Abstract:
An implantable device for providing one-way flow of air through a lumen in a human lung to reduce the volume of air trapped in a diseased portion of the lung by occluding the lumen to prevent inhalation while permitting expiration out of the diseased portion. The implantable device is deployable in the lumen with a catheter. The device comprises an umbrella-shaped, one-way valve. The valve is collapsible for containment within a catheter and expandable in situ when deployed to occlude the lumen. The valve defines a longitudinal axis and comprises a plurality of metal struts, a resilient membrane, and a central post. The device further comprises an anchor for securing the implantable device within the lumen. The anchor comprises a tapered distal end for penetrating the wall of the lumen, and a planar member positioned to limit advancement of the anchor into the lumen. The implantable device further comprises a mechanism connecting the one-way valve to the anchor. The mechanism is disposed along the longitudinal axis when the device is collapsed. The mechanism is configured to permit the valve to be oriented at an angle to said anchor when deployed. Accordingly, the anchor can be positioned in a section of the lumen that is at an angle to a section of said lumen in which said one-way valve is positioned.

Description:
RELATED APPLICATIONS 
   This application claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 60/787,995, filed Mar. 31, 2006, which is incorporated in its entirety by reference herein. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The inventions relate in general to the field of pulmonary treatments, and specifically to systems, devices, and methods for treating a patient&#39;s lung or portion thereof. 
   2. Description of the Related Art 
   Chronic Obstructive Pulmonary Disease (“COPD”) has become a major cause of morbidity and mortality in the United States. COPD is typically characterized by the presence of airflow obstructions due to chronic bronchitis or emphysema. The airflow obstructions in COPD are due largely to structural abnormalities in the smaller airways in the lungs. 
   Mortality, health-related costs, and the segment of the population having adverse effects due to COPD are substantial. COPD is a progressive disease that can severely affect a person&#39;s ability to accomplish normal tasks. One method of treating COPD is the insertion of one-way valves into lumens in the lung. The valves inhibit inhalation, but permit exhalation of air already within the lung. The lung presents challenge in mounting such valves because lumens within it are rarely linear over a useful distance. Accordingly, there is a need for a device to permit mounting of valves within non-linear lumens in the lung. 
   SUMMARY OF THE INVENTION 
   Accordingly, one aspect of the invention comprises an implantable device for providing substantially one-way flow of air through a lumen in a human lung to reduce the volume of air trapped in a diseased portion of the lung. The implantable device occludes the lumen to substantially prevent inhalation while substantially permitting expiration out of said diseased portion of the lung. The implantable device is deployable into the lumen with a catheter. 
   One aspect of an embodiment of the implantable device can comprise a one-way valve being generally umbrella-shaped in configuration. The valve is collapsible for containment within a delivery catheter and expandable in situ when deployed. The valve substantially occludes the lumen. The valve is configured so that when deployed in an orientation to substantially preclude inhalation, inhaled air is prevented from flowing past the valve into said lung by capturing said air within the umbrella-shaped valve. The air exerts an outward force on the umbrella shape and forces said valve to tightly engage the lumen. The valve is configured to permit expiration to occur between the perimeter of the valve and the lumen. 
   The valve also defines a longitudinal axis and comprises a plurality of metal struts that define a generally bell-shaped frame. Each of the struts have a first end that curves slightly inward towards the longitudinal axis of said implantable device when deployed and a second end proximal a junction of the second ends of the other struts, The valve also has a resilient membrane that wraps around at least a part of the metal struts and is supported by them. The membrane extends from the junction of the plurality of metal struts toward the first end of said struts. The valve also comprises a central post with a first part that extends within the membrane from the junction of said plurality of metal struts at the center of the bell-shaped frame. The post has a flange at an end distal from the strut junction. The flange is configured to permit deployment, positioning, and recapture of said implantable device. The central post further comprises a second part that extends axially outside the membrane. 
   Another aspect of the invention comprises an anchor for securing the implantable device within the lumen by inhibiting migration of the device once deployed. The anchor comprises a plurality of resilient arms extending outwardly and radially from the second part of the central post. Each of said arms are configured so as to be collapsible for containment within a delivery catheter and expandable to engage the lumen when deployed in situ. Each of the arms comprises a generally tapered distal end to permit the arm to penetrate the wall of the lumen. The arms further comprise a planar member proximal the tapered distal end and positioned at an angle to the arm to limit advancement of said arm into the lumen wall by contacting the surface of said lumen wall. 
