Wound site management and wound closure device

• US 6,322,580 B1
• Filed: 09/11/2000
• Issued: 11/27/2001
• Est. Priority Date: 09/01/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Angiolink, Inc. (Medtronic Plc)
• Original Assignee: Angiolink Corporation (Medtronic Plc)
• Inventors: Kanner, Glenn
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/658,786
• Time in Patent Office: 442 Days
• Field of Search: 606/213, 606/219, 606/139, 606/144, 606/148
• US Class Current: 606/213
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/2913 cams or guiding means
• CPC Class Codes: A61B 2017/292 connection of actuating rod to handle, e.g. ball end in recess
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

A staple and stapler and introducer are disclosed for closing a wound and for wound site management. The staple is deformable, and includes a plurality of tissue-piercing prongs which are expanded outwardly, inserted into tissue and collapsed inwardly to close the wound. The stapler includes a plurality of mechanisms to deform the staple into various positions. An introducer is provided that includes a plurality of spaced-apart wire guides for securing and centering the wound opening during a medical procedure, and during closure of the wound.

Claims

1. An introducer, comprising:

a sheath having an inside diameter and a distal end,

a dilator sized to fit within the inside diameter of the sheath,

a plurality of flexible wire guides having first ends and second ends, the first ends coupled to the distal end of the sheath, wherein the sheath being approximated to a wound site and the wire guides placed approximate to tissue surrounding the wound site to hold said sheath approximately centered on said wound site.

2. The introducer of claim 1, wherein the guide wires are coupled to the sheath in geometrical opposed positions.

3. The introducer of claim 1, wherein the wire guides urge the wound opening into an elongated configuration.

4. The introducer of claim 2, wherein said wound site is formed in an artery or vein and at least two of said guide wires placed at opposing ends of said wound and transverse to a long axis of said artery or vein.

5. The introducer of claim 1, further comprising a blood marker to signal when said dilator is inserted into the wound opening to a predetermined depth.

9. An introducer of claim 1, further comprising a dilator inserted into said tubular sheath, at least a portion of said dilator being also inserted into said wound.

10. An introducer as claimed in claim 9, said dilator further comprising a fluid passageway to permit fluid to flow therethrough to indicate when said dilator is inserted into the wound opening to a predetermined depth.

11. An introducer as claimed in claim 9, wherein a portion of said wire guide being removably attached to said dilator.

12. An introducer as claimed in claim 1, wherein said sheath having an outside diameter approximately equal to the diameter of said wound.

6. An introducer, comprising:

a tubular sheath, and

at least one flexible wire guide affixed the sheath, said wire guide placed approximate to tissue surrounding a wound site to hold said sheath approximately centered on said wound site.

7. An introducer as claimed in claim 6, wherein said tubular sheath includes two flexible wire guides affixed at opposing sides of said tubular sheath.

8. An introducer as claimed in claim 7, wherein said wound site is formed in an artery or vein and said two of wire guides placed in said wound along a transverse axis relative to a long axis of said artery or vein.

13. A method for stabilizing a wound in an artery or vein comprising the steps of:

approximating an elongated sheath to a wound site;

placing one or more wire guides into the wound site;

placing said wire guides approximate to tissue surrounding said wound site; and

allowing opposing sides of said tissue surrounding said wound site to approximate one another.

14. A method for stabilizing a wound site, comprising the steps of:

approximating an elongated sheath to a wound site;

inserting one or more wire guides into the wound site;

placing said wire guides approximate to tissue surrounding said wound site; and

centering said sheath about said wound site.