JP2009508657A - Embolic filter device and related systems and methods - Google Patents

Abstract

  The adjustable embolic filter module includes an adjustable lock assembly and an adjustable filter assembly having a filter support scaffold and a filter member. The lock assembly and filter support scaffold are integrally formed from a piece of nickel titanium tube that is cut and shaped into a shape memory pattern. The locking assembly is locked onto the guidewire and the adjustable filter assembly is self-expanding to filter blood at the location when released from radial compression. The delivery system provides low profile delivery and assembly release for guidewire locking and filter deployment. The dynamic coupling is placed between the lock and the filter, thereby allowing a limited range of movement between the lock and the filter as the locked guidewire moves. The system includes a guidewire that is actuated and sensed in combination with an adjustable filter module. A guidewire lockable filter includes a needle coupled within a guidewire lumen for energy or material delivery to lock the filter to the guidewire.

Description

  The present invention relates to a system and method for filtering emboli from fluid flowing through a body lumen of a patient. In particular, the present invention relates to an embolic filter system and method adapted for adjustment use through an indwelling guidewire for filtering emboli from blood flowing through a patient's blood vessels.

[Cross-reference of related applications]
This application claims priority from US Provisional Patent Application No. 60 / 719,303, filed Sep. 20, 2005, which is incorporated herein by reference in its entirety.

[Description of research or development supported by the federal government]
Not applicable

[Incorporation by reference to materials submitted on compact discs]
Not applicable

[Notes on materials subject to copyright protection]
Some of the materials in this patent document are subject to copyright protection based on the copyright laws of the United States and other countries. This copyright holder will not challenge any person to copy the patent document or patent disclosure if the file or record is publicly available in the United States Patent and Trademark Office. Otherwise, all copyrights are retained. Accordingly, the copyright holder does not waive any rights in order to maintain the confidentiality of this patent document, including, but not limited to, the rights stipulated by US Patent Enforcement Rules §1.14.

  Several filtration techniques have been disclosed for filtering emboli released during interventional procedures. One particular situation in which embolization research has been conducted is for emboli that flow toward the brain during carotid artery treatment, such as endarterectomy, angioplasty, stent treatment, atherectomy or rotational resection. For distal protection. Another situation under investigation is the filtration of the distal effusion fluid of an embolus during recanalization of a graft such as a coronary artery bypass graft.

  In general, distal embolic protection systems and methods provide a pre-placed filter on the distal end of a guidewire chassis. The guidewire and filter are typically placed in an antegrade fashion through the intervention site and translumenally so that the filter is placed downstream of the occlusion to be recanalized. The filter then generally expands (through a passage port, for example, through a filter hole or other opening) to allow blood to pass except for a predetermined size of the embolus. Deployed as a cage or porous material. Intervention upstream of the filter releases the embolus, which flows downstream and flows into the deployed filter where it is captured. A mechanism is provided that allows adjustment of the filter for removal, including capture of captured emboli, after the intervention is complete.

  Despite the great advances that have been made in recent years to provide distal embolic protection while intervening in a blood vessel, existing systems and methods still present many shortcomings and still embolic filtration systems There are many significant needs for improved embolic filtration methods.

  There are still various needs in clinical medicine to improve embolic filtration systems, including but not limited to the following needs.

  The ability to filter emboli during guidewire-based medical procedures while delivering the guidewire to the filtration location within the body without the need to carry a filter integrally attached to the guidewire itself There remains a need for an embolic filter system that provides.

  A filter assembly that is advanced through a separate guide wire and is efficiently and reliably locked onto the guide wire so that the filter wire can be formed in situ with the locked filter and wire combination There still exists a need for.

  There is also a need for an adjustable and lockable filter assembly that can be tracked through a guidewire and locked onto the guidewire in the body and that can be manufactured relatively efficiently and at a relatively low cost. It still exists.

  There is still a need for an adjustable and lockable filter assembly that can be tracked through a guidewire and locked onto the guidewire in the body and that can produce relatively few parts or joints between parts. To do.

  An adjustable and lockable filter assembly including an adjustable locking assembly having a substantially tubular structure, which can be radially expanded and loaded on an adjustable inner sheath and is tubular Of the inner sheath with respect to elastic shape or superelastic recovery to a memory shape and a radially closed diameter, which can be maintained in a radially open diameter, inflated state, and in a shape that tracks through a guide wire There also remains a need for a filter assembly that provides an improved ability that can be released by contraction so that the restoring force of the material locks the tubular structure onto the guidewire.

  There is still a need for an improved ability to filter emboli that are released or produced during a procedure that includes a dedicated guidewire that is coupled to an actuator and performs a specialized guidewire procedure other than filtration. . There is a particular need for an adjustable and lockable filter assembly provided or used in combination with an actuated chronic total occlusion crossing system that filters emboli for chronic total occlusion interventions.

  One aspect of the present disclosure is an embolic filter system that includes an embolic filter device adapted for use through a guidewire. The guide wire cooperates with the filter device but is provided independently of the filter system.

  Another aspect of the present disclosure is capable of tracking on a separate guidewire to a location within the patient's body and is securely and efficiently locked on the guidewire at the location and thereby locked An adjustable filter assembly that forms a filter wire within the body including a combination of a filter assembly and a guide wire.

  Another aspect is an adjustable and lockable filter assembly that can be efficiently manufactured.

  Another aspect is an adjustable and lockable filter assembly that is designed to be manufactured at low cost.

  Another aspect is an adjustable and lockable filter assembly that is made so that there are only a few joints formed between parts or parts.

  Another aspect is an adjustable and lockable filter assembly that includes a filter membrane support scaffold and a guide wire lock assembly that are integrally formed from a single piece of material.

  Another aspect is an adjustable and lockable filter assembly designed for easy and efficient clinical use.

  Another aspect is an adjustable and lockable provided for delivery in a relatively low profile through the guidewire to the filter position where the filter wire can be formed within the body by locking the filter wire over the guidewire Filter assembly.

  Another aspect is an improved delivery assembly for an adjustable and lockable filter assembly that enhances one or more of the following: delivery to a filter position through a guidewire, on the guidewire Lock, release of expandable filter membrane from radial restriction to filter the lumen, withdrawal of filter assembly from delivery system locked onto guidewire.

  According to another aspect, the embolic filter device is adjustable between the first configuration and the second configuration, and is adjustable between an unlocked state relative to the guide wire and a locked state. . In the first configuration and the unlocked state, the embolic filter device is slidably disposed through a guide wire at a location where filtration is desired. The filter device is adjusted to a locked state on the guide wire at the above-mentioned place. The filter device is further adapted for adjustment in the body to a second configuration adapted to filter the embolus from fluid flowing therein at a filtration position corresponding to the lock location of the filter device along the guidewire.

  In one mode of this embodiment, the filter device is adapted to filter emboli from blood.

  In this mode of embodiment, the filter device is positioned downstream from the intervention site by a guide wire. In a further embodiment, the location is within the patient's carotid artery and requires filtration of emboli that are released during intervention at the intervention site. In yet another embodiment, the filter system is adapted to be placed downstream from the anastomotic artery or vein graft, embolizing from blood flowing downstream from the graft, such as during an intervention such as graft recanalization. Is to be filtered.

  In another mode of this aspect, the filter device has a filter assembly secured on a substantially tubular support member. The tubular support member has a guide wire passage therethrough and is adjustable between a first configuration and a second configuration. In the first configuration, the guidewire passage allows the tubular support member to be movably engaged on the guidewire for adjustable placement of the filter device along the length of the guidewire. Having a first inner diameter configured as such. In a second configuration, the guidewire passageway is sufficient for the guidewire to lock the filter device onto the guidewire so that the filter device remains on the guidewire during in-vivo use. Having a second inner diameter adapted to engage.

  In another mode of this aspect, the filter device is adjusted to the second configuration in response to the applied energy. In one embodiment, the filter device is adapted to the second configuration in response to a current applied to a conductor coupled to the filter device. In another embodiment, the filter device is adapted to the second configuration in response to the applied ultrasonic energy. In another embodiment, the adjustment is made in response to the applied light energy. In another embodiment, the applied energy includes thermal energy.

  In another mode of this aspect, the filter system includes a control system that is coupled to the filter device and is adapted to control placement, locking, and radial adjustment of the filter device relative to the guidewire. .

  According to one embodiment of this mode, the control system includes a delivery member that holds the filter device and advances the filter device through the guidewire to the position where locking is desired. Yes. In another embodiment, the locking member is controlled by a control system and is adapted to lock the filter device in position along the guide wire.

  In another embodiment, the control system includes a radial adjustment system that is coupled to the filter device and adjusts the filter device between the first configuration and the second configuration. It is supposed to be. In one variation of this embodiment, the radial adjustment system includes an outer sheath that is movable longitudinally through the guidewire between a first position and a second position relative to the filter device. . In the first position, the filter device is accommodated radially in a radially contracted state within the passage of the outer sheath. In the second position, the filter device is located outside the passage and expands into a memorized state, which is a radially expanded state corresponding to the second configuration. In another variation, a puller wire is coupled to the radial support member.

  In another form of the present disclosure, the embolic filter system is provided with a filter device that includes a filter assembly with a radial support member coupled to the filter wall. In the radially expanded state, the radial support member at least partially supports the filter wall in a shape adapted to filter blood flowing into the radial support member and wall assembly.

  In one mode of this aspect, the filter wall is a sheet material. In one embodiment, the sheet material comprises a porous membrane that has a size sufficient to allow normal physiological blood components to pass through, but does not allow larger size components such as emboli to pass through. In another embodiment, the sheet material has a plurality of through openings.

  In another mode, the filter wall is a strand material having a space between the strands that is large enough to allow normal physiological blood components to pass but not larger size components such as emboli to pass by filtration. Including a network.

  Another aspect of the present disclosure includes an embolic filter device coupled to a control system that includes at least one removable member that is removable from the embolic filter device when the embolic filter device is located at a remote body location. An embolic filter system is provided.

  In one mode of this embodiment, the removable member is a conductor lead adapted to couple energy from an extracorporeal energy source to the embolic filter device at a remote body location. In one embodiment of this mode, when sufficient electrical energy is applied to the sacrificial link between the conductor lead and the filter device, the conductor lead can be removed from the filter device by electrolysis.

  Another aspect of the present disclosure provides an embolic filter system comprising an embolic filter device that includes a filter assembly coupled to a locking member. The lock member is adjustable between an unlocked state and a locked state. In the unlocked state, the filter device is advanced to a desired position through the guide wire. In the locked state, the filter device is substantially locked at the location on the guidewire.

  Another aspect of the present disclosure provides an embolic filter system comprising an embolic filter device that includes a filter assembly that cooperates with an adjustable member. The adjustable member is adjustable between the first shape and the second shape. In the first shape, the adjustable member is configured to pass the penetrating guidewire. In the second shape, the filter device is locked onto the guide wire.

  In one mode, the adjustable member has a first inner diameter in the first shape and a second inner diameter that is smaller than the first inner diameter in the second shape.

  In another mode, the adjustable member is at least partially formed from a shape memory material. In one embodiment, the shape memory material is a nickel titanium alloy. In one variation, the nickel titanium alloy forms an annular member such as a ring. In a further feature, the ring can have a memory state in the second shape. In a further feature, the ring is adjustable between a first shape and a second shape at a particular temperature. In a further feature, the temperature is higher than normal resting body temperature. In another mode, the adjustable member includes a superelastic material that becomes superelastic to the memory shape when released from an applied force that causes the material to superelastically deform from the memory shape to the adjusted shape. Elastic recovery.

  In another mode, the adjustable member is adapted to be disposed along the guide wire and has a first outer diameter in the first shape and a second outer diameter in the second shape. . The first outer diameter is small enough to provide a slidable gap between the guide wire at the adjustable member location and the guide wire passage of the filter device. The second outer diameter is greater than the first outer diameter and is sufficient to radially engage the guidewire passageway to lock the filter device onto the guidewire at the position of the adjustable member. Is.

  Another aspect of the present disclosure provides an embolic filter system comprising an embolic filter device having a filter assembly that cooperates with an annular member that is adjustable between a first inner diameter and a second inner diameter. The first inner diameter is larger than the outer diameter of the guide wire. The second inner diameter is smaller than the outer diameter of the guide wire.

  In one mode, the annular member is at least partially formed from a shape memory material. In one embodiment, the shape memory material is a nickel titanium alloy.

  In another mode, the annular member is a ring.

  In another mode, the annular member is a coil.

  In another mode, the annular member is a tubular member.

  In another mode, the annular member consists of a pattern of interconnected struts separated by void areas.

  In another mode, the annular member is formed, at least in part, from a solid tubular member with a voided pattern cut therein.

  In another mode, the annular member has a memory state in the second shape. In one embodiment, the annular member is adjustable between a first shape and a second shape at the transition temperature. In one variation, the transition temperature is higher than normal resting body temperature. In another variation, the transition temperature is approximately equal to normal resting body temperature.

  In another mode, the annular member includes a superelastic material, and the superelastic material recovers superelastically to the memory shape when released from an applied force that causes the material to superelastically deform from the memory shape to the adjusted shape. .

  Another aspect of the present disclosure is a method of providing an embolic filter system, the method of providing the embolic filter system comprising: providing an embolic filter device; positioning a distal end of a guidewire at a remote body location within a patient's body. Positioning the filter device in a first shape and unlocked position through the guide wire to a position along the distal end of the guide wire where filtration is desired; The filter device is locked onto the guide wire by adjusting from the unlocked state to the locked state, and the locked filter device is filtered from the first configuration, and the embolus is filtered from the fluid flowing into the filter. Adjusting to a second configuration.

  According to one mode of this aspect, the method further includes heating the filter device at the remote body location by coupling the filter device to an energy source disposed outside the body, the heat causing the filter to The device is adjusted from the unlocked state to the locked state. In a further embodiment, the heating includes applying a current to a conductor coupled with the filter device, and in one variation, the method includes applying an RF current to the conductor. In another embodiment, the heating includes optically coupling the light to a conductor coupled to the filter that is adapted to heat when absorbed. In another embodiment, the heating includes coupling ultrasonic energy to a conductor coupled to the filter device that is adapted to heat when absorbing the ultrasound. For example, by coupling an ultrasonic crystal unit (ultrasound crystal) coupled to a filter device to an external power source that excites the ultrasonic crystal unit to generate ultrasonic energy, Energy can also be generated within the body system itself.

  According to another mode, the superelastic material is adjusted between a memory state and a superelastically deformed state. According to one embodiment, the material is a nickel titanium alloy material.

  Another mode of this aspect is to adjust the adjustable member of the filter device from a first shape corresponding to the unlocked state of the filter device to a second shape corresponding to the locked state of the filter device. including. In the first shape, there is a gap for the filter device to slidably engage the guide wire and move through the guide wire. In the second shape, the adjustable member engages the guide wire. In one embodiment, the adjustment includes shrinking the inner diameter of the annular ring. In another embodiment, the adjustment includes contracting the inner diameter of the longitudinally extending coil or blade.

  Another aspect of the present disclosure provides an embolic filter as a module adapted to removably engage on a guidewire.

  Another aspect of the present disclosure is to be delivered through a guidewire in the body and located at a position along the distal end of the guidewire distal from the intervention site and locked onto the guidewire at the above position. An embolic filter is provided.

  Another aspect of the present disclosure provides an embolic filter that can be adjusted between a radially contracted state and a radially expanded state by a guidewire disposed at a location distal to the planned intervention site.

  Various additional aspects of the present disclosure include adaptations of aspects, modes, embodiments, variations and features as described herein as proximal embolic filtration systems and methods.

  Another aspect of the present disclosure is an embolic filter system comprising a filter assembly and an adjustable lock assembly as follows. The filter assembly has a filter member that is adjustable between a radially contracted configuration and a radially expanded configuration. The filter assembly is adapted to be locked by a locking assembly adjustable at a selected position along the distal end of the guidewire at a position within the patient's body lumen, at least partially with the guidewire. It is delivered to the position in the locked configuration. The filter member can be adjusted in this position from a radially contracted configuration to a radially expanded configuration that extends across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the above position is also configured to filter a component exceeding a predetermined size of the fluid flowing in the lumen at the position.

  Another aspect of the present disclosure is an embolic filter system comprising a delivery member that cooperates with a filter assembly as follows. The delivery member has an elongated body having a proximal end and a distal end. The filter assembly has a filter member that is adjustable between a radially contracted configuration and a radially expanded configuration. The distal end of the delivery member is coupled to the filter assembly, and manipulating the proximal end outside the patient's body causes the filter assembly in the radially contracted configuration to be at least partially within the patient's body lumen. Is advanced to a certain position. The filter member is adjustable at the above position from a radially contracted configuration to a radially expanded configuration extending across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the position is configured to filter a component exceeding a predetermined size of the fluid flowing in the lumen at the position. The distal end of the delivery member is removable from the filter assembly at the location.

  Another aspect of the present disclosure is an embolic filter system comprising a delivery member, a filter assembly and an adjustable lock assembly as follows. The delivery member has an elongated body having a proximal end and a distal end. The filter assembly includes a guide wire tracking member and a filter member coupled to the guide wire tracking member and adjustable between a radially contracted configuration and a radially expanded configuration. The distal end of the delivery member is removably coupled to the guidewire tracking member, and manipulating the proximal end of the delivery member outside the patient's body guides the filter assembly with the radially contracted configuration of the filter member. It is made to advance to the said position through a wire. The filter member is adjustable at the above position from a radially contracted configuration to a radially expanded configuration extending across a substantial cross-section of the lumen. The filter member in the radially expanded configuration at the above position is configured to filter a component exceeding a predetermined size of the fluid flowing in the lumen at the position. An adjustable locking assembly is adapted to lock the filter assembly onto the distal end of the guidewire in the above position and the delivery member is removable from the guidewire tracking member in that position.

  Another aspect of the present disclosure is an embolic filter system comprising a delivery assembly that cooperates with the filter assembly as follows. The filter assembly has a filter member having a wall with a substantially annular passage along the circumference and a loop-shaped member coupled to the filter member along the circumference within the annular passage. The super elastic loop type support member has a radial contraction state corresponding to the elastic deformation state of the super elastic loop type support member and a radial expansion corresponding to the material recovery from the elastic deformation state of the super elastic loop type support member to the memory state Adjustable between states. By adjusting the support member from the radially contracted state to the radially expanded state, the filter member is adjusted between the radially contracted configuration and the radially expanded configuration, respectively. The filter assembly is at least partially adapted for delivery to a location within a patient's body lumen, with a support member radially limited in a radially contracted state and a filter member in a radially contracted configuration. The support member and the filter member can be adjusted from the radially contracted state and the radially contracted configuration to the radially expanded configuration and the radially expanded configuration, respectively, at the above positions. The filter member in the radially inflated configuration at the above position extends across the effective cross-section of the lumen, and filters components above a predetermined size of the fluid flowing through the lumen at the above position. Yes.

  Another aspect of the present disclosure is an embolic filter system as follows. The system extends between an elongate body having a proximal end and a distal end along a long axis, and a proximal port and a distal port, each positioned along the distal end. A delivery member having a lumen to communicate with. The system also includes a filter assembly that includes a filter member coupled to the support member and adjustable from a radially contracted configuration corresponding to the elastically deformed state to a radially expanded configuration by memory recovery from the elastically deformed state to the memorized state. . The radially contracted configuration of the filter assembly is radially constrained within the lumen for delivery to a location within the patient's body lumen. By removing the filter assembly from the radially restricted lumen, the filter assembly can be adjusted from the radially contracted configuration to the radially expanded configuration at that location. The filter member in the radially inflated configuration at the above position extends across a substantial cross section of the lumen, and filters out components at a location exceeding a predetermined size of the fluid flowing through the lumen. Yes.

