or more kits for such use. The kits may comprise an obstruction device deployable within a lung passageway and instructions for use. Optionally, such kits may further include any of the other system components described in relation to the present invention and any other materials or items relevant to the present invention.
- Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.
-
FIG. 1 is a perspective illustration of an access catheter useful in the methods, systems, and kits of the present invention. -
FIG. 2 is a cross-sectional view taken alongline 2 to aFIG. 1 . -
FIGS. 3A-3F illustrate alternative cross-sectional views of the access catheter ofFIG. 1 . -
FIGS. 4A-4C illustrate a steerable imaging guidewire which may be used to facilitate positioning of the access catheter used in the methods of the present invention. -
FIG. 5A illustrates use of the access catheter ofFIG. 1 for accessing a target lung tissue segment according the to the methods of the present invention. -
FIG. 5B illustrates use of a visualizing tracheal tube with the access catheter ofFIG. 1 for accessing a target tissue segment according the to the methods of the present invention. -
FIG. 6 illustrates a method of deployment or delivery of an obstructive device. -
FIGS. 7A-7B are perspective views of embodiments of obstructive devices having, among other features, radial and longitudinal structural supports. -
FIG. 8 is a perspective view of an embodiment of an obstructive device in a rolled configuration prior to release in a lung passageway. -
FIG. 9 is a perspective view of an embodiment of a rolled, cylindrical shaped obstructive device in an expanded state within a flexible sack. -
FIG. 10 illustrates an embodiment of a double conical shaped obstructive device. -
FIG. 11 is a perspective view of an embodiment of an obstructive device having, among other features, a mesh structural support encased by a polymer film. -
FIG. 12 is a perspective view of an embodiment of an obstructive device having, among other features, a spiral structural support. -
FIG. 13 is a perspective view of an embodiment of an obstructive device having a cone shape with an inlet port at the apex of the cone. -
FIGS. 14A-14C illustrate embodiments of self-sealing septums of the present invention. -
FIG. 15 illustrates a method of aspirating through an obstructive device by inserting an access tube through a septum of an inlet port. -
FIG. 16 illustrates a method of aspirating through an obstructive device by contacting an aspiration catheter to an inlet port. -
FIG. 17 illustrates a method of aspirating through an obstructive device by sliding the distal end of an aspiration catheter over an inlet port. -
FIGS. 18A-18C illustrate a method of deploying, anchoring and aspirating through an obstruction device while such a device is connected to an aspiration catheter. -
FIG. 19A is a front view of an embodiment of a unidirectional valve of the present invention.FIGS. 19B-19C are perspective views of the unidirectional valve ofFIG. 19A in various stages of operation. -
FIGS. 20-21 illustrate positioning of embodiments of unidirectional valves of the present invention in a lung passageway. -
FIGS. 22A-22B are front views of an embodiment of a unidirectional valve of the present invention. -
FIGS. 23A-23B are perspective views of the unidirectional valve ofFIGS. 21A-21B in various stages of operation. -
FIG. 24 illustrates a method of deployment or delivery of a blockage device. -
FIG. 25 illustrates an embodiment of a blockage device comprising a coil encased in a polymer film. -
FIG. 26 illustrates an embodiment of a blockage device comprising a mesh connected to a polymer film. -
FIG. 27 illustrates an embodiment of a blockage device comprising a barb-shaped structure. -
FIG. 28 illustrates an embodiment of a blockage device having a cylindrical-type balloon with textured friction bands. -
FIG. 29 depicts an embodiment of a blockage device comprising a multi-layer balloon which has an adhesive material between an outer layer and an inner layer of the balloon. -
FIG. 30 illustrates an embodiment of a blockage device which is similar to that ofFIG. 29 , including openings in the outer layer through which adhesive may seep. -
FIG. 31 illustrates a kit constructed in accordance with the principles of the present invention. - Lung volume reduction is performed by collapsing a target lung tissue segment, usually within lobar or sub-lobular regions of the lung which receive air through a single lung passage, i.e., segment of the branching bronchus which deliver to and receive air from the alveolar regions of the lung. Such isolated lung tissue segments are first isolated and then collapsed by aspiration of the air (or other gases or liquids which may be present) from the target lung tissue segment. Lung tissue has a very high percentage of void volume, so removal of internal gases can reduce the lung tissue to a small percentage of the volume which it has when fully inflated, i.e. inflated at normal inspiratory pressures. The exemplary and preferred percentages for the volume reduction are set forth above.