   Another aspect of the invention comprises a mechanism connecting the one-way valve to the anchor and being disposed generally along the longitudinal axis when the device is in a collapsed state. The mechanism is configured to permit the valve to be oriented at an angle to the anchor when deployed, thereby allowing the anchor to be positioned in a section of the lumen that is at an angle to a section of said lumen in which the one-way valve is positioned. The mechanism comprises at least one connector at a first end to connect the mechanism to the valve. In some embodiments, the mechanism comprises a flexible member configured to be articulable to permit angled orientation of the anchor. In some embodiments, the flexible member comprises a helical spring. In some embodiments, the flexible member comprises a generally cylindrical mesh. 
   In some embodiments of the connector, a second end of the mechanism comprises a generally spherical connector. In some embodiments, the second end of the mechanism resides in a cavity within the anchor. In some embodiments the cavity is elongated. In some embodiments, the first end of the mechanism comprises a generally spherical connector. 
   In some embodiments, a cavity is within the anchor, wherein the first end of the mechanism can reside. In some embodiments, the implantable device comprises a second end of the mechanism which comprises a generally spherical connector. In some embodiments, the second end of the mechanism resides in a cavity within the valve. In some embodiments, at least one of the cavities is elongated. 
   Another aspect of an embodiment is an implantable device for deployment in an anatomical lumen wherein the device comprises an occluding device and an articulable anchor for securing the occluding device within the lumen in a manner that permits the anchor to articulate substantially with respect to said occluding device. The articulable anchor comprises a mechanism connecting said anchor to the occluding device. Additionally, the mechanism comprises at least one connector at a first end to connect said mechanism to at least one anchoring member and the articulable anchor includes a cavity. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of an implantable device with a one-way valve, an anchor, and a connector; 
       FIG. 2  is a side view of an implantable device with an articulable anchor. 
       FIG. 3  is a cross-sectional view of the device of  FIG. 2 . 
       FIG. 4  is a cross-sectional view of an air passageway and an implantable device with an articulable anchor that spans a bifurcated air passageway; 
       FIG. 5  is a cross-sectional view of an implantable device with an articulable anchor in accordance with another embodiment; 
       FIG. 6  is a cross-sectional view of an implantable device with an articulable anchor in accordance with another embodiment; 
       FIG. 7  is a side view of an implantable device with an articulable anchor in accordance with another embodiment; 
       FIG. 8  is a side view of a flexible connector for use in an implantable device with an articulable anchor; 
       FIG. 9  is a side view of an implantable device with an articulable anchor having a biasing member and a connector positioned between an obstruction member and the anchor system; 
       FIGS. 10A-10C  are side views of alternative embodiments of frames for implantable devices with articulable members embodied as flexible connectors; and 
       FIG. 11  is a cross-sectional view of an air passageway and a flexible implantable device positioned in the air passageway. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIG. 1  illustrates an implantable device in an expanded position. The implantable device  10  is configured to affect airflow in an air passageway in a lung. The implantable device comprises an anchor  12  and an obstruction member  14 . A connecting mechanism  16  couples the anchor  12  to the obstruction member  14 . The illustrated implantable device  10  includes a support structure  18  that can form the frame of the implantable device  10 . At least a portion of the anchor  12 , the connecting mechanism  16 , and the obstruction member  14  can be formed by the support structure  18 . An elongated member  20  extends axially through obstruction member  14  and can be directly or indirectly coupled to the support structure  18 . 
   The obstruction member  14  surrounds at least a portion of the elongated member  20  and is configured to interact with an anatomical lumen, such as an air passageway, to regulate the flow of fluid through the lumen. The obstruction member  14  can effectively function as a one-way valve. One example of an obstruction member is an occluding device. 
   The anchor  12  comprises a plurality of anchor members  22  that extend from the connecting mechanism  16 . In the illustrated embodiment, each of the anchor members  22  is an elongated member that extends radially outward from the connecting mechanism  16  and terminates at a piercing end  24 , although the anchor members  22  can have any number of piercing ends. One or more stops  26  can be positioned along each anchor member  22 , preferably positioned at some point near the piercing members  24 . The stops  26  can be configured to limit the puncturing by the piercing member  24  through lung tissue beyond a desired depth. 