  Another aspect of the present disclosure is a method of filtering an embolus from fluid flowing across an internal location of a patient's body lumen, the method comprising the following steps. The filter assembly is delivered to the position through the guide wire in a radially contracted configuration. The filter assembly is locked onto the guide wire at the above position and then adjusted from the radially contracted configuration to the radially expanded configuration at that position. The filter assembly in the radially expanded configuration at the location extends across a substantial cross-section of the body lumen and is adapted to filter emboli from fluid flowing through the location.

  Another aspect of the present disclosure is a method of filtering an embolus from fluid flowing across an internal location of a patient's body lumen as follows. The filter assembly is delivered to the position through a guidewire with a delivery member in a radially contracted configuration. The filter assembly is removed from the delivery member in the above position. The filter assembly is adjusted from a radially contracted configuration to a radially expanded configuration at the location described above and extends across a substantial cross-section of the body lumen to filter emboli from fluid flowing across the location. Thereafter, the filter assembly is deflated while capturing the filtered emboli. The deflated filter assembly is then withdrawn from the body lumen.

  Another aspect of the present disclosure is another method of filtering emboli from fluid flowing across a location within a patient's body lumen as follows. The filter assembly is disposed within a capture lumen of a radial confining cuff having an adjustable position relative to the filter assembly in a radially contracted configuration. A filter assembly is provided along the distal end of the delivery member within an adjustable radial restriction cuff in a radially contracted configuration. The distal end of the delivery member and the filter assembly are delivered in the radially contracted state to the position within the cuff so that the filter assembly is released from the radial restriction and auto-expands by material storage into the radially expanded state. By adjusting the relative position of the cuff relative to the filter assembly, the filter assembly is adjusted from the radially contracted configuration to the radially expanded configuration at the position. The filter assembly in the radially expanded configuration at the location extends across a substantial cross-section of the body lumen and is adapted to filter emboli from fluid flowing through the location. Thereafter, by placing the filter assembly at least partially within the radial restriction cuff, the filter assembly is deflated with the captured emboli captured and at least partially restricted to the interior of the cuff. In the state of being removed from the body lumen. Furthermore, in this method, the capture lumen extends along the length between the proximal and distal ports, such as when the filter assembly is placed in the above position within the cuff, etc. , The entirety of which is placed inside the body lumen.

  Another aspect of the present disclosure is a method of assembling an embolic filter as follows. A proximal end and a distal end having a first length adapted to be disposed at a location within a patient's body lumen while the proximal end extends outside the patient's body A guide wire having a portion is prepared. A filter assembly is also provided having a filter member coupled to a guidewire tracking member having a guidewire lumen extending a second length between the proximal port and the distal port. A guidewire lumen is slidably engaged on the guidewire. The second length is shorter than the first length to make the filter assembly a shuttle that tracks through the guidewire. A further mode shuttle filter assembly is locked onto the distal end of the guidewire.

  Another particularly advantageous aspect of the present invention is a system for filtering emboli from a fluid at a location within a lumen within a patient's body. The system includes an adjustable, integral scaffold body and a filter member. The scaffold body includes an adjustable guidewire lock assembly integral with an adjustable filter support scaffold. The filter member is coupled to the adjustable filter support scaffold body. The adjustable integrated scaffold body in the first configuration has the guide wire lock assembly in an open configuration and the adjustable filter support scaffold in a radially contracted configuration, whereby the filter member is in the first configuration. In a state of expanding in diameter, it is slidably engaged on the guide wire and is tracked to the position through the guide wire. In the filtration position, the adjustable integrated scaffold body is adjusted to a locking configuration such that the guide wire lock assembly is substantially locked onto the guide wire and the adjustable filter support scaffold is calibrated. A second configuration adjusted to a directional expansion configuration, whereby the filter member is expanded to a second diameter larger than the first diameter and adapted to engage the lumen wall at the position Can be adjusted.

  Another aspect is a system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising a filter member that is provided with the following specific modes: Means are provided for delivering the filter member through the guidewire to a location. Means are also provided for adjusting the filter member between the radial contraction configuration extending to the first diameter and the radial expansion configuration extending to the second diameter at the position. Means are also provided for substantially securing the filter member relative to the guidewire at the location in the body. Further provided are means for supporting the filter member in the radially expanded configuration at the above position. The means for substantially fixing the filter member to the guide wire and the means for supporting the filter member in the radially expanded configuration at the above position are integral.

  According to one mode of this aspect, the means for substantially securing the filter member to the guide wire includes an adjustable guide wire lock assembly that is open for tracking through the guide wire. Adjustable between the configuration and a locking configuration locked onto the guide wire. Further, the means for supporting the filter member includes an adjustable filter support scaffold, the adjustable filter support scaffold having a radially contracted configuration extending to the first inner diameter and a first larger than the first diameter. It is adjustable between a radial expansion configuration that extends to a diameter of two. The adjustable guidewire lock assembly and the adjustable filter support scaffold together constitute one integrated scaffold body. The scaffold body includes a first configuration corresponding to an open configuration of the lock assembly and a radial contraction configuration of the filter support scaffold, and a second configuration corresponding to a lock configuration of the lock assembly and a radial expansion configuration of the filter support scaffold. It is possible to adjust between the configurations.

  According to the immediately preceding aspect, the further modes include:

  According to one mode, the integrated scaffold body is a patterned piece of monolithic integral piece across the adjustable guidewire lock assembly and adjustable filter support scaffold. of material).

  According to one embodiment of this mode, the monolithic material comprises one continuous wire filament in a patterned shape. In another embodiment, the monolithic material comprises a shape memory material. According to one further feature, the scaffold body is configured from the first configuration to the second configuration in the position by the superelastic recovery force of the shape memory material from the superelastic deformation shape to the memory shape characterizing the first configuration. Can be adjustable. According to another feature, the scaffold body can be adjusted from the first configuration to the second configuration at the position by heating the shape memory material to a temperature above the transition temperature.

  In another mode, the monolithic material has a substantially tubular wall along the lock assembly. The substantially tubular wall has a memory shape having a first inner diameter. In the open configuration, the substantially tubular wall is held open in a radially expanded state having a second inner diameter that is greater than the first inner diameter, under a force applied from the memory shape. When the substantially tubular wall is released from the applied force, it automatically contracts to the memory shape due to the recovery force of the material.

  According to one embodiment of this mode, the substantially tubular wall in the locked configuration is larger than the first inner diameter when confronting engagement with the outer surface of the guidewire. It has a third inner diameter that is smaller than the inner diameter. In another embodiment, the substantially tubular wall has a pattern with voids of nickel titanium material around the interior passage. In another embodiment, the delivery assembly comprises an adjustable lock retainer. The lock retainer is in a first state where the adjustable guidewire lock assembly is held in an open configuration by a force applied from the lock retainer and the adjustable guidewire lock assembly is released from the adjustable lock retainer. And a second state in which the material is automatically retracted to the locked configuration by the restoring force of the material to the memory shape. In another embodiment, the monolithic material has a patterned shape that is cut from a nickel titanium tube.

  According to another mode, a delivery system comprising a filter support scaffold retainer is provided. The filter support scaffold retainer is configured such that, in the first state, the filter support scaffold is held in a radially contracted configuration, and in the second state, the filter support scaffold is released and automatically expands to a radially expanded configuration. For an adjustable filter support scaffold, adjustment is possible between the first state and the second state.

  According to another mode, a delivery assembly is provided that includes a guidewire lock retainer and a filter support scaffold retainer. A guide wire lock retainer cooperating with the adjustable guide wire lock assembly and wherein the adjustable guide wire lock assembly is held in an open configuration by a force applied from the guide wire lock retainer; A corresponding first condition and a second, wherein the adjustable guidewire lock assembly is released from the adjustable guidewire lock retainer and automatically retracts to the lock configuration by the restoring force of the material to the first memory shape Adjustable between the configuration and the corresponding second state. The filter support scaffold retainer has a first state corresponding to the first configuration, wherein the adjustable filter support scaffold is held in a radially contracted configuration, and the adjustable filter support scaffold is released to the first position. Adjustable between a second configuration and a corresponding second state that automatically expands into a radially expanded configuration by the restoring force of the material to the two memory shapes.

  According to one embodiment of this mode, the guide wire lock assembly retainer comprises an inner tubular member and the filter support scaffold retainer extends along a length relative to the longitudinal axis. An external tubular member having a retention lumen is provided. In the first configuration, the inner tubular member is disposed at a first longitudinal position within the outer tubular member. In the second configuration, the inner tubular member is withdrawn from the first longitudinal position relative to the outer tubular member to a second longitudinal position proximal from the first longitudinal position.

  Another aspect of the invention is a method of manufacturing an embolic filter assembly that filters emboli from a fluid at a location within a lumen within a patient's body. The method includes forming a scaffold body comprising an adjustable guide wire lock assembly and an adjustable filter support scaffold, the scaffold body comprising an adjustable guide wire lock assembly and an adjustable filter support scaffold. Formed from one integral piece of patterned shaped material throughout Ford.

  According to one mode, the method includes cutting the scaffold body from a precursor material into a patterned shape.

  In another mode, the scaffold body is cut from a tube made of shape memory material into a first patterned memory shape. In one embodiment, the shape memory material comprises nickel titanium. In another embodiment, the cut scaffold body is shaped from a first patterned memory shape to a second patterned memory shape that is different from the first patterned memory shape. Retrain.

  According to one further feature of this embodiment, the method provides the guidewire lock assembly with a substantially tubular member having a first inner diameter in a first patterned memory shape, and Also included is shaping the substantially tubular member of the guidewire lock assembly into a second patterned memory shape having a second inner diameter that is smaller than the first inner diameter.

  Another feature is to provide an integral piece of material along a guidewire lock assembly having a substantially tubular structure with an internal guidewire passage and adjustable to a first position within the internal guidewire passage. A substantially tubular structure from a memorized shape having a radially contracted inner diameter smaller than a radially expanded inner diameter to a superelastically deformed shape having a radially expanded inner diameter. Placing the lock retainer so as to expand and deform radially. The expanded inner diameter corresponds to the open configuration of an adjustable guidewire lock assembly that is slidably engaged on the guidewire and configured to track through the guidewire. The lock retainer is adjustable from a first position to a second position, and the lock retainer is withdrawn from the inner guidewire passage to cause the substantially tubular member to be rejuvenated by the material recovery force. It is automatically contracted radially inward from a deformed shape having a radially expanded inner diameter to a memory shape having a smaller radially contracted inner diameter.

  In yet another feature to the above features, the method includes disposing a guidewire in the internal guidewire passage when the lock retainer is in the first position and the guidewire lock assembly is in an open configuration; And holding the guidewire within the inner guidewire passage while adjusting the lock retainer to the second position. The guidewire has an outer diameter that is greater than the radially contracted inner diameter corresponding to the memory shape relative to the substantially tubular member of the guidewire lock assembly. The substantially tubular member of the guide wire lock assembly is struck against the guide wire and compressed by the restoring force of the radially inward material from the deformed shape to the memory shape. A guidewire lock assembly that is compressed onto the guidewire corresponds to a locked condition where the guidewire lock assembly is substantially locked onto the guidewire. In yet another deployment according to this feature, the lock retainer comprises a tubular member having a guidewire lumen. A guide wire is disposed within the guide wire lumen.

  Another mode of this aspect is to place the outer retaining sheath of the adjustable filter support scaffold retainer in a first position around the adjustable support scaffold, wherein the adjustable filter support scaffold To limit Ford radially from a memory shape having a radially expanded outer diameter greater than a radially contracted outer diameter to a superelastic deformed shape in a radially contracted configuration having a radially contracted outer diameter. It also includes placing a retaining sheath. The radial contraction configuration of the support scaffold corresponds to the first configuration of the scaffold body and to the guide wire lock assembly in the open configuration, whereby the scaffold body is slidable through the guide wire Configured to be delivered to a location within a lumen within the patient's body. The method according to this mode also includes adjusting the filter support scaffold retainer from the first position to the second position, wherein the retainer is withdrawn from the adjustable filter support scaffold and thereby adjustable. Filter support scaffolds from a deformed shape with a radially contracted outer diameter to a memory shape with a larger radially expanded outer diameter, automatically expanded radially outward, radially expanded configuration by material recovery Let

  According to another mode related to the features preceding the above mode, the method places the outer retaining sheath of the adjustable filter support scaffold retainer in a first position around the adjustable support scaffold. A super elastic deformation in which the adjustable filter support scaffold is in a radially contracted configuration having a radially contracted outer diameter from a memory shape having a radially expanded outer diameter greater than the radially contracted outer diameter. Arranging the outer retaining sheath to constrain the shape to the radial direction. The radial contraction configuration of the support scaffold corresponds to the first configuration of the scaffold body and to the guide wire lock assembly in the open configuration, whereby the scaffold body is slidable on the guide wire And configured to be delivered to a location within a lumen within the patient's body. The filter support scaffold retainer is adjusted from the first position to the second position, and the retainer is withdrawn from the adjustable filter support scaffold so that the adjustable filter support scaffold is The material's recovery force automatically expands radially outward from a deformed shape having a radially contracted outer diameter to a memory shape having a larger radially expanded outer diameter in a radially expanded configuration. Further, the tubular member of the lock retainer is disposed within the outer retaining sheath.

  According to a further embodiment associated with this mode, the method comprises a filter held in a radially contracted configuration by each of the guide wire lock assemblies held open by a guide wire lock retainer and an external retaining sheath. It also includes placing a support scaffold within the outer retaining sheath. In yet another feature, the method includes the guidewire lock assembly being held open by the lock retainer and the filter support scaffold being retained in a radially contracted configuration within the outer retaining sheath. Positioning within the lumen and extending distally from the outer retaining sheath. In another further embodiment, the method is to provide a stop in the outer retaining sheath, wherein the guidewire is removed when the tubular member of the lock retainer is to be proximally removed from the outer retaining sheath. Including providing a stopper so that the lock assembly may be bumped against the stopper and removed with the tubular member, thereby allowing the tubular member to be removed from the internal guidewire passage of the lock assembly. .

  According to another mode of this aspect, the method includes coupling the radiopaque material to the integral piece of material along at least one of the lock assembly and the filter support scaffold.

  In another mode, the method removes the filter support scaffold from the fluid flowing through the filter member when supported by the filter support scaffold at a location throughout the lumen in the patient's body. Coupling to a filter member configured to filter the embolus.

  Another aspect of the invention is a system for filtering emboli from a fluid at a location within a lumen within a patient's body, the system comprising a guide wire lock assembly and an emboli filter assembly. A filter module is provided. The adjustable embolic filter module in the first configuration is slidable on the guide wire with the guide wire lock assembly in an open configuration and the embolic filter assembly in a radially contracted configuration having a first diameter. And tracking to the above position through a guide wire. The adjustable embolic filter module is in the locked configuration such that the guidewire locking assembly is substantially locked onto the guidewire in the position, and the embolic filter assembly is larger than the first diameter. The second configuration can be adjusted at that position in a radially expanded configuration that extends to a second diameter adapted to engage the lumen wall at that location. The adjustable embolic filter module in the second configuration in the position further includes a guide wire lock assembly in the locked configuration and radial expansion by a force applied to at least one of the guide wire lock assembly and the embolic filter assembly. Limited relative motion is possible with the embolic filter assembly in the configuration.

  Another aspect of the invention is a system for filtering emboli from a fluid at a location within a lumen within a patient's body, the system comprising a guide wire lock assembly and an emboli filter assembly. A filter module is also provided. The adjustable embolic filter module in the first configuration is slidable on the guide wire with the guide wire lock assembly in an open configuration and the embolic filter assembly in a radially contracted configuration having a first diameter. And tracking to the above position through a guide wire. The adjustable embolic filter module is in a locking configuration such that the guidewire locking assembly is substantially locked onto the guidewire, and the embolic filter assembly is larger than the first diameter in the lumen at the above position. The second configuration can be adjusted at this position in a radially inflated configuration extending to a second diameter adapted to engage the wall. A force applied to at least one of the guidewire lock assembly and the embolic filter assembly in the second configuration at the above position between the guidewire lock assembly in the locked configuration and the embolic filter assembly in the radially expanded configuration. Means are also provided that allow for limited relative movement.

  One mode of the preceding embodiment includes a dynamic motion coupler that extends between the guidewire lock assembly and the embolic filter assembly.

  In one embodiment of this mode, the dynamic motion coupler includes a spring that extends between the guide wire lock assembly and the embolic filter assembly. In another embodiment, the dynamic motion coupler includes a tether that extends between the guidewire lock assembly and the embolic filter assembly.

  According to another mode, the embolic filter assembly includes a filter support scaffold. The guide wire lock assembly, filter support scaffold, and dynamic motion coupler are monolithic and consist of a single unitary piece of material with a patterned shape. In a further embodiment of this mode, the filter member is coupled to the filter support scaffold. In another embodiment, the piece of material includes a cut tube made of shape memory material.

  Another aspect of the invention is a method of filtering an embolus from a fluid at a location within a lumen within a patient's body. The method includes providing an adjustable embolic filter module comprising a guidewire lock assembly and an embolic filter assembly, advancing the guidewire to the position, and an adjustable in a first configuration on the guidewire Slidably engaging the embolic filter module, tracking the adjustable embolic filter module in the first configuration to the position through the guide wire, locking the guide wire lock assembly onto the guide wire The embolic filter module by substantially securing the adjustable embolic filter module to the guidewire at the position and extending the embolic filter assembly radially to engage the vessel wall at the position. Adjusting from the first configuration to the second configuration; and Embolic filter module, while in the second configuration in the position, comprising adding at least one force of the guidewire lock assembly and embolic filter assembly. In addition, the applied force allows limited relative motion between the guidewire locking assembly locked onto the guidewire and the radially inflated embolic filter assembly engaged to the lumen wall.

  According to one mode of this aspect, limited relative motion is provided by a dynamic motion coupler that extends between the guidewire lock assembly and the filter assembly. According to one embodiment, the dynamic motion coupler includes a tether between the guidewire lock assembly and the filter assembly. According to another embodiment, the dynamic motion coupler includes a spring.

  According to another mode, the applied force is transmitted by the movement of the guide wire.

  In one embodiment of this mode, moving the guide wire includes moving the guide wire in the longitudinal direction at the location within the lumen. The applied force includes a force applied in the long axis direction, and the limited relative movement includes a relative movement in the long axis direction. In one additional feature, the longitudinal relative movement includes reducing the relative distance between the lock assembly and the filter assembly. In another additional feature, the longitudinal relative movement includes increasing the distance between the lock assembly and the filter assembly.

  According to another embodiment, moving the guide wire includes rotating the guide wire, the applied force includes a rotational force, and the limited relative motion includes rotational relative motion.

  Another aspect of the invention is a system for treating tight occlusion in a patient's blood vessels and filtering emboli from blood distal to the occlusion in the patient's body. The system includes a vascular occlusion crossing system, the vascular occlusion crossing system having a proximal end, a distal end, and an intermediate portion between the proximal and distal ends. A guide wire is provided and also includes at least one of an actuator or a sensor that cooperates with the distal end of the guide wire. If the delivery assembly is coupled to an adjustable embolic filter assembly, an adjustable embolic filter assembly is also included. The vaso-occlusive crossing system is adapted to advance the distal end of the guidewire across the blockage to a filtration location within the vessel, at least in part with the aid of an actuator or sensor. Yes. The delivery assembly is adapted to deliver the embolic filter assembly to a location along the distal end of the guidewire at the location described above. The adjustable embolic filter assembly in the position is locked onto the guide wire and released from the delivery assembly in a configuration adapted to filter the embolus from blood in the position. Both the adjustable embolic filter assembly and the guide wire are adapted to be withdrawn from the blood vessel through the capture sheath.

