Closed system catheter with guide wire

• US 4,525,157 A
• Filed: 07/28/1983
• Issued: 06/25/1985
• Est. Priority Date: 07/28/1983
• Status: Expired due to Fees

• Current Assignee: Manresa, Inc.
• Original Assignee: Manresa, Inc.
• Inventors: Vaillancourt, Vincent L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/518,122
• Time in Patent Office: 698 Days
• Field of Search: 604/52, 604/53, 604/164-170, 604/171, 128/658, 128/772, 128/DIG. 9, 128/DIG. 16
• US Class Current: 604/510
• 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 cannula 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 the cannula extends through this hub and into flow communication with a "flashback" indicator. In one embodiment the cannula is formed with a transverse hole near its interior end and in the other embodiment the cannula'"'"'s inner end is in flow communication with a channel and then to a longitudinal 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 guidewire is manipulated forwardly 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needle hub and advanced along the guidewire until placement is achieved after which the needle, guidewire and bag are withdrawn from the patient and discarded.

Claims

1. A catheter system for the introduction and placement of a flexible catheter in and into the lumen of a blood vessel such as an artery or vein by a practitioner and using an advancement of a guide wire into said lumen to guide the catheter as it is positioned in said lumen, said catheter system including:

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

(d) a needle hub axially secured and mounted to said cannula and in an assembled condition providing a manipulable needle, said hub positioned at a selected distance from the sharpened end of the cannula, this hub having a skirt portion providing an interior cavity and open to the rear thereof, this hub having a contoured forward end;

(c) a flashback indicating means disposed at or near the exit end of said cannula, this flashback indicating means in flow communication with said cannula to indicate an initial penetration of said wall of the vessel by a flow of blood through this cannula;

(d) a flexible catheter that is formed with a through bore that is sized so as to be slideable on and along the outer diameter of the cannula, said catheter having an entering end tapered so as to be easily insertable with the introduction of the cannula into the lumen and with a rear end of said catheter attached to a hub, the catheter of a length so that in mounted condition on the cannula and with the hub of the catheter slideably and removably mounted on the contoured forward end of the cannula whereat the sharpened end of the cannula extends beyond the tapered entering end of the catheter, the hub of the needle being manipulated and advanced by a practitioner so that penetration of a wall of a vessel is achieved by the sharpened end of the cannula;

(e) a centering plug within the needle hub and means for retaining said centering plug within said cavity, this plug having a small through guideway axially positioned and terminating so as to be substantially contiguous with the exit end of the cannula and in alignment with the bore of the hollow cannula;

(f) a guide wire positioned and sized so as to be a slide fit in the guideway in the centering plug and in the bore of the cannula and disposed to be advanced by manipulation to and through said guideway and bore of the cannula and as said guide wire exits from the entering end of the cannula the advancing guide wire is bent as it enters and follows the lumen of the vessel;

(g) inhibiting means cooperatively positioned in and with the guideway and guide wire so as to prevent accidental and unwanted advancement of the guide wire into the guideway and bore of the cannula, and

(h) a tubular enclosure of a very thin wall and flexible and secured at one end to the needle hub and providing within said enclosure a sterile environment as and while attached to the needle hub and said guide wire is advanced, whereas and after the guide wire and catheter are advanced to the desired placement in the lumen of the vessel said needle hub and attached cannula, guide wire and tubular enclosure are separated as an array from the catheter and its hub and with said separated array now discarded.

2. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the hollow cannula is sharpened by and with a bevel slope and the flash back indicator includes, at least in part, a transverse aperture formed in the cannula near the exit end thereof and to the rear of the needle hub that is away from the contoured forward end of the hub and this aperture in the cannula is opened to a flash chamber formed by said skirt portion in the rear of the needle hub.

3. A catheter system for introducing and placing a flexible catheter as in claim 2 in which the guide wire is directed toward and to a tapered entrance to said guideway formed in and extending through said centering plug.

4. A catheter system for introducing and placing a flexible catheter as in claim 3 in which the centering plug is spaced from the end of the needle hub and closes off the skirt portion of said needle hub with a sufficient skirt portion uncovered to provide a chamber which is the flash back indicator.

5. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the guide wire has a button secured to and carried on the rear end of the guide wire and away from the cannula.

6. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the hub for the catheter is formed with a tapered socket which is compatible with and disposed to releaseably retain a like taper formed on the contoured forward end of the needle hub.

7. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the guide wire is provided with an indicia portion intermediate its ends, said indicia corresponding to a determined distance between the indicia portion and the hub of the needle, this distance corresponding to the distance needed for advancing the guide wire to the needle hub which is also the distance for advancing the guide wire to the sharpened end of the cannula.

8. A catheter system for introducing and placing a flexible catheter as in claim 1 in which said centering plug has a tapered guide merging into said through guideway for the guide wire, said centering plug having a forward end away from the tapered guide and in said forward end and in flow communication with the guideway there is formed a transverse slot which also communicates with a longitudinal vent slot formed in the outer surface of the centering plug, this vent slot open to the rear of the plug to provide a flow path for blood flowing through the cannula after penetration of the vessel.

9. A catheter system for introducing and placing a flexible catheter as in claim 8 in which the centering plug is sized so as to retain the tubular enclosure when and as a forward end of said tubular enclosure is positioned on the centering plug and said plug and said positioned tubular enclosure are sized so as to be a press fit into the rearwardly extending skirt of the needle hub, this press fit providing the desired securing means for said tubular enclosure.

