This application is a divisional application of a patent application entitled "articulable anchor" having application number 200780019455.6, filed 30.3.2007.
This application claims the benefit of U.S. provisional patent application No. 60/787,995, filed 2006, month 3, 31, and U.S. provisional patent application No. 11/585,415, filed 2006, month 10, 24, both of which are hereby incorporated by reference in their entirety.
Disclosure of Invention
Accordingly, one aspect of the present invention includes an implantable device for providing substantially one-way air flow through a lumen in a human lung of a human to reduce the amount of air trapped in a diseased portion of the lung. The implantable device occludes the lumen to substantially prevent inhalation while substantially allowing exhalation of the diseased portion of the lung. The implantable device may be deployed into the lumen using a catheter.
According to one aspect of the present invention, there is provided an implantable device for deployment in a tissue lumen, the device comprising:
an occlusion device, and
an anchor comprising a plurality of resilient arms, wherein the resilient arms are capable of collapsing and extending, the anchor configured to secure the occluding device within the lumen in a manner that allows the anchor to be articulable about the occluding device.
According to another aspect of the present invention there is provided an implantable device configured to provide one-way airflow through a tissue lumen by occluding the lumen, the implantable device being deployable into the lumen using a catheter, the device comprising:
a one-way valve retractable to be received within the catheter and deployable in situ when deployed, the one-way valve defining a longitudinal axis, further comprising:
a plurality of metal supporting rods are arranged on the base,
an elastic membrane wrapped around at least a portion of the metal struts and supported thereby, and
a central post having a first portion extending from the junction of the plurality of metal struts, the post having a flange at an end distal from the strut junction;
an anchor comprising a plurality of resilient arms; and
a mechanism connecting a one-way valve to the anchor, the mechanism configured to allow the one-way valve to be oriented at an angle to the anchor when deployed, thereby allowing the anchor to be positioned in a portion of a lumen positioned at an angle to a portion of the lumen in which the one-way valve is disposed.
According to yet another aspect of the present invention, there is provided an implantable device for deployment in a tissue lumen, the device comprising:
an occlusion device, and
an anchor for securing the occluding device within the lumen in a manner that allows the anchor to be articulable about the occluding device, the anchor comprising a mechanism for connecting the anchor to the occluding device, the mechanism comprising at least one connector at a first end to connect the mechanism to at least one anchor component.
According to a further aspect of the present invention there is provided an implantable device configured to provide one-way airflow through a tissue lumen by occluding the lumen, the implantable device being deployable into the lumen using a catheter, the device comprising:
a one-way valve retractable to be received within the catheter and deployable in situ when deployed, the one-way valve defining a longitudinal axis, further comprising:
a plurality of metal supporting rods are arranged on the base,
an elastic membrane wrapped around at least a portion of the metal struts and supported thereby, and
a central post having a first portion extending from the junction of the plurality of metal struts, the post having a flange at an end distal from the strut junction;
an articulable anchor; and
a mechanism connecting the one-way valve to the anchor, the mechanism including at least one connector at a first end to connect the mechanism to the one-way valve, and the mechanism being configured to allow the one-way valve to be oriented at an angle to the anchor when deployed, thereby allowing the anchor to be located in a portion of a lumen that is at an angle to a portion of the lumen in which the one-way valve is deployed.
An aspect of an embodiment of the implantable device can include a one-way valve having a generally umbrella-like configuration. The one-way valve is collapsible for receipt within a delivery catheter and may be deployed in situ. The one-way valve substantially occludes the lumen. The valve is configured to prevent the flow of inhaled air through the one-way valve into the lungs by trapping the air in the umbrella valve when the valve is disposed in an orientation to substantially prevent inhalation. This air exerts an outward force on the umbrella shape and forces the one-way valve into tight engagement with the lumen. The one-way valve is configured to allow exhalation to occur between a periphery of the one-way valve and the lumen.
