US20160135984A1

Movatterモバイル変換

Info

Publication number: US20160135984A1
Application number: US15/008,316
Authority: US
Inventors: Leon Rudakov; Tanner J. Hargens; Phillip M. Leopold
Original assignee: Artventive Medical Group Inc
Current assignee: Artventive Medical Group Inc
Priority date: 2010-06-29
Filing date: 2016-01-27
Publication date: 2016-05-19
Also published as: US9247942B2; US20120192872A1

Abstract

An occlusive device can reversibly block flow through a lumen of a patient, such as a blood vessel, a reproductive structure, a ureter, a colon, and other body lumens. The device can include a frame comprising having a distal portion that tapers inwardly toward a central axis of the frame. The frame can expand from a compressed configuration to a deployed configuration. The device can also include a flow reducing member coupled to the frame for restricting flow through the lumen and a withdrawal component that can engaged by a retrieval device to retrieve the device from within the lumen.

Description

RELATED APPLICATIONS

The present application claims priority to and is a divisional of U.S. patent application Ser. No. 13/367,338, filed on Feb. 6, 2012, which is a continuation-in-part of co-pending U.S. patent application Ser. No. 12/826,593, filed on Jun. 29, 2010, now U.S. Pat. No. 9,017,351, the contents of each which are hereby incorporated by reference in their entirety.

FIELD

The present invention generally relates to methods and apparatus for reducing or stopping flow through a tubular structure of a patient. More particularly, the present invention relates to methods and apparatus for preventing passage of sperm through a reproductive structure of a patient, and subsequently reversing the preventative measure in order to restore fertility to the patient.

BACKGROUND

Devices exist for stenting tubular structures in patients. Stents typically maintain patency in tubular structures such as blood vessels. As a result, flow of fluid such as blood through the tubular structures is generally maintained. Two occlusion devices on the market, ESSURE® and ADIANA®, are used to permanently block the fallopian tubes. These irreversible contraception devices rely on scar tissue growth around the device to occlude the fallopian tube.

SUMMARY

Problems associated with typical devices for occluding flow through tubular structures of patients include inaccurate deployment and positioning of these devices within the tubular structures, as well as having continuous and significant residual flow. These devices, once deployed, do not provide mechanisms allowing for their repositioning and/or removal in a simple manner. Thus, once these devices have been deployed, the devices are typically committed to their initially-deployed position. It is therefore desirable to provide devices that can be used to reduce or stop flow through a tubular structure of a patient, and also allow for their repositioning and/or removal.

According to various embodiments of the subject technology, an apparatus is provided for reducing or stopping flow through a tubular structure of a patient. The apparatus comprises a first elongate member arranged to form a first frame having a distal opening and a proximal opening. The first frame is configured to be positioned within a lumen of the tubular structure. The first frame includes a proximal portion, a distal portion, and a middle portion therebetween. The distal portion is tapered such that a cross-sectional dimension of the distal opening is less than a cross-sectional dimension of the middle portion. The first frame is configured to be inverted such that the distal portion moves within and toward the middle portion for removing the first frame from within the lumen. The apparatus also comprises a first flow reducing member coupled to the first frame such that when the first frame is positioned within the lumen, the first flow reducing member substantially reduces or totally obstructs flow of at least one of emboli and fluid flowing through the lumen.

In some embodiments the first elongate member is arranged in a spiral configuration to form the first frame. In some embodiments, the first flow reducing member totally obstructs flow of the at least one of emboli and fluid flowing through the lumen. In some embodiments, the first flow reducing member is coupled to the first frame using surgical suture. In some embodiments, the first frame is further configured to expand from an undeployed configuration to a deployed configuration such that the first frame engages an inner surface of the lumen. The first frame may be expanded with a balloon or may be self expandable.

According to certain embodiments, the proximal portion is tapered such that a cross-sectional dimension of the proximal opening is less than the outer cross-sectional dimension of the middle portion. In some embodiments, the outer cross-sectional dimension of the proximal opening is larger than a cross-sectional dimension of the distal opening.

In some embodiments, the first elongate member comprises at least one of stainless steel, nickel titanium (NiTi), cobalt chromium (CoCr), titanium, a polymer, a polyester based material, a tyrosine based polycarbonate, a polyethylene based material, and Teflon (e.g., including expanded Teflon). The first elongate member may also comprise at least one of polyethylene, polyglicolide, polylactide, ε-caprolactone, polycarbonate, hydroxyalkanote, para dioxinine, PLA, PGA, PLLA, PDLLA, PDO, and PCL. In some embodiments, the first elongate member comprises bioabsorbable material.

According to certain embodiments, the first elongate member comprises a substantially rectangular cross-section. A length of the rectangular cross-section may be between about 0.008 inches and about 0.014 inches and a width of the rectangular cross-section may be between about 0.004 inches and about 0.006 inches. Corners of the rectangular cross-section may be radiused or curved.

In some embodiments, the first frame is coated with biological glue. The biological glue may comprise glue from at least one of crab shells, spider webs, gecko feet, burrowing frogs, mussels, and caulobacter crescentus bacteria.

In some embodiments, the first flow reducing member comprises at least one of a polyurethane and a polyanhidrate. In some embodiments, the first flow reducing member comprises expanded polytetrafluoroethylene (ePTFE). In some embodiments, the first flow reducing member comprises bioabsorbable material. In some embodiments, the first flow reducing member comprises a self sealing material. The first flow reducing member may be configured to facilitate an extension of a guide wire therethrough. In some embodiments, the first flow reducing member comprises a plurality of pores each having a diameter of between about 5 microns and about 10 microns.

According to certain embodiments, the first flow reducing member is disposed over an exterior of the first frame. The first flow reducing member may be disposed over the distal portion. A hole may be defined in the first flow reducing member. The hole may allow a guide wire to extend therethrough. The first flow reducing member may comprise a portion configured to partially, substantially, or totally block the hole when the guide wire is removed therefrom. Swelling material may be disposed in or on the portion. When fluid contacts the swelling material, the swelling material and the portion may be expanded to substantially or totally block the hole. In some aspects, the portion may comprise a pocket. In some aspects, the swelling material may be comprised of microparticles. In some aspects, the swelling material may comprise hydrogel.

In some embodiments, at least a portion of the first flow reducing member extends from the exterior of the first frame into an interior of the first frame through the distal opening to form a flap in the interior of the first frame. The flap is configured to substantially prevent distal flow through the distal opening and facilitate proximal flow through the distal opening.

In some embodiments, an average thickness of the first flow reducing member is between about 0.0005 inches and about 0.006 inches. In some embodiments, an average thickness of a distal portion of the first flow reducing member is greater than an average thickness of a proximal portion of the first flow reducing member. The average thickness of the distal portion of the first flow reducing member may be between about 0.002 inches and about 0.012 inches and the average thickness of the proximal portion of the first flow reducing member may be between about 0.0005 inches and about 0.006 inches.

In some embodiments, the first flow reducing member is disposed over the distal opening. In some embodiments, the first flow reducing member is disposed over the proximal portion, the middle portion, and the distal portion.

According to certain embodiments, a radio-opaque marker is placed on a first coil of the first frame. A cross-sectional dimension of the first coil may be less than a cross-sectional dimension of a second coil of the first frame. The radio-opaque marker may surround an exterior of the first coil. The first coil may be adjacent to a second coil of the first frame. The first flow reducing member may be coupled to the second coil. The radio-opaque marker may comprise a platinum iridium alloy.

In some embodiments, the first flow reducing member is disposed in an interior of the first frame. The first flow reducing member may be coupled to the middle portion. The first flow reducing member may be coupled to a first coil of the first frame such that the first flow reducing member substantially covers an opening through the first coil. A portion of the first elongate member from a first point on the first elongate member to a second point on the first elongate member may form the first coil. The first flow reducing member may be coupled to the first elongate member from the first point on the first elongate member to the second point on the first elongate member. A thickness of the first coil of the first frame measured along an axial dimension of the first frame may be less than a thickness of a second coil of the first frame measured along the axial dimension of the first frame.

In some embodiments, the tubular structure comprises at least one of a blood vessel, a Fallopian tube, a cervical canal, a vagina, a cervix, a vas deferens, a bronchus, a ureter, a colon, a rectum, an anus, a bile duct, and a pancreatic duct. In some embodiments, the apparatus comprises a retrieving member configured to couple to the distal portion and to retrieve the distal portion toward an interior of the first frame for inverting the first frame. The retrieving member may comprise at least one jaw having a compressed configuration and a deployed configuration. The at least one jaw may be configured to expand from the compressed configuration to the deployed configuration for coupling to the distal portion. The at least one jaw may comprise a curved portion.

In certain embodiments, the apparatus comprises a tube configured to extend through the distal opening to be positioned at a target site of the patient. The apparatus also comprises a vacuum source configured to apply a vacuum through the tube for removing at least one of emboli and fluid from the target site.

In some embodiments, the apparatus comprises an outer catheter configured to be positioned within the lumen at a first deployment site. The apparatus also comprises an inner catheter disposed within the outer catheter. The first frame is configured to be positioned between the inner catheter and the outer catheter for stowage of the first frame before the first frame is deployed within the lumen.

In some embodiments, the apparatus also comprises one or more threads formed in or on an outer surface of the inner catheter such that the first elongate member wraps around the one or more threads for securing the first elongate member to the inner catheter. In some embodiments, the apparatus comprises one or more blocks disposed on an outer surface of the inner catheter such that the first elongate member wraps around the one or more blocks for securing the first elongate member to the inner catheter. The one or more blocks may comprise electroactive polymer (EAP) and may be configured to swell when electric signals are applied to the one or more blocks. The first elongate member wrapped around the one or more blocks may be substantially locked to the one or more blocks when the electric signals are applied.

In some embodiments, the inner catheter comprises a hole configured such that a proximal tip of the first elongate member extends through the hole from an exterior of the inner catheter into an interior of the inner catheter for securing the first frame to the inner catheter. In some embodiments, the inner catheter comprises a groove configured such that a proximal tip of the first elongate member is disposed in the groove for securing the first frame to the inner catheter.

In certain embodiments, the first flow reducing member is disposed over the distal portion. The distal portion and the first flow reducing member extend distally beyond a distal opening of the outer catheter such that when the outer catheter is moved within the lumen to the first deployment site, the distally extended portion of the first flow reducing member is configured to engage a wall of the lumen to reduce friction.

In some embodiments, the apparatus comprises a first stop disposed between the outer catheter and the inner catheter. The first stop is coupled to an inner surface of the outer catheter and is disposed proximal the first frame when the first frame is positioned between the inner catheter and the outer catheter. The apparatus also comprises a second stop disposed between the outer catheter and the inner catheter. The second stop is coupled to an outer surface of the inner catheter and is disposed proximal the first stop. When the inner catheter is shifted distally relative to the outer catheter for deploying the first frame, the second stop engages the first stop to substantially prevent the inner catheter from further distal shifting relative to the outer catheter. In some embodiments, the second stop comprises a groove configured such that a proximal tip of the first elongate member is disposed in the groove for securing the first frame to the inner catheter.

In some embodiments, the apparatus comprises a stop disposed between the outer catheter and the inner catheter. The stop is further disposed proximal the first frame when the first frame is positioned between the inner catheter and the outer catheter. The stop is configured to substantially prevent the first frame from moving proximally relative to at least one of the outer catheter and the inner catheter. In some embodiments, the stop comprises a groove configured such that a proximal tip of the first elongate member is disposed in the groove for securing the first frame to the inner catheter.

In some embodiments, the apparatus also comprises a guide wire configured to extend through the inner catheter and the distal opening of the first frame. In some embodiments, the apparatus also comprises a second elongate member arranged in a spiral configuration to form a second frame having a distal opening and a proximal opening. The second frame is configured to be positioned within the lumen. The second frame includes a proximal portion, a distal portion, and a middle portion therebetween. The distal portion of the second frame is tapered such that a cross-sectional dimension of the distal opening of the second frame is less than a cross-sectional dimension of the middle portion of the second frame. The second frame is configured to be inverted such that the distal portion of the second frame moves within and toward the middle portion of the second frame for removing the second frame from within the lumen. The apparatus also comprises a second flow reducing member coupled to the second frame such that when the second frame is positioned within the lumen, the second flow reducing member substantially reduces or totally obstructs flow of at least one of emboli and fluid flowing through the lumen.

In some embodiments, the second frame is configured to be positioned between the outer catheter and the guide wire for stowage of the second frame before the second frame is deployed within the lumen. The apparatus also comprises one or more threads formed in or on an outer surface of the guide wire such that the second elongate member wraps around the one or more threads for securing the second elongate member to the guide wire. In some embodiments, the apparatus comprises one or more blocks disposed on an outer surface of the guide wire such that the second elongate member wraps around the one or more blocks for securing the second elongate member to the guide wire. The one or more blocks may comprise electroactive polymer (EAP) and are configured to swell when electric signals are applied to the one or more blocks. The second elongate member wrapped around the one or more blocks may be substantially locked to the one or more blocks when the electric signals are applied.

In some embodiments, the first flow reducing member is disposed over the distal portion of the first frame and the second flow reducing member is disposed over the proximal portion of the second frame. In some embodiments, the first flow reducing member is disposed over the distal portion of the first frame and the second flow reducing member is disposed over the distal portion of the second frame.

According to certain embodiments, the guide wire is configured to shift distally relative to the outer catheter until the second frame extends beyond a distal opening of the outer catheter into the first deployment site for deploying the second frame from the outer catheter. The outer catheter is configured to be positioned within the lumen at a second deployment site for deploying the first frame at the second deployment site. The inner catheter is configured to shift distally relative to the outer catheter until the first frame extends beyond the distal opening of the outer catheter into the second deployment site.

In some embodiments, the guide wire is configured to shift distally relative to the outer catheter until a portion of the second frame extends beyond a distal opening of the outer catheter into the first deployment site for partially deploying the second frame from the outer catheter. The guide wire is configured to shift proximally relative to the outer catheter until the portion of the second frame is retracted proximally into the outer catheter for retracting the second frame into the outer catheter. The outer catheter is configured to be positioned within the lumen at a second deployment site for deploying the second frame at the second deployment site. The guide wire is configured to shift distally relative to the outer catheter until the second frame extends beyond the distal opening of the outer catheter into the second deployment site.

