Vascular sealant delivery device and sheath introducer and method

• US 7,008,442 B2
• Filed: 01/20/2003
• Issued: 03/07/2006
• Est. Priority Date: 01/20/2003
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Brightbill, Jerry
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/348,406
• Publication Number:
  US 20040143290A1
• Time in Patent Office: 1,142 Days
• Field of Search: 606213-215, 604/57, 604/59, 604/60, 604/96.01, 604/164.02, 604/164.03, 604/164.1, 604/167.02, 604/167.6, 604/168.01
• 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 17/12136 Balloons
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

A sheath introducer is inserted through the skin and into a body lumen, e.g., the femoral artery, for a medical procedure. Upon completion of the medical procedure, the sheath introducer is partially withdrawn from the body lumen so that at least one through-wall hole in a body region of the sheath introducer is positioned outside the body lumen, but under the skin. An opening in a distal end tip of the sheath introducer is sealed so that no blood is flowing into the sheath introducer the after sheath introducer is partially withdrawn. A surgical sealant is injected into the sheath introducer and flows out of the at least one through-wall hole and surrounds the access site. After injection of the surgical sealant, the sheath introducer is removed. The surgical sealant seals the puncture and minimizes any blood flow from the body lumen through the puncture.

Claims

1. A structure comprising:

a sheath introducer having a distal end tip, said sheath introducer comprising;

a body region at about a predefined distance from said distal end tip, said body region comprising;

a wall bounded by an outer wall surface of said sheath introducer and by an inner wall surface of said sheath introducer wherein said body region is oriented about a longitudinal axis of said body region; and

at least one through-wall hole extending from said outer wall surface to said inner wall surface and having a longitudinal axis oriented at an angle to said longitudinal axis of said body region; and

a dilator comprising;

a shaft having a distal end; and

a dilator plug formed about said shaft and extending from about said distal end of said shaft to about a predefined distance from said distal end of said shaft wherein following insertion of said dilator into said sheath introducer, said dilator plug forms a seal in said distal end of said sheath introducer, and further wherein said predefined distance is selected so that said dilator plug does not block said at least one through-wall hole.

2. The structure of claim 1 wherein said body region further comprises:

a plurality of through-walls holes including said at least one through-wall hole.

3. The structure of claim 1 wherein said angle is about a 90°

angle.

4. The structure of claim 1 wherein said angle is other than a 90°

angle.

5. The structure of claim 1 wherein said at least one through-wall hole has a uniform cross section along said longitudinal axis of said at least one through-wall hole.

6. The structure of claim 1 wherein said at least one through-wall hole has a non-uniform cross section along said longitudinal axis of said at least one through-wall hole.

7. The structure of claim 1 wherein said body region comprises a cylindrical body region.

8. The structure of claim 1 further comprising:

a balloon clamp catheter extending through said sheath introducer.

9. The structure of claim 1 further comprising:

a guidewire extending through said sheath introducer.

10. The structure of claim 1 further comprising:

a surgical sealant delivery system coupled to said sheath introducer to inject a surgical sealant into said sheath introducer.

11. The structure of claim 1 wherein said sheath introducer further comprises:

a plurality of depth indicators on said outer surface.

12. A system comprising:

a sheath introducer having a distal end tip, said sheath introducer comprising;

a body region at about a predefined distance from said distal end tip, said body region comprising;

a wall bounded by an outer wall surface of said sheath introducer and by an inner wall surface of said sheath introducer wherein said body region is oriented about a longitudinal axis of said body region; and

at least one through-wall hole extending from said outer wall surface to said inner wall surface and having a longitudinal axis oriented at an angle to said longitudinal axis of said body region;

a dilator comprising;

a shaft having a distal end; and

a dilator plug formed about said shaft and extending from about said distal end of said shaft to about a predefined distance from said distal end of said shaft,

wherein following insertion of said dilator into said sheath introducer, said dilator plug forms a seal in said distal end of said sheath introducer, and further wherein said predefined distance is selected so that said dilator plug does not block said at least one through-wall hole;

a balloon clamp catheter extending through said sheath introducer;

a guidewire extending through said sheath introducer; and

a surgical sealant delivery system coupled to said sheath introducer to inject a surgical sealant into said sheath introducer.

13. The system of claim 12 wherein said body region further comprises:

a plurality of through-walls holes including said at least one through-wall hole.

14. The system of claim 12 wherein said at least one through-wall hole has a uniform cross section along said longitudinal axis of said at least one through-wall hole.

15. The system of claim 14 wherein said at least one through-wall hole has a non-uniform cross section along said longitudinal axis of said at least one through-wall hole.

16. The system of claim 12 wherein said body region comprises a cylindrical body region.