The check valve also defines a longitudinal axis and includes a plurality of metal struts defining a generally bell-shaped frame. Each strut has a first end that curves slightly inwardly toward the longitudinal axis of the implantable device when deployed and a second end that is proximate to a junction (junction) of the second ends of the other struts, and an elastic membrane that wraps around at least a portion of the metal struts and is supported by them. The flexible membrane extends from a junction of a plurality of metal struts toward the first ends of the struts. The check valve further includes a central post, a first portion of which extends within the elastic membrane from a junction of the plurality of metal struts at a center of the bell-shaped frame. The post has a flange at the end remote from the strut junction. The flange is configured to allow placement, positioning, and retrieval of the implantable device. The central post further includes a second portion extending axially outside the membrane.
Another aspect of the present invention includes anchors for securing the implantable device 10 within the lumen by inhibiting migration of the implantable device once deployed. The anchor includes a plurality of resilient arms extending outwardly and radially from a second portion of the central post. Each of the arms is configured to be collapsible for receipt within a delivery catheter and expandable to engage the lumen when deployed in position. Each arm includes a generally tapered distal end to allow the arm to penetrate the wall of the lumen. The arm further includes a planar element proximate the tapered distal end and positioned at an angle relative to the arm to limit the arm from entering the lumen wall by contacting a surface of the lumen wall.
Another aspect of the invention includes a mechanism connecting the one-way valve to the anchor and disposed generally along the longitudinal axis when the device is in the collapsed condition. The mechanism is configured to allow the valve to be oriented at an angle to the anchor when deployed, thereby allowing the anchor to be located in a portion of the lumen at an angle to a portion of the lumen in which the one-way valve is deployed. The mechanism includes at least one connector at a first end to connect the mechanism to the valve. In some embodiments, the mechanism comprises a flexible element configured to be articulable to allow the anchor to be oriented at an angle. In some embodiments, the flexible element comprises a coil spring. In some embodiments, the flexible member comprises a mesh that is substantially cylindrical.
In some embodiments of the connector, the second end of the mechanism comprises a substantially spherical connector. In some embodiments, the second end of the mechanism is located in a lumen within the anchor. In some embodiments, the lumen is elongated. In some embodiments, the first end of the mechanism comprises a substantially spherical connector.
In some embodiments, a lumen is located in the anchor, wherein the first end of the mechanism may reside within the lumen. In some embodiments, the implantable device comprises a second end of the mechanism comprising a substantially spherical connector. In some embodiments, the second end of the mechanism is located in a cavity in the valve. In some embodiments, at least one of the lumens is elongated.
Detailed Description
Fig. 1 illustrates an implantable device in a deployed state. The implantable device 10 is configured to affect airflow in the pathway of air in the lungs. The implantable device includes an anchor 12 and an occlusion element 14. A connection mechanism 16 couples anchor 12 to occlusion element 14. The illustrated implantable device includes a support structure 18 that can form a frame for the implantable device 10. Anchor 12, connection mechanism 16, and at least a portion of obstruction member 14 may be formed from a support structure 18. The elongated element 20 extends axially through the obstruction element 14 and may be coupled directly or indirectly to the support structure 18.
The occlusion element 14 surrounds at least a portion of the elongate element 20 and is configured to interact with a tissue lumen, such as an air passageway, to regulate fluid flow through the lumen. The blocking element 14 may effectively function as a one-way valve. One example of an occlusion element is an occluding device.
Anchor 12 includes a plurality of anchor elements 22 extending from attachment mechanism 16. In the illustrated embodiment, each anchor member 22 is an elongated member that extends radially outward from attachment mechanism 16 and terminates at a piercing end 24, although anchor member 22 may have any number of piercing ends. One or more stops 26 may be positioned along each anchor member 22, preferably at a point near piercing member 24. Stop 26 may be configured to limit piercing element 24 from penetrating lung tissue beyond a desired depth.
Stop 26 may be formed by cleaving the distal end of anchor member 22. One of the split portions may be bent downwardly to form the stop 26 while the second split portion is extended outwardly to form the piercing member 24. Although the stop 26 may be integrally formed with the anchor element 22, the stop 26 may be added in a subsequent process. For example, each stop 26 may be a piece of metal that is mounted to the anchor member 22. Thus, each anchor element 22 may be of unitary or multi-piece construction.