In some embodiments, the inner catheter is configured to shift distally relative to the outer catheter until the first frame extends beyond a distal opening of the outer catheter into the first deployment site for deploying the first frame from the outer catheter. In some embodiments, the inner catheter is configured to shift distally relative to the outer catheter until a portion of the first frame extends beyond a distal opening of the outer catheter into the first deployment site for partially deploying the first frame from the outer catheter. The inner catheter is configured to shift proximally relative to the outer catheter until the portion of the first frame is retracted proximally into the outer catheter for retracting the first frame into the outer catheter. The outer catheter is configured to be positioned within the lumen at a second deployment site for deploying the first frame at the second deployment site. The inner catheter is configured to shift distally relative to the outer catheter until the first frame extends beyond the distal opening of the outer catheter into the second deployment site for deploying the first frame from the outer catheter.

In some embodiments, the inner catheter comprises a proximal handle. The first frame and the first flow reducing member are deployed from the outer catheter by shifting the proximal handle and the inner catheter distally relative to the outer catheter until the first frame and the first flow reducing member extend beyond a distal opening of the outer catheter into the lumen. In some embodiments, the apparatus comprises a security block coupled to the proximal handle. The security block is configured to substantially prevent the proximal handle and the inner catheter from shifting distally relative to the outer catheter.

According to various embodiments of the subject technology, a method for reducing or stopping flow through a tubular structure of a patient is provided. The method comprises positioning a first elongate member within a lumen of the tubular structure. The first elongate member is arranged to form a first frame having a distal opening and a proximal opening. The first frame includes a proximal portion, a distal portion, and a middle portion therebetween. The distal portion is tapered such that a cross-sectional dimension of the distal opening is less than a cross-sectional dimension of the middle portion. The method also comprises substantially reducing or totally obstructing, with a first flow reducing member coupled to the first frame, flow of at least one of emboli and fluid flowing through the lumen. The method also comprises removing the first frame from within the lumen by inverting the first frame such that the distal portion moves within and toward the middle portion.

In some embodiments the first elongate member is arranged in a spiral configuration to form the first frame. In some embodiments, the method comprises totally obstructing, with the first flow reducing member coupled to the first frame, flow of the at least one of emboli and fluid flowing through the lumen. In some embodiments, the first flow reducing member is coupled to the first frame using surgical suture. In some embodiments, the method comprises expanding the first frame from an undeployed configuration to a deployed configuration such that the first frame engages an inner surface of the lumen. The first frame may be expanded with a balloon or may be self-expandable.

In some embodiments, the first flow reducing member comprises at least one of a polyurethane and a polyanhidrate. In some embodiments, the first flow reducing member comprises expanded polytetrafluoroethylene (ePTFE). In some embodiments, the first flow reducing member comprises bioabsorbable material. In some embodiments, the first flow reducing member comprises a self sealing material. The first flow reducing member may be configured to facilitate an extension of a guide wire through therethrough. In some embodiments, the first flow reducing member comprises a plurality of pores each having a diameter of between about 5 microns and about 10 microns. In some embodiments, an average thickness of the first flow reducing member is between about 0.0005 inches and about 0.006 inches.

In some embodiments, at least a portion of the first flow reducing member extends from the exterior of the first frame into an interior of the first frame through the distal opening to form a flap in the interior of the first frame. In some embodiments, the substantially reducing or totally obstructing comprises: substantially preventing, with the flap, distal flow through the distal opening; and facilitating, with the flap, proximal flow through the distal opening.

In some embodiments, the tubular structure comprises at least one of a blood vessel, a Fallopian tube, a cervical canal, a vagina, a cervix, a vas deferens, a bronchus, a ureter, a colon, a rectum, an anus, a bile duct, and a pancreatic duct. In some embodiments, the removing comprises: coupling a retrieving member to the distal portion; and retrieving, with the retrieving member, the distal portion toward an interior of the first frame for inverting the first frame. The retrieving member may comprise at least one jaw having a compressed configuration and a deployed configuration. The method may further comprise expanding the at least one jaw from the compressed configuration to the deployed configuration for coupling to the distal portion. The at least one jaw may comprise a curved portion.

In some embodiments, the method further comprises extending a tube through the distal opening to position the tube at a target site of the patient. The method also comprises applying, with a vacuum source, a vacuum through the tube for removing at least one of emboli and fluid from the target site.

In some embodiments, the method further comprises positioning an outer catheter within the lumen at a first deployment site. An inner catheter is disposed within the outer catheter. The first frame is configured to be positioned between the inner catheter and the outer catheter for stowage of the first frame before the first frame is deployed within the lumen.

In some embodiments, one or more threads are formed in or on an outer surface of the inner catheter such that the first elongate member wraps around the one or more threads for securing the first elongate member to the inner catheter. In some embodiments, one or more blocks are disposed on an outer surface of the inner catheter such that the first elongate member wraps around the one or more blocks for securing the first elongate member to the inner catheter. The one or more blocks may comprise electroactive polymer (EAP) and may be configured to swell when electric signals are applied to the one or more blocks. The first elongate member wrapped around the one or more blocks may be substantially locked to the one or more blocks when the electric signals are applied. In some embodiments, the method further comprises applying electric signals to the one or more blocks. The first elongate member wrapped around the one or more blocks may be substantially locked to the one or more blocks when the electric signals are applied.

In certain embodiments, the first flow reducing member is disposed over the distal portion. In some embodiments, the distal portion and the first flow reducing member extend distally beyond a distal opening of the outer catheter. In some embodiments, the positioning the outer catheter comprises moving the outer catheter within the lumen to the first deployment site. In some embodiments, the method further comprises engaging, with the distally extended portion of the first flow reducing member, a wall of the lumen to reduce friction.

In some embodiments, a first stop is disposed between the outer catheter and the inner catheter. The first stop is coupled to an inner surface of the outer catheter and is disposed proximal the first frame when the first frame is positioned between the inner catheter and the outer catheter. A second stop is disposed between the outer catheter and the inner catheter. The second stop is coupled to an outer surface of the inner catheter and is disposed proximal the first stop. When the inner catheter is shifted distally relative to the outer catheter for deploying the first frame, the second stop engages the first stop to substantially prevent the inner catheter from further distal shifting relative to the outer catheter. In some embodiments, the second stop comprises a groove configured such that a proximal tip of the first elongate member is disposed in the groove for securing the first frame to the inner catheter.

In some embodiments, a stop is disposed between the outer catheter and the inner catheter. The stop is further disposed proximal the first frame when the first frame is positioned between the inner catheter and the outer catheter. The method comprises substantially preventing, with the stop, the first frame from moving proximally relative to at least one of the outer catheter and the inner catheter. In some embodiments, the stop comprises a groove configured such that a proximal tip of the first elongate member is disposed in the groove for securing the first frame to the inner catheter.

In some embodiments, a guide wire extends through the inner catheter and the distal opening of the first frame. In some embodiments, the method further comprises positioning a second elongate member within the lumen. The second elongate member is arranged in a spiral configuration to form a second frame having a distal opening and a proximal opening. The second frame includes a proximal portion, a distal portion, and a middle portion therebetween. The distal portion of the second frame is tapered such that a cross-sectional dimension of the distal opening of the second frame is less than a cross-sectional dimension of the middle portion of the second frame. The method also comprises substantially reducing or totally obstructing, with a second flow reducing member coupled to the second frame, flow of at least one of emboli and fluid flowing through the lumen. The method also comprises removing the second frame from within the lumen by inverting the second frame such that the distal portion of the second frame moves within and toward the middle portion of the second frame.

In some embodiments, the second frame is configured to be positioned between the outer catheter and the guide wire for stowage of the second frame before the second frame is deployed within the lumen. In some embodiments, the guide wire comprises one or more threads such that the second elongate member wraps around the one or more threads for securing the second elongate member to the guide wire. In some embodiments, one or more blocks is disposed on an outer surface of the guide wire such that the second elongate member wraps around the one or more blocks for securing the second elongate member to the guide wire. The one or more blocks may comprise electroactive polymer (EAP) and are configured to swell when electric signals are applied to the one or more blocks. In some embodiments, the method further comprises applying electric signals to the one or more blocks. The second elongate member wrapped around the one or more blocks may be substantially locked to the one or more blocks when the electric signals are applied.

In some embodiments, the method further comprises deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until the second frame extends beyond a distal opening of the outer catheter into the first deployment site. The method also comprises positioning the outer catheter within the lumen at a second deployment site for deploying the first frame at the second deployment site. The method also comprises deploying the first frame from the outer catheter by shifting the inner catheter distally relative to the outer catheter until the first frame extends beyond the distal opening of the outer catheter into the second deployment site.

In some embodiments, the method further comprises partially deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until a portion of the second frame extends beyond a distal opening of the outer catheter into the first deployment site. The method also comprises retracting the second frame into the outer catheter by shifting the guide wire proximally relative to the outer catheter until the portion of the second frame is retracted proximally into the outer catheter. The method also comprises positioning the outer catheter within the lumen at a second deployment site for deploying the second frame at the second deployment site. The method also comprises deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until the second frame extends beyond the distal opening of the outer catheter into the second deployment site.

In some embodiments, the inner catheter comprises a proximal handle. In some embodiments, the method further comprises deploying the first frame and the first flow reducing member from the outer catheter by shifting the proximal handle and the inner catheter distally relative to the outer catheter until the first frame and the first flow reducing member extend beyond a distal opening of the outer catheter into the lumen. In some embodiments, the method further comprises substantially preventing, with a security block coupled to the proximal handle, the proximal handle and the inner catheter from shifting distally relative to the outer catheter.

According to various embodiments of the subject technology, a method for reducing or stopping flow through a tubular structure of a patient is provided. The method comprises positioning an outer catheter within a lumen of the tubular structure at a first deployment site. An inner catheter is disposed within the outer catheter. A first elongate member is positioned between the inner catheter and the outer catheter. The first elongate member is arranged to form a first frame that can have, in some embodiments, a distal opening and a proximal opening. The first frame includes a proximal portion, a distal portion, and a middle portion therebetween. The distal portion is tapered such that a cross-sectional dimension of the distal opening is less than a cross-sectional dimension of the middle portion. The method also comprises partially deploying the first frame from the outer catheter by shifting the inner catheter distally relative to the outer catheter until a portion of the first frame extends beyond a distal opening of the outer catheter into the first deployment site. The method also comprises retracting the first frame into the outer catheter by shifting the inner catheter proximally relative to the outer catheter until the portion of the first frame is retracted proximally into the outer catheter. The method also comprises positioning the outer catheter within the lumen at a second deployment site for deploying the first frame at the second deployment site. The method also comprises deploying the first frame from the outer catheter by shifting the inner catheter distally relative to the outer catheter until the first frame extends beyond the distal opening of the outer catheter into the second deployment site. The method also comprises substantially reducing or totally obstructing, with a first flow reducing member coupled to the first frame, flow of at least one of emboli and fluid flowing through the lumen.

In some embodiments the first elongate member is arranged in a spiral configuration to form the first frame. In some embodiments, the method comprises totally obstructing, with the first flow reducing member coupled to the first frame, flow of the at least one of emboli and fluid flowing through the lumen. In some embodiments, the first flow reducing member is coupled to the first frame using surgical suture. In some embodiments, the method comprises expanding the first frame from an undeployed configuration to a deployed configuration such that the first frame engages an inner surface of the lumen. The first frame may be expanded with a balloon or may be self expandable.

In some embodiments, the method further comprises deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until the second frame extends beyond a distal opening of the outer catheter into the first deployment site.

In some embodiments, the method further comprises partially deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until a portion of the second frame extends beyond a distal opening of the outer catheter into a third deployment site. The method also comprises retracting the second frame into the outer catheter by shifting the guide wire proximally relative to the outer catheter until the portion of the second frame is retracted proximally into the outer catheter. The method also comprises positioning the outer catheter within the lumen at a fourth deployment site for deploying the second frame at the fourth deployment site. The method also comprises deploying the second frame from the outer catheter by shifting the guide wire distally relative to the outer catheter until the second frame extends beyond the distal opening of the outer catheter into the fourth deployment site.

In some embodiments, an apparatus for prevention of sperm passage through a reproductive structure of a patient is disclosed. The apparatus may include an elongate member forming a frame having a distal opening and a proximal opening and being configured to be positioned within a lumen of the reproductive structure, the frame further having a proximal portion, a distal portion, and a middle portion extending therebetween. The apparatus may further include a flow reducing member coupled to the frame such that when the frame is positioned within the lumen, the flow reducing member reduces or totally obstructs passage of sperm through the lumen. In some embodiments, the frame is formed by a plurality of contiguous coils axially-offset from each other. Moreover, the frame may be made of a shape-memory material expandable from a compressed configuration and into a deployed configuration upon being unrestrained. In one or more embodiments, the flow reducing member is coupled to one of the plurality of contiguous coils in an interior of the frame such that the flow reducing member substantially encompasses an opening defined by the one of the plurality of contiguous coils.

In some embodiments, the flow reducing member is disposed over an exterior of the frame. For example, the flow reducing member may be disposed over the distal portion of the frame. In at least one embodiment, the flow reducing member closes the distal opening of the frame but the proximal opening remains unobstructed. In one or more embodiments, the middle portion of the apparatus is tapered such that a cross-sectional dimension of the middle portion is less than a cross-sectional dimension of at least one of the proximal and distal portions.

In some embodiments, the apparatus may further include a withdrawal component configured to be engaged by a retrieving device to retrieve all or a portion of the apparatus. The withdrawal component may be coupled to the distal portion of the frame and the withdrawal component is configured to be pulled toward an interior of the frame to invert the frame. In other embodiments, the withdrawal component is coupled to the flow reducing member.

In some embodiments, the apparatus may also include a tubular scaffold configured to be positioned within the lumen and separate the lumen from the flow reducing member and the frame. The tubular scaffold may be made of a shape memory material expandable from a compressed configuration to a deployed configuration when unrestrained.

