In-line retractable safety catheter needle insertion assembly

• US 6,050,976 A
• Filed: 12/23/1998
• Issued: 04/18/2000
• Est. Priority Date: 12/23/1998
• Status: Expired due to Fees

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, Kendall P., Barrus, Roy L., Thorne, David L., Thorne, Gale H.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US09/220,104
• Time in Patent Office: 482 Days
• Field of Search: 604/164, 604/167, 604/168, 604/195, 604/198, 604/171, 604/523
• US Class Current: 604/164.01
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands

Abstract

Disclosure of methods and apparatus providing bases for design of compact catheter insertion needle retraction safety devices wherein actuators are displaced away from slender needle sheathing bodies to initiate a needle retraction cycle for safely containing a catheter insertion needle after use. Such actuation guards against inadvertent acts, such as depression of an actuator, which may result in untimely needle retraction. Four embodiments of the instant invention are disclosed. In one embodiment, needle retracting energy is stored as a catheter insertion needle is extended for use and is expended to retract the needle into safe containment. Other embodiments comprise power assist mechanisms which store energy during an initial phase of needle retraction to be used to enhance and assist needle retraction during a needle retraction completing phase. In some embodiments, retraction is facilitated by a pair of rigid, elongated, hingedly interconnected arms which are further pivotally coupled to a needle hub assembly and to a device body such that one arm is rotated approximately 180° to retract the needle a distance greater than the length of the so rotated arm to facilitate retraction actuation. One power assist mechanism comprises a part molded as a distortable member of one of the arms. To realize low cost manufacture, the operating device can be made from as few as two injection molded parts. A readily viewable, blood flash chamber permits early detection of evidence of needle entry into a blood vessel.

Claims

1. A safety catheter insertion needle retracting device comprising:

a needle hub assembly comprising a needle hub and a catheter insertion needle securely affixed at a proximal end thereof to a distal portion of the needle hub, said catheter insertion needle having a sharpened tip on its distal end and an elongated cannula disposed along a longitudinal axis of said hub assembly between the sharpened tip and the proximal end, said hub portion comprising a through hole in line with said cannula for providing a communicating fluid pathway there through;

a catheter releasibly affixed about said catheter insertion needle;

an elongated body assembly in which said needle hub assembly is slidably affixed, said elongated body assembly comprising a distal part, which is proximally disposed relative to said sharpened tip during the catheter insertion procedure and which surrounds and encloses said sharpened tip when the needle is retracted, and a proximal part which comprises a guide path through which a proximal portion of said needle hub is confined to glide proximally as said needle is retracted; and

said body assembly further comprising a pair of substantially rigid elongated parts each of which is hingeably affixed to the other, one end of one of the pair of parts being hingeably affixed to said elongated body part and the other being hingeably affixed to the needle hub such that the parts pivot in line with said longitudinal axis, with one of said parts rotating approximately 180°

to urge retraction of said needle hub and catheter insertion needle from an extended state to a retracted state whereat said needle tip is enclosed within the distal part.

2. The safety catheter insertion needle retracting device according to claim 1 further comprising a releasibly affixed needle cover which is removed to bare the needle for use in the catheter insertion procedure.

3. The safety catheter insertion needle retracting device according to claim 1 wherein one of said rigid elongated parts further comprises a distortable part which is stressed to store energy during a first portion of a needle retraction and which responsively releases the stored energy during a subsequent portion of needle retraction to assist completion of needle retraction.

4. A safety catheter insertion needle retraction device for use in percutaneous catheter insertion procedures, said device comprising:

a needle enclosure housing assembly comprising;

a slender, elongated base part comprising an extended longitudinal axis and a planar slide channel for a needle hub assembly, said slide channel being disposed in-line with the longitudinal axis;

a first substantially rigid, elongated pivoting part;

a second substantially rigid, elongated pivoting part;

a first hinge connection adjoining one end of said first pivoting part to said second pivoting part such that articulation of the first and second parts is in line with the longitudinal axis of the elongated base part;

a second hinge connection adjoining said base part to said first pivoting part at an end opposite the one end such that articulation of the first part is in line with the longitudinal axis of the base part;

a needle hub assembly slidably disposed within said slide channel and comprising;

a catheter insertion needle comprising an elongated, hollow bore cannula defining a long axis of said needle hub assembly, said cannula having a sharpened tip disposed at a distal end and a proximally disposed end;

a needle hub comprising a through borehole disposed in alignment with said long axis and securely affixed at a distal end to the proximally disposed e nd of said cannula and a distally disposed hub whereat a fluid flow apparatus is affixed for use in catheter insertion procedures; and

a third hinge connection disposed to hingeably affix said second pivoting part to said hub such that articulation of said second part is in line with the longitudinal axis of the base part;

said pivoting parts and assemblies cooperating to fold into a first stable state such that the device has the characteristics of a compact, slender, low silhouette, catheter insertion implement when said catheter insertion needle is disposed for use in a catheter insertion procedure, further cooperating to retract said needle hub assembly as said pivoting parts are rotated away from said elongated base part and, upon rotating one of the pivoting parts substantially 180°

to fold said pivoting parts and assemblies cooperatively to a second stable state, thereby slidably retracting said hub along said slide channel to fully enclose said sharpened t tip within a distal portion of said needle enclosure housing assembly.