   The stops  26  can be formed by splitting the distal ends of the anchor members  22 . One of the split sections can be bent downwardly to form the stop  26 , while leaving the second split section to extend outwardly to form the piercing member  24 . Although the stops  26  can be formed integrally with the anchor member  22 , the stops  26  can also be applied in a subsequent process. For example, each stop  26  can be a piece of metal that is mounted to the anchor members  22 . Thus, each of the anchor members  22  can be of a one piece or multi-piece construction. 
   Any number of anchor members  22  can be used to limit migration of the implantable device  10  implanted at a desired deployment site. The illustrated implantable device  10  comprises five anchor members  22  that are coupled to the connecting mechanism  16 . However, the anchor  12  can comprise any suitable number of anchor members in any various configurations. A skilled artisan can select the number of anchor members  22  based on the size of an air passageway, anchor design, and the like. The anchor members  22  can be positioned at regular or irregular intervals. When the anchor  12  is positioned in situ, the piercing members  24  can engage tissue of an air passageway wall of a lung to retain the implantable device  10  at a desired location. One non-limiting example of such an engagement occurs when at least one piercing member punctures the wall of the air passageway. 
   With continued reference to  FIG. 1 , the obstruction member  14  is generally umbrella-shaped and comprises an obstructing member frame  28  that carries a membrane  32 . The obstructing frame  28  includes a plurality of arcuate struts  30  that support the membrane  32 . 
   A plurality of pathways can be defined by the obstruction member  14  between each pair of struts  30 . When the implantable device  10  is securely anchored in a lung passageway, the struts  30  can bias the obstruction member  14  outwardly against the air passageway wall. Between each pair of struts  30 , the membrane  32  can define the pathway that permits mucus transport past the obstruction member  14  through the associated air passageway. 
   Proper mucociliary functioning can be maintained to ensure that the respiratory system continues to self clean after an implantable device has been deployed. To maintain mucociliary transport the membrane  32  can be folded inwardly away from the air passageway wall, especially during exhalation when the implantable device  10  has the anchor  12  positioned distally. The membrane  32  can press lightly against the air passageway wall in order to permit cilliary action for the movement of mucus past the membrane  32 . Of course, the implantable device can have other configurations that permit mucus transport. 
   The membrane  32  can be treated to enhance sealing, improve biostability, and/or enhance mucus transport. To enhance valving action, the membrane  32  can be treated with a material that interacts with a wall of an air passageway to improve functioning. A coating on the membrane can reduce airflow in at least one direction between the air passageway and the expanded membrane engaging the air passageway wall. The coating can be a hydrogel that helps the membrane  32  adhere to the air passageway wall to further limit air flow past the implantable device in at least one direction. Other coating materials can be applied to the membrane or other portions of the implantable device depending on the intended application. The coating can be applied before, during, or after the implantable device is placed in a passageway. 
   In some embodiments, the membrane  32  can be coated with a lubricious material to limit adherence to an air passageway. Additionally, an implantable device may partially or fully collapse when subjected to rapid pressure changes, such as when a person coughs. If the membrane is folded together, the lubricious material can inhibit sticking of the membrane to itself so that the implantable device can quickly re-expand to function effectively again. 
   The implantable device can be adapted to facilitated movement through a delivery lumen. To reduce frictional forces between the implantable device and a lumen of a delivery instrument, a release agent can be applied to the implantable device. The release agent can reduce the force required to eject the implantable device out of the lumen as detailed above. 
   The struts can have first strut ends connected to the connecting mechanism  16  and opposing second strut ends. The proximal tips of the struts can curve radially inward toward the longitudinal axis of the implantable device  10 . 
   With continued reference to  FIG. 1 , the elongated member  20  comprises a rod  34  that is connected to the connecting mechanism  16  and a gripping head  36 . The rod  34  is a generally cylindrical body that extends along the longitudinal axis of the implantable device  10 , although the rod  34  can be at other suitable locations. For example, the rod  34  can be angled or offset from the longitudinal axial of the implantable device  10 . 
   The rod  34  is connected to the gripping head  36  that is positioned exterior to the chamber defined by the membrane  32 . The rod  34  extends from the opening such that the gripping head  36  is spaced outwardly from the opening defined by the membrane  32 . The elongated member  20  can be of such a length that it extends beyond the second end of the struts when the implantable  10  occupies an expanded position. When the gripping head  36  is spaced from the proximal ends of the struts and the membrane  32 , a removal device (not shown) can easily grip the exposed gripping head  36 . In alternative embodiments, the rod  34  terminates to form the gripping head  36  positioned inwardly of the opening defined by the member  32 . Other embodiments of the gripping head  36  can include various changes in shape and size of the gripping head  36  to cooperate with different coupling mechanisms. 
