Arterial stapling device

• US 5,861,005 A
• Filed: 02/11/1997
• Issued: 01/19/1999
• Est. Priority Date: 02/11/1997
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: X-Site LLC
• Inventors: Kontos, Stavros B.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/799,667
• Time in Patent Office: 707 Days
• Field of Search: 606/213, 606/217, 606/219, 606/139, 227/175.1, 227/181.1, 227/901
• US Class Current: 606/219
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• 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

Abstract

A method and device for efficiently and effectively stapling an opening in an anatomical structure such as veins, arteries, organs, and other body members within a living body is disclosed. The opening may be from a deliberately placed incision, as from an invasive surgical procedure, or caused by other damaging events. The device includes a stapling mechanism having a main body with a handle, a trigger for activating the staples, and a central passage through which a balloon catheter may pass. The balloon catheter supports the artery and helps position the stapling mechanism properly on the artery. Alternatively, the device may have a main body that has an inflatable member attached to it and extending from it. The main body provides a passage through which a pressurized media such as saline can be supplied to the inflatable member. In either case, the main body may advantageously include a flashback lumen through which blood or other fluid may flow as an indication of the position of the device within the anatomical structure.

Claims

1. A device for sealing a wall opening in an anatomical structure of a living body comprising:

a body having a proximal portion and a distal end, wherein an inflation lumen extends within the body from an inflation lumen outlet formed on the distal end of the body, to an inflation lumen inlet formed on the proximal portion of the body;

a stapling mechanism disposed within the distal end of the body;

an actuating mechanism coupled between the proximal portion of the body and the stapling mechanism; and

an inflatable member coupled to the distal end of the body and extending distally therefrom, wherein, when the inflatable member is in position on the distal end of the body, an internal space of the inflatable member is in fluid communication with the inflation lumen outlet;

wherein, when the device is in an operative position, the inflatable member extends through the wall opening, the distal end of the body is located within the living body adjacent to the wall opening, the proximal portion of the body remains outside the living body, and the stapling mechanism is located such that, upon activation of the actuating mechanism, a staple is placed into the anatomical structure so that the staple extends across a portion of the wall opening to thereby seal the wall opening.

2. The device according to claim 1 further comprising:

a guide wire lumen extending through the inflatable member from a guide wire inlet formed on the distal end of the inflatable member to a guide wire exit formed on the proximal portion of the inflatable member.

3. The device according to claim 1, further comprising:

a first flashback lumen section extending within the body between a first connection port formed on the distal end of the body and a fluid exit port formed on the proximal portion of the body; and

a second flashback lumen section extending within the inflatable member from a second connection port in fluid communication with the first connection port to a fluid entry port formed on the inflatable member distally of the second connection port.

4. A method for sealing a wall opening in a wall of an anatomical structure within a living body comprising the steps of:

inserting an apparatus for sealing a wall opening in a wall of an anatomical structure into a desired position within the living body wherein the apparatus includes an inflatable structure which, when the device is in the desired position, extends from a housing of the apparatus into the wall opening and, wherein the apparatus further includes a stapling mechanism which, when the device is in the desired position, is located adjacent to the opening;

inflating the inflatable member to seal the wall opening;

partially actuating the stapling mechanism, sufficient only to insert a staple into the wall of the anatomical structure, but not sufficient to place the staple into the balloon catheter located within the anatomical structure, wherein the staple is placed into the wall across a portion of the opening;

withdrawing the balloon catheter from the proximal end of the stapling device by decreasing the volume of the balloon catheter distal to the stapling device, by purging pressurizing medium from the balloon catheter, so that the balloon catheter will fit through the insertion lumen of the stapling device;

further actuating the stapling mechanism to form the staple into a sealing configuration that draws the sides of the wall opening together to seal the wall opening; and

withdrawing the apparatus from the living body.