ARTICULATED NÄHVORRICHTUNG

SEAM DEVICE WITH JOINTS AND ASSOCIATED PROCEDURE

METHODS FOR FORMING TRACTS IN TISSUE

Described here are methods for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods comprise advancing a tissue-locating member adjacent to a tissue wall, deforming at least a portion of the tissue wall with the tissue-locating member, and advancing a tissue-piercing member through the deformed tissue to form the tract, where the tract provides access for one or more tools. Also described here are methods of forming tracts through rotated or tented tissue. Any of the methods described here may also be used with tissue having at least one irregular surface. 1a. advancing a tissue-locating member adjacent to a tissue wall;b. deforming at least a portion of the tissue wall with the tissue-locating member, causing the portion to assume a tented configuration wherein the portion does not become folded; andc. advancing a tissue-piercing member through the tented configuration to form the tract, wherein the tract provides access for one or more tools.. A method for forming a tract in a tissue comprising: The present application is a continuation of pending U.S. patent application Ser. No. 11/873,957, filed Oct. 17, 2007, the priority of which is claimed under 35 U.S.C. §120, and the contents of which is incorporated herein by reference in its entirety, as though set forth in full.Described here are methods for forming tracts in tissue. More specifically, described here are methods for forming tracts in tissue, where at least a portion of the tissue has been deformed.A number of devices and methods have previously been described for forming tracts in or through tissue. For example, U.S. patent application Ser. Nos. 10/844,247, 11/544,196, 11/545,272, 11/544,365, 11/544,177, 11/544,149, 10/888,682, 11/432,982, 11/544,317, 11/788,509, all of which are incorporated by reference in their entirety herein, describe ...

Biologically Implantable Prosthesis and Methods of Using the Same

A method of using a prosthetic heart valve assembly can include implanting a first prosthesis directly into a native annulus. The first prosthesis can have a central longitudinal axis and a first engagement element. The method can also include engaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis. The second prosthesis can have a prosthetic valve. The first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element. 19-. (canceled)10. A method of using a prosthetic heart valve assembly , the method comprising:implanting a first prosthesis directly into a native annulus, the first prosthesis having a central longitudinal axis and a first engagement element; andengaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis, the second prosthesis having a prosthetic valve,wherein the first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.11. The method of claim 10 , wherein the first prosthesis comprises an annular ring having a circular latitudinal cross-section perpendicular to the central longitudinal axis.12. The method of claim 11 , wherein implanting the first prosthesis directly into the native annulus comprises circumferentially expanding a diameter of the first prosthesis such that the first prosthesis frictionally engages the native annulus.13. The method of claim 10 , wherein implanting the first prosthesis ...

Access and Closure Device and Method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed. 1an elongated member comprising a longitudinal member axis, wherein the member is configured to access the lumen at a first angle, and wherein the first angle is defined by the longitudinal lumen wall axis and the longitudinal member axis, wherein the first angle is less than about 19 degrees.. A device for accessing a biological lumen having a lumen wall having a longitudinal lumen wall axis, the device comprising: The present application is a continuation of copending U.S. patent application Ser. No. 10/844,247, filed May 12, 2004, the priority of which is claimed under 35 U.S.C. §120, and the contents of which is incorporated herein by reference in its entirety, as though set forth in full.The present invention relates to the field of accessing a biological lumen and closing the access port thereby created.A number of diagnostic and interventional vascular procedures are now performed translumenally, where a catheter is introduced to the vascular system at a convenient access location—such as the femoral, brachial, or subclavian arteries—and guided through the vascular system to a target location to perform therapy or diagnosis. When vascular access is no longer required, the catheter and other vascular access devices must be removed from the vascular entrance and bleeding at the puncture site must be stopped.One common approach for providing hemostasis is to apply external force near and upstream from the puncture site, typically by manual compression. This method is time-consuming, frequently requiring one-half hour or more of compression before hemostasis. This procedure is uncomfortable for the patient and frequently requires administering analgesics. Excessive pressure can also present ...

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed. 1. A method for filling an abnormal void within the body , the method comprising:placing in a void within the body a catheter having a distal exit, the distal exit placed at a treatment site;passing a space-occupying device through the catheter and distal exit, the space-occupying device having a device volume and comprising a flexible leader, a first non-expandable space-occupying element connected to the leader, and a second non-expandable space-occupying element connected to the leader; anddeploying the device into the treatment site.2. The method of claim 1 , further comprising selecting a device volume wherein the device volume is large enough to substantially fill the treatment site claim 1 , and selecting a device volume wherein the device volume is small enough to prevent substantial alteration of the natural fluid flow through an adjacent element.3. The method of claim 2 , wherein the adjacent element is a vascular prosthesis.4. The method of claim 1 , further comprising placing a vascular prosthesis at the treatment site.5. The method of claim 4 , wherein deploying the device into the treatment site comprises deploying the device into the volume between a vascular wall at the treatment site and the vascular prosthesis.6. The method of claim 1 , wherein the device further comprises a radiopaque agent claim 1 , and wherein the method further comprises visualizing the location of the device after passing the device through the distal exit.7. The method of claim 1 , further comprising releasing a therapeutic and/or diagnostic agent and releasing at the treatment site.8. The method of claim 1 , wherein passing and deploying the device further comprises pushing the device with a driver.9. The method of claim 8 , ...