Any number of anchor members 22 can be used to limit movement of the implantable device 10 implanted at a desired deployment location. The illustrated implantable device 10 includes five anchor members 22 coupled to the connection mechanism 16. However, in various configurations, anchor 12 may include any suitable number of anchor elements. The number of anchor elements 22 can be selected by the technician based on the size of the air passageway, the design of the anchor, and the like. The anchor members 22 may be positioned at regular or irregular intervals. When the anchor 12 is in place, the piercing element 24 can engage the wall tissue of the air passageway of the lung to hold the implantable device at a desired location. One non-limiting example of such engagement occurs when at least one piercing element pierces the air passageway wall.
With continued reference to fig. 1, the occlusion element 14 is generally umbrella-shaped and includes an occlusion element frame 28 carrying a membrane 32. The occlusion frame 28 includes a plurality of arcuate struts 30 that support a membrane 32.
Multiple paths may be defined by the obstruction member 14 between each pair of struts 30. When the implantable device 10 is securely anchored in the pulmonary pathway, the struts 30 can bias the obstruction members 14 outward against the walls of the air pathway. Between each pair of struts 30, the membrane 32 may define a passage that allows mucus to be transported across the obstruction member 14 through the associated air passage.
Normal mucociliary function may be maintained to ensure that the respiratory system continues to self-clean after the implantable device has been deployed. To maintain mucociliary transport, the membrane 32 may be folded inwardly away from the air passageway walls, particularly during exhalation when the implantable device 10 has an anchor 12 at the distal end. The membrane 32 may be pressed gently against the walls of the air passageway to enable a ciliary action to be achieved to move mucus through the membrane 32. Of course, the implantable device may have other configurations that allow for mucus transport.
The film 32 may be treated to enhance sealing, improve biostability, and/or enhance mucus transport. To enhance the valve action, membrane 32 may be treated with a material that interacts with the air passage walls to enhance performance. The coating on the film may reduce airflow in at least one direction between the air passageway and the unrolled film engaging the air passageway wall. The coating may be a hydrogel that helps the membrane 32 adhere to the walls of the air passageway to further restrict air flow in at least one direction through the implantable device. Other coating materials may be applied to the membrane or other portions of the implantable device depending on the desired application. The coating may be applied before, during, or after placement of the implantable device in the passageway.
In some embodiments, the film 32 may be coated with a lubricious material to limit adhesion to the air passageway. Additionally, the 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 may prevent the membrane from sticking to itself so that the implantable device can be quickly re-deployed to function effectively again.
The implantable device can be adapted through the delivery lumen to assist in movement. To reduce friction between the implantable device and the delivery instrument lumen, a release agent can be applied to the implantable device. The release agent can reduce the force required to expel the implantable device out of the lumen as described in detail above.
The strut may have a first strut end connected to the connection mechanism 116 and an opposing second strut end. The proximal tips of the struts may curve radially inward toward the longitudinal axis of the implantable device 10.
With continued reference to fig. 1, the elongate member 20 includes a rod 34 connected to the coupling mechanism 16 and a collet 36. The rod 34 is a generally cylindrical body that extends along the longitudinal axis of the implantable device 10, although the rod 34 may be in other suitable positions. For example, the rod 34 may be angled or offset from the longitudinal axis of the implantable device 10.
The stem 34 is connected to a collet 36 located outside the chamber defined by the membrane 32. The stem 34 extends from the opening such that the collet 36 expands outwardly from the opening defined by the membrane 32. The elongate member 20 can have a length such that the elongate member extends beyond the second end of the strut when the implantable device 10 occupies the deployed 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 an alternative embodiment, the stem 34 terminates to form a collet 36 positioned inside an opening defined by the element 32. Other embodiments of the collet 36 may include various changes in the shape and size of the collet 36 to accommodate different coupling mechanisms.
