Vascular blood containment device

• US 5,820,596 A
• Filed: 03/22/1996
• Issued: 10/13/1998
• Est. Priority Date: 11/02/1993
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Larsen, Charles E., Hillstead, Richard A., Rosen, Jonathan J., Weldon, Thomas D., Williams, David O.
• Primary Examiner(s): Rimell, Sam
• Assistant Examiner(s): Yeh, Luke
• Application Number:
  US08/620,922
• Time in Patent Office: 935 Days
• Field of Search: 604/167, 604/168, 604/118, 604/164, 604/169, 604/900
• US Class Current: 604/108
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a compliant outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. The visualization channel may have one, two, or more stages, with a first stage chamber which indicates initial penetration of a selected blood vessel, and a second stage chamber which fills more slowly and indicates that the needle remains positioned within the blood vessel. A third stage chamber with entrapped air which compresses slightly due to the heartbeat may also be used. Preferably, a compliant outer wall portion pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned. The device has a guideway with a barrier of elastomeric material which prevents blood from passing therethrough, but which allows passage of an elongated medical instrument such as catheterization apparatus. A flange may also be disposed within the compliant membrane to prevent excess depression of the compliant membrane.

Claims

1. A blood containment device for use with a vascular entry needle, comprising:

a main body portion including distal opening and a proximal opening and a guideway extending therebetween, said distal opening being adapted to communicatively connect to a vascular entry needle, and said proximal opening being adapted to receive an elongated medical instrument for passage through said guideway and said vascular entry needle;

a barrier disposed in said guideway between said proximal and distal openings which prevents passage of blood through said guideway but allows passage therethrough of an elongated medical instrument;

said main body portion including a touch accessible compliant membrane in fluid communication with said distal opening of the device such that blood pressure at said distal opening is transmitted to said compliant membrane, thereby causing said compliant membrane to move responsively to changes in blood pressure at said distal opening; and

a support member disposed internally of said compliant membrane to prevent excess depression of said compliant membrane.

2. The blood containment device of claim 1 wherein said support member is a flange having a square shape with rounded curves.

3. The blood containment device of claim 1, wherein said barrier disposed in said guideway includes a pre-formed aperture that facilitates penetration thereof by an elongated medical instrument.

4. The blood containment device of claim 1, wherein said compliant membrane contains at least one area of reduced thickness which provides greater movement in response to changes in blood pressure within the device than areas of unreduced thickness.

5. The blood containment device of claim 1, wherein said compliant membrane contains a tactile enhancing structure on the surface.

6. The blood containment device of claim 5, wherein said tactile enhancing structure includes one or more dimples.

7. The blood containment device of claim 1 further comprising a gas permeable member disposed between the compliant membrane and the outside environment to allow the venting of air from said membrane.

8. The blood containment device of claim 1, wherein said main body portion includes a rigid inner member with the guideway formed therethrough, the compliant membrane which fits around at least a portion of said rigid inner member, and a rigid outer member which fits around said compliant membrane but allows touch access to said compliant membrane.

9. The blood containment device of claim 8, wherein said rigid outer member has a proximal and a distal end and wherein said proximal end is dome shaped and further comprising a second guideway at said proximal end of said outer member, said guideway being tapered in a funnel-like shape and extending through said dome shape of said outer member to facilitate the insertion of a "J"-tipped elongated medical instrument into the device.

10. The device of claim 8, wherein said rigid outer member has openings to provide touch access to said compliant member and said compliant member includes tactile enhancing dimples which protrude out through said openings in said rigid outer member.

11. A blood containment device for use with a vascular entry needle, comprising:

a rigid inner member with a guideway formed therethrough and having an exterior and an interior surface and a proximal and a distal end, said distal opening being adapted to communicatively connect to a vascular entry needle;

a compliant membrane, having an exterior and an interior surface and a proximal and a distal end, said membrane being disposed around at least a portion of said inner member to define a blood containment chamber therebetween, said compliant membrane being in fluid communication with said distal opening of said rigid inner member such that blood pressure at said distal opening is transmitted to said compliant membrane, thereby causing said compliant membrane to move responsively to changes in blood pressure at said distal opening;

a rigid outer member including a proximal and a distal end, said outer member disposed over said compliant membrane and said portion of said inner member and having openings to provide touch access to said compliant member, said compliant membrane and said rigid outer member being adapted to receive an elongated medical instrument for passage through said guideway and said vascular entry needle; and

a support member disposed internally of said compliant membrane to prevent excess depression of said compliant membrane.

12. The blood containment device of claim 11, wherein said blood containment chamber comprises a cylindrically shaped space defined around the interior surface of said compliant membrane and the exterior surface of said inner member.

13. The blood containment device of claim 11 further comprising a gas permeable member disposed between the proximal end of said compliant membrane and said rigid outer member and above a vent opening in said compliant membrane to allow venting of air from said compliant membrane while preventing the passage of blood from said membrane.

14. The blood containment device of claim 13 wherein the gas permeable member is comprised of a self-sealing material that congeals upon contact with a liquid.

15. The blood containment device of claim 11 further comprising an annular rest disposed at the proximal end of said inner member, wherein the interior surface at the proximal end of said compliant membrane rests on said annular rest.

16. The blood containment device of claim 15 wherein said annular rest has a plurality of cut outs and wherein the proximal end of said compliant membrane includes at least one vent opening which is aligned with one of said cut outs.

17. The blood containment device of claim 11 further comprising a luer lock at the distal end of said inner member, said luer lock having sealing grooves for coupling the luer lock to said compliant membrane and said outer member.

18. The blood containment device of claim 17 wherein said outer member includes at least one cut out area and wherein said luer lock includes at least one orientation tab which is adapted to fit within said cut out area in said outer member.

19. The device of claim 11, wherein said compliant membrane includes tactile enhancing dimples which protrude out through openings in said outer member.

20. The blood containment device of claim 11 wherein said proximal end of said outer member is dome shaped.

21. The blood containment device of claim 20 further comprising a guideway at said proximal end of said outer member, said guideway being tapered in a funnel-like shape and extending through said dome shape of said outer member to facilitate the insertion of a "J"-tipped elongated medical instrument into the device.

22. The blood containment device of claim 11 further comprising at least one vent hole in said outer rigid member.

23. The blood containment device of claim 11 further comprising a barrier disposed in said guideway between said proximal and distal openings which prevents passage of blood through said guideway but allows passage therethrough of an elongated medical instrument.

24. The blood containment device of claim 11, wherein said compliant membrane contains at least one area of reduced thickness which provides greater movement in response to changes in blood pressure within the device than areas of unreduced thickness.

25. The blood containment device of claim 11, wherein said compliant membrane contains a tactile enhancing structure on the surface.