  Another aspect of the invention is a method of treating a patient suffering from a close occlusion within a body vessel while providing distal protection against blood emboli. The method comprises providing a vascular occlusion crossing system comprising a guide wire and at least one of an actuator or sensor cooperating with the guide wire, providing an adjustable embolic filter module, vascular occlusion crossing system at least in part In the blood vessel, with the help of an actuator or sensor, to advance across the dense occlusion to the above position, the adjustable embolic filter module is slid over the guide wire advanced to that position. Movably engaging, tracking the adjustable embolic filter module to the position on the guide wire, locking the adjustable embolic filter module on the guide wire at that position, locking on the guide wire Occluded from blood using an adjustable embolic filter module Filtering the containing and guide wire, and an adjustable embolic filter module that is locked on the guide wire, that withdrawing from the vessel through the capture sheath.

  Another aspect of the invention is a system for filtering emboli from a fluid at a location within a lumen within a patient's body as follows. The guide wire is provided with a proximal end and a distal end, and at least one of an actuator and a sensor is coupled to the guide wire. An adjustable embolic filter assembly is also provided in the system. A delivery assembly is coupled to the adjustable embolic filter assembly. The distal end of the guidewire is configured to be placed across the position, with the proximal end extending outside the patient's body. The delivery assembly is configured to deliver the embolic filter assembly along the distal end of the guidewire at the above location to a location through the guidewire. The embolic filter assembly can be released from the delivery assembly at the location of the location such that the delivery assembly is withdrawn from the patient independently of the embolic filter assembly. When the embolic filter assembly is released from the delivery assembly at the location, the embolic filter assembly can be withdrawn from the location by proximally withdrawing the guide wire from the location into the capture sheath. Cooperate with guide wire.

  Another aspect of the invention is a method of filtering an embolus from a fluid at a location within a lumen within a patient. The method of this aspect includes providing a guide wire, coupling at least one of an actuator or a sensor to the guide wire, providing an adjustable embolic filter module, vascular occlusion crossing system, at least partially actuator or With the help of a sensor, in a blood vessel, across a tight occlusion and advanced to the above position, the adjustable embolic filter module is slidably engaged on a guide wire advanced to that position. Matching, tracking the adjustable embolic filter module through the guidewire to the above position, locking the adjustable embolic filter module on the guidewire in that position, adjustable adjustable on the guidewire An embolus filter module to filter emboli from blood Including the, and a guide wire, and an adjustable embolic filter module that is locked on the guide wire, that withdrawing from the vessel through the capture sheath.

  Another aspect of the invention is a system for filtering emboli from a fluid at a location within a lumen within a patient's body. The system includes an embolic filter module comprising a guide wire having a proximal end, a distal end having an enlarged distal tip, a guide wire lock assembly, and a filter assembly. And an embolic filter module that is delivered through the guidewire to a proximal location and is adapted to be locked onto the guidewire in the above position via a guidewire lock assembly.

  Another aspect of the present invention is a system for filtering emboli from a fluid at a location within a lumen within a patient, the system comprising a proximal end and a distal end having a distal tip. A guide wire having a guide wire, an embolic filter module, and capable of being delivered through the guide wire to a location along the guide wire proximal to the dilating distal tip and in a coupled relationship with the guide wire An embolic filter module adapted to be released from the delivery assembly at said location. At least one of the actuator or the sensor is coupled to the guide wire. At least one of the actuator or sensor is configured to actuate or sense at least one characteristic associated with the guidewire and other characteristics related to the coupling relationship between the guidewire and the filter module.

  In connection with previous aspects of providing several types of guidewires in combination with a filter assembly, various additional modes are possible as follows.

  In one mode, an actuator is mechanically coupled to the guidewire to actuate the guidewire.

  In one embodiment, the actuator includes a mechanical rotation assembly that mechanically rotates the guidewire.

  In another embodiment, the actuator includes a mechanical translational assembly that moves the guidewire along the longitudinal axis.

  In another embodiment, the actuator includes a vibration source that vibrates the guidewire.

  According to another mode, the actuator is electrically coupled to the guide wire.

  According to another mode, the actuator is configured to adjust the shape of the guide wire in the body.

  According to another mode, the sensor is configured to be configured to visualize or sense a property of at least one tissue structure in a region proximate to the guidewire when the guidewire is disposed within the lumen. Is coupled to the guide wire.

  Another aspect of the invention is an adjustable embolic filter system. The system includes a tubular body having a tubular wall defining an internal guidewire lumen, and a filter assembly coupled to the tubular wall and adjustable between a radially contracted configuration and a radially expanded configuration. Is provided. An implanted lumen having a mouth, which is in communication with the internal guidewire lumen through the mouth, is disposed in the tubular wall.

  According to one mode of this aspect, an injectable material delivery system is coupled to the implantable lumen and configured to inject the injectable material through the mouth and into the internal guidewire lumen.

  In one embodiment, the injectable material is configured to be injected by the delivery system into the implantable lumen and through the mouth into the internal guidewire lumen. An infusion adhesive material is configured for the guidewire lumen and the guidewire within the guidewire lumen to secure the tubular body to the guidewire.

  In another embodiment, an injection needle is provided having a proximal end configured to be coupled to a source of injectable material and a distal end having a thread. The implantable lumen has a second thread. The injection needle is configured to be detachably coupled to the implantable lumen by threading the first threaded portion and the second threaded portion. According to one further feature, the needle has at least two lumens extending into the distal end from the proximal coupler along the proximal end. In another further feature, the needle has a mixing chamber along the distal end in which at least two lumens communicate. In another additional feature, an injectable multi-part adhesive material is provided comprising a first component precursor material and a second component precursor material. Here, the first component precursor material and the second component precursor material polymerize or cure when mixed.

  According to another mode, a delivery assembly is provided that includes a delivery member consisting of an elongated tubular body having a delivery lumen. The delivery member is configured to couple the injection needle to the implantable lumen via the delivery lumen. In one embodiment, the delivery assembly further comprises an outer cut member having a tubular wall defining an inner capture lumen, and the filter assembly is configured to be disposed within the inner capture lumen in a radially contracted configuration. And is releasable from the internal capture lumen and automatically expands into a radially expanded configuration by the recovery force of the material to the memory shape.

  According to various system aspects described herein, it is understood that in further modes, at least one of the following additional components or devices is further provided as the following additional modes: I want. Additional components or devices are guidewires, atherectomy devices, balloon catheters, stents, delivery catheters, introducer sheaths.

  The various aspects, modes, embodiments, variations and features described above should not be limited by others, but should be considered independently advantageous. However, further combinations and subcombinations as may be apparent to those skilled in the art are also contemplated as further aspects below. Other advantageous aspects, modes, and embodiments will be well understood by those of ordinary skill in the art based on a further review of the following disclosure, the appended claims, and the accompanying drawings.

  The invention will be more fully understood with reference to the accompanying drawings. The accompanying drawings variously demonstrate some highly advantageous embodiments of the present invention that are considered independent of value, and these are also provided for illustration regarding the broad aspects of the present invention. It is not necessarily intended to limit these broad aspects except as indicated as such.

  Referring to the drawings in more detail, FIGS. 1A-19B variously provide some details of various advantageous embodiments illustrating one or more aspects and modes contemplated herein. . Although each is considered to be advantageous independently, additional combinations and subcombinations of the drawings are also conceivable.

  It will be appreciated that according to various embodiments of the present invention, an embolic filter system is provided that includes a via-wire filter assembly coupled to a delivery assembly. The filter assembly has a guidewire tracking assembly that is adapted to slidably engage a guidewire that is initially positioned across the vessel occlusion and is disposed distally. It is advanced by the radially contracted delivery assembly to slide or “reciprocate” over the guided guidewire and follow the guidewire past the vessel occlusion to the distal filtration position. The filter assembly is adjustable between an open position that allows the filter assembly to reciprocate over the guide wire and a locked position that locks the filter assembly onto the body guide wire in a distal position past the vessel occlusion An adjustable lock assembly. When locked on the guidewire, the filter can be adjusted to a radially expanded state and can be removed from the delivery assembly, and thus becomes part of the guidewire in the body at a distal location. Thereafter, the filter assembly is withdrawn along with the guidewire and groomed into a configuration for capture within the capture sheath.

  According to other aspects illustrated by the various embodiments below, the loop-shaped support member is housed within a circumferential passage formed within the filter member wall. The support member can be automatically adjusted from a radially contracted state substantially corresponding to the radially contracted configuration of the filter member wall to a radially expanded state corresponding to the radially expanded configuration of the filter member wall. The support member is a memory alloy, and is automatically adjusted to the radially expanded state by the material recovery from the deformed state of the material substantially corresponding to the radially contracted state to the memorized state. The support member is adjusted to a radially contracted state within radial constraints, such as within the delivery lumen of the delivery sheath or guide sheath.

  Accordingly, even more detailed embodiments are provided as follows, which provide further illustrations of the various aspects described above, along with other advantageous aspects as will be apparent to those skilled in the art from this disclosure. To do.

  1A-1D illustrate various modes of operation according to one embodiment that provides an embolic filter assembly 10 as follows.

  FIG. 1A shows the filter module 12 coupled to the actuator assembly 30 and separated from the guide wire 40. The filter module 12 includes a tubular support spine 14 having an internal lumen 16 on which an adjustable filter member 20 is coupled. The actuator assembly 30 includes an actuator 32 and a coupling member 36 that couples the actuator 32 to the filter module 12.

  FIG. 1B shows the filter module 12 slidably engaged with the distal end 42 of the guidewire 40 via the inner lumen 16 by a “backloading” technique initiated from the guidewire tip 44. Usually provided as a steering tip that is either preformed or moldable. Filter module 12 is actuated by actuator 32 and coupling member 36 at a desired position along guidewire distal end 42 and locked onto the guidewire. When the filter module 12 is locked onto the guide wire 40, the coupling member 36 is removed from the filter module 12, so that the filter module 12 and the guide wire 40 are integrated assembly as shown in FIG. 1C. ) As further shown in FIG. 1C, this integration occurs while the guidewire 40 is slidably engaged within the delivery lumen 56 of the delivery sheath 50 and at the distal end of the guidewire. 42 extends distally from the distal tip 54 of the delivery sheath distal end 52. However, the assembly of the filter module 12 and the guide wire 40 may be performed by other methods of operation, such as before the guide wire 40 is engaged with the interior of the delivery lumen 56.

  As shown in FIG. 1D, when the filter module 12 and the guidewire 40 are locked together, the filter module 12 is on the longitudinal axis L of the delivery sheath 50 so as to be located within the delivery lumen 56. As a result, the adjustable filter member 20 is contracted from the radially expanded state shown in FIGS. 1A to 1C to the radially restricted state shown in FIG. 1D. FIG. 1D shows certain additional details of one embodiment relating to the filter member 20 for further illustration, showing the contracted configuration of the proximal support member 24 and the folded filter wall 22. Yes. The proximal support member is made of a superelastic alloy material having a memory shape that further corresponds to a radially expanded configuration corresponding to the expanded state of the filter member 20 shown in FIGS. 1A-1C, such as, for example, a nickel titanium material. It is a ring-shaped support member. The filter wall 22 is, for example, a porous thin plate material or other filter membrane or filter structure. Further aspects of each of these components are described in further detail by reference to the following other exemplary embodiments.

  Thus, the embodiment illustrated by FIGS. 1A-1D may be positioned along its length of the guidewire along the guidewire, for example with respect to other structures such as the distal guidewire tip 44. It will be appreciated that it provides the advantageous ability to customize the position of the filter assembly. This provides the ability to customize the filtration location for placing the guidewire tip 44 in the body as desired. In addition, the filter can be used with a wide variety of guidewires, such as harder, more flexible, different tip shapes, different diameter sizes, different materials, etc. Good. The physician need not use a specific guidewire with a filter. Thus, specific anatomical or procedural issues inherent in patient intervention can be addressed by the ability to customize the filtration device. In addition, this arrangement nevertheless allows the guidewire and filter assembly to be integrated outside the body prior to intervention, eg via some other “wire” tracking on the guidewire inside the body. Several other effects are achieved, including the potential to achieve a lower profile than filtration assemblies and techniques.

  2A and 2B show further details of a filter module 60 according to a more specific embodiment as follows, after locking and removing on the guide wire 40, the delivery tube of the delivery sheath 50 The state before the radial restriction to the inside of the cavity 56 (FIG. 2A) and the state after (FIG. 2B) are shown.

  Specifically, FIG. 2A shows the filter member 61 in a radially expanded state outside the sheath 50. A distally tapered circumferential wall 63 locks onto the open proximal end 62 supported by a ring-shaped or “loop” -shaped support member 64 and the wire 40 inside the internal lumen 72. Extending between a distal end 66 secured on a tubular support spine 70 that is secured. Thus, in the radially expanded configuration shown in FIG. 2A extending distally from the delivery sheath 50, the filter member 61 provides a pocket 65 that is open along the proximal end 62 and closed at the distal end 66. . The wall 63 passes through the wall 63 for normal physiologic blood components that flow into the pocket 65, while depleted tissue exceeds a predetermined dimension, such as by upstream (eg, proximal to the module 60) intervention. The piece is substantially porous so that it does not pass through the wall and is trapped inside the pocket 65.

  FIG. 2B illustrates the engagement of the module 60 within the delivery lumen 56 of the delivery sheath 50 with several debris trapped inside the filter member 61 after the filtration operation. As shown in one particular exemplary mode, such a depleted tissue piece may increase the profile with respect to the contracted state of the filter module 60, and thus the filter module 60 may be configured with a radial restriction tube of the sheath 50. In some cases, the cavity 56 can only be partially engaged. However, in such situations, the filter module can also be removed from the body as a system while properly filtering, capturing and extracting the debris pieces.

  2B shows in more detail the relationship between the proximal support member 64 and its radially contracted state when the module 60 is configured to be radially contracted within the delivery lumen 56 of the sheath 50. Yes. The sheath 50 is basically a ring-shaped or “loop” -shaped support member 64 arranged in a relatively linear direction along the longitudinal axis L, otherwise the open ring is radially contracted and radially contracted. To. This orientation provides enough real estate within the delivery lumen 56 to accommodate the contracted support member 64. In order to accommodate the smooth relative advancement of the sheath 50 beyond the ring shape during the process of aligning the radial engagement within the lumen 56, the support member 64 is slightly inclined in the radially expanded state outside the sheath 50. May be provided in any orientation.

  Although certain advantageous modes presented herein are described below for purposes of illustration (not shown), in a wide variety of modes that will be apparent to those skilled in the art, the support member 64 may include the filter member 61. It can be joined to the annular end of the material sheet to be formed. Annular end 62 flips or flips the end of the material sheet forming filter member 61, and then joins the flipped or flipped edge to the wall, for example by thermal bonding, material welding, solvent bonding, adhesive bonding, stitching, etc. A circumferential pouch formed by The loop-shaped support member 64 may be arranged to be captured inside the pouch as it is, or leave or form a non-bonded part such as a hole or a mouth to the pouch, etc. May later be inserted into the inside of the pouch.

  All this can be achieved, for example, by forming the member initially as a flat sheet and providing the support member 64 as a partial loop-shaped region between the free ends of two opposing wires. With such an arrangement, the inverted or flipped pouch leaves two opposing openings along the axis at the edge of the sheet transverse to the long axis of the sheet. One of the opposing upper free ends of the wire is inserted into the pouch and strung therethrough until the partial loop-shaped region is placed inside the pouch. The opposing free ends may be joined together by joining them together, or joined to the support spine or support tube 70. In this arrangement, such a free end may be oriented in a bending direction transverse to the plane of curvature radius of the intermediate loop arranged inside the pouch. In either case, the opposing long axis direction edges of the thin plate may be combined into one part to form a tubular member, and the opposing long axis direction edges may be joined together or joined to the spine 70. The filter module 60 may be formed. Of course, in this arrangement, the lamella may be post-processed or cut along a predetermined correlation pattern so that it is closed and secured to the guide wire tracking and support spine 70. A shaped taper towards the end 66 is formed.

  The radially contracted state of the support member 64 corresponds to the radially contracted configuration of the entire filter assembly or module 60, which further includes the folding orientation of the filter member 61. The radially expanded state of the support member 64 corresponds to the radially contracted configuration of the filter assembly module 60, which extends across a substantial cross-section of each lumen in which the filter member 61 is disposed. The directionality of the filter member 61 is included. In the particularly advantageous embodiment shown, the support member 64 is substantially shaped, for example, an alloy such as a nickel titanium alloy that exhibits a superelastic shape memory when the shape memory under thermal changes or changes in conditions for its components. A material having a member. For example, the radially contracted state corresponds to the deformed state of the material from the memory state. The support member 64 is kept in a deformed state inside the radially restricting lumen 56 of the sheath 50. From there, distal advancement pulls out the radial limiting force, so that the material recovery to the memorized state automatically adjusts the support member 64 to the radially expanded or expanded state. Such memory state and associated memory shape may correspond to the shape shown for the radially expanded state, or may be slightly different from that, even in the radially expanded state, the support member 64 There are still some constraints or deformations from it. For example, the vessel wall itself may impose such constraints, and in fact, planes that are angled transversely to the longitudinal axis of the lumen to spread across the cross-section of the lumen of different diameters. Because the shape above may change the radially expanded state of the support member 64 under outer wall constraints, such constraints can allow a range of lumens to be properly treated. There is also.

  The particular shape and arrangement of the filter member 61 of FIGS. 2A and 2B is for illustration, and various other embodiments or variations are contemplated.

  For example, FIGS. 3A and 3B illustrate a particular arrangement that is modified from the embodiment of FIGS. 2A and 2B as follows. The filter module 80 is shown already locked and removed on the guidewire 40 and includes a filter member 81 secured to a tubular support spine 90 that is locked onto the guidewire 40 through an internal lumen 92. . Filter member 81 has a circle extending between a proximal end 82 coupled to ring-shaped proximal support member 84 and a distal end 86 coupled to second ring-shaped distal support member 88. A circumferential filter wall 81 is included. A further filter wall 87 is provided that extends across the circumferential boundary of the distal support member 88 at the distal end 86. According to this arrangement, the radially expanded state or the radially expanded state of the proximal support member 84 and the distal support member 88 corresponds to the radially expanded configuration of the filter member 81. In this state, the filter wall 83 extends along the blood vessel wall, while the filter wall 87 extends substantially over the entire blood vessel. Thus, a pocket 85 is formed with the filter wall 87 as the distal end, which pocket 85 acts as a “catch” or backstop that captures and prevents passage of a sufficiently sized debris.

  These various support rings can also be provided in a similar manner as described above with reference to FIGS. Furthermore, as shown by the relative comparison of FIGS. 3A and 3B, the operational relationship and mode between the radially contracted state and the radially expanded state can be realized and verified in a similar manner.

  While the dual support member embodiments just described are illustrative of the many different structures that can be provided, it is sufficient that such specific embodiments also provide some specific advantageous results. Will be understood. In a sense, by doubling the radially inflatable support ring, the filter assembly properly engages the individual lumen wall and thus captures any desired large reduced tissue piece passing therethrough. The chance to do is doubled. If only one such structure is provided to engage the wall, the dimensions may not be optimal. However, because the blood vessels are tapered, in certain situations it may be beneficial to have two separate filters. Further, although the filters are shown in the same size in FIG. 3A, they can be of different sizes or shapes, for example by providing a distal support 88 that has a smaller circumference than the proximal support 84 as described above. Such a distally tapered lumen can be accommodated.

  Various adjustable locking systems and methods are contemplated to provide the ability to lock an adjustable filter assembly in a selected position along a guidewire, and in particular for coupling within the body.

  One specific example is shown in FIG. 4A as follows. The system 100 is shown to include a filter assembly or module 110 that includes a filter member 111 engaged with a guidewire tracking member as a support spine 120 for the filter member 111. The support spine 120 moves over the guidewire through a guidewire lumen 125 that extends between the opposing guidewire ports at the proximal and distal ends 122,126. The support spine 120 is formed as a composite tubular member with a coiled or reticulated filament support 123 embedded in or laminated onto a polymer or other substrate 121. Filter member 111 is shown in a radially expanded configuration, with a distally reducing tapered funnel-shaped wall 113 having a larger diameter open end 112 and a support spine at distal end 126. Extending between a closed distal end 116 secured on 120.

