Technique to confirm correct positioning of arterial wall sealing device

• US 7,044,916 B2
• Filed: 11/12/2003
• Issued: 05/16/2006
• Est. Priority Date: 01/12/2001
• Status: Expired due to Term

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Radi Medical Systems AB (Abbott Laboratories)
• Inventors: Åkerfeldt, Dan, Tenerz, Lars
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/704,556
• Publication Number:
  US 20040098046A1
• Time in Patent Office: 916 Days
• Field of Search: 600/481, 600/488, 600/485, 600/486, 606213-215, 606/139, 606/144, 606/148, 606/264
• US Class Current: 600/485
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 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 2090/064 for measuring force, pressure or mechanical tension

Abstract

Methods and systems related to sealing punctures in blood vessels (such as following an angio or PTCA procedure) are disclosed. The position of a distal end of an introducer assembly in tissue is determined using a pressure sensor. The pressure sensor is connected to the proximal end of the introducer assembly. The introducer assembly has a fluid path between its distal end and its proximal end. Measured blood pressure is outputted as an indication of the position of the distal end of the introducer assembly in the tissue. Proper positioning of a seal is confirmed by placing the introducer assembly such that its distal end is in tissue outside a puncture in a blood vessel wall and observing a characteristic of blood at the proximal end of the introducer assembly. In both techniques, a waveform of the blood pressure at the distal end of the introducer assembly may be displayed on a display to provide additional information to a surgeon as to the relative position of the components with respect to various tissues.

Claims

1. A method to detect sealing of a puncture in a blood vessel wall by a seal inside a blood vessel, comprising:

(a) providing an introducer assembly having a distal end and a proximal end and a fluid path between the distal end and the proximal end;

(b) placing the introducer assembly such that the distal end of the introducer assembly is inside a blood vessel;

(c) placing a seal against an inner wall of the blood vessel by deploying the seal inside the blood vessel and then retracting the seal until contact with the inner wall of the blood vessel;

(d) placing the introducer assembly such that the distal end of the introducer assembly is outside the inner wall of the blood vessel; and

(e) determining whether the puncture is sealed by said seal by observing a characteristic of blood at the proximal end of the introducer assembly.

2. A method as set forth in claim 1, wherein step (e) includes:

visually observing a flow of blood at the proximal end of the introducer assembly.

3. A method as set forth in claim 1, wherein step (e) includes

measuring blood pressure at the proximal end of the introducer assembly with a pressure sensor and outputting an indication of measured blood pressure.

4. A method as set forth in claim 1, wherein step (e) includes

measuring blood pressure at the proximal end of the introducer assembly with a pressure sensor and displaying a numerical indication of measured blood pressure.

5. A method as set forth in claim 1, wherein step (e) includes

measuring blood pressure at the proximal end of the introducer assembly with a pressure sensor;

and

displaying a blood pressure waveform on a display.

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

after step (c), placing a seal outside the blood vessel.