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

• US 6,863,680 B2
• Filed: 11/08/2001
• Issued: 03/08/2005
• Est. Priority Date: 11/08/2001
• Status: Expired due to Fees

• 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
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/007,204
• Publication Number:
  US 20030088269A1
• Time in Patent Office: 1,216 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

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 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 delivering hemostasis promoting material to a blood vessel puncture to facilitate hemostasis, the system comprising:

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

a hydration chamber configured to receive and hydrate a pledget 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 tube 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.

2. The system of claim 1, wherein the control tip has a proximal end extending through a side of the hydration chamber between the proximal and distal ends of the hydration chamber.

3. The system of claim 1, wherein the control tip has a central lumen extending from a distal end to a proximal end of the control tip configured to receive a guidewire.

4. The system of claim 1, wherein the enlarged distal tip of the control tip extends beyond the distal end of the introducer sheath when the distal end of the hydration chamber is engaged with the proximal end of the introducer sheath.

5. The system of claim 1, wherein the hydration chamber has a first inner diameter, a second inner diameter, and a tapered portion between the first and second inner diameters for compressing the hemostasis promoting material.

6. The system of claim 5, wherein the second inner diameter is substantially the same as an inner diameter of the introducer sheath.

7. The system of claim 1, further comprising an exhaust vent in fluid connection with a distal end of the introducer sheath for providing a bleed back indication of position.

8. The system of claim 7, wherein the exhaust vent is located at the proximal end of the introducer sheath.

9. The system of claim 8, wherein the exhaust vent is configured to be opened and closed by at least one of a cap, a valve, and a stopcock.

10. The system of claim 7, wherein the exhaust vent is located in the distal end of the hydration chamber.

11. The system of claim 10, wherein the exhaust vent is configured to be opened and closed by at least one of a cap, a valve, and a stopcock.

12. The system of claim 1, wherein the control tip is fixed to the hydration chamber.

13. A system for delivering sponge material to a blood vessel puncture to facilitate hemostasis, the system comprising:

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

a hydration chamber configured to received and hydrate a pledget of sponge material, the hydration chamber having a proximal end and a distal end configured to be connected to the proximal end of the introducer sheath;

a syringe connectable to the proximal end of the hydration chamber for delivering the sponge material through the sheath by fluid pressure; and

means for preventing the injected sponge material from entering an interior of the blood vessel.

14. The system of claim 13, wherein the means for preventing the injected sponge material from entering an interior of the blood vessel is 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 tube 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.

15. The system of claim 14, wherein the second diameter of the control tip is smaller than an inner diameter of the introducer sheath.