Vascular access device with air-tight blood containment capability

• US 5,295,969 A
• Filed: 04/27/1992
• Issued: 03/22/1994
• Est. Priority Date: 04/27/1992
• Status: Expired due to Term

• Current Assignee: Cathco, Inc.
• Original Assignee: Cathco, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/874,366
• Time in Patent Office: 694 Days
• Field of Search: 604/158, 604/164, 604/167-169, 604/900
• US Class Current: 604/168.01
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0666 Flap-valve
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: Y10S 604/90 Telltale showing entry of blood into body inserted conduit

Abstract

The present invention is a means for accessing blood vessels for the insertion of a guide wire while preventing the free release of blood. Specifically, a hollow, thin-walled metal tube typically having a sharp point at its distal end is joined at its proximal end to a transparent viewing section. The viewing section has a distal narrow lumen and a proximal chamber which has a cap at its proximal end. The cap encloses a pressure sealing means through which a guide wire can be passed. After the distal end of the metal tube is placed in an artery, blood will rush through the metal tube and into the viewing section. The air in the air-tight proximal chamber will alternatively be compressed between diastolic and systolic blood pressure. Feedback to the operator that the distal end of the metal tube is properly placed within an artery can be achieved by observing the reciprocating pulsatile motion of the blood column within the distal narrow lumen of the viewing section. When the proper pulsatile motion is observed, a guide wire can be passed through the sealing means in the cap, through the viewing section, through the metal tube and finally the guide wire will enter the lumen of the artery.

Claims

1. A vascular access device comprising:

a hollow thin-walled metal tube having distal and proximal ends, and having an opening at the tube'"'"'s distal end, and further having a lumen extending freely from the opening at the tube'"'"'s distal end to the tube'"'"'s proximal end; and

,

a transparent viewing section having distal and proximal ends, the distal end of the viewing section forming a first pressure tight seal with the metal tube'"'"'s proximal end and having an interior lumen which is in fluid communication with the lumen of the metal tube, guide wire access means forming a portion of said transparent viewing section and having a second pressure tight seal at the viewing section'"'"'s proximal end thereby forming an enclosed fixed volume non-venting chamber within the viewing section so as to contain any blood that enters into the opening at the tube'"'"'s distal end, the blood being contained within the metal tube and viewing section, and the guide wire access means being adapted to allow passage of a guide wire through the viewing section and into the metal tube, the guide wire access means being further adapted to provide said second pressure tight seal to prevent free release of the blood prior to insertion of the guide wire through the guide wire access means.

2. The access device of claim 1 wherein the viewing section has a distal lumen having a first, smaller diameter within which the reciprocating pulsatile motion of a column of arterial blood can be observed and a second, larger diameter proximal lumen which forms a proximal chamber which is sealed at its proximal end by the pressure tight seal formed within the guide wire access means, said proximal chamber having air trapped within it which becomes pressurized alternatively at systolic and diastolic pressure when the opening at the distal end of the metal tube is placed within an arterial lumen.

3. A vascular access device comprising:

a hollow thin-walled metal tube having distal and proximal ends and having a central lumen extending freely from the tube'"'"'s distal end to the tube'"'"'s proximal end and further having an opening at the tube'"'"'s distal end;

a transparent viewing section having distal and proximal ends, the distal end of said viewing section forming a pressure tight seal with the metal tube'"'"'s proximal end, the viewing section having a first, smaller diameter elongated distal lumen which is in fluid communication with the metal tube'"'"'s lumen, said viewing section also having a second, larger proximal diameter lumen forming a proximal chamber extending into the viewing cylinder'"'"'s first lumen, said second lumen being in fluid communication with said first lumen; and

,

a separate end cap removeably connected to the viewing cylinder'"'"'s proximal end, the end cap incorporating an air-tight eleastomer valve within a central lumen of said end cap which central lumen is designed for the passage of a guide wire, which guide wire is adapted to pass through the elastomer valve as the guide wire is advanced through the end cap and into the viewing section.

4. The vascular access device of claim 3 wherein the viewing section has a flat-walled section whose distal extremity is joined to a bulbous section which cooperates with the flat-walled section to form a region which is adapted to allow the force of the thumb and forefinger to be conveniently applied for exerting forward thrust on the vascular access device for the purpose of readily pushing the distal end of the thin-walled metal tube through body tissue so as to place the opening at the tube'"'"'s distal end into the lumen of an artery.

5. The vascular access means of claim 4 wherein the flat-walled section has a known and controlled orientation relative to the plane of the opening at the metal tube'"'"'s distal end so as to allow the physician to place the perpendicular to the plane of the tube'"'"'s distal opening in generally the same direction as the longitudinal axis of the lumen of the blood vessel that is being accessed.