- The methods of the present invention will generally rely on accessing the target lung tissue segment using an access catheter adapted to be introduced endotracheally into the bronchus of the lung. An
exemplary access catheter 10 is illustrated inFIGS. 1 and 2 and comprises acatheter body 12 having adistal end 14, aproximal end 16, and at least one lumen therethrough. Optionally, thecatheter 10 further comprises aninflatable occlusion balloon 18 near its distal end. In this case, the catheter will have at least two lumens, acentral lumen 20 and aballoon inflation lumen 22. As shown inFIG. 2 , theballoon inflation lumen 22 may be an annular lumen defined byinner body member 24 andouter body member 26 which is coaxially disposed about the inner body member. Thelumen 22 opens to port 30 on aproximal hub 32 and provides for inflation ofballoon 18. Thecentral lumen 20 opens to port 36 onhub 32 and provides for multiple functions, including optional introduction over a guidewire, aspiration, introduction of secondary catheters, and the like. - The dimensions and materials of
access catheter 10 are selected to permit endotracheal introduction and intraluminal advancement through the lung bronchus or passageway, optionally over a guidewire and/or through a primary tracheal tube structure (as illustrated inFIG. 4B below). Suitable materials include low and high density polyethylenes, polyamides, nylons, PTFE, PEEK, and the like, particularly for theinner tubular member 24. The outer member, including the occlusion balloon, can be made from elastomeric materials, such as polyurethane, low density polyethylene, polyvinylchloride, silicone rubber, latex, and the like. Optionally, portions of the outertubular member 26 proximal to the inflatable balloon can be made thicker and/or reinforced so that they do not dilate upon pressurization of the balloon. Exemplary dimensions for theaccess catheter 10 are set forth in the table below.ACCESS CATHETER DIMENSIONS Exemplary Preferred Inner Outer Inner Outer Tubular Tubular Tubular Tubular Member Member Member Member Outer Diameter (mm) 0.4-4 0.6-4.5 1-1.5 2-4 Wall Thickness (mm) 0.05-0.25 0.5-0.25 0.1-0.2 0.15-0.25 Length (cm) 50-150 same 50-80 same Balloon Length (mm) 5-50 10-20 Balloon Diameter (mm) 2-20 6-15 (inflated) - The
access catheter 10 may be modified in a number of ways, some of which are illustrated inFIGS. 3A-3F . For example, instead of an inner and outer coaxial tube construction, the catheter can be a single extrusion having acatheter body 30 with a circularmain lumen 32 and a crescent-shapedinflation lumen 34, as illustrated inFIG. 3A . Alternatively,catheter body 40 may be formed as a single extrusion having three lumens, i.e., aprimary lumen 42 for receiving a guidewire, applying aspiration, and/or delivering secondary catheters. Asecond lumen 44 can be provided for inflating the occlusion balloon, and athird lumen 46 can be provided as an alternative guidewire or aspiration lumen.Catheter body 50 comprising a maintubular body 52 having anouter layer 54 fused thereover to define alumen 56 suitable for balloon inflation as shown inFIG. 3C . Aprimary lumen 58 is formed within the maintubular member 52. As a slight alternative,catheter body 60 can be formed from aprimary tubular member 62, and asecondary tubular member 64, where the tubular members are held together by anouter member 66, such as a layer which is applied by heat shrinking. Theprimary tubular member 62 provides themain lumen 68 whilesecondary tube 64 provides asecondary lumen 70. Thesecondary lumen 70 will typically be used for balloon inflation, while theprimary lumen 68 can be used for all other functions of the access catheter. - Optionally, the access catheter in the present invention can be provided with optical imaging capability. As shown in
FIG. 3E ,catheter body 80 can be formed to include four lumens, typically by conventional extrusion processes.Lumen 82 is suitable for passage over a guidewire.Lumens light fibers 88 for illumination.Lumen 90 carries an optical wave guide orimage fiber 92.Lumen 82 can be used for irrigation and aspiration, typically after the guidewire is withdrawn. Balloon inflation can be effected through the space remaining andlumens light fibers 88. Asecond catheter body 100 is formed as a coaxial arrangement of a number separate tubes.Outer tube 102 contains aseparate guidewire tube 104 defininglumen 106 which permits introduction over a guidewire as well as perfusion and aspiration after the guidewire is removed. Second innertubular member 110 will carry anoptical image fiber 112 and a plurality oflight fibers 112 are passed within the remaining space 114 within the outer tubular member. In bothcatheter constructions - Usually, positioning of a guidewire through the branching bronchus will be manipulated while viewing through the imaging components of the access catheter. In this way, the access catheter can be “inched” along by alternately advancing the guidewire and the access catheter. As an alternative to providing the access catheter with imaging, positioning could be done solely by fluoroscopy. As a further alternative, a steerable, imaging guidewire 300 (
FIGS. 4A-4C ) could be used. Theguidewire 300 includes adeflectable tip 302 which can be deflected in a single plane using push/pull ribbon 304. Usually, the tip will comprise aspring 306 to facilitate deflection. In addition to steerability, theguidewire 300 will include an opticalimaging wave guide 310 and illuminatingoptical fibers 312, as best seen in cross-sectional view ofFIG. 4C . Thus, theguidewire 300 can be steered through the branching bronchus to reach the target tissue segment using its own in situ imaging capability. Once theguidewire 300 is in place, an access catheter can be introduced to the target lung tissue segment as well. Since the guidewire has imaging capability, the access catheter need not incorporate such imaging. This can be an advantage since it permits the access lumen to be made larger since the catheter need not carry any optical wave guides. - Referring now to