INTRAVASCULAR IMPLANTS AND METHODS OF USING THE SAME

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. The method of attaching a second implant, such as a vascular graft, to the intravascular implant is also disclosed. The implant can be made from an anchor, a connector and a seal. 1. An intravascular implant system comprising:a seal configured to allow a second material to pass through the seal, wherein the second material comprises a fluid,a connector comprising a connector first end and a connector second end, wherein the connector second end is attached to a first side of the seal, and wherein the connector comprises a first flexible member and a second flexible member, and wherein the first flexible member is attached to the second flexible member, and wherein the connector has a first transverse flow port and a second transverse flow port, andan anchor, wherein the connector first end is attached to the anchor.2. The system of claim 1 , wherein device comprises at least one of a graft or a stent.3. The system of claim 1 , wherein the seal has an expanded configuration claim 1 , and wherein the anchor has an expanded configuration claim 1 , and wherein the outer diameter of the seal in the expanded configuration is approximately equal to the outer diameter of the anchor in the expanded configuration.4. The system of claim 1 , wherein the seal has a first conduit and a second conduit claim 1 , and wherein the first and second conduits pass from a first terminal end of the seal to a second terminal end of the seal.5. The system of claim 1 , wherein the seal has a flow port extending through the seal claim 1 , and wherein the flow port is configured to allow the second material to pass through the seal claim 1 , and wherein the flow port has a cylindrical configuration.6. The system of claim 1 , wherein the seal is configured to be positioned adjacent to a vascular aneurysm.7. The system of claim 1 , wherein the seal has ...

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A system for creating translumenal vascular access , comprising:a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;b. a guidewire having an outer shape defined by a guidewire outer diameter profile;c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into the dilator member lumen;wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly ...

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a geometric adaptor apparatus for assisting with translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A geometric adaptor apparatus for assisting with translumenal vascular access , comprising:a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.2. The apparatus of claim 1 , wherein a maximum outer diameter of the guidewire is substantially smaller than a minimum inner diameter of the dilator member.3. The apparatus of claim 2 , wherein without the dilator adaptor interposed between the guidewire and dilator member claim 2 , an annular gap would be defined at the intersection of the guidewire and a distal end of the dilator member.4. The apparatus of claim 2 , wherein the maximum outer diameter of the guidewire is at least about 25% smaller than the minimum inner ...

Vascular access configuration

One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

Access closure configuration

One embodiment is directed to a device for forming a tract, comprising an anchor assembly wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of a blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage; and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood vessel and into contact with a saddle-shaped needle receiving structure, thereby creating an expandable tract between overlapping tissue portions of the vessel wall.

ACCESS CLOSURE CONFIGURATION

A method may comprise creating a first passage across a wall with a sharpened member at a first angle relative to a lumen; advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the blood vessel; applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly; and while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall, wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the expandable tract. 1. A method for forming an expandable tract across a wall of a blood vessel , comprising:a. creating a first passage across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by a lumen of the blood vessel in the region adjacent the first passage;b. advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the lumen of the blood vessel;c. applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly;d. while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall,wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the ...

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leaden Methods of making and using the devices are also disclosed. 1. A device for tilling a void within the body comprising:a flexible leader;a first space-occupying element having a first channel, wherein the flexible leader is configured to pass through the first channel; anda second space-occupying element having a second channel, wherein the flexible leader is configured to pass through the second channel, and wherein the flexible leader couples the first space-occupying element and the second space-occupying element;wherein the flexible leader is configured to bend within the first space-occupying element and the second space-occupying element; wherein the first space-occupying element and the second space-occupying element are configured to move along the flexible leader; and wherein the device is configured to be bioabsorbed by the body.2. A device for filling a void within the body comprising:a helical leader having a longitudinal axis, wherein the helical leader is configured to form a longitudinally compressed shape in a first configuration and a longitudinally elongated shape in a second configuration; anda structural reinforcement element coupled to the helical leader, wherein the structural reinforcement element is configured to maintain the compressed shape of the helical leader in the first configuration and the elongated shape of the helical leader in the second configuration.3. A device for filling a void within the body comprising:a first space-occupying element comprising a male interference-fit piece; anda second space-occupying element comprising a female interference-ft piece coupled to the male interference-fit piece. This application is a continuation of U.S. application Ser. No. 13/569,348, filed Aug. 8, 2012, issued as U.S. Pat. No. 8,562,636 on Oct. 22, 2013, ...

