Tissue closure system

• US 7,320,692 B1
• Filed: 06/22/2005
• Issued: 01/22/2008
• Est. Priority Date: 03/28/2005
• Status: Expired due to Fees

• Current Assignee: Aesculap AG (Lonza Group AG)
• Original Assignee: Cardica Incorporated
• Inventors: Knodel, Bryan D., Bender, Theodore M., Hausen, Bernard A., Warder-Gabaldon, Zachary, Newell, Matthew B., DuBois, Brian R.
• Primary Examiner(s): Gartenberg; Ehud
• Assistant Examiner(s): Anderson; Gregory A
• Application Number:
  US11/158,414
• Time in Patent Office: 944 Days
• Field of Search: 606/153, 606/139, 623/23.72
• US Class Current: 606/139
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple

Abstract

A method for closing an opening in tissue, such as an opening in heart tissue, may include moving a housing to a location in proximity to the opening, registering the housing to the opening, and deploying a staple from the housing into tissue in proximity to the opening. The opening in heart tissue may be a patent foramen ovale, atrial septal defect, or other opening. The housing may be moved to the opening through the vasculature, utilizing a guidewire, steering catheter, or other mechanism.

Claims

1. A method for closing an opening in tissue, comprising:

providing a staple having a plurality of tines and a longitudinal centerline, and a housing within which at least part of said staple is held, said housing having a fixed diameter;

advancing the entirety of said housing into and then through the vasculature to a location in proximity to the opening;

plastically deforming said staple to a splayed configuration such that the distal ends of at least two said tines are spaced apart from one another a distance greater than the diameter of said housing;

penetrating at least one said tine into tissue in proximity to the opening; and

plastically deforming said staple to a closed configuration.

2. The method of claim 1, wherein said holding comprises holding said staple at a location spaced apart from the distal end of said housing.

3. The method of claim 1, wherein said holding comprises holding said staple completely within said housing at a location spaced apart from the distal end of said housing before said plastically deforming said staple to a splayed configuration.

4. The method of claim 1, further comprising registering the opening in tissue to said housing.

5. The method of claim 4, wherein said registering includes

maintaining said housing substantially stationary;

and

moving the tissue toward said housing.

6. The method of claim 4, wherein said registering includes:

providing at least one butterfly member extending substantially distally from said housing;

inserting at least part of at least one said butterfly member through the opening in a collapsed configuration;

expanding at least part of at least one said butterfly member to an expanded configuration; and

moving at least one of said butterfly member in said expanded configuration and said housing toward the other.

7. The method of claim 6, further comprising:

collapsing each said butterfly member in said expanded configuration to said collapsed configuration; and

withdrawing each said butterfly member from the opening.

8. The method of claim 1, further comprising pushing said staple in a direction angled relative to said longitudinal centerline after said plastically deforming said staple to a closed configuration, whereby said pushing releases said staple.

9. The method of claim 8, wherein said direction is substantially perpendicular to said longitudinal centerline.

10. The method of claim 1, wherein the opening is in heart tissue.

11. The method of claim 10, wherein the opening is a patent foramen ovale.

12. The method of claim 10, wherein the opening is an atrial septal defect.

13. The method of claim 1, wherein said advancing is performed with a steering catheter.

14. The method of claim 1, wherein said advancing is performed along a guidewire.

18. The method of claim 1, wherein said staple has two tines, and wherein said deforming said staple to a splayed configuration maintains said staple substantially in a single plane.

19. The method of claim 1, wherein said staple has two tines, and wherein said deforming said staple to a closed configuration maintains said staple substantially in a single plane.

20. The method of claim 1, wherein said housing includes at least one lateral opening defined in a side thereof;

and wherein said plastically deforming said staple to a splayed configuration causes the distal ends of at least two said tines to extend outward from said housing through said at least one lateral opening.

15. A method for closing an opening in heart tissue, comprising:

providing a staple and a housing that holds said staple, wherein said housing has a fixed width;

moving said housing to a location in proximity to the opening;

registering said housing to the opening;

splaying said staple to a splayed configuration, wherein said splaying moves the distal ends of at least two said tines a distance further apart from one another than the width of said housing;

penetrating at least one said tine into heart tissue in proximity to the opening after said splaying; and

plastically deforming said staple to a closed configuration after said penetrating, wherein said plastically deforming substantially closes said opening.

16. The method of claim 15, wherein said registering includes

providing at least one butterfly member;

advancing at least one said butterfly member through the opening;

expanding at least one said butterfly member; and

moving at least one of said butterfly member and said housing toward the other.

17. The method of claim 15, further comprising viewing at least a portion of said moving with an imaging device.