FIG. 5A , acatheter 10 can be advanced to a lung tissue segment, specifically a diseased region DR, within a lung L through a patient's trachea T. Advancement through the trachea T is relatively simple and will optionally employ an endotracheal tube and/or a guidewire to select the advancement route through the branching bronchus. The endotracheal tube may have a thin-walled design wherein the inner diameter is larger than in standard endotracheal tubes. Standard endotracheal tubes have a 7.0 mm ID with a 10 mm OD. The thin-walled design would have a 9.0 mm ID with a 10 mm OD; the larger ID allows the insertion of a larger instrument while providing adequate ventilation. Steering can be effected under real time imaging using the imaging access catheters illustrated inFIGS. 3E and 3F . Optionally, theaccess catheter 10 may be introduced through a visualizing tracheal tube, such as that described in U.S. Pat. No. 5,285,778, licensed to the assignee of the present application. As shown inFIG. 5B , the visualizingendotracheal tube 120 includes anocclusion cuff 122 which may be inflated within the trachea just above the branch of the left bronchus and right bronchus LB and RB, respectively. The visualizingendotracheal tube 120 includes a forward-viewing optical system, typically including both illumination fibers and an image fiber to permit direct viewing of the main branch between the left bronchus LB and right bronchus RB. Thus, initial placement of theaccess catheter 10 can be made under visualization of the visualizingendotracheal tube 120 and optionally theaccess catheter 10 itself. It may be appreciated that the access catheter may be positioned with or without the use of a trachea tube or similar device. When such a device is used, it may take a number of forms and may be positioned in a number of locations. For example, the trachea tube or device may be positioned as shown inFIG. 5A , or it may be positioned to achieve “one lung ventilation” wherein the side of the lung not involved in the corrective procedure will be properly ventilated. Likewise, the access catheter may be positioned under local anesthesia without intubation. In any case, referring again in particular toFIG. 5A , theaccess catheter 10 is advanced until itsdistal end 14 reaches a region in the bronchus or lung passageway which leads directly into the diseased region DR. - Once the
distal end 14 of theaccess catheter 10 is positioned in a desired location within the lung passageway, an obstructive device may be deployed in the passageway. The method of deployment or delivery of the obstructive device is dependent on a number of factors, particularly the design of the obstructive device itself. Typically, the obstructive device is housed within theaccess catheter 10 or within a catheter that may be passed through theaccess catheter 10. As depicted inFIG. 6 , theobstructive device 150 may be compressed or collapsed within an interior lumen of theaccess catheter 10. Theobstructive device 150 depicted is one of many designs which may be utilized. Theobstructive device 150 may then be pushed out of thedistal end 14 of thecatheter 10, in the direction of the arrow, into thelung passageway 152. If thedevice 150 is self-expanding, for example by tension or shape-memory, thedevice 150 will expand and anchor itself in thepassageway 152. If thedevice 150 is not self-expanding, it may be expanded with the use of a balloon or other mechanism provided by theaccess catheter 10, a catheter or device delivered through theaccess catheter 10, or another device. Similarly, theobstructive device 150 may be mounted or crimped over the access catheter 10 (not shown) or a delivery catheter and delivered to the desired location. A sheath may then be placed over thedevice 150 during insertion. Deployment of thedevice 150 may be achieved by withdrawing the sheath and allowing thedevice 150 to self-expand or expanding thedevice 150 with the use of a balloon or other mechanism. - A variety of embodiments of
obstructive devices 150 are provided. To begin, a number of embodiments of theobstructive device 150 are comprised of structural supports which expand to anchor thedevice 150 in thepassageway 152. Referring toFIG. 7A , thesupports 154 may be comprised ofradial segments 160 andlongitudinal segments 162. Theradial segments 160 allow thedevice 150 to expand to fill thepassageway 152 and thelongitudinal segments 162 rest against the walls of thepassageway 152 to help anchor thedevice 150. Thesupports 154 may be individual, as shown inFIG. 7A , or may be connected to one another, as shown inFIG. 7B , for example. In addition, thesupports 154 may continue along aproximal end 164 anddistal end 166 of thedevice 150, as shown inFIG. 7A , or thesupports 154 may not be present atsuch ends FIG. 7B . - Referring to
FIGS. 8-11 , thesupports 154 may be comprised of amesh 170 or similar interlocking structure. As shown inFIG. 8 , themesh 170 may be coiled or rolled into a cylindrical shape to fit within an inner lumen of a delivery or access catheter or to be mounted on the end of a such a delivery or access catheter. In either case, thedevice 150 may be released within thelung passageway 152 where themesh 170 expands, uncoils and/or unrolls to fill thepassageway 152. Such release may allow self-expansion or may involve the use of mechanical means to expand themesh 170. The expandeddevice 150 may fill thepassageway 152 in a generally cylindrical shape, as shown inFIG. 9 , in single or double conical shape, as shown inFIG. 10 , or it may form a variety of other shapes, an example of which is shown inFIG. 11 . - Referring now to
FIG. 12 , thesupports 154 may be a helix or spiral 171 comprised of helically wound or spiral wound wire. The spiral 171 may be compressed in a number of ways to load the spiral 171 within a lumen or on a distal end of a delivery catheter. For example, the spiral 171 may be wound tightly, similar to a watch spring, to reduce the cross-section of the spiral and provide spring tension. Upon release of the spiral 171, thecoils 173 expand to contact the walls of thepassageway 152 and anchor thedevice 150. - In any of the above embodiments, the