  The adjustable lock assembly 130 includes a power source 132 that is coupled to the filament support wire 123 by a coupling joint 138 at the proximal end 122. In the present embodiment, the wire 123 is made of a shape memory alloy exposed in the lumen 125 and / or at one end or both ends 122 and 126, and is a conductor. The power source 132 is also coupled to a second electrical lead 133 that is adapted to couple to the body. In this configuration, a bipolar plate system is formed so that, by activating the power supply 132, current flows through a conductive path disposed between the wire filament 123 and the electrode 133. For example, in the electrolytic bath or in a particularly advantageous example, the lead electrode 133, for example a patch electrode placed along the patient's back or other surface, and the guide wire 40 at the desired filtration location in the body. Such a flow of current can also be caused by using the patient as a conductor with the wire filament 123 disposed along with the module 110. By allowing such current flow, the wire filament 123 is heated, resulting in shape memory characteristics, and in this configuration, an inner diameter id smaller than the inner diameter ID shown in the radially expanded state of FIG. 4A. (FIG. 4B) can be restored to the memory shape.

  The resulting locked state of the adjustable lock assembly is shown in FIG. 4B, where the inner diameter id contracts in response to the radially contracted state and contracts due to the radial force on the guidewire 40 to lock the components together. A member 120 is shown. In order to achieve this reconfiguration in heat shrink mode, the remaining features of the composite tubular member 120, in particular the substrate 121 in which the wire filament 123 is embedded, must be restored with the material recovery of the filament 123. It will be appreciated that this must be done. Thus, such a substrate can be, for example, an elastomer that is itself in a deformed state in the radially expanded configuration of member 120 shown in FIG. 4A. Therefore, the material recovery of the filament 123 to the contracted state shown in FIG. 2B also corresponds to the material recovery of the base material 121. In this particular arrangement, the radially expanded filament 123 shown in FIG. 4A generally has a mating matrix 121 until the composite member is adjusted to the radially contracted configuration shown in FIG. 4B. Has a sufficient radial strength to keep it in an elastically deformed state.

  As shown also in FIG. 4B, the conductor 120 combined with the wire filament 123 and the power supply 132 is no longer required or desired for the wire 40 and module 110 to operate as an integrated assembly, so the member 120 Removed from. Such removal can also be accomplished by utilizing electrolytic removal, such as by providing an electrolytic joint in joint 138. For example, for use in a Guglielmi Detachable Coils (“GDC”) to deliver and remove an embolic coil for the purpose of treating a neuroaneurysm, the electrolytic coupling and associated electrolytic removal mechanism is described above. It can also be arranged in the same mode. These prior art disclosures may be suitably applied to this new application, or will be described herein or readily apparent from the description and illustrated embodiments of the present invention based upon a review of the present disclosure. Those skilled in the art may make appropriate changes within a range that does not impair the consistency with the desired purpose and result.

  In addition, multiple conductor leads 136 can be used, which are actuated simultaneously to heat the filament 123, but are individually coupled to the filament 123 by individual sacrificial electrolytic joints. It will be fully understood that Following the joint actuation of the leads to lock the member 120 on the wire 40 and the associated heat shrinking action, the individual leads can also be excited by a higher current that exceeds the threshold at which the sacrificial joint dissolves by electrolysis. As a result, the array is removed from the filament 123. This allows low individual currents along each conductor lead that may be below the electrolytic threshold in any sacrificial joint to obtain a total current sufficient to heat shrink the coiled or mesh filament conductor 123. It is then possible to combine higher currents at each joint that exceeds the threshold for melting each joint.

  Other adjustable locking mechanisms are conceivable.

  For example, FIG. 5A and FIG. 5B are related to the radial expansion configuration in which the inner diameter ID is larger than the outer diameter OD of the guide wire 40 as shown in FIG. 5A and the outer diameter OD of the guide wire 40 as shown in FIG. Two modes of operation of the filter assembly 150 having a guidewire tracking support spine 160 with the illustrated adjustable locking mechanism that is adjusted between a radially contracted configuration with a retracted inner diameter id sufficient to match are shown. Is.

  In particular, separate adjustable diameter cuffs 164, 168 are located at opposite ends 162, 166 of guidewire tracking support spine 160. Distal cuff 168 is disposed distally with respect to the distal attachment of filter member 151 onto support spine 160. In this arrangement, the tubular wall 161 of the support spine 160 is deflated by the distal cuff 168, but need not be deflated where the filter member 151 is secured to the tubular wall 161. Therefore, all that is required of the tubular wall 161 is to provide the necessary flexibility for changing the diameter between the radially contracted configuration and the radially expanded configuration in the isolated region. There, the filter member 151 may be made of a material that is unsuitable for “shrinking” to a smaller diameter, such as a preformed diameter that is non-rubber elastic. Thus, it is also conceivable that the tubular member 161 has a structure at the middle portion, for example, another adjustable structure that is more rubber-elastic at the end where the cuffs 164, 168 are located. It has been. In any case, these areas of the tubular member 161 corresponding to the cuffs 164, 168 are kept in an elastically expanded state, for example, by bonding with the expansion cuffs 164, 168, for example, by adhesive bonding or other modes of fixed engagement. You can also. Accordingly, such a region is restored to a radially contracted configuration by rubber elasticity under the radial recovery force of the cuffs 164, 168 to a radially contracted state having an inner diameter id that matches the outer diameter OD of the guidewire 40. You can also

  The cuffs 164, 168 may be made of a shape memory material, such as a nickel titanium alloy or other shape memory alloy, and the local delivery energy provided by applied external energy or current flowing through the device, eg, for resistance heating , Or electrical coupling to a cuff as a conductive monopolar plate for a complete circuit including a patient, as described above, or light energy by a local emitter cooperating with, for example, a fiber optic coupling or assembly, or heating the cuff Therefore, it may be adjustable in response to temperature changes by an ultrasonic quartz crystal or other transducer arranged therefor. Alternatively, the cuffs 164, 168 can have a transition temperature that is lower than body temperature but higher than its storage temperature, such as room temperature (or can be refrigerated). In such a situation, raising the temperature above the critical transition temperature causes the cuffs 164, 168 to recover or “shrink” to the memory shape, which is the radially contracted state shown in FIG. 5B. In addition, the cuff may be rubber elastic, such as superelastic, and an internally adjustable sheath that allows recovery of the material to a memorized state that causes the cuff to contract on the guidewire when removed from the inner diameter ID. By such a mechanism, it is possible to keep the superelastic stretched state in the open configuration. The cuff may be solid or already disclosed for use with an adjustable diameter, for example with an interconnecting pattern of struts and interventional gaps, such as cut from a tube using laser or etching etc. It may have other shapes as well as various different types of stent designs.

  Other types of cuff embodiments are contemplated, as illustrated by way of example in FIGS. 6A and 6B. Here, the filter assembly module 180 includes a tubular support spine 190 having a tubular wall 191 that provides a guidewire tracking member with a guidewire lumen 195 adapted to track over the guidewire 40 in the illustrated radially expanded configuration. It is shown in partial cross-section with the filter member 181 to be joined. A proximal cuff 194 and a distal cuff 198 are disposed at each end 192, 196 of the support spine 190 and within the lumen 195 of the tubular wall 191, while the exterior thereof is illustrated in FIGS. This is the same as in the above-described embodiment of 5B. In situations where the tubular wall 191 whose ends are coupled to the cuffs 194, 198 can be kept in a rubber elastically expanded state with the radially expanded state of the cuffs 194, 198 as shown in FIG. Would be advantageous. By adjusting the cuff to the respective radially contracted state of the cuff shown in FIG. 6B, the outer tubular member 191 surrounding the cuff can be elastically recovered together with the cuff.

  The various separate cuff type embodiments described immediately above are considered to be very advantageous, but are exemplary and other configurations, shapes, sizes, positions, numbers, or individual arrangements of cuffs. Will be fully understood. For example, a single cuff may be sufficient in some arrangements because the cuff is for selectively locking the entire associated filter assembly onto the guidewire. This would simplify and reduce the cost of the entire arrangement, for example, requiring only one actuator or coupler to deliver energy transcutaneously to the cuff.

  Providing a selective lock assembly that provides a selective lock between the guidewire tracking filter assembly and the individually tracked guidewire can be considered broadly. Many types of selective locking can also be used. In fact, such a lock assembly does not necessarily have to be merged with the filter assembly itself, but instead may be a third assembly that cooperates with the guidewire and / or filter assembly, or provided by a specially designed guidewire. May be. However, providing a lock other than a guidewire may use a wide variety of guidewires, which can have a significant effect on the choice and technique of the physician performing the full customization or treatment.

  Nonetheless, as variously shown in FIGS. 7 and 8, the following embodiments provide further details of a system 200 that provides an adjustable locking mechanism for a dedicated guidewire 240 constructed according to the following description. provide.

  FIG. 7 illustrates a system 200 that includes a filter module 210 with a filter member 214 secured to a tubular support spine 212 that slidably engages a guidewire 240 as a guidewire tracking member. Guidewire 240 is formed from an inner tubular member 246 inside an outer coil 248 and is a molded distal tip 244 that extends from a body 242 having a mouth or hole 247 that leads to an interior space defined by a pressure-expandable outer cuff 250. The pressure-expandable external cuff 250 is fixed to the external coil 248 at one end of the hole 247. By coupling the external pressurizable fluid source 256 to a passage inside the tubular member 246, the external cuff 250 expands radially through the hole 247 under pressure, as shown by the dashed line at the expansion cuff 251. Sized enough to radially engage the inner surface of the tubular support spine 212, thereby locking the guidewire 240 with the filter assembly 210 in a friction fit under the normal force of the expansion cuff 250. .

  Various structural modes can also provide such a lock on a suitable guidewire to achieve the purpose of locking the filter assembly inside the guidewire tracking member. Further details of one construction of a core member suitable for use with the embodiment shown in FIG. 7 are shown in FIG. Tubular member 246 provides a proximal underlying guidewire chassis, for example, manufactured as a metal hypotube, such as stainless steel, nickel titanium alloy, etc., or generally for guidewires. It can also be made from other suitable materials (e.g., high density polyethylene, or polyamide, or a composite) to provide sufficient stiffness for torque and pushability requirements as understood. The tubular member 246 is secured to the distal core member 243 by tapering the proximal end 245 of the core member 243 for fitting into the bore or mouth 241 at the distal end of the tubular member 246. Thereafter, the tubular member 246 and the core member 243 are fixed in coaxial engagement, for example, by welding, soldering or using an adhesive. The tubular member 246 and the core member 243 may be made of the same material, or may be made of different materials, for example, one is stainless steel and the other is nickel titanium. In the case of different materials, depending on the fixing means chosen, such as for example certain adhesives or solders (generally welding does not work, but this is a further possible mode, Of course, customization for these different metals may be required. Tip 244 typically includes a moldable member therein, such as a flat ribbon or flat portion of distal core 243, for example, an external coil in that region, such as a platinum, tungsten or gold coil. The 248 is typically radiopaque for fluoroscopy with an atraumatic distal tip such as a smooth ball solder or weld cap.

  Another embodiment shown in FIGS. 9A-9C has a diameter relative to the guidewire 40 from a first position (FIG. 9A) that is radially expanded relative to the guidewire 40 as follows. A tubular spine member 210 that includes a tubular wall 211 that includes an adjustable lock along its inner diameter in the form of another inflatable membrane that is adjusted to a second position (FIGS. 9B, 9C) that is deflated in a direction. A filter assembly 200 is provided that includes a filter member 201 secured thereto. The inner liner 213 is laminated or otherwise tubular such that it provides a baffle, non-laminated pouch or reservoir 218 that is coupled to the platypus valve 220 along the end 216 of the tubular member 210. Coupled to wall 211. Actuator assembly 230 includes a releasably engaged inflation member 236 shown in FIG. 9B that is inserted inside platypus valve 220 and coupled to a source of pressurizable fluid 232 outside the patient's body. In this arrangement, pressurizing the reservoir 218 causes the reservoir wall to expand toward the interior of the tubular wall 211, resulting in a contraction of the effective inner diameter for locking onto the guidewire 40. Thereafter, the expansion member 236 is withdrawn when the platypus valve 220 shuts off the permanent pressure generated within the reservoir 218 and permanently locks the assembly onto the guidewire 40 for integral operation.

  It will be appreciated by those skilled in the art that the particular arrangement shown is exemplary and modifications may be made to suit a particular purpose without departing from the intended scope of the invention. Let ’s go. For example, the platypus valve 220 can be moved to the opposite side of the tubular spine 210 to make the relative orientation relative to the orientation of the filter member 201 upon coupling to the actuator assembly 230 different. As will be apparent to those skilled in the art, this can be modified such that the proximal end 212 is located downstream of the inflow path to the filter member 201, eg, for antegrade delivery.

  Further aspects of the present disclosure are shown in FIGS. 10A-10D. The aspect provides a filter system 250 that incorporates a movable cuff 280 that is used to adjust the filter member 280 between a radially contracted configuration and a radially expanded configuration, respectively. A "rapid exchange" type system, further illustrated by these and other features as follows.

  Filter assembly 250 includes a filter member 288 secured to support spine 260. Filter member 288 includes a thin plate or membrane similar in shape to the preceding tapered embodiment, one with an open end and the other with a closed end, but as shown by the dashed line in FIG. 10B, A plurality of circumferentially spaced splines 288 having shape memory in a radially expanded state corresponding to a radially expanded configuration. However, as shown in FIGS. 10A and 10B, the filter member 280 is elastically deformed in a radially contracted state corresponding to the radially contracted configuration of the filter member 280 when engaged with the movable cuff 270. Is held together with a spline 288.

  As further shown in FIG. 10A, the support member 260 includes a plurality of lumens that are various coupling members having various functions and arrangements as follows. Lumen 268 has a longitudinal spline 272 with a distal end coupled to an adjustable cuff 270, the proximal end (not shown) of which can be either manual or It extends outside the body for remote control by an actuator. Another guidewire lumen is located between the proximal port 262 and the distal port 264, both located at the distal ends of the respective proximal and distal support members 260 of the filter member 280. It extends. This provides a “rapid exchange” or “monorail” type of engagement on the guidewire 254 so that the proximal end of the guidewire 254 is “backloaded” through the distal port 264 and the proximal guide The wire mouth 262 can also exit, while the distal end of the guide wire 254 is located at or beyond the desired filter location in the body.

  The proximal portion of member 260 has another lumen and extends proximally from the external proximal port 262 for remote control, and advances filter member 280 through guidewire 254 to the desired filter position. An array of distal ports 266 is circumferentially spaced around support member 260 and extends distally therefrom to the proximal end of extracorporeal member 260. A plurality of tethers 276 that extend circumferentially around the filter member 280 extend through the distal port 266, as shown in FIG. To control re-contraction of the filter member 280 as described in more detail below, the tether 276 extends proximally along the member 260 from the distal port 266, passes through a plurality of lumens, and is remote from the body. The proximal position for operation has been reached.

  As shown in FIG. 10B, the filter member 280 can be adjusted from the contracted configuration having the contracted outer diameter od to the expanded outer diameter OD. This is accomplished by proximal removal of the longitudinal spline 272 that proximally removes the cuff 270 from the filter member 280, thereby releasing the filter member 280 from radial restriction and supporting spline 288 into an expanded state. Memory recovery becomes possible. This detail is shown in FIG. 10C. In this expanded configuration, the filter member 280 is adapted to extend across a substantial cross-section of the body lumen to which it is delivered, allowing components exceeding a predetermined size, such as depleted tissue fragments from upstream intervention, to flow. It is manufactured to have a porosity such that it can be filtered from. Accordingly, the filter member 280 can also reconfigure its shape under a number of such destructive tissue pieces, as indicated by the dashed lines in FIG. 10C.

  As further shown in FIG. 10C, the tether 276 is stretched between the proximal open end in the expanded configuration of the filter member 280 in the expanded configuration and the distal port 266. After the internal filtration operation, the assembly 280 is removed in a state in which the contents are captured. According to this embodiment, this is accomplished by withdrawing the tether 276 from the circumferential port 266, thereby pulling the proximal open end of the filter member 280 down onto the support member 260. In addition, as shown in FIG. 10D, inclusions may leave a bulging drawn down condition in the filter member 280, which may or may not be compatible with the individual delivery sheath or introducer sheath. . If so, the system 250 is removed from the body through the sheath. If not, the system 250 is extracted with the individual sheath.

  It will be appreciated that several advantages are obtained by the above embodiments of FIGS. 10A-10D as compared to some other embodiments. One point replaces the adjustable delivery sheath 50 of the previous embodiment, which may extend proximally over almost all of the delivery member components of the individual filter assembly and even through the vascular introduction site. Thus, a relatively short cuff 270 can be used. This lowers the profile of the entire system. Another point is that the rapid exchange feature allows the guidewire to be proximally positioned for balloon angioplasty, stent treatment, or advancement to other catheter intervention sites such as atherectomy devices or thrombectomy devices. The great advantage is that the filter assembly is advanced distally relative to the intervention site while allowing the rail to be provided freely. Another additional point is that the retractable tether provides the desired mode for securely capturing the debris-containing filter member on the individual support members and lowering the profile for efficient removal. To help.

  Accordingly, the features described above are considered to be a broad and independently advantageous aspect described by the embodiments of the present invention and may be considered to have independent value in addition to its various combinations and subcombinations. it can.

  The “rapid change” feature can be incorporated into a lockable filter assembly similar to embodiments of the present invention, whether or not illustrated, once one skilled in the art has fully reviewed this disclosure. One highly advantageous example is provided by reference to FIGS. 11A-11C as follows.

  FIG. 11A illustrates a filter system 300 that includes a filter assembly 320 that cooperates with a delivery member 350 and a guidewire 340. Delivery member 350 includes a proximal shaft portion 351 and a distal shaft portion 355. Proximal shaft portion 351 further provides a tubular wall around lumen 353 extending along distal shaft portion 355. However, the distal shaft portion 355 forms a second lumen 356 that extends between the proximal port 358 and the distal port 359, both extending along the distal end of the member 350, respectively. A wall 352 is further included. Thus, lumen 356 is a guidewire lumen that slidably engages guidewire 340 in a “rapid exchange” or “monorail” fashion.

  The filter assembly 320 is shown in FIG. 11A and FIG. 11B in a radially contracted configuration housed within the lumen 356 and is engaged therein by a friction fit and is disposed within the lumen 353, It is held in place by a coupler 364 that is coupled to the filter assembly 320 through a mouth 354 between the cavities 353 and 356. Although the filter assembly 320 can be many different shapes, in the particular embodiment shown, for purposes of illustration, it will be similar to the embodiment shown and described with reference to FIGS. 1A-2B. Yes. For clarity, the filter is described by reference to applicable combinations with features that are not shown in detail herein but that are apparent in other figures shown and described herein. The assembly 320 includes a guidewire lumen that is coupled to the filter member through a support spine, and such guidewire lumen is also coaxially engaged on the guidewire 340, as shown in FIGS. .

  Thus, by advancing the proximal end of delivery member 350 outside the body, lumen 356 and coaxial engagement guidewire lumen of filter assembly 320 are moved through the guidewire to the desired location within the body. Thereafter, the filter assembly 320 is adjusted to lock onto the guide wire 340, which adjustment may be due to the actuation of a locking mechanism, for example by applying energy through the coupler 364. Thereafter, the coupler 364 is removed from the filter assembly 320 that is integral with the guidewire 340 for operational purposes. This can also be done, for example, by electrolytic removal of the coupling joint 366 (FIG. 11A), according to one or more of the various mechanisms described herein in further examples. Thereafter, as shown in FIG. 11B, the distal end 365 of the coupler 364 is drawn through the port 354.