10. A catheter system for introducing and placing a flexible catheter as in claim 9 in which the forward outer diameter of the centering plug is formed with a small taper to assist in the positioning and advancement of the plug, tubular enclosure and guide wire into the skirt of the needle hub.

11. A catheter system for introducing and placing a flexible catheter as in claim 8 in which the rear end of the centering plug is formed with a mold flash portion disposed to partially block the guide way and provide said means for preventing unwanted free movement of the guide wire in the centering plug and bore of the cannula.

12. A catheter system for introducing and placing a flexible catheter as in claim 8 in which the needle hub and the skirt forming the flash back indicator are made of plastic that is at least substantially translucent.

13. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the centering plug is formed with an annular surface and shoulder adapted to engage and retain the skirt portion of the needle hub to provide a seal when the skirt is mounted on the centering plug.

14. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the tubular enclosure is secured to the outer surface of the needle hub by means such as heat sealing, cement, shrink fit and the like sufficient to prevent unwanted contamination of the interior of the tubular enclosure during and when the guidewire is manipulated for advancement.

15. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the centering plug is formed with a contoured front to and into the guideway for the guide wire, said contoured front of the guideway adapted to mate with the exiting end of the cannula so as to be in alignment with said bore of the cannula.

16. A catheter system for introducing and placing a flexible catheter as in claim 1 in which the centering plug is formed with at least one groove or annular ring which is in flow communication to the rear end of the cannula and blood is directed to and in contact with the skirt of the needle hub.

17. A method for introducing and placing a flexible catheter into the lumen of a vessel such as an artery or vein by a practitioner using an advancement of a guide wire into said lumen and then over and along said guide wire advancing said catheter, said method including the steps of:

(a) supplying a hollow cannula of a determined length and sharpening an entering end of the cannula providing an exit end;

(b) securing axially a needle hub on and to said cannula and at a selected distance from said sharpened end, and forming this hub with an outward and forward contoured end and a skirt portion in which the annular cavity open to the rear is provided, this hub and cannula providing a manipulable needle assembly;

(c) providing a flashback indicating means so as to be in fluid communication with or near the exit end of the cannula, this flashback indicating means showing a penetration of the wall of the vessel by the sharpened end of the cannula;

(d) forming a flexible catheter with a through bore and sliding this catheter on the outer diameter of the cannula, and securing the rear end of the catheter to a hub formed so that its rearwardly facing end is releaseably retained on the contoured end of the needle hub, the flexible catheter when mounted on the shank of the cannula adapted to have the needle hub releaseably mounted to the catheter hub and when so positioned having the entering end of the catheter so as to be slightly to the rear of the sharpened end of the cannula;

(e) positioning a centering plug with the needle hub and retaining said centering plug in position so that a small through guideway is axially positioned so as to terminate at or substantially at the exit end of said cannula and in alignment with the bore of said hollow cannula;

(f) positioning a guide so as to be advanced to and through the guideway of the centering plug and into the bore of the cannula and as said guide wire is advanced bending the guide wire as it enters and follows the lumen of the vessel;

(g) positioning inhibiting means in the guideway of the centering plug so as to prevent unwanted and accidental movement of the guide wire, and

(h) enclosing the guide wire in a very thin and flexible tubular sheath and securing the end of the sheath to said needle hub to provide a sterile environment as and while the guide wire is advanced to a desired placement in the lumen of the vessel, and after said placement is made advancing the catheter forward over the cannula to follow the path of the guide wire until placement in the vessel is achieved followed by separation of the cannula, attached needle hub and removal of the needle hub and attached cannula, the guide wire and sheath and discarding of same.

18. A method for introducing and placing a flexible catheter into the lumen of a vessel as in claim 17 which further includes the step of securing the cannula in the needle hub so that a portion of the cannula extends rearwardly of said hub and in this extending portion of the cannula forming a transverse aperture in the wall of the cannula so as to be in flow communication with the flash back indication means.

19. A method for introducing and placing a flexible catheter as in claim 18 which further includes applying to the guide wire and intermediate its ends and at a precisely selected position an indicia band which establishes a determined distance from the sharpened end of the cannula to the rear of the secured needle hub, this distance corresponding to the distance required for advancing the guide wire so as to bring the entering end of the guide wire to the sharpened end of the cannula.

20. A method for introducing and placing a flexible catheter as in claim 17 in which the centering plug is formed with at least one radially disposed slot leading from the exiting end of the cannula to the skirt of the needle hub and providing therewith the flash back indicating means.

21. A method for introducing and placing a flexible catheter as in claim 17 which further includes forming in the centering plug a tapered guide with the larger end of the taper open to the tubular enclosure and merging this taper into the passageway in said centering plug, and forming a transverse slot in the forward portion of said centering plug and with said slot at its inner end in flow communication with the exiting end of the cannula and at the outer end in flow communication with a longitudinal groove providing a flow path for the blood flowing through the cannula after penetration of the wall of the vessel.

22. A method for introducing and placing a flexible catheter into the lumen of a vessel as in claim 21 which further includes forming the centering plug so as to retain the tubular enclosure when the plug and tubular enclosure are brought to and into a press fit in the rearwardly extending skirt portion of the needle hub and forming this centering plug with a small taper so as to assist the positioning and mounting of said centering plug in said skirt of the needle hub.

23. A method for introducing and placing a flexible catheter as in claim 17 which includes molding the centering plug so that the guideway includes a mold flash disposed to at least partially block said guideway and providing brake means which inhibits unwanted movement and advancement of the guide wire in the guideway and bore of the cannula.