supports 154 may be connected to, encapsulated in, coated or impregnated with a material to prevent flow of gases or liquids through thestructural supports 154, thereby providing an obstruction. In addition, the material may include an antibiotic agent for release into the lung passageway. Examples of obstructive materials include athin polymer film 156, such as webbing between thestructural supports 154, which may be used to seal against the surface of thelung passageway 152. Such a design is depicted inFIGS. 7A-7B , 10 and 12. Similarly, thestructural supports 154 may be filled with an adhesive or sealant which will adhere the structural support members together and prevent flow or gasses or liquids through thedevice 150. This is particularly useful in coiled or mesh designs in where the structural support members are relatively close together. Alternatively, as shown inFIG. 9 andFIG. 11 , thesupports 154 may be encased in asack 158 comprised of a thin polymer, foam or other material. Expansion of thesupports 154 within thesack 158 presses thesack 158 against the walls of thepassageway 152 forming a seal. InFIG. 9 , thesack 158 has been extended beyond the ends of the rolledsupport structure 154 for illustration purposes to differentiate between thesack 158 andsupport structure 154. However, typically, thesupport structure 154 will fill thesack 158. Again, the presence of thesack 158 prevents flow of gases or liquids through thesupports 154, thereby providing an obstruction. It may be appreciated that the structural supports may comprise a variety of designs, creatingdevices 150 of various lengths and shapes. Alternatively, thesack 158 may be utilized withoutstructural supports 154. The sack may expand to fill the passageway by a variety of methods and may be held in position by impregnation with an adhesive or other material. Such impregnation may rigidify or support the sack to provide obstruction of the lung passageway. - In addition and also shown in
FIGS. 7A, 7B , 9, 11-13, a number of embodiments of theobstructive device 150 include aninlet port 172, located near theproximal end 164, and anoutlet port 174, located near thedistal end 166.Such ports devices 150 may only include aninlet port 172 near theproximal end 164, as shown inFIG. 13 . In this case, thedistal end 166 is expanded to contact the walls of thelung passageway 152 and anchor thedevice 150. Thus, theobstruction device 150 appears to have a cone shape with theinlet port 172 at the apex of the cone. To ensure concentric placement of theobstruction device 150, thedevice 150 should contact the walls of thepassageway 152 for a length of at least 1.0 to 1.5 times the internal diameter of the passageway that thedevice 150 occupies. - The
inlet port 172,outlet port 174 or both may comprise a membrane orseptum 176 covering the opening of the port. Theseptum 176 will typically be self-sealing. One type of self-sealingseptum 176 comprises asolid membrane 178, illustrated inFIG. 14A . Other types comprise pre-cut membranes in which theseptum 176 includescuts 180 or slits, as shown inFIGS. 14B and 14C .Such cuts 180 may allow ease of penetration through theseptum 176 by an access tube or penetrating element, as will be later described, while preventing flow through the septum when the penetrating element is removed. - After the
obstruction device 150 is deployed and anchored within alung passageway 152 leading to a lung tissue segment, thedevice 150 may be left as an implant to obstruct thepassageway 152 from subsequent airflow. Airflow may include air and/or any other gas or combination of gases, such as carbon dioxide. However, immediately after placement or at any time thereafter, the above described embodiments of thedevice 150 may be accessed to aspirate the lung tissue segment through theobstructive device 150. This will cause the segment to at least partially collapse as part of a method for lung volume reduction. Aspirating through theobstructive device 150 may be accomplished by a variety of methods. For example, referring toFIG. 15 , aspiration may be achieved by first inserting a penetration element, needle oraccess tube 200 through theseptum 176 of theinlet port 172. Positioning of theaccess tube 200 for such insertion may be achieved by any method, however, theaccess tube 200 is typically positioned by inserting theaccess tube 200, or a catheter carrying theaccess tube 200, through a lumen in theaccess catheter 10 until it passes out of thedistal end 14. Inflating theballoon 18 on theaccess catheter 10 may center thedistal end 14 of the catheter in thelung passageway 152. If theinlet port 172 is similarly centered, theaccess tube 200 may be passed directly out of thecatheter 10 and through theseptum 176 of theinlet port 172. - If the
septum 176 is asolid membrane 178, theaccess tube 200 may be sharp enough to puncture or pierce themembrane 178. If theseptum 176 hascuts 180 or slits, theaccess tube 200 may be pushed through thecuts 180. In either case, the membrane orseptum 176 will seal around theaccess tube 200. If theobstruction device 150 also has anoutlet port 174, theaccess tube 200 may optionally be passed through both the inlet andoutlet ports access tube 200 is inserted, gases and/or liquids may be aspirated through theaccess tube 200 from the lung tissue segment and associated lung passageways. Optionally, prior to aspiration, a 100% oxygen, Helium-Oxygen mixture or low molecular weight gas washout of the lung segment may be performed by introducing such gas through theaccess tube 200. In this case, aspiration would removed both the introduced gas and any remaining gas. Similarly, liquid perfluorocarbon or certain drugs, such as antibiotics, may be introduced prior to aspiration. This may allow access to the collapsed lung segment at a later time, for example, in the case of an infection. In most cases, aspiration will at least partially collapse the lung segment, as previously described. Theaccess tube 200 may then be withdrawn. Theseptum 176 of theinlet port 172 and/oroutlet port 174 will then automatically seal, either by closing of the puncture site or by closure of the cuts. Optionally, the ports may be additionally sealed with a sealant or by use of a heat source or radiofrequency source. - Referring to