HEART VALVE ASSEMBLIES

A heart valve assembly comprises a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen. The heart valve assembly also comprises a second prosthesis comprising a valve, and a connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference. 1. A heart valve assembly comprising:a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen;a second prosthesis comprising a valve; anda connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference.2. The heart valve assembly of claim 1 , wherein the first prosthesis is configured to resiliently expand within the body lumen.3. The heart valve assembly of claim 1 , wherein the first prosthesis comprises an annular ring configured to be folded at the unexpanded state and unfolded at the expanded state.4. The heart valve assembly of claim 1 , wherein the first prosthesis comprises a plurality of fixturing device connectors configured to allow a plurality of fixturing devices to pass.5. The heart valve assembly of claim 4 , wherein the plurality of fixturing devices comprises sutures claim 4 , clips claim 4 , staples claim 4 , or pins.6. The heart valve assembly of claim 1 , wherein:the first prosthesis comprises a first engagement element; andthe connection adapter comprises a second engagement element configured to couple to the first engagement element such that the connection adapter is secured to the first prosthesis.7. The heart valve assembly of claim 6 , wherein:the first engagement element comprises a lip; andthe second engagement element comprises a spring lock tab.8. The heart valve assembly of claim 1 , wherein the second prosthesis further comprises a frame having ...

Vascular access configuration

One embodiment is directed to a geometric adaptor apparatus for assisting with translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

INTRAVASCULAR IMPLANTS AND METHODS OF USING THE SAME

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff. 1. A device for treating an aneurysm , the device comprising:a vascular graft comprising a tubular channel having a first end and a second end, wherein the tubular channel is bifurcated at a bifurcated portion at the second end;an expandable anchoring member attached to the first end of the tubular channel, wherein the expandable anchoring member comprises longitudinal anchor arms, wherein each of the longitudinal anchor arms extends radially outward along a length of the longitudinal anchor arm; and wherein the seal cuff comprises a first seal portion and a second seal portion,', 'wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff,', 'wherein the first seal portion has a first portion radius measured from a longitudinal axis of the device to a furthest point on an exterior surface of the first seal portion,', 'wherein the second seal portion has a second portion radius measured from the longitudinal axis of the device to the furthest point on the exterior surface of the second seal portion,', 'wherein the first gap has a first gap radius measured from the longitudinal axis of the device to the furthest point along the exterior surface of ...

Vascular access configuration

One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A system for creating translumenal vascular access , comprising:a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;b. a guidewire having an outer shape defined by a guidewire outer diameter profile; 'wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly capable of forming substantially atraumatic outer shape profile configuration defined by longitudinally sequential increases in overall outer diameter from exposed distal ends of the guidewire, dilator adaptor, dilator member, and introducer.', 'c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate ...

ACCESS CLOSURE CONFIGURATION

One embodiment is directed to a device for forming a tract, comprising an anchor assembly wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of a blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage; and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood vessel and into contact with a saddle-shaped needle receiving structure, thereby creating an expandable tract between overlapping tissue portions of the vessel wall. 1. A device for forming an expandable tract across a wall of a blood vessel , comprising:an anchor assembly comprising a proximal portion having a handle, a flexible distal portion, and a pre-bent midportion intercoupled between the proximal and distal portions, the pre-bent midportion comprising a saddle-shaped needle receiving structure configured to receive, support, and constrain lateral movement of a needle that may be inserted through a portion of the proximal portion;wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of the blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage;and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood ...

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

A method of filling an aneurysm space within the abdominal aorta is disclosed. The method involves placing a prosthesis in the abdominal aorta; delivering a fillable bladder in a deflated state into the aneurysm space using a catheter; placing a filler tube in fluid communication with an inflow port of the fillable bladder. The fillable bladder comprises a bladder seal surrounding the tillable bladder and the bladder seal has a first side, a second side, a third side, and a fourth side. The first side is symmetric with the second side with respect to a first axis of the tillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the fillable bladder. The first axis is perpendicular to the second axis. The method further involves filling the finable bladder with a filling agent and removing the filler tube. 1. A method of filling an aneurysm space within the abdominal aorta , the method comprising:placing a prosthesis in the abdominal aorta of a subject;delivering a finable bladder in a deflated state into the aneurysm space using a catheter;placing a filler tube in fluid communication with an inflow port of the Tillable bladder, wherein the filler tube accesses an interior of the tillable bladder, and wherein the tillable bladder comprises a bladder seal surrounding the tillable bladder, wherein the bladder seal has a first side, a second side, a third side, and a fourth side, wherein the first side is symmetric with the second side with respect to a first axis of the tillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the tillable bladder, wherein the first axis is perpendicular to the second axis;filling the finable bladder with a filling agent through the filler tube until the fillable bladder reaches a desired size in the aneurysm space, wherein the desired size is a size which prevents dislodgment of the prosthesis and allows natural fluid flow through the prosthesis ...