In some embodiments, the flow reducing member includes one or more occlusion caps. In one or more embodiments, at least one of the one or more occlusion caps is a biodegradable material. The biodegradable material may have a degradation profile that is stable until a triggering event occurs. In some embodiments, the flow reducing member is at least partially coated with a tissue growth inhibitor.

In some embodiments, a method for preventing the passage of sperm through a reproductive structure of a patient is disclosed. The method may include positioning a first elongate member within a first lumen of the reproductive structure, the first elongate member forming a first frame having a first proximal portion that defines a first proximal opening, and a first distal portion that defines a first distal opening. The method may also include expanding the first frame within the first lumen, and expanding a first flow reducing member coupled to the first frame. The method may further include reducing or totally obstructing the passage of sperm through the first lumen with the first flow reducing member.

In some embodiments, the method may further include positioning a tubular scaffold in the first lumen to separate the first lumen from the first flow reducing member and the first frame. The method may also include injecting at least one of an occlusion gel and an occlusion foam within or around the first elongate member. The method may further include substantially covering the first distal opening with the first flow reducing member. In some embodiments, the method may further include positioning a second elongate member within a second lumen of the reproductive structure, the second elongate member forming a second frame having a second proximal portion that defines a second proximal opening, and a second distal portion that defines a second distal opening, expanding the second frame within the second lumen, expanding a second flow reducing member coupled to the second frame, and reducing or totally obstructing the passage of sperm through the second lumen with the second flow reducing member.

In some embodiments, a method for restoring fertility to a patient having a contraceptive apparatus positioned within a reproductive structure of the patient is disclosed. The method may include deactivating the contraceptive apparatus, the contraceptive apparatus comprising an elongate member forming a frame having a proximal portion and a distal portion, and a flow reducing member coupled to the frame, and allowing sperm to pass through the flow reducing member. In one or more embodiments, deactivating the contraceptive apparatus includes breaching the integrity of the flow reducing member. In other embodiments, the flow reducing member is an absorbable polymer and deactivating the contraceptive apparatus includes accelerating degradation of the absorbable polymer. In yet other embodiments, the contraceptive apparatus further includes a withdrawal component coupled to the frame, and deactivating the contraceptive apparatus includes engaging the withdrawal component with a retrieving device, and pulling the withdrawal component proximally to remove all or a portion of the contraceptive device from the reproductive structure. In some embodiments, the withdrawal component is coupled to the distal portion of the frame and pulling the withdrawal component proximally includes pulling the distal portion of the frame toward an interior of the frame to invert the frame.

Additional features and advantages of the invention will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate aspects of the invention and together with the description serve to explain the principles of the invention.

FIG. 1 illustrates an example of an apparatus for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology.

FIG. 2 illustrates an example of an apparatus, in accordance with various embodiments of the subject technology.

FIG. 3 illustrates an example of an apparatus having a flow reducing member disposed in an interior of a frame, in accordance with various embodiments of the subject technology.

FIG. 4 illustrates a cross-sectional dimension of an elongate member, in accordance with various embodiments of the subject technology.

FIGS. 5A and 5B illustrate an apparatus deployed within a lumen of a tubular structure of a patient, in accordance with various embodiments of the subject technology.

FIG. 6 illustrates an example of a frame and a flow reducing member being positioned within an outer catheter, in accordance with various embodiments of the subject technology.

FIGS. 7A and 7B illustrate detailed views of a frame and a flow reducing member positioned within an outer catheter, in accordance with various embodiments of the subject technology.

FIG. 8 illustrates an example of a frame and a flow reducing member positioned within an outer catheter, in accordance with various embodiments of the subject technology.

FIG. 9 illustrates an example of an inner catheter, in accordance with various embodiments of the subject technology.

FIGS. 10A and 10B illustrate an example of a frame and a flow reducing member positioned within an outer catheter, in accordance with various embodiments of the subject technology.

FIG. 11 illustrates an example of two frames and two flow reducing members positioned within an outer catheter, in accordance with various embodiments of the subject technology.

FIG. 12 illustrates an example of deploying frames, along with corresponding flow reducing members, in accordance with various embodiments of the subject technology.

FIG. 13 illustrates an example of frames, along with corresponding flow reduction members, deployed within a lumen for occluding an aneurysm, in accordance with various embodiments of the subject technology.

FIGS. 14A, 14B, and 14C illustrate an example of a retrieving member, in accordance with various embodiments of the subject technology.

FIG. 15 illustrates an example of a method for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology.

FIG. 16 illustrates an example of a method for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology.

FIG. 17 illustrates an example of a reversible tubal contraceptive device placed in an isthmus of a fallopian tube, in accordance with various embodiments of the subject technology.

FIG. 18 illustrates a side view of a reversible tubal contraceptive device, in accordance with various embodiments of the subject technology.

FIG. 19 illustrates removal of a reversible tubal contraceptive device, in accordance with various embodiments of the subject technology.

FIG. 20 illustrates a pair of deployed contraceptive devices, in accordance with various embodiments of the subject technology.

FIG. 21 illustrates an exemplary contraceptive device in its deployed configuration, in accordance with various embodiments of the subject technology.

FIG. 22 illustrates the contraceptive device ofFIG. 21 in an inverted configuration for removal, in accordance with various embodiments of the subject technology.

FIG. 23 illustrates the contraceptive device in a compressed configuration prior to deployment, in accordance with various embodiments of the subject technology.

FIG. 24 illustrates the contraceptive device ofFIG. 23 in a partially-deployed configuration, in accordance with various embodiments of the subject technology.

FIG. 25 illustrates the contraceptive device ofFIG. 23 as it is being removed from a tubular structure, in accordance with various embodiments of the subject technology.

FIG. 26 illustrates an alternative configuration of a contraceptive device, in accordance with various embodiments of the subject technology.

FIG. 27 illustrates another alternative configuration of the contraceptive device, in accordance with various embodiments of the subject technology.

FIG. 28 illustrates the contraceptive device as deployed within a tubular scaffold, in accordance with various embodiments of the subject technology.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are set forth to provide a full understanding of the present invention. It will be apparent, however, to one ordinarily skilled in the art that the present invention may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the present invention.

FIG. 1 illustrates an example ofapparatus10 for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology. Theapparatus10 comprises anelongate member12 arranged to form aframe76 having adistal opening16 and aproximal opening18. Theframe76 is configured to be positioned within a lumen of the tubular structure. Theframe76 includes aproximal portion20, adistal portion24, and amiddle portion22 extending therebetween. Thedistal portion24 may be tapered such that a cross-sectional dimension of thedistal opening16 is less than a cross-sectional dimension of themiddle portion22. In one or more embodiments, the tapereddistal portion24 may allow for easy passage of a guide wire or a retrieval tool to pass therethrough. Theframe76 may be configured to be inverted such that thedistal portion24 moves within and toward themiddle portion22 for removing theframe76 from within the lumen.

Theapparatus10 may also include aflow reducing member14 coupled to theframe76 such that when theframe76 is positioned within the lumen, theflow reducing member14 substantially reduces or totally obstructs flow of at least one of emboli and fluid flowing through the lumen. In one or more embodiments, theflow reducing member14 may be secured and placed inside and/or outside of theframe76. In some aspects, theflow reducing member14 may be coupled to theframe76 using surgical suture.

In some embodiments, theelongate member12 is formed by a plurality of contiguous coils34 (seeFIG. 3) axially-offset from each other and generally arranged in a spiral configuration. As a result of the spiral configuration, theframe76 may be configured to be expanded radially to engage an inner surface of the lumen. Should the inner surface of the lumen apply a radially compressive force on any portion of theframe76, the spiral configuration disperses such a force along the entirety of theelongate member12, thereby providing strong structural support for theapparatus10 while arranged within the lumen. In some embodiments, the spiral configuration of theelongate member12 allows theframe76 to withstand long-term pulsatile loads of torque and bending, and reduces the risk of fatigue breaks, cracks, etc.

In some embodiments, theelongate member12 may be defined by more or less coils than are depicted inFIG. 1. For example, the number of axially-spaced coils in the spiral configuration may vary depending on the required size and compressibility of theframe76, a desired placement of theapparatus10, and/or other factors known to those skilled in the art. In some embodiments, theelongate member12 is highly flexible while providing sufficient rigidity to be guided through the lumen. In at least one embodiment, the tapereddistal portion24 is defined by or otherwise includes one or more of the coils of theframe76.

In some embodiments, theframe76 may be reduced in the radial direction by applying an axial force to a tip or end of theelongate member12, thereby allowing theapparatus10 to be disengaged from the inner surface of the lumen and repositioned and/or removed. For example, an axial force in the proximal direction may be applied to aproximal tip13 of theelongate member12, resulting in the radial reduction of theframe76. Although theelongate member12 is depicted inFIG. 1 as arranged in the spiral configuration, other suitable configurations known to those of ordinary skill in the art may be used. In some embodiments, theelongate member12 includes one or more anchors configured to engage an inner surface of the lumen for resisting axial movement of theframe76 when theframe76 is deployed within the lumen. For example, the one or more anchors may be protrusions, or hair-like wires of the same material as theelongate member12.

According to certain embodiments, theapparatus10 may be removed from within the lumen by inverting theframe76. For example, an axial force in the proximal direction may be applied to thedistal portion24 such that thedistal portion24 moves inverts within itself and toward themiddle portion22. In some embodiments, such an inversion causes theelongate member12 to “unwind” from its spiral configuration, in which case the axial force may continue to be applied until theelongate member12 disengages from the inner surface of the lumen. In some embodiments, theelongate member12 may maintain its spiral configuration after the inversion, but otherwise exhibit a reduced cross-sectional dimension as aninverted frame76. In such a case, theinverted frame76 may be easily removed from within the lumen because of the reduced cross-sectional dimension.

According to various embodiments of the subject technology, theelongate member12 may be made of at least one of stainless steel, nickel titanium (NiTi), cobalt chromium (CoCr), titanium, a polymer, a polyester based material, a tyrosine based polycarbonate, a polyethylene based material, polytetrafluoroethylene (PTFE) (i.e., TEFLON® and including expanded polytetrafluoroethylene (ePTFE)), combinations thereof, and/or the like. In some embodiments, theelongate member12 may be made of at least one of polyethylene, polyglicolide, polylactide, ε-caprolactone, polycarbonate, hydroxyalkanote, para dioxinine, PLA, PGA, PLLA, PDLLA, PDO, PCL, combinations thereof, and/or the like. In some embodiments, theelongate member12 and/or theflow reducing member14, may be formed of a bioabsorbable material that allows for their respective, controlled degradation. In some embodiments, theelongate member12 and/or theflow reducing member14 may be formed of a bioabsorbable material configured to provide a controlled degradation of between about 3 months to about 3 years, depending on the desired application of theapparatus10. In some embodiments, the controlled degradation may be less than about 3 months or greater than about 3 years. For example, hydrolysis of ester linkages or effects of enzymatic degradation may be utilized for the controlled degradation.

In some embodiments, theframe76 may be coated with various suitable agents that facilitate engagement of theframe76 to the inner surface of the lumen. For example, theframe76 may be coated with a biological glue, such as, but not limited to, glue from at least one of crab shells, spider webs, gecko feet, burrowing frogs, mussels, caulobacter crescentus bacteria, combinations thereof, or the like. In some embodiments, theframe76 may be coated with a friction-resistant coating, such as a friction-resistant polymer coating, configured to facilitate slidable engagement between theframe76 and the inner surface of the lumen.

In some embodiments, radio-opaque markers may be located on theframe76, theflow reducing member14, and/or a catheter delivering theapparatus10 for endovascular or other image-guided procedures. For example, a radio-opaque marker may be placed on a first coil of theframe76. In some embodiments, a cross-sectional dimension of the first coil is less than a cross-sectional dimension of a second coil of theframe76, which will allow space for the radio-opaque marker to surround, at least in part, an exterior of the first coil. In some embodiments, the first coil is arranged adjacent the second coil, and theflow reducing member14 may be coupled to the second coil. In this regard, having the radio-opaque marker placed on the first coil adjacent the second coil where theflow reducing member14 is coupled will allow a user of theapparatus10 to identify where embolization may occur. In some embodiments, the radio-opaque marker may be a platinum iridium alloy or other suitable markers known to those skilled in the art.

According to various embodiments of the subject technology, theflow reducing member14 may be used to partially or completely occlude the tubular structure into which theapparatus10 is deployed. As used herein, the term “occlusion” may refer to either partial or complete occlusion. In some embodiments, at least a portion of theflow reducing member14 extends from an exterior of theframe76 into an interior of theframe76 through thedistal opening16. Specifically, aflap78 extending from theflow reducing member14 may extend into the interior of theframe76 through thedistal opening16. Theflap78 may be configured to substantially prevent distal fluid flow (e.g., from proximal toward distal) through thedistal opening16 and otherwise facilitate proximal fluid flow (e.g., from distal toward proximal) through thedistal opening16. For example, a guide wire (not shown) may be extended through thedistal opening16 for deploying theapparatus10. Consequently, theflap78 may be pressed against the guide wire and held in place, thereby maintaining thedistal opening16 in its open configuration. Upon removing the guide wire proximally, theflap78 is released from engagement with the guide wire and may operate to close thedistal opening16 such that distal fluid flow through thedistal opening16 is substantially prevented. In some embodiments, theflap78 may serve as a one-way valve to substantially or totally obstruct flow in one direction. For example, theflap78 may substantially or totally obstruct distal flow while allowing proximal flow. As will be appreciated by those skilled in the art, such an arrangement may be advantageously used in partial lung obstruction to treat chronic obstructive pulmonary disease (COPD), for example.

In some embodiments, theflow reducing member14 comprises at least one of a polyurethane, a polyanhidrate, polyethylene, fluoropolymers such as polytetrafluoroethylene (PTFE) and expanded polytetrafluoroethylene (ePTFE), bioabsorbable polymers, and other suitable materials known to those of ordinary skill in the art. In other embodiments, theflow reducing member14 may be generally made of an elastomeric material, such as elastics.