FIGS. 16 and 17 , aspiration through theobstructive device 150 may be achieved by contacting theobstructive device 150 with a suction tube oraspiration catheter 202 and aspirating gas or liquids through thedevice 150. As shown inFIG. 16 , the distal end 204 of theaspiration catheter 202 may be held against theinlet port 172. Positioning of theaspiration catheter 202 for such contact may be achieved by any method, however thecatheter 202 is typically positioned in a manner similar to the access tube described above. By holding theaspiration catheter 202 against theport 172, a seal may be created and gases and/or liquids may be aspirated from the lung tissue segment through thedevice 150. In this case, theinlet port 172 and theoutlet port 174, if present, must not be covered by asolid membrane 178. Ifcuts 180 are present, the gas or liquid may flow through the port due to the pressure of the suction. As shown inFIG. 17 , the distal end 204 of theaspiration catheter 202 may be slid over theinlet port 172 to form a seal. Again, gases and/or liquids may then be aspirated through thedevice 150 in a similar manner. Theaspiration catheter 202 may then be withdrawn. Theseptum 176 of theinlet port 172 and/oroutlet port 174 will then automatically seal, typically by closure of the cuts. Optionally, the ports may be additionally sealed with a sealant or by use of a heat source or radiofrequency source. - Referring to
FIGS. 18A-18C , theobstruction device 150 may be deployed, anchored and aspirated therethrough while connected to anaspiration catheter 210. In this case, theaccess catheter 10 is positioned within thelung passageway 152 at a desired location. If thecatheter 10 has aninflatable occlusion balloon 18 near itsdistal end 14, theballoon 18 may be inflated to secure and center thecatheter 10 within thepassageway 152; however, this step is optional. As shown inFIG. 18A , anaspiration catheter 210 carrying anobstruction device 150 is then introduced through a lumen in theaccess catheter 10. As shown inFIG. 18B , theaspiration catheter 210 is advanced so that theobstruction device 150 emerges from thedistal end 14 of theaccess catheter 10 and deploys within thelung passageway 152. Expansion and anchoring of theobstruction device 150 within thepassageway 152 may be achieved by self-expansion or by expansion with the aid of a balloon, for example. The lung tissue segment isolated by thedevice 150 is then aspirated through thedevice 150 and the attachedaspiration catheter 210. Such aspiration may remove air, gases, or liquids from the segment andlung passageway 152 to at least partially collapse the lung segment. As shown inFIG. 15C , theobstruction device 150 is then detached from theaspiration catheter 210 and left behind in thepassageway 152. Theproximal end 164 of theobstruction device 150 may comprise aninlet port 172 which would allow subsequent access to the isolated lung tissue segment at a later time. Alternatively, theproximal end 164 may comprise a sealed end, wherein theobstruction device 150 may not be subsequently accessed and may provide long-term isolation of the terminal lung tissue segment. - It may be appreciated that the above described method may be similarly achieved without the use of an
aspiration catheter 210. In this case, theobstruction device 150 may be carried directly by theaccess catheter 10 and may be deployed while remaining attached to theaccess catheter 10. Aspiration may be achieved through theobstruction device 150 and theaccess catheter 10 to remove gases from the isolated lung tissue segment andpassageway 152. Theobstructive device 150 may then be detached from theaccess catheter 10 and left behind in thepassageway 152 for subsequent access or simple occlusion. - At this point, all catheters and instruments may be withdrawn from the patient and the
obstruction device 150 may remain in its anchored position, as described. Theobstruction device 150 will essentially occlude thelung passageway 152 and prevent the inflow or outflow of air or gases to the isolated lung tissue segment or diseased region DR. This may be effective in maintaining the desired level of collapse of the lung tissue segment to achieve lung volume reduction. However, at any point, the lung tissue segment may be reaccessed and/or reaspirated by repeating the steps described above. In addition, at any point, theobstruction device 150 may be removed from thelung passageway 152, either by collapse of the expandable structure or by other means. - Additional embodiments of the
obstructive device 150 are comprised of a unidirectional valve. The valve may be operated upon access or it may operate in response to respiration. For example, when the valve is positioned in the lung passageway, the valve may be accessed by engaging an aspiration catheter or a coupling member to the valve. Aspiration through the aspiration catheter or coupling member then opens the valve to remove gases and/or liquids from the isolated lung segment. Alternatively, the valve may open automatically in response to respiration. The valve may open during expiration to allow outflow of gas from the lung segment and the close during inspiration to prevent inflow of gas to the lung segment. In either case, the unidirectional valves may take a number of forms. - One embodiment of such a unidirectional valve is illustrated in
FIGS. 19A-19C . In this embodiment, theunidirectional valve 230, front-view shown inFIG. 19A , is comprised of aport 232 and aflexible layer 233 which is attached to theport 232 by at least one point ofconnection 234. As shown, theflexible layer 233 may be attached to the front surface of theport 232 at four symmetrical points ofconnection 234. In preferred embodiments, edges 236 of thelayer 233 are positioned outside of the opening of the port 232 (indicated by dashed lines). This provides a desired seal when the valve is in the closed position. - Side-views shown in
FIGS. 19B and 19C depict thevalve 230 during different stages of the respiratory cycle. During expiration, thevalve 230 opens, as depicted inFIG. 19B . Here, expiration of gases is illustrated by arrows. Gases exiting through the lung passageway, within which thevalve 230 is positioned, apply force to the backside of theflexible layer 233 causing thelayer 233 to expand outwardly away from the surface of theport 232 as shown. This allows the gases to flow through the spaces between the points ofconnection 234. During inspiration, thevalve 230 closes, as depicted inFIG. 19C . Here, inspiration of air is illustrated by an arrow. Air entering the lung passageway applies force to the front side of theflexible layer 233 causing thelayer 233 to seal against the surface of theport 232 as shown. This prevents gases from flowing through thevalve 230. -
