Passively activated safety shield for a catheter insertion needle

• US 6,972,002 B2
• Filed: 06/03/2003
• Issued: 12/06/2005
• Est. Priority Date: 04/28/2000
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): DeSanto, Matthew F.
• Application Number:
  US10/453,357
• Publication Number:
  US 20030199827A1
• Time in Patent Office: 917 Days
• Field of Search: 604/162, 604/263, 604/264, 604/164.07, 604/125, 604/193, 604/195, 604/197, 604/198, 604/170, 604/181, 604/187, 604/264.02, 604/110, 604/192, 604/164.01, 604/165.02
• US Class Current: 604/164.08
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

A passively activated shielding device for a catheter insertion needle. Disclosure of shielding devices according to the instant invention is provided in four embodiments. Unreleasible locking apparatus is the major differentiator in three of the devices. An accordionated or folded needle shield which markedly reduces preshielded length of one of the embodiments is the major differentiator in a fourth embodiment. Each embodiment employs a mechanical sensor which detects presence of the catheter insertion needle and its tip insertion needle within protective cover of a needle shield and passively responds to provide separation of the needle shield from an associated catheter assembly.

Claims

1. A passively activated safety system used for catheter insertion said system comprising:

a catheter assembly comprising a catheter and a hub proximally affixed thereto, said hub comprising an attachable fitting, an appurtenance for displacing the catheter relative to the needle and stabilizing the catheter assembly during withdrawal of a catheter insertion needle and a catch whereby the catheter assembly is securely, but releasibly, affixed to a needle shield;

the catheter insertion needle, slidably disposed within the catheter and used to facilitate inserting the catheter into a patient, but removed thereafter, leaving the inserted catheter in place, said needle comprising a distal end having a sharpened tip and a proximal end for connecting to a needle hub;

a handle for gripping the device, said handle comprising exterior gripping surfaces, an interiorly disposed slide track and the needle hub medially disposed within and aligned with the slide track;

the needle shield slidably engaged on a proximal end to said handle in line with the insertion needle, said shield comprising a hollow interior and a length adequate to contain said insertion needle;

said needle shield further comprising a latching part having a latch which firmly joins the shield to the catheter assembly via the catch, a mechanical sensor and actuator which detects full displacement of the catheter insertion needle into protective cover of the needle shield and which passively releases the latch from the catch and therefore the catheter assembly from the catheter insertion needle, the handle and the needle shield when such full displacement occurs;

a lock disposed with said needle shield which assures the shield is retained in protective engagement about said needle and needle tip upon release of the catheter assembly from the catheter insertion needle, the handle and the needle shield, wherein said lock comprises a spring clip formed with a proximally disposed plate and a spring arm extending distally from said plate, wherein said spring arm is held in tension through contact against said needle when said needle is disposed through said latching part, and said spring arm is freed when said handle is fully retracted relative to said needle shield thereby lifting said plate in line with said needle tip to unreleasibly lock said needle inside said needle shield; and

a shroud extending from an outside surface of said needle shield to prevent inadvertent engagement with said latch to prevent accidental displacement of said lock.

2. A passively activated safety system according to claim 1 wherein said handle comprises at least one stem by which said needle hub is medically displaced from said track.

3. A passively activated safety system according to claim 2 wherein said at least one stem comprises a proximal stem and a distal stem separated by a predetermined distance.

4. A passively activated safety system according to claim 3 wherein said track comprises a slit disposed lengthwise along said track.

5. A passively activated safety system according to claim 4 wherein said track comprises a pair of arms which meet at a proximally disposed separable juncture.

6. A passively activated safety system according to claim 5 where said lock is formed by said arms at said juncture and the proximal stem.

7. The system according to claim 1 wherein said plate includes a clearance hole substantially centered in said plate wherein said needle is disposed through said hole when said needle is in a distally disposed position and wherein said spring arm biases said hole away from said needle path when said needle is retracted out of said clearance hole thereby blocking subsequent distal displacement of said needle.

8. The system according to claim 7 wherein said spring clip further comprises a latching part engaging said catch when said needle is extended through said through hole and releasing said catch when said needle is withdrawn from said through hole.

9. A passively activated safety system according to claim 1 wherein said needle shield comprises a rigid cylindrical part.

10. A passively activated shielding apparatus for protective safety of a catheter insertion-needle, said apparatus comprising:

an elongated housing comprising externally accessible sidewalls which are configured for use as handles, the housing further comprising an inwardly disposed surface and a medially disposed catheter insertion-needle hub raised from said surface upon a stem, said surface defining a slide track for guiding an elongated, hollow needle guard therein;

the catheter insertion-needle affixed on one end to the needle hub and projecting distally to a sharpened tip in alignment with the slide track;

the elongated, hollow needle guard disposed about at least a portion of the catheter insertion-needle and engaged inside said surface along said track to slide from a first position where the needle guard is displace away from said sharpened needle tip such that the catheter insertion-needle is bared for insertion into a patient to a second position where said needle tip is covered and protected by the needle guard, said needle guard comprising a releasable latching assembly for a catheter hub and a slot wherethrough a latching part is disposed to communicate with the catheter insertion-needle when the catheter insertion-needle is unprotected by the needle guard;

