Surgical fastener and delivery system

• US 6,113,611 A
• Filed: 05/27/1999
• Issued: 09/05/2000
• Est. Priority Date: 05/28/1998
• Status: Expired due to Fees

• Current Assignee: ONUX Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: Advanced Vascular Technologies, LLC
• Inventors: Allen, William J., Miller, Arnold
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/321,077
• Time in Patent Office: 467 Days
• Field of Search: 606/232, 606/139, 606/151, 606/157, 606/158, 606/219, 606/213, 606/222, 606/215, 606/216
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0649 Coils or spirals

Abstract

A surgical fastener preferably made from a shape memory alloy is provided which can access internal tissue or other synthetic material through a small surgical access port or incision. After the fastener is deployed through layers of tissue, it assumes a shape that automatically applies to the layers of tissue an appropriate hemostatic compression which is relatively independent of tissue thickness. The fastener is a suitable replacement for conventional non bio-absorbable sutures and staples in certain clinical applications. Its shape, method of deployment and low force requirements make it suitable for standard surgical procedures and especially suitable for laparoscopic and other less invasive surgery where access to the wound site is limited, including endovascular surgery. A delivery instrument for deploying the fastener is also provided.

Claims

1. A surgical fastener for clamping surfaces of a plurality of layers of material together, comprising:

an element having first and second ends and made from a material which enables the element to be transformed from a first stressed elongate shape to a second unstressed shape upon the release of the element from a stressed condition, the first stressed elongate shape of the element enabling its first end to be extended through the 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 so as to enable coils on opposite sides of the layers to clamp the layers of material together along the spring axis.

2. The surgical fastener according to claim 1, and further including:

a hypodermic needle for penetrating said layers and having a lumen sized to slidingly receive the element in its first shape and an externally manipulatable plunger sized to slidingly move through said lumen to advance the element stored therein to a distal end of the needle to enable a distal portion of said element to resume its unstressed coiled shape on the one side of said layers of material when projected from said lumen by the plunger while another portion of said element remains within said lumen in said stressed shape until ejected from said lumen by said plunger on the other side of said layers of material to form an unstressed coiled shape to clamp the layers of material together.

3. The surgical fastener according to claim 1, wherein one of the layers is tissue and wherein said coils are spring biased so as to produce between said coils a sufficiently high compressive hemostasis gripping force when said tissue and said other layer of material are between said pair of adjacent coils to maintain said tissue and said layer of material in sealed contact with each other.

4. A surgical fastener delivery system for securing together a plurality of layers of material, comprising:

an element having first and second ends and made from a material which enables the element to be transformed from a first substantially straight elongate prestressed wire shape to a second unstressed shape upon a removal of the stress upon the element, the first shape of the element enabling its first end to be extended through the layers of material, and with the second shape of the element including a plurality of spring biased coils around an axis and urged towards each other to provide a clamping force along the axis;

a restraining tube in the form a hypodermic needle having a lumen sized to slidingly receive the element in its first prestressed elongate wire shape and store the element in said elongate wire shape under said stress; and

an externally manipulatable plunger sized to slidingly move through said lumen to advance the element stored therein to a distal end of the restraining tube; and

a stop located on the plunger and oriented so as to to project a predetermined distal portion of the element from the tube after its penetration of the layers of material to enable the formation of a coiled shape on a distal side of the layers of material, whereby emergence of said entire element from the lumen in response to further actuation of said plunger removes said stress upon the element so that it can assume its second coiled shape on a proximate side of the layers of materials and grip the layers of material between coils of the element.

5. A surgical fastener delivery system for securing together a plurality of layers of material, comprising:

an element having first and second ends and made from a material which enables the element to be transformed from a first substantially straight elongate prestressed wire shape to a second unstressed shape upon a removal of the stress upon the element, the first shape of the element enabling its first end to extend through the layers of material, and with the second unstressed shape of the element including a plurality of spring biased coils around an axis and urged towards each other to provide a clamping force along the axis;

a restraining tube in the form a hypodermic needle having a lumen sized to slidingly receive the element in its first prestressed elongate wire shape and store the element in said straight shape under said stress; and

an externally manipulatable plunger sized to slidingly move through said lumen to advance the element stored therein to a distal end of the restraining tube;

a sleeve to slidingly receive the hypodermic needle and limit its advance there through;

a first stop located and operative between said sleeve and said hypodermic needle so as to in effect limit advance of said hypodermic needle after it has penetrated the layers of material;

a second stop element attached to the plunger and operative with respect to said hypodermic needle for projecting a predetermined distal portion of said element from the lumen with a withdrawal of the hypodermic needle while maintaining the position of said plunger to enable the distal projected and unstressed portion of the element to form coils on a distal side of the layers of material with the coils being oriented around an axis that is aligned with the lumen;

whereby subsequent full withdrawal of the hypodermic needle from said sleeve releases an unstressed proximate portion of said element from the lumen on a proximate side of the layers of material to form coils on said proximate side so that said coils of said unstressed element can clamp the layers of material together.

6. The surgical fastener delivery system of claim 5, wherein the first and second stops are pivotally attached to the plunger.

7. A surgical fastener delivery system for securing together a plurality of layers of material, comprising:

an element having first and second ends and made from a shape memory alloy that enables the element to be transformed from a first substantially straight prestressed shape to a second shape upon a removal of the stress upon the element, the first shape of the element enabling its first end to penetrate the layers of material, and with the second end of the second shape of the element including a plurality of coils around a spring axis being spring biased toward each other along said spring axis;

a hypodermic needle having a lumen sized to slidingly receive the element in its first shape and store the element under said stress; and

an externally manipulatable plunger sized to slidingly move through said lumen to advance the element stored therein to a distal end of the restraining tube; and

stops located to limit movements of said plunger through said hypodermic needle to obtain a secure and reliable placement of said element after its release from the lumen by the plunger.

8. A method for inserting a surgical fastener into a plurality of layers of material, the steps comprising:

providing an element having first and second ends and made from a material which enables the element to be transformed from a first substantially straight shape to a second shape upon a removal of stress on the element, the first shape of the element enabling its first end to penetrate the plurality of layers of material, wherein the second shape of the element includes a plurality of coils which are spring biased towards each other along an axis;

placing the element under stress in a restraining device;

advancing the first end from the restraining device through the layers of material such that the element projects in an unstressed state to form at least one coil on a distal side of the plurality of layers of material;

withdrawing the restraining device on a proximate side of the plurality of layers of material such that stress from the restraining device is removed and the element transforms from the first shape to the second shape with at least one coil on said proximate side whereby coils at the first and second ends of the element axially press the plurality of layers of material together.

9. The method for inserting a surgical fastener of claim 8, wherein the restraining device is a hypodermic needle, and further comprising the step of penetrating the needle through the layers of material such that the element penetrates the plurality of layers of material.

10. The method for inserting a surgical fastener of claim 9, further comprising the steps of:

guiding the hypodermic needle through a sleeve; and

limiting an advance of the hypodermic needle through the sleeve.

11. The method for inserting a surgical fastener of claim 8, further comprising the steps of:

placing a sleeve against a proximate side of the layers of material;

guiding the restraining device with the element through the sleeve and advancing the restraining device through the layers of material sleeve for a predetermined distance determined by the sleeve.

12. The method for inserting a surgical fastener of claim 8, further comprising the steps of:

guiding the restraining device through a sleeve; and

limiting an advance of the restraining device through the sleeve.