System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure

• US 7,008,440 B2
• Filed: 09/26/2002
• Issued: 03/07/2006
• Est. Priority Date: 11/08/2001
• Status: Expired due to Term

• Current Assignee: Allen Family Trust, Andrew H. Cragg, Boston Scientific Scimed (Boston Scientific Corporation), Bruce Feuchter, FirstMark II LP (FirstMark Capital, LLC), Geoffrey O. Hartzler, George Wallace, Pacific Venture Group II, L.P., PVG Associates II, L.P., Kingsbury Capital Partners, L.P. III (Timothy J. Wollaeger, MBA), Kingsbury Capital Partners, L.P. IV (Timothy J. Wollaeger, MBA)
• Original Assignee: Sub-Q, Inc. (Merit Medical Systems, Inc.)
• Inventors: Ashby, Mark, Urquidi, Luis, Sing, Eduardo Chi
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/256,493
• Publication Number:
  US 20040019328A1
• Time in Patent Office: 1,258 Days
• Field of Search: 606/213, 606/215, 606/216, 606228-231, 604/11, 604/13, 604/15, 604/60, 604/131, 604/116, 604/117, 604/168.01, 604/500
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• 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 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

A system for delivering hemostasis promoting material of the present invention allows the hemostasis promoting material to be delivered to a blood vessel puncture site by fluid pressure. The system allows the hemostasis promoting material to be delivered through an producer sheath which is already in place within a tissue tract. The system includes a controlled tip which is insertable through the introducer sheath to locate and occlude the blood vessel puncture site and a hydration chamber for receiving and delivering the hemostasis promoting material to the blood vessel puncture site. The system accurately locates the blood vessel wall at a puncture site and for properly placing a hemostasis plug over the puncture site.

Claims

1. A system for determining a location of a blood vessel puncture for delivery of a hemostasis promoting material to the blood vessel puncture to facilitate hemostasis, the system comprising:

an introducer sheath having a lumen, a proximal end, and a distal end configured to be inserted into a blood vessel puncture;

a hemostasis promoting material delivery system having a connector for forming a fluid tight connection with the proximal end of the introducer sheath;

a bleed back exhaust tube having a first end in fluid communication with the lumen of the introducer sheath and a second end positioned to deliver blood to an exterior of the system to provide a visual indication of the location of the distal end of the introducer sheath, wherein the bleed back exhaust tube has an inner diameter of less than 2 mm and, wherein the bleedback exhaust tube is on the hemostasis promoting material delivery system.

2. The system of claim 1, wherein the bleedback exhaust tube is connected to the introducer sheath.

3. The system of claim 1, wherein the hemostasis promoting material delivery system comprises:

a hydration chamber configured to receive and hydrate a pedget of hemostasis promoting material, the hydration chamber having a distal end configured to be connected to the proximal end of the introducer sheath and a proximal end configured to be connected to a syringe; and

a control tip including a tube having a first diameter and an enlarged distal tip having a second diameter larger than the first diameter, the rube configured to extend from an interior of the hydration chamber through the distal end of the hydration chamber, through the introducer, and out the distal end of the introducer.