a catheter assembly comprising an elongated catheter, sized to be disposed about said catheter insertion-needle for insertion, and a luer type hub whereby said catheter is aligned with and securely, but releasibly, affixed to said latching assembly, said hub comprising a raised proximal portion, having an edge which acts as a catch, and a tab for displacing the catheter assembly relative to the elongated housing;

the latching part, disposed to fit through the slot to thereby provide an external segment, which communicates with the proximal edge portion of the luer type hub to form the latching assembly, and an internal segment which is disposed to communicate with the catheter insertion-needle, the external segment comprising a latch for said catch and the internal segment comprising a hole through which the catheter insertion-needle passes and by which the catheter insertion-needle maintains sufficient stress upon the latching part to cause the latch and catch to remain securely affixed until the catheter insertion-needle is displaced sufficiently far within the needle guard for safety to the second position whereat the catheter insertion-needle and sharpened needle tip clear the hole relieving the stress on the latching part which responsively releases the latch from the catch permitting the housing, guard, catheter insertion-needle and latching part to be passively displaced away from the catheter assembly by the act of simply pulling the catheter insertion-needle out of the catheter assembly;

a lock disposed with said needle guard which unreleasibly secures the catheter insertion-needle inside the needle guard for safety, wherein said lock comprises a spring clip formed with a proximally disposed plate and a spring arm extending distally from said plate, wherein said spring arm is held in tension through contact against said needle when said needle is disposed through said latching part, and said spring arm is freed when said housing is fully retracted relative to said needle guard thereby lifting said plate in line with said needle tip to unreleasibly lock said needle inside said needle guard; and

a shroud extending from an outside surface of said needle guard to prevent inadvertent engagement with said latch to prevent accidental displacement of said lock.

11. The apparatus according to claim 10 wherein said plate includes a clearance hole substantially centered in said plate wherein said needle is disposed through said hole when said needle is in a distally disposed position and wherein said spring arm biases said hole away from said needle path when said needle is retracted out of said clearance hole thereby blocking subsequent distal displacement of said needle.

12. The apparatus according to claim 11 wherein said spring clip further comprises a latching part engaging said catch when said needle is extended through said through hole and releasing said catch when said needle is withdrawn from said through hole.

13. The apparatus according to claim 12 wherein said needle guard further comprises a shroud protruding from an outside service of said needle shield said shroud covering external parts of said spring clip to prevent accidental displacement of said spring clip and inadvertent alignment of said through hole with said needle tip after said spring arm is released.

14. A method for passively activating a safety shield while withdrawing a catheter insertion-needle from a hypodermically inserted catheter comprising the steps of:

providing;

an elongated housing comprising externally accessible finger grips, the housing further comprising a medially disposed catheter insertion-needle hub and a slide track for guiding an elongated, hollow needle guard therein;

the catheter insertion-needle affixed on one end to the needle hub and projecting distally to a sharpened tip in alignment with the slide track;

the elongated, hollow needle guard engaged to slide linearly along said track from a first position to a second position, said needle guard comprising a releasable fitting for a catheter hub and a slot wherethrough a latching part is disposed for communicating with the catheter insertion-needle;

a catheter assembly comprising an elongated catheter, sized to be disposed about said catheter insertion-needle for insertion, and a luer type hub whereby said catheter is aligned with and securely, but releasibly, affixed to said fitting, said luer type hub comprising a raised edge which acts as a catch, and a digitally accessible member;

the latching part, disposed to fit through the slot to thereby provide an external segment, which communicates with the raised edge, and an internal segment which is disposed to communicate with the catheter insertion-needle, the external segment comprising a latch for said catch and the internal segment comprising a hole through which the catheter insertion-needle passes and by which the catheter insertion-needle maintains sufficient stress upon the latching part to cause the latch and catch to remain securely affixed;

a lock disposed with said needle guard which unreleasibly secures the catheter insertion-needle inside the needle guard for safety, wherein said lock comprises a spring clip formed with a proximally disposed plate and a spring arm extending distally from said plate, wherein said spring arm is held in tension through contact against said needle when said needle is disposed through said latching part, and said spring arm is freed when said handle is fully retracted relative to said needle shield thereby lifting said plate in line with said needle tip to unreleasibly lock said needle inside said needle shield; and

a shroud extending from an outside surface of said needle guard to prevent inadvertent engagement with said latch to prevent accidental displacement of said lock;

inserting said catheter insertion-needle and catheter into a patient;

assuring the catheter is properly positioned at a predetermined site;

while applying restraining force to assure the catheter stays at the predetermined site, applying proximally directed force at the finger grips thereby displacing the catheter insertion-needle, proximally relative to the stationary catheter, into the needle guard until the catheter insertion-needle is disposed, sufficiently far within the needle guard to protect the needle tip, at the second position and to clear the hole relieving the stress on the latching part which responsively releases the latch from the catch permitting the luer type hub to be separated from the fitting allowing the housing, guard, catheter insertion-needle and latching part to be passively displaced away from the catheter assembly by the act of simply pulling the catheter insertion-needle out of the catheter assembly; and

concurrently, within the applying step, unreleasibly locking the needle guard relative to the housing to assure needle safety.