According to certain embodiments, ahole15 may be defined in theflow reducing member14. During deployment of theapparatus10, the guide wire may be configured to extend through thehole15. In some embodiments, theflow reducing member14 includes means to partially, substantially, or totally block thehole15 when the guide wire is removed therefrom. In one or more embodiments, swelling material may be disposed in or about thehole15 or on a portion of theflow reducing member14 adjacent thehole15. Upon coming into contact with fluids, the swelling material, and possibly the portion, may expand to substantially or totally block thehole15. For example, the portion of theflow reducing member14 adjacent thehole15 may include a pocket configured to hold or otherwise store the swelling material until needed. In some embodiments, the swelling material may include microparticles. In other embodiments, the swelling material may be hydrogel or other suitable swelling materials known to those skilled in the art. When fluid, such as blood, contacts the swelling material, the swelling material and the pocket may expand (e.g., up to 3 to 5 times their initial size) to substantially block thehole15.

According to certain embodiments, theflow reducing member14 forms a continuous cover without using theflap78. For example, theflow reducing member14 may form a cover that is generally disposed over the exterior surface of thedistal portion24, thereby covering thedistal opening16. In some embodiments, theflow reducing member14 is made of a self-sealing material, which allows for an extension of the guide wire to extend therethrough while maintaining a fluid-tight seal. Once the guide wire is removed, theflow reducing member14 may self-seal and maintain the fluid-tight seal about thedistal opening16. In some embodiments, theflow reducing member14 may define a plurality of pores used to occlude particular fluids, such as, blood. In one embodiments, the pores may have a diameter ranging between about 5 microns and about 10 microns. In other embodiments, the pores may have a diameter that is less than about 5 microns or greater than about 10 microns, less than about 3 microns, or less than about 1 micron. In yet other embodiments, the pores may have a diameter that is greater than about 13 microns or greater than about 16 microns.

Although theflow reducing member14 is depicted inFIG. 1 as being disposed over or about thedistal portion24, theflow reducing member14 may be disposed over other portions of theframe76, without departing from the scope of the disclosure. For example, theflow reducing member14 may be disposed over theproximal portion20,middle portion22, or a combination of both. In another example,flow reducing member14 may be disposed over the entirety or portions of each of the proximal, middle, and

distal portions

20,22,24.

In some embodiments, theframe76 may have a length ranging between about 7 millimeters (mm) and about 9 mm. In other embodiments, the length of theframe76 may be less than about 7 mm or greater than about 9 mm. According to certain embodiments, a combined length of the proximal and

middle portions

20,22 may range between about 4 mm and about 5 mm to provide adequate anchoring of theframe76 with respect to the distal portion24 (e.g., between about 40% and about 70% of the length of the frame76). In some embodiments, the combined length of proximal and

middle portions

20,22 may be less than about 4 mm or greater than about 5 mm. In some embodiments, thedistal portion24 may have a length ranging between about 3 mm and about 4 mm. In other embodiments, however, the length of thedistal portion24 may be less than about 3 mm or greater than about 4 mm.

In some embodiments, a diameter of theproximal portion20 and/or themiddle portion22 may be between about 2 mm and about 10 mm. In other embodiments, the diameter of theproximal portion20 and/or themiddle portion22 may be less than about 2 mm or greater than about 10 mm. In some embodiments, a diameter of thedistal portion24 may be between about 0.4 mm and about 0.5 mm. In other embodiments, the diameter of thedistal portion24 may be less than about 0.4 mm or greater than about 0.5 mm.

According to various aspects of the subject technology, theapparatus10 may be used to reduce or stop flow through a tubular structure of a patient. Theapparatus10 may be used for rapid, well-controlled, and reliable occlusion of various tubular structures. As used herein, “tubular structure” may refer to at least one of a blood vessel, a fallopian tube, a cervical canal, a vagina, a cervix, a vas deferens, a bronchus, a ureter, a colon, a rectum, an anus, a bile duct, a pancreatic duct, or other muscular ducts or tubing found in the human body. In someembodiments apparatus10 may be used as a birth control (contraceptive) device. Such use may allow for reversible contraception without surgery. In some embodiments, theapparatus10 may be used for temporary occlusion in cases of lung disease, or for temporary occlusion of female reproductive organs for contraceptive purposes. In some embodiments, theapparatus10 may be removed, or flow may be restored through the tubular structure to restore original organ functions.

In some embodiments, theapparatus10 may be used for various endoluminal occlusion procedures, including procedures for the lungs (e.g., selective endobronchial occlusion for lung reduction, occlusion of bronchopleural or bronchocutaneous fistulas, endovascular occlusion of pulmonary AVMs and fistulas or aortopulmonary anastomoses) and procedures for reproductive organs (e.g., endoluminal occlusion of vas deferens or fallopian tubes for minimally-invasive contraceptive intervention, endovascular occlusion of varicocele in males and low abdominal gonadal veins for reducing or completely eliminating chronic pelvic pain syndrome in females). In some embodiments, theapparatus10 may be used for stopping blood loss from a damaged blood vessel, closing an abnormal blood vessel or a blood vessel supplying a vascular anomaly, or interrupting blood supply to an organ or part of an organ for permanent devascularization (e.g., closure of splenic artery in spleen laceration, devascularization of tissues involved by neoplastic process, either pre-operatively or as a palliative measure). In some embodiments, theapparatus10 may be used for various endovascular (e.g., neural and peripheral) procedures including procedures for giant cerebral and skull base aneurysms (ruptured and non-ruptured), head and neck arteriovenous fistulas, dissecting intracranial and extracranial vessels, traumatic and non-traumatic vessel injury or rupture (e.g., pelvic hemorrhages in trauma patients, carotid blow-out in patients with head and neck cancers, hemorrhage induced by a neoplasia, etc.), and devascularization prior to (or as an alternative to) surgical resection of various organs or tumors.

In certain embodiments, theapparatus10 may be used for various organs, including for example, the spleen (e.g., endovascular occlusion as a preoperative intervention or as an alternative to surgical resection with indications including traumatic hemorrhage, hypersplenism, bleeding secondary to portal hypertension or splenic vein thrombosis, and various disorders such as thalassemia major, thrombocytopenia, idiopathic thrombocytopenic purpura, Gaucher disease, and Hodgkin disease), the liver (e.g., occlusion of portal veins collaterals as adjunct to a transjugular intrahepatic portosystemic shunt (TIPS), occlusion of the TIPS itself in cases of encephalopathy, occlusion of intrahepatic arterioportal fistulas), the kidney (e.g., endoluminal ureteral occlusion for intractable lower urinary tract fistula with urine leakage, or for the treatment of uretero-arterial fistulae, endovascular occlusion as an alternative to surgical resection for end-stage renal disease or renovascular hypertension requiring unilateral or bilateral nephrectomy and renal transplant with native kidneys in situ), and the heart (e.g., occlusion of coronary arteriovenous fistulas, transarterial embolization of Blalock-Taussig shunts). As will be appreciated, use of theapparatus10 is not limited to applications for human patients, but may also include veterinary applications, without departing from the scope of the disclosure.

In some embodiments, theapparatus10 may further include a tube (not shown) configured to extend through theflow reducing member14 and thedistal opening16 to be positioned at, for example, a target site of the patient. Theapparatus10 may also be communicably coupled to a vacuum source (not shown) configured to apply a vacuum through the tube for removing at least one of emboli and fluid from the target site. For example, the tube may be placed in a diseased area that has been subjected to occlusion, and the tube may be used to remove bodily fluids and/or solid components (e.g., blood clots) from the diseased area.

FIG. 2 illustrates an example ofapparatus10, in accordance with various embodiments of the subject technology. In some embodiments, theproximal portion20 is tapered such that the outer cross-sectional dimension of theproximal opening18 is less than the outer cross-sectional dimension of themiddle portion22. Tapering theproximal portion20 provides several advantages. For example, theapparatus10 may be deployed within a lumen of a tubular structure of a patient, and removing or repositioning theapparatus10 within the lumen may cause theapparatus10 to shift axially within the lumen. In removing theapparatus10 from within the lumen, a catheter (not shown) may be placed proximal to theapparatus10 to receive theapparatus10. While theapparatus10 is being removed, such as by inversion as described above, theapparatus10 may shift proximally. Thus, the tapering ofproximal portion20 may ensure thatapparatus10 shifts into the catheter whenapparatus10 is being removed.

As shown inFIG. 2, theflow reducing member14 may be disposed or otherwise arranged inside of theframe76. Specifically, theflow reducing member14 may be disposed in the interior of theframe76 and coupled to themiddle portion22. In this configuration theflow reducing member14 may be configured to occlude the tubular structure when theapparatus10 is disposed within the lumen of the tubular structure. Because themiddle portion22 includes portions of theframe76 that are adapted to expand and engage the inner surface of the lumen, theflow reducing member14 may be configured to stretch or otherwise expand correspondingly in order to properly occlude the tubular structure.

When used to occlude the tubular structure, theflow reducing member14 may capture emboli or other particles flowing through the lumen of the tubular structure. Because the ends at both the proximal and

distal portions

20,24 are tapered, the emboli or other particles may be contained or otherwise trapped within theframe76. For example, theflow reducing member14 may be used to reduce or stop blood flow in a vessel, thereby resulting in clotting of the blood. In some embodiments, the blood clot(s) may be trapped within the interior of theframe76 between the taperedproximal portion20 and theflow reducing member14, such that the blood clot is prevented from flowing proximally out of theframe76.

According to certain embodiments, the outer cross-sectional dimension of theproximal opening18 may be larger than the outer cross-sectional dimension of thedistal opening16, which may be useful for achieving a reduction or stoppage of flow through thedistal opening16.

Referring now toFIG. 3, illustrated is an example of theapparatus10 wherein theflow reducing member14 is disposed within theframe76, in accordance with various embodiments of the subject technology. As shown, theflow reducing member14 may be coupled to one ormore coils34 of theframe76 such that theflow reducing member14 substantially encompasses the opening defined by thecoil34. In one or more embodiments, thecoil34 is formed by a portion of theelongate member12, extending frompoint36ato point36b,and theflow reducing member14 is coupled or otherwise attached to theelongate member12 frompoint36ato point36b.As can be appreciated, when theflow reducing member14 is coupled to thecoil34, the opening defined by thecoil34 may be substantially or entirely occluded.

In certain embodiments, the thickness or axial depth of the coil34 (i.e., a first coil), as measured along anaxial dimension80 offirst frame76, may be less than the thickness or axial depth of another (second) coil of theframe76. Having a decreased axial depth may beneficially allow theflow reducing member14 to span the opening through thecoil34 without being stretched too far along theaxial dimension80 and thereby cause tears or weakened portions of theflow reducing member14.

FIG. 4 illustrates a cross-sectional view of theelongate member12, in accordance with various embodiments of the subject technology. In some embodiments, theelongate member12 may exhibit a substantially rectangular cross-section. It was found that such a cross-section stabilized theapparatus10 within a lumen of a tubular structure, thereby minimizing its axial shifting once deployed within the lumen. The substantially rectangular cross-section also provides additional strength for preventing theframe76 from collapsing under the various forces exerted by the lumen. The rectangular cross-section also allows theelongate member12 to be easily arranged or otherwise formed into the spiral configuration to form theframe76.

In some embodiments, the corners of the rectangular cross-section are radiused or arcuate. In some embodiments, thelength26 of the rectangular cross-section is between about 0.008 inches and about 0.014 inches. In other embodiments, thelength26 may be less than about 0.008 inches or greater than about 0.014 inches. In some embodiments, thewidth28 of the rectangular cross-section is between about 0.004 inches and about 0.006 inches. In other embodiments, thewidth28 may be less than about 0.004 inches or greater than about 0.006 inches.

According to certain embodiments, theflow reducing member14 may be coupled to theelongate member12 as shown inFIG. 4. For example, theflow reducing member14 may wrap around or otherwise be disposed about theelongate member12. Accordingly, theflow reducing member14 may form a drum-like cover. In other embodiments, as shown inFIG. 3 above, the flow reducing member may extend through an opening defined by one or more coils34.

FIGS. 5A and 5B illustrate theapparatus10 as deployed within alumen30 of a tubular structure of a patient, in accordance with various embodiments of the subject technology. For simplicity, theframe76 is illustrated in outline form, but otherwise includes one or more of the variations described herein. As illustrated, theflow reducing member14 may be coupled to aninterior surface17 of theframe76 at or near themiddle portion22. One benefit of having theflow reducing member14 coupled to themiddle portion22 is that theflow reducing member14 may be provided with enough axial space to stretch proximally or distally depending on the direction of theflow32. For example, as shown inFIG. 5A, theflow32 is in the proximal direction, and hence, theflow reducing member14 may also be stretched distally. As shown inFIG. 5B,flow32 is in the distal direction, and hence, theflow reducing member14 may be stretched distally. Consequently, by coupling theflow reducing member14 to themiddle portion22 of theframe76, theflow reducing member14 may be used to reduce or stop theflow32 through thelumen30 in either direction.

Referring now toFIG. 6, illustrated is an example of theapparatus10 as arranged within a catheter for delivery, in accordance with various embodiments of the subject technology. As used herein, the term “catheter” may be given at least its ordinary meaning, but may also refer to any elongate member having a lumen passing axially therethrough. Accordingly, a “catheter” can be tubular and have various suitable cross-sectional shapes, such as circular, elliptical, polygonal (e.g., triangular, rectangular, hexagonal, octagonal, etc.), combinations thereof, or the like. Theapparatus10 may include anouter catheter38 configured to be positioned within a lumen at a first deployment site, and aninner catheter40 disposed within theouter catheter38. Theouter catheter38 may have atip42 arranged at its distal end, and adistal opening43 defined therein. Thetip42 may be a soft tip adapted to reduce or otherwise prevent trauma and/or friction when theouter catheter38 is being navigated through the lumen to the first deployment site. Theframe76 may be configured to interpose the outer and

inner catheters

38,40 during delivery and before theframe76 is deployed for use within the lumen. As shown inFIG. 6, theflow reducing member14 may be disposed over thedistal portion24 offrame76, and aguide wire46 may be configured to extend through theinner catheter40 and the distal opening16 (FIG. 1) of theframe76.

