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Home Heart Surgery Method-for-the-percutaneous-suturing-of-a-vascular-puncture-site

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 Method for the percutaneous suturing of a vascular puncture site

Details
Inventors: Klein, Enrique J.; Gross, T. Daniel; Hinohara, Tomoaki; Vetter, James W.;
Assignee: Perclose, Inc. (Menlo Park, CA)
Primary Examiner: Buiz; Michael Powell
Assistant Examiner: Trinh; Vikki
Attorney, Agent or Firm: Gens; Timothy H. Trial & Technology Law Group

A suture applying device comprises a shaft which carries a pair of needles near its distal end. The needles are joined by a length of suture, and the shaft is used to both introduce the needles into a lumen of a body structure and to push the needles back through tissue on either side of the puncture site. After the needles have passed through the tissue, they are captured on the shaft and drawn outward through the tract, leaving a loop of suture behind to close the puncture site near the body lumen. The suture can then be tied and the knot pushed back through the tract to complete the closure. Alternatively, a locking fastener formed of a resorbable material can be placed into the penetration over the sutures and the sutures tied over the fastener.

DETAILED DESCRIPTION The present invention provides devices and methods for suturing percutaneous lumenal puncture sites.
The devices will comprise a shaft, a pair of needles removably carried near the distal end of the shaft, and a length of suture secured to and extending between the needles.
As described below, the shaft is used to introduce the needles inwardly through the tract and puncture site and into the lumen.
Thereafter, the shaft is used to draw the needles outwardly back through the tissue on either side of the puncture site to begin forming a loop of the suture at the intimal surface of the puncture site.
The device may farther include means on the shaft for capturing the pointed ends of the needles after they have passed through the tissue and back into the tract, and the shaft can then be withdrawn to carry the needles and attached suture outwardly back through the tract.
Alternatively, the shaft and needles can be made sufficiently long so that the pointed ends of the needles may be drawn completely through the tract so that they-may be manually grasped (without the need for capture on the shaft).
In either case, the free ends of the suture can then be tied (or otherwise secured) and the resulting knot pushed back through the tract to complete the suture loop at the adventitial surface of the puncture site.
The ability to provide a secured suture loop at the puncture site is particularly advantageous since a reliable closure is formed.
Furthermore, suture closure of puncture sites has been universally accepted as the standard of care for many decades.
The devices and methods of the present invention are useful whenever it is desirable to place a tied suture loop to close a lumen puncture site, and will be particularly useful for suturing percutaneous vascular puncture sites.
The devices can achieve closure wholly through the tract puncture site and can be manipulated entirely in a percutaneous manner.
The present invention will find its greatest use in the sealing of femoral artery cannulation sites made in connection with percutaneous transluminal procedures, such as angiography, angioplasty, atherectomy, laser ablation, stent placement, intravascular imaging, and the like



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