   The elongated member  20  can also be of such a length that the elongated member  20  and the struts  30  extend substantially the same distance from the connecting mechanism  16  when the implantable device  10  is in a fully collapsed state (not shown). The struts  30  can lie flat along the rod  34  for a low profile configuration. The gripping head  36  preferably remains exposed so that the implantable device  10  can be pushed out of a delivery instrument by conveniently applying a force to the gripping head  36 . 
   A variety of removal devices can be used to engage the implantable device to, for example, reposition, re-implant, or remove the implantable device as discussed above. The enlarged gripping head  36  can be designed to facilitate removal of the implantable device  10  by any of numerous extracting devices and methods as are known in the art. The removal gripping head  36  can be gripped by a removal device (such as forceps, an extractor, a retractor, gripping device, or other suitable device for gripping a portion of the implantable device  10 ). A sufficient proximal force can be applied to displace the implanted implantable device  10  from the implantation site. The illustrated gripping head  36  is a somewhat cylindrical knob having an outer diameter that is greater than the outer diameter of the rod  34 . The gripping head  36  can have other configurations for engaging a removal device. Exemplary gripping heads can comprise a hook, ring, enlarged portion, connectors (e.g., snap connector, threaded connector, etc), or other structure for permanently or temporarily coupling to a removal device. 
     FIG. 2  is a side view of an embodiment of an implantable device  50 . The obstruction member  58  is coupled with the anchor  56  by a connecting mechanism  52 . In the illustrated embodiment, the connecting mechanism  52  comprises a connecting member  54 . The connecting mechanism  52  permits articulation between the obstruction member  58  and the anchor  56 . In the illustrated position, the obstruction member  58  and the anchor  56  are collinear along the longitudinal axis of the implantable device  50 . Through articulation of the connecting mechanism  52 , the obstruction member  58  and the anchor  56  can be configured to no longer be collinear along the longitudinal axis of the implantable device  50 . As one non-limiting example, the obstruction member  58  can be maintained at an unaltered orientation while the connecting mechanism  52 , either by pivoting or flexing, can continue to couple the obstruction member  58  to the anchor  56  while the anchor  56  is moved to a different orientation than that of the obstruction member  58 . In some embodiments, the connecting mechanism  52  can permit axial movement, changing the distance between the distal end of the obstruction member  58  and the proximal end of the anchor  56 . In some embodiments, the articulation of the connecting mechanism  52  is accomplished through discrete pivotal orientation changes. In other embodiments, the connecting mechanism  52  is configured to articulate through continuous flexing, such as the bending of a flexible member. In still other embodiments, the connecting mechanism  52  can be configured to permit changes in orientation between the obstruction member  58  and the anchor  56  by limiting separation between the obstruction member  58  and the anchor  56  when the connecting mechanism  52  is not rigidly coupled to the two components. In these embodiments, the connecting mechanism  52  can comprise a tether or other limiting component. 
     FIG. 3  is a cross-sectional view of another embodiment of an implantable device  100 . The implantable device  100  is configured to permit an angled position. The implantable device  100  can be positioned in a naturally angled air passageway (e.g., a bifurcated air passageway, tortuous air passageway, etc.) in a lung. The implantable device  100  has an anchor sufficiently articulable so as to permit deployment of the implantable device  100  within the angled air passageway without substantially altering the natural geometry of the air passageway. The implantable device  100  can effectively function even though the obstructing member  102  conforms to the natural shape of the air passageway. The implantable device  100  can be generally similar to the implantable device  10  of  FIG. 1 , and accordingly, the following description of the implantable device  100  can equally apply to the implantable devices described below, unless indicated otherwise. 
   As used herein, the term “implantable device” is a broad term and is used in its ordinary meaning and includes, without limitation, articulated implantable devices, actuatable implantable devices, and other implantable devices that have one or more means for providing articulation, actuating, or flexibility between an anchor and a functional member, such as an obstruction member. The implantable devices may have any number of pivot points or flexible portions. These implantable devices can be placed along tortuous pathways, such as a section of a lung passageway that is substantially curved along its length. Some embodiments include a means for providing flexibility that comprises any combination of a biasing member, a flexible member, a ball and socket arrangement, a joint, a linkage, a hinge, and/or a flexible connector. As such, the flexible implantable device can be selectively curved or angled along its length to match the shape of the air passageway. 