Elongate member 20 may also have a length such that when implantable device 10 is in a fully folded state (not shown), elongate member 20 and strut 30 extend substantially the same distance from connection mechanism 16. The struts 30 can lie flat along the rods 34 to form a low profile configuration. The collet 36 preferably remains exposed so that the implantable device 10 can be pushed out of the carrier by simply applying a force to the collet 36.
Various removal devices may be used to engage the implantable device, for example, to reposition, re-implant, or remove the implantable device as described above. The enlarged collet 36 may be designed to facilitate removal of the implantable device by any of a number of extraction devices or methods known in the art. The removal cartridge 36 may be gripped by a removal device, such as forceps, an extractor, a retractor, a clamp, or other suitable device for gripping a portion of the implantable device 10. Sufficient proximal force may be applied to displace the implanted implantable device 10 from the implantation site. The illustrated collet 36 is a somewhat cylindrical handle having an outer diameter greater than the outer diameter of the rod 34. The collet 36 may have other configurations for engaging a removal device. Exemplary collets may include hooks, loops, enlarged portions, connectors (e.g., snap connectors, threaded connectors, etc.), or other structures for permanent or temporary coupling to a removal device.
Fig. 2 is a side view of an embodiment of an implantable device 50. The blocking member 58 is coupled to the anchor 56 by the connection mechanism 52. In the illustrated embodiment, the attachment mechanism 52 includes an attachment element 54. The connection mechanism 52 allows articulation between the blocking member 58 and the anchor 56. In the illustrated configuration, the occlusion element 58 and the anchor 56 are collinear along the longitudinal axis of the implantable device 50. Through articulation of the attachment mechanism 52, the occlusion element 58 and the anchor 56 may be configured to no longer be collinear along the longitudinal axis of the implantable device 50. As a non-limiting example, the obstruction member 58 may remain in an unaltered orientation and the coupling mechanism 52, by rotating or flexing, may continue to couple the obstruction member 58 to the anchor 56 while the anchor 56 moves to a different orientation than the obstruction member 58. In some embodiments, the connection mechanism 52 can allow 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, articulation of the linkage mechanism 52 is achieved by discrete pivotal direction changes. In other embodiments, the connection mechanism 52 is configured to articulate through continuous bending, such as through bending of a flexible member. In other embodiments, the connection mechanism 52 may be configured to allow a change in orientation between the obstruction element 58 and the anchor 56 by a limited spacing between the obstruction element 58 and the anchor 56 when the connection structure 51 is not rigidly coupled to both components of the obstruction element 58 and the anchor 56. In these embodiments, the attachment mechanism 52 may include a tether or other limiting member.
Fig. 3 is a cross-sectional view of another embodiment of an implantable device 100. The implantable device 100 is configured to allow an angled configuration. The implantable device 100 can be positioned in a naturally angled air passageway (e.g., a bifurcated air passageway, a tortuous air passageway, etc.) in the lung. The implantable device 100 has an anchor sufficiently articulable to allow placement 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 function effectively even if the obstruction 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 thus, the following description of the implantable device 100 can apply equally to the various implantable devices described below, unless otherwise noted.
As used herein, the term "implantable device" is a broad term and is used in its ordinary sense and includes, without limitation, articulating implantable devices, and other implantable devices having one or more mechanisms for providing articulation, actuation, or flexibility between an anchor and a functional element (e.g., an occlusion element). The implantable device can have any number of pivot points or flexible portions. These implantable devices may be placed along a tortuous path, such as a portion of the pulmonary pathway that curves substantially along its length. Some embodiments include means for providing flexibility including any combination of biasing members (biasing members), flexible members, ball and socket arrangements, joints, links, hinges, and/or flexible connectors. As such, the flexible implantable device can be selectively bent or angled along its length to match the shape of the air passageway.