Aproximal handle48 may be coupled to the proximal end of theinner catheter40. Theframe76 and theflow reducing member14 may be deployed from theouter catheter38 by forcing theproximal handle48 and theinner catheter40 distally relative to theouter catheter38 and until theframe76 and theflow reducing member14 extend beyond thedistal opening43 and into the lumen.

In some embodiments, theapparatus10 may include asecurity block50 coupled to theproximal handle48. Thesecurity block50 may be configured to stop the axial translation of theproximal handle48 such that theinner catheter40 does not extend beyond what is required to properly deploy theframe76 and theflow reducing member14. In one or more embodiments, thesecurity block50 may have a predetermined axial length and be configured to bias aproximal portion52 of theouter catheter38 when theproximal handle48 has translated sufficiently to fully the deployframe76 and theflow reducing member14. In some embodiments, when thesecurity block50 stops axial translation of theproximal handle48, the user may understand that theframe76 and theflow reducing member14 has been fully deployed from theouter catheter38, so it may serve as an indicator of full deployment.

FIGS. 7A and 7B illustrate enlarged views of theframe76 and theflow reducing member14 as positioned within theouter catheter38, in accordance with various embodiments of the subject technology. In some embodiments, theinner catheter40 defines a series ofthreads44 at its distal end, and theframe76 may be threaded onto the series ofthreads44 in order to secure theelongate member12 to theinner catheter40. The series ofthreads44 may be made of nylon, metal, or other suitable material known to those of ordinary skill in the art. In some embodiments, theflow reducing member14 may be of a suitable radial thickness to interpose theouter surface45 of theinner catheter40 and aninner surface47 of theouter catheter38. For example, an average radial thickness of theflow reducing member14 may be between about 0.0005 inches and about 0.006 inches, or other suitable ranges.

Theouter catheter38 generally prevents theframe76 from expanding radially when theframe76 is secured between theinner surface47 of theouter catheter38 and theouter surface45 of theinner catheter40. As theinner catheter40 shifts until theframe76 extends beyond thedistal opening43 of theouter catheter40, theouter catheter38 no longer prevents theframe76 from radially expanding. As a result, theframe76 may expand from an undeployed (compressed) configuration into a deployed (expanded) configuration such that theframe76 engages an inner surface of the tubular structure. In some embodiments, theframe76 does not automatically expand into its deployed configuration but is instead expanded into the deployed configuration with a balloon or other expansion-inducing device. In some embodiments, however, theframe76 may be self-expandable.

According to various embodiments of the subject technology, theframe76 and theflow reducing member14 are capable of being deployed at the deployment site, resheathed within thecatheter38, repositioned at the deployment site, and redeployed. For example, if an operator decides that an initial placement of theframe76 and theflow reducing member14 is incorrect or otherwise undesirable, the operator may redeploy and/or reposition theframe76 and theflow reducing member14. To accomplish this, theinner catheter40 may be configured to shift distally relative to theouter catheter38 until at least a portion of theframe76 extends beyond thedistal opening43 of theouter catheter38 and into a first deployment site where theframe76 is partially deployed. Subsequently, theinner catheter40 may be configured be retracted proximally relative toouter catheter38 until theframe76 is again resheathed within theouter catheter38. Since a proximal portion of the elongate member12 (e.g. the frame76) is still secured to the series ofthreads44, theframe76 is also retracted once theinner catheter40 is retracted. Once resheathed, theouter catheter38 may be moved to the correct (second) deployment site for correctly deploying theframe76. The process described above is repeated to redeploy theframe76 from theouter catheter38 and into the second deployment site.

In some embodiments, theapparatus10 may also include one or more stops, depicted inFIGS. 7A and 7B as afirst stop54aand asecond stop54b.The stops54a,bmay be generally disposed between theouter catheter38 and theinner catheter40 and configured to prevent theframe76 from moving proximally relative to at least one of theouter catheter38 and theinner catheter40. In some embodiments, thesecond stop54bis coupled to theinner surface47 of theouter catheter38 and thefirst stop54amay be coupled to theouter surface45 of theinner catheter40, or vice versa. The stops54a,bmay be annular or may be defined by one or more protrusions extending from the

respective surfaces

45,47. In operation, when theinner catheter40 moves distally relative to theouter catheter38 in order to deploy theframe76, thefirst stop54aaxially engages thesecond stop54b,thereby preventing theinner catheter40 from advancing further relative to theouter catheter38.

FIG. 8 illustrates an enlarged view of theexemplary frame76 andflow reducing member14 as positioned within theouter catheter38, in accordance with various embodiments of the subject technology. In some embodiments, theapparatus10 may further include one ormore blocks56 disposed on or otherwise coupled to theouter surface45 of theinner catheter40 such that the elongate member12 (e.g., the frame76) wraps around the one ormore blocks56 to secure theelongate member12 to theinner catheter40. In some embodiments, the one ormore blocks56 are made of an electroactive polymer (EAP) and are configured to swell when electric signals are applied thereto. In one or more embodiments, when the electric signals are applied to theblocks56, theelongate member12 may be substantially locked to the one or more blocks56. During deployment of theelongate member12, however, including deployment of theframe76 and theflow reducing member14, the electric signals are discontinued to allow theframe76 to disengage from the one or more blocks56. However, should repositioning be desired, the electric signals may be reapplied to theblocks56, thereby securing a proximal portion ortip13 of theelongate member12 to theinner catheter40 once more, and theinner catheter40 may subsequently be retracted proximally, which will resheath theframe76 into theouter catheter38.

FIG. 9 illustrates an enlarged view of the exemplaryinner catheter40, in accordance with various embodiments of the subject technology. In some embodiments, theinner catheter40 defines ahole60 in itsouter surface45. Thehole60 may be configured to receive the proximal tip13 (FIGS. 1 and 8) of theelongate member12 in order to secure theframe76 to theinner catheter40. In other embodiments, theinner catheter40 may define one or more grooves (e.g., groove62aand62b) about itsouter surface45. Similar to thehole60, the

grooves

62aor62bmay be configured to receive theproximal tip13 of theelongate member12, thereby securing theframe76 to theinner catheter40. As illustrated, at least one of thegrooves62amay be formed on or otherwise defined in thefirst stop54a,andother grooves62bmay be formed on theouter surface45 of theinner catheter40.

FIGS. 10A and 10B illustrate an example of theframe76 and theflow reducing member14 as positioned within theouter catheter38, according to various embodiments of the subject technology. As shown inFIG. 10A, theflow reducing member14 may be coupled to themiddle portion22 of theframe76, such as being coupled to theinterior surface17 of theframe76. Thus, when theframe76 and theflow reducing member14 are stowed within theouter catheter38 during delivery, theinner catheter40 may be configured to bias theflow reducing member14 against theinterior surface17 of theframe76, such as at thedistal portion24. In other embodiments, theflow reducing member14 may be disposed over thedistal portion24 of theframe76, as shown inFIG. 10B.

In one or more embodiments, thedistal portion24 and theflow reducing member14 may be configured to extend beyond thedistal opening43 of theouter catheter38 during delivery of theapparatus10. The exposed portions of thedistal portion24 and theflow reducing member14 may be atraumatic and prevent injury or damage to tubular structures during device tracking and delivery to the deployment site. Accordingly, when theouter catheter38 is moved within the lumen to a deployment site, the exposed portions of thedistal portion24 and theflow reducing member14 that extend beyond thedistal opening43 may be configured to engage the inner wall (not shown) of the lumen to reduce friction and potential vessel injury. In such a case, the tip42 (seeFIG. 6) may not be necessary. In some embodiments, the distally extended portion of theflow reducing member14 may be extended about 2 mm beyond thedistal opening43, and the distally extended portion of theflow reducing member14 may be extended less than about 2 or greater than about 2 mm beyond thedistal opening43.

Referring now toFIG. 11, illustrated is another embodiment of theapparatus10 where twoframe76 are employed, according to one or more embodiments disclosed. Specifically, illustrated are afirst frame76aand asecond frame76b,axially-spaced from thefirst frame76a.Theapparatus10 inFIG. 11 may also include a firstflow reducing member14aand a secondflow reducing member14b,also positioned within theouter catheter38 in conjunction with the first andsecond frames76a,b,respectively. Accordingly, theapparatus10 may be configured to implant or otherwise deploy twoframes76a,band correspondingflow reducing members14a,bwithin a lumen. As can be appreciated,multiple frames76a,bandflow reducing members14a,bdeployed from the sameouter catheter38 may serve to simplify surgery techniques to implant these devices. For example, significant amounts of time and effort may be saved by deploying the pair offrames76a,bandflow reducing members14a,bfrom the sameouter catheter38.

In some embodiments, thesecond frame76bis configured to be positioned between theouter catheter38 and theguide wire46 for stowing theframe76bprior to its deployment. Thesecond frame76bmay be deployed in a manner similar to the deployment of thefirst frame76a,as generally described above. In other embodiments, however, thesecond frame76bmay secured to theguide wire46 by, for example, threading thesecond frame76bto the outer surface of theguide wire46. In yet other embodiments, thesecond frame76bmay be coupled to theguide wire46 without threads, but instead using other means known in the art. For example, thesecond frame76bmay be coupled to theguide wire46 using the one or more blocks made of EAP and configured to swell when electric signals are applied to the one or more blocks, as generally described above with reference toFIG. 8.

In certain embodiments, theflow reducing members14a,bmay be disposed over various portions of theframes76a,b,respectively, depending on their desired applications. For example, theflow reducing members14a,bmay be disposed over respective distal portions of theframe76a,b,or the firstflow reducing member14amay be disposed over the distal portion of thefirst frame76awhile the secondflow reducing member14bmay be disposed over the proximal portion of thesecond frame76b,or combinations thereof.

FIG. 12 illustrates an exemplary method of deploying one ormore frames76 and correspondingflow reducing members14, in accordance with various embodiments of the subject technology. Theouter catheter38 may advanced through thelumen30 of a tubular structure31 (e.g., blood vessel) until positioned adjacent a first deployment site, such as at ananeurysm66, where thesecond frame76bis to be deployed. In one or more embodiments, the first deployment site may be distal theaneurysm66. Theguide wire46 is advanced distally relative to theouter catheter38 until thesecond frame76bextends beyond thedistal opening43 of theouter catheter38 and into the first deployment site. In some embodiments, thesecond frame76bmay also be partially deployed, retracted (i.e., resheathed within the catheter38), and repositioned in a manner similar to frame76a.After thesecond frame76bis properly deployed, theouter catheter38 may then be positioned within thelumen30 at a second deployment site, such as proximal theaneurysm66, in order to deploy thefirst frame76a.Theinner catheter40 may then be translated distally relative to theouter catheter38 until thefirst frame76aextends beyond thedistal opening43 of theouter catheter38 and deploys into thelumen30.

Referring toFIG. 13, illustrated are theexemplary frames76a,band correspondingflow reduction members14a,bdeployed within thelumen30, in accordance with various embodiments of the subject technology. In some embodiments, thesecond frame76band secondflow reducing member14bmay be deployed distal theaneurysm frame76aandflow reducing member14a,relative to flow32, in order to impede, reduce, or stop flow that may emanate from a direction opposite of theflow32. Thesecond frame76band secondflow reducing member14bmay also be used to impede, reduce, or stop flow that may travel from withinaneurysm66, including blood clots, thereby promoting thrombosis within theaneurysm66. In some embodiments, theflow reducing members14a,bmay be disposed over various portions of theframes76a,b,respectively, depending on the direction offlow32, the position of theframes76a,b,a combination thereof, or other factors known to those in the art.

Referring now toFIGS. 14A, 14B, and 14C, illustrated is an exemplary retrievingmember68, in accordance with various embodiments of the subject technology. The retrievingmember68 may be used to remove theframe76 and/orflow reducing member14 from within alumen30. In some embodiments, the retrievingmember68 may be stowed in a compressed configuration (FIG. 14A) within adelivery catheter70 for delivery to theframe76 and/orflow reducing member14 to be removed. Once deployed from thedelivery catheter70, the retrievingmember68 expands radially into a deployed configuration (FIG. 12B). In some embodiments, the retrievingmember68 is self-expanding, but in other embodiments, the retrievingmember68 may be expanded using external means.

In some embodiments, the retrievingmember68 may be advanced distally such that it extends through theflow reducing member14. The retrievingmember68 is configured to couple to the distal portion24 (FIGS. 1 and 2) of theframe76 and to pull or otherwise force thedistal portion24 into the interior of theframe76, thereby inverting theframe76 as generally discussed above. In one or more embodiments, a separate retrieval catheter (not shown) may be positioned proximal to the site in which theframe76 and theflow reducing member14 are deployed for retrieving theinverted frame76. In at least one embodiment, thedelivery catheter70 may be extendable within the retrieval catheter.

The retrievingmember68 may include one ormore jaws72 having adistal end73 and being moveable between the compressed and deployed configurations. In some embodiments, thejaws72 may expand radially to an angle ranging between about 45 degrees and about 60 degrees with respect to a central axis of the retrievingmember68. In one or more embodiments, thedistal end73 of eachjaw72 may include acurved portion74, as shown inFIG. 14C. Thecurved portion74 may be configured to hook or otherwise capture thedistal portion24 of theframe76 for inverting theframe76. In some embodiments, however, the retrievingmember68 may include other means for retrievingframe76, such as, but not limited to, alligator clips or other pinching means adapted to grip a portion of theframe76 for retracting and/or inverting theframe76. In some embodiments, the retrievingmember68 may couple to theproximal tip13 of theelongate member12, and retrievingmember68 may be used to retract theframe76 by applying a force in the proximal direction to theproximal tip13, and thereby allowing for its removal through the retrieval catheter (not shown) ordelivery catheter70.

According to certain embodiments, occlusion provided by theflow reducing member14 may be permanent or temporary. If temporary occlusion is desired, the retrievingmember68 may be used to create an opening through theflow reducing member14 to restore flow therethrough. In some embodiments, theframe76 may be allowed to remain in the lumen after the opening through theflow reducing member14 has been created. This may be advantageous when occlusion is no longer desired, but the removal of theframe76 is not necessarily a concern. In some embodiments, theflow reducing member14 may also be removed using the foregoing techniques as described above.