ACCESS AND CLOSURE DEVICE AND METHOD

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed. 1an elongated member comprising a longitudinal member axis, wherein the member is configured to access the lumen at a first angle, and wherein the first angle is defined by the longitudinal lumen wall axis and the longitudinal member axis, wherein the first angle is less than about 19 degrees.. A device for accessing a biological lumen having a lumen wall having a longitudinal lumen wall axis, the device comprising: The present application is a continuation of copending U.S. patent application Ser. No. 13/332,899, filed Dec. 21, 2011, which is a continuation of copending U.S. patent application Ser. No. 10/844,247, filed May 12, 2004, the priority of which is claimed under 35 U.S.C. §120, and the contents of which are incorporated herein by reference in their entirety, as though set forth in full.The present invention relates to the field of accessing a biological lumen and closing the access port thereby created.A number of diagnostic and interventional vascular procedures are now performed translumenally, where a catheter is introduced to the vascular system at a convenient access location—such as the femoral, brachial, or subclavian arteries—and guided through the vascular system to a target location to perform therapy or diagnosis. When vascular access is no longer required, the catheter and other vascular access devices must be removed from the vascular entrance and bleeding at the puncture site must be stopped.One common approach for providing hemostasis is to apply external force near and upstream from the puncture site, typically by manual compression. This method is time-consuming, frequently requiring one-half hour or more of compression before hemostasis. This procedure is ...

ACCESS CLOSURE CONFIGURATION

A method may comprise creating a first passage across a wall with a sharpened member at a first angle relative to a lumen; advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the blood vessel; applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly; and while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall, wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the expandable tract. 1. A method for forming an expandable tract across a wall of a blood vessel , comprising:a. creating a first passage across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by a lumen of the blood vessel in the region adjacent the first passage;b. advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the lumen of the blood vessel;c. applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly;d. while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall,wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the ...

Access closure configuration

One embodiment is directed to a device for forming a tract, comprising an anchor assembly wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of a blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage; and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood vessel and into contact with a saddle-shaped needle receiving structure, thereby creating an expandable tract between overlapping tissue portions of the vessel wall.

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed. 1. A system for treating an aneurysm comprising:a catheter having a distal exit, wherein the distal exit is configured to be placed between an outer surface of a scent and a wall of the aneurysm when the catheter is in a deployed configuration; anda material configured to pass through the distal exit of the catheter such that the material deploys between the outer surface of the stem and the wail of the aneurysm, and wherein the material comprises at least one of glass, metal, acid, and silicone.2. The system of claim 1 , wherein the stem bifurcates at a bifurcation point into a first leg and a second leg claim 1 , wherein a first length of a longitudinal axis of the catheter is parallel to a length of a longitudinal axis of at least the first leg or the second leg of the stem claim 1 , wherein the catheter is configured to deploy the material such that the material exits the catheter in a direction parallel to a second length of the longitudinal axis of the catheter claim 1 , wherein the distal exit of the catheter is superior to the bifurcation point when the catheter is in the deployed configuration claim 1 , wherein the material further comprises a coating claim 1 , wherein the coating is configured to cover the material claim 1 , and wherein the coating is an agent.3. The system of claim 1 , wherein the stem bifurcates at a bifurcation point into a first leg and a second leg claim 1 , and wherein a first length of a longitudinal axis of the catheter is parallel to a length of a longitudinal axis of at least the first leg or the second leg of the stent.44. The system of claim 3 , wherein the distal exit of the catheter is superior to the bifurcation point when the catheter is in the deployed configuration.5. The ...

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed. 1. A device for filling a void within the body comprising:a flexible leader;a first space-occupying element having a first channel, wherein the flexible leader is configured to pass through the first channel; anda second space-occupying element having a second channel, wherein the flexible leader is configured to pass through the second channel, and wherein the flexible leader couples the first space-occupying element and the second space-occupying element;wherein the flexible leader is configured to bend within the first space-occupying element and the second space-occupying element, wherein the first space-occupying element and the second space-occupying element are configured to move along the flexible leader, wherein the first and second space-occupying elements are hollow, and wherein the device is configured to be bioabsorbed by the body.2. The device of claim 1 , wherein the first element comprises polymer.3. The device of claim 2 , wherein the polymer comprises polypropylene.4. The device of claim 1 , wherein the first element comprises collagen.5. The device of claim 1 , further comprising a radiopaque agent fixed to or integrated with the device.6. The device of claim 1 , further comprising a coating claim 1 , wherein the coating covers the device claim 1 , and wherein the coating comprises a therapeutic agent and/or a diagnostic agent.7. The device of claim 1 , wherein the device comprises a time-release coating.8. A device for filling a void within the body comprising:a helical leader having a longitudinal axis, wherein the helical leader is configured to form a longitudinally compressed shape in a first configuration and a longitudinally elongated shape in a second configuration; anda structural ...

