Closed system catheter with guide wire

• US 4,655,750 A
• Filed: 11/22/1985
• Issued: 04/07/1987
• Est. Priority Date: 11/22/1985
• Status: Expired due to Fees

• Current Assignee: Manresa, Inc.
• Original Assignee: Manresa, Inc.
• Inventors: Vaillancourt, Vincent L.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/800,817
• Time in Patent Office: 501 Days
• Field of Search: 604/52-53, 604/164-165, 604/168-169, 604/171, 604/173, 604/177
• US Class Current: 604/165.01
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices

Abstract

A catheter system is provided for the introduction and placement of a flexible catheter into the lumen of an artery or vein. A guide wire is provided and is kept in a sterile condition within a flexible bag-like enclosure attached to the hub of a needle. The needle is hollow and is sharpened in the usual manner and is secured in a hub to provide a needle assembly. This hub is provided with a skirt and extends through this hub and into flow communication with a "flashback" chamber. In one embodiment, the needle is connected to a tubular member having a transverse hole near its interior end, and in another embodiment the needle'"'"'s inner end is in flow communication with a channel or annular groove in a centering plug. In every embodiment, there is a centering plug which provides a guideway for the guide wire which is positioned in this guideway to prevent fluid flow. The guide wire is manipulated forwardly by grasping the wire through the bag-like enclosure and advanced forwardly by "feel" and into the lumen after penetration has been made as indicated by the "flashback." The catheter is separated from the needle hub and advanced along the guide wire until placement is achieved, after which the needle, guide wire and bag are withdrawn from the patient and discarded.

Claims

1. A closed catheter system for the introduction and placement of a flexible catheter in the lumen of a blood vessel and using the advancement of a wire into said lumen to guide the flexible catheter as said catheter is advanced and positioned in said lumen, said closed catheter system including:

(a) a hollow needle of a determined length and having a sharpened entering end and an exit end;

(b) a hub axially secured and mounted to said needle and positioned at a selected distance from the sharpened end of said needle, this hub having a skirt portion providing an interior cavity which is open to the rear thereof, this hub having a contoured forward end;

(c) a flexible catheter formed with a through bore and slideable on and along the outer diameter of the needle, said catheter having an entering end sized to be easily inserted with the needle into the lumen of the vessel and with the other end of said flexible catheter attached to a hub adapted to be removably mounted on the contoured forward end of the needle hub;

(d) a centering plug within the needle hub with means for retaining said centering plug within the interior cavity of the needle hub, this centering plug having a through guideway positioned and terminating so the exit end of said guideway is substantially in alignment with the bore of the needle;

(e) a wire positioned and sized so as to be slide fit in the bore of the needle, said wire disposed to be advanced by manipulation to and through said guideway and bore of the needle, and as the wire is advanced and exits the sharpened entering end of the needle, this wire is caused to follow the lumen path of the blood vessel, and

(f) a lay-flat tube enclosure providing an envelope having a distal end sealed to at least partially encapsulate and restrain this distal end of the wire, this enclosure attached at its other end to the guide assembly and providing therewith a sealed enclosure of the wire.

2. A closed catheter system as in claim 1 in which there is provided a flashback indicating means disposed at or near the exit end of the needle and in flow communication with said needle so as to indicate an initial penetration of a wall of said blood vessel.

3. A closed catheter system as in claim 2 in which the needle extends into the interior cavity of the needle hub and the forward end of the centering plug is formed with a recess which is larger than the needle diameter and provides a flow path from the exit end of the needle and into the skirt portion of the needle hub.

4. A closed catheter system as in claim 3 in which the centering plug is also formed with a tapered recess whose small portion terminates at a guideway sized to slideably guide the wire and with this guideway terminating at the recess in the forward end of said centering plug.

5. A closed catheter system as in claim 4 in which the centering plug is formed with a shroud, with a receiving tubular groove into which the forward end of the envelope may be and is secured.

6. A closed catheter system as in claim 4 in which the centering plug is formed with a vent from the enclosure envelope to the interior cavity formed in the needle hub.

7. A closed catheter system as in claim 6 in which the centering plug is also formed with an outwardly-extending flange portion providing a shoulder stop for the front end of the envelope.

8. A closed catheter system as in claim 3 in which the recess in the forward end of the centering plug is provided with a transverse groove providing a fluid flow path from the recess to the outer surface of the centering plug.

9. A closed catheter system as in claim 8 in which said recess is substantially cylindrical.

10. A closed catheter system as in claim 3 in which the centering plug is molded of porous plastic that is hydrophilic to exclude the passage of blood produced as a result of the puncturing of the vessel.

11. A closed catheter system as in claim 10 in which the recess in the forward end of the centering plug is provided with a transverse groove providing a fluid flow path from the recess to the outer surface of the centering plug.

12. A closed catheter system as in claim 2 in which the needle extends into the interior cavity and there is provided a tubular member or sleeve slideably retained on this extending needle portion, with this sleeve having its exit end portion secured in a passageway formed in the centering plug, and in this sleeve is provided an aperture formed in the side wall of the sleeve and providing therewith a fluid pathway from the needle into said interior cavity of the needle hub.

13. A closed catheter system as in claim 12 in which the sleeve is of right material, with this sleeve secured to the needle as by cement, and the centering plug is formed with a tapered guideway extending from the rear end of the centering plug so as to terminate said adjacent sleeve.

14. A closed catheter system as in claim 12 in which the sleeve is of rigid material and with this sleeve secured to the exit end of the needle by at least one crimp.

15. A closed catheter system as in claim 2 in which the wire is secured to the distal end of the tube enclosure as by forming the distal end of the wire into a curl and securing this curled end with a sealing of this distal end of the enclosure.

