Vascular access devices having hemostatic safety valve

• US 6,592,544 B1
• Filed: 11/24/1999
• Issued: 07/15/2003
• Est. Priority Date: 11/24/1999
• Status: Expired due to Term

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Currier, Clifford E., Mooney, Charles R.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/450,032
• Time in Patent Office: 1,329 Days
• Field of Search: 604/30, 604/31, 604/35, 604/43, 604/99.03, 604/164.04, 604/164.12, 604/164.13, 604/167.01, 604/167.03
• US Class Current: 604/43
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 39/0693 including means for seal penetration
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A vascular access device is provided that has a device lumen valve and a safety valve feature to prevent leakage of blood from a lumen of such device. The vascular access device includes a sheath which may have an outer tube and structure defining a device lumen located therein. The access device further includes a detachable device valve which provides sealing of the device lumen. In addition, a non-detachable hemostasis safety valve is provided on the proximal end of the device lumen to seal the device lumen when no device valve is present. The device valve attaches to and simultaneously opens the proximal end of the hemostasis safety valve. In one embodiment, the device valve includes a distal projection that pierces an elastomeric valve member of the hemostasis safety valve. The elastomeric valve member of the hemostasis safety valve is stiffer than an elastomeric valve member of the device valve, and prevents introduction of guidewires and highly flexible catheters therethrough.

Claims

1. A vascular access system for use in providing an entry port into the human body, comprising:

an outer tube which has a distal end for introduction into the body, a device lumen being defined within the outer tube, the device lumen having a distal end and a proximal end, wherein medical devices may be passed through the device lumen;

a hemostatic safety valve non-detachably secured on the proximal end of the device lumen to prevent leakage of blood from the device lumen;

a detachable device lumen valve attachable to the proximal end of the hemostatic safety valve to open the hemostatic safety valve and allow passage of an elongate device through the device lumen while preventing leakage of blood therefrom.

2. The system of claim 1, further including:

a junction housing having a proximal end and a distal end and located between the outer tube and hemostatic safety valve, the junction housing having an internal channel in communication with the device lumen; and

an extension tube attached to the proximal end of the junction housing, the hemostatic safety valve being secured to the free end of the extension tube.

3. The system of claim 2, wherein the junction housing further includes at least one auxiliary channel in fluid communication with at least one auxiliary lumen defined within the outer tube, separate from the device lumen, the main channel and auxiliary channel diverging from the outer tube to be non-intersecting in the junction housing.

4. The system of claim 3, further including a second extension tube attached to the proximal end of the junction housing in fluid communication with the auxiliary channel.

5. The system of claim 4, further including at least one flexible wall located within the outer tube having a distal end and a proximal end and opposite sides, wherein one side of the wall partly defines the device lumen and the other side of the wall partly defines the auxiliary lumen, the wall being sufficiently flexible to be movable from a relaxed position wherein the device lumen has a first cross-sectional area to flexed positions wherein the device lumen has cross-sectional areas which are greater than or less than the first cross-sectional area and less than the cross-sectional area of the outer tube.

6. The system of claim 1, wherein the detachable device lumen valve comprises a distal body member and a proximal body member threadingly connected together and housed within an elastomeric valve member.

7. The system of claim 6, wherein the elastomeric valve member comprises a duckbill valve.

8. The system of claim 7, wherein the elastomeric valve member further comprises first, second and third elastomeric disks each having a hole in the center.

9. The system of claim 7, wherein the elastomeric valve member further comprises a compressible O-ring having a central hole with a size that can be changed by rotatably advancing or retracting the proximal body member relative to the distal body member.

10. The system of claim 1, wherein the hemostatic safety valve includes an elastomeric valve member, and the detachable device lumen valve comprises an elastomeric valve member that is more compliant than the elastomeric valve member of the hemostatic safety valve so as to enable introduction of guidewires and flexible catheters through the detachable device lumen valve.

11. The system of claim 1, wherein the hemostatic safety valve includes an elastomeric valve member, and the detachable device lumen valve has a distally-directed projection that opens the elastomeric valve member of the hemostatic safety valve.

12. The system of claim 11, wherein the distally-directed projection comprises a tubular member within a surrounding distal portion of the detachable device lumen valve, the surrounding distal portion having internal threading to mate with external threading provided on the hemostatic safety valve.

13. The system of claim 11, wherein the hemostatic safety valve has a proximal tubular portion with the external threading, and wherein the elastomeric valve member extends on the outside of and occludes the proximal end of the proximal tubular portion.

14. The system of claim 11, wherein the elastomeric valve member of the hemostatic safety valve is a slit valve.