   The illustrated implantable device  100  comprises an obstructing member  102  articulably and pivotally connected to an anchor system  104 . The anchor system  104  can be moved relative to the obstructing member  102  to a desired position depending on the functional application of the device  100 . An articulating connecting portion  106  connects and permits movement between the obstructing member  102  and the anchor system  104 . The articulating connecting portion  106  permits articulation of the device  100  such that the device  100  can be implanted in curved air passageways without significantly altering the natural geometry of the air passageway. For example, the implantable device  100  can span a bronchial branching section of a lung. The implantable device  100  can be articulated repeatedly (e.g., during normal lung functioning) without appreciable trauma to the lung, or to the implantable device  100 . Traditional stent-based devices for implantation in air passageways are typically rigid elongated structures that are not suitable for placement in bifurcated or substantially curved air passageways. These stent-based devices maintain their linear configuration thus rendering them unsuitable for use in these types of air passageways. 
   With reference again to  FIG. 3 , the articulating connecting portion  106  can have various configurations for permitting relative movement between the anchor system  104  and the obstructing member  102 . In some embodiments, including the illustrated embodiment, the articulating connecting portion  106  comprises at least one ball and socket arrangement. The illustrated anchor system  104  has an anchor socket  120  comprising a generally spherical cavity that holds one end of the connecting rod  124 , while the obstructing member  102  has an obstructing socket  122  that holds the other end of the connecting rod  124 . 
   The connecting rod  124  has a first end  128  and an opposing second end  126 . Each of the ends  126 ,  128  is generally spheroidal and sized to be received by the corresponding socket  122 ,  120 . The spheroidal shape the ends  126 ,  128  can be integral with the connecting rod  124  or generally spheroidal-shaped members can be coupled to or mounted on the ends  126 ,  128 . The first end  128  is rotatably mounted in the obstructing socket  122 . The second end  126  is rotatably mounted in the anchor socket  120 . As such, the sockets  120 ,  122  can rotate freely about the ends of the connecting rod  124 . Thus, the implantable device  100  has a plurality of joints that permit articulation. The implantable device can have any number of articulable connecting portions for a particular application. 
   To reduce wear of the balls and the sockets, the surface(s) of the sockets and/or ends  126 ,  128  can be coated with a material to reduce frictional interaction. For example, the interior surface  130  of the anchor socket  120  can comprise one or more of the following: a somewhat lubricious material (e.g., Teflon®), ceramics, metals, polymers (preferably hard polymers), or combinations thereof. However, other materials can be utilized to limit or inhibit wear between the connecting rod  124  and the obstructing member  102  and/or the anchor system  104 . When the implantable device  100  is deployed in the lungs, the anchor socket  120  can move, preferably slightly, with respect to the ball at the second end  126  during normal respiration. The wear-resistant surfaces can minimize debris build up that can impede performance of the implantable device  100 . In view of the present disclosure, one of ordinary skill in the art can determine the appropriate combination of materials, geometry of the ball and socket arrangement, and the length of the connecting rod  124  to achieve the desired positioning of the implantable device  100 . 
   The connecting rod  124  can have a one-piece or multi-piece construction. In some embodiments, the connecting rod body  142  and the ends  126 ,  128  are formed of a single material (e.g., a metal such as Nitinol or titanium). In other embodiments, the connecting rod body  142  is formed of a flexible material, and the ends  126 ,  128  are formed of a somewhat hard, rigid material, such as a ceramic. 
   The connecting rod  124  can be generally straight, as shown in  FIG. 3 . However, the connecting rod  124  can have other configurations based on clinical need. For example, the connecting rod  124  of  FIG. 8  has an angled shape that allows placement of the implantable device in a complex shaped airway (e.g., an airway with sharp curves, branching portions, etc.). 
   With continued reference to  FIG. 3 , an elongated member  134  includes a rod  138  having an end portion  140  that is connected to the obstructing member frame  136 . The end portion  140  can be connected to the frame  136  by one or more mechanical fasteners, adhesives, welding, boarding, interference fit, threads, or other suitable coupling means for securely coupling the rod  138  to the frame  136 . In some embodiments, including the illustrated embodiment, the rod  138  is connected to the interior portions of the struts  110 , although the rod can be connected to other portions of the frame  136 . The rod  138  can also be formed integrally with at least a part of the frame. 