The illustrated implantable device 100 includes an obstructing member 102 articulatably and pivotally connected to an anchor system 104. The anchor system 104 may be moved to a desired position relative to the obstructing member 102 depending on the functional application of the device 100. The articulating connecting portion 106 connects between the obstructing member 102 and the anchor system 104 and allows the obstructing member 102 and the anchor system 104 to move. The articulating connecting portion 106 allows the device 100 to articulate so that the device 100 can be implanted in a tortuous air passageway without significantly altering the natural geometry of the air passageway. For example, the implantable device 100 may span a bronchial branch portion of the lung. The implantable device 100 can be repeatedly articulated (e.g., during normal lung function) without significant damage to the lung or implantable device 100. Conventional stent-based devices (stent-based devices) for implantation in air passageways are generally rigid, elongated structures that are not adapted for placement in bifurcated or substantially curved air passageways. These stent-based devices retain their linear configuration, thus making them unsuitable for use in these types of air passageways.
Referring again to fig. 3, the articulating connecting portion 106 can have a variety of configurations for allowing relative movement between the anchor system 104 and the obstructing member 102. In some embodiments, including the illustrated embodiment, the articulating connecting portion 106 includes at least one ball and socket arrangement. The illustrated anchor system 104 has an anchor socket 120 that includes a generally spherical cavity that retains one end of a connecting rod 124, while the obstructing member 102 has an obstructing socket 122 that retains the other end of the connecting rod 124.
The connecting rod 124 has a first end 128 and an opposite second end 126. Each end 126, 128 is generally spherical and sized to be received by a corresponding socket 122, 120. The spherical ends 126, 128 may be integral with the connecting rod 124, or a generally spherical element may be coupled or mounted to the ends 126, 128. First end 128 is rotatably mounted in occlusion socket 122. Second end 126 is rotatably mounted in anchor socket 120. As such, the sockets 120, 122 may freely rotate about the end of the connecting rod 124. Thus, the implantable device 100 has multiple joints that allow articulation. The implantable device can have any number of articulatable connecting portions for a particular application.
To reduce wear of the ball and socket, the socket and/or the endThe surfaces of the portions 126, 128 may be coated with a material to reduce the interaction caused by friction. For example, the interior surface 130 of the anchor socket 120 may include one or more of the following: slightly slippery materials (e.g. teflon)) Ceramic, metal, polymer (preferably a hard polymer), or a combination thereof. However, other materials may be utilized to limit or prevent wear between the connecting rod 124 and the obstructing member 102 and/or the anchor system 104. The anchor socket 120 may move, preferably slightly, relative to the ball of the second end 126 during normal breathing when the implantable device 100 is disposed in the lung. The wear resistant surface may minimize the accumulation of debris that may interfere with the performance of the implantable device 100. From the present disclosure, one of ordinary skill in the art can determine the appropriate combination of materials, geometries, and lengths of the connecting rods 124 of the ball and socket arrangement to achieve the desired positioning of the implantable device 100.
The connecting rod 124 may have a unitary or multi-piece construction. In some embodiments, the connecting rod body 142 and the ends 126, 128 are made of a single material (e.g., a metal such as nitinol or titanium). In other embodiments, the connecting rod body 142 is made of a flexible material and the ends 126, 128 are made of a somewhat stiff, rigid material, such as ceramic.
The connecting rod 124 may be substantially straight, as shown in FIG. 3. However, the connecting rod 124 may have other configurations based on clinical needs. For example, the connecting rod 124 of fig. 8 has an angled shape that allows the implantable device to be placed into an airway having a complex shape (e.g., an airway having sharp turns, branching portions, etc.).
With continued reference to fig. 3, the elongated member 134 includes a rod 138 having an end portion 140, the end portion 140 being connected to the obstructing member frame 136. The end portion 140 may be attached to the frame 136 by one or more mechanical fasteners, adhesives, welding, stitching, 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 an interior portion of the strut 110, although the rod may be connected to other portions of the frame 136. The rod 138 may also be integrally formed with at least a portion of the frame.