  As shown in FIG. 11C, the delivery member 350 can then be retracted proximally with respect to the guidewire 340 and the locked filter member 320, thereby removing the filter member 320 from the radial restriction and the filter. Allows member 320 to expand radially and to have the radially expanded configuration shown in FIG. 11C that is spread across the lumen to filter a predetermined size component of the fluid stream flowing through it. To do. At the end of the filtration operation, the cuff portion forming lumen 356 can be advanced again distally, the filter assembly 320 can be trimmed back and the contents contained therein can be captured for withdrawal (not shown). Alternatively, other mechanisms can be used to adjust the filter assembly 320 to return to a radially contracted state and / or to extract filtered contents.

  The present disclosure illustrates a relatively broadly contemplated aspect that can be achieved by many other modes without departing from the broadly intended scope of the various aspects that will become apparent to those skilled in the art. Nevertheless, it will be appreciated that the above embodiment of FIGS. 11A-11C is highly advantageous. For example, as shown in FIG. 12, the lumen 353 may terminate distally closer to the mouth 366. This results in a lower distal profile for the region of the entire assembly containing the filter member 320, and thus one difference between FIG. 11 and FIG. 12 is that the tube having conductor leads to the filter device lock cuff. Since the cavity terminates just distal from the joint, the profile of the radially restricted outer sheath area around the contained filter assembly is reduced. This provides substantial benefits for distal embolic filters used in methods and situations that require, for example, that the occlusion must first be traversed before being deployed for filtration.

  As also shown in FIG. 12 for further illustration, one or more markers 370 are provided on the delivery member 350 for the purpose of providing an indication regarding the relative position of the delivery member 350 with respect to the underlying filter member 320. You can also. The particular configuration shown for the filter member 320 is illustrative for purposes of clarity in the present embodiment, such as various other embodiments described herein as appropriate for those skilled in the art. Other types of filter members can also be used. Alternatively, other filter assemblies that are otherwise known, anticipated or proposed, or otherwise apparent to those skilled in the art, are appropriately modified or adapted to this embodiment. You can also.

  The “filter” assembly referred to herein with reference to the drawings has been modified by various novel aspects described herein by way of illustration through the present embodiment, but is already disclosed elsewhere. Various features and modes of operation and use of the filter assembly may be incorporated. Examples of such acceptable filter materials and designs are described in various documents incorporated herein by reference, in combination with other devices in all medical treatment systems, in addition to various modes of use. Is provided.

  In general, various mechanical, electromechanical, or optomechanical modes can be used to adjust the embolic filtration module and alternately slide or lock on the guidewire. Some of the drawings provided herein show a schematic of an external energy source, such as a power supply, coupled through a conductor to a portion of a filter device that acts as a plate. The electrode plate, in the illustrated monopolar embodiment, is coupled to the patch electrode plate through the patient's tissue to complete the circuit. A sufficient amplitude AC RF frequency will heat the plate in the filter device to raise the temperature and cause the shape memory member to contract on the guidewire. The shape memory member may be the same member that serves as a plate, such as a cuff, coil, or mesh that is coupled to a support tube to which the filter assembly is secured.

  For example, the conductors of various embodiments, such as the coupling member 36 shown in FIGS. 1A-1C, can be removed. This is because such components are not required after the individual filter modules are locked onto the wires. This is a sacrificial electrolysis between the wire and the adjustable member, for example in an arrangement similar to that already disclosed for a commercially available removable embolic coil, such as to occlude an AVM, fistula or aneurysm. It can also be done by using a link.

  For illustration of the electrically operated embodiment, unipolar embodiments are provided in various forms. However, even if not shown, these embodiments should be considered applicable as further illustrated embodiments. Furthermore, other embodiments are also contemplated. Bipolar arrangements or “closed loop” electrical circuits (eg, resistive heating) can be used to adjust the heating of the material and lock the filter device onto the guidewire. Other heating modes include ultrasonic, light, heat conduction, or other energy sources that are integrated with or coupled to the filter device itself. For example, an ultrasonic quartz crystal coupled to the inner diameter of the outer radial limiting sheath can be used (not shown) to sufficiently heat the adjustable member for locking. Alternatively, where electrical lead wire coupling is shown, light energy such as laser or UV is coupled to the adjustable member and the member is contracted or otherwise reshaped to provide the desired lock. An optical fiber can be used instead to make this possible.

  It will also be appreciated that the adjustable locking mechanism using heat-shrinkable materials and modes can also vary for a number of specific features. For example, FIGS. 4A and 4B illustrate adjustability along the entire length of the support tubular member for locking onto the guidewire, whereas FIGS. 5A-6B illustrate guides. Fig. 7 shows an alternative embodiment in which the radial adjustment function region for locking the wire is more localized. Furthermore, modes other than those shown in the embodiments are also available for adjusting the shape of various members, such as, for example, a coil or mesh torsion or longitudinal tension to adjust the inner or outer diameter. It can be used for locking, including for example radial or longitudinal mechanical forces. In a further mode not shown, a small amount of local adhesive, such as a two-part component that is mixed in the body or within an appropriate delivery time prior to “curing” for bonding. A lock can also be obtained by delivery. Alternatively, a portion of the plastic can be melted onto the guidewire (and vice versa) for coupling with individual filter members.

  In other respects, for example, the various embodiments in FIGS. 1A-6B show the external adjustment sheath as separate from the energy coupling system that provides the locking mechanism. However, these embodiments are separate parts of a collaborative control system that provide multiple functions to operate the filter device to provide medical care in combination with a guidewire and other intercooperative components. You can also think about it. As shown in FIGS. 10A-12, such a control system may also include a more integrated assembly of component parts.

  With reference to the present invention and various exemplary embodiments, an embolic filter device will be apparent to those skilled in the art, at least in part based on a review of the present disclosure, from various materials, and various dimensions. Can be manufactured. However, for purposes of illustration, in certain embodiments, the filter device will operate through guidewires having outer diameters of 0.010 ", 0.014", 0.018 ", and 0.035". It is thought that In addition, each has a filter assembly that is specifically adapted to be used through different sized guidewires or that is specifically adapted to filter blood flowing through various sized arteries. A kit of such a device can also be provided.

  Various references have been made herein to “intervention” or interventional devices for use with the filter system (s) shown and described herein. Many more detailed examples are applicable and are contemplated by those skilled in the art, examples include angioplasty, stent treatment and atherectomy devices, and methods of occlusion recanalization.

  For further illustration, in order to make the understanding more complete by referring to recanalization procedures in carotid artery occlusion, one mode using some of the embodiments of the embolic filtration system of the present invention is as follows: Explained.

  First, using conventional techniques, typically using femoral or radial artery access techniques with antegrade delivery to the occlusion site (often involving the use of a guide catheter and introducer sheath) A guide wire is placed over the carotid artery occlusion. For example, the Seldinger method can be used to provide such luminal access. The embolic filter system is then engaged onto the guidewire by “backloading” the guidewire through a guidewire lumen provided through the tubular support member of the embolic filter device. This is done by a radial limiting sheath placed above the embolic filter device to keep the embolic filter device in a radially contracted folded state. The embolic filter system is slidably advanced through the guidewire across the occlusion site until the embolic filter device reaches the desired distal position for filtration. Thereafter, the embolic filter system is activated for locking onto the wire at a distal location within the body. The assembly with the radial restricting sheath is then withdrawn proximally to release the filter assembly from restriction, and the shape memory of the assembly is sufficient to extend almost the entire artery at a distal location for filtration. An expansion configuration allows the assembly to expand. For locking purposes, the coupler or lead is removed prior to proximal removal where, for example, an electrical coupling lead leads to direct coupling to the embolic filter device. Various components of the control system can also be completely removed from the guidewire, after which the interventional device is placed instead and advanced to the occlusion site for recanalization.

  During the intervention, a filter is placed and inflated to filter emboli released into the downstream bloodstream. In addition, the filter can be left in place for a sufficient period of time after the intervention to capture the embolus.

  In any case, if appropriate for the treating physician, the filter assembly is adjusted back to a radially contracted state to capture emboli filtered from downstream blood flow. This can be done in the same way, for example, by advancing the radial restriction sheath again over the wire and over the filter, for example by the second use of the first control system or the use of a second outer sheath. . Alternatively, one or more puller wires can be used to pull down the support member (s) supporting the filter assembly in the expanded configuration. Depending on the amount of emboli captured, the entire deflated filter assembly may be too large to fit within the outer sheath, in which case the entire system must be removed from the body through the guidewire. Sometimes. Otherwise, the deflated filter can be removed through the outer sheath, or the filter and outer sheath can be removed simultaneously into the guide catheter guide lumen.

  In general, the various embodiments described above are all embolic filtration systems intended to be used in conjunction with other devices primarily to filter emboli from blood flowing downstream from the intervention site. It is intended for use in. For purposes of illustration, some mention will be made of particularly advantageous applications, but such specific applications are not intended to be limiting. For example, references to the embolic filter of the present invention are often specified as the most frequently used type of filtration in conventional interventions, for distal filtration downstream from the intervention site. However, according to various embodiments described herein, other filters can be made for all uses, including, for example, a proximal filter. In addition, areas of the body other than those specifically described herein are advantageous, such as other body lumens including, for example, veins, gastrointestinal lumens, urinary tract lumens, lymphatic vessels, hepatic ducts, pancreatic ducts, etc. It is also conceivable that it can be filtered. In addition, while many types of filters can be used, guidewire tracking or coupling of the filter to the lock chassis according to embodiments can be done by any conventional acceptable alternative mode. In addition, various locking mechanisms have been described in order to provide a detailed illustration of the acceptable modes of making and using the embodiments herein that are characterized in this disclosure. However, other lock modes may be used without departing from the scope contemplated herein.

  Where a “proximal” or “distal” relative arrangement of components, or modes of use, are described, other arrangements may be envisaged, although not shown. For example, where the various embodiments are suitable for antegrade use, these embodiments may be modified for retrograde delivery and use. In addition, the present invention provides proximal filtration, for example, by placing the filter device proximal to the occlusion and using retrograde flow applied to flush the embolus proximally into the filter. You can also

  Embodiments of the present invention are known in the art without departing from the scope of the various aspects that are intended to be construed as broadly as possible with respect to the intended purpose described herein. Various changes can be made to the extent that they provide unique benefits or aspects as compared to some. While there may be significant implications for some such specific changes or embodiments, many examples of such changes are provided for illustration and are not intended to be limiting. Absent. As described herein as certain structures, devices, systems and methods are highly advantageous for the primary purpose of providing an adjustable embolic filter, in vivo and in vivo applications in medicine and other fields Is considered. For example, it will become apparent that the various adjustable locking assemblies described above are extremely advantageous when used to lock other devices and assemblies onto guidewires or other internal structures. In another example, an embodiment showing a guidewire having an inflatable member used to lock the filter to the guidewire may be used for internal locking onto other external coaxial structures.

  Other applications may include an adjustable annular collar that is used to lock down a centrally located device that extends into the bore. Another additional application for further illustration is such adjustment for joining two adjacent workpieces, such as a medical application as a bone grafting tool for attaching two pieces of bone together. There is the use of possible locking members and associated assemblies.

  It will be appreciated that, despite the various specific advantages of the specific embodiments described elsewhere below, further aspects and highly advantageous adjustable embolic filter assemblies are also contemplated. Let ’s go. Some such additional aspects are described as follows.

  FIGS. 13A-13C show another highly advantageous structure having both an adjustable lock assembly and a filter support assembly formed from a single piece of material as an integrated support scaffold body structure as follows. Various views of various sequential steps for manufacturing the embolic filter module 400 are shown.

  FIG. 13A shows an elongate tubular body or tube 410 as the starting material, in particular a tube made of nickel titanium, for example. The tube 410 ultimately forms a guide wall lumen 414 extending between a tubular wall 412 having an outer diameter d1 and two guidewire through ports at each end 416, 418, respectively. And a through lumen 414.

  FIG. 13B shows the tube 410 after laser cutting patterned as follows. A first region of the tube 410 is cut into a first pattern that is adapted to function as an adjustable lock assembly 420. In the particular version shown schematically, the adjustable lock assembly 420 includes a tissue of interconnect struts 422 separated by a gap 424 left by a laser cut. These struts are adapted to flex from the memory state (and recover from the flexed state to the memory state), so that this patterned cut causes the tube in this region to become a guidewire lumen. 414 has an adjustable diameter throughout. The second region 430 is cut into a second pattern adapted to provide a filter support scaffold 430. This includes a plurality of longitudinal struts or splines 432 spaced about the outer periphery by longitudinal cuts or gaps 434. Additional structural considerations along with the relative function and purpose of the patterned tissue of these first regions 420 and second regions 430, and the corresponding nickel titanium struts 422, 432, are discussed in this book. Further details will be described elsewhere in the specification.

  It will be appreciated that the tube 410 in the first cut configuration shown in FIG. 13B has a diameter d1 in both regions 420, 430 along its length L1. Accordingly, the term “tubular” or “substantially tubular” as used and contemplated herein by one of ordinary skill in the art who has reviewed the present disclosure refers to an “enclosed” tubular shape such as that shown in FIG. 13A, for example. Or may have a groove in the wall or otherwise have a gap, for example as shown in FIG. 13B, through which the inner space and the outer It will be appreciated that spaces can be communicated. In any case, the structure is substantially such that the internal passageway can be defined along a length and in any case the passage is “surrounded” along the length. It is considered to be tubular.

  After the cutting operation and after each patterned region has been formed as shown schematically in FIG. 13B, each patterned region then changes the properties of the substance and thus the material (tubular starting material). Subject to nickel-titanium material processing techniques that shape to a new shape memory state (for memory). This shaping and the resulting geometry is hereinafter referred to as a “trained configuration”. A shaping configuration according to an embodiment of the present invention is shown in FIG. 13C and will be described in more detail below.

  FIG. 13C shows a recovery smaller than the outer diameter of the guide wire (as schematically shown in this view as guide wire 440) that is smaller than the initial tube diameter d1 and that allows the lock assembly 420 to be locked. The adjustable lock assembly 420 is shown in its shaped memorized state by memory at a recovery diameter d2. Due to the superelastic alloy mode of the nickel titanium alloy material used here, the tube recovered to this dimension d2 expands to a larger diameter and is shown in the radial direction as schematically shown by the diameter d3 with a dashed line in FIG. 13C. It can be opened and held by an internal member (not shown) that supports it. This forms an open or delivery configuration of the adjustable lock assembly 420.

  Thus, it is well understood that the adjustable lock assembly 420 is initially provided at d1, shaped to the contraction diameter d2, and subjected to an applied force to artificially flex to open the enlarged diameter d3. It will be. This radially outward deflection is achieved by an internal retaining member adapted to slidably track the lock assembly 420 released to the position where filtration is performed on the guide wire. When placed in this position, the internal retaining member is removed from the underside of the adjustable lock assembly, so that the adjustable lock assembly is released and lower back toward its stored state of diameter d2. Recover. However, because the adjustable lock assembly encounters a guide wire having an external dimension that is larger than the diameter d2, in this case it continues to push the material recovery strength against the wire. This is considered the locking configuration of the adjustable lock assembly 420.

  FIG. 13C also shows the filter support scaffold 430 in its shaped, restored storage state. Here, as a result of the initial length l1 of the region (FIG. 13B) being reduced to l2 (FIG. 13C), the major axis splines 432 are deflected radially outward. This forms a lantern-shaped pattern of splines that are curved and spaced around the circumference. This pattern forms a scaffold where the filter members 436 combine to form an adjustable filter assembly. Filter member 436 is shown in FIG. 13C as a porous membrane that can be selected from a number of acceptable materials as would be apparent to one of ordinary skill in the art based on a review of the present disclosure. In the recovered state and radially expanded configuration of the filter scaffold 430 shown in FIG. 13C, the spline 432 supports the filter member 436 so as to extend substantially to the diameter d4. The recovery diameter d4 is larger than the original diameter d1 of the tube region where the filter support assembly was formed (before shaping the material) and the diameter of the blood vessel on which filtration is performed (or slightly larger than the diameter of the blood vessel). It comes to be close to. Accordingly, the supported filter member 436 extends substantially across the cross section of the blood flow through each filtration region.

  As described above, the adjustable filter module according to the present embodiment is generally adjustable between the first configuration and the second configuration. In the first configuration, the adjustable lock assembly 420 is held open radially in each open configuration, and the adjustable filter assembly 430 is held in a radially contracted state. This combination of the configuration of each component part of the entire assembly allows the entire assembly to be slidably engaged with the guide wire 440 and tracked through the guide wire 440 to the desired filtration position. Thereafter, the adjustable lock assembly 420 is adjusted to a lock configuration having a retracted diameter and pressed onto the guidewire 440, and the adjustable filter assembly 430 is adjusted to a radially expanded configuration for efficient filtration. For this purpose, the filter member 436 is spread over substantially the entire blood vessel.

  The particular tube used to form this integrated support scaffold shown in FIGS. 13A-13C, and the associated shaping process, on the corresponding guidewire during final assembly while maintaining a low profile. Is based on the dimensions of the inner diameter of the first tube that has sufficient tolerance to track. Among other possible speculations, some annular cuff regions remain (eg, between the filter support scaffold and the lock assembly and distal to the filter support scaffold) and remain at their original dimensions. For example, a 0.016 "or 0.017" inner diameter tube is suitable for constructing an integrated support scaffold body as shown when used on a 0.014 "guidewire (and the figure). (Similar to the type selected for the physical embodiment shown in the diagrams of FIGS. 15A-16C.) However, selecting other sized tubes in response to changes in design and shaping methods For example, as long as all parts can be shaped or expanded to a larger size to accommodate the trackability on the guide wire intended for use, not much A tube of diameter d2 that is not allowed to recover may be used as the starting material.

  Although various embodiments of the present invention describe a superelastic shape made of nickel titanium used in an assembly, the shape memory state of the material is also used to achieve the overall broad purpose of the present embodiment. It is also possible to be able to. In addition, other materials other than nickel titanium, such as other superelastic alloys or other elastomeric materials, may be substituted in certain circumstances with the nickel titanium embodiments described in detail herein. Further, the particular design and arrangement shown and described are very advantageous, but other combinations may be made with other embodiments or otherwise without departing from the intended broad scope of the various aspects. Changes may be made.

  It will be appreciated that the above may be accomplished using various delivery assemblies. However, one particular advantageous delivery assembly 500 is described by way of example with reference to FIG. FIG. 14 illustrates an embolic filtration system including a delivery assembly 500, an adjustable filter module 550, and a guide wire 580, according to an embodiment of the present invention. Further details about these components, their respective interrelationships to the overall structure, and the resulting use of the filtration system are described as follows.

  Delivery assembly 500 includes an inner member 510 having a tubular wall 512 defining an inner lumen 511 and a distal end 514. The inner lumen 511 is fairly tight tolerant over the outer diameter of the underlying guidewire 580, but allows for an acceptable slidable engagement and tracking function. The delivery assembly 500 is a tubular wall having a proximal end 522 and a distal end 524 and an interior having a lumen 521 and an inner lumen 523 along the proximal end 522 and the distal end 524, respectively. Also included is an outer member 520 that defines a passage. This internal passage of the external member 520 is coaxially engaged on the internal member 510 along the internal lumen 521 and the internal lumen portion 523. Proximal end 522 and distal end 524 are coupled together at a joint 528 that also includes a circumferential band 526 disposed at the distal end of proximal end 522 and the proximal end of distal end 524. The distal end 524 is larger in diameter than the proximal end 522 and extends distally beyond the distal end 514 of the inner member 510.

  Similarly, as shown in FIG. 14, the adjustable filter module 550 has a structure similar to that described above with reference to FIG. 13C. Filter module 550 includes an adjustable lock assembly 560 having a plurality of cooperating nickel titanium struts in tissue having an adjustable diameter as described above. Filter module 550 also includes an adjustable filter assembly 570 having a support scaffold with a plurality of splines 572 similar to that described in FIG. 13C. A porous filter membrane 574 supported by splines 572 is also included.

