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US 5,282,827 AGranted
Hemostatic puncture closure system and method of use
AssigneeKensey Nash Corporation
InventorsKenneth Kensey, John E. Nash, Douglas Evans
Life of this patent
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AssigneeKensey Nash Corporation
InventorsKenneth Kensey, John E. Nash, Douglas Evans
Estimating the term…
A system, a closure, and method of use for determining the position of a blood vessel via a percutaneous puncture and for sealing the percutaneous puncture in the blood vessel. The system includes an introducer sheath and associated positioning device, a hemostatic puncture closure, and a deployment instrument. The positioning device enables the introducer sheath to be positioned at a desired position within the vessel. The deployment instrument includes a tubular carrier storing the closure. The carrier has a distally located free end to be extended via an introducer through the puncture and its associated tract. The closure comprises a radiopaque rigid anchor, a compressed collagen plug, and a thin filament connecting the two in a pulley-like arrangement. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer. The instrument and introducer are then withdrawn together to pull the anchor against the tissue contiguous with the puncture inside the artery. Further withdrawl draws the plug out of the carrier into the puncture tract, whereupon the plug moves with respect to the anchor into engagement with the outside of artery wall to seal the puncture or incision. A tensioning device limits the force applied to the filament. The carrier also includes a tamper which is used to mechanically deform the plug within the tract. Once positioned hemostasis occurs rapidly, thereby locking the closure in place.
A system for sealing a percutaneous puncture in a blood vessel of a living being, said system comprising carrier means, introducer means, and closure means, said puncture comprising a tract extending through tissue overlying the vessel, said closure means comprising anchoring means, sealing means, and filament means, said filament means coupling said anchoring means and said sealing means, said introducer means comprising a tubular member having a distal free end insertable into the puncture tract and through the puncture, said carrier means being insertable through said introducer means and including means to expel said anchoring means therefrom, and said carrier means being retractable with respect to said introducer means after said anchoring means has been expelled from said carrier means, whereupon when said carrier is retracted it draws said anchoring means into engagement with said distal free end of said introducer means, said introducer means and said carrier means coupled for movement together to draw the anchoring means which is in engagement with said distal end of said introducer means into engagement with the interior tissue of the vessel generally adjacent the puncture, said filament means being operative to move said anchoring means and said sealing means relative to each other to cause said sealing means to engage tissue generally adjacent the puncture outside of the vessel.
Apparatus for determining the location of the wall of a vessel or lumen in a living being via a percutaneous incision or puncture, said apparatus comprising a liquid entrance port, passageway means, liquid flow control means, a first elongated member, and a second elongated member, said first elongated member being tubular and having a distal end of a fixed predetermined size arranged to be inserted through said incision or puncture and moveable with respect thereto, said second elongated member being removably located within said first elongated member and comprising a cylindrical member having a longitudinally extending relieved surface on the exterior thereof, said surface cooperating with said first elongated member to define said passageway means therebetween, said passageway means extending longitudinally down said first elongated member and in fluid communication with said liquid entrance port, said apparatus being arranged to be inserted through said incision or puncture so that said port is located within said vessel or lumen, whereupon liquid within said vessel or lumen may flow into said port and through said passageway means, said liquid flow control means being coupled to said passageway means and selectively operable to enable said liquid from said passageway to flow to a point at which it may be observed.
Apparatus for determining the location of the wall of a vessel or lumen in a living being via a percutaneous incision or puncture, said apparatus comprising a passageway means, a first elongated tubular member having a distal end portion of a fixed predetermined size including an liquid entrance port, and a second elongated member, said first elongated member being insertable through said incision or puncture and moveable with respect thereto, said second elongated member being removably located within said first elongated member, being cylindrical and having a longitudinally extending relieved surface on the exterior thereof, said relieved surface comprising an annular groove extending about said second elongated cylindrical member for a substantial length thereof and cooperating with said first elongated member to define therebetween said passageway means, said passageway means being in fluid communication with said liquid entrance port, whereupon liquid within said vessel or lumen may flow into said port and through said passageway means to flow to a point at which it may be observed.
A device for positioning a component at an internal situs within the body of a living being, said component having a filament secured thereto and arranged to extend through an incision or puncture to said situs, said device comprising tensioning means engagable with said filament to enable said filament to be pulled away from the body of said being by the application of a pulling force on said device, said tensioning means comprises a ball, a ball seat, and spring means to bias said ball against said seat, said filament extending between said ball and said seat, said ball being releasable to release said filament in the event that said pulling force reaches a predetermined value, whereupon the force applied to said filament by the pulling of said device away from the body of said being does not exceed said predetermined value.
