Suture delivery device

• US 8,574,245 B2
• Filed: 12/08/2009
• Issued: 11/05/2013
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Hyde, Gregory M., Renati, Richard, Schaer, Alan, Chou, Tony M.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/633,730
• Publication Number:
  US 20100185216A1
• Time in Patent Office: 1,428 Days
• Field of Search: 606/139, 606/144, 606/148, 606/108, 606/150, 606/233
• US Class Current: 606/148
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 5/027 using catheters
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A suture-based vessel closure device can perform the dilation of an arteriotomy puncture and does not require previous dilation of the arteriotomy puncture by a separate device or by a procedural sheath dilator. The suture-based vessel closure device can place one or more sutures across the vessel access site such that, when the suture ends are tied off after sheath removal, the stitch or stitches provide hemostasis to the access site.

Claims

1. A method of performing a procedure on a vascular or cardiac structure comprising:

inserting a guidewire into the common carotid artery through a puncture in the wall of the common carotid artery;

inserting a suture delivery device over the guidewire into the common carotid artery such that a distal tip of the suture delivery device dilates an opening of an arteriotomy into the artery, the distal tip having an outer surface that tapers at an angle of 3 to 7 degrees relative to a longitudinal midline of a distal portion of the device, the distal tip having a length of about 1 to 3 cm, and wherein the suture delivery device is used to dilate the opening of the arteriotomy without having previously dilated the opening using a catheter or introducer sheath;

drawing at least one end of a suture outside the body of the patient using the suture delivery device such that the suture can be held until such time as the suture is to be tied off to create a permanent closure of the arteriotomy;

removing the suture delivery device while leaving the guidewire in place;

inserting a procedural sheath over the guidewire into the common carotid artery;

inserting a therapeutic device or devices through the sheath to the treatment site, performing a therapeutic procedure, and removing the therapeutic device or devices from the sheath;

removing the sheath; and

tying off the ends of the suture to close the arterial access site.

2. A method as in claim 1, wherein the therapeutic device is a prosthetic aortic valve and the therapeutic procedure is transcatheter aortic valve implantation.

3. A method as in claim 1, wherein the suture delivery device includes a vessel wall locator, and further comprising actuating the vessel wall locator from a first position which is generally in line with the suture delivery device to a second position which is generally extended away from the suture delivery device.

4. A method as in claim 1, further comprising the step of occluding the common carotid artery.

5. A method as in claim 4, wherein the procedural sheath includes a Y-arm connection to a flow line and further comprising the step of connecting the sheath to a reverse flow shunt.

6. A method as in claim 1, further comprising:

advancing a needle in a proximal to distal direction along at least a portion of an elongate body of the suture delivery device toward the arteriotomy, the needle being advanced through tissue of the common carotid artery;

engaging a portion of the needle with the portion of the suture; and

retracting the needle.

7. A method as in claim 1, wherein a distal-most end of the distal tip has an equivalent stiffness and smoothness to polyethylene material.