Referring toFIG. 15, illustrated is amethod1500 for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology. Themethod1500 may include positioning a first elongate member within a lumen of the tubular structure, as at1502. The first elongate member may be arranged to form a first frame having a distal opening and a proximal opening. The first frame includes a proximal portion, a distal portion, and a middle portion extending therebetween. In one or more embodiments, the distal portion may be tapered such that a cross-sectional dimension of the distal opening is less than a cross-sectional dimension of the middle portion.

Themethod1500 may also include reducing or totally obstructing, with a first flow reducing member coupled to the first frame, flow of at least one of emboli and fluid flowing through the lumen, as at1504. Themethod1500 may further include removing the first frame from within the lumen by inverting the first frame such that the distal portion moves within and toward the middle portion, as at1506.

FIG. 16 illustrates anotherexemplary method1600 for reducing or stopping flow through a tubular structure of a patient, in accordance with various embodiments of the subject technology. Themethod1600 may include positioning an outer catheter within a lumen of the tubular structure at a first deployment site, as at1602. An inner catheter may be disposed within the outer catheter, and a first elongate member may be interposed between the inner catheter and the outer catheter. The first elongate member forms a first frame having a distal opening and a proximal opening. The first frame further includes a proximal portion, a distal portion, and a middle portion extending therebetween. The distal portion is tapered such that a cross-sectional dimension of the distal opening may be less than a cross-sectional dimension of the middle portion.

Themethod1600 may also include partially deploying the first frame from the outer catheter, as at1604. In one or more embodiments, this may be accomplished by shifting the inner catheter distally relative to the outer catheter until a portion of the first frame extends beyond a distal opening of the outer catheter and into the first deployment site. The first frame may be retracted or otherwise resheathed into the outer catheter, as at1606. This may be accomplished by shifting the inner catheter proximally relative to the outer catheter until the portion of the first frame is retracted proximally into the outer catheter.

Themethod1600 may further include positioning the outer catheter within the lumen at a second deployment site for deploying the first frame at the second deployment site, as at1608. The first frame may then be deployed from the outer catheter, as at1610. In one or more embodiments, this may be accomplished by shifting the inner catheter distally relative to the outer catheter until the first frame extends beyond the distal opening of the outer catheter and into the second deployment site. Themethod1600 may further include reducing or totally obstructing, with a first flow reducing member coupled to the first frame, flow of at least one of emboli and fluid flowing through the lumen, as at1612.

In some embodiments theguide wire46 may be absent when theframe76 and theflow reducing member14 are introduced. Thus, theflow reducing member14 may lack a hole for theguide wire46, thereby resulting in enhanced occlusion. In some embodiments, delivery of theframe76 does not require theguide wire46 to run throughflow reducing member14, thereby obviating the need to create a hole through theflow reducing member14 with theguide wire46 for delivery of theframe76. Such embodiments are discussed in co-pending U.S. patent application Ser. No. 12/906,993, entitled “Expandable Device Delivery,” filed on Oct. 18, 2010, the contents of which are hereby incorporated by reference to the extent not inconsistent with the present disclosure.

Referring now toFIG. 17, illustrated is another application of theapparatus10 used, for example, as a birth control (contraceptive) device, according to one or more embodiments of the disclosure. As illustrated, theapparatus10 may be positioned reliably and firmly into the ostium or “isthmus”82 of afallopian tube84, thereby preventing the passage of sperm through thefallopian tube84 and meeting/penetrating ovum. Similarly, theapparatus10 may be positioned into a vas deferens (not shown) providing complete blockage of passage of sperm through the vas deferens. Theapparatus10 may alternatively be placed in any lumen of a reproductive structure of a patient through which sperm or ovum are capable of passing. The procedure for placement of theapparatus10 in thefallopian tube84, vas deferens, or other reproductive structure may be outpatient and minimally invasive with minimal or no use of anesthesia.

When used as a contraceptive device, theapparatus10 may be reversible or removable, as generally described above. Thus, theapparatus10 may be removed or otherwise inactivated per the desire of the patient. Upon reversal or inactivation, theapparatus10 may subsequently allow passage of sperm and/or ovum through the corresponding reproductive structure. The procedure for reversal may be noninvasive or minimally invasive, non-traumatic, and/or may not involve any surgery.

Use of occlusion devices, such as the ESSURE® and ADIANA® devices intentionally results in scar tissue growth in fallopian tubes. Thus, such occlusion devices are considered irreversible. As can be appreciated, embodiments of the present disclosure may provide a reversible contraceptive device for use in reproductive structures (e.g., fallopian tubes, vas deferens, etc.) and may alleviate difficulties associated with scar tissue growth by preventing or otherwise ameliorating the effects of such growth while still preventing passage of sperm through particular lumens of the reproductive structures. In some embodiments, theapparatus10 has a structural design or specific design feature(s) allowing for the retrieval of theapparatus10 from the deployment site via a standard or specially-designed retriever. If retraction of theentire apparatus10 from the site is precluded, for example, because of scarring tissue growth over the apparatus and/or risk of bleeding, a portion of theapparatus10 may be removed or compromised to permit conception. For example, anocclusion cap86 or various other adaptations of theflow reducing member14 may be punctured, thereby effectively allowing for fluid flow within the lumen where theapparatus10 is located. In some embodiments, theflow reducing member14 may include an anti-inflammatory drug or other tissue-growth inhibitor. Such tissue-growth inhibitors may be used to partially or wholly coat or coverflow reducing member14 and/or any other portion of theapparatus10.

In some embodiments, theapparatus10 includes materials useful for preventing or otherwise ameliorating the effects of scar tissue growth in the reproductive structures, and more particularly in lumens in which theapparatus10 may be situated. As discussed above, utilizing properties of bioabsorbable or biodegradable materials may provide advantages. For example, bioabsorbable or biodegradable materials may have a unique quality of having been stable for a desirable period of time, such time being at least as long as the patient desires contraception. Moreover, bioabsorbable or biodegradable materials may be useful in any of a number of elements of theapparatus10, including, but not limited to theocclusion cap86, and/or other portions or adaptations of theflow member14. Such materials may include materials with a plateau degradation up until a moment when degradation is triggered. In other words, the materials may have a degradation profile that is stable or “flat” until a triggering event occurs. Thus, when the patient wishes to reverse the contraception, a polymer barrier made of a bioabsorbable or biodegradable material may be removed by triggering its degradation.

Such triggering of degradation can be a well-controlled process, happening only when desired. Many methods of triggering may be used. For example, an enzyme may be used as a trigger to change or modify a surface pH of theflow reducing member14. Another example may be via physical methods, including, but not limited to, the application of ultraviolet light, an electrical charge, a thermal charge, or another mechanical trigger to breach theflow reducing member14, which may have a thermoset, charged, or other surface useful for selective breach. Alternatively, or additionally, theflow reducing member14 may be constructed of a biodegradable material, covered by a removable coating configured to preserve the stability offlow reducing member14. When the removable coating is removed, theflow reducing member14, which may have a predetermined degradation profile, may quickly degrade or dissolve. Yet another example of triggering degradation includes the use of biostable film configured to be breached when acted upon by mechanical, electromechanical, or chemical methods and/or processes. Such methods including partial or complete degradation of theflow reducing member14 to allow for a fluid flow channel to be restored in the reproductive structure, even when theapparatus10 remains in place. Thus, in the event scarring tissue is present and such tissue prevents removal or retrieval of theapparatus10, the contraceptive function of theapparatus10 may nonetheless be reversed.

Theframe76 and theflow reducing member14 of theapparatus10 are described above in detail. Many features described above, such as theelongate member12, spiral configuration, cross-sectional configuration, and other specifics may be very similar or even identical when theapparatus10 is intended for use in contraception. However, minor modifications may offer design alternatives providing features tailored for use in reproductive structures.

Still referring toFIG. 17, when used for female contraception, the shape of theframe76 of theapparatus10 may allow for theproximal portion20 to effectively anchor to theisthmus82, with themiddle portion22 anddistal portion24 inside of thefallopian tube84 extending distally toward an ovary (not shown). In one or more embodiments, themiddle portion22 may be free from theflow reducing member14, withfew coils34 exposed for attaching theapparatus10 to aninner wall83 of thefallopian tube84. Theflow reducing member14, including theocclusion cap86, may be disposed about thedistal portion24 and may contact theinner wall83 of thefallopian tube84, thereby securing itself together withframe76 to thefallopian tube84.

Theframe76 may have taperedmiddle portion22, with a cross-sectional dimension that is less than the outer cross-sectional dimensions of the corresponding distal and

proximal portions

24,20. In some embodiments, the narrowedmiddle portion22 may engage theinner wall83 of thefallopian tube84. In other embodiments, however, the narrowedmiddle portion22 may be configured to be offset a short distance from theinner wall83. Such design may allow for the proximal and

distal portions

20,24 to provide an anchoring effect to thefallopian tube84, thereby substantially preventing distal movement of theapparatus10. Moreover, tapering of themiddle portion22 may provide an arrangement to secure complete and effective blockage when contraception is desired, while allowing cilia to remain intact and properly aligned for subsequent functioning to “push” embryos through thefallopian tube84 after theapparatus10 is removed or otherwise inactivated. When used for male contraception, theframe76 may have a shape similar to that described above for female contraception, with optional modifications to accommodate differences between thefallopian tube84 and the vas deferens (not shown).

Theflow reducing member14 may be made from a thin polymeric film. Theflow reducing member14 may be expandable, such that it covers thedistal portion24 of theframe76, theproximal portion20 of theframe76, and/or most or all of theframe76. Theflow reducing member14 may be disposed about theframe76, disposed within theframe76, or partially disposed on or in theframe76. For example, theflow reducing member14 may form a plug, diaphragm, cap, or other feature to impede, reduce, or stop passage of sperm or ovum therethrough.

Theflow reducing member14 may be coupled to theframe76 such that when theframe76 is positioned within the lumen of the reproductive structure (e.g., a fallopian tube84), theflow reducing member14 substantially impedes, reduces, or totally obstructs passage of sperm therethrough. Theflow reducing member14 may be formed of an impermeable or impenetrable material, or other materials described herein or otherwise useful for blockage and/or reduction in activity of sperm. Theflow reducing member14 may be formed of a single sheet or may be formed of multiple components, including theocclusion cap86. Theocclusion cap86 may be provided as a component of theflow reducing member14, or may be a separate component used with or without theflow reducing member14. Theocclusion cap86 may be oriented substantially orthogonal to an axis of the lumen of the reproductive structure, providing a barrier with a minimal surface area. Moreover, theocclusion cap86 may have a substantially flat surface, or may be curved or rounded, as illustrated. When curved, such curvature may be concave or convex, relative to the center of theapparatus10. Theocclusion cap86 serves to occlude passage of sperm, and may be constructed of solid elastomeric polymer that does not allow tissue in-growth therethrough.

Theocclusion cap86 may be positioned on one or either ofproximal portion20 or thedistal portion24 and attached to or between metallic or otherwise rigid structures of theflow reducing member14 and/or theframe76. In one embodiment, theocclusion cap86 may be positioned in themiddle portion22 or elsewhere in or on theapparatus10. In some embodiments, multiple occlusion caps86 may be positioned on or in theapparatus10. For example, threeocclusion caps86 may be set in sequence from thedistal portion24 to theproximal portion20 of theapparatus10. In some embodiments, theflow reducing member14 may have multiple occlusion caps86 joined by an impermeable surface lying within theframe76. In other embodiments, the impermeable surface of theflow reducing member14 may lie partially or wholly outside theframe76. In some embodiments,multiple frames76 may be used with a singleflow reducing member14, and in other embodiments, multipleflow reducing members14 may be used with asingle frame76. Similarly, in some embodiments,multiple apparatus10 may be used in the same tubular structure, potentially providing a higher degree of blockage of the tubular structure.

Theframe76 may be constructed with a stronger material than that of theflow reducing member14, thereby allowing theframe76 to support theflow reducing member14 and resist any tendency to collapse. Thus, theflow reducing member14, including the occlusion cap(s)86, may be presented as a sleeve resembling a sock or stockings placed or stretched over thestronger frame76 shaped to support theflow reducing member14. Both theframe76 and theflow reducing member14 may be fabricated from ribbon with rectangular shape. Both elements can be made from NiTi or medical grade steel, platinum or any other appropriate metal.

In one or more embodiments, theframe76 may not be placed in direct contact with the inner wall83 (FIG. 17) of thefallopian tube84 or vas deferens (not shown), but may rather serve to support theflow reducing member14 and theocclusion cap86. Moreover, in some embodiments, it may be important for theframe76 not to have direct contact with the biological structure, so as to reduce potential scar tissue growing over struts or structures of theframe76.

For either or both of male and female contraception, theapparatus10 may have physical properties that function to disable sperm from penetrating ovum. Such physical properties may include physically preventing sperm from passing through theapparatus10 installed in the vas deferens and exiting the body of the male, physically preventing sperm from passing through theapparatus10 installed in afallopian tube84 of a female's body and penetrating an ovum therein, or both. Additionally or alternatively, theflow reducing member14 or other portion of theapparatus10 may include an electrically-charged coating on the surface to “discharge” sperm, thereby reducing their energy and ability to penetrate into thefallopian tube84. Such an electrically-charged barrier may be formed by ion coatings and may neutralize tail activity in sperm tails. Other coatings or spermacides may be used instead of or in conjunction with the electrically-charged coating. Such spermacides may be provided in the form of a renewable cartridge or other time released installation.