A system for sealing a percutaneous puncture in a blood vessel in a living being by use of closure means, said system comprising carrier means and tamping means, said puncture comprising a tract extending through tissue overlying said vessel, said closure means comprising anchoring means, sealing means, and filament means, said filament means being operatively connected between said anchoring means and said sealing means for moving said anchoring means and said sealing means relative to each other, said carrier means being insertable into the puncture tract and through the puncture and including means to expel said anchoring means therefrom, said carrier means being movable out of said puncture to draw said anchoring means into engagement with the interior tissue of said vessel generally adjacent said puncture, said filament means being operative to move said anchoring means and said sealing means relative to each other to cause said sealing means to engage tissue generally adjacent said puncture outside of said vessel, said tamping means comprising a first portion formed of a resorbable material to extend into said puncture tract to assist said sealing means to conform to said artery and to assist in retaining said closure means in place.
A method of sealing a percutaneous puncture in a blood vessel of a living being, comprising providing a system comprising carrier means, introducer means, and closure means, said puncture comprising a tract extending through tissue overlying said vessel, said closure means comprising anchoring means, sealing means, and filament means, said filament means being connected between said anchoring means and said sealing means, said introducer means comprising a tubular member having a distal free end, said method additionally comprising the steps of:
A method of determining the location of the wall of a vessel or lumen of a living being, said vessel or lumen having a liquid therein, said method comprising providing a system comprising introducer means, position indicator means, a liquid entrance port, and a passageway, said introducer means and said position indicator means being coupled together, said liquid entrance port and said passageway being in fluid communication, said method additionally comprising the steps of:
A method of positioning a component having a filament coupled thereto at an internal situs within the body of a living being via a percutaneous incision or puncture having a tract, said method comprising locating said component within said tract so that said filament extends through said tract, providing a tamping device having a distal end portion oriented along said filament, sliding said tamping device along said filament into said tract of said percutaneous incision or puncture to said situs, and causing said distal end portion of said tamping device to engage said component to apply pressure thereto to cause a first portion of said component to be deformed within said tract of said percutaneous incision or puncture.
A method of moving a component at an internal situs within the body of a living being to a desired position therein, said component having a filament secured thereto and extendable through an incision or puncture to said situs, said method comprising the steps of providing a component having a filament secured thereto, inserting said component in an incision or puncture to said situs so that said filament extends therethrough, engaging said filament with a device including tensioning means, said tensioning means having a portion engaging said filament to hold said filament in place with respect thereto to enable said filament to be pulled away from the body of said being by the application of a pulling force on said device, whereupon said component is moved to said desired position, and arranging said tensioning means so that it releases said filament in the event that said pulling force reaches a predetermined value, whereupon the force applied to said filament by the pulling of said device away from the body of said being does not exceed said predetermined value.
A method of sealing an incision or puncture in a blood vessel within the body of a living being by use of closure means, said closure means having a filament secured thereto and extendable through an incision or puncture, said method comprising engaging said filament with a device including tensioning means to enable said filament to be pulled away from the body of said being by the application of a pulling force on said device, pulling on said filament to cause said closure means to move to a position to seal said incision or puncture, said tensioning means being releasable to release said filament in the event that said pulling force reaches a predetermined value, whereupon the force applied to said filament by the pulling of said device away from the body of said being does not exceed said predetermined value.
A method of sealing a small percutaneous puncture in a blood vessel of a living being utilizing a system comprising carrier means, tamping means and closure means, said puncture comprising a tract extending through tissue overlying said vessel, said filament means being connected between said anchoring means and said sealing means, said method comprising providing a system comprising carrier means, tamping means, and closure means, said closure means comprising anchoring means, sealing means, and filament means, said tamping means comprising a first portion formed of a resorbable material, inserting said carrier means into said tract and through said puncture, expelling said anchoring means from said carrier means, drawing said anchoring means into engagement with the interior tissue of said vessel contiguous with said puncture, applying a pulling force on said filament means to pull said anchoring means and said sealing means relative to each other to cause said sealing means to engage tissue contiguous with said puncture outside of said vessel, and introducing said first portion of said tamping means into said puncture tract to assist said sealing means to assist in retaining said closure means in place.
The method of claim 57 wherein said first portion of tamping means comprises a first member, and wherein said tamping means additionally comprises a second member having a passageway extending therethrough through which said filament extends, said second member being an elongated tubular member located proximally of said first member, said method comprising moving said second member to cause said first member to move so that said distal end of said first member engages said sealing means to deform said sealing means.
Dependencies are inferred from the claim text.