Unidirectional valves 230 may be positioned in thelung passageway 152 by methods similar to those previously described for other types ofobstruction devices 150. As shown inFIG. 20 , thevalve 230 may be positioned in thepassageway 152 so that the outside perimeter of theport 232 contacts the walls of thepassageway 152. In this way, thevalve 230 is essentially the size of the passageway lumen and provides the maximum area for potential flow-through of gas. Thevalve 230 is depicted in its open state, with gas flow traveling from an isolated lung tissue segment, through the valve and out of the patient's airways. As shown inFIG. 21 , thevalve 230 may alternatively be attached to or part ofstructural supports 154 which expand radially to anchor thedevice 150 in thepassageway 152.Such supports 154 are similar to those previously described. Again, thevalve 230 is depicted in its open state. It may be appreciated that thevalve 230 may be of any size or shape and may substituted for any of the inlet and/or outlet ports previously described. - Another embodiment of a unidirectional valve is illustrated in
FIGS. 22A-22B . In this embodiment, thevalve 230 is comprised of aport 232 and aflexible layer 233 as in the previous embodiment. However, here theflexible layer 233 has a series ofholes 250 through the layer. In addition, thevalve 230 is comprised of apartition 252 which also hasholes 250. Theholes 250 may be of any size, shape or arrangement throughout the entire or a portion of thelayer 233 andpartition 252. Thepartition 252 covers theport 232 and thelayer 233 is positioned over thepartition 252, as illustrated inFIG. 22A and depicted by arrows, so that theholes 250 are substantially misaligned and therefore blocked. The assembled valve, illustrated inFIG. 22B , does not have any throughholes 250 in the closed position. Theholes 250 in thelayer 233 are blocked by theunderlying partition 252. Likewise, theholes 250 in thepartition 252 are blocked by theoverlying layer 233. Thelayer 233 is attached to thepartition 252 and/orport 232 along its perimeter; it may be a continuous attachment or may have discrete points of connection with spaces therebetween. - Side-views shown in
FIGS. 23B and 23C depict thevalve 230 during different stages of the respiratory cycle. During expiration, thevalve 230 opens, as depicted inFIG. 23B . Here, expiration of gases is illustrated by arrows. Gases exiting through the lung passageway, within which thevalve 230 is positioned, pass through theholes 250 in thepartition 252 and apply force to the backside of theflexible layer 233. This causes thelayer 233 to expand outwardly away from thepartition 252 as shown. This allows the gases to flow through theholes 250 in thelayer 233. During inspiration, thevalve 230 closes, as depicted inFIG. 23C . Here, inspiration of air is illustrated by an arrow. Air entering the lung passageway applies force to the front side of theflexible layer 233 causing thelayer 233 to seal against the surface of thepartition 252 as shown. This prevents gases from flowing through thevalve 230. This embodiment of aunidirectional valve 230 may be positioned in alung passageway 152 by methods similar to those previously described for other types ofobstruction devices 150, particularly as shown inFIGS. 20 and 21 . - Although the unidirectional valves described above are shown as operating during different stages of the respiratory cycle, the valves may additionally or alternatively be operated manually. Valves positioned in a lung passageway, as depicted in
FIGS. 20-21 , may be accessed by coupling an aspiration catheter to the valve. Coupling may comprise engaging the aspiration catheter, a suitable catheter or a coupling member to the valve. In some cases, particularly when thevalve 230 comprises aport 232 which is smaller in diameter than the lumen of the lung passageway, as depicted inFIG. 21 , the distal end of the aspiration catheter or coupling member may be slid over the port to form a seal. This was previously depicted inFIG. 17 in relation to sealing of theaspiration catheter 202 around aninlet port 172 of a non-valved obstruction device. When a valve is present in this case, aspiration through the aspiration catheter will open the valve and draw gases and/or liquids from the lung tissue segment. With the describedunidirectional valves 230, the suction force of the aspiration will draw theflexible layer 233 away from theport 232 or thepartition 252 to open the valve. - Further embodiments of the
obstructive device 150 are comprised of ablockage device 280 having no ports through which aspiration of the isolated lung tissue segment may be achieved. After theblockage device 280 is deployed and anchored within alung passageway 152 leading to a lung tissue segment, thedevice 280 is to be left as an implant to obstruct thepassageway 152 from subsequent airflow. Although the previously described embodiments ofobstructive devices 150 having inlet and/oroutlet ports blockage device 280 may not be later accessed to aspirate the lung tissue segment through the device. An example of such ablockage device 280 is illustrated inFIGS. 24 and 25 . - As with the previous obstructive devices, the
blockage device 280 may be housed within theaccess catheter 10 or within a catheter that may be passed through theaccess catheter 10. As depicted inFIG. 24 , theobstructive device 150 may be compressed or collapsed within an interior lumen of theaccess catheter 10. Theblockage device 280 depicted is one of many designs which may be utilized. Theblockage device 280 may then be pushed out of thedistal end 14 of thecatheter 10, in the direction of the arrow, into thelung passageway 152. Thedevice 280 is to be self-expanding by tension or shape-memory so that it will expand and anchor itself in thepassageway 152. - Referring to
