Low-Profile Vascular Closure Systems and Methods of Using Same

• US 20080173692A1
• Filed: 01/24/2007
• Published: 07/24/2008
• Est. Priority Date: 01/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Mas, Juan-Pablo, Epperly, Scott J., Lobello, Richard D., Eliasen, Kenneth A., Spurchise, Matthew F.
• Granted Patent: US 7,628,306 B2
• Time in Patent Office: Days
• US Class Current: 227/175.1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

A closure device for an arteriotomy includes an elongate tube having a distal opening, a staple disposed within the tube, and a frangible cap mounted across the distal opening to guard the staple tips against contact with the tissue track. The frangible cap is pierced, fractured or torn when the staple is advanced through the distal opening. A portion of the torn frangible cap may be implanted with the staple as a pledget. The staple may be carried within the elongate tube by a stapler comprising an elongate hollow shaft and an elongate driver slidably disposed therein. A pair of opposing actuation tips is disposed at a distal end of the hollow shaft to define an open-sided staple chamber there between. An anvil is fixedly disposed within the staple chamber, which holds at least a proximal portion of the staple.

Claims

1. A closure device for an arteriotomy comprising;

an elongate tube having a distal opening;

a staple being slidably disposed within the tube; and

a frangible cap mounted across the distal opening, wherein the frangible cap is pierceable, or fractureable or tearable when the staple is advanced through the distal opening and the frangible cap.

2. The closure device of claim 1, wherein the frangible cap comprises a biocompatible material selected from the group consisting of metallic foil, polyurethane, polyester or polystyrene, natural or synthetic rubber, butadiene/acrylonitrile copolymers, copolyesters, ethylene vinylacetate (EVA) polymers, ethylene/acrylic copolymers, ethylene/propylene copolymers, fluorosilicone, latex, polyalkylacrylate polymers, polybutadiene, polybutylene, polyethylene, polyisobutylene, polyisoprene, polyurethane, silicone, styrenebutadiene copolymers, styrene-ethylene/butylene-styrene, thermoset elastomer, thermoplastic elastomer and combinations thereof.

3. The closure device of claim 1, wherein the frangible cap includes perforations, grooves or disruptions that define tear lines within the cap.

4. The closure device of claim 1, wherein the frangible cap is capable of tearing into a configuration having one or more deflectable sections that move aside as the staple is advanced through the distal opening and the frangible cap.

5. The closure device of claim 1, wherein the frangible cap is tearable into a configuration having a pledget separated from a remainder of the frangible cap, the pledget being retainable with the staple.

6. The closure device of claim 5, wherein the pledget includes a physiologically active agent selected from the group consisting of Cefazolin, chlorhexidine, collagen or derivatives thereof, fusidic acid, heparin, Novobiocin, phosphorylcholine, polymyxin B, rifampicin, silver or a silver compound, and tetracycline.

7. The closure device of claim 1 wherein the elongate tube further comprises at least two opposing longitudinal slots extending proximally from the distal opening, the staple being disposed within the tube and having at least two opposing legs aligned with the at least two slots.

8. The closure device of claim 1 wherein the elongate tube includes at least two side tubes for riding along a pair of stabilization wire guides, the side tubes being coupled parallel to, and disposed on opposing sides of a distal portion the elongate tube.

9. The closure device of claim 8 further comprising an elongate stapler slidably disposed within the elongate tube, the stapler comprising:

an elongate hollow shaft and an elongate driver slidably disposed therein;

a pair of opposing actuation tips disposed at a distal end of the shaft and defining an open-sided staple chamber there between, the open sides of the chamber being aligned with the at least two slots in the elongate tube; and

an anvil disposed within the staple chamber and affixed to one of the actuation tips;

wherein at least a proximal portion of the staple is held within the staple chamber.

10. The closure device of claim 1 further comprising an elongate stapler slidably disposed within the elongate tube and holding at least a proximal portion of the staple.

11. The closure device of claim 10 wherein the stapler comprises:

an elongate hollow shaft and an elongate driver slidably disposed therein;

a pair of opposing actuation tips disposed at a distal end of the shaft and defining a staple chamber there between; and

an anvil disposed within the staple chamber and affixed to one of the actuation tips;

wherein at least a proximal portion of the staple is held within the staple chamber.