Embolization device and a method of using the same

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

INTRAVASCULAR IMPLANTS AND METHODS OF USING THE SAME

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff. 1. (canceled)2. A device for treating an aneurysm having a device longitudinal axis , the device comprising:a bifurcated vascular graft comprising a main branch, a first leg, and a second leg, wherein the second leg is longer than the first leg, wherein the main branch is positionable across the aneurysm, and wherein the first leg and the second leg are positionable across the aneurysm;a fillable seal comprising a first port, a second port, a third port, and a fourth port, wherein the first port and the second port are closer to a fillable seal proximal end than to a fillable seal distal end, wherein the third port and the fourth port are closer to the fillable seal distal end than to the fillable seal proximal end, wherein the first port is opposite the third port, wherein the second port is opposite the fourth port, wherein the first port and the third port are on a fillable seal first side, wherein the second port and the fourth port are on a fillable seal second side, wherein the fillable seal first side is opposite the fillable seal second side, wherein the third port is closer to the first leg than the first port, the second port, and the fourth port, and wherein the fourth port is closer to the second leg than the first port, ...

ACCESS CLOSURE CONFIGURATION

A method may comprise creating a first passage across a wall with a sharpened member at a first angle relative to a lumen; advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the blood vessel; applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly; and while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall, wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the expandable tract. 1. A method for forming an expandable tract across a wall of a blood vessel , comprising:a. creating a first passage across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by a lumen of the blood vessel in the region adjacent the first passage;b. advancing an anchor assembly through the first passage such that a distal portion of the anchor assembly is placed within the lumen of the blood vessel;c. applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly;d. while maintaining the desired contact configuration, advancing a needle through a portion of the anchor assembly and through a portion of the wall of the blood vessel to form an expandable tract between overlapping tissue portions of the vessel wall,wherein a portion of the anchor assembly comprises a saddle-shaped needle receiving structure configured to receive and support the needle after it has been advanced across the portion of the wall to create the ...

Heart Valve Assemblies

A heart valve assembly comprises a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen. The heart valve assembly also comprises a second prosthesis comprising a valve, and a connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference.

Vascular access configuration

One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A system for creating translumenal vascular access , comprising:a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;b. a guidewire having an outer shape defined by a guidewire outer diameter profile; 'wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly capable of forming substantially atraumatic outer shape profile configuration defined by longitudinally sequential increases in overall outer diameter from exposed distal ends of the guidewire, dilator adaptor, dilator member, and introducer.', 'c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate ...

Embolization device and a method of using the same

A method of filling an aneurysm space within the abdominal aorta is disclosed. The method involves placing a prosthesis in the abdominal aorta; delivering a fillable bladder in a deflated state into the aneurysm space using a catheter; placing a filler tube in fluid communication with an inflow port of the fillable bladder. The fillable bladder comprises a bladder seal surrounding the fillable bladder and the bladder seal has a first side, a second side, a third side, and a fourth side. The first side is symmetric with the second side with respect to a first axis of the fillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the fillable bladder. The first axis is perpendicular to the second axis. The method further involves filling the fillable bladder with a filling agent and removing the filler tube.

EMBOLIZATION DEVICE AND A METHOD OF USING THE SAME

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed. 1. A system for treating an aneurysm comprising:a catheter having a distal exit; anda self-fusing material,wherein the self-fusing material has a deployed configuration and an undeployed configuration,wherein when the self-fusing material is in the undeployed configuration, the distal exit and the self-fusing material are between an outer surface of a prosthesis and a wall of the aneurysm,wherein when the self-fusing material is in the deployed configuration, the distal exit and the self-fusing material are between the outer surface of the prosthesis and the wall of the aneurysm, and the self-fusing material has fused to itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material and the prosthesis, andwherein the self-fusing material is configured to promote fusing or other coagulative effect.2. The system of claim 1 , wherein the self-fusing material comprises a polymer formulation.3. The system of claim 1 , wherein the self-fusing material is radiopaque such that in the deployed configuration claim 1 , the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.4. The system of claim 1 , wherein at the distal exit of the catheter claim 1 , the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.5. The system of claim 1 , further comprising a visualization tool for visualizing the self-fusing material before claim 1 , during claim 1 , and after the self-fusing material has been deployed.6. The system of claim 1 , wherein the self-fusing material comprises a coating claim 1 , wherein the coating is an agent claim 1 , and wherein the agent is at least one of a therapeutic agent and a ...

