Pledget-handling system and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure

• US 7,037,323 B2
• Filed: 12/09/2003
• Issued: 05/02/2006
• 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: Sing, Eduardo Chi, Ashby, Mark, Cragg, Andrew, Urquidi, Luis
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US10/732,441
• Publication Number:
  US 20040176723A1
• Time in Patent Office: 875 Days
• Field of Search: 606/213, 606/215, 606/216, 606228-231, 604/11, 604/13, 604/15, 604/60, 604/131
• 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 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 2090/062 penetration depth
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

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 introducer sheath which is already in place within a tissue tract. This system includes a control 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 delivering a pledget of hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:

an introducer sheath having a proximal end;

a pledget handling system configured to receive a pledget of hemostasis promoting material, said pledget handling system having a connector configured to be connected to the proximal end of said introducer sheath, said pledget handling system comprising a valve to permit a user to control the staging and delivery of the pledget; and

,

a control tip coupled to said pledget handling system.

2. A system according to claim 1 wherein said pledget handling system comprises a body which is substantially cylindrical.

3. A system according to claim 1 wherein said pledget handling system comprises a delivery syringe.

4. A system according to claim 1 wherein said pledget handling system comprises a hose connected to provide fluid flow communication between said delivery syringe and said valve.

5. A system according to claim 4 wherein at least two connectors are connected to said hose to permit a user to connect a hydration chamber to said hose at a selected connector.

6. A system according to claim 1 wherein said valve is constructed to allow the user to control the flow of fluid from the distal end of said pledget handling system.

7. A system according to claim 1 wherein said valve is constructed to allow the user to control the hydration, staging and delivery of the pledget.

8. A method of promoting hemostasis of a blood vessel puncture using a pledget handling system which includes a valve, the method comprising:

locating a pledget inside a hydration means;

connecting said hydration means to said pledget handling system;

setting the valve to a first position and hydrating the pledget in said hydration means;

thereafter setting the valve to a second position and staging the pledget in said pledget handling system; and

,

thereafter setting the valve to a third position and delivering the pledget to promote hemostasis of the blood vessel puncture.

9. A method according to claim 8 wherein when the valve is in the first position the valve prevents fluid from flowing from the distal end of the pledget handling system.

10. A method according to claim 8 wherein the step of hydrating the sponge material includes applying pressurized fluid to the sponge material.

11. A method according to claim 8 wherein when the valve is in the second position the valve allows fluid to flow from the pledget handling system at a controlled rate while preventing the sponge material from traveling out of the pledget handling system.