  The interaction between the inner member 510 and the outer member 520 of the delivery assembly 500, ie, the adjustable lock assembly 560 and the adjustable filter assembly 570 of the adjustable filter module 550, and the guide wire 580 will be described below. This will be described in more detail as follows.

  The distal end 514 of the inner member 510 extends distally beyond the joint 528 of the outer member 520 and provides radial internal support. The internal support holds the struts 562 made of superelastic nickel titanium of the lock assembly 560 radially open in a flexed state corresponding to the open configuration of the adjustable lock assembly 560. This is accomplished, for example, by sliding the lock assembly 562 over a suitably larger sized tapered hypotube to release the lock assembly 560 on the outer surface of the inner member 510. Next, the shaped lock assembly and internal member are approximated to the lock assembly 560 in a manner designed by their respective dimensions to provide a mechanical tolerance interface to the longitudinal axis L. The top end 568 is extracted into the external member 520 in a “backload” manner until it hits the joint 528.

  At this point, the lock assembly 560 held on the distal end 514 of the inner member 510 and the filter assembly 570 are within the larger distal inner lumen 523 within the distal end 524 of the outer member 520. Each is housed. Only the inner member 510 extends proximally through the fitting 528 and along each smaller proximal inner lumen 521 within the proximal end 522 of the outer member 520. The distal end 524 of the outer member 520 provides a radial limiting sheath and housing to allow the adjustable filter assembly 570 to be removed from the superelastic radial expansion memory state of each nickel titanium support scaffold of the strut 572. A radially restricted configuration with a deflected, highly shrunken diameter. Proximal end 522 provides a low profile assembly proximal to fitting 528.

  Thus, this arrangement described above provides an efficient use of radial dimensioning to minimize the profile while maintaining the overall function and purpose of the system where possible. Thus, the assembly described above and illustrated in FIG. 14A represents a first configuration of the filter assembly and system. This configuration suitably integrates the filter assembly 550 through the inner lumen 511 and guidewire lumen 554 of the inner member 510 while preserving the profile to the site where filtration is performed through the vasculature. A guide wire 580 extending through the formed scaffold body is slidably engaged and tracked through the guide wire 580.

  When placed in the filtration position, the filter assembly deploys on the guide wire and into the blood vessel as follows. As shown schematically by the opposing thick arrows in FIG. 14, the inner member 510 is a long-axis resistor disposed on the outer member 520 in a “push-pull” coordinated arrangement. Removed proximal to (resistance). In doing so, the proximal end 568 of the lock assembly 560 impacts the fitting 528, which acts as a stopper against further proximal withdrawal of the lock assembly 560. As a result, the distal end 514 of the inner member 510 slides proximally out of the underlying lock assembly 560 from the inner lumen 523 of the distal end 524 to the proximal end of the outer member 520. 522 is extracted into the internal lumen 521. This frees the lock assembly 560 from radial retention of the inner member in the open configuration and allows memory recovery of the radially inward superelastic material onto the guidewire 580 to the lock configuration.

  In this way, once the lock assembly 560 is locked onto the guidewire 580, then all the external members 550 are then applied to the guidewire 580, again in a “push-pull” cooperating configuration. Withdrawn proximally. By maintaining the positioning of the guide wire 580 within the artery, the filter assembly 550 is also held in a filtration position locked onto the guide wire. Thus, during proximal withdrawal of the outer member 520, the distal end 524 of the outer member 520 is withdrawn proximally from the filter assembly 550, and the support scaffold struts 572 diametrically insert them into the inner lumen 523. Freed from the limitations held in the directional contracted configuration. This releases the support scaffold 570 and allows memory recovery of the superelastic struts 572 radially outward in a radially expanded configuration, as shown in the embodiment of FIG. 13C. As a result, the porous filter membrane 574 is developed over the entire blood vessel at the filtration position where the thrombus is efficiently filtered.

  It will be appreciated that the filter assembly 550 is then withdrawn from the patient when deployed on the guidewire 580 and across each vessel in the filtration position. In this mode of operation, a continuous capture sheath is advanced distally over the guidewire 580 to recapture the filter assembly 570 back to a radially contracted state for withdrawal. This may be an external member 520 similar to that used in the delivery assembly 500 described above. In general, there are some differences between the initial capture sheath and the retrieval capture sheath with respect to the desired structural features. For example, the initial capture sheath is typically a robust radial for tolerance damage to traverse proximal lesions, along with structural integrity under tension during withdrawal from the contained filter assembly Completeness and low profile. However, the retrieval sheath is subject to few profile constraints, for example after recanalization of the proximal occlusion. Also, the entire system including the introducer needle can be removed together after the procedure is completed. Conversely, the retrieval sheath generally provides several mechanical properties under compression by distal advancement relative to the spline 562 to trim the expanded filter assembly 560 back to its reduced profile. It is also. Thus, it is contemplated that the capture sheath used may be different from the outer sheath assembly used for initial delivery in certain circumstances.

  A wide variety of specific materials can be selected as appropriate for the specific component portions of the delivery system 500 described above, as will be apparent to those skilled in the art based on a review of the present disclosure. However, for the sake of brevity, some specific advantageous materials are described as follows. A low profile configuration is desirable, for example, a filter system with a delivery assembly as described for use on a 0.014 "guidewire is less than about 3 French, and in a further embodiment less than about 2.7 French, More particularly, in certain situations, having a profile of less than about 2.5 French or even about 2.3 French is particularly desirable in many cases, where a high strength, thin walled tube is highly desirable. Also, in many cases, a composite tube configuration may be particularly advantageous.

  In general, due to the desire for tracking on guidewires, and sometimes difficult, tortuous anatomy, most components require lateral flexibility. However, other structural considerations are often made in the same way. For example, radial strength is often required, such as strength to resist impingement against inward forces at the distal end 514 of the inner member 510 of the embodiment of FIG. In some such situations, a coil reinforced polymer composite may be suitable for the construction of this part. However, if the design of the lock assembly provides fairly uniform radial compression, the annular tubular support is sufficient to provide the desired quality in some material configurations (eg, polyimide). Can do. In another example, the distal end 524 of the outer member 520 can be a high radial strength, thin-walled material. This is because it is not necessary to provide the same amount of substantial pressing force as radial retention against outward expansion of the contents of the distal end 524 and tensile strength with respect to removal. Here, polyimide may be sufficient as well, but more flexible materials such as thin-walled materials that are integrity to high radial pressures such as PET, HDPE, nylon, etc. may be particularly desirable. It is also conceivable that certain surface characteristics may be desirable at certain locations within the assembly. This may be, for example, the outer surface of the retaining portion of the inner member 510, or the inner surface of the distal retaining portion 524 of the outer member 520, or a “push pull” sliding interface between the inner member 510 and the outer member 522. interface) and the like. Coatings such as silicon coatings or hydrophilic coatings may be practical, but within a radial locking mechanism, smoothness is usually not desirable when the ultimate goal is to grip tightly on the guidewire. Thus, PTFE, FEP, or other coated materials having some structural integrity (for chemical products that can migrate or migrate) may be desirable.

  In accordance with various aspects of the illustrated and described embodiments of the present invention, several exemplary physical samples of tunable filter modules are created and observed during various modes that simulate intended use. It was. Where similar structures are shown as other examples of other embodiments shown or described herein, like reference numerals are used throughout the figures to simplify and to facilitate understanding. .

  In particular, FIG. 15A shows an integrally formed filter scaffold body 550 having an adjustable lock assembly 560 in the form of a self-deflating stent integrally coupled with a self-expanding filter support scaffold 570 shown in an expanded configuration. It is a thing. A NiTi collapsing stent lock assembly 560 is held in an open configuration on a polyimide inner member 510 having approximately 0.017 "ID and approximately 0.022" OD. This partial assembly is shown slidably engaged on a 0.014 "guidewire 580 for reference.

  FIG. 15B shows the filter module 550 retained on the inner member 510 after removal into the inner lumen 523 of the distal end 524 of the outer member 520 in the complete delivery assembly for the system. FIG. 15B shows a view of the assembly shown in 15A. Only the outer member 520 is visible in this view, but the mesh polyimide proximal end 522 and the non-mesh and more flexible, trackable simple polymer tubular distal end 524 are radiopaque visible. The band is shown as joined at seam 528 where it is placed.

  FIG. 15C shows the filter assembly 550 deployed distally from the distal end 524 of the outer member 520 of the delivery assembly. This view shows the assembly after the internal lock assembly 560 has been released onto the guidewire 580 from the internal member holder 510 (located on the left side outside the figure but not shown).

  According to a further mode, one system and method for retrieving the adjustable locking filtering system described above with reference to FIGS. 15A-15C is shown in FIGS. 16A-16C as follows. For further illustration.

  FIG. 16A shows the guide wire 580 being advanced over the guide wire 580 to the lock filter assembly 550 such that the second capture sheath 590 slides over the lock assembly 560 and the radial expansion filter member 570. The filter module 550 is shown locked and released.

  FIG. 16B shows capture sheath 590 partially engaged to be further advanced over lock assembly 560 to align filter support scaffold 570 within internal capture lumen 591.

  FIG. 16C shows the capture sheath 590 advanced fully further within the capture lumen 591 with the filter support scaffold 550 fully captured. As shown in particular detail, this particular embodiment of the capture sheath 590 is joined to the distal end portion 594 with a large distal outer diameter via a seam 598 in the region of the radiopaque marker band 596. A relatively small outer diameter proximal end 592. This system provides an optimally low profile along the smaller diameter proximal end, as generally desired for transluminal procedures, while the distal end 594 is given a larger diameter. , Corresponding to the capture and containment of the filter assembly 550. They also have, in one arrangement, a high elastic material at the proximal end and a low elasticity at the larger distal end to accommodate the desired pushing and tracking functions in different regions along the length. Different materials, including materials, may be used.

  It will be appreciated that the above figures are provided for a more complete understanding of the various components described elsewhere herein with reference to the exemplary drawings. Although the assembly characterized in these figures does not include a filter membrane, those skilled in the art will know from the appropriate lumen (s) in which the system to be subsequently cleaned, sterilized, and deployed is placed. Obviously, steps can be taken to complete a functional filter assembly, such as for use in filtering emboli.

  FIGS. 17A-17C illustrate further aspects, modes, and embodiments of the present invention that are similarly contemplated herein in the context of a reference vessel or reference lumen. In particular, these figures illustrate an adjustable filter assembly 600 that is similar to most of them with respect to many embodiments described elsewhere herein, using an adjustable lock on the guidewire. Illustrate various modes of using. However, according to embodiments of the present invention, adjustable lock assembly 610 and adjustable filter member 650 are coupled together and filter member 650 is deployed in the artery and lock assembly 610 is over guidewire 660. When locked in a manner that provides a range of movement between adjustable lock assembly 610 and adjustable filter member 650. This is accomplished by a dynamic coupler 630 that allows such relative motion, structure, and use described in more detail below (although within certain limits).

  It is highly undesirable in the case of embolic filtration of the present invention that the filter assembly can not be retrieved and is released, especially the release of the filter assembly beyond the distal end of the guidewire. It is. These should generally be extracted in some mutually engaged manner. Thus, when the lock 610 is locked in place on the guidewire 660, the dynamic coupler 630 allows the guidewire 660 to move within a certain range without applying significant force to the filter assembly 650. To. This is beneficial to limit the movement of the filter assembly 650 against the vessel wall A, which can detach the vessel and possibly even more severely damage.

  Accordingly, the dynamic coupler 630 shown in FIG. 17A is adapted to allow a range of relative longitudinal movement between the filter member 650 and the guidewire 660 about the locking point of the filter member 650. Yes. In the embodiment shown, this is done via a dynamic coupler 630 in the form of a spring. The spring extends longitudinally relative to the guide wire 660 between the distal end 614 of the lock assembly 610 and the proximal end 652 of the filter member 650. The locked state is indicated by the reference numeral at position “a” at the distal end 614 of the lock assembly 610. Position a is an engagement over a locking spring to the proximal end 652 of the filter assembly 650 (desirably relatively fixed over a range of guidewire motion with relatively little or no motion). It is defined by the stop distance D1. When the guidewire 660 moves proximally along the vessel during the procedure (FIG. 17B), the lock assembly 610 moves with the guidewire 660 along the vessel wall without applying significant force to move the filter assembly 550 from position A. Move. This is because the lock assembly 610 and the guide wire 660 are from the locking point a (shown in dashed lines in FIG. 17B for reference) and the distal end 614 of the lock 610 is moved from the locked position to position b (FIG. 17B). Happens to a point that moves to a point that is adjusted to. This results in an increased distance D2 from the distal end 614 of the lock 610 to the proximal end 652 of the filter member 650. This represents a certain range of movement of D2-D1 (D2 minus D1). This distance represents the limit of movement that is “absorbed” by the spring when it reaches a longitudinal deflection force that transmits sufficient force to the filter member to cause movement here. Thus, the dynamic coupler 630 disables significant further relative movement and separation beyond this point between the respective coupled filter and lock components of the assembly without moving the filter member 650 by that movement.

  For further illustration, a reverse relative motion scenario in which the guidewire 660 is advanced distally is illustrated in FIG. 17C. FIG. 17C shows a guidewire 660 moving through a distance limit of D1-D3, where D3 represents the critical compression distance across the spring coupler 630 between the lock component 610 and the filter component 650. .

  In a further highly advantageous embodiment, it is envisaged that the dynamic coupler is integrally formed from the same piece of material as the locking mechanism and the filter assembly. This is similar to that described elsewhere below with reference to FIGS. 13A-13C, and the dynamic coupler includes a patterned spring structure cut into a nickel titanium hypotube. Body shape is given.

  As will be apparent to those skilled in the art, various modes of patterning, processing, and training can directly or indirectly affect the performance of such dynamically integrated necomponents in the assembly. In either case, for example, one particular pattern is shown in assembly 690 of FIG. 17D (in two dimensions, as if the patterned tubular member was cut longitudinally and lying flat on the page. It is shown). Exemplary structures of the lock assembly 610, dynamic coupler 630, and filter member assembly 650 are shown for further illustration and understanding. In the particular spring design alternative shown, other types of coil springs, leaf springs, tethers, stretchable materials, etc. may be used without departing from the intended broad scope of this particular embodiment. These particular advantages not only provide the ability to lock the filter assembly directly onto the guidewire for extraction in one piece, but also mechanically during active intervention and on the guidewire extending under the filter or inside the filter A range of dynamic relative motion is provided for the purpose of protecting the vessel wall during other procedures that stress.

  Providing an embodiment of the present invention that forms all three components (lock assembly, dynamic coupler, filter support scaffold) of a single integrated structure from a single piece of material, reducing complexity and safety There is also a very nice advantage that the stubborn structure to improve is strengthened. However, alternatives including forming one or more of these components separately and then assembling them together, such as by welding, soldering, adhesive bonding, or other adjoining techniques apparent to those skilled in the art Forms may also be used.

  In order to provide significant benefits for improved medical care, additional aspects of the present invention that are similarly contemplated are illustrated in FIGS. 18A-18G and described as follows. These aspects take advantage of the flexibility of the adjustable and lockable filter assembly embodiments described herein to make integral filter wires undesirable or a functional alternative to treatment. It offers significant advantages in the area of interventional medicine, even in form. Specifically, this mutually excludes conventional optional filtration to address procedures that require a guidewire designed specifically for other additional specific advantages other than filtration.

  This is especially true when a dedicated guidewire and / or associated crossing system is often required to cross a chronic total occlusion. In order to remotely apply some form of energy to the distal tip of the guidewire when attempting to remotely traverse a dense occlusion in the body, a dedicated guidewire and / or associated crossing system is electrically Often, mechanical or electromechanical actuators are used. These actuators are typically placed outside the patient's body in the case of mechanically actuated wires that propagate energy in the rotary, longitudinal, or other mechanical form to the wire to enhance crossing. For example, remotely transfer energy to the tip, such as along the wire itself. Other actuators include, for example, a power source that generates a situation at the tip of the guidewire that facilitates crossing. Sensors are often used with or without actuators. The sensor is coupled to a crossing wire or crossing system to evaluate the surrounding tissue and other environmental information within the body, for example, during a procedure.

  Accordingly, FIG. 18A is a particular embodiment of a chronic total occlusion (CTO) crossing system 700 comprising a mechanically actuated guidewire 710 having an elongated wire portion 712 having an expanded distal tip 716. Is shown. The guidewire 710 is provided in combination with an outer pilot lumen tissue ablation and / or atherectomy sheath 740 so that the guidewire 710 is movable within the lumen 742 by the sheath 740. To extend an adjustable distance distally from the distal tip 746 of the sheath 740. FIG. 18A shows the assembly in one mode of use at the proximal end or cap 704 of a chronic total occlusion CTO 702 prior to initiating a crossing. The actuation system 750 includes two actuators 752 shown schematically, one coupled to the guidewire 710 and actuating the guidewire 710 and the other coupled to the sheath 740 and actuating the sheath 740. 756.

  FIG. 18B shows the system 700 after it has been able to traverse the CTO 702 and traverse into the distal lumen 706. FIG. 18C shows that the pilot lumen sheath 740 has been removed and the system 700 has been placed in position across the pilot lumen 708 formed through the lesion by the external and / or atherectomy sheath 740. The present system 700 is shown in another continuous mode after leaving a crossing wire 710 of FIG.

  As shown in FIG. 18D, an adjustable comprising an adjustable lock assembly 762 and an adjustable filter assembly 766, eg, according to one or more other inventive embodiments described herein. A filter module 760 is advanced through this guidewire to the distal filtration position. Here, the adjustable filter module 760 is locked to the dedicated wire 710 that is activated and deployed across the tube in the distal lumen 706 to filter the debris tissue downstream of the occlusion 702. The locked and deployed configuration is shown schematically in FIG.

  Subsequent sequential steps for recanalization intervention by deploying stent 770 to open obstruction 702 are shown in FIGS. 18E-18F. The particular embodiment shown provides a balloon 780 for expanding the stent 770. This is for purposes of illustration, and other deployable stents may be used, such as self-expanding types (which may or may not be used in conjunction with inflation of a pressurized balloon). In particular, as shown in FIG. 18F, depleted tissue fragments are released with this particular type of intervention and with long CTOs of the peripheral vasculature, such as but not limited to, for example, the legs (eg, superficial femoral artery) There are many cases. According to the illustrated embodiment of the invention, this depleted tissue piece is captured by a filter 760 that is locked onto a CTO crossing wire 710. The recovery and withdrawal of a “filter wire” (including a combination of filters 760 locked onto a dedicated guide wire 710) that has been successfully used and formed in the body is illustrated in one mode of FIG. 18G.

Thus, it will be appreciated that aspects of the present invention provide a therapeutic CTO system having distal embolic filtration capabilities in certain respects. The system comprises a crossing system, a recanalization system, and a filtration system that all work together to provide significant benefits in treating these very difficult and harmful conditions. However, with reference to such “systems” (and other systems referred to herein), various sub-combinations of various component parts are also contemplated, which sub-combinations alone or with other components It will be appreciated that the ability to be combined later may also be advantageous independently. For example, a CTO crossing system and an embolic filter system can be considered advantageous in their own combination with each other. This allows a wide variety of recanalization treatments to be selected while providing the desired access and distal protection. Furthermore, the crossing wire or pilot lumen sheath of the CTO crossing system may be provided in combination with a filter, which combination is advantageous by allowing later combination and use with other omitted components. is there. These combinations alone are highly advantageous and are also illustrative of several even broader embodiments as combinations, including but not limited to:
(1) A deployable filter on a guide wire provided in combination with an actuator or sensor coupled to the guide wire;
(2) in combination with (1), further comprising the additional feature of an extended distal tip on the guidewire;
(3) An adjustable and guidewire lockable filter in combination with a guidewire having an expanded distal tip.

