Technique to confirm correct positioning of arterial wall sealing device

• US 7,073,509 B2
• Filed: 03/12/2004
• Issued: 07/11/2006
• Est. Priority Date: 01/12/2001
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Coordination Center BVBA (Abbott Laboratories Incorporated)
• Original Assignee: Radi Medical Systems AB (Abbott Laboratories Incorporated)
• Inventors: Åkerfeldt, Dan, Tenerz, Lars
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/798,438
• Publication Number:
  US 20040172059A1
• Time in Patent Office: 851 Days
• Field of Search: 604506-510, 604/171, 604/198, 604/264, 604/523, 600/482, 600/485, 600/486, 600/500, 600/501, 600/504, 600/506, 606/1, 606/159, 606/213
• US Class Current: 128/887
• 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 system to detect the position of a distal end of an introducer assembly in tissue containing a blood vessel, the system comprising:

(a) an introducer assembly having a distal end and a proximal end;

(b) a pressure sensor, coupled to and in fluid communication with a proximal end of the introducer assembly, to measure blood pressure and output a waveform indicative of blood pressure at a distal end of the introducer assembly;

(c) a core pin with a channel at least partially forming a blood path between the distal end and the proximal end of the introducer assembly; and

(d) a side hole in fluid communication with the proximal end of the introducer assembly via the channel.

2. A system as set forth in claim 1, further comprising:

a display to display said waveform.

3. A system as set forth in claim 1, further comprising at least one of a seal or anchor inside a lumen of the introducer assembly and deployable therefrom.

4. A system as set forth in claim 1, further comprising a hemostatic valve at the proximal end of the introducer assembly.

5. A system as set forth in claim 1, wherein the channel is created in a space between the core pin and the introducer assembly.

6. A system to detect the position of a distal end of an introducer assembly in tissue containing a blood vessel, comprising:

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

a pressure sensor, coupled to the proximal end of the introducer assembly, to measure blood pressure and output a waveform indicative of blood pressure at the distal end of the introducer assembly;

wherein the introducer assembly comprises;

an introducer with a side hole at a distal end of the introducer; and

a core pin, insertable into the introducer, with a channel as said fluid path, the channel being in communication with the side hole of the introducer when the core pin is inserted into the introducer.

7. A system as set forth in claim 6, further comprising:

a display to display said waveform.

8. A system as set forth in claim 6, further comprising at least one of a seal or anchor inside a lumen of the introducer assembly and deployable therefrom.

9. A system as set forth in claim 6, further comprising a hemostatic valve at the proximal end of the introducer assembly.