16. A closed catheter system as in claim 2 in which the wire is secured to the distal end of the tube enclosure by securing an end sleeve to the wire end and securing this end sleeve and wire by an interior seal proximate to said end sleeve and interior thereof and sealing the distal end of the tube enclosure to maintain the exclusion property of the interior of the enclosure.

17. A closed catheter system as in claim 15 in which the interior seal of the tube enclosure is V-shaped, with the apex of the "V" substantially at the retaining location of the wire.

18. A closed catheter system as in claim 16 in which the sealing of the distal end of the enclosure is by a heat seal of the lay-flat tube enclosure.

19. A closed catheter system as in claim 2 in which at least the skirt portion of the needle hub is of molded plastic and is at least translucent.

20. A method for constructing a closed catheter system adapted for placing a flexible catheter into the lumen of vessel and using the advancement of a guide wire into said lumen to guide the flexible catheter as it is advanced and positioned in said lumen, said construction method including the steps of:

(a) supplying a hollow needle of a determined length and having a sharpened entering and an exit end;

(b) securing axially a needle hub to said needle and positioning said hub at a selected distance from the sharpened end, and forming said hub with a forward contoured end and having a skirt portion providing an interior cavity which is open to the rear thereof;

(c) providing a flashback indicating means at or near the exit end of the needle and in flow communication with said needle so as to indicate an initial penetration of a wall of said blood vessel;

(d) forming a flexible catheter with a through bore and slideable on and along the outer diameter of the needle, said catheter having an entering end sized to be easily inserted with the sharpened end of the needle into the lumen of the vessel, and fixedly securing the other end of the flexible catheter in a hub member which is formed so as to be mounted on the contoured forward end of the needle hub;

(e) providing, forming and positioning a centering plug so that its forward end is retained within the skirt portion of the needle hub and forming in said centering plug a through guideway and positioning and terminating said guideway so that said guideway is substantially in alignment with the bore of the needle and proximate to the exit end of said needle;

(f) providing a guide wire of a selected length and having a blunted entering end sized to be a slide fit in the bore of the needle and advancing this wire by manipulation to and through the bore of the needle, and as this wire is advanced it exits the sharpened end of the needle and, with further advancement, the practitioner causes the advancing wire to follow the lumen path of the blood vessel, and

(g) providing and securing to the open rear end of the needle hub a flexible enclosure from lay-flat tubing, this tubing of a determined length and at least partially encapsulating the guide wire and restraining the distal end of said guide wire at or near the unsecured end of the tubing and sealing this unsecured end of the tubing.

21. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 20 which further includes extending the needle into the interior cavity of the needle hub and forming in the forward end of the centering plug a forced recess which with the centering plug in mounted condition is slightly distant from the exit end of the needle and with this formed recess larger than the needle diameter, therewith providing a flow path from the exit end of the needle and into the skirt portion of the needle hub.

22. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 21 which further includes forming the centering plug with a tapered recess and configuring said recess so that the small portion terminates at a guideway sized to slideably guide the wire and with this guideway terminating at the recess in the forward end of said centering plug.

23. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 20 which further includes forming the centering plug with a vent from the lay-flat enclosure envelope to the interior cavity formed in the needle hub.

24. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 23 which further includes forming the centering plug with an outwardly-extending flange portion providing a shoulder stop for the front end of the envelope.

25. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 21 which further includes forming in the recess in the forward end of the centering plug a transverse groove providing a fluid flow path from the recess to the outer surface of the centering plug.

26. A method for constructing a closed catheter system adapted for placing a flexible catheter as in claim 21 which further includes molding the centering plug of porous plastic that is hydrophilic to exclude the passage of blood produced as a result of the puncturing of the vessel.

27. A closed catheter system and device for the introduction and placement of a flexible catheter in the lumen of a blood vessel and using the advancement of an enclosed wire into said lumen to guide the flexible catheter as said catheter is advanced and positioned in said lumen, this device retaining the "feel" properties of an Intravenous Catheter without attached guide wire during initial penetration, said closed catheter system including

(a) a conventional Intravenous Catheter (I.V.) characterized as having:

(a-1) a hollow needle of a determined length and having a sharpened entering end and an exit end;

(a-2) a hub axially secured and mounted to said needle and positioned at a selected distance from the sharpened end of said needle, this hub having a skirt portion providing an interior cavity which is open to the rear thereof, this hub having a contoured forward end;

(a-3) a flexible catheter formed with a through bore and slideable on and along the outer diameter of the needle, said catheter having an entering end sized to be easily inserted with the needle into the lumen of the vessel and with the other end of said flexible catheter attached to a hub adapted to be removably mounted on the contoured forward end of the needle hub;

(b) a centering plug contiguous to the needle hub with means for retaining said centering plug within the interior cavity of the needle hub, this centering plug having a through guideway positioned and terminating so the exit end of said guideway is substantially in alignment with the bore of the needle;

(c) a flexible wire positioned and sized so as to be a slide fit in the guideway of the centering plug and bore of the needle of the conventional Intravenous Catheter, said wire disposed to be advanced by manipulation to and through said guideway in the centering plug and the bore of the needle and, as the wire is advanced, a blunt (non-sharp) entering end exits the sharpened end of the needle, this advancing wire caused to follow the path of the lumen of the blood vessel, and

(d) a flexible enclosure from lay-flat tubing and having one end attached to the open rear end of the needle hub, this tubing at least partially encapsulating the guide wire, to achieve a closed system, said flexible enclosure and enclosed wire maintaining a balanced catheter when center of gravity is within the confines of the conventional Intravenous Catheter to be able to "feel" the wire as it is advanced.