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A system for creating translumenal vascular access , comprising:a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;b. a guidewire having an outer shape defined by a guidewire outer diameter profile; 'wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly capable of forming substantially atraumatic outer shape profile configuration defined by longitudinally sequential increases in overall outer diameter from exposed distal ends of the guidewire, dilator adaptor, dilator member, and introducer.', 'c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate ...

Heart Valve Assemblies

A heart valve assembly comprises a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen. The heart valve assembly also comprises a second prosthesis comprising a valve, and a connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference. 119-. (canceled)20. A prosthetic valve assembly comprising:a first annular prosthesis having a frame configured to have a first diameter in a collapsed state for introduction into a body lumen and a second diameter in an expanded state for implantation within an annulus of a heart, the first annular prosthesis having a first alignment element; anda second annular prosthesis including a prosthetic valve, the second annular prosthesis having a second alignment element that is configured to align with the first alignment element when the second annular prosthesis is positioned within the first annular prosthesis in the expanded state.21. The prosthetic valve assembly of claim 20 , wherein the first alignment element is a groove that extends in parallel with a longitudinal axis of the first annular prosthesis.22. The prosthetic valve assembly of claim 21 , wherein the second alignment element is a rib that protrudes outwardly from the second annular prosthesis claim 21 , the rib being configured to slide within the groove of the first annular prosthesis when the first annular prosthesis and the second annular prosthesis are mated with each other in vivo.23. The prosthetic valve assembly of claim 22 , wherein when the second annular prosthesis is positioned within the first annular prosthesis the first and second alignment elements prevent rotation of the first annular prosthesis relative to the second annular prosthesis.24. The prosthetic valve assembly of claim 20 , wherein during positioning of the second annular prosthesis within the first annular ...

INTRAVASCULAR IMPLANTS AND METHODS OF USING THE SAME

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff. 1. A device for treating an aneurysm having a longitudinal axis , the device comprising:a vascular graft comprising a seal and a tubular channel having a first end and a second end; and wherein the seal comprises a first seal portion and a second seal portion,', 'wherein the first seal portion is separated from the second seal portion by a first length of material and a second length of material,', 'wherein the first seal portion has a first portion radius measured from the longitudinal axis to a furthest point on an exterior surface of the first seal portion,', 'wherein the second seal portion has a second portion radius measured from the longitudinal axis to the furthest point on an exterior surface of the second seal portion,', 'wherein the first length of material has a first length of material radius measured from the longitudinal axis to the furthest point along an exterior surface of the first length of material,', 'wherein the second length of material has a second length of material radius measured from the longitudinal axis to the farthest point along an exterior surface of the second length of material,', 'wherein the first portion radius is greater than the first length of material radius and the second length of ...

VASCULAR ACCESS CONFIGURATION

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member. 1. A system for creating translumenal vascular access , comprising:a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;b. a guidewire having an outer shape defined by a guidewire outer diameter profile; 'wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly capable of forming substantially atraumatic outer shape profile configuration defined by longitudinally sequential increases in overall outer diameter from exposed distal ends of the guidewire, dilator adaptor, dilator member, and introducer.', 'c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate ...

Access and closure device and method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Biological tissue closure device and method

Devices and methods for biological tissue closure are disclosed. Arteriotomy closure and hemostasis devices and methods are disclosed. A device that can provide a lateral tension across an opening in the tissue and apply energy to seal the tissue is disclosed. Methods for using the device are also disclosed.

Access and closure device and method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel's intima and adventitia. Methods for using the device are also disclosed.

Methods for forming tracts in tissue

Described here are methods for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods comprise advancing a tissue-locating member adjacent to a tissue wall, deforming at least a portion of the tissue wall with the tissue-locating member, and advancing a tissue-piercing member through the deformed tissue to form the tract, where the tract provides access for one or more tools. Also described here are methods of forming tracts through rotated or tented tissue. Any of the methods described here may also be used with tissue having at least one irregular surface.

Devices, methods, and kits for forming tracts in tissue

Described here are methods and devices for forming tracts in tissue. Some of the devices comprise an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices comprise more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device comprises one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Devices, methods, and kits for forming tracts in tissue

Tissue tract-forming devices, methods, and kits are disclosed. In some variations, a method for forming a tract in a tissue wall having an interior surface and an exterior surface may comprise advancing an anchor member through the tissue wall and into a lumen defined by the tissue wall, the anchor member comprising a proximal portion, a distal portion, and an intermediate portion therebetween, wherein the proximal and intermediate portions are angled with respect to each other and the intermediate and distal portions are angled with respect to each other, positioning the anchor member so that the intermediate portion contacts the interior surface of the tissue wall and the distal portion is angled toward the interior surface of the tissue wall, and advancing a tissue-piercing member into the tissue wall while the intermediate portion is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.

Devices, methods, and kits for forming tracts in tissue

Described here are methods and devices for forming tracts in tissue. Some of the devices feature an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices feature more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device features one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Embolization device and a method of using the same

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Access and closure device and method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel's intima and adventitia. Methods for using the device are also disclosed.

