Multi-fastener surgical apparatus and method

• US 6,837,893 B2
• Filed: 08/31/2001
• Issued: 01/04/2005
• Est. Priority Date: 09/01/2000
• Status: Expired due to Fees

• Current Assignee: ONUX Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: ONUX Medical, Inc. (Becton, Dickinson & Co)
• Inventors: Miller, Arnold
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/944,841
• Publication Number:
  US 20030105473A1
• Time in Patent Office: 1,222 Days
• Field of Search: 606/143, 606/139, 606/140, 606/142, 606/199, 606/232, 606/157, 606/158
• US Class Current: 606/139
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0649 Coils or spirals

Abstract

A fastener preferably made from a shape memory alloy is provided which can access internal tissue or other synthetic material by catheter delivery through an endovascular pathway. After the fastener is deployed through layers of tissue or other material, it assumes a shape that automatically applies to the layers of tissue or other material an appropriate hemostatic compression which is relatively independent of tissue or material thickness. The fastener is a suitable replacement for conventional non bio-absorbable sutures and staples in certain clinical applications. The shape, method of deployment, and low force requirements make the disclosed apparatus suitable for endosurgical procedures where access to the wound site is limited. A method for deploying the fastener is also provided.

Claims

1. Apparatus for inserting a surgical fastener through a plurality of portions of material, said apparatus comprising:

a surgical fastener having first and second ends and made from a material which enables said fastener to be transformed from a first stressed elongate shape to a second unstressed shape upon release of said fastener from a stressed condition, the first stressed elongate shape of said fastener enabling the first end to be extended through a plurality of layers of material, and with the second shape of the fastener being in the form of a spring with a plurality of coils around a spring axis, with the coils being spring biased towards each other along the spring axis with sufficient axial force to enable the coils on opposite sides of the layers of material to clamp the layers of material together along the spring axis;

a single needle having first and second ends,

penetration means adjacent the first end of said single needle, said penetration means being configured to pierce through the plurality of layers of material, and insertion means adjacent to the first end of said single needle, said insertion means being configured to place said surgical fastener through the plurality of layers of material pierced by said penetration means;

wherein said insertion means comprises a magazine comprising a plurality of chambers, with each chamber adapted to hold a fastener therein, and means for moving the magazine so as to sequentially align one of said chambers with said needle.

2. Apparatus for inserting multiple surgical fasteners through a plurality of portions of material, said apparatus comprising:

a plurality of surgical fasteners, each of said surgical fasteners having first and second ends and made from a material which enables said fastener to be transformed from a first stressed elongate shape to a second unstressed shape upon the-release of said fastener from a stressed condition, said first stressed elongate shape of said fastener enabling said first end to be extended through a plurality of layers of material, and with said second shape of the fastener being in the form of a spring with a plurality of coils around a spring axis, with said coils being spring biased towards each other along said spring axis with sufficient axial force so as to enable coils on opposite sides of layers to clamp the layers of material together along the spring axis;

a cartridge having a plurality of delivery tubes, said cartridge having first and second ends, each of said delivery tubes adapted to hold one of said surgical fasteners therein, each of said delivery tubes having first and second ends, said first end of said delivery tubes adapted to be slideably disposed from said first end of said cartridge, said first end of each of said delivery tubes having penetrating means to pierce through the plurality of layers of material;

a body in adjustable connection to said cartridge, said body having delivery tube control means and surgical fastener insertion means, said delivery tube control means being adapted to move said first end of each of said delivery tubes through said first end of said cartridge to pierce through the plurality of layers of material, said surgical fastener insertion means being adapted to place said surgical fastener through the plurality of layers of material pierced by said penetrating means of each of said delivery tubes; and

means for moving said cartridge with respect to said body to sequentially align one of said delivery tubes having one of said surgical fasteners of said cartridge with said delivery tube control means and said surgical fastener insertion means of said body, wherein said plurality of surgical fasteners is sequentially placed without reloading after each placement.