FIG. 25 , one embodiment of theblockage device 280 comprises acoil 282. Thecoil 282 may be comprised of any type of wire, particularly superelastic or shape-memory wire, polymer or suitable material. The tension in thecoil 282 allows thedevice 280 to expand to fill thepassageway 152 and rest against the walls of thepassageway 152 to anchor thedevice 280. In addition, thecoil 282 may be connected to athin polymer film 284, such as webbing between the coils, to seal against the surface of thelung passageway 152. Such afilm 284 prevents flow of gases or liquids through the coils, thereby providing an obstruction. Alternatively, as depicted inFIG. 25 , thecoil 282 may be encased in asack 286. Expansion of thecoil 282 within thesack 286 presses thesack 286 against the walls of thepassageway 152 forming a seal. Again, this prevents flow of gases or liquids, depicted by arrows, through thecoil 282, thereby providing an obstruction. Similarly, as depicted inFIG. 26 , another embodiment of theblockage device 280 comprises amesh 283. Themesh 283 may be comprised of any type of wire, particularly superelastic or shape-memory wire, polymer or suitable material. The tension in themesh 283 allows thedevice 280 to expand to fill thepassageway 152 and rest against the walls of thepassageway 152 to anchor thedevice 280. In addition, themesh 283 may be connected to athin polymer film 284, such as webbing between the lattice of the mesh, to seal against the surface of thelung passageway 152. Such afilm 284 prevents flow of gases or liquids through the mesh, thereby providing an obstruction. - Referring now to
FIG. 27 , another embodiment of theblockage device 280 comprises a barb-shapedstructure 304 designed to be wedged into alung passageway 152 as shown. Such astructure 304 may be comprised of a solid material, an inflatable balloon material, or any material suitable to provide a blockage function. Thestructure 304 may be inflated before, during or after wedging to provide sufficient anchoring in the lung passageway. Similarly, thestructure 304 may be impregnated or infused with an adhesive or sealant before, during or after wedging to also improve anchoring or resistance to flow of liquids or gasses through thepassageway 152. - Referring to
FIG. 28 , another embodiment of theblockage device 280 comprises an inflated balloon. Such a balloon may take a number of forms. For example, the balloon may have take a variety of shapes, such as round, cylindrical, conical, dogboned, or multi-sectional, to name a few. Or, a series of distinct or interconnected balloons may be utilized. Further, the surface of the balloon may be enhanced by, for example, corrugation or texturing to improve anchoring of the balloon within the lung passageway.FIG. 28 illustrates a cylindrical-type balloon 300 withtextured friction bands 302 which contact the walls of thelung passageway 152 when theballoon 300 is inflated as shown. - It may be appreciated that such balloons may be inflated with an number of materials, including saline, gas, suitable liquids, expanding foam, and adhesive, to name a few. Further, a
multi-layer balloon 310 may be utilized, as shown inFIG. 29 , which allows the injection of adhesive 312 or suitable material between anouter layer 314 and aninner layer 316 of theballoon 310. Such adhesive 312 may provide a hardened shell on theobstruction device 280 to improve its obstruction abilities. As shown, theballoon 310 may be inflated within theinner layer 316 with afoam 318 or other material. Similarly, as shown inFIG. 30 , theouter layer 314 of theblockage device 280 may contain holes, pores, slits oropenings 320 which allow the adhesive 312 to emerge through theouter layer 314 to the outside surface of themulti-layer balloon 310. When theballoon 310 is inflated within alung passageway 152, theouter layer 314 of theballoon 310 will press against the walls of thepassageway 152 and the adhesive 312 will bond with the walls in which it contacts. Such adhesion is designed to improve anchorage and obstructive abilities of theblockage device 280. - It may also be appreciated that the above described blockage devices may be impregnated, coated or otherwise deliver an antibiotic agent, such as silver nitrate. Such incorporation may be by any means appropriate for delivery of the agent to the lung passageway. In particular, a multi-layer balloon may be provided which allows the injection of an antibiotic agent between an outer layer and an inner layer of the
balloon 310. As previously described and depicted inFIG. 30 , theouter layer 314 of theblockage device 280 may contain holes, pores, slits oropenings 320 which allow the agent to emerge through theouter layer 314 to the outside surface of themulti-layer balloon 310. Thus, the agent may be delivered to the walls and/or the lung passageway. - It may further be appreciated that the
blockage device 280 may comprise a variety of designs having various lengths and shapes. In addition, many of the designs illustrated for use as ablockage device 280 may also be adapted with an aspiration port for use as described in relation to the previously illustrated embodiments ofobstruction devices 150. For example, such aport 172 having aseptum 176 is shown inFIG. 30 . If the port is not accessed, the device simply serves as ablockage device 280. Thus, in some cases,blockage devices 280 andobstructive devices 150 are synonymous. - Referring now to
FIG. 31 , kits 400 according to the present invention comprise at least an obstruction orblockage device 500 and instructions for use IFU. Optionally, the kits may further include any of the other system components described above, such as anaccess catheter 10,guidewire 402,access tube 200,aspiration catheter 202 or other components. The instructions for use IFU will set forth any of the methods as described above, and all kit components will usually be packaged together in a pouch 450 or other conventional medical device packaging. Usually, those kit components which will be used in performing the procedure on the patient will be sterilized and maintained sterilely within the kit. Optionally, separate pouches, bags, trays, or other packaging may be provided within a larger package, where the smaller packs may be opened separately and separately maintain the components in a sterile fashion. - While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.
