Device and method for positioning a closure device

• US 7,850,654 B2
• Filed: 04/24/2003
• Issued: 12/14/2010
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Terumo Puerto Rico, L.L.C. (Terumo Corporation)
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Inventors: Belhe, Kedar Ravindra, Forsberg, Andrew Thomas
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US10/422,614
• Publication Number:
  US 20040215232A1
• Time in Patent Office: 2,791 Days
• Field of Search: 604/167.06, 606/153, 606/213, 600/504
• US Class Current: 604/167.06
• 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 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

A vascular closure device including a sheath with one or more orifices therein to detect blood flow, indicating that the sheath has entered an artery and the relative position of the sheath within the artery. Thus, the sheath can be moved and positioned relative to the artery without having to completely extract the sheath from the artery after initial penetration.

Claims

1. A device for positioning a vascular wound closure device comprising:

a sheath having a distal end and a proximal end, a sealing device being insertable through the sheath;

a first detection orifice in the sheath near the distal end;

a second detection orifice in the sheath near the distal end;

a first locator orifice in the sheath near the proximal end, and

a second locator orifice in the sheath near the proximal end,

wherein the first detection orifice is in fluid communication with the first locator orifice such that when the first detection orifice is disposed within the blood vessel and exposed to blood flow, such blood flow is indicated at the first locator orifice; and

wherein the second detection orifice is in fluid communication with the second locator orifice such that when the second detection orifice is disposed within the blood vessel and exposed to blood flow, such blood flow is indicated at the second locator orifice.

2. The device of claim 1, wherein the second detection orifice is in fluid communication with the locator orifice.

3. The device of claim 1, wherein the first detection orifice and the second detection orifice are linearly aligned about a circumference of the sheath.

4. The device of claim 1, wherein the first detection orifice and the second detection orifice are linearly offset with respect to one another along an axis of the sheath so that upon non-perpendicular entry into the blood vessel, the first detection orifice and the second detection orifice are generally equidistant from a wall of the blood vessel.

5. The device of claim 1, wherein a fluid communication path from the first detection orifice to the first locator orifice is isolated from a second fluid communication path from the second detection orifice to the second locator orifice.

6. The device of claim 1, wherein the position of the first detection orifice is such that blood flow indicates a proper positioning of the sheath within the blood vessel and the position of the second detection orifice is such that blood flow indicates that the sheath has penetrated the blood vessel too far.

7. The device of claim 1, wherein the first locator orifice is an open outlet enabling passage of fluid from the device.

8. The device of claim 1, wherein the first locator orifice is a window that allows for the viewing of blood flow as the indication of blood flow.

9. The device of claim 1, wherein the first locator orifice is a gauge.

10. The device of claim 1, further comprising:

an arteriotomy locator insertable through the sheath;

wherein the arteriotomy locator includes an arteriotomy locator orifice disposed on the arteriotomy locator is in a position aligned with one of the first detection orifice or the second detection orifice when the arteriotomy locator is fully inserted into the sheath.

11. A method of positioning a vascular closure device comprising the steps of:

inserting a distal end of a sheath through an existing tract to a blood vessel wall, a sealing device being insertable through the sheath;

advancing the sheath through the blood vessel wall until blood flows into a first detection orifice of the sheath and blood flow is detected at a first locator orifice in the sheath;

retracting the sheath until the blood flow ceases without completely withdrawing the sheath from the blood vessel and determining that the orifice is positioned adjacent an edge of the wall while the tip of the sheath is positioned within the blood vessel;

wherein advancing the sheath forward further comprises stopping the forward advancement if blood flow is detected at a second locator orifice disposed in the sheath, wherein the second locator orifice is in fluid communication with a second detection orifice disposed further from the distal end of the sheath than the first orifice.

12. The method of claim 11, further comprising an arteriotomy locator wherein the arteriotomy locator is inserted through the sheath over a guidewire positioned in the blood vessel.

13. The method of claim 11, further comprising positioning a arteriotomy locator within the sheath as the sheath is inserted.

14. The method of claim 11, further comprising:

passing an anchor member through the sheath;

retracting the sheath from the blood vessel; and

sealing a puncture in the blood vessel caused by the sheath with the anchor.

15. A method of using a vascular wound closure device for a vascular closure procedure, comprising:

inserting a distal end of a sheath into an artery until blood flows into a first detection orifice and blood flow is detected at a first locator orifice in the sheath, the blood flow indicating that the first detection orifice has entered the artery;

advancing the sheath a predetermined distance into the artery; and

stopping advancement when blood flows into a second detection orifice of the sheath and blood flow is detected at a second locator orifice in the sheath, the second detection orifice being located proximal of the first detection orifice;

wherein the sheath provides an access point for a sealing device into the artery.

16. A vascular wound closure device comprising:

a sheath for penetrating an artery, the sheath having a distal end and a proximal end and providing an access point for a sealing device into the artery;

a first detection orifice disposed on the sheath;

a second detection orifice disposed on the sheath further from the distal end that then first detection orifice;

a first indicator in fluid communication with the first detection orifice via a first fluid passageway, the first indicator disposed in the sheath proximate the proximal end, wherein the first indicator indicates when the first detection orifice is exposed to blood flow; and

a second indicator in fluid communication with the second detection orifice via a second fluid passageway, the second indicator disposed in the sheath proximate the proximal end, wherein the second indicator indicates when the second detection orifice is exposed to blood flow.

17. The device of claim 16, wherein the first fluid passageway is a first lumen disposed within the sheath interconnecting first indicator with the first detection orifice.

18. The device of claim 17, wherein the second fluid passageway is a second lumen disposed within the sheath interconnecting second indicator with the second detection orifice.

19. The device of claim 16, wherein the first fluid passageway is formed from an gap between an internal portion of the sheath and a arteriotomy locator passed through the sheath.