   As shown in  FIG. 4 , the implantable device  150  can be placed at a branching air passageway of the bronchial tree. The obstructing member  152  is within a proximal passageway  160  and the anchor system  154  is positioned within a distal sub-branch air passageway  162 . The implantable device  150  can therefore span the junction  164  of the air passageway of the lung and, thus, permits flexibility in positioning of the device  150 . The air passageway can generally retain its natural shape, such as its shape before implantation of the implantable device  150 , to minimize trauma to the lung tissue. The orientations of the implantable devices are not limited solely to the illustrated orientations. The implantable device  150  can be reversed from the illustrated orientation so that the anchors are located proximally of the obstruction member. Thus, the implantable device  150  can be oriented to permit air flow in any desired direction. 
   The implantable device  150  can also be implanted in non-branching portions of lungs. If desired, the implantable device  150  can be implanted in continuous air passageways that are generally straight, curved, angled, or having any other configuration. Because the implantable device  150  can assume various configurations, there is significant flexibility in selecting a deployment site. The implantable device  150  can also be implanted in air passageways that have a substantially constant or varying cross-section. Advantageously, the physician can implant the implantable device  150  at various locations throughout the lung to treat specific portions of the lung. If the implantable devices are in the form of occluding devices or flow regulating devices (e.g., a one-way valve, flow resistor, etc.), these devices can be implanted proximally of, and adjacent to, the diseased portions of a lung, thus maximizing the amount of healthy lung tissue that can function, even if the diseased lung tissue is in the far distal portions of the bronchial tree. 
     FIG. 5  illustrates an implantable device  200  that comprises an anchor system  202  that is pivotally coupled to an elongated member  204  that extends through the obstructing member  206 . The elongated member  204  has a generally spheroidal member  208  that is rotatably mounted in an anchor socket  210  of the anchor system  202 . The obstructing member  206  can be fixedly attached at some point along the elongated member  204 . 
   To secure the obstructing member  206  to the elongated member  204 , a portion of an obstructing member frame  212  and/or a membrane  214  can be coupled to the elongated member  204 . In the illustrated embodiment, the struts of the obstructing member frame  212  and the membrane  214  are both coupled to the outer surface of the elongated member  204 . 
   Once deployed, the implantable device  200  illustrated in  FIG. 5  can be retained in place by the anchor system  202 . The implantable device  200  can be positioned in a non-linear lumen, such as those illustrated in  FIG. 4 , because the anchor system  202  may remain at a first orientation while the obstructing member  206  is pivoted to a second orientation by the generally spheroidal member  208  and the anchor socket  210 . The obstructing member  206  can be configured to move axially from the anchor system  202  through travel along the elongated member  204 , which can be limited to prevent inefficient operation of the implantable device  200 . 
     FIG. 6  is a cross-sectional view of a implantable device  250  that has an articulable connecting portion  252  that permits axial movement between an anchor system  254  and an obstructing member  256 . The connecting portion  252  includes a holder  260  of the anchor system  254  and a holder  262  of the obstruction member  256 . Each of the holders  260 ,  262  is configured to receive an end of a connector  264 . The illustrated connector  264  has enlarged ends that are held by the holders  260 ,  262 . The chambers  268 ,  278  of the holders  260 ,  262 , respectively, permit axial movement of the connector  264 . The enlarged ends of the connector  264  that are held by the holders  260 ,  262  can also be constructed to permit pivotal movement in addition to axial movement. 
   The anchor system  254  and the obstructing member  256  of the device  250  can move freely towards and away from each other. However, one or more biasing members (not shown) can be positioned between the anchor system and obstructing member of the implantable device to adjust positioning of the implantable device. The biasing member can cooperate with the connecting portion to ensure that the implantable device remains in a desired position. 
