Locator and closure device and method of use

• US 8,852,229 B2
• Filed: 10/17/2003
• Issued: 10/07/2014
• Est. Priority Date: 10/17/2003
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Ginn, Richard S.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US10/687,848
• Publication Number:
  US 20050085854A1
• Time in Patent Office: 4,008 Days
• Field of Search: 606/213, 606/232, 606138-143, 606151-158, 606139-143, 606219-221, 623/23.72
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• 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 2090/062 penetration depth
• 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

Abstract

An apparatus for sealing a vascular puncture and for properly locating and deploying a sealing member. The apparatus comprises a lumen which extends from an opening in the distal region of the apparatus to another opening in the proximal region of the apparatus. A sealing member is located at the end of the lumen. When the distal opening is positioned within the blood vessel lumen, blood flows through the distal opening, through the lumen and out of the proximal opening indicating that the sealing member is within the blood vessel lumen. When the sealing member is withdrawn from the vessel lumen, it blocks the blood flow into the distal opening. The sealing member may be further withdrawn a predetermined distance so that no part of the sealing member extends into the blood vessel lumen. The sealing device is then detached from the delivery apparatus to seal the vascular puncture.

Claims

1. A locator and closure device comprising

an elongate member, said elongate member having a lumen, a distal opening and a proximal opening which are connected by the lumen and a distal portion with a substantially uniform outer diameter wherein said distal opening is located within said distal portion,

said elongate member being adapted to be advanced through an introducer member to extend into a blood vessel of a patient such that said distal opening is located in the lumen of the blood vessel, and

said device being provided with a bioabsorbable occlusion member releasably attached by an attachment formed by contact between said occlusion member and said elongate member at a specific position of said elongate member, in contact with said lumen of said elongate member and located distally of said distal opening, said occlusion member comprising an unrestrained maximal outer diameter configured to correspond to a diameter of a tissue passageway opening into said blood vessel lumen, said occlusion member configured to substantially block blood flow out of said blood vessel when released into the tissue passageway opening,

wherein when said distal opening is located in the lumen of the blood vessel, blood can enter said distal opening without passing through said occlusion member, flow through said lumen, exit through said proximal opening and be visible outside of the patient'"'"'s body.

2. The device of claim 1 wherein said occlusion member is expandable.

3. A method of installing a closure device for sealing a puncture in a blood vessel wall comprising the steps of

introducing an elongate member through an introducer member disposed in a tract extending from said puncture to a patient'"'"'s skin, said elongate member having a lumen, a first opening in its distal region, a second opening in its proximal region such that the lumen extends between said first opening and said second opening, said elongate member being provided with a bioabsorbable occlusion member located distally of said first opening such that said lumen of said elongate member contacts said occlusion member and wherein said elongate member has a distal portion with a substantially uniform outer diameter wherein said first opening is located within said distal portion and is adapted to extend into a blood vessel of a patient such that said occlusion member is fully inserted into the lumen of said blood vessel and said first opening is located in the lumen of the blood vessel such that blood entering said first opening without passing through said occlusion member, flowing through said lumen and exiting through said second opening is visible outside of the patient'"'"'s body, and said occlusion member is releasably attached by an attachment formed by contact between said occlusion member and said elongate member at a specific position of said elongate member and wherein said occlusion member comprises an unrestrained maximal outer diameter configured to correspond to a diameter of a tissue passageway opening into said blood vessel lumen,

advancing said elongate member until said first opening is located within the lumen of said blood vessel such that blood flows into said first opening and out of said second opening,

withdrawing said elongate member until the flow of blood into said first opening is substantially prevented;

and

releasing said occlusion member from said elongated member within the tract to substantially block blood flow out of said blood vessel.

4. The method of claim 3 wherein releasing said occlusion member occurs at substantially the same time that blood flow into said first opening is substantially prevented.

5. A locator and closure device comprising

an elongate member having a lumen and having a first opening in its distal region, wherein said distal region has a substantially uniform outer diameter, and a second opening in its proximal region such that the lumen extends between said first opening and said second opening;

an occlusion member attached to a specific position of said distal region of said elongate member such that said lumen of said elongate member contacts said occlusion member and said occlusion member includes a bioabsorbable material and is distal from said first opening;

said elongate member being adapted to be advanced through an introducer member to extend into a blood vessel of a patient such that said occlusion member is fully inserted into the lumen of said blood vessel and said first opening is located in the lumen of the blood vessel such that blood entering said first opening without passing through said occlusion member, flowing through said lumen and exiting through said second opening is visible outside of the patient'"'"'s body, and said occlusion member is releasably attached by an attachment formed by contact between said occlusion member and said elongate member at a specific location on said elongate member and wherein said occlusion member comprises an unrestrained maximal outer diameter configured to correspond to a diameter of a tissue passageway opening into said blood vessel lumen, said occlusion member configured to substantially block blood flow out of said blood vessel when released into the tissue passageway opening.

6. The device of claim 5 wherein said occlusion member is expandable.