5. The safety catheter insertion needle retraction device according to claim 4 wherein said hub comprises a latch and said needle enclosure housing assembly comprises a catch disposed to securely affix said hub when fully retracted to permanently enclose said needle tip.

6. The safety catheter insertion needle retraction device according to claim 4 wherein said first and second hinges are living hinges formed as part of a single injection molded part comprising said pivoting parts and said needle enclosure housing assembly.

7. The safety catheter insertion needle retraction device according to claim 4 further comprising a needle cover which is disposed to shield said needle tip during shipment and storage and removed for access to said needle during a catheter insertion procedure.

8. The safety catheter insertion needle retraction device according to claim 4 wherein said elongated base part and needle hub assembly cooperatively each comprise a blood flash visualization section disposed proximally from said proximally disposed end of said cannula.

9. The safety catheter insertion needle retraction device according to claim 4 wherein said elongated base part comprises a pair of laterally juxtaposed handles.

10. The safety catheter insertion needle retraction device according to claim 4 wherein said slide channel comprises a "U" shaped channel formed from planar base, adjoining vertical side walls having inwardly biased lips at the top thereof.

11. The safety catheter insertion needle retraction device according to claim 4 wherein the cooperating pivoting parts and assemblies comprise means for rotating said second pivoting arm 180°

to fully retract and enclose said needle tip.

12. The safety catheter insertion needle retraction device according to claim 4 wherein the cooperating pivoting parts and assemblies comprises means for rotating said first pivoting arm arm 180°

to fully retract and enclose said needle tip.

13. The safety catheter insertion needle retraction device according to claim 4 wherein said second pivoting arm comprises an actuator tab disposed on a proximal end thereof.

14. The safety catheter insertion needle retraction device according to claim 4 wherein said second pivoting arm comprises an actuator tab disposed on a distal end thereof.

15. The safety catheter insertion needle retraction device according to claim 4 wherein said second pivoting arm comprises an elastic member which stores energy as the second pivoting arm is outwardly displaced to initiate needle retraction and releases energy to urge the needle and needle tip into fully shielded enclosure as the second pivoting arm is inwardly displaced.

16. The safety catheter insertion needle retraction device according to claim 4 wherein said needle enclosure housing assembly comprises an elastic band disposed between said elongated base part and the first pivoting arm which stores energy as the first pivoting arm is outwardly displaced to initiate needle retraction and releases energy to urge the needle and needle tip into fully shielded enclosure as the first pivoting arm is inwardly displaced.

17. The safety catheter insertion needle retraction device according to claim 4 wherein said third hinge comprises means for snapping the corresponding hinged parts together.

18. A safety catheter insertion needle retracting device comprising:

an elongated body assembly comprising a slide containment channel for a needle hub and a distal enclosure for safely enclosing an associated retracted catheter insertion needle;

the needle hub and associated catheter insertion needle being slidably disposed in said containment channel, said needle hub being securely affixed to the catheter insertion needle, said needle comprising a distally disposed sharpened tip for percutaneous entry and a long axis direction in line with said hub and said sharpened tip; and

said body further comprising a needle retraction actuator which is a part of a communicating link between said hub and said body, said actuator being angularly displaced away from the rest of said device with a linear displacement along said long axis to urge said catheter insertion needle and said sharpened tip to travel a sufficient distance to fully retract said sharpened tip into said enclosure, the displacement of said actuator being a shorter distance than the travel distance of the sharpened tip.

19. A method for retracting a catheter insertion needle into safe confinement comprising the steps of:

providing a safety catheter insertion needle retracting device comprising;

a needle hub assembly comprising a needle hub and a catheter insertion needle securely affixed at a proximal end thereof to a distal portion of the needle hub, said catheter insertion needle having a sharpened tip on a distal end and an elongated cannula disposed along a longitudinal axis of said hub assembly between the sharpened tip and the proximal end, said hub portion comprising a through hole in line with said cannula for providing a communicating fluid pathway there through;

an elongated body assembly in which said needle hub assembly is slidably affixed, said elongated body assembly comprising a distal part, which is proximally disposed relative to said sharpened tip during the catheter insertion procedure and which surrounds and encloses said sharpened tip when the needle is retracted, a proximal part, which comprises a guide path through which a proximal portion of said needle hub is confined to glide proximally as said needle is retracted, and a pair of substantially rigid elongated parts each of which is hingeably affixed to the other, one end of one of the pair of parts being hingeably affixed to said elongated body part and the other being hingeably affixed to the needle hub such that the parts pivot in line with said longitudinal axis, with one of said parts rotating approximately 180°

to urge retraction of said needle hub and catheter insertion needle from an extended state to a retracted state whereat said needle tip is enclosed within the distal part;

initiating needle retraction through a mechanical advantage derived from outwardly pivoting said pivotal parts; and

rotating one of said pivotal parts substantially 180°

to completely retract and enclose the needle.

20. The method according to claim 19 wherein the rotating step comprises rotating the one of said pivotal parts distally.

21. The method according to claim 19 wherein the rotating step comprises rotating the one of said pivotal parts proximally.