Theflow reducing member14 may be constructed of the bioabsorbable polymer or other materials indicated above, or metallic mesh. Thus, the coating may be removed from the surface of theflow reducing member14, or otherwise made neutral so that the “discharging” or “disabling” effect to the sperm may be manipulated or otherwise terminated. In case of use of polymeric or metallic mesh, the size of mesh might be small enough to enable use of ionic charge of coating, but large enough to allow free sperm penetration upon removal of the charge. Similarly, theflow reducing member14 may have an aperture large enough for passage of fluids but small enough to prevent passage of sperm. Alternatively, when theflow reducing member14 provides multiple barriers, such as when two or more occlusion caps86 are provided, an aperture may be formed in one of the barriers, but not all barriers, thereby allowing fluids to pass without providing a passageway for sperm.

When placing theapparatus10 in the patient, theframe76 may have an initially-shaped diameter larger than theflow reducing member14, when both are deployed. Such diameter may be equal or about 1-2 mm larger than the biological tubular structure in which it is deployed. Theflow reducing member14 may be made with an initially-shaped diameter smaller than the tubular structure in which it is deployed and smaller than the outer diameter of theframe76, thereby resulting in theflow reducing member14 having a tendency to collapse when/if theframe76 is removed therefrom. Delivery, visualization, and control methods may include endoscopic and angiography techniques.

Multiple apparatus

10 may be positioned in a single reproductive structure in sequence or simultaneously. Similarly,multiple apparatus10 may be positioned in a patient to provide contraception. For example, in a female patient, eachfallopian tube84 may be provided with one ormore apparatus10. Likewise, in a male patient, each vas deferens may be provided with one ormore apparatus10. Thus, a method for prevention of sperm passage through a reproductive structure of a patient may involve positioning theelongate member12 within a lumen (e.g., left fallopian tube84) of the reproductive structure. Theelongate member12 may be arranged to form theframe76, as described above. Once positioned in the lumen, theflow reducing member14 coupled to theframe76 may substantially impede, reduce, or totally obstruct passage of sperm through first lumen. The process may be repeated at another location within the same lumen, or may be repeated in another lumen (e.g., right fallopian tube84), or both.

Referring toFIG. 19, removal of theapparatus10 may involve use of a retrieving member (not shown) configured to engage or otherwise capture a withdrawal component, such as afirst withdrawal component88 associated with or otherwise coupled to thedistal portion24. As illustrated, thewithdrawal component88 is formed as a hook, but it will be appreciated that thewithdrawal component88 may be formed of various shapes or configurations without departing from the scope of the disclosure. In one or more embodiments, thefirst withdrawal component88 may be made of polyethylene or nitinol, but may be made of other materials without departing from the scope of the disclosure.

Thefirst withdrawal component88 may be formed integrally with thedistal portion24 of theframe76, or may be attached thereto using various means including, but not limited to, mechanical fasteners, welding techniques, adhesives, combinations thereof, or the like. In other embodiments, thefirst withdrawal component88 may be an extension of theflow reducing member14 or coupled thereto. In some embodiments, thefirst withdrawal component88 may facilitate the retrieval of theelongate member12 through inversion of theframe76 or straightening of theframe76 from its distal end. In operation, the retrieving member may pull thewithdrawal component88 proximally, toward an interior of theframe76, thereby inverting theframe76 and removing theapparatus10.

Alternatively, removal may involve the use of a retrieving member engaging asecond withdrawal component90 associated with theproximal portion20. Similar to thefirst withdrawal component88, thesecond withdrawal component90 may be formed integrally with theproximal portion20 of theframe76, or may be attached thereto using various means including, but not limited to, mechanical fasteners, welding techniques, adhesives, combinations thereof, or the like. Using thesecond withdrawal component90, theapparatus10 may be retrieved through tension to theframe76 in theproximal direction91, by pulling thewithdrawal component90 away from the interior of theframe76. Thus, theframe76 may be removed via a standard snare device or a specially-designed retriever, by pulling theframe76 outward, causing theframe76 to collapse from a coil-shaped structure into a straightened element, and allowing theflow reducing member14 to collapse and be removed.

While complete removal of theapparatus10 is one way to inactivate theapparatus10 and restore fertility, theapparatus10 may be inactivated in a number of other manners, as described herein. In instances where complete or even partial removal is undesirable, such as when scar tissue has formed over a portion of theapparatus10, inactivation may be performed without surgical intervention. For example, fertility may be restored while theapparatus10 remains in place by puncturing or otherwise compromising the integrity offlow reducing member14 or theocclusion cap86. As previously discussed, any of a variety of triggering events can cause material of theapparatus10 to degrade rapidly, and thereby restore a passageway through the lumen. Thus, a method for restoring fertility to a patient having theapparatus10 blocking sperm passage through a lumen of a reproductive structure may include deactivating theapparatus10 in situ (i.e., at the delivery site of theapparatus10 within the lumen). Such deactivating may include breaching the integrity offlow reducing member14, and breaching may include any of puncturing, applying ultraviolet light, applying an electrical charge, applying a thermal charge, or otherwise triggering biodegradation.

Referring now toFIG. 20, illustrated is an exemplary application of theapparatus10 used, for example, as a female contraceptive device, according to one or more embodiments of the disclosure. Specifically, afirst apparatus10ais shown deployed within a first (left)fallopian tube84a,and asecond apparatus10bis shown deployed within a second (right)fallopian tube84b.While in use, theapparatus10a,bgenerally occlude thefallopian tubes84a,b,respectively, and effectively sterilize the patient by preventing the passage of sperm or ovum therethrough. Theapparatus10a,bmay be non-surgically implanted and subsequently inactivated or otherwise reversed non-surgically in order to restore fertility to the patient. Moreover, theapparatus10a,bmay be biocompatible to avoid eliciting a toxic response from the patient.

FIG. 21 illustrates an enlarged view of anexemplary apparatus10, according to embodiments disclosed herein. As with prior embodiments, theapparatus10 may be formed by a plurality of axially-spacedcontiguous coils34 extending between theproximal end20 and thedistal end24. In some embodiments, theframe76 is made of shape-memory materials, such as, but not limited to, nitinol. Theframe76 provides a generally cylindrical scaffolding or support structure over which theflow reducing member14 can be arranged. In some embodiments, theflow reducing member14 covers theframe76 so as to generally close one end of theframe76, such as thedistal end24, and define or otherwise define anopening21 at the opposing end (i.e., the proximal end20).

In one or more embodiments, the generally cylindrical shape of theframe76 may be achieved by braiding wire (e.g., nitinol wire) or over a mandrel or other shape-forming device. The braided wire may be “heat set” by maintaining the wire in the desired shape while simultaneously exposing it to elevated temperatures. In some embodiments, between 8 strands and 48 strands of wire may be utilized to form theframe76. In other embodiments, however, theframe76 may be formed utilizing less than 8 strands or more than 48 strands, without departing from the scope of the disclosure, and depending at least partially on the desired dimensions of the application. In some embodiments, the wire used to form theframe76 may have a diameter ranging between about 0.001 inches and about 0.010 inches. In other embodiments, however, the wire may have a diameter less than 0.001 inches and greater than 0.010 inches, without departing from the scope of the disclosure. The wires may be braided over a mandrel having an outside diameter that can range between about 0.080 inches and about 0.500 inches. Once properly heat set, the wire braid can be removed from the mandrel and altered, if desired, by compressing or elongating certain segments to achieve a more variable shape before being held constant to the new shape and exposed to a second round of heat setting.

In other embodiments, the cylindrical shape of theframe76 may be achieved using a ribbon, such as nitinol ribbon, that is braided or otherwise wrapped around a mandrel or the like and subsequently heat set to the desired shape. In one or more embodiments, the ribbon may have a width ranging between about 0.2 mm and about 2 mm, and a thickness ranging between about 0.05 mm and 1 mm. As will be appreciated, the width and thickness of the exemplary ribbon may be varied to more or less without departing from the scope of the disclosure, and depending at least partially on the dimensions of the specific application. mandrel may have an outside diameter ranging between 9 mm and about 16 mm. In at least one embodiment, the ribbon may include a helix on one end of theframe76 which reduces the outside diameter of theframe76 at thedistal end24, for example, to about 0.1 mm to about 3 mm, seemingly closing thedistal end24 of theframe76.

In yet other embodiments, the general shape of theframe76 may be achieved by laser processing a sheet of shape-memory material, such as nitinol, to obtain a sheet thickness ranging between about 0.05 mm and about 1 mm. The sheet may then be heat set using, for example, a mandrel to form a generally cylindrical shape having an outside diameter that ranges between about 9 mm and about 16 mm. In at least one embodiment, the heat setting process reduces the outside diameter of theframe76 at one end (e.g., the distal end24) to between about 0.1 mm to about 3 mm, seemingly closing thedistal end24 of theframe76. In yet other embodiments, theframe76 may be made from shape-memory tubing, such as nitinol tubing, with segments removed by laser processing. After being laser processed, the tubing may be heat set in order to achieve an expanded outer diameter ranging between about 9 mm and about 16 mm diameter, with a reduced diameter at one end (e.g., the distal end24) to between about 0.1 mm to about 3 mm, seemingly closing thedistal end24 of theframe76.

Theflow reducing member14 may be an injection molded component that forms a thin-walled membrane configured to be positioned over theframe76 so as to generally close one end (e.g., the distal end24) of theapparatus10. In some embodiments, theflow reducing member14 covers the entire outer radial surface of theframe76. In other embodiments, however, theflow reducing member14 only covers a portion of theframe76, such as described above with reference toFIG. 1. As shown inFIG. 21, the flow reducing member entirely encases theframe76 except for anopening21 defined at theproximal end20 of theframe76.

In some embodiments, theflow reducing member14 is formed as a separate or individual component from theframe76 and secured to theframe76 by various means such as, but not limited to, adhesives, mechanical fixtures, combinations thereof, or the like. With theflow reducing member14 coupled thereto, theframe76 may be capable of maintaining an expanded outer diameter (e.g., 9 mm or larger). In other embodiments, however, theflow reducing member14 may be manufactured as an integral part of theframe76, thereby being integrated into the elastomeric matrix of theframe76.

As generally described above, theflow reducing member14 may be made from materials such as, but not limited to, silicone, polyurethane, polyethylene, fluoropolymers such as polytetrafluoroethylene, and bioabsorbable polymers. In at least one embodiment, theflow reducing member14 is made of a silicone material having a durometer ranging between 00 A and about 50 A, and an elongation percentage of about 500% to about 1200%. In some embodiments, the silicone material may be dip cast or molded directly onto the outer radial surface of theframe76. The silicone material may be cast or molded so as to obtain a wall thickness ranging between about 0.10 mm to about 1.00 mm. Those skilled in the art will appreciate that the durometer, elongation percentages, and wall thickness may vary, depending on the application, and nonetheless remain within the scope of the disclosure.

In some embodiments, theflow reducing member14 is an absorbable polymer, such as a bioabsorbable polymer. As described above, the absorbable polymer may be a temporary occlusion device that reverses thefallopian tube84 occlusion after a predetermined amount of time or after being exposed to a particular stimulus. This includes polymers which begin degradation by hydrolysis when positioned in thefallopian tube84 or polymers which commence or accelerate degradation when the local environment is deliberately altered. Environmental changes include, but are not limited to, modification of local pH, modification of local temperature, and/or exposing the absorbable polymer to any of the following: ultrasound energy, irradiation, light, a solvent, an enzyme, fluids, a magnetic field, electricity, combinations thereof, or the like. In at least one embodiment, the absorbable polymer may be configured to remain intact or otherwise not fully degrade for a minimum of two years.

In one or more embodiments, the outer surface of theflow reducing member14 may be coated with a lubricative substance, chemical, or material, thereby forming a lubricious coating. The lubricious coating may be configured to lubricate the outer surface of theflow reducing member14, thereby making it less prone to tissue attachment and/or less prone to bonding to other surfaces. In one embodiment, the lubricious coating may be a chemical vapor deposited poly(p-xylylene) polymer, better known as Parylene. In one or more embodiments, Parylene C, AF-4, SF, and/or HT may be used, without departing from the scope of the disclosure. The chemical vapor deposition may have an applied thickness ranging between about 0.1 nm and about 1,000 nm, but may vary depending on the application. Using Parylene provides several advantages, such as its barrier properties, its cost, its use as an accepted coating for stents, defibrillators, pacemakers, and other devices permanently implanted into the body, and its other processing advantages. Moreover, Parylene C bonds well to silicone and can act as a barrier layer to occlude the nanoporous silica, prevent tissue in-growth, prevent bonding to other surfaces, and otherwise reduce the elastomeric surface friction coefficient.

Still referring toFIG. 21, theapparatus10 further includes awithdrawal component95. Thewithdrawal component95 may serve substantially the same purpose as the first and

second withdrawal components

88,90 described above with reference toFIG. 19, that is, to facilitate the retrieval of theapparatus10, or portions thereof, from the lumen of a patient's body. In some embodiments, thewithdrawal component95 is made of materials such as, but not limited to, polyethylene, nitinol, combinations thereof, or the like. Although relatively inert, polyethylene has been credited with triggering a white cell response capable of killing foreign sperm, which may prove advantageous for a contraceptive device application.

As illustrated, thewithdrawal component95 may be an elongate rod having afirst end96aand asecond end96b.Thewithdrawal component95 may be configured to extend through the interior of theframe76 and be either coupled to theframe76 or theflow reducing member14, or both, using various means including, but not limited to, mechanical fasteners, welding techniques, adhesives, combinations thereof, or the like. In at least one embodiment, thesecond end96bof thewithdrawal component95 penetrates thedistal end24 of theframe24 and/or theflow reducing member14. In one embodiment, thewithdrawal component95 is an extension of theflow reducing member14 and formed integrally therewith as a single component. In other embodiments, however, thewithdrawal component95 is an extension of theframe76 and formed integrally therewith as a single component.

Thefirst end96aof thewithdrawal component95 may facilitate grasping of thewithdrawal component95 by a standard snare device or a specially-designed retriever (not shown). For example, thefirst end96amay be formed as a hook, a ring, a textured surface, or the like, but it will be appreciated that thefirst end96amay be formed of a variety of shapes and/or configurations suitable to facilitate grasping of thewithdrawal component95, without departing from the scope of the disclosure.