  As a further example, with respect to aspect (1) above, the deployable filter may be of the lock type or of the “floating” type that is not locked on the guide wire but is coaxially mounted on the wire in the released state. May be. In this regard, when further combined with aspect (2) above, this assembly has a limited range of relative motion, and due to the interference fit between the filter on the guidewire and the expansion tip, Can be extracted. This very advantageous combination of the above presents a particularly new advantage and practicality at the present time, for example in the case characterized herein for chronic total occlusion crossing for filtration and for chronic total occlusion intervention. It is thought to provide.

  These various components of the assembled combination shown and described herein (as well as other components used in combination with assemblies described elsewhere herein) can be packaged and / or packaged together. It will be appreciated that these may be sold, or these components may be made available separately.

  Similarly, another aspect of the invention contemplated herein is shown in system 800 illustrated in FIGS. 19A-19B. System 800 provides an adjustable guidewire lock filter assembly 810. The guide wire lock filter assembly 810810 uses glue to lock the filter assembly 802 to a guide wire (not shown) as follows.

  Specifically, the filter support body 812 is shown in FIG. 19A. The filter support body 812 has an injection lumen 814 having a threaded portion 816 and remains, for example, unjoined between two tubes 820, 822 that may be stacked. It is formed in a gap region 818 that is a void. An internal port 819 communicates between the gap region 818 and the internal guidewire lumen 824 of the tubular support body 812 in which a guidewire (not shown) is slidably engaged. As also shown in FIG. 19A, the threaded delivery needle 830 has a needle shank 832 having a threaded portion 836 along its distal end 834. To simplify the description of other components associated with locking and delivering the filter assembly 800, the filter member 802 is shown only in partial view and between the two ends 804, 806 of the filter membrane support loop or scaffold. Only the coupling of 812 to the filter body is revealed. This can be done in a number of ways, and in the advantageous embodiment shown, the two ends 804, 806 are secured between the stacked walls 820, 822 of the body 812. More particularly, the ends 804, 806 bend into a memory shape at the time of this coupling and, as will be described later, upon release from the restriction, support scaffold (and supported filter membrane (not shown)). Allows radial expansion. Bonding to the laminated wall forms a hole through the outer tube 820 in which the ends 820, 822 are disposed, for example, while the inner tube 822 is disposed within the outer tube 820. Is achieved by In this manner, the ends 804 and 806 are disposed between the tubes before lamination, and are fixed in place during thermal bonding, solvent bonding, or adhesive bonding between the tubes 820 and 822. Additional shapes or holes are held in the lamina end to provide robust integrity with increased retention and increase resistance to “pull-out” when tension is applied. 804 and 806 may be provided. The threaded portion 836 is adapted to detachably threadably engage with the threaded portion 816 of the lumen 814 by the delivery member, as described below with reference to FIG. 19B. Accordingly, FIGS. 19A and 19B should be considered in the context of each other.

  A delivery assembly 840 adapted for use in cooperation with the system 800 shown in FIG. 19A is shown in FIG. 19B. Delivery member 840 includes a delivery member 841 coupled to an external member or housing 850. Delivery assembly 840 comprises a tubular body 842 having a delivery lumen 844 and is coupled to an outer member 850. The outer member 850 has a tubular wall 852 with an inner housing housing 854. The housing lumen 854 is coupled to the delivery member 844 by a delivery lumen 844 that communicates with the housing lumen 854.

  The housing lumen 854 is also adapted to accommodate the self-expanding filter assembly 800 in a radially contracted configuration and in a specific orientation upon delivery. According to this orientation, the injection lumen 814 is aligned and correctly overlaid with the delivery lumen 844 so that the needle 830 that is advanced distally from the delivery lumen 844 is threaded portion 816 and thread Between the portions 836, the lumen 814 is engaged by screwing. Further, when housed within housing lumen 854, assembly 800 is oriented with guidewire lumen 824 aligned with proximal port 856 and distal port 858 of housing lumen 854. This is because the combined system of (a) delivery assembly 840 with (b) filter assembly 800 housed in housing lumen 854 and threaded through needle 830 through delivery member 841 is guided wire lumen 824. And slidably engage and guide through the guidewires extending through the mouths 856, 858.

  Further, the needle 830 is coupled to a glue source (schematically shown in FIGS. 19A and 19B as a source 860) during or after the guidewire tracking of the combined system to the target filtration location. It will be appreciated that it further includes a proximal end.

  When delivered to the filtration position in the above direction, the needle 830 injects glue from the source 860 that exits the distal port 838 through the internal port 819 and surrounding the guidewire. Flow into 824. Thereby, the inner lumen 824 is joined to the guide wire via a glue that bonds the two together. This is done while the filter assembly 800 is housed in the housing 850. Before or after curing, threaded needle 830 is then withdrawn from threaded lumen 814 and delivery assembly 840 is then proximal to the longitudinal resistance applied to the guidewire. Extracted. Since the tubular body 812 is locked to the guidewire, it releases the filter assembly 800 from within the outer member housing 850 for self-expansion and filtration of the thrombus.

  The “glue” described herein may be any injectable material that locks the tubular member and the guide wire, and is a glue in the conventional sense using a chemical adhesive bonding method. Alternatively, mechanical interference may be generated, such as curing to a solid substrate that fills the area between spaced coils of the guidewire and cannot move relative to the wire. For example, biocompatible materials such as fibrin glue, methacrylate, or alginic acid, or other forms of “bioglue” or curable adhesives that are approved for use in the body are desirable. However, if the delivery member is well contained within the lumen, strict biocompatibility may not be required for robust and safe results. In addition, energy such as UV light may be delivered to the region via an optical fiber that is advanced through a needle or other delivery lumen coupled to the guidewire support tube interface to enhance curing. . Furthermore, rather than injection of a curable material, such energy delivery is used to flow or otherwise respond to satisfy an interface sufficient to lock the guidewire to the inner lumen of the filter support housing. The material may be heated.

  The glue is a two-part that polymerizes or otherwise cures when two (or more) parts involved in the curing of the adhesive are mixed, such as, for example, the fibrin glue described above or a certain amount of alginic acid. It will also be appreciated that it can be a two-part adhesive system. In this case, the needle 841 can have a dual lumen (the double lumen can separate the components until they are mixed in the body, and the components are ejected) May intermingle in the gap region 818 or lumen 824) or may include a mixing reservoir in the tip region 834 of the needle 830. The various modes of multi-part polymer injection system described above can be suitably modified for use in this additional embodiment as will be apparent from the teachings of this disclosure.

  Embodiments of the present invention are particularly considered to be very advantageous as described herein. On the other hand, further combinations of this embodiment with some aspects of other disclosures also consider additional advantages that are considered below.

  The entire various disclosures of the following PCT international patent publications are hereby incorporated by reference: WO 2004/039287 to Peacock et al., WO 2005/042081 to Peacock, and International publication to Peacock. 2006/084256.

  The following additional issued US patents are hereby incorporated by reference in their entirety: No. 5,911,734 to Tsugita et al., No. 6,027,520 to Tsugita et al., No. 6 to Tsugita et al. No. 6,042,598, 6,168,579 to Tsugita, 6,179,859 to Bates et al., 6,270,513 to Tsugita et al., US Pat. No. 6,277,139 to Levinson et al. U.S. Pat. No. 6,319,242 to Patterson et al., 6,371,971 to Tsugita et al., 6,537,295 to Petersen, 6,544,280 to Daniel et al., Thielen 6,616,680, 6,616,681 to Hanson et al., 6,620,148 to Tsugita, 6,652,505 to Tsugita, Root 6,673,090 to others, 6,676,682 to Tsugita et al., 6,902,572 to Beulke et al., 6,939,361 to Kleshinski.

The following additional PCT international patent application publications are also incorporated herein by reference: WO 00/67664 to Salviac Limited, WO 01/49215 to Advanced Cardiovascular Systems, Inc, Salviac Limited International Publication No. 01/80777 to and Advanced International Publication No. 02/43595 to Advanced Cardiovascular Systems, Inc.

  Various detailed descriptions of specific embodiments may be further combined in many different iterations, making other improvements and modifications equivalent to the above structures and methods or apparent to those skilled in the art. It can be done without departing from the scope of the invention. Accordingly, the illustrative examples are not intended to limit the scope of the appended claims or to limit the Summary of the Invention. However, this limitation does not apply if such a limitation is clearly stated.

  While the above description includes many details, these should not be construed as limiting the scope of the invention, but merely as exemplifying some of the presently preferred embodiments of the invention. It is. Therefore, the scope of the present invention is intended to completely cover other embodiments that will be apparent to those skilled in the art, and the scope of the present invention is therefore limited only by the appended claims. Will be fully understood. Herein, references to an element in the singular are not intended to mean “one and only one” but rather “one or more” unless explicitly stated. . All structurally, chemically, and functionally equivalent elements of the above-described preferred embodiments known to those skilled in the art are expressly incorporated herein by reference and are claimed herein. Is intended to be covered by the scope of Further, the apparatus or method contained by the claims need not address each of the problems believed to be solved by the present invention. In addition, any element, component, or method step in the present disclosure may be provided publicly regardless of whether such element, component, or method step is expressly recited in the claims. Not intended. The elements of a claim herein are based on the provisions of 35 USC 112, sixth paragraph, unless the element is explicitly stated using the phrase "means for" Should not be interpreted.

FIG. 6 is a schematic plan view of one of four consecutive modes of a system and method for attaching an embolic filter onto a guidewire prior to placing the attached assembly in a patient's body. FIG. 6 is a schematic plan view of one of four consecutive modes of a system and method for attaching an embolic filter onto a guidewire prior to placing the attached assembly in a patient's body. FIG. 6 is a schematic plan view of one of four consecutive modes of a system and method for attaching an embolic filter onto a guidewire prior to placing the attached assembly in a patient's body. FIG. 6 is a schematic plan view of one of four consecutive modes of a system and method for attaching an embolic filter onto a guidewire prior to placing the attached assembly in a patient's body. FIG. 10 is a side view of the distal end of one particular assembly with a distal embolic filter module engaged on a guidewire in a radially expanded state. FIG. 10 is a side view of the distal end of one particular assembly with a distal embolic filter module engaged on a guidewire in a radially contracted state. FIG. 10 is a side view of the distal end of another particular assembly with a distal embolic filter module engaged on a guidewire in a radially expanded state. FIG. 10 is a side view of the distal end of another particular assembly with a distal embolic filter module engaged on a guidewire in a radially contracted state. FIG. 6 is a side cross-sectional view along the longitudinal direction of another embolic filter assembly in which a tubular support member is coaxially engaged on a guide wire in a radially inflated unlocked state with respect to the guide wire. FIG. 6 is a side cross-sectional view along the longitudinal direction of another embolic filter assembly in which a tubular support member is coaxially engaged on a guide wire in a radially contracted lock with respect to the guide wire. FIG. 6 is a side cross-sectional view along the major axis of another embolic filter embodiment in a radially inflated unlocked state with respect to the coaxially engaged penetrating guidewire shown schematically. FIG. 6 is a side cross-sectional view along the major axis of another embolic filter embodiment in a radially contracted lock with respect to the coaxially engaged penetrating guidewire shown schematically. FIG. 6 is a side cross-sectional view along the major axis of another embolic filter embodiment in a radially inflated unlocked state with respect to the coaxially engaged penetrating guidewire shown schematically. FIG. 6 is a side cross-sectional view along the major axis of another embolic filter embodiment in a radially contracted lock with respect to the coaxially engaged penetrating guidewire shown schematically. The embolic filtration device is adjustable between a filter and a guide wire between a radially contracted state and a radially expanded (illustrated by shadow) state corresponding to the locked and unlocked positions, respectively. FIG. 6 is a side cross-sectional view along the longitudinal direction of an embolic filtration assembly in coaxial engagement on a guidewire having an inflatable member on the guidewire. FIG. 8 is a side cross-sectional view along the longitudinal direction of a portion of a guidewire chassis adapted for use with an assembly such as the assembly shown in FIG. 7. FIG. 9 is a side cross-sectional view along the longitudinal direction of another embolic filter embodiment in various modes of use during a locking procedure on a guidewire. FIG. 9 is a side cross-sectional view along the longitudinal direction of another embolic filter embodiment in various modes of use during a locking procedure on a guidewire. FIG. 9 is a side cross-sectional view along the longitudinal direction of another embolic filter embodiment in various modes of use during a locking procedure on a guidewire. FIG. 6 is a partial perspective view of the distal end of another embolic filter system in one mode of use for delivery to a filtration location within a patient's body. FIG. 10B is an exploded perspective view of the distal end of a filter similar to the filter shown in FIG. 10A, with the filter adjustment function in each of the radially contracted state and the radially expanded state shown by broken lines. The filter system shown in FIGS. 10A and 10B showing the outer sheath adjusted to a proximal position such that the filter is adjusted to a radially expanded state adapted to filter emboli from blood in the body. FIG. 6 is an exploded perspective view of a distal end of a filter system similar to FIG. The same distal as the filter system shown in FIG. 10C, except that the filter is in another mode of use, adjusted to return to a radially contracted state that captures the embolus for removal from the patient's body. It is a disassembled perspective view of an edge part. Longitudinal direction of another embolic filter system adapted to provide in-body placement of the filter and locking engagement on the “in-dwelling” guide wire during modes of use including slidable placement on the guide wire FIG. Partial side view along the longitudinal direction of another embolic filter system adapted to provide in-body placement of the filter and locking engagement on the “in-place” guidewire during modes of use including locking engagement and removal It is sectional drawing. Another embolic filter adapted to provide in-body placement of the filter and locking engagement on the “in-dwelling” guidewire during use modes including radial adjustment to a radially expanded state for filtering blood It is a partial side sectional view along the major axis direction of the system. FIG. 11C is a side cross-sectional view along the major axis of another alternative embodiment of the filter system shown in FIGS. 11A-11C. 1 is a side view of a tube in a first state corresponding to a first mode of manufacturing an integral lockable scaffold used to support and deliver a filter assembly over a body guidewire. FIG. FIG. 13B is a side view of the tube shown in FIG. 13A in a second state corresponding to a second mode of manufacturing a monolithic lockable scaffold where the tube is cut into a patterned scaffold assembly. . Includes a patterned scaffold assembly shown in FIG. 13B in a third state corresponding to a third mode of manufacturing an integral lockable scaffold and coupled to the integral lockable scaffold FIG. 3 is a side view of an embolic filter assembly that also includes a filter membrane that has been applied. FIG. 7 is a side cross-sectional view along the longitudinal direction of another adjustable filter module in a particularly advantageous delivery assembly on a guidewire. FIG. 6 is a diagram of another manufactured adjustable filter module showing the module in one mode of use on the guidewire. FIG. 6 is a diagram of another manufactured adjustable filter module showing the module in one mode of use on the guidewire. FIG. 6 is a diagram of another manufactured adjustable filter module showing the module in one mode of use on the guidewire. FIG. 16 is an illustration of the adjustable filter module shown in FIGS. 15A-15C during a further use mode with a guidewire. FIG. 16 is an illustration of the adjustable filter module shown in FIGS. 15A-15C during a further use mode with a guidewire. FIG. 16 is an illustration of the adjustable filter module shown in FIGS. 15A-15C during a further use mode with a guidewire. Side surface of another embolic filter assembly in a first configuration corresponding to a first mode of use when locked between a locking assembly and a filter assembly on a guide wire in the body using a dynamic coupler FIG. Side surface of another embolic filter assembly in a second configuration corresponding to a second mode of use when locked between a locking assembly and a filter assembly onto a body guide wire using a dynamic coupler FIG. Side surface of another embolic filter assembly in a third configuration corresponding to a third mode of use when locked between a lock assembly and a filter assembly onto a body guide wire using a dynamic coupler FIG. FIG. 7 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a schematic side view of another adjustable embolic filter assembly during continuous use mode in the overall system and method for treating chronic total occlusion with distal protection. FIG. 10 is a partial side cross-sectional view along the longitudinal direction of another adjustable embolic filter assembly component embodiment. FIG. 10 is a partial side cross-sectional view along the longitudinal direction of another adjustable embolic filter assembly component embodiment.

Claims (77)