     FIG. 7  illustrates an implantable device  300  that has an articulating connecting portion  302  that includes a flexible member  304  connected to the anchor system  306  and the obstructing member  308 . The flexible member  304  can comprise a somewhat flexible elongated member (e.g., a solid rod, a hollow tube, ribbon, etc.) and can comprise metal, polymers (preferably a somewhat rigid polymer), filaments, and the like. The flexible member  304  preferably does not substantially stretch or buckle when an axial force is applied thereto. Alternatively, the flexible member  304  can be configured to allow significant axial movement between the anchor system  306  and the obstructing member  308 . The flexible member  304  can be, for example, a tether that holds together and limits the axial movement of the anchor system  306  away from the obstructing member  308 . However, the flexible member  304  may be easily collapsed as the anchor system  306  is moved towards the obstructing member  308 . The flexible member  304  can comprise a rope, wire, filaments, or other suitable member for providing relative movement between the anchor system  306  and the obstructing member  308 . 
   With reference to  FIG. 8 , the connecting rod  350  can have or bend to have an angled central portion  352  that defines an angle θ. The length L 1  and L 2  can be selected to achieve the desired orientation and size of an implantable device. If the implantable device is deployed at a sharp bend of an air passageway, the angle θ can be matched with the angle of the bend to generally align the longitudinal axis of an anchor system with one of the passages and the longitudinal axis of an obstructing member with the other passage. The implantable device, for example, can include a connecting rod for deployment in air passageways that together form an acute angle. Accordingly, the configuration of the connecting rod  350  can be selected based on the target deployment site. 
   As illustrated in  FIG. 9 , the implantable device  400  can have a biasing member  402  positioned between an obstructing member  404  and an anchor system  406 . One example of such a biasing member is a helical spring. In the illustrated embodiment, a tether  408  extends through the biasing member  402  between the obstructing member  404  and the anchor system  406 . Other embodiments can have a tether  408  connecting the obstructing member  404  and an anchor system  406  that does not extend through the biasing member  402  and instead passes at least partially outside the biasing member  402 . Alternatively, a flexible cylindrical member (not shown) can extend between the obstructing member  404  and the anchor system  406 , substantially completely enclosing the biasing member  402 . The tether can also be a connector such as the one illustrated in  FIG. 7 . 
     FIGS. 10A-10C  illustrate various embodiments of support frames of implantable devices, each having a means for flexing. Each of the support frames has a flexible connecting portion that permits relative movement between an anchor system and an obstructing member frame. The frames as illustrated do not have membranes; however, any of various types of membranes can be applied to the obstructing member frames.  FIG. 10A  illustrates a frame support  450 A that includes a flexible connecting portion  452 A in the form of slots in an alternating pattern. The connecting portion  452 A can be an integral piece with the frame, as illustrated, or can be coupled or mounted to an anchor system  454 A and an obstruction frame  456 A. The flexible connecting portion  452 A can be formed by cuffing slots out of a tube. The number and size of the slots can be selected to achieve the desired flexibility. Additionally, the material used to construct the connecting portion can be selected for its flexibility characteristics. 
     FIG. 10B  illustrates a frame support  500 B that is generally similar to the frame support  450 A of  FIG. 10A . In the illustrated embodiment, the frame support  500 B includes a flexible connecting portion  502 B in the form of a spring member extending axially along the longitudinal axis of the frame support  500 B. As such, the spring member can be arranged in a spiral fashion about the longitudinal axis of the flexible connecting portion  502 B. The illustrated spring member is in the form of a helical spring, although other types of springs or resilient members can be utilized. The spring can comprise the connecting member alone or can act as a biasing member, as described above. Additionally, as described above, the spring can be formed integrally with the frame, or serve as a coupler for both an anchor system and obstruction frame. 
     FIG. 10C  illustrates a frame support  550 C that comprises a flexible connecting portion  552 C comprising a mesh. The connecting portion  552 C can comprise a mesh of various sizes, with large or small mesh spaces. Additionally, the mesh can be constructed of a variety of materials, such as metals, synthetics, or any other resilient material. The mesh can permit flexing, as when the obstructing frame  554 C and anchor system  556 C are positioned at different orientations, as described above. In some embodiments, the mesh can also permit axial compression along the longitudinal axis of the frame support  550 C. As described, the mesh can be formed integrally with the frame, or be mounted or coupled at either end to the obstructing frame  554 C and anchor system  556 C. 
   The illustrated struts  600 A,  600 B,  600 C of  FIGS. 10A-10C  each have two generally elongated straight portions connected by a bend. The struts  600 A,  600 B,  600 C can also have a continuously curved configuration similar to the struts described above. The frame supports can carry a membrane to form an obstructing member, such as an obstructing member adapted to function as a valve (preferably a one-way valve). The connecting portions can enhance the seating of the obstructing member within an air passageway to enhance valve functioning. 
