Abstract: A method and apparatus for sealing a puncture or incision formed percutaneously in a tissue. The apparatus includes an anchor, a sealing plug, a suture, a compaction member assembly, a spool assembly, and a release member. The compaction member assembly is structured and arranged to apply a compressive force to compact the sealing plug toward the anchor. The spool assembly includes a plurality of post members, and the suture is wound about the post members to define a suture cam path. Unspooling the suture along the suture cam path provides driving of the compaction member assembly. The release member is operable to move the post members to release the suture member from the spool assembly.

Abstract: A tissue puncture closure device includes a delivery member, a handle assembly, and a sealant cartridge. The delivery member includes a sealant lumen and is insertable into a tissue puncture. The handle assembly is mounted to a proximal end of the delivery member and includes a cartridge chamber and a plunger member. The sealant cartridge is insertable into the cartridge chamber. The sealant cartridge has at least first and second sealant chambers carrying at least first and second sealant components, respectively. Operation of the handle assembly ejects the first and second sealant components into the sealant lumen for delivery to the tissue puncture.

Abstract: A tissue puncture closure device includes an anchor, a suture connected to the anchor at a distal end of the suture, a sealing plug positioned proximal of the anchor, and a compaction assembly. The compaction assembly includes a compaction tube having a distal end and a proximal end, and a pivot arm having first and second ends and being rotatable about a pivot axis. The proximal end of the compaction tube is connected to the first end of the pivot arm and a proximal end of the suture is connected to the second end of the pivot arm. The compaction assembly also includes a release member operable to release the pivot arm to rotate between a first position wherein the compaction tube is withdrawn, and a second position wherein tension is applied in the suture and the compaction tube is advanced to compact the sealing plug.

Abstract: The present disclosure provides a strong, flexible catheter shaft for use in a catheter system. The flexible catheter shaft includes a nitinol tube having one or more sets of cuts therein in combination with one or more outer jacket layers. The flexible catheter shaft provides a shaft having sufficient stiffness and kink resistance to allow an operator to advance an electrode basket connected to the flexible catheter shaft through a guide catheter to a target ablation site without causing vessel trauma. The distal tip of the flexible catheter shaft is designed to have sufficient flexibility to reduce any risk of kicking out a guide catheter when tracking the electrode basket around turns in the vasculature of a patient.

Abstract: In a catheter system and method for controlling such a system, an elongate hollow shaft has a proximal end connected to a handle and a distal end remote from the handle. A working component is carried by the shaft and has at least one characteristic that is adjustable. An actuator is rotatably mounted on the handle for selectively adjusting at least one characteristic of the working component. A control line extends at least in part within the shaft. The control line operatively couples the actuator with the working component such that rotation of the actuator relative to the handle effects linear translation of the control line to adjust the at least one characteristic of the working component.

Abstract: A tissue puncture closure device includes an anchor, a suture connected to the anchor at a distal end of the suture, a sealing plug positioned proximal of the anchor, and a compaction assembly. The compaction assembly includes a compaction tube having a distal end and a proximal end, and a pivot arm having first and second ends and being rotatable about a pivot axis. The proximal end of the compaction tube is connected to the first end of the pivot arm and a proximal end of the suture is connected to the second end of the pivot arm. The compaction assembly also includes a release member operable to release the pivot arm to rotate between a first position wherein the compaction tube is withdrawn, and a second position wherein tension is applied in the suture and the compaction tube is advanced to compact the sealing plug.

Abstract: A manifold for the delivery of bioadhesive sealant may comprise an inlet, a first outlet, a second outlet, and at least one valve positioned and configured to facilitate selective fluid communication between the inlet and the first outlet and the inlet and the second outlet. A syringe for delivering a bioadhesive sealant may comprise at least one barrel, at least one plunger, and at least one feature positioned and configured to prevent movement of the at least one plunger relative to the at least one barrel after a first predetermined quantity of bioadhesive sealant has been delivered. A bioadhesive sealant delivery system may comprise a manifold, a syringe, and a catheter, wherein a first lumen of the catheter is coupled to a first outlet of the manifold and a second lumen of the catheter coupled to a second outlet of the manifold.

Abstract: A vascular closure device includes an inflation balloon and a delivery tube. The delivery tube includes an inflation lumen configured to deliver inflation fluid to the inflation balloon, a sealant lumen configured to deliver a sealant to a vessel puncture, and a delivery tip in flow communication with the sealant lumen and having a plurality of outlet openings.

Abstract: A bioadhesive mixing assembly includes first and second syringes and an adapter. The first syringe includes first and second chambers holding a first sealant component and an activator, respectively. The second syringe includes third and fourth chambers holding a second sealant component and one of an activator or a third sealant component, respectively. The adapter is mounted to the first syringe and includes first and second channels in flow communication with the first and second chambers, a first seal member providing sealed access to the first and second channels, first and second needles connected in flow communication with the third and fourth chambers, and a second seal member enclosing the first and second needles. Connecting the adapter to the second syringe punctures the first and second seal members with the first and second syringes to create flow communication between the first and third chambers and the second and fourth chambers.

