Vascular sheath with bioabsorbable puncture site closure apparatus and methods of use

• US 8,758,396 B2
• Filed: 04/27/2006
• Issued: 06/24/2014
• Est. Priority Date: 01/05/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Ginn, Richard S., Aldrich, William N.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US11/411,925
• Publication Number:
  US 20060195124A1
• Time in Patent Office: 2,980 Days
• Field of Search: 606/153, 606/139, 606/142, 606/213, 606/215, 606/216, 606/219
• 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 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes a fastener and an advanceable, deformable clip having a delivery configuration in which opposing sides do not contact one another, and a deployed configuration, in which the fastener causes opposing sides of the deformable clip to close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The clip is then deformed with the fastener to draw opposing sides of the puncture together, and the sheath is withdrawn to seal the wound. The clip and fastener preferably are bioabsorbable.

Claims

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

providing an apparatus comprising an introducer sheath and an integrated annularly-shaped wound closure mechanism;

advancing said introducer sheath into tissue, through a tissue opening;

providing a housing coupled to and slidably disposed on the exterior of said introducer sheath, said housing cooperating with at least one bleedback tube extending from said housing toward a proximal end of said apparatus;

moving said housing, with said at least one bleedback tube, distally along said introducer sheath to move said wound closure mechanism from a stowed position to a distal deployment position, wherein when said wound closure mechanism is moved from the stowed position to the distal deployment position, the wound closure mechanism being located radially around at least a portion of the introducer sheath.

2. The method of claim 1, further comprising advancing said integrated wound closure mechanism and an integrated wound closure component that comprises at least two elongated tissue-piercing members.

3. The method of claim 2, wherein said tissue-piercing members comprise spikes.

4. The method of claim 2, wherein said integrated wound closure component is provided with spikes which pierce the tissue and wherein when said integrated wound closure mechanism is moved from a stowed position to a distal deployment position, a deforming step comprises urging said spikes toward each other.

5. The method of claim 2, wherein said integrated wound closure component has longitudinally extending legs which comprise at least two elongated tissue-piercing members and wherein when said integrated wound closure mechanism is moved from a stowed position to a distal deployment position opposing legs of the wound closure component are directed inwardly towards one another.

6. The method of claim 1, further comprising before moving said wound closure mechanism from a stowed position to a distal deployment position:

performing an interventional procedure through the introducer sheath.

7. A method for sealing a puncture in tissue comprising:

providing an apparatus comprising an introducer sheath with a proximal hub, a closure mechanism, and an integrated annularly-shaped wound closure component that includes at least two elongated tissue-piercing members;

advancing said introducer sheath into a vessel, through a vascular puncture;

providing a housing slidably disposed on and exterior to said introducer sheath, said housing cooperating with at least one bleedback tube extending from said housing toward said hub and being slidably received within said hub;

moving said housing, with said at least one bleedback tube, distally along said introducer sheath to move said wound closure component from a stowed position toward a distal deployment position, wherein when said wound closure component is moved from the stowed position to the distal deployment position, said wound closure component being located radially around at least a portion of said introducer sheath

directing tissue near the puncture in said vessel together to limit liquid flowing through the puncture following healing of the puncture.

8. The method of claim 7, wherein said integrated wound closure component comprises at least two elongated tissue-piercing members.

9. The method of claim 8, wherein said tissue-piercing members comprise spikes.

10. The method of claim 7, wherein said integrated wound closure component is provided with spikes which pierce the vessel wall and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position, a deforming step comprises urging said spikes toward each other.

11. The method of claim 7, wherein said integrated wound closure component has longitudinally extending legs which comprise at least two elongated tissue-piercing members and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position opposing legs of the wound closure component are directed inwardly towards one another.

12. The method of claim 7, further comprising before moving said wound closure component from a stowed position to a distal deployment position:

performing an interventional procedure through the introducer sheath.

13. A method for vascular puncture closure comprising:

providing an apparatus comprising a housing having at least one lumen and an integrated annularly-shaped wound closure mechanism cooperating with said at least one lumen, said housing comprising a bleedback lumen coupled with a bleedback tube extending proximally from said housing towards a proximal end of said apparatus, said bleedback tube being movable with said housing;

advancing said housing, with said bleedback tube, distally along said apparatus to advance said lumen into a vessel through a vascular puncture, wherein when said integrated wound closure mechanism is coupled to and slidably disposed on the exterior of said lumen;

moving said integrated wound closure mechanism from a stowed position to a distal deployment position, said integrated wound closure mechanism being located radially around at least a portion of said lumen.

14. The method of claim 13, further comprising advancing said integrated wound closure mechanism and an integrated wound closure component that comprises at least two elongated tissue-piercing members.

15. The method of claim 14, wherein said tissue-piercing members comprise spikes.

16. The method of claim 14, wherein said integrated wound closure component is provided with spikes which pierce the vessel wall and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position, a deforming step comprises urging said spikes toward each other.

17. The method of claim 14, wherein said integrated wound closure component has longitudinally extending legs which comprise at least two elongated tissue-piercing members and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position opposing legs of the wound closure component are directed inwardly towards one another.

18. The method of claim 13, further comprising before moving said integrated wound closure mechanism from a stowed position to a distal deployment position:

performing an interventional procedure through said lumen.

19. A method for sealing a puncture in a vessel wall comprising:

providing an apparatus comprising a housing having at least one lumen, an integrated wound closure mechanism, and an integrated annularly-shaped wound closure component that includes at least two elongated tissue-piercing members, said integrated wound closure mechanism cooperating with said at least one lumen, said housing comprising a bleedback lumen coupled with a bleedback tube extending proximally from said housing towards a proximal end of said apparatus, said bleedback tube being movable with said housing;

advancing said housing, with said bleedback tube, distally along said apparatus to advance said lumen into a vessel through a vascular puncture wherein when said integrated wound closure mechanism is slidably disposed on and exterior to said lumen, said integrated wound closure component being located radially around at least a portion of said lumen;

moving said integrated wound closure mechanism from a stowed position to a distal deployment position; and

directing tissue near the puncture in said vessel together to prevent liquid flowing through the puncture following healing of the puncture.

20. The method of claim 19, wherein said integrated wound closure component comprises at least two elongated tissue-piercing members.

21. The method of claim 20, wherein said tissue-piercing members comprise spikes.

22. The method of claim 19, wherein said integrated wound closure component is provided with spikes which pierce the vessel wall and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position, a deforming step comprises urging said spikes toward each other.

23. The method of claim 19, wherein said integrated wound closure component has longitudinally extending legs which comprise at least two elongated tissue-piercing members and wherein when said integrated wound closure component is moved from a stowed position to a distal deployment position opposing legs of the wound closure component are directed inwardly towards one another.

24. The method of claim 19, further comprising before moving said integrated wound closure mechanism from a stowed position to a distal deployment position:

performing an interventional procedure through said lumen.