Access closure configuration

One embodiment is directed to a device for forming a tract, comprising an anchor assembly wherein at least a distal tip of the flexible distal portion is configured to be placed within a lumen of a blood vessel through a first passage created across the wall with a sharpened member at a first angle relative to a lumen longitudinal axis defined by the lumen of the blood vessel in the region adjacent the first passage; and wherein upon applying a force to the anchor assembly to position an adjacent portion of the blood vessel wall into a desired contact configuration relative to the anchor assembly, the needle is operatively coupled to the anchor assembly such that it may be advanced across the wall of the blood vessel and into contact with a saddle-shaped needle receiving structure, thereby creating an expandable tract between overlapping tissue portions of the vessel wall.

Intravascular implants and methods of using the same

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff.

Device for forming tracts in tissue

Described here are methods, devices and kits for locating tissue and/or forming one or more tracts in tissue. In some variations, tissue may be located (e.g., using one or more optical sensors, ultrasound sensors, thermal sensors, or the like) and one or more tracts may be formed through the tissue after it has been located. In certain variations, the same device may be used both to locate tissue and to form one or more tracts in the tissue. In some variations, a tissue-piercing member for forming one or more tracts in tissue may comprise a first elongated portion and a second elongated portion, and an angle there between.

Biologically implantable prosthesis and methods of using the same

A biological implantable prosthesis (2) is disclosed. The prosthesis (2) can have a circumferentially expandable wall (4) with engagement elements (148) that enable the prosthesis (2) to engage a second prosthesis (68). The prosthesis (2) can be placed accurately into annulus (204) which has an initial annulus diameter (206). The prosthesis (2) can be used to expand the annulus (204) to an expanded annulus diameter (208).

Micro-gripper assembly

Devices and methods for forming tracts in tissue

Devices, methods, and kits for forming tracts in tissue

Described here are methods and devices for forming tracts in tissue. Some of the devices comprise an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices comprise more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device comprises one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Fixturing assembly

A fixturing assembly is provided that includes a needle and a fixturing device. The needle includes a first sharpened end and a second end including a can. The fixturing device includes an elongate filament having first and second ends, and an enlarged fixturing device on the first end of the filament. The second end of the filament is held by the can by frictional resistance, the second end of the filament being removable from the can when a tensile force is applied between the needle and the second end of the filament that exceeds the frictional resistance. For example, the can may include a coil, corrugations, or a roughened inner surface to removably hold the end of the fixturing device.

Biological tissue closure device and method

Devices and methods for biological tissue closure are disclosed. Arteriotomy closure and hemostasis devices and methods are disclosed. A device that can provide a lateral tension across an opening in the tissue and apply energy to seal the tissue is disclosed. Methods for using the device are also disclosed.

Access and closure device and method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel's intima and adventitia. Methods for using the device are also disclosed.

Devices, methods, and kits for forming tracts in tissue

Described here are methods and devices for forming tracts in tissue. Some of the devices comprise an elongate member, a suction member coupled to a distal portion of the elongate member, and a tissue-piercing member slidably housed within the elongate member for forming a tract in tissue. Other devices comprise more than one suction member. Methods for forming tracts in tissue are also described here. In some methods, a device is advanced adjacent tissue, where the device comprises one or more suction members and a tissue-piercing member. Suction is applied so that the tissue is drawn against the one or more suction members, and a tissue-piercing member is advanced in a first direction through the drawn tissue to form a tract in or through the tissue. Kits incorporating one or more of the devices described here, in conjunction with one or more tools or the like, are also described here.

Biologically implantable prosthesis and methods of using the same

A biological implantable prosthesis (2) is disclosed. The prosthesis (2) can have a circumferentially expandable wall (4) with engagement elements (148) that enable the prosthesis (2) to engage a second prosthesis (68). The prosthesis (2) can be placed accurately into annulus (204) which has an initial annulus diameter (206). The prosthesis (2) can be used to expand the annulus (204) to an expanded annulus diameter (208).

Vascular access configuration

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Access and closure device and method

Devices and methods for accessing and closing vascular sites (114) are disclosed. Self-sealing closure devices (2) and methods are disclosed. A device (2) that can make a steep and controlled access path into a vascular lumen (114) is disclosed. Methods for using the device (2) are also disclosed.

Devices and methods for forming tracts in tissue

Described here are devices and methods for forming one or more tracts in tissue. The tracts may be formed in any suitable or desirable tissue, and may seal relatively quickly without the need for a supplemental closure device. In some variations, the methods may comprise clamping at least a portion of a tissue and advancing a tissue-piercing member through the clamped tissue to form a tract. The tract may, for example, provide access for one or more tools.