As shown in fig. 4, the implantable device 150 may be placed in a branch air passageway of the bronchial tree. The obstructing member 152 is in the proximal passageway 160 and the anchor system 154 is located in the distal sub-branch air passageway 162. Thus, the implantable device 150 can span the junction 164 of the air passageway of the lung and, thus, allow flexibility in the positioning of the device 150. The air passageway may substantially maintain its natural shape, such as the shape prior to implantation of the implantable device 150, to minimize damage to lung tissue. The orientation of the implantable device is not limited to the orientation shown. The implantable device 150 can be oriented opposite to that shown so that the anchor is proximal to the occlusion element. Thus, the implantable device 150 can be oriented to allow airflow in any desired direction.
The implantable device 150 may also be implanted in a non-branched portion of the lung. If desired, the implantable device 150 can be implanted in a continuous air pathway that is generally straight, curved, angled, or has any other configuration. Because the implantable device 150 can take on a variety of configurations, there is considerable flexibility in selecting placement locations. The implantable device 150 can also be implanted in an air passageway having a substantially constant or varying cross-section. Advantageously, the physician can implant the implantable device 150 in 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., one-way valves, flow resistors, etc.), these devices may be implanted near and adjacent to diseased portions of the lung, thereby maximizing the amount of healthy lung tissue that can function even if the diseased lung tissue is at a distal portion of the bronchial tree.
Fig. 5 illustrates an implantable device 200 including an anchor system 202, the anchor system 202 pivotally coupled to an elongate member 204 extending through an obstructing member 206. The elongate member 204 has a generally spherical member 208 that is rotatably mounted to an anchor socket 210 of the anchor system 202. The occlusion element 206 may be fixedly attached to a point along the elongated element 204.
To secure the occlusion element 206 to the elongated element 204, a portion of the occlusion element frame 212 and/or the membrane may be coupled to the elongated element 204. In the illustrated embodiment, the struts of the occlusion element frame 212 and the membrane 214 are both coupled to the outer surface of the elongated element 204.
Once deployed, the implantable device 100 illustrated in fig. 5 may be held in place by the anchor system 202. The implantable device 200 can be positioned in a non-linear lumen, such as the lumen shown in fig. 4, because the anchor system 202 can be maintained in a first orientation while the obstructing member 206 is pivoted to a second orientation by the generally spherical member 208 and the anchor socket 210. The blocking member 206 can be configured to move axially from the anchor system 202 by traveling along the elongate member 204, which can be limited to prevent inefficient operation of the implantable device 200.
FIG. 6 is a cross-sectional view of an implantable device 250 having an articulatable connecting portion 252 that allows axial movement between an anchor system 254 and an obstructing member 256. The connecting portion 252 includes a retainer 260 of the anchor system 254 and a retainer 262 of the blocking member 256. Each holder 260, 262 is configured to receive an end of a connector 264. The illustrated connector 264 has enlarged ends that are retained by the retainers 260, 262. The chambers 268, 278 of the cages 260, 262, respectively, allow the connector 264 to move axially. The enlarged ends of the connecting members 264 retained by the retainers 260, 262 may also be configured to allow pivotal movement in addition to axial movement.
The anchor system 254 and the obstructing member 256 of the device 250 are free to move toward and away from each other. However, one or more biasing elements (not shown) may be positioned between the anchor system and the obstructing element of the implantable device to adjust the position of the implantable device. The biasing element can cooperate with the connecting portion to ensure that the implantable device remains in a desired position.
Fig. 7 illustrates an implantable device 300 having an articulating connecting portion 302, the articulating connecting portion 302 including a flexible member 304 connected to an anchor system 306 and an obstructing member 308. Flexible member 304 may comprise a somewhat flexible elongate member (e.g., a solid rod, hollow tube, ribbon, etc.) and may comprise metal, polymer (preferably a somewhat rigid polymer), filament, etc. Preferably, the flexible member 304 does not substantially stretch or bend when an axial force is applied. Alternatively, the flexible element 304 may be configured to allow significant axial movement between the anchor system 306 and the obstructing element 308. For example, the flexible member 304 may be a tether that holds together and limits axial movement of the anchor system 306 away from the obstructing member 308. However, the flexible member 304 can easily collapse as the anchor system 306 is moved toward the obstructing member 308. The flexible member 304 may comprise a rope, wire, filament, or other suitable member for providing relative movement between the anchor system 306 and the obstructing member 308.
