Surgery – Instruments – Sutureless closure
Reexamination Certificate
1998-03-10
2004-05-11
Casler, Brian L. (Department: 3763)
Surgery
Instruments
Sutureless closure
C606S213000, C604S264000
Reexamination Certificate
active
06733515
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a wound closure device, and more particularly to a device for delivering a catheter to a vessel within a tissue site and closing a wound caused by the catheter delivery.
BACKGROUND OF THE INVENTION
A wide variety of surgical procedures are performed by introducing a catheter into a vessel. After the surgical procedure is completed, closure of the vessel at the site where the catheter was introduced is needed. Vessel punctures formed in the process of performing a catheter based surgical procedure are commonly 1.5 mm to 7.0 mm in diameter and can be larger. Closure of these punctures is frequently complicated by anticoagulation medicine given to the patient which interferes with the body's natural clotting abilities.
Closure of a vessel puncture has traditionally been performed by applying pressure to the vessel adjacent the puncture site. This procedure requires the continuous attention of at least one medical staff member to apply pressure to the vessel puncture site and can take as long as 30 minutes.
Devices have been developed for effecting the closure of vessel punctures through the application of energy. See U.S. Pat. Nos. 5,626,601; 5,507,744; 5,415,657; and 5,002,051. Devices have also been developed for effecting the closure of vessel punctures through the delivery of a mechanical mechanism which mechanically seals the puncture. See U.S. Pat. Nos.: 5,441,520; 5,441,517; 5,306,254; 5,282,827; and 5,222,974. Devices have also been developed for effecting the closure of vessel punctures through the delivery of a composition to block the vessel puncture. See U.S. Pat. Nos. 5,601,602; 5,591,205; 5,441,517; 5,292,332; 5,275,616; 5,192,300; and 5,156,613. Despite the various devices that have been developed for closing vessel punctures, a need still exists for a single device which can be used for both introducing a catheter into a vessel and for closing the resulting wound.
SUMMARY OF THE INVENTION
The invention relates to a device for introducing a catheter through a puncture in a vessel and for sealing the puncture. The device includes an elongated body having a proximal end and a distal end sized to be positioned within a tissue site which includes the puncture. The elongated body includes a utility lumen sized to allow delivery of a catheter through the utility lumen. The utility lumen is positioned within the elongated body so positioning the elongated body within the tissue site allows a catheter delivered through the utility lumen to enter the vessel. The elongated body also includes a closure lumen having an entrance port. A closure composition can be delivered through the entrance port into the closure lumen. The closure lumen also includes an exit port adjacent the distal end of the elongated body. The closure composition delivered into the closure lumen can be delivered through the exit port to the tissue site adjacent the puncture.
The invention also relates to a device for introducing a catheter through a puncture in a vessel and for sealing tissues adjacent the puncture. The device includes an elongated body having a proximal end and a distal end sized to be positioned within a tissue site which includes the puncture. A membrane is included at an outer surface of the elongated body. The membrane is positioned on the elongated body so the membrane is adjacent a portion of the tissue adjacent the puncture when the elongated body is positioned within the tissue site. The membrane is sufficiently porous to allow a closure composition to pass through the membrane. The closure composition can be delivered into the closure lumen through an entrance port. The closure composition can be delivered from the closure lumen to the membrane through at least one exit port.
The invention also relates to a system for introducing a catheter through a puncture within a vessel and sealing the puncture. The device includes an elongated body having a proximal end and a distal end sized to be positioned within a tissue site which includes the puncture. The elongated body includes a utility lumen within the elongated body. The utility lumen is sized to allow delivery of a catheter through the utility lumen. The utility lumen is positioned within the elongated body so when the elongated body is positioned within the tissue site a catheter delivered through the utility lumen can enter the vessel. A first closure lumen is coupled with the utility lumen. A closure composition can be delivered into the first closure lumen through an entrance port. The closure composition can be delivered from the first closure lumen to the utility lumen through an exit port. The system also includes an obturator with a structure which allows the obturator to be at least partially positioned in the utility lumen. Positioning the obturator within the utility lumen causes a second closure lumen to be formed. The second closure lumen is at least partially defined by the obturator and the utility lumen. The second closure lumen receives the closure composition delivered from the first closure lumen to the utility lumen and is configured to deliver the received closure compound to the tissue site.
The invention also relates to a system for introducing a catheter through a puncture within a vessel and for sealing the puncture. The system includes an elongated body having a proximal end and a distal end sized to be positioned at a tissue site which includes the puncture. The elongated body includes a utility lumen and a closure lumen through which a closure composition can be delivered to tissue at the tissue site. The system also includes a catheter guide obturator configured to be positioned within the utility lumen of the elongated body. The catheter guide obturator includes a utility lumen. The utility lumen is sized to permit delivery of a catheter through the utility lumen. The utility lumen has a geometry which permits a catheter delivered through the utility lumen to enter the vessel when the catheter guide obturator is positioned within the utility lumen of the elongated body which is positioned at the tissue site.
The invention also relates to a system for introducing a catheter through a puncture within a vessel and for sealing the puncture. The system includes an elongated body having a proximal end and a distal end sized to be positioned at a tissue site which includes the puncture. The elongated body includes a utility lumen and a closure lumen through which a closure composition can be delivered to tissue at the tissue site. The invention also includes a trocar configured to be positioned within the utility lumen, the trocar includes a sharpened tip configured to puncture the tissue making up the tissue site.
The invention also relates to a system for introducing a catheter through a puncture within a vessel and for sealing the puncture. The system includes an elongated body having a proximal end and a distal end sized to be positioned at a tissue site which includes the puncture. The elongated body includes a utility lumen and a closure lumen through which a closure composition can be delivered to tissue at the tissue site. The system also includes a sealing mold configured to be positioned within the utility lumen. The sealing mold has a structure which causes a cavity to be formed at the distal end of the elongated body when the sealing mold is positioned within the utility lumen. Closure composition delivered through the closure lumen is delivered into the cavity.
The invention also relates to a method for introducing a catheter through a puncture within a vessel and for sealing the puncture. The method is initiated by providing a device with an elongated body configured to be positioned within a tissue site. The body includes a utility lumen sized to accommodate a catheter and at least one closure lumen. A closure composition can be delivered through the closure lumen. The method concludes by positioning the elongated body within the tissue site; delivering a catheter through the utility lumen into the vessel; performing a treatment with th
Edwards Stuart D.
Kucklick Theodore
Lax Ronald
Parker Theodore L.
Wehman Thomas C.
Casler Brian L.
NeoMend, Inc.
Ryan Kromholz & Manion S.C.
Williams Catherine S.
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