Access and closure device and method

Articulating suturing device and method

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Access and closure device and method

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Coiled endoluminal prosthesis system, delivery catheter and method

A delivery assembly includes a catheter, a generally helical endoluminal prosthesis, placeable in a radially contracted state on the catheter, means for engaging portions of the prosthesis to maintain it in the contracted state, and means for controllably releasing the portions so the prosthesis controllably expands. A delivery catheter comprises a first, flexible, polymer-based tube and a second, metal tube with flexibility enhancing relief areas to enhance the bending flexibility while retaining good torsional stiffness. A coiled endoluminal prosthesis system may include means for rotating a delivery catheter while axially releasing the prosthesis. A release element may be retracted simultaneously with rotation of the delivery catheter. The prosthesis may be configured to reduce or eliminate any difference between the length of the prosthesis when expanded and contracted.

Articulating suturing device and method

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract. The suture may be provided with a bight between first and second ends, the bight including one or more loops prearranged to define a pre-tied knot when one or more ends of the suture past therethrough.

NEEDLE ASSEMBLY AND ASSOCIATED METHOD

Articulating suturing device and method

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot (24) near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs (50), and needles (38) are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions (52) within the foot can guide the advancing needles into engagement with the cuffs, The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Biologically implantable prosthesis

Intravascular implants and methods of using the same

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. The method of attaching a second implant, such as a vascular graft, to the intravascular implant is also disclosed. The implant can be made from an anchor, a connector and a seal.

Articulating suturing device and method

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Biological tissue closure device and method

Devices and methods for biological tissue closure are disclosed. Arteriotomy closure and hemostasis devices and methods are disclosed. A device that can provide a lateral tension across an opening in the tissue and apply energy to seal the tissue is disclosed. Methods for using the device are also disclosed. Fig. 23 ..-'---:a. 52 ..-- 2 - - 16b 57 ..- 70 Fig. 24

Gelenkige nähvorrichtung

血管アクセス構成

【課題】周囲組織構造への断裂を最小限にしながら、血管壁を横断して、伸長器具アクセスを促進するための血管アクセスシステムを提供する。 【解決手段】近位端２２および遠位端２０を有し、それを通る拡張器アダプタ内腔２８を画定する、拡張器アダプタ部材４を備える。拡張器アダプタ内腔は、ガイドワイヤの１つ以上の部分の挿入に対応するように定寸される、内径プロファイルによって画定され、拡張器アダプタは、拡張器部材を通して形成される拡張器部材内腔内への拡張器アダプタの近位端の少なくとも部分挿入に対応するように定寸される、外径プロファイルによってさらに画定され、拡張器部材は、導入器部材を通して形成される導入器部材内腔を通して、導入器カテーテル２に連結可能である。 【選択図】図２Ａ

Nahtvorrichtung mit gelenken und zugehöriges verfahren

Vascular access configuration

One embodiment is directed to a geometric adaptor apparatus for assisting with translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

連接型縫合装置および方法

【課題】体の内腔を縫合する装置、システム、および方法は、経皮的組織路の遠位端に位置する血管穿刺部位の縫合を可能にする。 【解決手段】シャフトの遠位端の近傍にある細長い連接された足部が貫通部を通って挿入され、足部が内腔の軸の方向に延在するよう作動される。足部は、縫合糸取り付けカフスを運び、針は、足部が血管の内皮表面に対して近位方向に引き出された後、シャフトから進められ、貫通部の外側で血管壁を通され、針カフスと係合される。組織路内のシャフトの断面は、針がシャフトから離れる前に針を横方向に反らすことで最小化され、足部内のテーパが付けられた凹みが、カフスと係合するよう進む針を案内する。 【選択図】図１

Embolization device and a method of using the same

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Embolization device and a method of using the same

A method of filling an aneurysm space within the abdominal aorta is disclosed. The method involves placing a prosthesis in the abdominal aorta; delivering a fillable bladder in a deflated state into the aneurysm space using a catheter; placing a filler tube in fluid communication with an inflow port of the fillable bladder. The fillable bladder comprises a bladder seal surrounding the fillable bladder and the bladder seal has a first side, a second side, a third side, and a fourth side. The first side is symmetric with the second side with respect to a first axis of the fillable bladder and the third side is symmetric with the fourth side with respect to a second axis of the fillable bladder. The first axis is perpendicular to the second axis. The method further involves filling the fillable bladder with a filling agent and removing the filler tube.

Embolization device and a method of using the same

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Intravascular implants and methods of using the same

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. The method of attaching a second implant, such as a vascular graft, to the intravascular implant is also disclosed. The implant can be made from an anchor, a connector and a seal.

Embolization device and a method of using the same

Space-occupying devices for treating voids within the body are disclosed. The devices can have multiple elements connected to a flexible leader. The devices can be coated by a binding agent. The devices can also be fillable. Methods of making and using the devices are also disclosed.