   With reference to  FIG. 11 , an implantable device  700  is illustrated as having a flexible connecting portion  702 , such as the one shown in  FIG. 10A . The implantable device  700  is deployed and implanted in an air passageway  708  and is held in place by its anchor system  704 . The flexible connecting position  702  can apply a force to the obstructing member  706  of the implantable device  700  to enhance seating between the membrane of the obstructing member  706  and the wall  708 . Thus, a bias of the flexible connecting portion  702  can ensure that an effective seal is maintained between the obstructing member  706  and the wall  708 , thereby limiting or preventing the flow of air distally past the implantable device  700 . Advantageously, the implantable device  700  can permit the passage of air proximally past the obstructing member  706  when the pressure differential across the implantable device  700  is sufficiently high. As the air flows proximally past the obstructing member  706 , the flexible connecting portion  702  can apply a distally directed force. When the pressure differential is reduced a sufficient amount, the obstructing member  706  is pulled distally against the air passageway wall  708  to once again form a seal with the air passageway wall. Thus, the obstructing member  706  can move slightly during normal lung functioning while the anchor system  704  can remain securely fixed in place. The flexible connecting portion  702  can therefore enhance the valving action of the implantable device  700 . 
   If desired, the connecting portion  702  can also be used to position the anchors  704  and the obstructing member  706  along a tortuous path within a lung, as shown in  FIG. 4  above. The connecting portion  702  can be positioned along sharp turns that may be unsuitable for rigid valves, such as stent-based devices. 
   All patents and publications mentioned herein are hereby incorporated by reference in their entireties. Except as further described herein, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in some embodiments, be similar to any one or more of the embodiments, features, systems, devices, materials, methods and techniques described in U.S. patent application Ser. Nos. 10/409,785 (U.S. Publication 2004-0200484), filed Apr. 8, 2003; Ser. No. 09/951,105 (U.S. Publication No. 2003/0050648A1), filed Mar. 13, 2003; Ser. No. 10/848,571, filed May 17, 2004; Ser. No. 10/847,554, filed May 17, 2004; Ser. No. 10/418,929, filed Apr. 17, 2003; Ser. No. 10/081,712 (U.S. Publication 2002-0112729), filed Feb. 21, 2002; Ser. No. 10/178,073 (U.S. Publication 2003-0154988), filed Jun. 21, 2002; Ser. No. 10/317,667 (U.S. Publication 2003-0158515), filed Dec. 11, 2002; Ser. No. 10/103,487 (U.S. Publication 2003-0181922), filed Mar. 20, 2002; Ser. No. 10/124,790 (U.S. Publication 2003-0195385), filed Apr. 16, 2002; Ser. No. 10/143,353 (U.S. Publication 2003-0212412), filed Mar. 9, 2002; Ser. No. 10/150,547 (U.S. Publication 2003/0216769), filed May 17, 2002; Ser. No. 10/196,513 (U.S. Publication 2004-0010209), filed Jul. 15, 2002; Ser. No. 10/254,392 (U.S. Publication 2004/0059263), filed Sep. 24, 2002; Ser. No. 10/387,963 (U.S. Publication 2004-0210248), filed Mar. 12, 2003; Ser. No. 10/745,401, filed Dec. 22, 2003; U.S. Pat. Nos. 6,293,951; 6,258,100; 6,722,360; 6,592,594, which are hereby incorporated herein and made part of this specification. In addition, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in certain embodiments, be applied to or used in connection with any one or more of the embodiments, features, systems, devices, materials, methods and techniques disclosed in the above-mentioned incorporated applications and patents. 
   The articles disclosed herein may be formed through any suitable means. The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described may be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods may be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as may be taught or suggested herein. 
   Furthermore, the skilled artisan will recognize the interchangeability of various features from different embodiments disclosed herein. Similarly, the various features and steps discussed above, as well as other known equivalents for each such feature or step, can be mixed and matched by one of ordinary skill in this art to perform methods in accordance with principles described herein. Additionally, the methods which are described and illustrated herein are not limited to the exact sequence of acts described, nor are they necessarily limited to the practice of all of the acts set forth. Other sequences of events or acts, or less than all of the events, or simultaneous occurrence of the events, may be utilized in practicing the embodiments of the invention. 
   Although the invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof. Accordingly, the invention is not intended to be limited by the specific disclosures of preferred embodiments herein.