Apparatus and method for vascular closure
AssigneePerclose, Inc.
InventorsBernard H. Andreas, T. Daniel Gross, Tomoaki Hinohara, James W. Vetter
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Abstract
A suture-applying device comprises a guide body having a needle guide at its distal end. Needles are reciprocatably carried on a shaft so that they may be advanced through the needle guide and tissue into the guide body. The suturing device is used by placing the needle guide within a vascular puncture. A contact surface is provided on the guide body, and the needle guide is configured so that the vascular wall surrounding the puncture is fully exposed to the needles passing therethrough. The suturing device may be combined with a predilator to form a system for suturing vascular punctures.
Claims62
A suturing device comprising:
- a guide body having a proximal end, a distal end, a central axis, and a contact surface at the distal end oriented at an angle in the range from 30.degree. to 80.degree. relative to the central axis;
- a needle guide connected to and spaced-apart from the distal end of the guide body, wherein said needle guide and guide body together define a tissue-receiving region therebetween and wherein at least one needle channel on said needle guide or said guide body is oriented to direct a needle passing therethrough into the tissue-receiving region;
- a shaft reciprocatably mounted within the guide body and the needle guide;
- and
- at least one needle carried by the shaft and disposed within the guide channel so that a sharpened proximal tip of the needle can be drawn from the needle guide, through the tissue-receiving region and into the guide body.
An improved suturing device of the type including a guide body having a proximal end and distal end and means on the guide body for translating at least one needle relative to the guide body, said needle having a sharpened distal tip disposed in the proximal direction, wherein the improvement comprises a generally planar contact surface disposed at a distal end of the guide body and oriented at an angle in the range from 30.degree. to 80.degree. relative to a central axis of the guide body, wherein the translating means translates the needle from a first position with the sharpened distal tip spaced distally from the planar surface to a second position with the sharpened distal tip within the guide body.
A suturing device comprising:
- a guide body having a proximal end and a distal end;
- a needle guide having a proximal end fixedly attached to the distal end of the guide body and a distal end having at least two needle guide channels, wherein said proximal end is disposed between the distal end of the guide body and the needle guide channels and has a non-circular periphery which is spaced inwardly from the two needle guide channels to position surrounding tissue to receive needles from the needle guide channels;
- a pair of needles having a length of suture extending therebetween;
- and
- a shaft reciprocatably mounted within the guide body and carrying the needles to reciprocate said needles within the needle guide channels.
A suturing device comprising:
- a guide body having a proximal end and a distal end, wherein the guide body has at least two lumens for receiving the pair of needles after said needles have been reciprocated proximally by a shaft;
- a needle guide having a proximal end attached to the distal end of the guide body and a distal end having at least two needle guide channels;
- a pair of needles having a length of suture extending therebetween;
- wherein shaft is reciprocatably mounted within the guide body and carries the needles to reciprocate said needles within the needle guide channels;
- and
- means for releasably securing the shaft to the guide body to prevent relative reciprocation.
A predilator comprising:
- a body having a proximal end and a distal end;
- and
- a flexible tube having a proximal end attached to the distal end of the body;
- wherein a guide wire lumen extends continuously from the distal end of the flexible tube to the proximal end of the body and wherein at least one blood marker lumen extends from a marker port disposed near the proximal end of the flexible tube to the proximal end of the body and wherein the flexible tube is rotatably attached to the body.
A system for suturing a vascular puncture at the distal end of a tissue tract, said system comprising:
- a predilator including a body having a proximal end and a distal end, and a flexible tube having a proximal end attached to the distal end of the body and a distal end, wherein continuous guide wire lumen extends from the distal end of the flexible tube to the proximal end of the body;
- and
- a suturing device including (a) a guide body having a proximal end and a distal end, wherein an axial passage is disposed within the guide body to receive the needle from the tissue-receiving region at the distal end and guide the needle to the proximal end, (b) a sheath extending distally from the guide body, and (c) a needle slidably disposed within the sheath so that the needle can be drawn proximally from the sheath into the guide body, wherein the diameter of the guide body is substantially the same as that of the predilator body.
A method for suturing a puncture site in a blood vessel wall disposed at the distal end of a percutaneous tissue tract, said method comprising:
- introducing a predilator having a body and a distally extending flexible tube to the puncture site so that said body lies within the tissue tract and the flexible tube lies in a lumen of the blood vessel;
- confirming that the predilator is properly positioned relative to the puncture site;
- removing the predilator;
- introducing a suturing device having a guide body and a distally extending flexible sheath to the puncture site so that said guide body lies within the tissue tract and the flexible sheath lies within the blood vessel lumen;
- drawing a needle carrying a length of suture from the sheath through the blood vessel wall adjacent the punctures and outward through the tissue tract;
- and
- securing a loop in the suture to close the punctures.
Dependencies are inferred from the claim text.