Clip applier having improved hemostasis and methods of use

• US 8,821,534 B2
• Filed: 12/06/2010
• Issued: 09/02/2014
• Est. Priority Date: 12/06/2010
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Voss, Laveille Kao
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/961,331
• Publication Number:
  US 20120143216A1
• Time in Patent Office: 1,366 Days
• Field of Search: 606/139, 606/142, 606/157, 606/158, 606/213
• 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 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body

Abstract

A hemostasis assembly having a selectively expandable hemostasis member can be used with a medical device and in a method for delivering a closure element through tissue and into an opening formed in, or adjacent to, a wall of a blood vessel or other body lumen of any size while maintaining or improving hemostasis. The medical device and method of use utilizes such an expandable hemostasis member to maintain or improve hemostasis throughout a medical procedure for closing and/or sealing openings through tissues and/or blood vessels.

Claims

1. A method of closing an opening in a body lumen of a subject, the method comprising:

providing a medical device having an expandable hemostasis member;

locating the body lumen with a locator;

expanding the expandable hemostasis member to conform to the wall of the body lumen so as to create hemostasis across the opening while the expandable hemostasis member is expanded; and

deploying a closure element having a plurality of tines tapering toward a distal end into the body lumen so as to close the opening and create hemostasis while the closure element is deployed.

2. The method of claim 1, further comprising expanding the locator from an unexpanded state to an expanded state and pulling the locator against the internal surface of the body lumen.

3. The method of claim 1, wherein the locator automatically expands when moved out from tube of a locator assembly.

4. The method of claim 1, further comprising deploying the locator in an expanded such that the locator remains within the body lumen in the expanded after the medical device is removed from the body lumen.

5. The method of claim 4, wherein deployment of the closure element traps the implantable locator adjacent to the internal surface of the body lumen.

6. The method of claim 4, wherein the locator assembly includes a suture coupled to the implantable locator, and the suture is cut after the opening of the body lumen is closed.

7. The method of claim 6, wherein the suture is biodegradable and any portion of the suture remaining in the subject degrades.

8. The method of claim 1, wherein the locator is biodegradable.

9. The method of claim 1, further comprising contracting the expanded locator or expanded expandable hemostasis member upon deployment of the closure element.

10. The method of claim 1, further comprising a locator assembly that includes at least a first wire portion and a second wire portion that are integrated or coupled to the locator such that pulling on both the first wire portion and second wire portion draws the locator against the internal surface of the body lumen, and puling on one of the first wire portion or second wire portion unwinds the locator and withdraws the locator from the body lumen.

11. The method of claim 1, wherein said expandable hemostasis member in an unexpanded state has a cross-section that is less than or substantially equal to a cross-section of said opening.

12. The method of claim 1, wherein said expandable hemostasis member in an expanded state has a cross-section that is greater than or substantially equal to a cross-section of said opening.

13. The method of claim 1, further comprising longitudinally compressing the expandable hemostasis member so as to laterally expand said expandable hemostasis member.

14. A method of closing an opening in a side of a body lumen of a subject, the method comprising:

providing a medical device for delivering a closure element to a wall of an opening formed in a body lumen with improved hemostasis, the medical device comprising;

a locator assembly having a distal locator configured to extend through tissue into the opening and expand to selectively engage an internal surface of the body lumen adjacent to the opening so as to provide a desired position of the medical device relative to the body lumen;

a hemostasis assembly associated with the locator assembly, the hemostasis assembly having a selectively expandable hemostasis member on a distal end configured to extend to the opening when the locator assembly is in contact with the internal surface of the body lumen, the expandable hemostasis member being configured to expand laterally when disposed at the opening so as to provide hemostasis; and

a carrier assembly being slidably associated with the locator assembly and hemostasis assembly, the carrier assembly having a carrier member supporting the closure element and a cover member retaining the closure element within the carrier assembly, the closure element including a plurality of tissue piercing tines tapering toward a distal end, the carrier assembly being configured to position the closure element adjacent to the opening and being configured to distally deploy the closure element into tissue surrounding the opening of the body lumen such that the body lumen is drawn substantially closed;

locating the body lumen with the distal locator;

expanding the expandable hemostasis member to conform to the wall of the body lumen so as to create hemostasis across the opening while the expandable hemostasis member is expanded; and

deploying the closure element into the body lumen so as to close the opening and create hemostasis while the closure element is deployed.