6. The vascular access device of claim 3 wherein the diameter of the smaller diameter lumen of the transparent viewing section is approximately the same diameter as the lumen of the metal tube.

7. The vascular access device of claim 3 wherein the transparent viewing section has a thick wall and has at least one outer surface which is convex in shape;

the combination of the thick wall and the convex shape resulting in optical magnification of the small diameter lumen so that a reciprocating pulsating column of arterial blood within the small diameter lumen is more readily observable.

8. The vascular access device of claim 3 wherein the thin-walled metal tube has a sharpened tip at its distal end.

9. The vascular access device of claim 3 wherein the thin-walled metal tube is cut off square at its distal end.

10. The vascular access device of claim 9 further comprising a stylet having a sharpened distal end which is adapted to pass through the elastomer valve, the viewing cylinder and the thin-walled metal tube with the sharpened distal end protruding beyond the distal end of the metal tube.

11. A vascular access device insertable into a blood vessel for allowing observation of a pulsating column of blood therein and providing insertion therethrough of a medical instrument into said blood vessel, comprising:

(a) a thin-walled metal tube having a lumen passing therethrough from a distal end to a proximal end thereof;

(b) a transparent viewing member having first and second sections in fluid communication with each other, said first section of said transparent viewing member having distal and proximal ends and being secured to said thin-walled metal tube and having a first section lumen extending therethrough in fluid communication with said lumen of said thin-walled metal tube, said second section of said transparent viewing member defining a pressure responsive chamber, said pressure responsive chamber forming a non-venting enclosure for containing pressurized air whereby said air pressure varies between systolic and diastolic pressures of said pulsating column of blood; and

,

(c) an elastomer valve that allows insertion of said medical instrument into said pressure responsive chamber, said pressure responsive chamber having a proximal end section and a distal end section, said elastomer valve being secured to said proximal end section of said pressure responsive chamber in fluid tight relation therewith for preventing egress of said pressurized air contained within said pressure responsive chamber prior to insertion therethrough of said medical instrument.

12. The vascular access device as recited in claim 11 wherein said pressure responsive chamber has a cross-sectional area greater than a cross-sectional area of said first section lumen, said pulsating column of blood being observable in said first section lumen.

13. The vascular access device of claim 11 wherein the diameter of said first section lumen is approximately the same diameter as said lumen of said metal tube.

14. The vascular access device of claim 11 wherein the respective volumes of said lumen of said metal tube, said first section lumen and said pressure responsive chamber are each adapted relative to each other such that said column of blood appears near the distal end of said first section lumen at typical diastolic blood pressures of a human being and near the proximal end of said first section lumen at typical systolic blood pressures of a human being.

15. The vascular access device of claim 11 wherein said elastomer valve is an elastomer septum.

16. The vascular access device as recited in claim 11 wherein said elastomer valve is a poppet type valve member.

17. The vascular access device as recited in claim 11 including an end cap member releasably secured to said transparent viewing member'"'"'s second section, which end cap includes said elastomer valve.

18. The vascular access device as recited in claim 17 wherein said end cap member includes an end cap central lumen formed therethrough for passage of said medical instrument.

19. The vascular access device as recited in claim 11 wherein said medical instrument is a guide wire.

20. The vascular access device as recited in claim 11 wherein said medical instrument is a stylet having a sharpened point at its distal end.

21. A collection of devices for accessing both the femoral artery and the femoral vein in order to place sheaths or guide wires into each of these blood vessels, the collection of devices being in the form of a single package or kit consisting of;

(1) a vascular access device having distal and proximal ends, an opening at its distal end and a fixed volume interior chamber in the form of a transparent viewing section which has a central lumen and being capable of determining that the opening at its distal end has been properly situated within the lumen of an artery by observation of a reciprocating pulsatile column of arterial blood within the central lumen of the transparent viewing section of the vascular device;

(2) an end cap that is capable of being removeably connected to the proximal end of the vascular device the end cap forming a pressure tight seal and an access means for a guide wire; and

,

(3) a guide wire or sheath for insertion into the lumen of the femoral vein or the femoral artery.

22. The collection of devices of claim 21 further consisting of a hypodermic syringe whose distal end is adapted to be removeably connected to the proximal end of the vascular access device when the end cap is removed.

23. The collection of devices of claim 21 further consisting of a scalpel.

24. The collection of devices of claim 21 further consisting of one or two introducer sheaths that are adapted to be advanced over the inserted guide wires.