A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
An adjustable integrated scaffold body with an adjustable guide wire lock assembly integral with the adjustable filter support scaffold; and
A filter member coupled to the adjustable filter support scaffold;
The adjustable integrated scaffold body in a first configuration has a guide wire lock assembly in an open configuration and the adjustable filter support scaffold in a radially contracted configuration, whereby the filter member is Slidably engages the guide wire in a state of spreading to a diameter of 1 and tracks to the position through the guide wire;
In the filtration position, the adjustable integrated scaffold body is adjusted to a locking configuration such that the guide wire lock assembly is substantially locked onto the guide wire and the adjustable filter A support scaffold is adjusted to a radially expanded configuration so that the filter member extends to a second diameter that is greater than the first diameter and is adapted to engage the lumen wall at the location. A system that is adjustable to a second configuration of the state. A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
A filter member;
Means for delivering the filter member to the position on a guide wire;
Means for adjusting, at the position, the filter member between a radially contracted configuration extending to a first diameter and a radially expanding configuration extending to a second diameter;
Means for substantially securing the filter member to the guidewire at the position in the body;
Means for supporting the filter member in the radially expanded configuration at the position;
The system wherein the means for substantially securing the filter member to the guide wire and the means for supporting the filter member in the radially expanded configuration at the location are integral. The means for substantially securing the filter member relative to the guidewire includes an adjustable guidewire lock assembly, the adjustable guidewire lock assembly having an open configuration for tracking on the guidewire, and a guidewire Adjustable between lock configurations locked on,
The means for supporting the filter member includes an adjustable filter support scaffold, the adjustable filter support scaffold having a radially contracted configuration extending to a first inner diameter, and a first larger than the first diameter. Adjustable between a radially inflated configuration extending to a diameter of 2;
The adjustable guidewire lock assembly and the adjustable filter support scaffold together constitute an integrated scaffold body, and the scaffold body includes the open configuration of the lock assembly and the filter support scaffold. Adjustable between a first configuration corresponding to the radially contracted configuration and a second configuration corresponding to the locked configuration of the lock assembly and the radially expanded configuration of the filter support scaffold; The system according to claim 2.   4. The integrated scaffold body comprises a unitary piece of material in a patterned shape across the adjustable guidewire lock assembly and the adjustable filter support scaffold. system.   The system of claim 4, wherein the monolithic material comprises one continuous wire filament of the patterned shape.   The system of claim 4, wherein the unitary piece material comprises a shape memory material.   The scaffold body can be adjusted from the first configuration to the second configuration at the position by the superelastic recovery force of the shape memory material from the superelastic deformation shape to the memory shape characterizing the first configuration. The system of claim 6, wherein   The system of claim 6, wherein the scaffold body is adjustable from the first configuration to the second configuration at the location by heating the shape memory material to a temperature above a transition temperature. . The piece of material has a substantially tubular wall along the lock assembly;
The substantially tubular wall has a memory shape having a first inner diameter;
In the open configuration, the substantially tubular wall is held open in a radially expanded state with a second inner diameter subjected to a force applied from the memory shape, the second inner diameter being The system of claim 4, wherein the system is larger than a first inner diameter and the substantially tubular wall automatically contracts to the memory shape by a material recovery force when released from the applied force.   The substantially tubular wall in the locking configuration has a third inner diameter when striking and engaging the outer surface of the guidewire, the third inner diameter being greater than the first inner diameter. The system of claim 9, wherein the system is smaller than the second inner diameter.   The system of claim 9, wherein the substantially tubular wall has a voided pattern of nickel titanium material around an interior passage. A delivery assembly comprising an adjustable lock retainer;
The lock retainer includes a first state in which the adjustable guidewire lock assembly is held in the open configuration by a force applied from the lock retainer, and the adjustable guidewire lock assembly is in the lock retainer. 10. The system of claim 9, wherein the system is adjustable between a second state that is released from and automatically contracts to the locked configuration by a restoring force of the material to the memory shape.   The system of claim 9, wherein the unitary piece material has a patterned shape cut from a nickel titanium tube. A delivery system comprising a filter support scaffold retainer;
In the first state, the filter support scaffold retains the adjustable filter support scaffold in the radially contracted configuration, and in the second state, the filter support scaffold is released to expand the radial support. The system of claim 4, wherein the system is adjustable between the first state and the second state with respect to the adjustable filter support scaffold to automatically expand to a configuration. A delivery assembly comprising a guide wire lock retainer and a filter support scaffold retainer;
The guidewire lock retainer cooperates with the adjustable guidewire lock assembly and the adjustable guidewire lock assembly is held in the open configuration by a force applied from the guidewire lock retainer. A first state corresponding to the first configuration, and the adjustable guidewire lock assembly is automatically released from the guidewire lock retainer and the lock configuration is automatically activated by a material recovery force to a first memory shape Adjustable between the second configuration and the corresponding second state of contraction;
The filter support scaffold retainer includes a first state corresponding to the first configuration, wherein the adjustable filter support scaffold is held in the radially contracted configuration, and the adjustable filter support scaffold. 8 is adjustable between the second configuration and the corresponding second state, wherein the second configuration is released and automatically expands to the radially expanded configuration by the restoring force of the material to the second memory shape. The system described in. The guidewire lock assembly retainer comprises an inner tubular member;
The filter support scaffold retainer comprises an outer tubular member having a retention lumen extending along a length relative to a longitudinal axis;
In the first configuration, the inner tubular member is disposed at a first long axis position in the outer tubular member, and in the second configuration, the inner tubular member is located with respect to the outer tubular member. 16. The system of claim 15, wherein the system is withdrawn from the first longitudinal position to a second longitudinal position that is proximal to the first longitudinal position. A method of manufacturing an embolic filter assembly for filtering an embolus from a fluid at a location within a lumen within a patient's body comprising:
Forming a scaffold body having an adjustable guidewire lock assembly and an adjustable filter support scaffold;
The method, wherein the scaffold body is formed from one integral piece of patterned shaped material across the adjustable guidewire lock assembly and the adjustable filter support scaffold.   The method of claim 17, further comprising cutting the scaffold body from a precursor material into the patterned shape.   The method of claim 17, further comprising cutting the scaffold body from a tube made of shape memory material into a first patterned memory shape.   The method of claim 19, wherein the shape memory material comprises nickel titanium.   Holding the cut scaffold body in a second patterned memory shape that is different from the first patterned memory shape from the first patterned memory shape; The method of claim 19. Providing the guidewire lock assembly with a substantially tubular member having a first inner diameter in the first patterned memory configuration; and the guidewire lock assembly with the substantially tubular member of the guidewire lock assembly. 24. The method of claim 21, further comprising: maintaining the second patterned memory shape having a second inner diameter that is smaller than the first inner diameter. Providing the integral piece of material with a substantially tubular structure having an internal guidewire passage along the guidewire lock assembly; and a lock adjustable to a first position within the internal guidewire passage. The cage is arranged so that the substantially tubular structure is changed from a memorized shape having a radially contracted inner diameter smaller than a radially expanded inner diameter to a superelastically deformed shape having the radially expanded inner diameter. Further comprising disposing an adjustable lock retainer that expands and deforms in a direction;
The expanded inner diameter corresponds to an open configuration of the adjustable guidewire lock assembly configured to slidably engage and track through the guidewire;
The lock retainer is adjustable from the first position to a second position, and the lock retainer is removed from the internal guidewire passage so that the substantially tubular member is made of material. The method of claim 21, wherein a restoring force automatically shrinks radially inward from the deformed shape having the radially expanded inner diameter to the memory shape having the smaller radially contracted inner diameter. Placing a guide wire in the inner guide wire passage when the lock retainer is in the first position and the guide wire lock assembly is in the open configuration;
Holding the guidewire in the internal guidewire passage while the lock retainer is adjusted to the second position;
Holding the guidewire having an outer diameter greater than the radially contracted inner diameter corresponding to the memory shape for the substantially tubular member of the guidewire lock assembly; and Allowing the substantially tubular member of the guidewire lock assembly to be compressed from the deformed shape to the memory shape by striking the guidewire by the recovery force of the material radially inward. Including
24. The method of claim 23, wherein the guidewire lock assembly that is compressed into the guidewire corresponds to a locked condition, and the guidewire lock assembly is substantially locked onto the guidewire.   25. The method of claim 24, wherein the lock retainer comprises a tubular member having a guidewire lumen, and the guidewire is disposed within the guidewire lumen. An outer retaining sheath of an adjustable filter support scaffold retainer is disposed in a first position around the adjustable support scaffold, wherein the adjustable filter support scaffold is radially contracted. An external holding sheath is arranged to radially limit the memory shape having a radially expanded outer diameter larger than the outer diameter to a superelastically deformed shape in a radially contracted configuration having the radially contracted outer diameter. Further including
The radial contraction configuration of the support scaffold corresponds to the first configuration of the scaffold body and the guide wire lock assembly in an open configuration, whereby the scaffold body slides on the guide wire Preferably, configured to be delivered to a location within a lumen within a patient's body, the method includes adjusting the filter support scaffold retainer from the first position to the second position. The retainer is removed from the adjustable filter support scaffold so that the adjustable filter support scaffold is larger than the deformed shape having the radially contracted outer diameter. 18. A self-expanding to the radial expansion configuration by a radially outward recovery force of material to the memory shape having a radially expanded outer diameter. The method described. An outer retaining sheath of an adjustable filter support scaffold retainer is disposed in a first position around the adjustable support scaffold, wherein the adjustable filter support scaffold is radially contracted. An external holding sheath is arranged to radially limit the memory shape having a radially expanded outer diameter larger than the outer diameter to a superelastically deformed shape in a radially contracted configuration having the radially contracted outer diameter. Further including
A radial contraction configuration of the support scaffold corresponds to the first configuration of the scaffold body and the guide wire lock assembly in an open configuration, whereby the scaffold body slides on the guide wire Possibly configured to be delivered to a location within a lumen within a patient's body;
The method includes adjusting the filter support scaffold retainer from a first position to a second position, wherein the retainer is removed from the adjustable filter support scaffold, thereby An adjustable filter support scaffold is adapted to recover the diameter of the material from the deformed shape having the radially contracted outer diameter to the memorized shape having the larger radially expanded outer diameter by radially recovering the material. 26. The method of claim 25, further comprising adjusting the filter support scaffold retainer to automatically expand to a directional expansion configuration and disposing the tubular member of the lock retainer within the outer retention sheath. the method of. Each of the guidewire lock assemblies held in the open state by the guidewire lock retainer and the filter support scaffold held in the radially contracted configuration by the outer holding sheath within the outer holding sheath. 28. The method of claim 27, further comprising placing. The guidewire lock assembly is held in the open state by the lock retainer, and the filter support scaffold is held in the radially contracted configuration in the outer holding sheath while the guidewire is inserted into the guidewire lumen. 29. The method of claim 28, further comprising disposing within and extending distally from the outer retaining sheath. Providing a stopper within the outer retaining sheath, wherein the guide wire lock assembly hits the stopper when attempting to remove the tubular member of the lock retainer proximally from the outer retaining sheath; 29. Further comprising providing a stopper that prevents removal with the tubular member, thereby allowing the tubular member to be removed from the internal guidewire passage of the lock assembly. The method described in 1. The method of claim 17, further comprising coupling a radiopaque material to the integral piece of material along at least one of the lock assembly and the filter support scaffold. The filter support scaffold is a filter member that, when supported by the filter support scaffold at a location throughout a lumen in a patient's body, filters emboli from fluid flowing through the filter member. The method of claim 17, further comprising coupling to a filter member configured to: A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
An adjustable embolic filter module comprising a guide wire lock assembly and an embolic filter assembly;
The adjustable embolic filter module in a first configuration includes a guide wire with the guide wire lock assembly in an open configuration and the embolic filter assembly in a radially contracted configuration having a first diameter. And slidably engages and tracks to the position through a guide wire,
The adjustable embolic filter module is in a locking configuration such that the guidewire locking assembly is substantially locked onto the guidewire, and in the position, the embolic filter assembly is the first embolic filter assembly. Adjustable to the second configuration in the second configuration, in a radially expanded configuration extending to a second diameter adapted to engage the lumen wall at the location greater than the diameter;
The adjustable embolic filter module in the second configuration at the position further includes the guidewire lock in the locking configuration by a force applied to at least one of the guidewire locking assembly and the embolic filter assembly. A system adapted to allow limited relative motion between an assembly and the embolic filter assembly in the radially expanded configuration. A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
An adjustable embolic filter module comprising a guide wire lock assembly and an embolic filter assembly;
The adjustable embolic filter module in a first configuration includes a guide wire with the guide wire lock assembly in an open configuration and the embolic filter assembly in a radially contracted configuration having a first diameter. It engages slidably and tracks to the position through a guide wire,
The adjustable embolic filter module is in a locking configuration such that the guidewire locking assembly is substantially locked onto the guidewire, and the embolic filter assembly is larger than a first diameter. Adjustable to the second configuration in the second configuration, in a radially expanded configuration extending to a second diameter adapted to engage the lumen wall of the location;
The system also includes the guidewire lock assembly in the locked configuration and the diameter by a force applied to at least one of the guidewire lock assembly and the embolic filter assembly in the second configuration in the position. A system comprising means for allowing limited relative motion with the embolic filter assembly in a directional expansion configuration.   35. The system of claim 33 or 34, further comprising a dynamic motion coupler extending between the guidewire lock assembly and the embolic filter assembly.   36. The system of claim 35, wherein the dynamic motion coupler includes a spring extending between the guidewire lock assembly and the embolic filter assembly.   36. The system of claim 35, wherein the dynamic motion coupler includes a tether that extends between the guidewire lock assembly and the embolic filter assembly.   The embolic filter assembly includes a filter support scaffold, and the guidewire lock assembly, the filter support scaffold, and the dynamic motion coupler are unitary and from a single piece of patterned shape. 36. The system of claim 35, comprising:   40. The system of claim 38, further comprising a filter member coupled to the filter support scaffold.   40. The system of claim 38, wherein the single piece of material comprises a cut tube made of shape memory material. A method of filtering an embolus from a fluid at a location within a lumen in a patient's body comprising:
Providing an adjustable embolic filter module comprising a guide wire lock assembly and an embolic filter assembly;
Advancing the guide wire to said position;
Slidably engaging the adjustable embolic filter module in a first configuration through the guidewire;
Tracking the adjustable embolic filter module in a first configuration to the position through the guidewire;
Locking the guidewire lock assembly onto the guidewire, substantially securing the adjustable embolic filter module to the guidewire in the position, and extending the embolic filter assembly radially. Adjusting the embolic filter module from the first configuration to the second configuration by engaging a vessel wall at the position;
With the embolic filter module in the second configuration at the position, applying a force to at least one of the guidewire lock assembly and the embolic filter assembly, and applying the force on the guidewire Allowing limited relative movement between the guidewire lock assembly locked to the radially inflated embolic filter assembly engaged to the lumen wall.   42. The method of claim 41, wherein the limited relative motion is provided by a dynamic motion coupler that extends between the guidewire lock assembly and the filter assembly.   43. The method of claim 42, wherein the dynamic motion coupler includes a tether between the guidewire lock assembly and the filter assembly.   43. The method of claim 42, wherein the dynamic motion coupler comprises a spring. Further comprising moving the guidewire;
42. The method of claim 41, wherein the applied force is transmitted by movement of the guidewire. Moving the guidewire includes moving the guidewire in a longitudinal direction at the location within the lumen;
The applied force includes a force applied in a major axis direction,
46. The method of claim 45, wherein the limited relative movement includes a longitudinal relative movement.   47. The method of claim 46, wherein the longitudinal relative movement includes reducing a relative distance between the guidewire lock assembly and the embolic filter assembly.   47. The method of claim 46, wherein the longitudinal relative movement includes extending a distance to the guidewire lock assembly and the embolic filter assembly. Moving the guidewire includes rotating the guidewire;
The applied force includes a rotational force,
46. The method of claim 45, wherein the limited relative motion includes rotational relative motion. A system for treating a tight occlusion in a patient's blood vessel and filtering emboli from blood distal to the occlusion in the patient's body
A guide wire having a proximal end, a distal end, and an intermediate portion between the proximal end and the distal end, and an actuator and sensor cooperating with the distal end of the guide wire A vascular occlusion crossing system having at least one of
An adjustable embolic filter assembly;
A delivery assembly coupled to the adjustable embolic filter assembly;
The vascular occlusion crossing system advances the distal end of the guidewire across an obstruction to the filtration position within the blood vessel, at least in part with the aid of the actuator or the sensor. And
The delivery assembly is adapted to deliver the embolic filter assembly to a location along the distal end of the guidewire at the location;
The adjustable embolic filter assembly in the position is locked onto the guidewire and is released from the delivery assembly in a configuration adapted to filter the embolus from the blood in the position. And
The adjustable embolic filter assembly and the guidewire are both adapted to be withdrawn from the blood vessel through a capture sheath. A method of treating a patient suffering from a close occlusion in a blood vessel in the body while providing distal protection against a thrombus,
Providing a vascular occlusion crossing system comprising a guide wire and / or an actuator or sensor cooperating with the guide wire;
Providing an adjustable embolic filter module;
Advancing the vascular occlusion crossing system at least partially with the aid of the actuator or the sensor within the vessel across a tight occlusion to the position;
Slidably engaging the adjustable embolic filter module with the guidewire advanced to the position;
Tracking the adjustable embolic filter module through the guidewire to the position;
Locking the adjustable embolic filter module to the guidewire in the position;
Filtering the embolus from the blood using the adjustable embolic filter module locked on the guidewire; and the adjustable embolic filter module locked on the guidewire and the guidewire Extracting from the blood vessel through a capture sheath. A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
A guidewire having a proximal end and a distal end;
At least one of an actuator and a sensor coupled to the guidewire;
An adjustable embolic filter assembly;
A delivery assembly coupled to the adjustable embolic filter assembly;
The distal end of the guidewire is configured to be disposed across the position with the proximal end extending out of the patient's body;
The delivery assembly is configured to deliver the embolic filter assembly at the location along the distal end of the guidewire through the guidewire to a location;
The adjustable embolic filter assembly is releasable from the delivery assembly at the location of the position such that the delivery assembly can be withdrawn from the patient independently of the embolic filter assembly;
When the embolic filter assembly is released from the delivery assembly at the location, the embolic filter assembly can be withdrawn from the position by withdrawing the guidewire from the position into a capture sheath. A system that cooperates with the guidewire. A method of filtering an embolus from a fluid at a location within a lumen within a patient comprising:
Preparing a guide wire,
Coupling at least one of an actuator or a sensor to the guidewire;
Preparing an adjustable embolic filter module,
Advancing the vascular occlusion crossing system across the dense occlusion within the vessel to the position, at least in part with the aid of the actuator or the sensor;
Slidably engaging the adjustable embolic filter module with the guidewire advanced to the position;
Tracking the adjustable embolic filter module through the guidewire to the position;
Locking the adjustable embolic filter module to the guidewire in the position;
Filtering the embolus from the blood using the adjustable embolic filter module locked on the guidewire; and the adjustable embolic filter module locked on the guidewire and the guidewire Extracting from the blood vessel through a capture sheath. A system for filtering an embolus from a fluid at a location within a lumen within a patient's body, comprising:
A guide wire having a proximal end and a distal end having an expanded distal tip;
An embolic filter module having a guide wire lock assembly and a filter assembly, wherein the embolic filter module is delivered through the guide wire to a location proximal to the tip and the guide at the location via the guide wire lock assembly. An embolic filter module adapted to be locked onto the wire. A system for filtering an embolus from a fluid at a location within a lumen within a patient comprising:
A guide wire having a proximal end and a distal end having a distal tip;
A delivery assembly;
An embolic filter module that is deliverable with the delivery assembly through the guidewire to a location along the guidewire proximal to the dilating distal tip, in a coupled relationship with the guidewire, in the position An embolic filter module adapted to be released from the delivery assembly at
And at least one of an actuator or a sensor coupled to the guide wire,
The system wherein at least one of the actuator or the sensor actuates or senses at least one characteristic related to the guidewire and other characteristics related to the coupling relationship between the guidewire and the filter module.   56. The system according to any one of claims 50, 52, 54, or 55, comprising an actuator mechanically coupled to the guidewire to activate movement of the guidewire.   57. The system of claim 56, wherein the actuator includes a mechanical rotation assembly that mechanically rotates the guidewire.   57. The system of claim 56, wherein the actuator includes a mechanical translation assembly that moves the guidewire along a longitudinal axis.   57. The system of claim 56, wherein the actuator includes a vibration source that vibrates the guidewire.   56. A system according to any one of claims 50, 52, 54, or 55 comprising an actuator electrically coupled to the guidewire.   56. The system of any one of claims 50, 52, 54, or 55, comprising an actuator configured to adjust the shape of the guidewire in the body.   When the guidewire is disposed in the lumen, the guidewire is coupled to the guidewire so as to be configured to visualize or sense a property of at least one tissue structure within a region proximate to the guidewire. 56. The system according to any one of claims 50, 52, 54, or 55, comprising a sensor. An adjustable embolic filter system comprising:
A tubular body having a tubular wall defining an internal guidewire lumen;
A filter assembly coupled to the tubular wall and adjustable between a radially contracted configuration and a radially expanded configuration;
An implantable lumen within the tubular wall and having a mouth, wherein the implantable lumen communicates internally with the internal guidewire lumen through the mouth.   64. The injectable material delivery system further coupled to the implantable lumen and configured to inject injectable material through the mouth and into the internal guidewire lumen. System. An injectable material configured to be injected by the delivery system into the implantable lumen and through the mouth into the internal guidewire lumen;
65. The system of claim 64, wherein the injected adhesive material is configured with respect to the guidewire lumen and guidewire therein to secure the tubular body to the guidewire. And further comprising an injection needle having a proximal end configured to be coupled to the source of injectable material and a distal end having a thread.
The implantable lumen has a second thread;
65. The infusion needle is configured to be removably coupled to the implantable lumen via thread engagement of the first thread portion and the second thread portion. The system described in.   68. The system of claim 66, wherein the needle has at least two lumens extending from a proximal coupler along the proximal end into the distal end.   68. The system of claim 67, wherein the needle has a mixing chamber along a distal end, wherein the at least two lumens are in communication.   68. The system of claim 67, further comprising a multi-part adhesive material comprising a first component precursor material and a second component precursor material, wherein the adhesive material polymerizes or cures when mixed. A delivery assembly having a delivery member comprising an elongated tubular body having a delivery lumen;
68. The system of claim 66, wherein the delivery member is configured to couple the injection needle to the implantable lumen via the delivery lumen.   The delivery assembly further comprises an outer cuff member having a tubular wall defining an inner capture lumen, and the filter assembly is configured to be disposed within the inner capture lumen in the radially contracted configuration. 71. The system of claim 70, wherein the system is detachable from the internal capture lumen and automatically expands to the radially expanded configuration by a restoring force of the material to a memory shape.   64. The system of any one of claims 1, 2, 33, 34, or 63, further comprising a guide wire.   64. The system of any one of claims 1, 2, 33, 34, 50, 52, 54, 55, or 63, further comprising an atherectomy device.   64. The system of any one of claims 1, 2, 33, 34, 50, 52, 54, 55, or 63, further comprising a balloon catheter.   64. The system of any one of claims 1, 2, 33, 34, 50, 52, 54, or 63, further comprising a stent.   64. The system of any one of claims 1, 2, 33, 34, 50, 52, 54, or 63, further comprising a delivery catheter.   64. The system of any one of claims 1, 2, 33, 34, 50, 52, 54, or 63, further comprising an introducer sheath.

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