Claims (23)
1. A method for lung volume reduction, said method comprising:
deploying an obstructive device in a lung passageway to a lung tissue segment; and
aspirating the segment to at least partially collapse the lung segment, wherein the obstructive device is removable.
2. A method as in claim 1 , wherein the device is removable by collapsing the structure.
3. A method as in claim 1 , further comprising collapsing the obstructive device and removing the device.
4. A method as in claim 1 , wherein the device biodegrades in the lung over time.
5. A method as in claim 1 , wherein the obstructive device is coated.
6. A method as in claim 5 , wherein the obstructive device is coated with an antibiotic.
7. A method as in claim 1 , wherein the device is impregnated with an adhesive.
8. A method as in claim 1 , wherein aspirating comprises coupling an aspiration catheter to the obstructive device and aspirating gas through the catheter from the segment.
9. A method as in claim 8 , wherein the obstructive device comprises an inlet port, the aspiration catheter comprises an access tube and coupling comprises passing an access tube through the inlet port.
10. A method for lung volume reduction, said method comprising:
deploying an obstructive device in a lung passageway to a lung tissue segment; and
aspirating the segment to at least partially collapse the lung segment, wherein the obstructive device is biodegradable when left in place in the lung.
11. A method as in claim 10 , wherein the device is removable.
12. A method as in claim 10 , wherein the device is coated.
13. A method as in claim 12 , wherein the device is coated with an antibiotic.
14. A method as in claim 10 , wherein the device is impregnated with an adhesive.
15. A method as in claim 10 , wherein aspirating comprises coupling an aspiration catheter to the obstructive device and aspirating gas through the catheter from the segment.
16. A method as in claim 15 , wherein the obstructive device comprises an inlet port, the aspiration catheter comprises an access tube and coupling comprises passing an access tube through the inlet port.
17. A method for lung volume reduction, said method comprising:
deploying an obstructive device in a lung passageway to a lung tissue segment; and
aspirating the segment to at least partially collapse the lung segment, wherein the obstructive device is coated and/or impregnated with a material.
18. A method as in claim 17 , wherein the obstructive device is coated with an antibiotic.
19. A method as in claim 17 , wherein the obstructive device is impregnated with an adhesive.
20. A method as in claim 17 , wherein the device is removable by collapsing.
21. A method as in claim 17 , wherein the device is biodegradable.
22. A method as in claim 17 , wherein aspirating comprises coupling an aspiration catheter to the obstructive device and aspirating gas through the catheter from the segment.
23. A method as in claim 22 , wherein the obstructive device comprises an inlet port, the aspiration catheter comprises an access tube and coupling comprises passing an access tube through the inlet port.
Priority Applications (1)
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US11/271,211 US20060095002A1 (en) | 2000-10-27 | 2005-11-09 | Methods and devices for obstructing and aspirating lung tissue segments |
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Application Number | Priority Date | Filing Date | Title |
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US09/699,302 US6527761B1 (en) | 2000-10-27 | 2000-10-27 | Methods and devices for obstructing and aspirating lung tissue segments |
US10/382,131 US6997918B2 (en) | 2000-10-27 | 2003-03-04 | Methods and devices for obstructing and aspirating lung tissue segments |
US11/271,211 US20060095002A1 (en) | 2000-10-27 | 2005-11-09 | Methods and devices for obstructing and aspirating lung tissue segments |
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US11/271,211 Abandoned US20060095002A1 (en) | 2000-10-27 | 2005-11-09 | Methods and devices for obstructing and aspirating lung tissue segments |
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US10/382,131 Expired - Lifetime US6997918B2 (en) | 2000-10-27 | 2003-03-04 | Methods and devices for obstructing and aspirating lung tissue segments |
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Also Published As
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US6997918B2 (en) | 2006-02-14 |
WO2002038038A9 (en) | 2003-09-12 |
EP1339445A4 (en) | 2004-07-14 |
WO2002038038A3 (en) | 2003-05-08 |
EP1339445B1 (en) | 2008-05-28 |
WO2002038038A2 (en) | 2002-05-16 |
US20040073191A1 (en) | 2004-04-15 |
US6527761B1 (en) | 2003-03-04 |
EP1339445A2 (en) | 2003-09-03 |
JP2004512893A (en) | 2004-04-30 |
DE60134259D1 (en) | 2008-07-10 |
ATE396761T1 (en) | 2008-06-15 |
AU2002239759A1 (en) | 2002-05-21 |
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