3. A method for inserting a surgical fastener through a plurality of portion of material, said method comprising:

providing apparatus for inserting multiple surgical fasteners through a plurality of portions of material, said apparatus comprising;

a plurality of surgical fasteners, each of said surgical fasteners having first and second ends and made from a material which enables said fastener to be transformed from a first stressed elongate shape to a second unstressed shape upon the release of said fastener from a stressed condition, said first stressed elongate shape of said fastener enabling said first end to be extended through a plurality of layers of material, and with said second shape of the element being in the form of a spring with a plurality of coils around a spring axis, with said coils being spring biased towards each other along said spring axis with sufficient axial force so as to enable coils on opposite sides of layers to clamp the layers of material together along spring axis;

a cartridge having a plurality of delivery tubes, said cartridge having first and second ends, each of said delivery tubes adapted to hold one of said surgical fasteners therein, each of said delivery tubes having first and second ends, said first end of said delivery tubes adapted to be slideably disposed from said first end of said cartridge, said first end of each of said delivery tubes having penetrating means to pierce through the plurality of layers of material;

a body in adjustable connection to said cartridge, said body having delivery tube control means and surgical fastener insertion means, said delivery tube control means being adapted to move said first end of each of said delivery tubes through said first end of said cartridge to pierce through the plurality of layers of material, said surgical fastener insertion means being adapted to place said surgical fastener through the plurality of layers of material pierced by said penetrating means of each of said delivery tubes; and

means for moving said cartridge with respect to said body to sequentially align one of said delivery tubes having one of said surgical fasteners of said cartridge with said delivery tube control means and said surgical fastener insertion means of said body, wherein said plurality of surgical fasteners is sequentially placed without reloading after each placement;

placing said first end of said cartridge adjacent the plurality of layers of material, with said surgical fastener being configured in said first elongate shape;

penetrating the plurality of layers of material with said first end of said delivery tube using said delivery tube control means;

inserting a first portion of said surgical fastener through the plurality of layers of material using said surgical fastener insertion means;

withdrawing said first end of said cartridge from the plurality of layers of material using said delivery control means; and

moving said cartridge with respect to said body to sequentially align said delivery tubes having one of said surgical fasteners of said cartridge with said delivery tube control means and said surgical fastener insertion means of said body, wherein said plurality of surgical fasteners are sequentially placed without reloading after each placement.

4. A method for inserting a surgical fastener through a plurality of portions of material, said method comprising:

providing apparatus for inserting a surgical fastener through a plurality of portions of material, said apparatus comprising;

a surgical fastener having first and second ends and made from a material which enables said fastener to be transformed from a first stressed elongate shape to a second unstressed shape upon release of said fastener from a stressed condition, the first stressed elongate shape of said fastener enabling the first end to be extended through a plurality of layers of material, and with the second shape of the element being in the form of a spring with a plurality of coils around a spring axis, with the coils being spring biased towards each other along the spring axis with sufficient axial force to enable the coils on opposite sides of the layers of material to clamp the layers of material together along the spring axis; and

a single needle having first and second ends, penetration means adjacent the first end of said single needle, said penetration means being configured to pierce through the plurality of layers of material, and

insertion means adjacent to the first end of said single needle, said insertion means being configured to place said surgical fastener through the plurality of layers of material pierced by said penetration means;

placing said single needle adjacent the plurality of layers of material, with said surgical fastener being configured in the first stressed elongate shape;

penetrating the plurality of layers of material with said penetration means of said single needle, said penetration of the plurality of layers of material being performed at the first end of said single needle;

inserting a first portion of said surgical fastener through the plurality of layers of material using said insertion means; and

withdrawing said penetration means of said single needle from the plurality of layers of material, wherein a second portion of said surgical fastener is positioned on the opposite side of the plurality of layers of material from said first portion of said surgical fastener so as to enable the coils on the opposite sides of the layers to clamp the material together;

wherein one of said plurality of portions of surgical fastener comprises a lumen segment and the other of said plurality of portions of surgical fastener comprises another lumen segment.

5. A method according to claim 4 wherein said surgical fastener occludes the lumen upon deployment of said surgical fastener.