Abstract: A closure assembly includes an insertion sheath insertable into a tissue puncture and a tissue puncture closure device insertable through the insertion sheath and into the tissue puncture. The tissue puncture closure device includes a dual lumen delivery tube, a first sealing sleeve, and a second sealing sleeve. The dual lumen delivery tube has a first lumen configured to deliver a volume of sealing material to the tissue puncture, and a second lumen sized for insertion of a balloon location device. The first sealing sleeve is positioned between an outer surface of the dual lumen delivery tube and an inner surface of the insertion sheath to limit backflow of the sealing material into the insertion sheath. The second sealing sleeve is positioned between an outer surface of the balloon location device and an inner surface of the second lumen to limit backflow of the sealing material into the second lumen.

Abstract: A vessel puncture closure device includes a balloon catheter and a sealant delivery device. The balloon catheter has an inflatable balloon positioned at a distal end thereof. The sealant delivery catheter has a sealant lumen configured to delivery a volume of sealant to a vessel puncture. The sealant delivery catheter is configured to move axially relative to the balloon between a first position in which the sealant delivery catheter delivers a first volume of sealant to the vessel puncture, and a second position spaced proximal of the first position to deliver a second volume of sealant to the vessel puncture.

Abstract: A deployment device having a carrier tube, for bringing a sealing plug into position within a puncture tract or incision and deploying the sealing plug within the incision or puncture tract, towards the outer surface of a tissue puncture, is provided. The carrier tube is designed to facilitate easier deployment and improved compaction of the sealing plug, the sealing plug often made of collagen. The carrier tube is adapted to prevent the premature hydration of the sealing plug, where premature hydration of the sealing plug may result in difficulty in deploying the sealing plug. The carrier tube is designed to facilitate easier loading of puncture tract closing elements into the distal end of the carrier tube.

Abstract: A tissue puncture closure device includes a delivery member, a handle assembly, and a sealant cartridge. The delivery member includes a sealant lumen and is insertable into a tissue puncture. The handle assembly is mounted to a proximal end of the delivery member and includes a cartridge chamber and a plunger member. The sealant cartridge is insertable into the cartridge chamber. The sealant cartridge has at least first and second sealant chambers carrying at least first and second sealant components, respectively. Operation of the handle assembly ejects the first and second sealant components into the sealant lumen for delivery to the tissue puncture.

Abstract: A bioadhesive sealant storage and preparation system may comprise a plurality of containers and an adapter. The plurality of containers may comprise a first container having a first bioadhesive sealant component therein, and a second container having a second bioadhesive sealant component therein. The adapter may comprise a manifold comprising a plurality of channels formed therein, an inlet region sized and configured to receive the plurality of containers and facilitate fluid communication between each container of the plurality of containers and a respective channel of the plurality of channels, and an outlet region sized and configured to receive a syringe and provide fluid communication between the syringe and the plurality of channels.

Abstract: Methods and apparatus are disclosed for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The methods and apparatus provide for a compaction device or a tamping device that improves control of the amount of force exerted upon the sealing plug. Further, the compaction tube or tamping device can deform upon application of excessive compaction force, thereby reducing the possibility of damage to the sealing plug, anchor, or artery.

Abstract: A method and apparatus for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The method and apparatus provide for disengagable automatic tamping and/or cinching of the sealing plug when the apparatus is withdrawn from the puncture site. The disengagable automatic tamping and/or cinching is facilitated by transducing a motive force generated by the withdrawal of the apparatus into a tamping and/or cinching force.

Abstract: A closure device operable to seal a vessel puncture and including a delivery member and a sealant material applicator. The delivery member is insertable through a tissue tract to the vessel puncture. The sealant material applicator is configured to supply a volume of sealant material to the delivery member and includes a housing, a plunger assembly, and at least one container. The housing includes at least first and second chambers, wherein the first chamber carries a first sealant component and the second chamber carries a second sealant component. The container is insertable into the first or second chamber and carries a third sealant component of the sealant material. The sealant material applicator creates flow communication between the container and at least one of the first and second chambers to mix the third sealant component with the first and second sealant components.

Abstract: A sealant delivery device includes a delivery tube, a bioadhesive container, and an adapter. The delivery tube includes proximal and distal ends. The bioadhesive container holds a sealant activator and a sealant precursor separated from each other. The adapter is interposed between the delivery tube and the bioadhesive container. The adapter includes a first channel member that couples a first lumen of the delivery tube to the sealant activator, and a second channel member that couples the first lumen to the sealant precursor. The adapter provides separation of the sealant activator and the sealant precursor until a position distal of the bioadhesive container.

Abstract: A method and apparatus for sealing a puncture or incision formed percutaneously in a tissue. The apparatus includes an anchor, a sealing plug, a suture, a compaction member assembly, a spool assembly, and a release member. The compaction member assembly is structured and arranged to apply a compressive force to compact the sealing plug toward the anchor. The spool assembly includes a plurality of post members, and the suture is wound about the post members to define a suture cam path. Unspooling the suture along the suture cam path provides driving of the compaction member assembly. The release member is operable to move the post members to release the suture member from the spool assembly.

Abstract: A tissue puncture closure device includes an anchor, a sealing plug, a suture coupled to the sealing plug, a compaction arrangement, and an automatic driving assembly. The automatic driving assembly includes first and second spool members and an actuation member. The first spool member is configured to coil a portion of the suture. The second spool member is configured to coil a portion of the compaction arrangement. The actuation member is coupled to the first and second spool members. Activation of the actuation member releases the first spool member for rotation to apply a tension force in the suture, and releases the second spool member for rotation to distally advance a portion of the compaction arrangement to compress the sealing plug.