Removal of theapparatus10, may be undertaken as generally described above. For example, in one embodiment theapparatus10 may be removed by inverting theframe76 within itself. This may be accomplished by pulling thewithdrawal component95 in the proximal direction, as indicated by thearrow91. Thewithdrawal component95 pulls theframe76 proximally and toward its interior, thereby inverting theframe76, as shown inFIG. 22. Once theframe76 has been inverted, theapparatus10 may be further advanced in theproximal direction90 to fully remove theapparatus10 from the patient. In other embodiments, however, only theframe76 is removed using thewithdrawal component95, thereby leaving theflow reducing member14 deployed within the fallopian tube84 (FIG. 20).

Referring now toFIGS. 23, 24, and 25, illustrated are various stages of deploying and retrieving theapparatus10, according to one or more embodiments disclosed. InFIG. 23, theapparatus10 is positioned within adelivery device98, such as a catheter as described above. Specifically, theframe76 and theflow reducing member14 are compressed within thedelivery device98, and thewithdrawal device95 extends concentrically therethrough. In the compressed configuration, theframe76 biases against aninner surface19 of the flow reducing member which is thereby forced into engagement with aninner surface23 of thedelivery device98. For purpose of clarity, theflow reducing member14 is not shown inFIG. 23 in direct contact with theinner surface23 of thedelivery device98, but it will be appreciated that contact would nonetheless be made. In at least one embodiment, thedelivery device98 has an inner diameter of about 3 mm or less.

Once reaching the proper location within the fallopian tube84 (FIG. 20), thedelivery device98 may be translated proximally such that thedistal end24 of theframe76 and thesecond end96bof the withdrawal device85 extend past the opening98adefined by thedelivery device98. In other embodiments, thedelivery device98 is maintained stationary and theapparatus10 is moved distally in order to expose thedistal end24 of theframe76 and thesecond end96bof the withdrawal device85 beyond the opening98a.

As shown inFIG. 24, as thedistal end24 of theframe76 exits the opening98aand is no longer restrained by thedelivery device98, it begins to expand into its deployed configuration. As theframe76 expands, theflow reducing member14 expands simultaneously and is biased against aninner surface84a(FIG. 25) of afallopian tube84 or other tubular structure of interest. As the remaining portions of theframe76 and theflow reducing member14 eventually exit thedelivery device98, theentire apparatus10 becomes fully deployed within thefallopian tube84. As an example,FIG. 21 shows theapparatus10 in a fully-deployed configuration.

FIG. 25 illustrates an exemplary embodiment of theapparatus10 as it is being removed from afallopian tube84, or other tubular structure, according to one or more embodiments. For simplicity or purposes of clarity, theframe76 is not illustrated inFIG. 25. As generally described above, theapparatus10 may be removed by inverting theframe76 within itself, which may be accomplished by pulling thewithdrawal component95 in theproximal direction91. As theflow reducing member14 is pulled proximally, it detaches from theinner surface84aof the fallopian tube84 (or other tubular structure) and is eventually fully detached for removal.

Referring now toFIGS. 26 and 27, illustrated are alternative configurations of theapparatus10, according to one or more embodiments. In order to better seat theapparatus10 in varying-shaped tubular structures, and thereby achieve a better seal against the inner surface of said tubular structure, theframe76 and/or theflow reducing member14 may be formed or otherwise designed with varying circumferential profiles. For example, theapparatus10 shown inFIG. 26 depicts a proximally-directed bell shape. Specifically, theframe76 and/or theflow reducing member14 may be formed to exhibit a generally bell-shaped structure, where theproximal end20 of theframe76 flares radially-outward. The embodiment shown inFIG. 26 may prove useful in seating theapparatus10 in, for example, the opening of afallopian tube84, where the opening to thefallopian tube84 is enlarged and also tapers outward in the proximal direction as it communicates with the uterus.

FIG. 27 reverses the configuration of theapparatus10, and the withdrawingdevice95 is instead coupled at or adjacent theproximal end20 of theframe76, thereby providing a distally-directed bell shape. In this configuration, theframe76 is positioned with a distally-directedopening21 that faces away from the uterus. Although a bell-shaped circumferential profile is shown inFIGS. 26 and 27, it will be appreciated that any number of circumferential profiles may be used, without departing from the scope of the disclosure, to fit any number of varying applications and varying shapes of tubular structures.

Referring now toFIG. 28, illustrated is another exemplary application of theapparatus10 as used as a female contraceptive device, according to one or more embodiments disclosed. Specifically, theapparatus10 may further include atubular scaffold99 configured to be positioned within the fallopian tube84 (FIG. 20) and otherwise engage theinner surface84a(FIG. 25) thereof. Accordingly, thetubular scaffold99 may be configured to interpose the flow reducing member14 (and/or the frame76) and theinner surface84a(FIG. 25) of thefallopian tube84. Thetubular scaffold99 may be formed to exhibit a variety of cross-sectional shapes. For example, thetubular scaffold99 can have a cross-sectional shape that is circular, elliptical, polygonal (e.g., triangular, rectangular, hexagonal, octagonal, etc.), combinations thereof, or the like. It will be appreciated by those skilled in the art that thetubular scaffolding99, as generally described and illustrated herein, may be used in conjunction with any or all of the disclosed configurations of theapparatus10, without departing from the scope of the disclosure.

In its deployed configuration, theframe76 biases theflow reducing member14 against aninner surface100 of thetubular scaffold99. In other embodiments, however, such as where theflow reducing device14 is disposed within the interior of the frame76 (seeFIGS. 2 and 3), it is theframe76 that biases against theinner surface100 of thetubular scaffold99. In operation, thetubular scaffold99 shields theflow reducing member14 and/or theframe76 from thefallopian tube84 wall, thereby preventing tissue in-growth into theflow reducing member14 and/or theframe76. Moreover, thetubular scaffold99 generally prevents bonding of theflow reducing member14 and/or theframe76 to other surfaces which would prevent nonsurgical reversal of theapparatus10. In at least one embodiment, thetubular scaffold99 may remain implanted in thefallopian tube84 upon removal of theapparatus10, thereby helping facilitate non-surgical fertility reversal.

In some embodiments, thetubular scaffold99 is made of a shape memory frame and may be deployed within thefallopian tube84, or another tubular structure, in a manner substantially similar to a self-expanding stent. Thetubular scaffold99 may be made from braided metallic wires, formed to a particular dimension using a mandrel or the like. Specifically, thetubular scaffold99 may be made from between about 8 and about 48 strands of braided metallic wire each having a diameter that ranges from about 0.001 inches to about 0.010 inches. The wire strands may be braided over a mandrel, for example, having an outside diameter that can range from about 0.080 inches to about 0.500 inches. As will be appreciated, however, the number of wire strands and the above-noted diameters may vary as more or less than noted above, without departing from the application, and depending on specific application dimensions.

In some embodiments, thetubular scaffold99 may be encased partially or entirely with a coating. For example, the coating may be made of silicone having a durometer between 00 A and about 80 A, and an elongation percentage ranging between about 100% to about 1200%. The coating may be dip cast or injection molded directly onto thetubular scaffold99 and may have a thickness that can range between about 0.10 mm to about 1.00 mm. In at least one embodiment, the coating applied to thetubular scaffold99 may subsequently be coated with a lubricious substance or material, such as, for example, Parylene C. The lubricious coating may be applied, in one or more embodiments, to a thickness ranging from about 0.1 nm to about 1,000 nm.

Any or all of theexemplary apparatus10 disclosed herein may further include the use of an occlusion gel as an additional barrier to more effectively prevent the passage of sperm and/or ovum. In at least one embodiment, the occlusion gel may be injected within or around theapparatus10 using a catheter or other delivery device. The occlusion gel may add a radiopaque element to theapparatus10, thereby providing increased radiopaque visibility to confirm proper placement of theapparatus10. In addition to removing theapparatus10, fertility may be restored by removing the occlusion gel. The occlusion gel may be removed, for example, by soft suction or the injection of saline with a temperature of less than about 37° C.

In some embodiments, the occlusion gel may be a precipitating gel. For example, the occlusion gel may be injected as a fluid which subsequently precipitates or otherwise converts into a gel-like substance in the presence of a stimulus, such as common physiological fluids. In at least one embodiment, this may require the concurrent injection of saline to help the occlusion gel precipitate sufficiently to fully occlude thefallopian tube84. In other embodiments, the occlusion gel may be a phase transfer gel which is injected as a fluid and subsequently converts into a gel when exposed to elevated physiological temperatures. The phase transfer gel may dissolve when exposed to a reduced physiological temperature. Accordingly, the phase transfer gel may be removed by non-surgically injecting a lower temperature fluid, such as cold saline. In at least one embodiment, the phase transfer gel may further include barium sulfate, or a similar substance, to improve radiopaque visibility.

Moreover, any or all of theexemplary apparatus10 disclosed herein may further include the use of an occlusion foam as an additional barrier to more effectively prevent the passage of sperm and/or ovum. The occlusion foam may be crimped and deployed or otherwise injected within or around theapparatus10 using a catheter or other delivery device. At least one type of occlusion foam that may be used is a closed cell foam including a shape memory polymer having mean pore sizes ranging between about 1 micron to about 1,000 microns. Another type of occlusion foam that may be used is an open cell foam including a shape memory polymer having mean pore sizes of ranging between about 1 micron to about 500 microns. It will be appreciated, however, that many other types of occlusion foams may be utilized, without departing from the scope of the disclosure.

The occlusion foam may be configured to expand or enlarge when exposed to a fluidic environment and/or when exposed to elevated temperatures, thereby increasing the effective occlusion of thefallopian tube84. In some embodiments, injection of the occlusion foam may require the concurrent injection of saline to aid in precipitation of the foam and thereby fully occlude thefallopian tube84. In one or more embodiments, the occlusion foam may include a radiopaque element for better radiopaque visibility to confirm proper placement. To restore fertility, besides also removing theapparatus10, the occlusion foam may be removed by soft suction through tubing, by mechanically grasping and withdrawing the resulting foam structure, or by capturing the resulting foam structure within theframe76 as it is being removed proximally from the tubular structure.

In yet other embodiments, any or all of theexemplary apparatus10 disclosed herein may further include the use of one or more types of particles disposed or otherwise arranged within theflow reducing membrane14 in order to alter the environment and/or impede sperm activity/penetration. For example, polyglycolide particles may be arranged within (e.g., embedded, coated, etc.) theflow reducing membrane14 and may serve to reduce the local pH, which has been shown to inhibit the movement of sperm.

The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the present invention has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the invention.

There may be many other ways to implement the invention. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the invention. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the invention, by one having ordinary skill in the art, without departing from the scope of the invention.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. A phrase such an embodiment may refer to one or more embodiments and vice versa.

Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.

A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” The term “some” refers to one or more. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the invention. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.

Claims

What is claimed is:

1. An apparatus for reversibly blocking flow through a lumen of a patient, the apparatus comprising:

a frame comprising an inner volume, a proximal portion, a distal portion, and a middle portion extending between the proximal and distal portions, the distal portion tapering inwardly toward a central axis of the frame, the frame being expandable from a compressed configuration to a deployed configuration;

a flow reducing member coupled to the distal portion of the frame for restricting flow through the lumen; and

a withdrawal component coupled to the distal portion of the frame, the withdrawal component extending proximally from the frame distal portion along the central axis within the inner volume, the withdrawal component being configured to be engaged by a retrieval device to retrieve the apparatus from within the lumen.

2. The apparatus ofclaim 1, wherein the frame comprises a helical coil.

3. The apparatus ofclaim 1, wherein the flow reducing member is disposed over an exterior of the frame.

4. The apparatus ofclaim 1, wherein the middle portion is tapered such that a cross-sectional dimension of the middle portion is less than a cross-sectional dimension of at least one of the proximal or distal portions.

5. The apparatus ofclaim 1, wherein the withdrawal component is coupled to the flow reducing member.

6. The apparatus ofclaim 1, further comprising a scaffold configured to be positioned within the lumen and to separate the lumen from the flow reducing member and the frame, wherein the scaffold is at least one of elliptical or tubular.

7. The apparatus ofclaim 1, wherein the flow reducing member comprises an occlusion cap.

8. The apparatus ofclaim 7, wherein the occlusion cap comprises a biodegradable material having a degradation profile that is stable until a triggering event occurs.

9. The apparatus ofclaim 1, wherein the withdrawal component extends at least partially along the central axis proximally beyond the proximal portion of the frame.

10. The apparatus ofclaim 1, wherein the withdrawal component is formed integrally with the frame as a single component.

11. An apparatus for reversibly blocking flow through a lumen of a patient, the apparatus comprising:

a helical frame comprising a central axis, a first portion, a second portion, and a middle portion extending between the first and second portions, the second portion comprising a plurality of windings whose diameters are successively smaller in a direction away from the first portion, the frame being expandable from a compressed configuration to a deployed configuration; and

an elongate withdrawal component coupled to a smallest winding of the plurality of windings of the second portion, the withdrawal component extending away from the frame second portion along the central axis, the withdrawal component being configured to be engaged by a retrieval device to retrieve the apparatus from within the lumen.

12. The apparatus ofclaim 11, wherein the withdrawal component comprises an elongate rod having an enlarged end, the elongate rod extending through an aperture of the smallest winding, the enlarged end having a cross-sectional profile larger than the aperture to inhibit disengagement between the withdrawal component and the frame.

13. The apparatus ofclaim 12, wherein the withdrawal component extends at least partially along the central axis through an inner volume of the apparatus and beyond the first portion of the frame.

14. The apparatus ofclaim 12, wherein the withdrawal component extends at least partially along the central axis away from the second portion of the frame.

15. The apparatus ofclaim 11, wherein the withdrawal component comprises a proximal hook portion.

16. The apparatus ofclaim 11, wherein the first portion flares radially outwardly from the central axis.

17. The apparatus ofclaim 16, wherein the apparatus comprises a bell shape in the deployed configuration.

18. The apparatus ofclaim 11, further comprising a flow reducing member coupled to the frame for restricting flow through the lumen.

19. The apparatus ofclaim 11, wherein the flow reducing member is coupled to the smallest winding.

20. The apparatus ofclaim 11, wherein the withdrawal component is formed integrally with the frame as a single component.