Valved sheath introducer for venous cannulation

• US 8,720,065 B2
• Filed: 03/29/2012
• Issued: 05/13/2014
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Christensen, Mark A., Smith, Steven M., Shang, Walter H., Beal, James D.
• Primary Examiner(s): Bryant, David
• Assistant Examiner(s): BESLER, CHRISTOPHER JAMES
• Application Number:
  US13/434,415
• Publication Number:
  US 20120184913A1
• Time in Patent Office: 775 Days
• Field of Search: 298/901.24, 298/901.25, 298/901.2, 604/264, 604/167.04, 604/167.06
• US Class Current: 29/890.124
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0693 including means for seal penetration
• CPC Class Codes: Y10T 137/788 Having expansible port
• CPC Class Codes: Y10T 137/7885 Multiple slit
• CPC Class Codes: Y10T 29/49405 Valve or choke making
• CPC Class Codes: Y10T 29/49412 with assembly, disassembly or composite article making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Claims

1. A method for inserting a medical device into a body vessel, comprising:

providing an introducer device, comprising;

a sheath body;

a handle including at least one receiving section, the handle attached to a proximal end of the sheath body;

a valve including a slit through a central portion and at least one anchoring member positioned in the at least one receiving section;

a cap attached to the handle under pressure to compress at least a portion of the valve contacted by the cap, the valve having an original shape following attachment of the cap to the handle; and

a dilator inserted through the sheath body, handle, and valve, the dilator having a distal end extending past a distal end of the sheath body, insertion of the dilator through the valve stretching the valve to a valve stretched shape;

inserting at least the distal end of the dilator and distal end of the sheath body through an access site and into the body vessel;

removing the dilator from the sheath body, removal of the dilator through the valve transitioning the valve from the valve stretched shape to a valve bunched shape;

inserting the medical device into the body vessel; and

wherein the at least one anchoring member of the provided valve includes a first anchoring member separated from a second anchoring member, wherein the at least one receiving section of the provided handle includes a first receiving section separated from a second receiving section, and wherein the first anchoring member is positioned in the first receiving section and the second anchoring member is positioned in the second receiving section.

2. The method according to claim 1, wherein the provided valve central portion has a thickness less than a thickness of the at least one anchoring member.

3. The method according to claim 1, wherein the central portion of the provided valve is separated from the at least one anchoring member of the provided valve by a reduced thickness section.

4. The method according to claim 1, wherein the slit of the provided valve is cut at an angle of approximately 60 degrees with respect to a proximal most surface of the valve.

5. The method according to claim 1, wherein the provided valve central portion has a thickness less than a thickness of the first and second anchoring members.

6. The method according to claim 1, wherein the provided valve includes two peripheral slits positioned at opposing edges of the valve, the method further comprising splitting the valve through the peripheral slits by pulling the handle in opposing directions.

7. The method according to claim 1, wherein the provided valve includes two peripheral notches positioned at opposing edges of the valve, the method further comprising splitting the valve through the peripheral notches by pulling the handle in opposing directions.

8. The method according to claim 1, wherein the provided valve includes a wire that is looped through the slit, the wire having free ends thereof positioned in the handle, the method further comprising slicing the valve by pulling the handle in opposing directions.