Referring to fig. 8, the connecting rod 350 may have or be bent to have an angled central portion 352 that defines an angle θ. The lengths L1 and L2 may be selected to achieve a desired orientation and size of the implantable device. If the implantable device is disposed at a sharp turn of the air passageway, the angle θ can match the angle of the bend to generally align the longitudinal axis of the anchor system with one of the channels and the longitudinal axis of the obstructing member with the other channel. The implantable device, for example, may include connecting rods for placement in the air passageway, which together form an acute angle. Accordingly, the configuration of the connecting rod 350 may be selected based on the target placement position.
As shown 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 element is a coil spring. In the illustrated embodiment, the tether 408 extends through the biasing member 402 between the obstructing member 404 and the anchor system 406. Other embodiments may have a tether 408 connecting the obstructing member 404 and the anchor system 406 that does not extend through the biasing member 402, but instead passes at least partially outside of the biasing member 402. Alternatively, a flexible cylindrical member (not shown) may extend between the obstructing member 404 and the anchor system, substantially completely surrounding the biasing member 402. The tether may also be a connector such as that shown in figure 7.
Fig. 10-12 illustrate various embodiments of support frames of implantable devices, each having a mechanism for flexing. Each support frame has a flexible connection portion that allows relative movement between the anchor system and the obstructing member frame. The frame shown does not have a membrane; however, any of various types of films may be applied to the blocking member frame. Fig. 10 illustrates a frame support 450 including flexible connecting portions 452 in the form of slots having an alternating pattern. The connecting portion 452 may be a unitary piece with the frame, as shown, or may be coupled or mounted to the anchor system and the obstructing frame 456. The flexible connecting portion 452 may be formed by cutting a slot into the tube. The number and size of the slots may be selected to achieve the desired flexibility. In addition, the materials used to construct the connecting portion may be selected to achieve its flexible characteristics.
Fig. 11 illustrates a frame support 500 substantially similar to frame support 450 of fig. 10. In the illustrated embodiment, the frame support 500 includes a flexible connection portion 502, the flexible connection portion 502 being in the form of a spring element extending axially along a longitudinal axis of the frame support 500. As such, the spring elements may be arranged in a helical pattern about the longitudinal axis of the flexible connecting portion 502. The illustrated spring element is in the form of a coil spring, although other types of springs or resilient elements may be utilized. The spring may comprise a separate connecting element or may serve as a biasing element, as described above. Additionally, as described above, the spring may be integrally formed with the frame or used as a coupler for the anchor system and blocking element.
Fig. 12 illustrates a frame support 550 including a flexible connecting portion 552 that includes a mesh. Connecting portion 552 may include mesh openings of various sizes with large or small mesh spacing. In addition, the mesh may be made of various materials, such as metal, synthetic materials, or any other elastic material. As described above, the mesh may allow for flexing as the obstructing frame 554 and anchor system 556 are positioned in different orientations. In some embodiments, the mesh may also allow for axial compression along the longitudinal axis of the frame support 550. As described above, the mesh may be integrally formed with the frame, or mounted or coupled at either end to the obstructing member 554 and the anchor system 556.
The struts 600 illustrated in fig. 10-12 each have two generally elongate linear portions connected by a bend (bend). The struts may also have a continuously curved configuration similar to the struts described above. The frame support may carry a membrane to form a blocking element, such as a blocking element suitable for use as a valve (preferably a one-way valve). The connecting portion may enhance the fixation of the blocking element in the air passage to enhance the function of the valve.
