Access and closure device and method

• US 8,002,792 B2
• Filed: 10/06/2006
• Issued: 08/23/2011
• Est. Priority Date: 05/12/2004
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Modesitt, D. Bruce
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US11/544,365
• Publication Number:
  US 20070032803A1
• Time in Patent Office: 1,782 Days
• Field of Search: 606/213, 606/215, 606/216, 606/221, 604/164.01, 604/44, 604/158, 604/115
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like

Abstract

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.

Claims

1. A method for forming a self-sealing tract in a vessel wall using a device comprising an introducer, the method comprising:

a. inserting an anchor across a vessel wall into a lumen defined by the vessel wall through a first arteriotomy that has a first angle with respect to the vessel wall;

b. applying a force to the anchor to position an adjacent portion of the vessel wall in a desired contact configuration relative to the anchor;

c. while maintaining the vessel wall portion in the desired contact configuration with the anchor, advancing the introducer through a proximal extension of the anchor and across the vessel wall to form a tract in the vessel wall, wherein a distal portion of the tract defines a second angle with respect to the vessel wall and wherein the first angle is larger than the second angle, and wherein the tract is defined between overlapping tissue portions of the vessel wall; and

d. expanding the tract with a sheath so that a procedure may be performed therethrough, wherein the tract includes at least one sloped region, and wherein after the procedure has been performed and the device and sheath have been withdrawn from the tract, blood pressure acting on the vessel causes the overlapping tissue portions to collapse and self-seal.

2. The method of claim 1, wherein the vessel wall defines a lumen, and wherein the method comprises advancing the introducer into the lumen.

3. The method of claim 2, wherein the vessel wall comprises intima, media, adventitia, or a combination thereof.

4. The method of claim 1, wherein the vessel comprises an artery.

5. The method of claim 1, wherein the tract has a diameter of about 1.0 mm to about 10.2 mm.

6. The method of claim 2, wherein the device further comprises an anchor having an anchor longitudinal axis and the introducer has an introduction longitudinal axis that forms an introduction angle with the anchor longitudinal axis.

7. The method of claim 6, wherein when the introducer enters the lumen, the introduction angle is less than or equal to about 19 degrees.

8. The method of claim 6, wherein when the introducer enters the lumen, the introduction angle is less than or equal to about 15 degrees.

9. The method of claim 6, wherein when the introducer enters the lumen, the introduction angle is from about 5 degrees to about 10 degrees.

10. The method of claim 1, wherein the force is a proximal force configured to urge the anchor into contact against the vessel wall.

11. The method of claim 10, wherein desired contact configuration comprises one in which a portion of the anchor is aligned to be substantially parallel with a wall surface of the lumen of the vessel.