Endovascular Flexible Stapling Device

• US 20080249565A1
• Filed: 06/17/2008
• Published: 10/09/2008
• Est. Priority Date: 08/22/1996
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Homma, Shunichi, Michler, Robert E.
• Granted Patent: US 8,167,905 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present invention concerns a flexible stapling device (1). More particularly, this invention concerns a flexible endovascular stapling device (1) for an intavascular procedure such as patent foramen ovale closure, which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means (26) which is positioned by using a flexible shaft/guidewire system.

Claims

1-30. -30. (canceled)

31. In a staple useful for surgical application in a body, the improvement wherein the distal portion of a filament having proximal and distal portions is fixedly attached to the staple.

32. A method for closing a defect, comprising the steps of:

introducing a guide wire into a femoral artery to locate the situs of a defect to be repaired;

providing a flexible shaft stapling device comprising;

a generally elongated flexible shaft having an axial direction and proximal and distal ends end; and

an actuator located at the proximal end of the flexible shaft;

mounting the flexible shaft stapling device onto the guide wire and moving the device along the guide wire into a position proximate the defect to be repaired; and

actuating the actuator such that the staple closes at least a portion of the defect.

33. A method of effecting intravascular closure comprising:

advancing a guide wire percutaneously or by incision into a patient'"'"'s vein;

advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient'"'"'s body;

advancing a guide wire through the introducer and distally to a position through a defect in the patient'"'"'s heart septum or other appropriate location;

advancing a flexible stapling device having distal and proximal ends, where said distal end comprises staples and the proximal end comprises actuating means to cause the staples to be fired;

positioning the distal end of the flexible shaft stapling device in proximity to the defect;

activating the actuating means to fire the staples to close at least a portion of the defect; and

withdrawing the flexible stapling device and then the introducer from the patient'"'"'s vein.

34. A method of effecting intravascular closure comprising:

advancing a guide wire percutaneously or by incision into a patient'"'"'s vein;

advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient'"'"'s body;

advancing a guide wire through the introducer and distally to a position through a defect in the patient'"'"'s heart septum or other appropriate location;

advancing a flexible stapling device having distal and proximal ends, where said distal end comprises staples and a retractable external housing and the proximal end comprises a slide mechanism operably connected to the external housing, said slide mechanism causing the external housing to move from an extended position to a retracted position and causing the staples to be fired in the retracted position;

positioning the distal end of the flexible shaft stapling device in proximity to the defect;

activating the slide mechanism to effect the positioning of the staples located at the distal end of the flexible shaft; and

withdrawing the flexible stapling device and then the introducer from the patient'"'"'s vein.

35. A method for closing a patent foramen ovale defect in the heart, comprising the steps of:

introducing a guide wire into a femoral vein to a location in the right atrium of the heart and through defect to be repaired;

placing a flexible shaft device over the guide wire;

moving the device along the guide wire into a position proximate the defect to be repaired under the guidance of echocardiography; and

activating the flexible shaft device to close at least a portion of the defect.

36. A method for correcting a defect in the heart by closing said defect, comprising the steps of:

introducing a guide wire into a femoral vein to a location in the heart and to the defect to be repaired;

placing a flexible shaft device over the guide wire;

moving the device along the guide wire into a position proximate the defect to be repaired under the guidance of echocardiography; and

activating the flexible shaft device to close at least a portion of the defect.

37. A method of claim 36 wherein the defect to be corrected is chosen from a list comprising:

a valvular leak, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, or an annulus of the heart.

38. A method for closing a defect, comprising the steps of:

introducing a guide wire into a femoral artery to locate the situs of a defect to be repaired;

mounting a stapling device onto the guide wire and moving the device along the guide wire into a position proximate the defect to be repaired; and

actuating the device such that a staple closes at least a portion of the defect.