Referring to fig. 13, an implantable device 700 is illustrated having a flexible connecting portion 702 such as that shown in fig. 11. The implantable device 700 is disposed and implanted in the air passageway 708 and is held in place by its anchor system 704. The flexible connecting portion 702 can apply a force to the obstructing member 706 of the implantable device 700 to enhance the fixation between the membrane of the obstructing member and the wall 708. Thus, the biasing of the flexible connecting portion 702 can ensure that an effective seal is maintained between the obstructing member 706 and the wall 708, thereby restricting or preventing air flow distally through the implantable device 700. Advantageously, the implantable device 700 can allow air to pass proximally through the obstruction element 706 when the pressure differential across the implantable device 700 is sufficiently high. The biasing member of flexible connection portion 702 may exert a distally directed force as air flows proximally through obstruction element 706. When the pressure differential decreases a sufficient amount, the obstruction member 706 is pulled distally against the air passageway wall 708 to again form a seal with the air passageway wall. Thus, during normal lung operation, the obstructing member 706 may move slightly while the anchor system 704 may remain securely fixed in place. Thus, the flexible connecting portion 702 can enhance the valving action of the implantable device 700.
If desired, the connecting portion 702 can also be used to position the anchor 704 and obstructing member 706 along a curved path within the lung, as shown in FIG. 4 above. The connection portion 702 may be placed along a sharp turn for which a rigid valve, such as a stent-based device, is not suitable.
All patents and publications mentioned herein are incorporated in their entirety by reference into this specification. In some embodiments, the embodiments, features, systems, devices, materials, methods, and techniques described herein may be similar to any one or more of the embodiments, features, systems, devices, materials, methods, and techniques described in the following patent applications, except as further described herein: U.S. patent application 10/409,798 (U.S. publication No. 2004-0200484) filed on 8/4/2003; 09/951,105 filed 3/13/2003 (U.S. publication No. 2003/0050648a 1); 10/848,571 filed 5/17/2004; 10/847,554 filed 5/17/2004; 10/418,929 filed on 17/4/2003; 10/081,712 filed on 21/2/2002 (U.S. publication 2002-0112729); 10/178,073 filed on 21/6/2002 (U.S. publication No. 2003-0154988); 10/317,667 filed on 12/11/2002 (U.S. publication No. 2003-0158515); 10/103,487 filed on 3/20/2002 (U.S. publication No. 2003-0181922); 10/124,790 filed on 16.4.2002 (U.S. publication No. 2003-0195385); 10/143,353 filed on 3/9/2002 (U.S. publication No. 2003-0212412); 10/150,547 filed on 5/17/2002 (U.S. publication No. 2003/0216769); 10/196,513 filed on 7/15/2002 (U.S. publication No. 2004-0010209); 10/254,392 filed on 24.9.2002 (U.S. publication No. 2004/0059263); 10/387,963 filed on 12/3/2003 (U.S. publication No. 2004-; 10/745,401 filed on 12/22/2003; us patent 6,293,951; 6,258,100, respectively; 6722360, respectively; 6,592,594, which are hereby incorporated by reference and form a part of this specification. In addition, in particular embodiments, the embodiments, features, systems, devices, materials, methods, and techniques described herein can be applied or used in conjunction with one or more embodiments, features, systems, devices, materials, methods, and techniques disclosed in the above-incorporated applications and patents.
The articles disclosed herein may be formed by any suitable means. The various methods and techniques described above provide a variety of ways to implement the invention. Of course, it is to be understood that not necessarily all such objects or advantages 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, one of ordinary skill will recognize the interchangeability of various features from different embodiments disclosed herein. Similarly, the various features and steps described above, as well as other known equivalents for each such feature or step, may be mixed and matched by one of ordinary skill in this art to perform methods in accordance with principles described herein. In addition, the methods described and illustrated herein are not limited to the exact order of the operations described, nor are they necessarily limited to the practice of all of the operations set forth. Other sequences of events or operations, or fewer than all of these events, or the simultaneous occurrence of these temporal events, may be used in the practice of the embodiments of the present invention.
Although the present invention has been disclosed in the context of certain embodiments and examples, it will be understood by those of ordinary skill in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications or equivalents thereof. Accordingly, the present invention is not intended to be limited by the preferred embodiments specifically disclosed herein.