Valved sheath introducer for venous cannulation

• US 9,108,033 B2
• Filed: 12/29/2009
• Issued: 08/18/2015
• 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, Beal, James D.
• Primary Examiner(s): BESLER, CHRISTOPHER JAMES
• Application Number:
  US12/648,533
• Publication Number:
  US 20100101069A1
• Time in Patent Office: 2,058 Days
• Field of Search: 298/901.24, 298/901.25, 298/901.2
• US Class Current: 1/1
• 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 assembling a valved sheath introducer, comprising:

providing a valve including a slit, the valve comprising a first anchoring member, a second anchoring member unconnected to the first anchoring member, and a central portion, the slit traversing through the central portion;

inserting the valve into a handle, the first and second anchoring members positioned respectively in a first and second receiving sections of the handle and the central portion positioned in a bore of the handle, the central portion having a diameter approximately equal to a diameter of the bore, the first and second anchoring members and central portion extending distally into the handle; and

attaching a cap to the handle under pressure, the cap contacting a proximal most surface of the valve and compressing the valve between the cap and the handle.

2. The method according to claim 1, wherein the providing step further comprises providing the central portion of the valve with a thickness less than a thickness of at least one of the first and second anchoring members.

3. The method according to claim 2, wherein the providing step further comprises providing the central portion of the valve with a concave surface.

4. The method according to claim 3, wherein the providing step further comprises providing the slit of the valve at an angle of approximately 60 degrees with respect to the proximal most surface of the valve.

5. The method according to claim 1, wherein the inserting step further comprises positioning the first anchoring member in the first receiving section in a first side of the handle and positioning the second anchoring member in the second receiving section in a second side of the handle opposite from the first side of the handle.

6. The method according to claim 5, wherein the providing step further comprises providing the central portion of the valve with a thickness less than a thickness of the first and second anchoring members.

7. The method according to claim 1, wherein the attaching step further comprises ultrasonically welding the cap to the handle.

8. The method according to claim 1, wherein the attaching step further comprises attaching a first part of the cap to a first side of the handle and attaching a second part of the cap to a second side of the handle such that a gap between the first and second parts of the cap is aligned with one or more slots in the handle.

9. The method according to claim 1, wherein the providing step further comprises providing the slit of the valve at an angle of approximately 45 degrees with respect to the proximal most surface of the valve.

10. The method according to claim 1, wherein the providing step further comprises providing the valve with a peripheral slit positioned at an edge of the valve, the peripheral slit aligned with the slit through the central portion.

11. The method according to claim 1, wherein the providing step further comprises providing the valve with two peripheral slits positioned at opposing edges of the valve, the peripheral slits aligned with the slit through the central portion.

12. The method according to claim 1, wherein the providing step further comprises providing the valve with two peripheral notches positioned at opposing edges of the valve, the peripheral notches aligned with the slit through the central portion.

13. The method according to claim 1, wherein the providing step further comprises providing the valve with a wire that is looped through the slit, the wire having free ends thereof positioned in the handle.

14. A method for assembling a valved sheath introducer, comprising:

providing a valve including a slit traversing through a central portion and at least a first anchoring portion at least partially circumscribing the central portion, a section of the valve between the first anchoring portion and the central portion having a thickness less than a thickness of both the first anchoring portion and the central portion;

inserting the valve into a handle, the first anchoring portion positioned in a corresponding first handle receiving section, the central portion positioned in a bore of the handle, the central portion having a diameter approximately equal to a diameter of the bore, the first anchoring portion and the central portion extending distally into the handle; and

attaching a cap to the handle under pressure, the cap contacting a proximal most surface of the valve and compressing the valve between the cap and the handle.

15. The method according to claim 14, wherein the providing step further comprises providing the valve with a second anchoring member, the inserting step further comprising positioning the second anchoring member in a corresponding second handle receiving section.