Suture delivery device

• US 9,011,467 B2
• Filed: 08/12/2009
• Issued: 04/21/2015
• 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): Woo, Julian W
• Application Number:
  US12/540,341
• Publication Number:
  US 20100042118A1
• Time in Patent Office: 2,078 Days
• Field of Search: 606/213, 606139-148, 606191-192, 606/198, 606/153, 606/200, 606/232
• 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 2017/00663 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
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• 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 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• 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 device for closing an aperture in a wall of a blood vessel, the device comprising:

a body;

at least one suture element held within the body; and

at least one suture capture rod within the body, the suture capture rod being operatively associated with the suture element and arranged to pass the suture element through the vessel wall such that opposed portions of the suture element extend from the vessel wall;

wherein a distal tip of the body is configured to dilate the aperture in the wall of the vessel, and wherein the distal tip has 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, and wherein the distal tip has a length of about 1 to 3 cm, wherein a distal-most end of the distal tip has an equivalent stiffness and smoothness to polyethylene material;

a pre-mounted sheath positioned over the body, the sheath configured to move from a proximal position to a distal position along the body, the pre-mounted sheath including an occlusion element,

wherein the occlusion element comprises at least one of an inflatable balloon, an inflatable cuff, a conical or other circumferential element which flares outwardly to engage an interior wall of the vessel to block flow therepast, a membrane-covered braid, and a slotted tube that radially enlarges when axially compressed.

2. A device as in claim 1, wherein the distal tip is about 3 cm distal from a location where the suture element passes through the vessel wall.

3. A device as in claim 1, further comprising a guidewire lumen.

4. A device as in claim 3, wherein the guidewire lumen extends through the device from a distal end of the device to a proximal end of the device.

5. A device as in claim 3, wherein the guidewire lumen extends through the distal tip and exits at a position distal to a suture capture mechanism of the device.

6. A device as in claim 3, wherein the guidewire lumen forms a distal opening in the distal tip and wherein the opening provides a smooth transition to the guidewire so the device can smoothly and atraumatically be inserted into the blood vessel over the guidewire.

7. A device as in claim 6, wherein the guidewire lumen has a diameter that is slightly larger than the diameter of a guidewire in the lumen at the distal opening of the guidewire lumen.

8. A device as in claim 7, wherein the diameter of the guidewire lumen at the distal opening of the guidewire lumen is between 0.039″

and 0.041″

.

9. A device as in claim 1, wherein the suture element defines a knot between opposed portions thereof after the suture element has been passed through the vessel wall.

10. A device as in claim 9, wherein the knot is formed after a procedural sheath is removed from the vessel.

11. A device as in claim 9, wherein the suture elements are pre-tied in a knot and held outside the tissue tract during a portion of the procedure, and wherein the knot is pushed down over the aperture after a procedure sheath is removed from the vessel.

12. A device as in claim 1, wherein the distal tip has a leading distal edge defined by a radius of about 0.050″

to 0.075″

.

13. A device as in claim 1, further comprising at least one vessel wall locator, wherein the vessel wall locator can be actuated from a first position which is generally in line with the device to a second position which is generally extended away from the device.

14. A device as in claim 1, wherein the device advances the suture capture rod in a proximal to distal direction along at least a portion of the body toward an arm, and wherein the suture capture rod engages a portion of the suture element such that the suture capture rod can be retracted with the suture element.

15. A device as in claim 1, wherein the pre-mounted sheath is configured to peel away a part of the suture element from the body when the pre-mounted sheath moves from the proximal position to the distal position along the body.

16. A device for closing an aperture in a wall of a blood vessel, the device comprising:

a body;

at least one suture element held within the body; and

at least one suture capture rod within the body, the suture capture rod being operatively associated with the suture element and arranged to pass the suture element through the vessel wall such that opposed portions of the suture element extend from the vessel wall;

wherein a distal tip of the body is configured to dilate the aperture in the wall of the vessel, and wherein the distal tip has 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, and wherein the distal tip has a length of about 1 to 3 cm, wherein a distal-most end of the distal tip has an equivalent stiffness and smoothness to polyethylene material;

a pre-mounted sheath positioned over the body, the pre-mounted sheath configured to move from a proximal position to a distal position along the body and configured to peel away a part of the suture element from the body when the pre-mounted sheath moves from the proximal position to the distal position along the body.